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Economic Brief The Richmond Fed Manufacturing and Service Sector Surveys: A User’s Guide

By David A. Price and Aileen Watson

The Richmond Fed conducts monthly surveys of business conditions in the manufacturing and service sectors of the Fifth Federal Reserve District. This article provides background information on these surveys and on other manufacturing and service sector surveys.

The Research Department of the Federal Reserve Bank of Richmond collects and disseminates two sector-specific surveys of business conditions each month: the Fifth District Survey of Manufacturing Activity (commonly called “Richmond Fed Manufacturing”) and the Fifth District Survey of Service Sector Activity. To assist researchers, analysts, and others who employ these surveys in assessing and forecasting economic conditions, this article provides background information on these surveys and their relationship to similar surveys conducted by other institutions.

The Landscape of Monthly Sector Surveys For current data on manufacturing activity, there are numerous sources. Five of the 12 Federal Reserve Banks administer monthly manufacturing sector surveys, three of them district-wide and two of them state-specific. In addition to the Richmond Fed’s, the district-wide manufacturing surveys are the Philadelphia Fed Business Outlook Survey and the Kansas City Fed Manufacturing Survey; the state-specific manufacturing surveys are the New York Fed Empire State Manufacturing Survey and the Dallas Fed Texas Manufacturing Outlook Survey. (Historically, the Chicago Fed has published the Midwest Manufacturing Index, which is based on hours-worked data rather than surveys; it was suspended in late

EB14-03 - Federal Reserve Bank of Richmond

after the end of the month. (There is also an advance report covering only durable goods.)

The predictive value of the various manufacturing surveys has been assessed in a number of articles and papers, which generally found movements in the surveys well correlated with subsequently announced movements in gross domestic product (GDP) and employment.1

Even though services dwarf manufacturing in their overall contribution to GDP and employment, there is far less coverage of services than manufacturing. Among Reserve Banks, apart from the Richmond Fed service sector survey, there is only the New York Fed Business Leaders Survey—which covers service firms in New York State, northern New Jersey, and southwestern Connecticut—and the Dallas Fed Texas Service Sector Outlook Survey (which also breaks out retail as the Texas Retail Outlook Survey). The Census Bureau does not conduct a monthly services survey, but it does conduct a quarterly services survey covering some 5,000 businesses.

The disparity in coverage of services and manufacturing may seem puzzling at first glance since manufacturing represents a much smaller share of the econo

my; manufacturing value added was 12.5 percent of GDP in 2012, compared with 66.6 percent of GDP for service industries.2 The likely reason for the disparity is that the manufacturing sector is believed to be far more sensitive, overall, to changes in the economy, and thus is of greater interest as a leading indicator of broader trends. In addition, when Reserve Banks began administering surveys of manufacturing, it was more difficult to define and measure the service sector than it is today.

What the Richmond Fed Surveys Measure The Richmond Fed sector surveys measure various types of economic activity at a representative sample of establishments within the Fifth District, which includes Washington, D.C., Maryland, North Carolina, South Carolina, Virginia, and most of West Virginia. Each survey reports on both current activity (the respondents’ assessment of activity at their establishments during the current month compared with the previous month) and expected activity (the level of activity anticipated by the respondents at their establishments during the next six months compared with the current month).

The manufacturing survey began in June 1986 and took its current monthly form in November 1993. It

Figure 1: Richmond Fed Manufacturing Survey Composite Index

40 30 20 10 0 -10 -20 -30 -40

-50

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Note: Index values are a composite of seasonally adjusted survey results for current shipments (weighted 33 percent), new orders (40 percent), and employment (27 percent). Index values represent the percentage of responding establishments reporting an increase minus the percentage reporting a decrease. Shaded area represents the recession of 2007–09.

Source: Federal Reserve Bank of Richmond

Page 2

reports indexes of both current and expected activity for shipments of finished products, new order volumes, order backlog volumes, capacity utilization (usage of equipment), lead times of suppliers, numbers of employees, average work week, and wages. In addition, the survey reports current conditions with respect to inventories of finished goods and inputs, as well as expectations with respect to capital expenditures. For each of these items, respondents are asked whether there has been (or will be) a decrease, no change, or increase. Results are reported as diffusion indexes that are calculated by subtracting the percentage of responses indicating a decrease from the percentage indicating an increase. (See Figure 1 on the previous page.)

The survey also reports both current conditions and expectations regarding price trends, specifically the annualized percentage change in prices paid for inputs and in prices received for goods. Finally, the survey reports an overall manufacturing index, which is a seasonally adjusted composite of current shipments (weighted 33 percent), new orders (40 percent), and employment (27 percent). The survey collects, but does not yet report, information on spending in several categories: business services, equipment or software, and capital expenditures.

The services survey, which began in November 1993, was the first such survey by a Reserve Bank; it reports current activity for revenues, numbers of employees, average wages, and prices received, as well as expectations for product demand and pricing. (Figure 2 shows the revenues index.) In addition to reporting those measures for the service sector as a whole, the survey breaks them out for retailers and other service firms. For retail firms, the survey also reports current activity for inventories, “big-ticket” sales (items expected to last at least three years), and shopper traffic.

Seasonal adjustment factors based on the Census Bureau’s methodology are applied to the surveys’ dif-fusion indexes to arrive at seasonally adjusted index values. The seasonal adjustment factors are recalculated annually and historical survey results are revised accordingly. Survey results on price trends also are seasonally adjusted.

For the purpose of these surveys, the Richmond Fed defines manufacturing establishments as business establishments with a three-digit Census Bureau NAICS (North American Industry Classification System) code in the 300s, effectively including all manu-facturing. The surveys treat all other firms as service establishments.3

Figure 2: Richmond Fed Service Sector Revenues Index

40 30 20 10

0 -10 -20 -30

-40

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Note: Index values represent seasonally adjusted survey results of the percentage of responding establishments reporting an increase in revenues minus the percentage reporting a decrease in revenues. Shaded area represents the recession of 2007–09.

Source: Federal Reserve Bank of Richmond

Page 3

The Richmond Fed releases the results on its website at 10 a.m. on the fourth Tuesday of every month.4 When that day is a holiday, the Bank typically releases the results one day earlier.

The Richmond Fed also conducts two state-specific surveys of general business activity: the Carolinas Survey of Business Activity and the Maryland Survey of Business Activity.

Constructing the Panels

Various sector surveys take different approaches to the issue of industry representation. The Richmond Fed seeks to balance its survey panels on a continuing basis as establishments drop out of any given panel for one reason or another. The objective is to represent industries in proportion to their employment within the Fifth District while maintaining a mix of firm sizes. The Quarterly Census of Employment and Wages (QCEW) from the Bureau of Labor Statistics is used to estimate employment by NAICS codes.

Firms that match the criteria are selected from various publicly available sources. In addition, firms that have requested to participate through a link on the Bank’s website are considered on the basis of their fit with current needs.

Once a company has been identified, a Richmond Fed researcher contacts its chief financial officer or another senior-level employee to request participation in the survey. Initial telephone contact is followed by an e-mail confirmation that explains the survey process.

Because the Richmond Fed sector surveys are voluntary (as are all the sector surveys referenced in this article), it may be necessary to contact multiple companies to recruit a new company that matches the criteria. Panel members remain in the survey panel until they decide to discontinue, either explicitly or implicitly (that is, through a prolonged period of not responding).

Taking the Survey to the Field

The Richmond Fed sector surveys are conducted online. Two days after the release of the survey results for the previous month, members of the panels

receive an automatically generated e-mail containing a link to the next month’s survey on a secure website. Panel members are not compensated for completing the survey. Each survey is sent to several hundred establishments, of which approximately 100 return responses in a typical month. Response rates tend to be somewhat lower in December and January and during summer factory shut-downs than during the rest of the year.

The names of contacts and their companies are not shared outside the Federal Reserve System. When participants choose to supplement their responses with open-ended comments, as they are invited to do, those comments may be incorporated in summary form (without identifying information) into the Richmond Fed’s contribution to the Fed’s national Summary of Commentary on Current Economic Conditions by Federal Reserve District, better known as the Beige Book.

While some Reserve Banks include monthly special, non-standard questions in sector surveys to solicit supplemental information on a topic of current interest, Richmond Fed surveys include special questions only infrequently. This policy is intended to minimize the burden of responding and thereby to encourage a higher response rate.

Like other Reserve Banks, the Richmond Fed continues to assess potential means of improving its survey programs, including possible provision of new data series that may aid public- and private-sector organizations in forecasting and analysis.

David A. Price is a senior editor and Aileen Watson is a senior economic analyst in the Research Department of the Federal Reserve Bank of Richmond.

Endnotes

1 Examples include: Owens, Raymond E., and Pierre-Daniel G. Sarte, “How Well Do Diffusion Indexes Capture Business Cycles? A Spectral Analysis,” Federal Reserve Bank of Richmond Economic Quarterly, Fall 2005, vol. 91, no. 4, pp. 23–42; Deitz, Richard, and Charles Steindel, “The Predictive Abilities of the New York Fed’s Empire State Manufacturing Survey,” Federal Reserve Bank of New York Current Issues in Economics and Finance, January 2005, vol. 11, no. 1; Harris, Matthew, Raymond E. Owens, and Pierre-Daniel G. Sarte, “Using Manufacturing

Page 4

Surveys to Assess Economic Conditions,” Federal Reserve Bank of Richmond Economic Quarterly, Fall 2004, vol. 90, no. 4, pp. 65–92; Keeton, William R., and Michael Verba, “What Can Regional Manufacturing Surveys Tell Us?—Lessons from the Tenth District,” Federal Reserve Bank of Kansas City Economic Review, Third Quarter 2004, pp. 39–69; Lacey, Robert L., “Gauging Manufacturing Activity: The Federal Reserve Bank of Richmond’s Survey of Manufacturers,” Federal Reserve Bank of Richmond Economic Quarterly, Winter 1999, vol. 85, no. 1, pp. 79–98. An exception is Bachman, Daniel, “The Information Content of the ISM Purchasing Managers’ Survey,” U.S. Commerce Department, August 3, 2010, which found “modest” predictive value in the ISM manufacturing survey.

2 Bureau of Economic Analysis, “Value Added by Industry as a Percentage of Gross Domestic Product,” January 24, 2014.

3 Establishments with three-digit NAICS codes in the 900s—public administration—are, of course, not included in either survey.

4 The Bank posts survey results and historical data at www.richmondfed.org/research/regional_economy/surveys_ of_business_conditions.

This article may be photocopied or reprinted in its entirety. Please credit the authors, source, and the Federal Reserve Bank of Richmond, and include the italicized statement below.

Views expressed in this article are those of the authors and not necessarily those of the Federal Reserve Bank of Richmond or the Federal Reserve System.

FEDERAL RESERVE BANK OF RICHMOND

Richmond Baltimore Charlotte

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Manual Prosedur

Audit Internal Mutu Akademik

Universitas Diponegoro

MPA

UNDIP

BPM

Revisi ke

Tanggal

17 Januari 2006

Dikaji ulang oleh

Pembantu Rektor Bidang Akademik

Dikendalikan oleh

Badan Penjaminan Mutu

Disetujui oleh

Rektor

UNIVERSITAS

Manual Prosedur

Disetujui

DIPONEGORO

Audit Internal Mutu

oleh

Revisi

Akademik

17-01-Tanggal

MPA.UNDIP.BPM.2.2

Rektor

2006

KEPUTUSAN

REKTOR UNIVERSITAS DIPONEGORO

NOMOR : 29/SK/J07/2006

Tentang

MANUAL PROSEDUR UNIVERSITAS DIPONEGORO

REKTOR UNIVERSITAS DIPONEGORO

Menimbang :a. bahwa dalam rangka Penjaminan Mutu Universitas Diponegoro perlu

menilaii kesesuaian pelaksanaan kegiatan mutu akademik dengan

kebijakan, standar dan peraturan akademik;

b. bahwa penilaian atas mutu akademik meliputi kegiatan penilaian kinerja akademik, menilai kesesuaian antara kinerja dengan standar yang ditetapkan serta memberikan rekomendasi untuk perbaikan;

c. bahwa untuk pedoman pelaksanaan serta kejelasan tugas dan tanggungjawab perlu ditetapkan Manual Prosedur Audit Internal Mutu Pendidikan Universitas Diponegoro dengan Keputusan Rektor;

Mengingat

:1. Undang-Undang Nomor 20 tahun 2003 tentang Sistem Pendidikan Nasional;

2. Peraturan Pemerintah Nomor 7 tahun 1961 tentang Pendirian Universitas Diponegoro ;

3. Peraturan Pemerintah Nomor 60 tahun 1999 tentang Pendidikan Tinggi ;

4. Keputusan Presiden RI nomor. 99/M/2002 tentang Pengangkatan Rektor Universitas Diponegoro ;

5. Keputusan Mendikbud Nomor. 0202/0/1995 tentang Organisasi dan Tatakerja Universitas Diponegoro ;

6. Keputusan Mendikbud Nomor. 0275/0/1996 tentang Penyempurnaan Organisasi dan Tatakerja Universitas Diponegoro.

7. Keputusan Mendiknas Nomor. 186/0/2002 tentang Statuta Universitas Diponegoro ;

Memperhatikan :1. Rapat Badan Pekerja Harian (BPH) Senat Universitas Diponegoro tanggal 9

Desember 2005;

2. Rapat senat Universitas Diponegoro tanggal 23 Desember 2005.

MEMUTUSKAN :

Menetapkan :KEPUTUSAN REKTOR UNIVERSITAS DIPONEGORO TENTANG MANUAL PROSEDUR UNIVERSITAS DIPONEGORO.

Pertama :Menetapkan Manual Prosedur Audit Internal Mutu Akademik Universitas Diponegoro sebagaimana tersebut dalam lampiran keputusan ini.

Kedua :Manual Prosedur Audit Internal Mutu Akademik Universitas Diponegoro merupakan prosedur penilaian atas mutu akademik yang bersifat independen dan obyektif.

Ketiga :Hal-hal yang belum diatur dalam keputusan ini akan ditetapkan dalam keputusan tersendiri.

Keempat :Pengelola dalam melaksanakan tugas bertanggungjawab kepada Rektor melalui Pembantu Rektor I Universitas Diponegoro.

Kelima :Surat keputusan ini berlaku sejak tanggal ditetapkan dengan ketentuan bahwa

segala sesuatunya akan ditinjau kembali dan diperbaiki sebagaimana mestinya

apabila ternyata terdapat kekeliruan dalam penetapan ini.

Ditetapkan di : Semarang

Pada tanggal : 30 Januari 2006

Rektor,

PROF. Ir. EKO BUDIHARDJO, M.Sc. NIP. 130 354 860

SALINAN disampaikan kepada :

1. Menteri Pendidikan Nasional di Jakarta;

2. Sekjen Depdiknas di Jakarta;

3. Irjen Depdiknas di Jakarta;

4. Dirjen Dikti Depdiknas di Jakarta;

5. Dirbinlitabmas Ditjen Dikti Depdiknas di Jakarta;

6. Dirbinsarak Ditjen Dikti Depdiknas di Jakarta;

7. Para Pembantu Rektor di Undip;

8. Para Dekan Fakultas di Undip;

9. Direktur Program Pascasarjana di Undip;

10. Para Ketua Lembaga di Undip;

11. Para Kepala Biro di Undip;

12. Para Kepala UPT di Undip;

LAMPIRAN : SURAT KEPUTUSAN REKTOR UNIVERSITAS DIPONEGORO

Nomor : 29/SK/J07/2006

Tentang :

MANUAL PROSEDUR UNIVERSITAS DIPONEGORO

KATA PENGANTAR

Sebagai Perguruan Tinggi terbesar di Jawa Tengah yang telah memiliki reputasi, Universitas Diponegoro (UNDIP) terus berbenah sehingga mampu menghasilkan lulusan yang berkualitas dan ipteks yang berdaya guna dan berhasil guna. Senat Universitas Diponegoro sebagai badan normatif dan perwakilan tertinggi di UNDIP, sesuai dengan tugasnya sebagaimana tertuang dalam Statuta Universitas Diponegoro no 186/0/2002, pasal 49 adalah menyusun Kebijakan Akademik sebagai arah kebijakan dan pedoman bagi penyelenggaraan kegiatan akademik di Universitas Diponegoro.

Kebijakan akademik ini disusun sebagai respon atas issu-issu pendidikan tinggi di tingkat lokal, regional, nasional dan global. Issu-issu dimaksud menuntut perubahan dalam manajemen, perubahan perilaku dan etos baru para pimpinan, dosen, dan staf administrasi dalam mengemban misi Tri Dharma Perguruan Tinggi. Kebijakan Akademik ini disusun dengan melibatkan berbagai stakeholders dan melalui proses yang panjang. Tersusunnya dokumen Kebijakan Akademik ini seiring dengan proses dimulainya gagasan untuk merintis penerapan penjaminan mutu di UNDIP pada bulan Oktober tahun 2002. Disusul kemudian pada Loka Karya Penjaminan Mutu yang menghadirkan Tim Kantor Penjaminan Mutu (KJM) UGM pada tanggal 9 dan 10 Maret 2005. Pembahasan terfokus tentang Kebijakan Akademik dilaksanakan pada Loka Karya tanggal 12 Oktober 2005 yang diikuti oleh para anggota Senat, para Dekan dan PD I serta para Ketua Lembaga dan UPT. Hasil Loka Karya ini kemudian di streamline yang kemudian dibahas pada Loka Karya Finalisasi Dokumen Penjaminan Mutu di Bandungan pada tanggal 25 dan 26 Nopember 2005. Pembahasan di Senat Universitas dilakukan melalui dua tahapan. Yang pertama di forum rapat Badan Pekerja Harian (BPH) Senat pada tanggal 9 Desember 2005. Perbaikan atas masukan di Forum BPH ini kemudian dibahas di forum rapat Senat lengkap tanggal 23 Desember 2005 yang kemudian mengesahkan dokumen Penjaminan Mutu yang di dalamnya termasuk dokumen Kebijakan Akademik.

Kebijakan Akademik, Standar Akademik, Peraturan Akademik, Manual Mutu, Manual Prosedur, Instruksi Kerja, dan dokumen penunjang merupakan dokumen yang saling terkait dan terus dikembangkan secara berkelanjutan sebagai panduan kegiatan akademik. Senat Universitas Diponegoro menyadari bahwa dokumen Kebijakan Akademik ini masih perlu penyempurnaan, karena itu diharapkan saran dan masukan baik dalam bentuk format maupun substansi. Semoga dokumen ini bermanfaat sebagai pedoman dalam melaksanakan tugas kita bersama mengemban misi Tri Dharma Perguruan Tinggi.

Semarang, 17 Januari 2006

Rektor

Universitas Diponegoro

Prof. Ir. Eko Budihardjo, M.Sc.

NIP 130 354 860

DAFTAR ISI

Judul i

Lembar Pengendalian ii

Surat Keputusan Rektor Univesitas Diponegoro iii

Kata Pengantar v

Daftar Isi vi

I. Pendahuluan 1

II. Bidang Pendidikan 3

2.1. Arah Kebijakan 3

2.2. Program 3

2.3. Kelembagaan 4

2.4. Sumberdaya

2.5. Evaluasi

III. Bidang Penelitian

3.1. Arah Kebijakan 5

3.2. Program 5

3.3. Kelembagaan 6

3.4. Sumberdaya 6

3.5. Evaluasi 6

IV. Bidang Pengabdian Kepada Masyarakat 8

4.1. Arah Kebijakan 8

4.2. Program 8

4.3. Kelembagaan 8

4.4. Sumberdaya 9

4.5. Evaluasi 9

V. Asas Penyelenggaraan 10

VI. Penutup 11

BAB I

PENJELASAN UMUM

A. Definisi

1. Audit Internal Mutu Akademik Universitas Diponegoro (AIMA-Undip) adalah suatu kegiatan penilaian atas mutu akademik yang bersifat independen dan objektif. Kegiatan ini dirancang untuk:

a. Menilai kinerja (kegiatan operasional) akademik Universitas Diponegoro;

b. menilai kesesuaian antara kinerja dengan standar yang telah ditetapkan

c. Memberikan rekomendasi untuk perbaikan.

2. Sistem mutu adalah sistem yang mencakup struktur organisasi, tanggung-jawab, prosedur, proses, dan sumberdaya untuk melaksanakan manajemen mutu.

3. Unit Pelaksana Akademik Undip adalah Fakultas, Program Pascasarjana, Jurusan/Bagian, dan Lembaga, yang bertugas menjalankan fungsi Tridharma Per-guruan Tinggi.

4. Auditor adalah orang yang mempunyai kualifikasi untuk melakukan audit mutu akademik.

5. Klien adalah orang atau organisasi yang mendapat pelayanan pengauditan. Klien dalam kegiatan AIMA ini dapat berupa :

a. Fakultas yang meminta sistem mutu akademiknya diaudit terhadap standar mutu yang telah ditentukan sendiri.

b. Universitas/Fakultas yang meminta dilaksanakan audit bagi unit–unit di bawah kewenangannya.

6. Teraudit (auditee) adalah organisasi yang diaudit.

7. Bukti objektif (BO) adalah informasi yang bersifat kualitatif ataupun kuantitatif, catatan ataupun pernyataan tentang fakta mengenai mutu pelayanan, eksistensi dan implementasi elemen-elemen sistem mutu, yang didasarkan pada pengamatan, pengukuran, dan dapat diverifikasi.

8. Hasil audit dikelompokkan ke dalam tiga kategori :

a. Tidak lengkap (TL) adalah pernyataan tentang temuan selama audit, didasarkan atas bukti objektif yang menunjukkan ketidaklengkapan atau ketidakcukupan yang memerlukan penyempurnaan dalam waktu singkat.

b. Tidak sesuai (TS) adalah tidak terpenuhinya persyaratan karakteristik mutu atau unsur sistem mutu yang telah ditetapkan.

c. Sesuai (S) adalah pernyataan tentang terpenuhinya persyaratan karakteristik mutu akademik sesuai dengan standar mutu akademik yang telah ditetapkan.

9. Permintaan Tindakan Koreksi (PTK) adalah surat perintah dari Pimpinan Unit kepada teraudit untuk menindaklanjuti temuan audit mutu akademik.

B. Tujuan dan Alasan Audit

1. Tujuan audit

Audit dirancang untuk salah satu atau lebih tujuan berikut:

a. Memeriksa kesesuaian atau ketidaksesuaian unsur-unsur sistem mutu dengan standar yang telah ditentukan;

b. Memeriksa keefektifan pencapaian tujuan mutu yang telah ditentukan.

2. Manfaat Audit :

a. Memfasilitasi evaluasi kinerja, sistem kontrol, dan prosedur penjaminan mutu.

b. Meyakinkan bahwa sebuah institusi memiliki akuntabilitas terhadap mutu dan standar yang telah ditentukan.

c. Meningkatkan kemampuan institusi untuk memprioritaskan lingkup tertentu dan memfasilitasi pengambilan keputusan.

d. Memudahkan institusi untuk memberikan tanggapan lebih baik terhadap persyaratan yang diminta audit mutu eksternal serta untuk menilai mutu.

e. Menyediakan sarana untuk identifikasi cara kerja yang baik untuk disebarluaskan.

f. Menyediakan sarana yang tepat untuk peningkatan dan pengembangan mutu.

C. Etika, Tanggungjawab, Independensi dan Kriteria Auditor Internal Mutu Akademik 1. Etika auditor

a. Tidak mengaudit pekerjaan yang pernah (dalam 2 tahun sebelumnya) atau sedang menjadi tanggung jawabnya.

b. Independen (dalam fakta dan proses pekerjaan).

c. Obyektif.

d. Memiliki integritas yang tinggi.

e. Menjaga kerahasiaan.

2. Tanggungjawab ketua tim audit

a. Membuka dan menutup rapat.

b. Memilih anggota tim audit.

c. Menyiapkan jadwal dan program audit.

d. Memimpin audit.

e. Membuat keputusan akhir atas temuan audit berupa pendapat hasil audit.

f. Menyerahkan laporan audit selambat-lambatnya 1 bulan setelah pekerjaan lapangan selesai.

3. Tanggungjawab auditor

a. Mengumpulkan dan menganalisis bukti.

b. Menyusun kertas kerja pemeriksaan.

c. Melakukan konfirmasi baik terhadap internal maupun eksternal.

d. Melakukan observasi dan pengujian fisik.

e. Bersama dengan ketua tim merumuskan hasil audit.

4. Independensi auditor

Auditor bebas dari bias dan hal-hal yang dapat mempengaruhi objektivitas. Semua orang dan organisasi yang terlibat dalam pengauditan harus menghormati dan mendukung independensi dan integritas auditor.

5. Kualifikasi auditor internal mutu akademik

a. Pendidikan minimum

Auditor minimal berpendidikan Sarjana (S1).

b. Pelatihan

Auditor telah mengikuti pelatihan/kursus Auditor Bersertifikat yang diselenggarakan/diakui oleh

Badan Penjaminan Mutu (BPM).

c. Atribut personal

Auditor berpikiran terbuka, memiliki kemampuan untuk mengambil keputusan, memiliki ketrampilan analitis dan keteguhan hati, memiliki kemampuan untuk memahami pelaksanaan audit yang kompleks, dan memiliki kemampuan untuk memahami peran unit organisasi, dan memiliki kemampuan berkomunikasi.

Auditor menerapkan atribut tersebut di atas untuk :

1) mendapatkan dan memeriksa bukti objektif secara wajar,

2) melaksanakan audit sesuai dengan program audit,

3) mengevaluasi secara konsisten pengaruh pengamatan audit dan interaksi personal selama audit,

4) memperlakukan teraudit secara wajar sehingga diperoleh hasil audit terbaik,

5) menaruh perhatian penuh dan mendukung proses audit,

6) tanggap dalam menghadapi situasi yang sulit,

7) mengambil kesimpulan audit yang dapat diterima,

8) tetap berpegang pada kesimpulan yang telah dihasilkan.

6. Meningkatkan kompetensi

Auditor meningkatkan kompetensinya dengan:

1) memutakhirkan pengetahuannya tentang syarat-syarat, standar sistem mutu, metode dan prosedur audit;

2) berpartisipasi dalam kursus penyegaran bila diperlukan;

3) evaluasi secara berkala oleh Manajer Audit Internal Mutu Akademik (MAIMA).

7. Kriteria Ketua Tim Audit

Ketua tim audit dipilih oleh MAIMA dari para auditor yang memenuhi kualifikasi dengan

mempertimbangkan kriteria sebagai berikut.

1) Calon sudah berpengalaman sebagai auditor.

2) Calon menunjukkan kemampuan berkomunikasi secara efektif, baik secara lisan maupun tertulis.

D. PENGAUDITAN

1. Uraian tugas dalam pengauditan

1.1. Ketua Tim Audit bertugas:

a. menentukan keperluan tiap penugasan audit termasuk kualifikasi auditor yang diperlukan;

b. merencanakan audit, menyiapkan piranti kerja untuk anggota tim, dan mengarahkan tim audit;

c. mengkaji ulang dokumen aktivitas mutu akademik yang berlaku untuk menentukan kecukupannya (audit system /desk evaluation);

d. membuat jadwal audit yang disepakati oleh teraudit;

e. melakukan supervisi terhadap anggota tim audit;

f. memberitahukan dengan segera ketidaksesuaian yang kritis kepada teraudit;

g. melaporkan setiap hambatan yang dihadapi dalam melaksanakan audit kepada MAIMA;

h. melakukan pertemuan akhir dengan teraudit;

i. melakukan presentasi hasil audit;

j. melaporkan segera hasil-hasil audit dan kesimpulannya secara jelas kepada MAIMA. 1.2. Auditor bertugas:

a. mengumpulkan dan menganalisis bukti yang relevan agar dapat menyimpulkan pelaksanaan sistem mutu yang diaudit;

b. mempelajari indikasi yang dapat mempengaruhi hasil audit yang mungkin memerlukan pengauditan lebih lanjut;

c. menyelesaikan kertas kerja audit;

d. menyiapkan laporan bersama dengan ketua tim;

e. pada saat kegiatan konsultansi dapat menjawab pertanyaan tentang:

1) prosedur, dokumen, atau informasi lain yang menggambarkan atau mendukung unsur-unsur sistem mutu yang diperlukan, diketahui, tersedia, dipahami, dan digunakan oleh teraudit;

2) semua dokumen dan informasi lain yang digunakan untuk menggambarkan sistem mutu yang memadai untuk mencapai tujuan mutu.

1.3. Klien bertugas:

a. meminta audit kepada BPM,

b. menentukan unit organisasi yang akan diaudit,

c. menyediakan data atau informasi yang diperlukan,

d. menyediakan counterpart/pendamping dalam proses audit

e. menyediakan tempat kerja

f. menerima laporan hasil audit melalui BPM

1.4. Teraudit bertugas:

a. menginformasikan kepada penanggung jawab unit organisasi/kegiatan yang akan diaudit tentang tujuan dan lingkup audit;

b. menunjuk staf yang bertugas mendampingi tim audit;

c. menyediakan sumberdaya yang diperlukan oleh tim audit untuk menjamin keefektifan dan keefisienan proses audit;

d. membuka akses ke fasilitas dan bukti yang diminta auditor;

e. melakukan kerjasama dengan auditor agar tujuan audit tercapai;

f. menentukan dan berinisiatif melaksanakan tindakan koreksi berdasarkan laporan audit.

2. Inisiasi Audit

2.1. Lingkup Audit

a. Klien bersama auditor menentukan unsur sistem mutu, lokasi, aktivitas unit organisasi, dan waktu audit.

b. Klien bersama auditor menentukan lingkup dan kedalaman audit.

c. Klien menentukan standar atau dokumen sistem mutu yang harus dipatuhi.

d. Teraudit menunjukkan bukti yang cukup dan tersedia pada saat audit.

e. Teraudit menyediakan sumberdaya yang memadai sesuai dengan lingkup dan kedalaman

audit.

2.2. Frekuensi Audit

Hal-hal yang perlu dipertimbangkan untuk menentukan frekuensi audit adalah :

a. Kebutuhan untuk melakukan audit ditentukan oleh klien dengan mempertimbangkan persyaratan atau peraturan tertentu.

b. Perubahan dalam manajemen, organisasi, kebijakan, teknik atau teknologi yang dapat mempengaruhi atau mengubah sistem mutu dan mengubah hasil audit terdahulu.

c. Dapat dilakukan secara berkala.

2.3. Telaah awal sistem mutu teraudit

a. Sebagai dasar perencanaan audit, auditor menelaah metode yang ada untuk memenuhi persyaratan sistem mutu teraudit.

b. Jika hasil telaah terhadap sistem mutu tidak memenuhi persyaratan, langkah audit selanjutnya tidak diteruskan sampai persyaratan tersebut dipenuhi.

3. Persiapan Audit

3.1. Perencanaan audit

Rencana audit disusun oleh ketua tim audit, disetujui oleh klien, dan dikomunikasikan kepada

auditor dan teraudit. Rencana audit dirancang secara fleksibel agar dapat diubah berdasarkan

informasi yang dikumpulkan selama audit dan memungkinkan penggunaan sumberdaya yang

efektif.

Rencana audit meliputi :

a. tujuan dan lingkup audit,

b. identifikasi individu yang bertanggung jawab langsung terhadap tujuan dan lingkup audit,

c. identifikasi dokumen acuan yang berlaku, antara lain standar sistem mutu dan manual mutu ter-audit,

d. identifikasi anggota tim audit;

e. tanggal dan tempat audit dilakukan;

f. identifikasi unit organisasi teraudit;

g. waktu dan lama audit untuk tiap aktivitas audit;

h. jadwal pertemuan yang diadakan dengan pimpinan teraudit;

i. jadwal penyerahan laporan audit.

Jika teraudit keberatan terhadap rencana audit segera memberitahukan kepada ketua tim audit,

dan harus diselesaikan sebelum pelaksanaan audit.

3.2. Penugasan tim audit

Masing-masing anggota tim audit mengaudit unsur sistem mutu atau bagian fungsional yang

telah ditentukan.

3.3. Dokumen kerja

Dokumen kerja yang diperlukan untuk memfasilitasi tugas tim audit adalah :

a. daftar pengecekan yang disiapkan oleh tim audit,

b. borang untuk melaporkan pengamatan audit dan mendokumentasi bukti pendukung. Dokumen kerja tidak membatasi aktivitas atau tugas audit tambahan yang mungkin diperlukan sebagai akibat informasi yang terkumpul selama audit. Dokumen kerja yang melibatkan informasi rahasia harus dijaga oleh organisasi audit.

4. Pelaksanaan audit

4.1. Pertemuan pembukaan

Tujuan pertemuan pembukaan untuk :

a. memperkenalkan anggota tim audit kepada pimpinan teraudit,

b. menelaah lingkup dan tujuan audit,

c. menyampaikan ringkasan metode dan prosedur yang digunakan dalam melaksanakan audit,

d. menegaskan hubungan formal antara tim audit dan teraudit,

e. mengkonfirmasikan ketersediaan sumberdaya yang diperlukan,

f. mengkonfirmasikan jadwal pertemuan-pertemuan dan penutupan audit,

g. mengklarifikasi setiap rencana audit yang tidak jelas. 4.2. Pemeriksaan lapangan

a. Pengumpulan bukti

Bukti dikumpulkan melalui wawancara, pemeriksaan dokumen, pengamatan aktivitas dan keadaan di lokasi. Hasil wawancara harus diuji dengan mencari informasi yang relevan dari sumber lain yang independen.

Selama kegiatan audit, ketua tim audit dapat mengubah tugas kerja tim audit dan rencana audit dengan persetujuan teraudit. Hal ini diperlukan untuk menjamin pencapaian tujuan audit yang optimal.

Jika tujuan audit tidak tercapai, ketua tim audit memberitahukan alasannya kepada teraudit.

b. Hasil pengamatan audit

Semua hasil pengamatan audit didokumentasikan. Setelah semua aktivitas diaudit, tim audit menelaah semua hasil pengamatannya untuk menentukan adanya kesesuaian/ketidaksesuaian yang akan dilaporkan. Hasil pengamatan ditelaah oleh ketua tim audit dengan pimpinan teraudit. Semua kesesuaian/ketidaksesuaian dari hasil pengamatan harus dituangkan dalam Berita Acara dan ditanda tangani oleh ketua tim audit dan pimpinan teraudit.

4.3. Pertemuan penutupan

Sebelum menyiapkan laporan audit, tim audit mengadakan pertemuan penutupan dengan teraudit. Tujuan utama pertemuan ini adalah untuk menyampaikan hasil audit. Catatan-catatan dalam pertemuan penutupan didokumentasikan.

5. Dokumen audit

5.1. Persiapan laporan audit

Laporan audit disiapkan dengan pengarahan ketua tim audit yang bertanggung jawab atas

keakuratan dan kelengkapannya.

a. Isi laporan

Laporan audit berisi hasil pelaksanaan audit secara lengkap. Laporan audit harus diberi

tanggal akhir pekerjaan lapangan dan ditandatangani oleh ketua tim audit.

Laporan audit berisi hal-hal berikut :

1) pernyataan pendapat audit

2) tujuan dan lingkup audit, serta legalitas audit,

3) rincian rencana audit, identitas anggota tim audit dan perwakilan teraudit, tanggal audit, periode audit, penanggung jawab dan identitas unit organisasi teraudit,

4) identitas dokumen standar yang dipakai dalam audit antara lain Standar Mutu Akademik yang berlaku, dan Manual Mutu Akademik teraudit,

5) butir-butir program audit yang dilaksanakan,

6) temuan audit,

7) rekomendasi perbaikan

8) daftar distribusi laporan audit.

b. Distribusi laporan

1) Laporan audit dikirim ke MAIMA oleh ketua tim audit. MAIMA meneruskan kepada Ketua BPM.

2) Laporan audit diterbitkan oleh BPM.

3) BPM mendistribusikan kepada Rektor dan Klien.

4) Klien menginformasikan laporan hasil audit kepada teraudit.

5) Laporan audit dijamin kerahasiaannya oleh semua pihak yang menerima laporan.

6) Jika laporan audit tidak dapat diterbitkan sesuai jadwal yang disepakati maka perlu disepakati jadwal baru penerbitan, dengan menyampaikan alasan penundaan kepada MAIMA.

c. Kertas kerja pemeriksaan disimpan oleh MAIMA dan dapat dijadikan dasar untuk pengauditan berikutnya.

d. Satu eksemplar laporan hasil audit disimpan oleh BPM.

E. KELENGKAPAN PELAKSANAAN AUDIT

Audit dinyatakan selesai dan lengkap jika laporan audit telah diserahkan kepada MAIMA

F. TINDAK LANJUT PERMINTAAN TINDAKAN KOREKSI

1. Rektor/Dekan memerintahkan teraudit untuk melakukan tindakan koreksi.

2. Tindakan koreksi harus diselesaikan dalam periode waktu yang disepakati oleh pimpinan teraudit setelah konsultasi dengan MAIMA.

3. BPM memantau pelaksanaan PTK.

BAB II

PROSEDUR IMPLEMENTASI

AIMA FAKULTAS OLEH AUDITOR UNIVERSITAS

Permintaan

Klien atau jadwal

berkala

Perintah Audit dari

Rektor/BPM

Penunjukan ketua tim

audit oleh MAIMA

Pembentukan tim audit

Penerbitan surat tugas

Penyusunan tujuan,

kewenangan dan

tanggungjawab tim audit

Pengesahan tujuan,

kewenangan dan

tanggungjawab tim audit

Penyusunan rencana

dan jadwal audit

Penyerahan dokumen

yang diperlukan kepada

ketua tim audit

Rapat persiapan tim

audit

(1)

Atas permintaan klien/jadwal berkala dilakukan audit

(2) Rektor/BPM memerintahkan atau mendisposisikan permintaan Klien kepada MAIMA

(3) MAIMA bersama ketua tim audit membentuk tim audit.

(4) Rektor/BPM menerbitkan surat tugas untuk tim audit.

(5) Tim audit menyusun tujuan, kewenangan dan tanggungjawab audit sesuai dengan ruang lingkup yang merujuk pada surat tugas Rektor atau permintaan Klien.

(6) Tujuan, kewenangan dan tanggungjawab tim audit disahkan oleh BPM.

(7) Tim audit menyusun rencana dan jadwal audit bersama teraudit.

(8) Teraudit menyerahkan dokumen yang diperlukan kepada ketua tim audit sesuai dengan waktu yang telah disepakati.

(9) Pembagian tugas tim audit untuk audit sistem.

(10) Melaksanakan audit dokumen (MM, MP) yang tersedia sesuai dengan standar yang disepakati dan menyusun checklist untuk persiapan audit kepatuhan.

(11) Ketua tim audit mengkomunikasikan jadwal visitasi kepada teraudit untuk disetujui.

(12) Berdasarkan daftar pengecekan bukti dikumpulkan melalui wawancara, pemeriksaan dokumen (IK, DP dan BO), pengamatan aktivitas dan keadaan di lokasi secara komprehensif..

Diskusi hasil temuan

audit

Pembuatan laporan audit

Penyerahan laporan

audit

Pembubaran tim audit

(13)

Semua hasil temuan audit didiskusikan dengan teraudit untuk mendapatkan persetujuan. Temuan Tidak lengkap (TL) harus segera diperbaiki dalam jangka waktu yang disepakati.

(14) Laporan dibuat sesuai jadwal berdasarkan hasil temuan yang telah disetujui oleh teraudit.

(15) Laporan audit diserahkan kepada Ketua tim audit kepada MAIMA untuk diteruskan kepada BPM, kemudian BPM mengirim laporan audit kepada Rektor dan Klien disertai Permintaan Tindakan Koreksi (PTK).

(16) Tim audit dibubarkan atas permintaan MAIMA dengan SK. Pemberhentian.

BAB III

IMPLEMENTASI AIMA

PADA SISTEM PENJAMINAN MUTU INTERNAL

AKADEMIK TINGKAT FAKULTAS

A. Tujuan Audit

1. Meneliti kepatuhan/ketaatan penjaminan mutu akademik fakultas terhadap kebijakan akademik, standar akademik, peraturan akademik, dan manual mutu akademik Universitas Diponegoro.

2. Meneliti kesesuaian arah dan pelaksanaan penjaminan mutu akademik fakultas terhadap kebijakan akademik, standar akademik, peraturan akademik, manual mutu akademik, dan manual prosedur akademik Universitas Diponegoro.

B. Ruang Lingkup Audit

1. Meneliti keberadaan organisasi penjaminan mutu akademik di tingkat fakultas sesuai dengan Manual Mutu Akademik, yaitu :

a. Tim Penjaminan Mutu Akademik Fakultas (TPMAF)

b. Gugus Penjaminan Mutu (GPM)

2. Meneliti:

a. Standar Akademik Fakultas

b. Manual Mutu Fakultas

c. Manual Prosedur Implementasi Penjaminan Mutu Akademik Internal di tingkat fakultas.

3. Meneliti pelaksanaan kegiatan penjaminan mutu akademik di tingkat fakultas.

4. Meneliti pelaksanaan sistem penjaminan mutu di tingkat fakultas.

C. Daftar Pengecekan

1. Implementasi Sistem Penjaminan Mutu di Tingkat Fakultas

a. SK pengangkatan penanggung jawab pelaksana sistem penjaminan mutu akademik.

b. SK pengangkatan TPMAF dan GPM

c. Perumusan dan pengesahan kebijakan akademik dan standar akademik fakultas.

d. Penyusunan Manual Mutu dan Manual Prosedur Implementasi Penjaminan Mutu di tingkat fakultas.

e. Kesesuaian Manual Mutu dan Manual Prosedur Implementasi Penjaminan Mutu di tingkat fakultas dengan acuannya, yaitu Kebijakan Akademik.

f. Penyusunan evaluasi diri dan rencana tindak lanjut untuk peningkatan mutu proses pembelajaran oleh TPMAF dan pelaporan ke Dekan.

g. Kendala untuk melaksanakan Standar Akademik Fakultas dan Manual Mutu dan Manual Prosedur.

h. Cara mengatasi kendala tersebut di tingkat fakultas.

i. Memeriksa butir Standar Akademik Fakultas yang belum dilaksanakan dan rencana pelaksanaannya.

2. Implementasi Sistem Audit Mutu di Tingkat Fakultas dilakukan oleh BPM melalui MAIMA

BAB IV

IMPLEMENTASI AIMA

PADA SISTEM PENJAMINAN MUTU AKADEMIK

TINGKAT JURUSAN/PROGRAM STUDI/BAGIAN

A. Tujuan Audit

1. Meneliti kepatuhan/ketaatan penjaminan mutu akademik internal tingkat jurusan/bagian terhadap standar akademik, manual mutu akademik dan manual prosedur implementasi penjaminan mutu akademik internal di tingkat fakultas.

2. Meneliti kesesuaian arah dan pelaksanaan penjaminan mutu akademik internal tingkat jurusan/bagian terhadap standar akademik, manual mutu akademik dan manual prosedur implementasi penjaminan mutu akademik internal di tingkat fakultas.

3. Meneliti kepastian bahwa lulusan memiliki kompetensi sesuai dengan yang ditetapkan oleh program studi.

B. Ruang Lingkup Audit

1. Meneliti:

a. Spesifikasi Program Studi (SP), termasuk di dalamnya Kompetensi Lulusan (KL);

b. Manual Prosedur (MP) dan Instruksi Kerja (IK) program studi yang sesuai dengan Standar Akademik (SA), Manual Mutu Akademik (MM), dan Manual Prosedur (MP) tingkat fakultas.

c. Kurikulum program studi.

2. Meneliti proses pembelajaran yang bermutu sesuai SP, KL, MP, dan IK.

3. Meneliti penyempurnaan SP, KL, MP, dan IK secara berkelanjutan.

4. Meneliti keberadaan dan kinerja GPM.

5. Meneliti sumberdaya pembelajaran program studi.

6. Meneliti kemajuan belajar mahasiswa (student progress).

7. Meneliti upaya perbaikan mutu (quality improvement) berdasarkan hasil evaluasi diri berkelanjutan.

C. Daftar Pengecekan

1. Tujuan pendidikan program studi.

2. Keterkaitan tujuan pendidikan dengan rujukan eksternal (kurikulum nasional, standar pendidikan nasional/internasional).

3. Keterkaitan tujuan pendidikan dengan misi program studi.

4. Kesesuaian tujuan pendidikan program studi dengan misi program studi.

5. Kesesuaian isi kurikulum dengan kompetensi lulusan yang disajikan dalam bentuk peta kurikulum.

6. Tujuan pendidikan telah dikomunikasikan kepada sivitas akademika, tenaga penunjang dan penguji eksternal.

7. Mahasiswa memahami dan memenuhi kewajibannya.

8. Strategi penilaian hasil belajar memiliki fungsi formatif dalam mengembangkan kemampuan mahasiswa.

9. Ketersediaan kriteria yang memudahkan penguji internal dan eksternal untuk membedakan berbagai kategori pencapaian kompetensi lulusan.

10. Penilaian hasil belajar mahasiswa menunjukkan pencapaian kompetensi lulusan.

11. Ketersediaan bukti-bukti yang menunjukkan bahwa mahasiswa mencapai standar kompetensi minimal program studi.

12. Tindakan kajiulang untuk mencapai standar kompetensi minimal program studi.

13. Efektivitas proses pembelajaran dikaitkan dengan isi kurikulum dan kompetensi lulusan program studi.

14. Penerapan hasil-hasil penelitian dosen dalam pembelajaran.

15. Mutu media ajar mendukung proses pembelajaran.

16. Partisipasi aktif mahasiswa dalam proses pembelajaran.

17. Peningkatan mutu pembelajaran melalui program pengembangan staf, kajian pembelajaran oleh mitra bestari (peer-review), integrasi tim pengajar yang efektif, program magang dan tutorial untuk staf junior.

18. Efektivitas pembelajaran dinilai dari :

a) keluasan dan kedalaman materi, tempo dan tantangan yang diberikan dalam proses pembelajaran,

b) variasi metode pembelajaran,

c) substansi ilmu,

d) ketrampilan spesifik dan praktis,

e) kesesuaian fasilitas sumber belajar dengan beban mahasiswa.

19. Strategi yang menunjang kegiatan akademik yang konsisten dengan profil mahasiswa dan tujuan program pendidikan.

20. Peraturan penerimaan mahasiswa baru dan program pengenalan kampus yang dipahami oleh staf dan

mahasiswa.

21. Efektivitas dalam pembimbingan akademik, umpan balik, dan mekanisme supervisi.

22. Staf akademik pelaksana program pendidikan adalah orang yang kompeten.

23. Program pengembangan profesional staf akademik untuk meningkatkan kepakaran dan profesionalisme sebagai dosen.

24. Dukungan teknis dan administrasi yang memadai untuk staf akademik.

25. Strategi penyediaan Kompetensi Lulusan dan Spesifikasi Program Studi.

26. Manual Prosedur dan Instruksi Kerja program studi.

27. SK pengangkatan GPM.

28. Pemantauan dan evaluasi proses pembelajaran semester oleh GPM.

29. Laporan Rencana Tindakan Koreksi proses pembelajaran dan pelaksanaannya.

30. Pelaksanaan peningkatan mutu proses pembelajaran oleh GPM.

31. Laporan penilaian program studi dan kegiatan program studi dari GPM ke TPMAF.

32. Fasilitas proses pembelajaran memadai.

33. Sumber belajar (buku, jurnal ilmiah, laboratorium, dan sebagainya) relevan dan memadai.

Semarang, 30 Januari 2006 R e k t o r ,

Prof. Ir. EKO BUDIHARDJO, M.Sc NIP. 130 354 860

ONLY FINGER PRINT ATTENDANCE SYSTEM

ONLY FINGER ATTENDANCE SYSTEM

OPERATION MANUAL

STARLINK COMMUNICATION P. LTD.

A-19, OKHLA PHASE-1,

NEW DELHI

INDEX

Content

1. Introduction

2. Keys of Only Finger machine

3. Application system modes

3.1 Normal Mode

3.2 Administrator Mode

4. Functionalities of keys

4.1 Normal Mode

4.1.1 Memory Used

4.1.2 Firmware Release Date and Machine Number

4.1.3 Firmware Version

4.1.4 IP Address

4.1.5 Netmask Address

4.1.6 Gateway Address

4.1.7 MAC Address

4.1.8 SMART CARD –W/A

4.1.9 Boot Loader

4.2 Administrator Mode

4.2.1 Functionalities of Key F1

4.2.2 Functionalities of Key F1

4.2.3 Functionalities of Key F1

4.2.4 Functionalities of Key F1

5. Technical information

1. Introduction

Starlink finger print attendance system is highly technology based attendance system. When you need to take attendance, you put the finger on finger sensor, LCD display shows name and card no.

Figure -1: Only Finger Print Attendance System

Starlink attendance system is a networking based attendance system with TCP/IP protocol. Finger print attendance has memory of mother board which is 2MB and you can store 62,500 recording in this system. You can enroll 9560 finger templates in the machine as well as in the computer.

2. Keys of Smartcard Machine

There are four kinds of keys in the finger print attendance system which is give below:

* Functional keys (F1, F2, F3, F4)

* Numeric keys ( 0 to 9)

* Enter /Exit Key

* Next key

There are total 16 keys on the key board.

3. Application System Modes

There are two types of modes in smart card attendance system:

* Normal mode

* Administer mode

3.1 Normal Mode

Normal mode is also known as Date Time Mode. It is a readable mode i.e. you can only read the information in this mode. In the normal mode there is only one functional key F3 which you can use.

DEC-21 2007

FRI 14:43:32

Administer Mode STARLINK PRODUCT

Set The time As

HR MT SEC?124709

Set The Date As

DY MH YR? 011207

Figure 1: Sequence Operation from Normal Mode to U Mode or L Mode You can take following steps to go to U or L mode from normal mode:

1. Date time mode

2. Press key ENTER/EXIT to switch the administer mode.

3. Press key F1 to switch for setting the time.

4. Press key NEXT to switch for setting the date.

5. Press key NEXT to switch for setting the password for unlock the access code.

6. Press key NEXT to come out in administer mode and then again press key ENTER/EXIT to come out in U mode.

7. Press key F2, machine will switch into L mode.

3.2 Administer Mode

DEC-21 2007

FRI 13:21:14

Administer mode

STARLINK PRODUCT

Press key “ENTER/EXIT” to switch from normal mode to administer mode.

4. Functionalities of Keys

Functionality of keys is discussed in both normal mode and administer mode below.

4.1 Normal Mode:

To proceed, press F3. Keys. Don’t use Keys F1, F2 and F4 in normal mode.

Functionalities of Key F3: Key F3 is generally used to find out the following features: Memory used, date of firmware and machine no., Firmware version, IP address, Network address, Gateway address, MAC address, and Finger print settings, Only Finger and Boot loader.

IP ADRESS IS:

192.168.000.046

Figure 2: Sequence Operation of key F3 in Normal Mode 4.1.1. Memory Used

You can see how much percentage memory has been used in machine.

If memory is empty (or no memory is used), LCD will appear as:

No Memory is in

*****USE*****

4.1.2. Firmware Release Date and Machine Number

You can see date of firmware and machine number of the machine.

4.1.3. Firmware Version

It shows Version of the firmware and the capacity of machine memory which is 2 MB.

4.1.4. IP Address

Starlink attendance system is a networking based attendance system with TCP/IP protocol. If you want to change IP Address, switch to functional key F2 in administer mode.

4.1.5. Netmask Address

You can see the netmask address of the machine.

4.1.6. Gateway Address

You can see the gateway address of the machine.

4.1.7. MAC Address

You can see the MAC address of the machine. It’s is a unique address of the LAN card for every machine.

4.1.8. Finger Print Settings

FIN-01 LIMT 1910

BaudRATE-115200

You can see the limits of finger and baud rate.

4.1.9. Only Finger

You can see that this machine is used for only finger.

4.1.10-Boot Loader

Bin file of assembling program can be uploaded through Boot loader. Now entering 4 digits password, Machine will go to boot loader mode. Password will be provided by starlink support engineer.

4.2 Administer Mode:

You can use keys F1, F2, F3 and F4 in administer mode.

4.2.1. Functionalities of Key F1

This functional key is used for setting date, time and access code of the attendance

DEC-22 2007

SAT 13:40:21

/EXIT

Administer mode

STARLINK PRODUCT

Set The time As

HR MT SEC? 124709

Set The Date As

DY MH YR?011207

Figure 3: Sequence of Operation of Key F1 in Administer Mode

i.Set The Time

Starlink attendance system has a 24 hours mode quartz real time clock. You can set time in Hour, Minute and Second in HR MT SEC .i.e. 124709 mean 12 pm 47 min and 9 second.

ii.Set The Date

You can set date in date, month and year in DY MH YR format. i.e. 011207 means 1st Dec

2007.

iii.Set Key Unlock

Starlink attendance system has one more characteristic which is access code for security. You can set three security codes and lock the machine and nobody can operate the machine without entering these codes.

You can set access code for security to unlock the keypad in normal mode. Access code is a four digits numeric code 0-9.Access code should be neither less nor greater than 4 digits.

Note: you can see U or L mode through setting this code.

iv.New Access Code

You can set this code to lock the administer mode. Set new access code should be neither less nor greater than 4 digits. If you don’t want to change the access code, just press key “NEXT”.

v.Set Security Access Code

You can set this security code to access the functional keys in administer mode. Security access code should be neither less nor greater than 4 digits. After setting security access code, the system will switch to administer mode.

4.2.2. Functionalities of Key F2

This key is used to set the attendance backup for months, LCD power saving, buzzer on/off, door mode/pulse mode, email facility, ID address, netmask address, gateway address and biometric setting.

DEC-22 2007

SAT 13:40:21

Administer mode STARLINK PRODUCT

*Buzzer On- 0

Buzzer off- 1

Machine Restart

0 Yes 1 No

ENTER GATEWAY ADD

255.255.255.255

BIOMETRIC SETTING

0 YES 1 NO

LCD Power saving Mode

0-YES 1- NO

Door Mode – 0

Pulse Mode- 1

NEXT NEXT NEXT

Figure 4: Sequence of Operation of Key F2 in Administer Mode

i. Attendance Backup

This function is used to limit the backup of the attendance data in months. You can enter months in numeric 1 to 9.

* If you set 0 in months, it means data of attendance will be stored till then memory of system will be full and LCD display shows memory is full.

* If you set 5 in month backup of attendance will be for 5 months. After that data will automatic erase from the memory of the system.

ii. Buzzer On and Off

Starlink attendance system has a piezoelectric buzzer for keypad sound. If you want to set the buzzer of the attendance system,

* Press 1 to set the buzzer off

* Press 0 to set the buzzer on

*mark in front of buzzer indicates the active state of the buzzer (on/off)

iii. LCD Power Saving

This feature is used to save the power of the machine.

* If you press key”1”, the machine will not save power. Light of LCD display will always be on.

* If you press key“0”, the machine will save power. Light of LCD display will be off after

duration of 3 minutes.

*mark in front of either on and off indicates the active state (on/off).

iv. Door Mode/Pulse Mode

You can use this option in access control process and used to connect and disconnect the electro magnetic lock.

1 for pulse mode

Pulse mode On-0

Pulse mode off-1

ENTER IP ADDRESS

192.168.030.015

Door Sensor On -0

Door sensor Off-*1

ENTER IP ADDRESS

192.168.030.015

Max. Off time of sensor (min) : 00

Figure 5: Sequence Operation of Door Mode and Pulse Mode.

Door Mode:

* If the door lock system is on, it will ask for the Door Open Time (door open time is the time taken by the system to close the door).

* Door open time is in seconds.

* By default the door open time is 2 seconds.

* Maximum time we can set is i.e. 2+ (by default) + 99= 101 sec.

Pulse Mode:

You can set a particular time of 0.5 sec in pulse mode to connect or disconnect the EM lock. It is used for tripod.

v.IP Address:

Starlink attendance systems are networking base attendance system with TCP/IP. You can set IP address on LCD display i.e. 192.168.030.015.

* This IP address should be unique.

* Key “NEXT” is used to switch to the next number.

* To directly go to the next operation press key “ENTER/EXIT”.

vi. Netmask Address:

You can see the netmask address of the machine.

vii. Gateway Address:

You can see the gateway address of the machine.

ix. Biometric Settings:

By this setting we can set security level, sensitivity level, image quality, enroll mode, displacement , free scan delay, Fast mode for 1:N search, timeout, baud rate, sensor type, finger enrolled, remaining fingers, light condition and set auto sensor.

Biometric Settings

0 Yes 1 No

Set Sensitivity level ?

0 Yes

Figure 6: Sequence Operation for Biometric Setting

> Security Level:

You can set security level. Security level will vary from 0 to 15.

If you set security level minimum, false rejection rate of the finger will be high and false

acceptance rate will be low.

But if you increase security level, false rejection rate of the finger will be decreased and FAR will

be high.

> Sensitivity Level:

You can set sensitivity level of finger sensor. It will vary from 0 to 8.

> Image Quality:

You can set level of image quality of finger. It will vary from 0-3.

> Enroll Mode:

You can set enroll mode of the finger.

> Displacement:

You can set displacement of 2 mm. If your finger is slightly displaced on sensor, sensor will automatically capture the approximate image of the finger within the range of 2 mm.

> Set Timeout:

This option is used for smart card with finger print attendance system. If you show the card, display shows “put finger”. In that case if you didn’t put the finger within duration of 10 seconds, display shows timeout. It will vary from 0 – 22 seconds.

> Baud Rate:

Baud rate is a predefine frequency for our machine. There are two baud rate for our machine i.e. 9600 and 115200.

> Sensor:

You can see what type of sensor you use in finger print machine.

> Finger print enrolled:

You can see how many finger you have enrolled.

> Remaining enrolled F space:

You can see how many fingers have been left in the machine.

> Light condition:

There are two type of light condition out door and in door condition.

If you put your attendance system under the light of sun, then you have to press 0 for OUT door condition. Machine will work properly.

If you put machine inside the company, you have to press 1 for IN door light condition. Machine will work properly.

> Auto scan:

This option is used for only finger and sensor will always be on in the case of only finger print attendance system.

> Scan Success :

This option is used to find/know whether the scan of the finger is successful or not while enrolling the finger. You have to set scan success always on in the case of enrolling the finger. If we set scan success off, at the time of enrolling the finger, display shows

Set Scan Success

Try Again

4.2.3. Functionalities of Key F3

This key is used to reset the whole system like variable, card list and punching data.

DEC-22 2007

SAT 13:40:21

Administer Mode

STARLINK PRODUCT

System Reset

0 YES 1 NO

Figure 7: Sequence of Operation of Key F2 in Administer Mode

i. System Reset

You can reset the whole system through this option.

If press key “0”, system will reset and all data will be deleted.

If press key “1”, system will not reset.

ii. Variable Reset

If you press key “0”, variables of machine will be deleted.

If you press key “1” variables of machine will not be deleted.

iii. Card List Reset

You can delete card list only.

If you press key “0”, list will be deleted.

If you press key “1”, cards list will not be deleted.

iv. Date Data Reset

You can use this option to delete the punching data from the machine.

If we press key “0”, punching data will be erased.

If we press key “1”, punching data will not be erased.

4.2.4. Functionalities of key F4

These functional key is used for enroll the finger and delete the finger with respect to card.

Card Wise – 0

Card No

Card wise-0

Sr. Number wise-1

Total cards:0001

Press key to cont.

Figure 8: Sequence Operation of Enroll Finger Card /Delete Finger with respect to Card i. Enroll the finger:

* Enter key “ENTER/EXIT” to switch to administer mode.

* Press key “F4” to switch to the enroll finger and delete finger.

* Press key 0 to enroll the finger. LCD display shows number of finger with respect to card have been registered in the machine

TOTAL CARDS:0004 Press Key to cont

Press key “NEXT” to switch the next operation.

* Enter the card number, you want to enroll finger with respect to that card.

Card No0001

To Enrole - NEXT

* Press key NEXT , LCD display shows

Press key 0 to register the finger

Now put the finger on the sensor and

Put finger !!!

0 YES 1 NO

PUT FINGER!!!

SCAN SUCCESS

Now again put finger on the sensor, LCD display shows

PUT FINGER!!!

SUCCESS

When process is complete, LCD display shows

DONE!!

SUCCESS

ii. Delete the card:

* Enter key “ENTER/EXIT” to switch to administer mode.

* Press key “F4” to switch to the enroll finger and delete finger.

* Press key 1 to delete finger with respect to card. LCD display shows

Card wise – 0

Sr. Number wise --1

You can delete the card through card number and sr. number wise. If you press key “0”, LCD display shows

Card wise - - 0

Card No. -

Enter the card number and press key “NEXT” to delete finger with respect to that card.

If you want to delete card through sr. no then press key “1”, LCD display shows

Card No. 11111111

To Erase Press F4

Card No: 11111111

USER DELETED

Manual Penggunaan Program

Yii

1. Install Xampp 1.7.3

2. Buatlah database dan tabelnya terlebih dahulu sebelum membuat aplikasi Yii agar bisa membuat CRUD.

3.Buka aplikasi yang sudah dibuat lalu buka folder protected kemudian buka lagi folder protected lalu buka file main cari tulisan

Jangan lupa hilangkan tanda /* dan tanda */, nama databasenya diganti dengan nama database yang sudah dibuat sebelumnya,password diisi bila menggunakan password.

Setelah itu masih dalam file main cari tulisan seperti dibawah ini, jangan lupa hilangkan tanda /* dan tanda */ dan berilah password sesuai keinginan

4.Berikutnya coba lakukan akses ke

http://localhost/kimora/index.php?r=gii kemudian masukan

password yang sudah di buat sebelumnya lalu pilih Model

Codeigniter

1. Install Xampp 1.7.3

2. Dump database yang ada di file blog.sql ke dalam database server, dengan cara menginport file blog.sql ke dalam database yang sudah dibuat di dalam database server

3. Pindahkan folder yang berisi sistem informasi ke dalam folder (xampp\htdocs)

4. Buka browser , kemudian masuk ke link dimana folder sistem informasi lowongan di simpan (http://localhost/blog/index.php) . Jika sistem belum tampil periksa kembali koneksi database atau server (php dan mysql) sudah dalam keadaan running.

GHTF/SG1/N70:2011

FINAL DOCUMENT

Global Harmonization Task Force

Title: Label and Instructions for Use for Medical Devices

Authoring Group: Study Group 1 of the Global Harmonization Task Force

Endorsed by: The Global Harmonization Task Force

Date: September 16th, 2011

Dr. Kazunari Asanuma, GHTF Chair

This document was produced by the Global Harmonization Task Force, a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia.

The document is intended to provide non-binding guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.

Label and Instructions for Use for Medical Devices

Study Group 1 Final Document GHTF/SG1/N70:2011

Table of Contents

1.0 Introduction

2.0 Rationale, Purpose and Scope

2.1 Rationale

2.2 Purpose

2.3 Scope

3.0 References

4.0 Definitions

5.0 General Principles

6.0 Label and Instructions for Use for Medical Devices other than IVD Medical Devices

6.1 Content of the Label

6.2 Content of the Instructions for Use .............................

7.0 Label and Instructions for use for IVD Medical Devices

7.1 Content of the Label

7.2 Content of the Instructions for Use .............................

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Preface

The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory authorities and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution, translation or use of this document. However, incorporation of this document, in part or in whole, into any other document does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.

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1.0 Introduction

The primary way in which the GHTF achieves its goals is through the production of a series of guidance documents that together describe a global regulatory model for medical devices. The purpose of such guidance is to harmonize the documentation and procedures that are used to assess whether a medical device conforms to the regulations that apply in each jurisdiction. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.

This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities (RAs), Conformity Assessment Bodies (CABs) and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of Regulatory Authorities to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry.

Labelling1 serves to identify a device and its manufacturer, and to communicate information on safety, use and performance. It is intended for users of medical devices, including IVD medical devices, both professional and lay, as appropriate, and for relevant third parties. RAs require and specify information that manufacturers are expected to incorporate in the labelling when the device is placed onto the market. The GHTF identified as a priority the need to harmonize the content of the labelling and has published guidance on the subject as GHTF/SG1/N043:2005 Labelling for Medical Devices.

This document supersedes that previous version. It has been changed to:

* indicate which information should be included on the label and in the instructions for use, and

* provide a separate section within the document for IVD medical devices.

Where other guidance documents within the series are referenced within this text, their titles are italicised for clarity.

Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this guidance document. Comments or questions should be directed to either the Chairman or Secretary of GHTF Study Group 1 whose contact details may be found on the GHTF web page2.

2.0 Rationale, Purpose and Scope

2.1 Rationale

Consistent worldwide requirements for medical device labelling would offer significant benefits to the manufacturer, user, patients and RAs. Eliminating or reducing differences

1 Some regional and national regulations use the term ‘information supplied by the manufacturer’ rather than ‘labelling’. This document uses the term ‘labelling’.

2 www.ghtf.org

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Study Group 1 Final Document GHTF/SG1/N70:2011

between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.

2.2 Purpose

To provide guidance to manufacturers and RAs on the content of the label and the instructions for use that provide users, both professional and lay as appropriate, and/or patients, and any relevant third parties with information such as:

* the device’s identity;

* the identity of the manufacturer;

* the device’s intended use/purpose;

* how the device should be used, maintained and stored;

* any residual device risks, warnings, limitations or contraindications;

* the device’s performance.

whilst also promoting:

* labelling commensurate with the technical knowledge, experience, education or training of intended users;

* consistent use of terminology;

* use of symbols;

* the avoidance of prescriptive country-specific requirements for text, content, or format of labelling that offers no benefit to the device user or, where applicable, the patient.

2.3 Scope

This document applies to all products that fall within the definition of a medical device that appears within the GHTF document Information Document Concerning the Definition of the Term “Medical Device”.

Advertising and promotional materials are outside the scope of this document.

3.0 References

GHTF final documents3

GHTF/SG1/N044:2008 Role of Standards in the Assessment of Medical Devices.

3 The listed documents are subject to periodic review and may be superseded by later documents. The reader is encouraged to refer to the GHTF website www.ghtf.org to confirm whether the referenced documents remain current. Revisions of both GHTF/SG1/N029:2005 an d GHTF/SG1/N041:2005 are at an advanced stage.

September 16th, 2011 Page 5 of 17

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GHTF/SG1/N029:2005 Information Document Concerning the Definition of the Term “Medical Device”.

GHTF/SG1/N041:2005 Essential Principles of Safety and Performance of Medical Devices.

GHTF/SG1/N055:2009 Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer.

4.0 Definitions

Clinical investigation: any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device.

Information supplied by the manufacturer: means ‘Labelling’.

Label: written, printed, or graphic information either appearing on the medical device itself, or on the packaging of each unit, or on the packaging of multiple devices.

Labelling: the label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents.

Lay person: individual that does not have formal training in a relevant field or discipline.

Instructions for use: information provided by the manufacturer to inform the device user of the medical device’s intended purpose and proper use and of any precautions to be taken.

Intended use / purpose: The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer.

Performance evaluation for an IVD medical device: investigation process of an IVD medical device for the purpose of establishing or verifying its performance.

Single use device: means the medical device is intended to be used on an individual patient during a single procedure and then disposed of. It is not intended to be reprocessed and used again.

User: the person, either professional or lay, who uses a medical device. The patient may be the user.

5.0 General Principles

This section describes the general principles that apply equally to all medical devices, including IVD medical devices.

The primary purpose of labelling is to identify the medical device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on packaging or as instructions for use. The following principles are recommended.

September 16th, 2011 Page 6 of 17

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Study Group 1 Final Document GHTF/SG1/N70:2011

* The medium, format, content, legibility, and location of the label and instructions for use should be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use should be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. Some devices may include separate information for the professional user and the lay person.

* The information required on the label, should be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.

* Where the manufacturer supplies multiple devices to a single user and/or location, it may be sufficient to provide only a single copy of the instructions for use. In these circumstances, the manufacturer should provide further copies upon request.

* Instructions for use may not be needed or may be abbreviated for devices if they can be used safely and as intended by the manufacturer without any such instructions for use.

* Labels should be provided in a human-readable format but may be supplemented by machine-readable forms, such as radio-frequency identification (RFID) or bar codes 4.

* Instructions for use may be provided to the user either in paper or non-paper format (e.g. electronic). They may be supplied by various means either with the medical device or separate from it. Examples of other means are information displayed on a screen incorporated into the device, information downloaded from the manufacturer’s web site using the internet, and machine-readable sources. The means chosen should be appropriate for, and accessible to, the anticipated user population.

* Where instructions for use are provided on a medium other than paper, the manufacturer should ensure the user has information on how to:

a) view the instructions for use;

b) access the correct version of the instructions for use; and

c) obtain a paper version of the instructions for use.

Note: the RA may set the conditions under which such non-paper format should be provided to guarantee a high level of protection of health. Those conditions may specify the types of devices that can use a non-paper format and the requirements the manufacturer needs to respect, such as, that the manufacturer should upon request provide a paper version of the instructions for use free of charge.

4 Also refer to the final version of the draft guidance document GHTF/AH/(PD2)N2R2 Unique Device Identification (UDI) System for Medical Devices for information on labels for UDI purposes.

September 16th, 2011 Page 7 of 17

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Study Group 1 Final Document GHTF/SG1/N70:2011

* Residual risks which are required to be communicated to the user5 and/or other person should be included as limitations, contraindications6, precautions or warnings in the labelling.

* The use of internationally recognised symbols7 should be encouraged provided that device safety is not compromised by a lack of understanding on the part of the user. Where the meaning of the symbol is not obvious to the device user, e.g. for a newly introduced symbol, an explanation should be provided within the instructions for use.

* Country-specific requirements for the content of the labelling should be kept to the minimum and, where they currently exist, eliminated as the opportunity arises.

* Where national legislation, such as customs statutes, trade agreements and the like, include requirements for additional documentation to accompany the medical device, there may be an inconsistency between the additional documentation and the content of medical device labelling described in this guidance document. An example is a customs requirement to indicate the ‘country of origin’ of the medical device which does not necessarily align with the address of the manufacturer indicated in the labelling according to Section 6.1(c) or Section 7.1(c) of this document.

* Provided that safe and correct use of the device is ensured, a RA may authorise labelling to be in one or more language(s) other than its national language(s).

6.0 Label and Instructions for Use for Medical Devices other than IVD Medical Devices

6.1 Content of the Label

The label should contain the following particulars which may appear on the medical device itself, or on the packaging of each unit, or on the packaging of multiple devices.

a) The name or trade name of the medical device.

b) The details strictly necessary for a user to identify the device and its use, e.g. ‘cardiac ablation catheter 10 French / 20 cms’ or ‘paediatric thermometer’ or ‘tongue depressor’, and a product catalogue code.

5 See essential principle 5.2 of GHTF/SG1/N41:2005 Essential Principles of Safety and Performance of Medical Devices.

6 ‘Contraindications’ is a term that is not relevant to IVD medical devices.

7 Such as those found in ISO 15223-1:2007 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements.

September 16th, 2011 Page 8 of 17

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Study Group 1 Final Document GHTF/SG1/N70:2011

c) The name and address of the manufacturer8 in a format that is recognisable and allows the location of the manufacturer to be established9.

d) For imported devices, the name and postal address of the authorised representative, or importer or distributor established within the importing country/jurisdiction may be required. This information may be added by the authorised representative, importer, or distributor within the country of import, rather than be provided by the manufacturer, in which case, the additional label should not obscure any of the manufacturer's labels.

e) Where appropriate, an indication that the device contains or incorporates a medicinal or biological substance, e.g. heparin coated catheter.

f) The batch code/lot number or the serial number of the device preceded by the word LOT or SERIAL NUMBER or an equivalent symbol, as appropriate, to allow post-market action to be taken if there is a need to trace or recall the device.

g) An unambiguous indication of the date until when the device may be used safely, expressed at least as the year and month (e.g. on devices supplied sterile or single use disposable devices), where this is relevant.

h) Where there is no indication of the date until when it may be used safely, the year of manufacture. This year of manufacture may be included as part of the batch or serial number, provided the date is clearly identifiable.

i) An indication of any special storage and/or handling condition that applies.

j) If the device is supplied sterile, an indication of its sterile state and, where appropriate, the sterilization method.

k) Warnings or precautions to be taken that need to be brought to the immediate attention of the user of the medical device as relevant, and to any other person where appropriate (e.g. ‘CAUTION – HOT SURFACE’ or ‘THIS PRODUCT CONTAINS LATEX’). This information may be kept to a minimum in which case more detailed information should appear in the instructions for use.

l) If the device is intended for single use, an indication of that fact.

Note: According to Note 5 of GHTF/SG1/N055:2009 Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer, any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device. As a consequence, a reprocessor of a single use device would be subject to the same requirements as those applicable to a manufacturer. In those jurisdictions where reprocessing of single use devices is allowed, the fact that a single use device has been reprocessed should be indicated on the label also”.

8 As defined in GHTF/SG1/N055:2009 Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer.

9 An abbreviated version of the address may be sufficient on the label if the device is accompanied by instructions for use that provide a full address.

September 16th, 2011 Page 9 of 17

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m) If the device is for use by a single individual and has been manufactured according to a written prescription or pattern (i.e. it is custom made), an indication of that fact.

n) If the device is intended for premarket clinical investigation only, an indication of that fact.

Note: In this situation, some of the label content listed above may not apply.

o) If the device is intended for non-clinical research, teaching or testing purposes only, an indication of that fact.

Note: In this situation, some of the label content listed above may not apply.

p) If the device is intended for presentation or demonstration purposes only, an indication of that fact.

Note: In this situation, some of the label content listed above may not apply.

For guidance on the information to be incorporated within the label for Unique Device Identification (UDI) purposes, refer to the GHTF guidance document on this subject10.

6.2 Content of the Instructions for Use

The instructions for use should contain the following particulars:

a) The name or trade name of the medical device.

b) The name and address of the manufacturer in a format that is recognisable and allows the location of the manufacturer to be established, together with a telephone number and/or fax number and/or website address to obtain technical assistance.

c) The device’s intended use/purpose including the intended user (e.g. professional or lay person), as appropriate.

d) The performance of the device intended by the manufacturer.

e) Where the manufacturer has included clinical investigations as part of premarket conformity assessment to demonstrate conformity to Essential Principles, a summary of the investigation, outcome data and clinical safety information, or a reference as to where such information may be accessed.

f) Any residual risks, contraindications and any expected and foreseeable side effects, including information to be conveyed to the patient in this regard.

g) Specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it.

10 See the final version of the draft document GHTF/AH/(PD2)N2R2 Unique Device Identification (UDI) System for Medical Devices.

September 16th, 2011 Page 10 of 17

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Study Group 1 Final Document GHTF/SG1/N70:2011

h) If the device contains, or incorporates, a medicinal substance and/or material of biological origin, identification of that substance or material, as appropriate.

i) Details of any preparatory treatment or handling of the device before it is ready for use (e.g. sterilization, final assembly, calibration, etc.).

j) Any requirements for special facilities, or special training, or particular qualifications of the device user and/or third parties.

k) The information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:

* details of the nature, and frequency, of preventative and regular maintenance, and of any preparatory cleaning or disinfection;

* identification of any consumable components and how to replace them;

* information on any necessary calibration to ensure that the device operates properly and safely during its intended life span;

* methods of eliminating the risks encountered by persons involved in installing, calibrating or servicing medical devices.

l) An indication of any special storage and/or handling condition that applies.

m) If the device is supplied sterile, instructions in the event of the sterile packaging being damaged before use.

n) If the device is supplied non-sterile with the intention that it is sterilized before use, the appropriate instructions for sterilization.

o) If the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of re-sterilization. Information should be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses.

p) For devices intended for use together with other medical devices and/or general purpose equipment:

* information to identify such devices or equipment, in order to obtain a safe combination,

and/or

* information on any known restrictions to combinations of medical devices and equipment.

q) If the device emits hazardous, or potentially hazardous levels of radiation for medical purposes:

* detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation;

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Study Group 1 Final Document GHTF/SG1/N70:2011

* the means of protecting the patient, user, or third party from unintended radiation during use of the device;

r) Information that allows the user and/or patient to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device. This information should cover, where appropriate:

* warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety;

* warnings, precautions and/or measures to be taken in regards to the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature;

* warnings, precautions and/or measures to be taken in regards to the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, therapeutic treatment or use (e.g. electromagnetic interference emitted by the device affecting other equipment);

* if the device administers medicinal or biological products, any limitations or incompatibility in the choice of substances to be delivered;

* warnings, precautions and/or limitations related to the medicinal substance or biological material that is incorporated into the device as an integral part of the device;

* precautions related to materials incorporated into the device that are carcinogenic, mutagenic or toxic, or could result in sensitisation or allergic reaction of the patient or user.

s) Warnings or precautions to be taken related to the disposal of the device, its accessories and the consumables used with it, if any. This information should cover, where appropriate:

* infection or microbial hazards (e.g. explants, needles or surgical equipment contaminated with potentially infectious substances of human origin);

* environmental hazards (e.g. batteries or materials that emit potentially hazardous levels of radiation);

* physical hazards (e.g. from sharps).

t) For devices intended for use by lay persons, the circumstances when the user should consult with a healthcare professional.

u) Date of issue or latest revision of the instructions for use and, where appropriate, an identification number.

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Label and Instructions for Use for Medical Devices

Study Group 1 Final Document GHTF/SG1/N70:2011

7.0 Label and Instructions for use for IVD Medical Devices

7.1 Content of the Label

The label should contain the following particulars which may appear on the medical device itself, or on the packaging of each unit, or on the packaging of multiple devices.

a) The name or trade name of the IVD medical device.

b) Where not obvious, the details strictly necessary for a user to identify the IVD medical device and its use, e.g. ‘HIV-1/HIV-2 Antibody Test’ or ‘Blood Glucose meter’ or ‘Blood Gas Analyzer’.

c) The catalogue number of the IVD medical device.

d) The name and address of the manufacturer11 in a format that is recognisable and allows the location of the manufacturer to be established12.

e) For imported IVD medical devices, the name and postal address of either the authorised representative, or importer or distributor established within the importing country/jurisdiction may be required. This information may be added by the authorised representative, importer or distributor within the country of import, rather than be provided by the manufacturer, in which case, the additional label should not obscure any of the manufacturer's labels.

f) An indication that the device is for in vitro diagnostic use.

g) The batch code/lot number or the serial number of the IVD medical device preceded by the word LOT or SERIAL NUMBER or an equivalent symbol, as appropriate, to allow post-market action to be taken if there is a need to trace or recall the IVD medical device. However for accessories this may be substituted with a control number and for software it should be substituted with a version number.

h) An unambiguous indication of the date until when the IVD medical device may be used safely, expressed at least as the year and month (e.g. on reagents or consumables), where this is relevant.

i) For instruments, where there is no indication of the date until when it may be used safely, the year of manufacture. This year of manufacture may be included as part of the batch or serial number, provided the date is clearly identifiable.

j) Where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of these or other terms which accurately reflect the contents of the package.

11 As defined in GHTF/SG1/N055:2009 Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer.

12 An abbreviated version of the address may be sufficient if the device is accompanied by instructions for use that provide a full address.

September 16th, 2011 Page 13 of 17

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Study Group 1 Final Document GHTF/SG1/N70:2011

k) An indication of any special storage and/or handling condition that applies.

l) If the IVD medical device is supplied as sterile, an indication of its sterile state and, where appropriate, the sterilization method.

m) Warnings or precautions to be taken that need to be brought to the immediate attention of the professional user, the lay person or other person (e.g. ‘CAUTION – LASER’ or ‘CONTAINS POTENTIALLY INFECTIOUS MATERIAL’). This information may be kept to a minimum in which case more detailed information will appear in the instructions for use.

n) Where relevant, if the IVD medical device is intended for single use and there is a potential risk of re-use, (e.g. blood collection tubes), an indication of that fact.

o) If the IVD medical device is intended for premarket performance evaluation only, an indication of that fact.

Note: In this situation, some of the label content listed above may not apply.

p) If the IVD medical device is intended for non-clinical research or use, teaching or testing purposes only, an indication of that fact. That indication may be added by the authorised representative, importer or distributor within the country of import, rather than be provided by the manufacturer.

Note: In this situation, some of the label content listed above may not apply.

q) If the IVD medical device is intended for presentation or demonstration purposes only, an indication of that fact. That indication may be added by the authorised representative, importer or distributor within the country of import, rather than be provided by the manufacturer.

Note: In this situation, some of the label content listed above may not apply.

r) IVD medical device kits include individual reagents and articles that may be made available as separate IVD medical devices. In this situation, these IVD medical devices should comply with the label content in this section.

For more guidance on the inner and outer container label elements refer to the ISO 18113 standard series.

For guidance on the information to be incorporated within the label for Unique Device Identification (UDI) purposes, refer to the GHTF guidance document on this subject13.

7.2 Content of the Instructions for Use

The instructions for use should contain the following particulars:

13 See the final version of the draft document GHTF/AH/(PD2)N2R2 Unique Device Identification (UDI) System for Medical Devices.

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Study Group 1 Final Document GHTF/SG1/N70:2011

a) The name or trade name of the IVD medical device.

b) The IVD medical device’s intended use/purpose (further guidance on elements which, when relevant, should be included in the intended use/purpose is provided in the STED document14):

* what is detected;

* its function (e.g. screening, monitoring, diagnosis or aid to diagnosis);

* the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate;

* whether it is automated or not;

* whether it is qualitative or quantitative;

* the type of specimen(s) required (e.g. serum, plasma, whole blood, tissue biopsy, urine); and

* testing population.

c) An indication that it is for in vitro diagnostic use.

d) The intended user, as appropriate (e.g. lay person).

e) Test principle.

f) A description of the reagent, calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated instrument only).

Note: IVD medical device kits include individual reagents and articles that may be made available as separate IVD medical devices. In this situation, where appropriate, these IVD medical devices should comply with the instructions for use content in this section.

g) A list of materials provided and a list of special materials required but not provided.

h) For IVD medical devices intended for use together with other medical devices, including IVD medical devices, and/or general purpose equipment

* information to identify such devices or equipment, in order to obtain a safe combination,

and/or

* information on any known restrictions to combinations of medical devices and equipment.

i) An indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling conditions that apply.

14 See GHTF/SG1/N063:2011 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED).

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Label and Instructions for Use for Medical Devices

Study Group 1 Final Document GHTF/SG1/N70:2011

j) In use stability which may include, the storage conditions, and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions, where this is relevant.

k) If the IVD medical device is supplied as sterile, instructions in the event of the sterile packaging being damaged before use.

l) Information that allows the user to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the IVD medical device. This information should cover, where appropriate:

* warnings, precautions and/or measures to be taken in the event of malfunction of the IVD medical device or its degradation as suggested by changes in its appearance that may affect performance;

* precautions related to materials incorporated into the IVD medical device that are carcinogenic, mutagenic or toxic, or could result in sensitisation or allergic reaction.

m) Any warnings and/or precautions related to potentially infectious material that is included in the IVD medical device.

n) Where relevant, requirements for special facilities (e.g. clean room environment) or special training (e.g. radiation safety), or particular qualifications of the device user.

o) Conditions for collection, handling, and preparation of the specimen.

p) Details of any preparatory treatment or handling of the IVD medical device before it is ready for use (e.g. reconstitution, calibration, etc.).

q) The information needed to verify whether the IVD medical device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:

* details of the nature, and frequency, of preventative and regular maintenance (including cleaning and disinfection);

* identification of any consumable components and how to replace them;

September 16th, 2011 Page 16 of 17

Label and Instructions for Use for Medical Devices

Study Group 1 Final Document GHTF/SG1/N70:2011

* information on any necessary calibration to ensure that the IVD medical device operates properly and safely during its intended life span;

* methods of mitigating the risks encountered by persons involved in installing, calibrating or servicing IVD medical devices, e.g. contaminated surfaces.

r) Where relevant, recommendations for quality control procedures.

s) The metrological traceability of values assigned to calibrators and trueness-control materials, including identification of applicable reference materials and/or reference measurement procedures of higher order.

t) Assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing should be considered.

u) Analytical performance characteristics, such as sensitivity, specificity, and accuracy (which is a combination of trueness and precision).

v) Where relevant, clinical performance characteristics, such as diagnostic sensitivity and diagnostic specificity.

w) Where relevant, reference intervals.

x) Information on interfering substances or limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age of specimen/sample) that may affect the performance of the assay.

y) Warnings or precautions to be taken related to the disposal of the device, its accessories, and the consumables used with it, if any. This information should cover, where appropriate:

* infection or microbial hazards (e.g. consumables contaminated with potentially infectious substances of human origin);

* environmental hazards (e.g. batteries or materials that emit potentially hazardous levels of radiation);

* physical hazards (e.g. explosion).

z) For IVD medical devices intended for use by lay persons, the circumstances when the user should consult with a healthcare professional.

aa) Where relevant, a bibliography.

bb) The name and address of the manufacturer in a format that is recognisable and allows the location of the manufacturer to be established, together with a telephone number and/or fax number and/or website address to obtain technical assistance.

cc) Date of issue or latest revision of the instructions for use and, where appropriate, an identification number.

September 16th, 2011 Page 17 of 17

Manual:TOC 1

Manual:TOC

[See Also TOC by Menus]

Basic

* First Time Startup

* Initial Configuration using WebFig

* Console Login Process

* Troubleshooting Tools

* Support output file

* RouterOS features

* RouterOS FAQ

* Connection Oriented Communication (TCP/IP)

Management tools

* Console

* Winbox

* WebFig

RouterOS Licensing

* License

* Purchasing a License for RouterOS

* Entering a RouterOS License key

* Replacement Key

Hardware

* Product Naming

What's New

* What's new in v6

RouterOS Installation and packages

* Default Configurations on RouterBOARDS

* RouterOS package types

* Upgrading RouterOS

* CD Install

* Netinstall

* Configuration Management

Interface

List of reference sub-pages Case studies List of examples

List of reference sub-pages Case studies List of examples

IPv6

List of reference sub-pages Case studies List of examples

Routing

List of reference sub-pages Routing protocol case studies List of examples

<splist parent=M:Routing showparent=yes /> BGP

OSPF

Other

MPLS

List of reference sub-pages Case studies List of examples

Manual:TOC 2

* Interface

* vpls

* traffic-eng

* MPLS

* ldp

* traffic-eng

General

* MPLS Overview and RouterOS MPLS Implementation Status

* EXP bit behaviour

* L2MTU

Layer2 VPN

* LDP and LDP based VPLS

* BGP based VPLS

* Cisco style VPLS

* VPLS Control Word

Layer3 VPN

* Virtual Routing and Forwarding (VRF)

* OSPF as PE-CE routing protocol

* EBGP as PE-CE routing protocol

Traffic Engineering

* TE Tunnels

* TE Tunnel Bandwidth Control

General

* MPLS over PPPoE

Layer2 VPN

* P2P L2VPN to Juniper router

Layer3 VPN

* A complete Layer-3 MPLS VPN example

* VRF Route Leaking

* Internet access from VRF

* Internet access from VRF with NAT

Traffic Engineering

* Simple TE configuration

* TE tunnels for VPLS

System

List of reference sub-pages Case studies List of examples

Tools

List of reference sub-pages Case studies List of examples

OLD

Basic

* First Time Startup

* Initial Configuration using WebFig

* Console Login Process

* Troubleshooting Tools

* Support output file

* RouterOS features

* RouterOS FAQ

* Connection Oriented Communication (TCP/IP)

Management tools

* Console

* Winbox

* WebFig

RouterOS Licensing

* License

* Purchasing a License for RouterOS

* Entering a RouterOS License key

* Replacement Key

Hardware

* Product Naming

What's New

* What's new in v6

RouterOS Installation and packages

* Default Configurations on RouterBOARDS

* RouterOS package types

* Upgrading RouterOS

* CD Install

* Netinstall

* Configuration Management

Interfaces Wireless VPN

Manual:TOC 3

General reference and protocols

* Wireless Interface Reference

* Wireless AP Client

* Wireless Station Modes

* NV2 protocol

* WMM

* Spectrum Analyzer

* Wireless Advanced Channels

* HWMP+

Configuration examples

* Making A Simple Wireless AP Misc

* Wireless FAQ

* Wireless Debug Logs

Virtual Lan Network (VLAN)

* IP Security (Ipsec)

Point to point Tunnels

* Ethernet Over IP (EoIP)

* GRE tunnel

* IPIP tunnel

PPP tunnels

* PPP

* PPPoE

* PPTP

* L2TP

* SSTP

* OpenVPN

* PPP tunnel bridging protocol (BCP)

* MLPPP

MPLS Based VPNs

* VPLS

IP/ IPv6 Addressing Simple IPv4/IPv6 Routing DHCP

* Ip security settings

IPv4

* Ip address

* ARP

* Load Balancing Multiple Same Subnet Links

IPv6

* Ipv6 Settings

* IPv6 Address

* Neighbor Discovery and Stateless Auto Configuration

* My First IPv6 Network

* Creating IPv6 Loopback Address

IP/IPv6 Firewall Dynamic Routing Traffic control

IP Firewall

* Filters

* NAT

* Mangle

* Address Lists

* Layer 7 (L7) rules

* Connection tracking

IPv6 Firewall

* Filters

* Mangle

* Address Lists

Misc

* RouterOS and firewall services

* Per connection classifier (PCC)

* Connection Rate

* NTH Matcher

* Routing Table Matcher

Routing filters

OSPF

* OSPF Case Studies

* OSPF Exampes

* OSPF and Point-to-Point Interfaces

OSPFv3

* OSPFv3 with Quagga

BGP

* BGP HowTo & FAQ

* BGP Soft Reconfiguration

* BGP Load Balancing

* Simple BGP Multihoming

* Using Scope and Target-scope Attributes

RIP

* Prefix list

MME

* MME Case Studies

Multicast Routing

Queue

* HTB

* Queue Size

* Bursting

* PCQ

* PCQ Examples

* Packet Flow Diagram

* Packet Flow Diagram for version 6

MPLS Based Traffic control

* Traffic Engineering Tunnels

* TE Tunnel Auto Bandwidth

* Simple TE tunnel Example

* TE Tunnels Example Setup for VPLS

* Traffic Engineering reference

Manual:TOC 4

MPLS User Management Virtualization

MPLS in General

* MPLS Overview

* MPLS Over PPPoE

* EXP Bit Behaviour

LDP

* LDP

* LDP Based VPLS

* Cisco VPLS

BGP VPLS

* BGP Based VPLS

* VPLS Control Word

L3VPN

* Router AAA

* PPP AAA

* RADIUS Client

* User Manager

Hotspot

* Hotspot Introduction

* Customizing Hotspot

* Hotspot Reference

Virtualization in general

* KVM

* Metarouter

* XEN

* Virtual Ethernets

* Virtual Routing And Forwarding

* Layer3 MPLS VPN Example

* EBGP as PE-CE Routing Protocol

* OSPF as PE-CE Routing Protocol

Traffic Engineering

* TE Tunnels

* TE Tunnel Auto Bandwidth

Reference

* mpls/traffic-eng

* interface/traffic-engineering

Console Monitoring Hardware

* Serial and USB port configuration

•

System Logging

•

NAND Partitions

* Console in general

•

UPS Control and Monitoring

•

Grounding

* Console Login Process

•

LCD Display Control

•

Wireless Card Diagnostics

* Line Editor

•

LCD Touch Screen Control

•

RouterBOARD Bad Blocks

Console Access Methods

•

GPS

•

Password Reset

•

Traffic Flow (NetFlow)

•

Flashfig

* Special Login

•

SNMP

•

Bootloader Upgrade

* Serial Console

•

Graphing

Scripting

•

CPU Profiler

* Console Scripting

•

Packet Sniffer

* Scripting Examples

•

Other Diagnostic Tools

* LUA Scripting

SSH

* SSH Client

* SSH Forwarding

Manual:TOC g

0ther

* Certificates

* Create Certificates

* Advanced Traffic Generator

* Bandwidth Test tool

* LED configuration

* Administrator Notes

* File List

* Resource Monitoring

* Health Monitoring

* Store

* Watchdog

* Scheduler

* System Time

* API

* Web Proxy

* Fast Path

* Fetch tool

Article Sources and Contributors 6

Article Sources and Contributors

Manual:TOC Source: http://wiki.mikrotik.com/indes.php7oldid=26701 Contributors: Becs, Marisb

Process Oriented Production System for Service Providing Companies

E. Schweitzer, J. C. Aurich

Institute for Manufacturing Technology and Production Systems, University of Kaiserslautern, Germany

schweitzer@cpk.uni-kl.de

Abstract

Design and realization of services are affected by high individuality and high requirements of quality and productivity. To meet these requirements, numerous approaches have been developed in service research. Although these existing approaches allow a selective methodological support of service design and realization, concepts that transparently display the interrelations between existing approaches and thus allow a coordinated and standardized methodological support of service design and realization are not common. Furthermore, an organizational framework for service providing companies that enables staff to continuously improve both service quality and productivity on the job is missing. To close these gaps, the concept of process oriented production systems that evolved from companies producing physical goods represents a promising starting point. This paper therefore illustrates a framework for a process oriented production system for service providing companies.

Keywords

Service, Production System, Methodology

1 INTRODUCTION

In recent years, market structures and competitive environment of service markets continuously changed. This also led to an increasing dynamic of innovation in the service sector [1]. As a consequence, service providing companies cannot gain advantages in competition by being the cost, quality or technology leader in the market. Furthermore, differentiation by innovative and sustainable services became a crucial factor of success.

To increase competitiveness and to fulfil customer requirements, service providing companies are forced to offer services of high individuality while ensuring high quality and productivity [2]. Thereby, it is up to the service providers to design and organize the service processes in a way that guaranties efficiency in terms of productivity and cost effectiveness. To meet these requirements, numerous approaches have been developed in service research. Although these existing approaches allow a selective methodological support of service design and realization, concepts that transparently display the interrelations between existing approaches and thus allow a coordinated and standardized methodological support of service design and realization are not common. Furthermore, an organizational framework for service providing companies that enables staff to continuously improve both service quality and productivity on the job is missing [3].

To close these gaps, the concept of process oriented production systems that evolved from companies producing physical goods represents a promising starting point. This paper therefore discusses chances and limits of transferring the concept of process oriented production systems to service providing companies and illustrates a framework for a process oriented production system for service providing companies. A concept for planning, implementing as well as steering the process oriented production system for service providing companies completes this paper.

CIRP IPS2 Conference 2010

2 SERVICES

2.1 Characteristics of Services

In the research community, the definitions of service are multifaceted. Up to now, there is no definition available that is generally accepted. Already existing definitions can be classified into following categories: enumerative, negative, institutional and constitutive definitions [4]. From a scientific point of view, the constitutive definition represents the most suitable. It defines service based on specific constitutive attributes [4]. Thereby, there is no global consensus in research concerning these service attributes.

The American literature distinguishes between four main characteristics specifying services:

* Intangibility: Services are predominantly performances of actions rather than objects that can be perceived using any of the physical senses.

* Heterogeneity: Service products quality is subject to variability because services are delivered by people to people.

* Simultaneity of production and consumption: Service products are typically produced and consumed at the same time – consumption cannot be separated from the means of production.

* Perishability: Services must be consumed as they are provided. In general, they cannot be saved, stored, returned or carried forward for later use or sale [5].

Authors in British literature also base their definitions on these characteristics. Additionally, relations between them are introduced. In this way, intangibility and cus-tomer integration are pointed out as the two main characteristics of services [5]. Thereby, the other service characteristics could be derived from the two main characteristics, e.g. perishability could be derived from intangibility and both simultaneity and heterogeneity could be derived from customer integration. German authors also consider intangibility and customer integration as the main service characteristics. Based thereon, every other characteristic can be derived [6]. Depending on the kind of service, external factors can be personnel resources as well as objects (e.g. physical goods) of the customer.

323

Service Production Process

Service Design Service Realization

Figure 1: Service Production Process.

When designing and realizing services, three dimensions of services need to be distinguished [4]:

* The result dimension: service components provide the customer with a certain set of expected func-tionalities.

* The process dimension: service realization is based on different processes that continuously change the state of both the service provider and the customer.

* The infrastructure dimension: the company offering the service provides the resources needed for executing the service realization.

2.2 Service Production Processes

A service life cycle consists of two main phases: service design and service realization, whereas service realization follows the service design process [7]. This service life cycle is also referred to service production [8] (Figure 1).

Service design comprises both the planning and the conceptualization of a service as well as the preparation of service realization [9]. Within the service realization, certain activities (process dimension) were carried out on or with the external factors by the service provider applying certain resources (potential dimension). The aim of the activities is to generate an expected result (result dimension). Customer interaction as one of the core characteristics of services primarily takes place during the service realization phase [9].

Service Design

Already existing approaches to systematic service design (e.g. [10]) mostly comprise three main phases:

* Service Planning

* Service Conceptualization

* Implementation Planning

Service planning comprises all activities necessary for finding, formulating and evaluating service ideas. After the analysis of internal potential, an analysis of the market situation follows. Based on the results, promising service ideas are chosen, formulated in detail and evaluated in a next step. Thus, service planning aims at getting formulated and evaluated service ideas.

The aim of the service conceptualization phase is to substantiate the idea gathered in the service planning phase. Thereby, the components of a service are defined and described by means of predefined service models comprising all characteristics of services. The result of this phase is represented by a model-based service description evaluated against feasibility and marketability.

Implementation planning aims at guaranteeing a systematic and efficient implementation of the service realization phase. This comprises the planning of the resources as well as the processes necessary for the implementation of service realization. At the end of this phase there is a completely designed service.

Service Realization

324

The service realization process can be divided into three main phases as well:

* Preparation

* Implementation

* Documentation

The preparation comprises the contacting as well as the planning of the later implementation. By contacting the customer, the appointment for the service implementation is granted. The implementation planning then focuses on the definition of the scope of work as well as the allocation of the required resources.

The implementation phase comprises the substantiation of the initial situation of the customer as well as the realization of the expected service result.

Following the service implementation, the information gathered during the servicing processes are documented and analyzed.

2.3 Service Production Management

Two essential functions of the service production management can be derived from the characteristics of service production processes:

* Service production has to be of a continuous customer orientation. Thereby, already existing infor-mation provides the basis for both design and realization of service providers’ activities that aim at providing the customer with an expected result [11].

* With respect to the efficiency of both the service production processes realized within the service providing company as well as the interaction with the customer, design and realization of service produc-tion processes has to consider the importance of the customer and to take advantage of him [12].

Strategic Service Management

The establishment, development and continuance of a service oriented business culture represent the essential strategic task of an intentional service management. This requires a consistently implementated customer orientation as a central value of the business culture [13].

The definition of standards concerning customer integration represents the major task of the functional service management. Thereby, the form of customer interaction during the service production has to be defined considering spatial, chronological, functional and social criteria.

Operational Service Management

The constitutive service characteristics as well as strategic decisions affect a multitude of activities that aim at supporting both design and organization of the service production. According to Stauss, these activities can be summarized as follows [14]:

* Tangibility management

* Management of environmental aspects

* Capacity management

* Time management and scheduling

* Human resource management

* Customer management

* Process management

* Quality management

2.4 Conclusions for Methodological Service Support

To strengthen the competitive situation of service providing companies as well as to improve their market position, services have to be realized in a high process and product quality, comparable to the standards of the production of physical goods. Therefore, it becomes necessary that the engineers involved in design and realization of service production processes would link the methods and tools that are already established in the production of physical goods. The experiences made in this step will help them to design and organize costumer oriented and innovative service production processes more efficiently [15].

3 PROCESS ORIENTED PRODUCTION SYSTEMS

The idea of process oriented production systems as they are widespread in companies producing physical goods goes back to the Toyota Production System (TPS).

The founder of Toyota, Sakichi Toyoda and his engineer Taiichi Ohno developed the so called Toyota Production System (TPS) to cope with the market pressure under turbulent market conditions [16]. The TPS can be regarded as a general framework and philosophy to organize the manufacturing facilities and processes at Toyota as well as the interaction of these facilities and processes with the suppliers and customers to provide best quality, lowest cost, and shortest lead time through the elimination of the seven forms of waste [17]. Thereby, one basic idea was the involvement of all employees [17]. Thus, a process was introduced that helped Toyota to continuously change the performance of the production for the better. Thereby, the basic idea is the increase of efficiency of the production by a stepwise continuous improvement.

Process oriented production systems represent a methodological framework that comprise basic principles, methods and tools necessary to design and organize production processes to produce marketable goods. Due to the success of the TPS and the need to continuously improve the own business, the TPS and several of its inherent methods have been adopted by many European producing companies in order to improve productivity and flexibility of the production [18]. Thereby, very often an adjustment of the basic principles, methods and tools according to the company individual requirements took place. Approaches to support production system planning and design are above all considering waste avoidance in the sense of lean manufacturing [19].

4 TOWARDS A PROCESS ORIENTED PRODUCTION SYSTEM FOR SERVICE PROVIDING COMPANY

In order to maximize product and process quality in service production, process oriented production systems as already established in the physical goods industry can be taken as a promising starting point.

Based on an analysis of current process oriented production system concepts, the following fields of action for the design and implementation of process oriented service production systems can be identified:

* To support the continuous improvement process in service production as well as to enhance the motivation of the employees, the characteristics of services require the visualization of services respectively the materialization of the services by means of tangible elements.

* The context of service realization significantly affects the service quality experienced by the customer. Thus, in view of design and organization of service production processes, environmental aspects have to be taken into account as well.

* The intangibility of services leads to increasing demands on the capacity management of the service provider that aims at realizing, evaluating and eliminating quantitative, qualitative, chronological ore spatial deficits between the customer demand and service providers offerings.

* Time management of physical goods production mainly focuses on the minimization of the throughput time while guaranteeing high quality products right in time. A comprehensive time management in service providing companies differs significantly. Thus, e.g. the analysis of customers time structures as well as his subjective and objective time perception, the planning of capacities provided by both customer and service provider as well as the scheduling of service production processes have to be taken into account.

* During service production, the employees of the service provider are often interacting with the customer. Thus, both the behaviour as well as soft skills of the employees becomes a significant role for the service quality and productivity perceived by the customer. Therefore, human resource management in service providing companies has to be comple-mented by service specific approaches.

* An efficient design and organization of service production processes also makes high demands on the customer, e.g. in view of providing necessary information. Therefore, the steering of customers’ behaviour in situations of interaction between the customer and the service provider has to be taken into account. Furthermore, the management of cus-tomer relationships becomes a crucial role since services very often are realized in long term cooperation between customer and service provider.

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Figure 2: Methodological Support of Service Production Processes.

* Since design and realization processes significantly are responsible for the quality and productivity of the service production, planning, organization, steering and controlling of service production processes have to be supported by appropriate methods. Thereby, customer integration has to be considered.

Approaches conceptualizing service quality (see e.g. [20, 21, 22]) consider a lot of aspects that can be reduced to the characteristics of services. These aspects have to be taken into account during the development of a comprehensive quality management supporting the planning, steering, measurement and improvement of service quality.

5 FRAMEWORK CONCEPT

5.1 Objectives

To enhance the controllability of service production processes represents the main objective of the process oriented production systems for service providing companies. Thus, both quality and productivity of the service production would increase strongly. The approach of the process oriented service production system thereby increases the understanding for the fundamentals of both design and realization of services as well as their methodological support.

The integration of already existing methodological approaches supporting design and organization of service production processes thereby not only enhaces the transparancy of single methods and tools in view of their effectiveness. Furthermore, fundamental interrelations between the methods and tools become clearer. In this way, an active design, controlling and assessment of service production processes becomes feasible.

Hence, further objectives can be derived as follows:

* A coordinated and standardized methodological support of service production processes requires a systematic identification of company specific demands.

Based thereon, an approach has to be provided that allows the service provider to systematically and individually identify and develop basic principles of methodological support as well as appropriate methods and tools included therein. Thereby, the mutual interrelations between the basic principles as well as the methods and tools included therein have to be taken into account.

* The way of realizing the customer integration in service production processes plays a key role for the effectiveness of service production. Therefore, the condition of the customer as well the resulting effects on both design and organization of the service production have to be described transparently and considered in view of the methodological support. This also includes the interface between customer and service provider.

* Design and organization of service production is influenced by multiple factors. Thus, the identification of customer and service providers objectives as well as of resulting demands on the service production has to be supported by appropriate methods. Thereby, influenceable and non-influenceable environmental aspects of service production have to be taken into account, too. Thus, the basis for the systematic integration of basic principles, methods and tools to a process oriented service production system is laid.

* The transparency of the performance of the process oriented service production system represents a further objective. Based on the individual characteristics of the service production, an approach to systematically measure the performance of the process oriented service production has to be provided as well. This also represents a basis for the systematic derivation of improvement potentials of the production system as a whole.

Figure 3: Process Oriented Service Production System: Overview.

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Figure 4: Guidelines for the Elimination of non-efficient Production Processes.

5.2 Overview

The process oriented service production system as a general framework and philosophy to design and organize the processes of service production comprises four essential elements (Figure 3):

* The understanding of service characteristics as well as the realization of a customer oriented business culture represents a necessary prerequisite to be fulfilled by every staff member.

* Basic principles of methodological service production support build enables the personnel to execute the service production processes in a predefined manner. In cause of occuring problems, the methods and tools help the employees to understand the problem and to analyse the causes of the problem.

* To avoid inefficient (wasteful) service production processes, the staff has to be enabled in order to identify these processes. The service production specific guidelines thereby represent a helpful mean.

* In case of identified inefficient service production processes, appropriate measures have to be taken in order to improve the service production processes. The systematic development of these solutions addressing a few fields of action is supported by a set of project specific methods.

5.3 Business Culture

Service oriented behavior highly depends from the specific situation of both customer and service provider. Thus, it comprises behavior pattern that exceed formalized instructions. From a personnel point of view it requires a high degree of freedom concerning the scope of the employees as well as their self dependency.

The service oriented business culture as the core element of the process oriented service production system therefore covers different points:

* Customer orientation in all production processes

* Production processes as the center of all business oriented action

* Customer management

* Forms of customer interaction

* Advancement of service orientation of the personnel being in contact with the customer

* Social and communicative skills of the personnel

* Abilities to emotional labour

* Prioritization of initializing and management of long term customer relationships

5.4 Guidelines

The process oriented service production system contains universal rules for the organization of service production that enables the staff of service providing companies to

execute his specific tasks while contributing to enhance the efficiency of service production as well as to improve working conditions. Thereby, improvements can only be realized by identifying and solving existing problems.

The guidelines for the identification of inefficient service production processes (Figure 4) provide a helpful tool to the personnel and enable them to identify weaknesses of the established production processes. Thus, deficits in view of service quality, service production productivity as well as working conditions can be identified systematically by the employees on the job.

5.5 Basic Principles of Methodological Support

The basic principles of methodological support comprise methods and tools that support both design and organization of service production processes as a whole. Thereby, most of the basic principles (e.g. visualization or continuous improvement) are universal, while the methods and tools included in these principles can be adapted individually according to the company specific requirements.

The most common basic principles for the methodological support of the service production are e.g.:

* Standardization

* Continuous improvement

* Visualization

* Quality management

* Skill oriented human resource management

For example, visualization (e.g. in form of process models) helps to clarify service production processes, service results as well as required resources. Thus, the personnel are enabled to identify weaknesses in processes that build the basis for a continuous improvement process.

5.6 Project Specific Methods

The basic principles of methodological support provide a non-exhaustive basis for a continuous improvement process, realized in iterative cycles of well-known phases (plan, do, check, and act). Furthermore, service specific methods have to be provided by the process oriented service production system that helps the employees to execute this iterative cycle.

This is realized by a sample of methods and tools that supports the execution of specific improvement projects within the service providing company. The methods and tools thereby address different field of action:

* Understanding existing problems,

* Analysis of causes,

* Development of product or process improvements,

* Planning of remedial action,

* Taking selective measures,

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* Testing measures for target achievement,

* Improvement of taken measures

* Definition of new standards.

6 REALIZATION

6.1 Overview

Within the concept supporting the realization of the process oriented service production system, firstly objects and processes of service production as well as their interrelations are structured systematically. In this context, also the personnel of the service provider are considered, comprising the agents in view of the design, controlling and assessment of service production processes.

Subsequently, activities for planning, designing, implementing and steering of the process oriented service production system are described. Their realization is supported by appropriate process models as well as corresponding methods and tools.

6.2 Planning

The management decision to implement a process oriented service production system represents the initial point for the planning phase. In this phase, focus is both on the development of organizational and operational prerequisites for the implementation of the production system as well as on the establishment of a service oriented business culture. In context of the latter, the clarification of interrelations between the design and organization of the service production and service oriented business ethics are of importance. This also applies to the importance of structural changes within the service providing company.

In a first step, an analysis of operational structures in context of service design and realization takes places. This analysis is complemented by an analysis of methods and tools supporting service production processes and already established within the service providing company. Further on, analyses take place in order to get transparency in view of the product portfolio, the design and realization of the customer interface as well as the influenceable and non-influenceable environmental aspects of service production. Based on the results of these analyses, an assessment of the current efficiency of the service production is realized.

The specification of customer and service provider demands on the design and organization of the service production follows in the next step. The identification of starting points for a coordinated and standardized methodological support of service production processes concludes the planning phase.

6.3 Design

In context of the design phase, the detailed composition of the process oriented service production system takes place.

The system configuration covers the selection of the approach to the company specific configuration of methods and tools. Furthermore, the basic principles providing already existing methods and tools to methodologically support the service production (e.g. capacity, customer, quality, process ore time management methods) are specified systematically. The system configuration is complemented by the development of a concept increasing professional and social skills of the personnel. Thus, the employees are qualified to actively participate in both design and improvement of the service production.

Based on the system configuration, the process oriented service production system is structured in detail. Thereby,

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the methods and tools applied in context of the production system as well as the scope of both methods and tools are specified according to the predefined customer and service provider objectives (e.g. the establishment of company-wide production standards or the enhancement of transparency of production processes). Parallel, the definition of appropriate key figures to control the efficiency of the methodological support takes place.

6.4 Implementation

The next phase covers the implementation of the process oriented service production system as well as the realization of the concept increasing the skills of the personnel. Thereby, this phase aims at a continuous implementation of a coordinated and standardized methodological support of service production.

The chronology of implementation of methods and tools in the service providing company represents an important factor for the success of the process oriented service production system. Therefore, the sequencialization of the methods and tools to be implemented takes place at the beginning of the implementation phase. Further on, this phase comprises the implementation of an appropriate organizational and operational structure within the service providing company as well as the company-wide communication of the concept as a whole. A completed implementation of the production system determines the phase of system implementation.

The concept increasing both professional and social skills of the personnel aims at acquaints the employees with the possibilities offered by a systematic methodological support of service production processes. In this way, the personnel’s orientation in their working environment is enhanced. Furthermore, a more efficient planning, performance and controlling of production processes that are realized by the employees becomes possible. Thereby, special requirements result from customer integration as well as the resulting customer interaction.

6.5 Steering

The steering of the process oriented service production system aims at continuously improving the efficiency of service production processes as well as improving the methodological support of the design and organization of the service production. Thereby, two aspects have to be distinguished.

In context of the operational steering the guidelines for the elimination of inefficient production processes as presented above are provided. By means of these guidelines, the personnel are enabled to identify deficits in service production processes. Thus both immediate measures as well as corrections of service production processes can be realized.

The strategic steering addresses both the continuous improvement of the mechanisms to avoid inefficient service production processes as well as measures to the strategic adaptation of the processes oriented service production systems, e.g. in case of changing customer and service provider requirements to the design and organization of service production processes.

7 SUMMARY

To meet these requirements, there are numerous existing approaches that allow a selective methodological support of service design and realization. This paper provided a concept that transparently displays the interrelations between existing approaches and thus allows a coordinated and standardized methodological support of service production processes. Furthermore, the approach of a process oriented production system for service providing companies enables the personnel to actively take part in a continuous improvement process enhancing the efficiency of service production processes.

8 REFERENCES

[1] Bullinger, H.-J., Meiren, T., Service Engineering – Entwicklung und Gestaltung von Dienstleistungen. In: Bruhn, M., Meffert, H. (Eds.), 2001, Handbuch Dienstleistungsmanagement, Gabler, Wiesbaden

[2] Jaschinski, C., 1998, Qualitätsorientiertes Redesign von Dienstleistungen, Shaker, Aachen

[3] Spath, D. (Edt.), 2003, Ganzheitlich produzieren, Log_X, Stuttgart

[4] Scheer, A.-W., Grieble, O., Klein, R., Modell-basiertes Dienstleistungsmanagement. In: Bullinger, H.-J., Scheer, A.-W., 2003, Service Engineering, Springer, Berlin

[5] Lasshof, B., 2005, Produktivität von Dienst-leistungen, Thesis, FernUniversität Hagen

[6] Bullinger, H.-J., Schreiner, P., Service Engineering: Ein Rahmenkonzept für die systematische Entwicklung von Dienstleistungen. In: Bullinger, H.-J., Scheer, A.-W., 2003, Service Engineering, Springer, Berlin

[7] Luczak, H., 2000, Service Engineering – Der systematische Weg von der Idee zum Leistungsangebot, TCW-report, München

[8] Sontow, K., 2000, Frühe Phasen des Service Engineering - Dienstleistungsplanung in Unter-nehmen des Maschinen- und Anlagenbaus, Thesis, RWTH Aachen

[9] Ramaswamy, R., 1996, Design and Management of Service Processes – Keeping Customers for Life, Edison Wesley, Reading

[10] Luczak, H., Liestmann, V., Winkelmann, K., Gill, C.,

2002, Service Engineering industrieller

Dienstleistungen. In: Bullinger, H.-J., Scheer, A-W. (Eds.), 2002, Service Engineering, Springer, Berlin

[11]

Kleinaltenkamp, M., Integrativität als Kern einer umfassenden Leistungslehre. In: Backhaus, K., Günter, B., Kleinaltenkamp, M., Plinke, W., Raffée, H. (Eds.), 1997, Marktleistung und Wettbewerb – Strategische und operative Perspektiven der marktorientierten Leistungsgestaltung, Gabler, Wiesbaden

[12] Kleinaltenkamp, M., Dahlke, B., Der Wert des Kunden als Informant – auf dem Weg zu einem „knowledge based customer value“. In: Günter, B., Helm, S. (Eds.), 2003, Kundenwert – Grundlagen, innovative Konzepte, praktische Umsetzungen, Gabler, Wiesbaden

[13] Gurt, J., Elke, G., Zimolong, B., 2008, Dienst-leistungsmanagement: Erfolgsfaktoren Servicekultur und Commitment, wt Werkstattstechnik online, 98: 573-580.

[14] Stauss, B., Engelmann, K., Kremer, A., Luhn, A., 2007, Service Science – Fundamentals, Challenges and Future Developments, Springer, Berlin

[15] Eversheim, W., Jaschinski, C., Reddemann, A., 1997, Qualitätsmanagement für Nonprofit-Dienst-leister, Springer, Berlin, Heidelberg, New York

[16] Ohno, T., 1998, Toyota Production System – Beyond large Scale Production, Productivity Press, Portland

[17] Liker, J. K., 2004, The Toyota Way, McGraw-Hill, New York

[18] Herrmann, C., Thiede, S., Stehr, J., Bergmann, L., 2008, An environmental perspective on Lean Production, The 41st CIRP Conference on Manufacturing Systems, Tokyo, Japan, 26-28 May: 83-88.

[19] Cochran D. S., Arinez, J. F., Duda, J.W., Linck, J., 2001, A Decomposition Approach for Manufacturing System Design, CIRP Journal of Manufacturing Systems 20: 371-389.

[20] Donabedian, A., 1980, The Definition of Quality and Approaches to its Assessment, Health Administration Press, Ann Arbor

[21] Grönroos, C., 1982, Strategic Management and Marketing in Service Sector, Marketing Science Institute, Cambridge

[22] Parasuraman, A., Zeithaml, V., Berry, L. L., 1985, A Conceptual Model of Service Quality and Its Implications for Future Research, Journal of Marketing 49: 41-50.

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Financial Administration Manual

Chapter 4 Financial Systems and Controls

Chapter 4

Financial Systems and Controls

4.0 GENERAL POLICY STATEMENTS

4.1 INTRODUCTION

4.2 SYSTEMS OVERVIEW

4.3 FUNCTIONAL RESPONSIBILITIES OVERVIEW

4.4 CLASSIFICATION AND CODING OF FINANCIAL INFORMATION

4.4.0 Coding Policy

4.4.1 Background

4.4.2 Major Classifications of the Chart of Accounts

4.4.3 Account Number Structure

4.4.3.0 Position and Meaning of “Elements” in the Account Structure

4.4.3.1 Account Break-out Pattern

4.4.4 Coding Guidelines

4.4.4.0 Mandatory Classification Requirements

4.4.4.1 Optional Classification

4.4.4.2 Application

4.4.4.3 Maintenance Responsibility

4.5 CONTROLS IN FINANCIAL SYSTEMS

4.5.0 Overview

4.5.1 Objectives

4.5.2 Policy

4.5.2.0 Responsibility

4.5.2.1 Internal Controls

4.5.2.2 Audit Trail

4.5.2.3 Organization

4.5.2.4 Systems Development

4.5.2.5 Security

4.5.2.6 Training

4.5.2.7 Documentation

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4.5.3 Control Guidelines

4.5.3.0 Nature & Scope

4.5.3.1 Responsibility

4.5.3.2 Control Considerations

4.5.3.3 Role of Internal Audit

4.6 FINANCIAL REPORTING

4.6.0 Policy Statements

4.6.1 Introduction

4.6.2 Reporting Sources/Facilities Overview

4.6.3 Information Requirements Overview

4.6.4 Reporting Standards

4.6.5 The Reporting Process

4.6.6 Responsibilities

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Chapter 4 Financial Systems and Controls

4.0 GENERAL POLICY STATEMENTS

* Central financial system(s) shall be designed, developed, maintained, and managed by the Department of Finance to fulfill its responsibilities under the Financial Administration Act for accounting, control and reporting for the Consolidated Revenue Fund and the Public Accounts. All departments are required to use these central systems.

* Individual departments are responsible for developing, maintaining and managing unique systems/sub-systems required for their operations to assist managers in meeting their financial administration, reporting, and program delivery responsibilities. Notwithstanding this requirement, departmental financial systems shall be complementary to and compatible with the central systems.

* Central and departmental financial systems shall be developed and implemented with adequate and cost-effective internal controls. Central and departmental systems and controls shall be evaluated periodically jointly with Internal Audit to ascertain their adequacy and effectiveness.

* Additions and changes to departmental financial systems directly or indirectly impacting on the central systems shall be subject to review by the Department of Finance, and approval of departmental executive group.

* The Department of Finance, as the central agency, and other departments shall ensure that qualified and adequately trained staff are available in their financial operation areas to effectively utilize central and departmental system facilities and to properly carry out their functions in financial operations.

* Departmental Financial Officers shall ensure implementation of proper accounting controls on the basis of a thorough understanding of provisions in the FAA, MBD and this manual, as well as an understanding of the reporting requirements and the services provided by Department of Finance.

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Chapter 4 Financial Systems and Controls

4.1 INTRODUCTION

The central financial systems provided and maintained by the Department of Finance are the principal systems of the government. These systems process transactions maintain the financial records of the government and provide the data used in the preparation of interim financial statements and the public accounts. These systems also assist in departmental financial operations by providing information for monitoring and control of expenditures against appropriations of the Legislature.

Departments establish and maintain sub-systems to manage financial resources within their own areas. Such systems include those that are directly or indirectly linked with the central systems and are mainly used in budget preparation and analysis, in the tracking of authorizations and recording of expenditures, in recording and collection of revenues and in reporting financial and non-financial information for the evaluation of the efficiency with which departmental programs and activities are carried out.

Departmental systems/sub-systems are generally designed to provide additional information to assist managers in their effort to meet program objectives and to supply data/information required by central agencies. To this end, departmental financial systems may be considered as extensions of, and complementary to, the central systems.

YTG’s Financial Information System is operated in a computerized environment with Mainframe applications and Micro facilities. Mainframe applications consist of packaged software and in-house-developed systems that are being used primarily for financial applications.

Without detailing the functions of specific systems or how they should be used, this section of the manual provides an overview of the systems. This overview outlines the policies and guidelines relating to data capture, controls and reporting considerations to assist users in planning, coordinating and implementing financial operations and systems activities within the computerized environment.

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Chapter 4 Financial Systems and Controls

4.2 SYSTEMS OVERVIEW

YTG’s overall budget, commitment and actual expenditure transactions are collected and maintained in a General Ledger System managed by the Department of Finance. Prior to being captured in the

G/L, external charges and commitments are received, approved and coded by individual departments and are then processed through the Accounts Payable and Commitment Systems. Employee labour time and related costs are captured and processed in the Payroll System using appropriate codes for subsequent distribution to the General Ledger System. An automated system utilizing SAS programs and CMS files is used for compiling departmental budgets and for budget input to the G/L system.

Standard reports are produced from each sub-system on completion of job cycle runs and from the General Ledger System after month-end closing. On-request reports can be generated according to the desired needs of users, applying SAS programs, from transaction files provided and maintained by the Department of Finance.

A direct payroll deposit system, automated cheque reconciliation and equipment and

labour cost distribution facility are also part of the computerized financial systems environment.

The General Ledger System and its related feeder systems are designed with adequate

manual and automated control features, such that data integrity, completeness of information and maintenance of back-up files are established routines.

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4.3 FUNCTIONAL RESPONSIBILITIES OVERVIEW

Under the existing operating environment, responsibilities for database maintenance,

processing and reporting activities which form the overall financial system(s) are assigned as outlined below.

FUNCTIONAL RESPONSIBILITIES

SYSTEM/ACTIVITY

DEPARTMENT OF FINANCE

USER DEPARTMENTS

Budget Process

•

Compile and prepare consolidated

budget using SAS/CMS facilities.

•

Prepare detailed departmental budgets using posting level

•

Load budget to G/L database.

accounts, and utilizing computerized facilities.

•

Variance analysis and reporting.

•

Provide departmental budget data to

•

Advising MB on financial planning and control

Finance as per directives.

•

Variance analysis and reporting to departmental managers and central agencies.

Disbursement

•

Process payments in accordance with established procedures and controls for all departments.

•

Preparation of cheque requisitions using appropriate distribution codes and in accordance with directives for

•

Monitor implementation of signing

authorization.

authorities as per MB directives.

•

Application of control procedures.

•

Centralized maintenance of vendor master file.

•

Verification of payments against

records/documents of request.

•

Generate disbursement and distribution entries to G/L.

•

Maintenance of manual files for all commitment documents.

•

Maintain manual files for all paid documents.

•

Monitor and maintain systems effectiveness.

Payroll Processing

•

Maintain Payroll Master File, process payroll and deposit pays to employee accounts for all

•

Provide accurate and timely employee payroll data including related distribution accounts.

government employees.

•

Verify accuracy and reconcile

•

Maintain detailed payroll records.

reports with contents of related

•

Generate payroll distributions to the

accounts in G/L.

G/L system.

•

Perform labour costs analysis.

•

Remit payroll deductions to

respective agencies.

•

Issue annual T-4s.

•

Monitor and maintain system effectiveness.

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4.3 Functional Responsibilities (Continued)

SYSTEM/ACTIVITY

DEPARTMENT OF FINANCE

USER DEPARTMENTS

Commitment

•

Monitor system and data integrity.

•

Record (input) commitments using

Processing

•

Manage access and maintenance controls.

affected budgetary accounts to assist managers in making decisions with respect to expenditures.

•

Ensure completeness and accuracy

of commitment data in the system.

General Ledger

•

Ensure integrity of financial

•

Develop required chart of account

Control

database.

per coding guidelines and

•

Maintain accounts and

information requirements.

relationships.

•

Ensure accuracy and

•

Input/Output control.

appropriateness of G/L contents in departmental accounts.

•

Maintain regular and monthly

processing and reporting

schedules.

•

Correct coding and other entry

errors in departmental accounts.

•

Liaise with and assist users in all

aspects of database maintenance.

•

Monitor and ensure accuracy of balances in balance sheet accounts.

Financial Reporting

•

Develop, maintain and distribute

standard management reports.

•

Develop and implement SAS report programs to meet specific

•

Prepare and issue annual financial statements.

departmental requirements and to provide information to central agencies.

•

Provide detail transaction files

accessible by all users for their reporting needs.

•

Provide financial reports as per

requirements of central agencies.

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Chapter 4 Financial Systems and Controls

4.4 CLASSIFICATION AND CODING OF

FINANCIAL INFORMATION

4.4.0 Coding Policy

* The Department of Finance, in conjunction with departments and agencies, shall develop the system for coding transactions to capture financial data in the General Ledger and is responsible for the maintenance of the chart of accounts such that the needs of users are met within the limitations of the entire system.

* All financial transactions of departments and agencies, except those excluded by legislation, shall be recorded in the central systems using the coding structure provided by Department of Finance. For purposes of this requirement, budgets shall constitute financial transactions.

* Departmental senior managers shall ensure that personnel involved in financial operations are familiar with the framework governing classification and coding of financial data for departmental and global reporting.

4.4.1 Background

The financial coding structure was introduced in April 1980 and revised in April 1986 as part of the Financial Management Information System implementation. The coding structure is designed to satisfy legislative requirements for financial reporting and control and to meet the information needs of departments and central agencies.

This section outlines the relationship of the account classification structure to the organizational structure and information requirements of the Government. It also describes how the coding system can meet the needs of the various users and authorities.

Conceptually, the design of the G/L database depicts the shape of a pyramid with a hierarchical structure of accounts. At the bottom of the hierarchy, posting level accounts accept transactions and provide the system with its basic level of detail. From this level, links are established between a number of base accounts and higher level summary accounts to provide summarization as defined by account relationships.

An all purpose 13 digit account code structure consisting of department, vote, program, activity, element, and object has been developed for use by all departments regardless of the nature of their operational functions.

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Chapter 4 Financial Systems and Controls

In addition to the relationship approach, aggregation and disaggregation is also made possible based on account breakdown pattern.

More details on the coding structure and departmental classification of accounts are provided in the Coding Manual issued by Department of Finance under separate cover.

4.4.2 Major Classifications of the Chart of Accounts

The General Ledger developed for the Government contains three major categories of accounts.

Assets and Liability accounts

Revolving funds

Revenues / Recoveries and Expenditure accounts

Segregation of these groupings within the chart of accounts has been designed such that;

* assets and liabilities are identified by the first two numeric characters of account codes being ‘99’ and followed by an ‘8’ or ‘9’ respectively,

* revolving funds are identified by the first two characters of account codes being in the range of 41 to 49 inclusive, and

* revenues/recoveries and expenditure accounts start with two digit numeric department codes followed by further breakdowns representing classifications discussed below under “account number structure”.

The approach taken in the development process has been such that the chart of accounts comprises all possible major categories in each class (i.e. assets, liabilities, income and expenditures) with finer classifications within each class to meet legislative and operational reporting requirements. The design approach includes considerations to maintain an effective self-balancing set of accounts.

4.4.3 Account Number Structure

The account numbering structure consists of seven distinct elements, each of specific significance to the financial operations/activities of the Government. Coding of financial transactions for data capture, and subsequent reporting requirements at different levels, are met by the definition assigned to each element in the structure. The seven elements are entity (department), vote, program, activity, element, object and sub-ledger.

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Chapter 4 Financial Systems and Controls

4.4.3.0 Position and Meaning of “Elements”

in the Account Structure

Position: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 22

Element: A A B C C D D E E F F F F XXXXXXXX

AA Represents a distinct reporting entity/department. The structure permits the establishment of 01 to 99 functional areas as separate entities within the G/L system.

B Represents a vote being part of an Appropriation Act authorizing payment of public money for specific purposes.

CC Represents programs which consist of groups of related activities designed to achieve specific objectives.

DD Represents operational activities that are the basis on which departments request funds for programs and serve as the basis for planning and decision-making to achieve program objectives.

EE Represents “elements” within activities, being sub-activities which serve as the basis for cost control and evaluation of efficiency by operational-level managers.

FFFF Represents objects, being basic elements of cost (i.e. labour, material, etc.) into which financial information can be broken down for purposes of analysis and decision-making with respect to the operation of programs. It is the level at which budgets are reviewed to evaluate the impact of Government spending on the national economy.

XXXXXXXX Represents sub-ledger field to facilitate data capture by unique departmental information requirements.

4.4.3.1 Account Break-out Pattern

The account number break-out pattern has been formatted as follows:

AAB-CCDDEE-FFFF-XXXX-XXXXX

This format allows for the listing of the entities (departments) sequentially in the order of codes assigned and performs department “breaks” when a sequential list of the Account Master is requested. Based on control record parameters, it is also possible to achieve totals and page breaks either where “-” is shown or other desired levels.

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4.4.4 Coding Guidelines

In general, the coding system and account structure will be common to all departments utilizing the central financial information system of the Government, and will be used as the level of input for Public Accounts reporting process.

Since day-to-day departmental operations involve extensive use of the revenue/expenditure category of the chart of accounts, the focus in this section is to outline the guidelines for coding transactions affecting that category.

The classification structure for recording revenue and expenditure transactions consists of mandatory and optional fields. Mandatory coding classification fields reflect the organizational structure of the Government and the way funds are allocated by the Legislative Assembly to carry-on activities of the Government. This classification is aimed at identifying the sources and purposes of transactions and the nature of resources acquired or services rendered.

Optional coding classification fields (sub-ledger fields), on the other hand, are not predefined and may be used by departments for further breakdown of activities to meet information requirements in a uniquely aggregated or disaggregated manner.

Within the framework of the classification logic discussed above, the following guidelines apply to all users of the central systems.

4.4.4.0 Mandatory Classification Requirements

Governmental responsibilities are carried out through departments and agencies which execute program activities funded by votes of the Legislative Assembly. Financial transactions must, therefore, be identified to originating functional areas and traced to specific classification fields to establish accountability for financial operations and for reporting. Therefore, departments are required to use the first six elements in the account structure (department, vote, program, activity, element, object) in coding all financial transactions affecting revenues/expenditures as illustrated below.

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4.4.4.0 (Continued)

i) Classification by Entity (department)

As financial transactions/operations need to be identified with department/agencies to which funds are allocated by the Legislative Assembly, the element in the account structure representing department becomes a required field in coding financial transactions.

ii) Classification by Vote

Since the Legislative Assembly authorized funding of programs by “vote”, and because departments are accountable for recording and reporting their financial operations within each “vote”, the second element in the account structure shall be used for this purpose.

iii) Classification by Program

Programs are the basic expenditure grouping debated in the Legislature and must be financed by at least one “vote”. Financial transactions on all votes relating to program(s) need to be captured and reported such that financial information for a program is made available in total. The third element in the account structure shall be used for this purpose.

iv) Classification by Program-Activity

Since programs embrace sizeable areas of operation and require many resources, they are broken down into “activities” for presentation to the Legislative Assembly, recording of transaction and subsequent reporting. “Activity” levels represent identifiable levels of output for which costs can be determined thus providing the basis for planning and control of program operations. The fourth element in the account structure shall, therefore, be used to identify “activities”.

v) Classification by Activity-Element

Breakdown of programs into activities cannot always meet the necessary or desirable attributes of the program. Therefore, it is necessary to further refine activities into “elements” to provide details to operational- level managers for exercising effective operational control and evaluation of efficiency.

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4.4.4.0 (Continued)

vi) Classification by Object Code

Using “object” code classification, financial information is broken down into types of resources required for the operation of programs. “Object” codes identify the nature of goods and services for which funds are expended or the nature of government services rendered in exchange for funds. “Object” codes essentially represent economic objects and are the required level of information for economic analysis. Therefore, departments must ensure that financial transactions are coded to this level.

4.4.4.1 Optional Classification

This classification is often referred to as the sub-ledger field and consists of the last nine characters in the account structure. Classification by sub-ledger is useful for identification and reporting of measurable output of program objectives where coding of such factors at the mandatory classification level has not been met.

The lowest level of measurable output for which cost should be determined can vary between departments and even between programs within a department. Output may refer to units of production, operations, processes, projects, geographical regions, locations, etc.

The choice as to whether or not a department should use the sub-ledger field is dependent upon the nature of financial information required by different levels of its management. Where aggregation/disaggregation of data for reporting and classification for cost allocation are required in addition to the use of mandatory fields, the sub-ledger is a useful tool.

4.4.4.2 Application

i) The account classification and structure shall be used by all users of the FMIS in all transaction coding including budgets, commitments and actuals.

ii) Departments and “votes” are created by statute or the Cabinet/Management Board. Program/activity/element fields are identified within departmental boundaries and are defined by departmental authorities. “Object” codes are defined by the Department of Finance in co-operation with the users. Full or partial use of the sub-ledger code field is left to the discretion of the users.

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4.4.4.2 (Continued)

iii) Where financial sub-systems are used by a department for such items as inventory, accounts receivable, grants/contributions, securities, etc., control accounts should be set up in central systems following the classification and structure format requirements.

4.4.4.3 Maintenance Responsibility

User departments should submit request for creation, change or inactivation of accounts via a standard maintenance form issued by the Department of Finance. The actual account maintenance in the Account Master File is the responsibility of the Department of Finance to ensure consistency in the application of the rules in structure and relationship.

All account maintenance requests should be approved by individuals at the financial operations management level of the user department and reviewed by the Department of Finance.

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4.5 CONTROLS IN FINANCIAL SYSTEMS

4.5.0 Overview

The usefulness of any financial system is dependent not only upon its performance efficiency and ability to provide information, but also on the effectiveness of controls that should be developed and exercised as an integral part of the system. Appropriate standards of organizational responsibility, authority, completeness and accuracy need to be established and applied with consistency to ensure legitimacy and usefulness of financial information, and to safeguard the assets of the organization.

Adequate controls have to be implemented based on a thorough assessment of their significance in terms of their contribution to meeting financial control requirements identified in related Acts, Directives and Regulations of the Government, and on the efficiency/effectiveness with which they can be applied.

Where financial systems are computerized, electronic controls are designed with complementary manual controls to ensure that there are no gaps; with due considerations to avoiding duplications and to achieving desirable levels of effectiveness as economically as possible.

Controls are established concurrently with the development of systems (manual or automated) and need to be maintained through all stages of manual, mechanical and electronic processing.

Control considerations in financial systems generally include:

i) Application control procedures which involve:

* Assignment of authority and responsibility with respect to activities resulting in financial transactions;

* Determination of flow and appropriate sequencing of transactions processing;

* Application of pre-processing checks and verification procedures;

* Application of post-processing checks and balancing procedures;

* Periodic testing and check of the control features of each system; and

* Analyzing errors and taking remedial actions to maintain effectiveness.

ii) General EDP controls which provide a framework of controls for systems development/acquisition, systems conversion, organization of users and systems activities, data/information processing, system security and documentation.

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Since details of accounting/administrative control procedures are covered in other chapters of this manual, the emphasis in this section is to outline the considerations relating to the above areas.

4.5.1 Objectives

The material in this section is aimed at identifying control responsibilities with respective functional areas, and at providing guidance to financial and EDP personnel involved in the development and maintenance of financial systems to ensure that appropriate controls are implemented as standard practices within YTG’s operating environment.

4.5.2 Policy

4.5.2.0 Responsibility

i) The Department of Finance is responsible for ensuring adequacy and effectiveness of controls in the central financial systems and for monitoring their performance. Enhancements and revisions to central systems or subsystems shall be developed and implemented under the supervision of the office of the Deputy Minister of Finance.

ii) Senior departmental managers are responsible for ensuring adequacy and effectiveness of controls in systems developed and used for their unique requirements, and for monitoring performance of such systems. They must actively participate in the planning, development and implementation of controls in central and departmental systems.

iii) Systems and Computing Services is responsible for the planning, coordination and monitoring of existing and proposed EDP facilities and resources for the government to provide assurance that:

* Appropriate EDP facilities and resources are made available to users in the most cost effective manner;

* Alternatives are adequately evaluated so that the best solutions are selected in view of relevant technical and cost considerations.

iv) All additions and enhancements to the central financial systems including

additions and enhancements to a department’s system

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that interface with any of the central systems shall be subject to approval of the Department of Finance.

4.5.2.1 Internal Controls

Central and departmental financial systems shall be developed and implemented with adequate and cost effective internal controls to achieve:

* Completeness and accuracy in processing only authorized transactions;

* Regular and timely processing of data, and availability of meaningful financial reports;

* Safeguarding of assets.

4.5.2.2 Audit Trail

Central and departmental systems/sub-systems shall provide an audit trail of all transactions processed.

4.5.2.3 Organization

Senior managers are responsible for establishing organization plans that ensure segregation of duties and responsibilities. In a computerized financial systems environment, such plans include:

i) Segregation of users, systems development, processing/operation and system support activities and responsibilities;

ii) Ensuring that transactions are processed against properly tested and approved programs only;

iii) Ensuring that personnel familiar with processing or development functions do not bypass security and control procedures to change programs or data;

iv) Ensuring that personnel responsible for protecting data integrity cannot process live data or change programs.

4.5.2.4 Systems Development

An established systems development methodology must be in place and followed such that:

i) Development or change requirements are approved at the appropriate level after review and evaluation of cost/benefit analysis;

ii) Required additions and changes are selected or developed in accordance with established standard and user objectives;

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iii) Implementation occurs only after adequate testing and conversion processes prove the efficiency and effectiveness of processing, operation and controls.

4.5.2.5 Security

All users, system support personnel, programmers and operations staff are responsible for observing security guidelines provided in this section with respect to application systems, and those issued by S&CS on the use of computer facilities and systems software.

4.5.2.6 Training

Departments are responsible for ensuring adequacy of training of their employees in financial operations and for the effective use of the financial systems in place by providing in-house training in conjunction with the Department of Finance, and by making available up-to-date systems, procedures and policy manuals to all functional areas involved.

4.5.2.7 Documentation

Departments are required to develop and maintain systems and procedures documentation for all financial systems/sub-systems under their ownership and responsibility. Documentation on systems/sub-systems interfaced with any of the central systems shall be reviewed by the Department of Finance to ensure compliance with requirements of the related central system(s). Copies of all departmental financial systems/sub-systems documentation, whether or not directly related to the central systems, shall be provided to Department of Finance for use as sources of reference for requirements analysis in current/future systems development efforts.

4.5.3 Control Guidelines

4.5.3.0 Nature & Scope

The material in this section outlines the general control guidelines and does not cover detailed control procedures. Since accounting/administrative guidelines are addressed in other relevant sections, more emphasis is given here to application and EDP controls. Detailed procedures covering all aspects of control will be made available in a “Financial Systems and Control Procedure Manual”.

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4.5.3.1 Responsibility

Senior level managers of departments using computerized financial information systems, facilities and resources should develop written statements identifying assignment of responsibility for specific activities within their various functional areas.

In the YTG environment, the Department of Finance should develop and provide such written statements with respect to the central systems.

In general, control responsibility at a higher level may be assigned as follows:

i) Senior management should be responsible for defining overall objectives of systems, for preparing strategic and operational plans and for monitoring processing and security activities;

ii) User managers should be responsible for defining their information needs and for designing and monitoring control procedures to ensure completeness, accuracy, authorization and timeliness of data and information;

iii) System managers should be responsible for developing and supporting systems, monitoring and evaluating systems performance, providing systems and detailed procedures manuals and for researching and identifying ways to improve services to the organization.

4.5.3.2 Control Considerations

a) General

User control procedures at the application level, programmed application controls and general EDP controls provide the framework for effective financial systems control in a computerized environment. Once developed and implemented, their use and effectiveness must be reviewed regularly. Detail procedures need to be developed along control guidelines and made available to users at the operational level. Guidelines and detail procedures have to be updated concurrently with changes in policies, operations and systems.

b) Organizational Controls

A system of internal controls which allows for the segregation of duties and responsibilities within user and processing departments, and which provides for effective application controls, is required.

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i) There should be adequate segregation of duties and responsibilities within user departments:

* For custody of assets and their related record-keeping and to prevent situations where an individual may initiate transactions and approve payments;

* To provide for physical arrangements that prevent unauthorized access to assets and accounting records;

* To facilitate proper supervision of work performed in daily operations and to allow the use of work performed by one person to be used as a check on the work of another;

* Providing for specific responsibilities for initiation and maintenance of transactions and accounting records.

ii) There should be adequate segregation of duties within computer processing activities such that:

* Processing support personnel may not update data files or run application programs;

* Maintenance personnel have no access to and do not run systems in production;

* Data processing, maintenance and development functional areas are separate.

iii) Application controls must include the following considerations:

* That all transactions are initially approved and recorded;

* That all recorded transactions are authorized;

* That all transactions authorized and recorded are processed accurately;

* That all outputs are reviewed by users for completeness, accuracy and consistency;

* That controls are properly enforced.

c) Input/Output Controls

Manual and automated input/output controls have to be developed as an integral part of each system/sub-system and exercised regularly to ensure accuracy and completeness. Techniques such as data validation, batch balancing, programmed checks, job scheduling, authorization checks and the use of prenumbered forms should be considered in developing detailed input/output control procedures.

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4.5.3.2 (Continued)

* Input data should be initially recorded in a manner allowing for an audit trail, subjected to independent verification and edited/validated prior to being accepted into the financial database.

* Input/output control logs, data transmittal forms, independent verification and subsequent balancing procedures should be developed and used on an ongoing basis.

* Automated systems should have features for data validation, input/output record count and batch balancing.

* Input/output cycles should follow established processing schedules and cut-offs to ensure that all period transactions have been received and entered on time.

* In addition, an organized system of physical maintenance of input/output documents and reports should be in place for user and audit reference.

d) Processing Controls

Processing steps and procedures should be designed with a view to establishing

controls through the segregation of duties and responsibilities.

Procedures should be established such that appropriate controls are exercised through all stages of receipt of source documents, input preparation, data entry and output verification

The flow of documents and data through the various stages in processing have to be controlled using special purpose forms. Establishing processing time frames and job scheduling that permit efficient utilization of resources, and that ensure availability of financial information on a timely basis, are essential considerations.

To ensure effectiveness and efficiency in processing, senior managers are required to conduct regular reviews of:

* processing requirements to assess whether or not system facilities and resources satisfy present and future financial information needs;

* Systems operations to ensure that effective processing and maintenance controls are in place, and that transactions are processed accurately on a timely basis;

* Use of systems facilities to ensure systems are accessed only by authorized personnel with adequate training;

* Overall processing activities and procedures in view of changing operational conditions.

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4.5.3.2 (Continued)

e) Error Handling

Financial systems and procedures should be developed such that instructions on error detection, handling of corrections and resubmission of corrected data/transaction are clearly identified and understood by users. These requirements should be reassessed periodically to ensure effectiveness and timeliness with which errors are being handled. Periodic analysis of error frequency and status follow-up procedures should be adopted for the determination of systematic corrective measures. Steps should be taken to avoid potential errors and irregularities in reprocessing source documents, incorrect input coding, submission of unauthorized input or loss of input/output.

f) Development Controls

Systems development plans should be prepared for each new financial system/sub-system and for each major addition and revision to existing systems. Such a plan should, in general, include:

* Statement of objectives of the project;

* Description of the components and phases of the project;

* Indication of timing considerations for each phase of the project including staff training;

* Indication of estimated cost savings by project phase and in aggregate;

* Indication of the level of involvement of the Department of Finance.

The project plan is useful in monitoring progress during

development/enhancement and for establishing accountability. To this effect, the plan should:

* Assign defined project responsibilities to groups and individuals;

* Require re-evaluation of anticipated benefits and costs at the completion of each phase of the project;

* Provide for submission of progress reports and for final report to management on completion.

Department of Finance will base the degree of involvement to monitor development/enhancement of departmental financial systems on:

* Objectives of the system;

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* Nature and degree of impact on the central system(s); and

* Adequacy of resource at its disposal for assignment to such development, testing, and implementation efforts.

Senior management should provide the following approvals for all systems development projects, depending on their significance in terms of requirements and objectives:

* Approval in principle after review of project objectives and development plans;

* Approval after completion of each phase of the project;

* Final approval after sufficient testing and implementation of the overall system.

g) Testing

Computer systems and programs should be adequately tested prior to implementation using:

i) Integrated tests which are performed by users applying data designed to test an entire system to ensure that:

* The system is operating as expected and can process anticipated volumes;

* Interfaces are operating properly with all modules functioning as desired;

* Reports generated meet information requirements of users properly;

* Adequate back-up and recovery procedures are available.

ii) Acceptance tests which are performed by users and operations to test the adequacy of operating procedures applying simulated transactions to ensure that:

* The system effectively processes transactions in the user environment;

* Required controls and procedures are in place and work effectively;

* Users are adequately trained and familiar with the detail controls and procedures.

h) Conversion

Conversion of existing data to a new or modified system should be controlled to ensure the data is completely and accurately transferred.

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4.5.3.2 (Continued)

Successful completion of a conversion process usually involves the following considerations:

* Assignment of conversion responsibility to specific individuals;

* Developing time schedules for the conversion and establishing a cut-off date so that all transactions are processed to proper accounting period;

* Taking printed copy of data stored on the existing system immediately before conversion and comparing to data on new or modified system;

* Running parallel for a reasonable period subsequent to conversion to ensure processing accuracy and completeness by the new or modified system; and

* Obtaining formal sign-off from user managers to indicate system acceptance.

i) Security

Security policies and procedures should provide assurance that:

* Only authorized users can access systems;

* Adequate safeguards are provided to prevent accidental errors or deliberate actions that result in loss of data/information or cause damage to systems;

* Only authorized transactions are processed on systems;

* Updates to system programs are made only by authorization and that adequate safeguards exist to prevent unauthorized changes;

* Adequate emergency back-up and recovery plans are established and well understood by personnel responsible for performing the functions; and

* Adequate safeguards are provided to avoid damage or destruction to physical facilities.

j) Documentation

Financial Systems procedure documentation must be tailored to meet the requirements of specific systems and the user departments. Although all systems and procedures have individual requirements and additional documentation may be needed, on average, consideration should be given to including:

* Systems Narrative which describes a system from the point of view of the user;

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4.5.3.2 (Continued)

* Interface Description which narrates how the system relates to other systems;

* Production Timetable listing all jobs within the system and showing when they should be run;

* Description of user procedures and tasks dealing with details of functions and identifying responsibility for each activity;

* Description of valid input data and forms to be used, including detailed instructions on how to handle different scenarios and use the required forms;

* Error recognition and correction procedures which should list all error messages and describe edits and error reports as well as corrective actions;

* Report descriptions of all printed outputs including explanations of purposed and uses of the reports;

* Descriptions of systems controls and audit features which should include detailed instructions on how to use them.

In addition, there should also be complete sets of system documentations and operations manuals, which are technical in nature, for use in managing the systems and for personnel in operations.

k) Maintenance

System software and hardware maintenance activities must be carried out based on plans and schedules. Maintenance contracts should be reviewed regularly to ensure adequacy of services and to investigate better alternatives.

4.5.3.3 Role of Internal Audit

While primary responsibility for the establishment and operation of a system of internal controls is that of Department of Finance, with Departmental Managers and Financial Officers being responsible for ensuring application, Internal Audit performs evaluation of systems as an independent body. Although the nature and scope of its activities depend on management directives, it should in general:

* Review, evaluate and report on the adequacy of the financial control framework;

* Examine and evaluate performance in relation to the established control framework and report the extent of compliance or non-compliance;

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* Review, in advance, any system being developed to ensure that designers have provided adequate consideration of audit trails and internal controls; and

* Appraise and evaluate reliability of accounting systems, degree of adherence to policies and legislations and provisions for the protection of assets.

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4.6 FINANCIAL REPORTING

4.6.0 Policy Statements

* As a central agency with responsibility for the monitoring and control of overall financial activities, as well as for the operation and maintenance of the central financial systems, the Department of Finance shall provide the global reports and statements required by different levels of government and external agencies.

* Individual departments and agencies shall be responsible for providing detail and summary financial reports required by their management and by central agencies.

* The Department of Finance will assist and advise departments in the development of reports and the application of reporting facilities. Primary responsibility for using available financial reporting sources and services, however, rests with the user departments.

* Financial reports produced by central systems shall include information on budgets, actuals and commitments. In addition to information extracted from the central systems, reports produced by individual departments shall include details for items such as inventory, forecasts and statistical data.

* Although the extent to which accrual accounting is practiced by individual departments during the year is left to their discretion, it is mandatory that year-end financial reporting be on an accrual basis.

* It shall be a requirement that all financial reports meet standards defined in this section.

* The Department of Highways and Public Works, through its Information and Communications Technology branch, shall ensure availability and maintenance of adequate reporting facilities and will assist users in the application of such facilities.

4.6.1 Introduction

This section outlines the data sources for reporting, the reporting process, standards and responsibilities. These sources and processes are addressed with the assumption that transaction data will be maintained in the database(s) in accordance with classification requirements outlined in the preceding section. Thus, the usefulness of information reported is closely linked to the accuracy and consistency of classification applied during data capture.

Within the limitations of available sources and facilities, financial reports are generated to meet information needs of users at different levels of the organization. In general, the principal reporting objectives are:

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4.6.1 (Continued)

* to facilitate operational control by providing detailed and current information on a regular and timely basis;

* to enhance operational management decision making and control processes by periodically providing comparative data on budgeted and actual performance;

* to meet the strategic information needs of management by providing summary-level actual, budgeted, and forecast data on a quarterly or as required basis.

The Financial Management Information System(s) has been designed in light of these objectives and to accommodate specific departmental requirements so that information needs can be extracted in formats desired by users.

4.6.2 Reporting Sources/Facilities Overview

A number of standard and customized reports are produced from central financial systems files. While some of these reports are generated as a result of regular transaction processing, others are user initiated period-end reports.

A variety of detail and summary level account balances and comparative reports can be extracted from the data bank of the G/L which contains budgetary data allocated to periods based on anticipated actuals for each period, commitment balances by account, cash receipts, expenditures and transfers between appropriations. This data bank is the source for producing trial balances for reporting in the Territorial Accounts and for extracting specialized financial reports required at the management level.

The Central Systems, which include the G/L and its sub-systems (A/P, Payroll, Fund Accounting) containing detail transactions, provide the database from which reports required for monitoring and control of financial activities can be generated.

Standard reports from the central systems are initiated by the Department of Finance and

distributed to users on a regular basis. Such reports include those that are system-generated and global management reports developed by the Department of Finance.

On-request reports can be initiated by departmental users depending upon their security level of access to each application system.

Customized and ad-hoc type reports can be created by individual users through SAS applications from daily-updated data warehouse. The Department of Finance assists in such endeavors based on analysis of requirements.

In addition to printed reports, on-line inquiry facilities are available to users for viewing data/information in the G/L, A/P and Fund Accounting Systems.

A diagrammatic overview of the financial systems and reporting basis is included at the end of this section as appendix A.

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4.6.3 Information Requirements Overview

Financial information requirements include those that are relevant for decision-making processes at different levels of responsibility centres in the organization and those that serve day-to-day operational needs.

Depending on organizational structure and the nature of the operations of individual departments/agencies, the concept of responsibility centre may apply to a Program, Project within Program, Activity, Element, or a combination of any of these levels in the account structure. While information requirements of Responsibility Centre Managers may vary depending on the scope of accountability based on departmental organizations, it is assumed that the current system of transaction coding and data storage will meet their needs. This section outlines the basic information requirements as follows:

INFORMATION REQUIREMENTS

PURPOSE

USERS

FREQUENCY

Year-to-date budgets, commitments, and actuals summarized by activity/ element and object breakdown for each program. Comparisons of year-to-date actuals and planned expenditures.

For control of expenditures and determination of corrective measures.

Responsibility centre managers

Monthly and on-request

Summary financial transactions by

To ensuring spending

Functional area

Monthly and

activity, element, and object for each level of responsibility centre.

activities remain within budgetary constraints and to evaluate performance in terms of expectations.

supervisors

on-request

(Continues)

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4.6.3. (Continued)

Appropriations/allotments, disbursements to date, commitments and free balances for each responsibility centre by allotments.

As a basis for cash forecasts and expenditure control at department level.

To monitor global expenditures by allotment within appropriations.

For Legislative Assembly review.

Financial Officers

Dept. of Finance

Legislative Assembly

Monthly and on-request

Variance analysis of planned and actual expenditures on periodic and cumulative basis for each responsibility centre, department and global with narrative explanations.

For analysis of causes and future impact of variances, for the projection of year-end positions and to initiate measures to prevent over expenditures.

Res. Centre Man. Financial Officers Finance

Quarterly and on-request

Summary of financial resources, commitments and obligations by date/due date.

For cash

management

Dept. of Finance

Weekly, monthly, and as required

Detail financial transactions, account balances and system edit/audit.

To verify accuracy of

all other reports and

for detailed analysis.

Maintenance of

system integrity and

data accuracy.

Managers

Financial Officers

Operational staff at all levels

Daily and as required

Financial Statements

For overall evaluation of financial performance and to meet statutory reporting requirements.

Legislative bodies

Dept. of Finance

External agencies

Annually

The above outline is an overview of information requirements that would, in one form or another, be necessary in the financial operation process of the government. Detailed descriptions of report formats and contents are to be provided in “Systems & Procedures Manuals”.

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4.6.4 Reporting Standards

Reports are the tool for the conversion of financial data into information, for the expression of the accountability of different levels of management and for exercising financial operations control.

In order for financial reports to be of maximum benefit to users, the following basic standards should be met.

Completeness

Reports should provide complete information for period(s) covered. For example, report cut-off dates that do not coincide with accounting period-end dates can result in the omission of significant information, or relevant explanations may be missing. Reports should be developed with a view to providing complete information to satisfy the objectives they are required for.

Accuracy

All financial data presented must be checked and verified for accuracy prior to distribution.

Reliability

Reliability of information in a report has to be established by cross references to sources and other related reports.

Usefulness

Reports should cover the information requirements of users at desired levels and be available on time for their needs. They should provide a clear picture of performance and serve as guides to action.

Timeliness

To be of maximum use, financial information should be in the hands of users as promptly as possible.

Reports that relate to a specific period need to be produced and made available to users immediately after that period end. Reports required daily for monitoring and control of transactions and system activities should be produced and made available routinely.

Consistency

Terminologies should be established and used consistently to promote clarity and usefulness. Changes in accounting policies and methods should be explained along with their impact on the information reported. Comparisons must be based on criteria applied consistently.

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Simplicity

Reports should present information concisely and avoid unnecessary details. Supporting details should be available in format(s) easy to relate to the contents of reports.

Accountability

Responsibility should be clearly shown on all reports by including originating functional areas as part of the report title or at the bottom of the report.

Disclosure

Any limitations and recent changes should be clearly disclosed to the users. 4.6.5 The Reporting Process

Data is input to the central systems for processing based on approved transactions. Edit reports are generated for verification of accuracy and input-output reconciliations are performed by users. Errors are identified and corrections are initiated for input. At this stage, input control logs, along with transaction documents and edit reports, provide the basic control information at the operational level.

Once all errors are corrected and further processing has occurred, other standard and on

request systems reports as well as management reports developed by Finance are produced and distributed to users.

Application systems reports from G/L, A/P, Payroll and commitments include information on current and historical detail transactions by distribution account and commitment type. The standard management reports developed by Finance consist of ”Statement of Appropriations“, ”Statement of Allotments“ and ”Expense Analysis“.

Departments can create customized reports using CMS/SAS facilities to meet financial information requirements of their different functional areas. for this purpose, the Department of Finance provides computer data files which contain:

* Current and previous year actuals and budgets with current year commitments for each account, by period

* Current year detail G/L transactions.

* Current year detail disbursement transactions and obligations.

* Current year detail commitment transactions.

Section 4.6 Financial Reporting Issue Date: 12/92

Financial Administration Manual

Chapter 4 Financial Systems and Controls

In addition to financial information that departments can extract from these files in formats and levels of detail desired by specific users, they can also create their own SAS data files for statistical reporting.

The standard application systems reports are produced at the end of each successful processing while the on-request systems reports are user-initiated. The standard management reports are produced monthly. Reports developed by departments can be produced as required.

With the exception of reports from the commitment system which are routed to departmental printers, all standard reports from other central systems are produced at the main computer area and issued to users based on distribution lists.

Information extractions from the computer data files via reports created by departments can be executed at any time for printing and distribution in their own areas.

4.6.6 Responsibilities

Financial information reporting and report maintenance responsibilities rest with:

i) Department of Finance to the extent of designing and developing standard management reports, preparation of statements on Public Accounts and distribution of reports to users; for the retention of all financial transactions data, statements and reports as required by policies and regulations.

ii) Individual Departments and Agencies to the extent of identifying special information requirements of their functional areas and central agencies, developing reports to meet the requirements identified and the retention of reports as sources for reference in financial operations, control and budget preparation.

iii) Information & Communication Technology Branch of the Department of Highways and Public Works to the extent of ensuring that adequate and cost-effective facilities are available for the retention of financial data and production of information as per user specifications

Section 4.6 Financial Reporting Amended: 04/2005

Jun 18 2020

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COMPANY NAME

Environmental Management

System Manual

Revision No. : 1

Date : DD – MM – YYYY

Prepared by :

(EMR)

Approved by :

(Top Management)

Revision History

Revision

Date

Description

Sections

Affected

Revised

Approved

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

Table of Content

0.0 Terms and Definitions 2

1.0 General 4

1.1 Company Profile 4

1.2 Purpose of this Manual 4

1.3 Scope of EMS 4

2.0 Policy 5

3.0 Organisation 6

3.1 Organisation Chart 6

3.2 Responsibility 6

3.2.1 (Top Management) 6

3.2.2 Environmental Management Representative (EMR) 6

3.2.3 Deputy Environmental Management Representative (DEMR) 7

3.2.4 Environmental Management System Committee (EMS Committee) 7

3.2.5 Management Review Committee 7

3.2.6 Function / Departmental Manager 8

3.2.7 All Employees 8

4.0 Environmental Management System Requirements 8

4.1 Environmental Management System Documents 8

4.2 Environmental Policy 9

4.3 Planning 9

4.3.1 Environmental Aspects 9

4.3.2 Legal and Other Requirements 10

4.3.3 Objectives, Targets and Programme(s) 10

4.4 Implementation and Operation 11

4.4.1 Resources, Roles, Responsibility and Authority 11

4.4.2 Competence, Training and Awareness 11

4.4.3 Communication 12

4.4.4 Documentation 12

4.4.5 Control of Documents 13

4.4.6 Operational Control 13

4.4.7 Emergency Preparedness and Response 14

4.5 Checking 14

4.5.1 Monitoring and Measurement 14

4.5.2 Evaluation of Compliance 14

4.5.3 Nonconformity, Corrective Action and Preventive Action 15

4.5.4 Control of Records 15

4.5.5 Internal Audit 15

4.6 Management Review 16

Appendix A Cross Reference of ISO 14001 Requirements and Sections in the EMS Manual and Environmental Procedures.

Appendix B Controlled Document List

Page 1

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

0.0 Terms and Definitions

Auditor Person with the competence to conduct an audit

Continual Recurring process of enhancing the environmental management

improvement system in order to achieve improvements in overall environmental performance consistent with the organisation’s environmental policy.

Corrective Action to eliminate the cause of a detected nonconformity. action

Document Information and its supporting media

Environment Surroundings in which an organisation operates, including air, water,

land, natural resources, flora, fauna, humans, and their interrelation.

Environmental Elements of an organisation’s activities or products or services that

aspect (EA) can interact with the environment.

Environmental Any change to the environment, whether adverse or beneficial,

impact wholly or partially resulting from an organisation’s environmental

aspects.

Environmental Part of an organisation’s management system used to develop and

management implement its environmental policy and manage its environmental

system (EMS) aspects.

Environmental Overall environmental goal, consistent with the environmental policy,

objective that an organisation sets itself to achieve.

Environmental Measurable results of an organisation’s management of its

performance environmental aspects.

Environmental Overall intentions and directions of an organisation related to its

policy environmental performance as formally expressed by top

management.

Environmental Detailed performance requirement applicable to the organisation or

target parts thereof, that arises from the environmental objectives and that

needs to be set and met in order to achieve those objectives.

Interested Person or group concerned with or affected by the environmental

party performance of an organisation.

Internal audit Systematic, independent and documented process for obtaining audit

evidence and evaluating it objectively to determine the extent to which the environmental management system audit criteria set by the organization are fulfilled.

Nonconformity Non-fulfilment of a requirement.

Organisation COMPANY NAME

Preventive Action to eliminate the cause of a potential nonconformity. action

Prevention of

pollution

Use of processes, practices, techniques, materials, products, services or energy to avoid, reduce or control (separately or in combination) the creation, emission or discharge of any type of pollutants or waste, in order to reduce adverse environmental impacts.

Page 2

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

Procedure Specified way to carry out an activity or a process.

Record Document stating results achieved or providing evidence of activities

performed.

Page 3

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

1.0 General

1.1 Company Profile

(Provide general background information on COMPANY NAME. Describe the nature and products / services of COMPANY NAME’s business)

1.2 Purpose of this Manual

This Manual defines the Environmental Management System (EMS) of COMPANY NAME’s activities and contains:

a) The Environmental Policy;

b) Statements of responsibility and authority;

c) An overview of the company’s environmental procedures and controls;

d) The identification of the resources and training allocated to management, performance of work and verification activities including internal audit;

e) The appointment of the Environmental Management Representative (EMR); and

f) The arrangement for periodic management reviews.

The purpose of this Manual is to demonstrate that this EMS meets all ISO 14001:2004 requirements and provide guidance and direction for the implementation and operation of the EMS to all personnel including all relevant documents.

1.3 Scope of EMS

The scope of the EMS applies to the (BUSINESS ACTIVITIES) related to the (PRODUCTS / SERVICES) provided / undertaken by COMPANY NAME. Also the locations and areas to be covered in the EMS.

Page 4

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

2.0 Policy

COMPANY NAME

Environmental Policy

(Briefly describe your company profile and scope of your Environmental Management System)

The Company is committed to protecting the environment of the Earth.

To minimize environmental impacts concerning our activities, products and services, we shall:

* Comply with applicable legal requirements and other requirements to which

Sample

the Company subscribes which relate to its environmental aspects.

* Prevent pollution, reduce waste and minimise the consumption of resources.

* Educate, train and motivate employees to carry out tasks in an environmentally responsible manner.

* Encourage environmental protection among suppliers and subcontractors.

The Company is committed to continual improvement of environmental performance. This Policy will be communicated to all staff, contractors and suppliers, and be available for the public.

Endorsed by

(Signature)

(Name and Title of Top Management)

Date :

Page 5

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

3.0 Organisation

3.1 Organisation Chart

(Insert Company Organisational Chart – be sure to identify major staff and their role in EMS development and implementation)

All Staff

3.2 Responsibility

(Define the role and responsibilities of the staff / function / department involved in the EMS such as top management, Environmental Management Representative, Deputy Environmental Management Representative, Environmental Management System Committee and Management Review Committee.)

3.2.1 Top Management

(Top Management) is responsible for:

a) endorsing the environmental policy;

b) ensuring appropriate resource allocation to enable the effective operation and continual improvement of the EMS.

3.2.2 Environmental Management Representative (EMR)

The (Position) is the appointed EMR and has the responsibility and authority for:

a) ensuring that EMS requirements are established, implemented and maintained in accordance with the ISO 14001 standard;

b) ensuring that sufficient resources are allocated for the proper implementation of the environmental policy and the EMS;

Page 6

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

c) regularly reviewing the policy and the effectiveness of the EMS, and ensuring that the necessary changes are made.

EMR is also the Chairman of the EMS Committee and has the responsibility and authority for :

a) leading the EMS Committee to establish and implement the EMS according to ISO 14001 standard, and monitoring the performance of the EMS;

b) coordinating internal EMS audits to ensure the EMS has been properly implemented and maintained;

c) handling and investigating nonconformity and ensuring corrective and preventive action has been taken to mitigate any impacts caused;

d) reporting on the performance of the EMS to the top management for review and as a basis for improvement of the EMS.

The EMR, the DEMR, the EMS Committee and (Top Management) shall undertake the EMS management review annually to ensure top management commitment and integration of the EMS with business strategies for its implementation and continual improvement.

3.2.3 Deputy Environmental Management Representative (DEMR)

The (Position) is the appointed DEMR and has the responsibility and authority for:

a) assisting the EMR to ensure the EMS is effectively implemented and maintained in accordance with ISO 14001 standard;

b) assuming the responsibility and action of the EMR when the EMR is unavailable.

3.2.4 Environmental Management System Committee (EMS Committee)

This committee is responsible for:

a) the establishment and implementation of the EMS;

b) the establishment and review of objectives, targets, and programmes;

c) ensuring the effective implementation of environmentally-related operational controls and programmes;

d) the internal communication of environmental matters between management and employees; and promoting environmental awareness among company staff;

e) the review of complaint records, nonconformity, corrective action and preventive action reports and the adoption of preventive actions as necessary;

f) providing leadership in the pursuit of environmental issues;

g) any other EMS activities that are assigned by the EMR;

h) holding regular meeting (at approximately three-month intervals). 3.2.5 Management Review Committee

The Committee systematically examines the EMS to ensure the suitability, adequacy and effectiveness of the EMS. The Committee comprises of the (Top Management), EMR, DEMR, and designated Function / Departmental Managers.

Page 7

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

3.2.6 Function / Departmental Manager

The Function / Departmental Managers are responsible for :

a) establishing controls for the identified significant environmental aspects for his/her function team / department according to procedures and instructions;

b) ensuring that the EMS is properly implemented and that environmental matters are properly handled at all stages;

3.2.7 All Employees

All employees are responsible for:

a) working in accordance with the documented environmental procedures and instructions, specific responsibilities defined in individual procedures and instructions; and

b) reporting problems or deviations associated with environmental issues and the EMS to the EMS Committee.

4.0 Environmental Management System Requirements

The EMS of COMPANY NAME is developed to manage significant environmental aspects so as to limit their impacts on the environment. The EMS is established in accordance with ISO 14001:2004 , and is described in this section. Procedures for each component is given in the relevant Environmental Procedures (EPs) listed in Appendix A.

4.1 Environmental Management System Documents

The purposes of these EMS documents are as follows:

Environmental Policy Describes the intention and principles to be adopted in relation to environmental performance, including but not limited to legal compliance, continual improvements and pollution prevention.

Environmental Describes the environmental management system and

Management System outlines how the requirements of the International Manual (EMS Manual) Standard (ISO 14001) are achieved. A cross-reference

of the ISO 14001 clauses to the sections of this Manual

is listed in Appendix A.

Objective(s) * The overall environmental goals that COMPANY NAME set to achieve.

Target(s) * The set of measurable performance requirements that COMPANY NAME establishes to achieve the objectives.

Programme(s) * The programme and schedule which COMPANY NAME implements to achieve the objectives and targets.

Environmental Procedures (EPs)

Define the roles, responsibilities, and actions to be taken to ensure that activities are performed and the EMS implemented in accordance with the environmental policy and the requirements of ISO 14001. A cross-reference of the ISO 14001 clauses to the EPs is listed in Appendix A.

Page 8

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

Environmental Instructions (EIs)

Environmental Forms/Records

Compiles the environmental aspects that are derived from the activities and services of COMPANY NAME. The register also denotes the significance of the environmental aspects and the respective operational controls for significant environmental aspects.

Compiles the legal and other requirements, which include legislation, codes of practice, regulatory and non-regulatory guidelines that are applicable to COMPANY NAME.

Describe which and how activities should be performed to manage significant environmental aspects and to achieve the EMS ISO 14001 requirements.

Record information for the audit trail and the assessment of environmental conditions and performance.

* Objectives and Targets, and associated Programmes are provided as a single document.

4.2 Environmental Policy

(ISO 14001 Standard Clause 4.2)

The environmental policy of COMPANY NAME is included in Section 2 of this document. It outlines the environmental commitments of COMPANY NAME with respect to its operations, activities, and overall environmental performance. During the development of this policy, the appropriateness to the nature, scale and environmental impacts of COMPANY NAME activities, products and services has been considered. The policy is endorsed by the (Top Management) and the policy shall be reviewed during the management review meeting.

The policy shall stipulate the commitments of COMPANY NAME to continually improve its environmental management and prevention of pollution. COMPANY NAME is also committed to comply with applicable legal requirements and other requirementsto which COMPANY NAME subscribes which relate to its environmental aspects. The environmental policy shall provide a framework for setting and reviewing objectives and targets, and must be maintained, implemented and communicated to all employees of COMPANY NAME and its contractors.

This policy shall be available to the public.

4.3 Planning

COMPANY NAME shall follow a “plan-do-check-act” process to facilitate continual environmental performance improvements. The planning process includes the identification and updating of COMPANY NAME’s Register of Environmental Aspects, and the Register of Legal and Other Requirements. Together with COMPANY NAME’s environmental policy, COMPANY NAME’s objectives and targets are established, and appropriate programmes are formulated to achieve the objectives and targets.

4.3.1 Environmental Aspects

(ISO 14001 Standard Clause 4.3.1)

The planning process commences with the identification and updating of

Page 9

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

environmental aspects. In order to evaluate the impacts of its activities to the environment, COMPANY NAME shall establish, implement and maintain a procedure to identify the environmental aspects of its activities, products or services that it can control and those that it can influence taking into account planned or new developments, or new or modified activities, products and services. These aspects, inclusive of those arising from works carried out by contractors, are registered in the "Register of Environmental Aspects".

COMPANY NAME shall ensure that all environmental aspects that may pose significant impacts to the environment are under control and prioritised for improvements.

COMPANY NAME shall keep this information up-to-date.

Relevant procedure : EP-01 Identification of Environmental Aspects and

Significance Evaluation

4.3.2 Legal and Other Requirements

(ISO 14001 Standard Clause 4.3.2)

COMPANY NAME shall establish, implement and maintain a procedure to identify and maintain access to legal requirements that are relevant to the company, as well as other requirements that the company subscribes to which relates to the company’s environmental aspects

COMPANY NAME shall identify all relevant regulations, codes of practice and guidelines that are applicable to the environmental aspects of its activities, products and services, and record this information in the Register of Legal and Other Requirements.

COMPANY NAME shall keep this information up-to-date.

Relevant procedure : EP-02 Review of Legal and Other Requirements

4.3.3 Objectives, Targets and Programme(s)

(ISO 14001 Standard Clause 4.3.3)

Based on the environmental policy and significant environmental aspects, environmental objectives and targets shall be established, implemented and maintained at each function and level within COMPANY NAME. Programmes are established, implemented and maintained for achieving its objectives and targets.

When establishing and reviewing its objectives, COMPANY NAME shall take into consideration the legal and other requirements, significant environmental aspects, technological options, financial/operational/business requirements, and the views of interested parties, and ensure that the objectives and targets are consistent with the environmental policy, including commitment to pollution prevention, to compliance with applicable legal requirements and other requirements, and to continual improvement.

The programmes designate the responsibility for achieving objectives and targets at each function and level of the company, together with the means and time frame by which they are to be achieved.

The (Top Management) shall approve the objectives, targets and programmes proposed by the EMS Committee before implementation. The EMR shall ensure that the objectives and targets are measurable if possible, and that the progress towards achieving the objectives and targets is continually monitored and reviewed.

The achievement of objectives, targets and programmes shall be reviewed by the

Page 10

COMPANY NAME Environmental Management

System Manual

Document Number : EM-01

Revision Number : 1

Date : DD-MM-YYYY

EMS Committee every 3 months. The EMR shall lead the EMS Committee in revising the objectives, targets and programmes as necessary.

COMPANY NAME shall ensure that the programmes are amended as appropriate for new projects and new or modified activities, products or services in order to ensure that environmental management applies to such projects and activities.

In the event that objectives and targets in the programmes are not met, the EMR shall revise the programme as necessary and maintain documented evidence / records for the actions taken to mitigate the problems.

The EMR shall also maintain obsolete objectives, targets and programmes as an EMS record for three years.

4.4 Implementation and Operation

The implementation of the EMS requires COMPANY NAME to clearly define roles, responsibilities and authorities of key personnel, commit to staff training, maintain effective communication channels, adopt effective document and operational controls, and maintain sufficient awareness on emergency preparedness among the staff.

4.4.1 Resources, Roles, Responsibility and Authority

(ISO 14001 Standard Clause 4.4.1)

Top management of COMPANY NAME shall commit to provide resources (including human resources and specialized skills, organizational infrastructure, technological and financial resources) essential to the implementation and control of the EMS. The roles, responsibilities and authorities of key personnel shall be defined, documented, and communicated in order to facilitate effective environmental management.

COMPANY NAME has appointed the (Position) as the Environmental Management Representative (EMR), and the (Position) as the Deputy Environmental Management Representative (DEMR) for the implementation and maintenance of the EMS. Their EMS responsibilities are described in section 3 of this manual.

4.4.2 Competence, Training and Awareness

(ISO 14001 Standard Clause 4.4.2)

COMPANY NAME shall ensure all persons performing tasks for it or on its behalf, whose work may have a significant impact on the environment, are competent on the basis of appropriate education, training and/or experience, and shall retain associated records.

COMPANY NAME will need to ensure that all people performing tasks for or on behalf of the organization, which includes contractors, sub-contractors, temporary staff and remote workers, have had an appropriate assessment for their potential to cause a significant environmental impact and the associated competence required.

COMPANY NAME shall establish, implement and maintain procedures to identify the training needs associated with its environmental aspects and its EMS, and develop programmes to ensure awareness and competence, at each relevant function and level, by addressing:

* the roles and responsibilities in achieving conformity with the environmental management system;

* the importance of conformity with the environmental policy, the procedures and the requirements of the structured EMS;

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* the significant environmental aspects and related actual or potential impacts associated from their work activities and the environmental benefits of improved personal performance;

* the potential consequences of departure from specified operating procedures; Relevant procedure : EP-03 Training

4.4.3 Communication

(ISO 14001 Standard Clause 4.4.3)

For internal communication, the EMR shall ensure information regarding the EMS (such as the policy, objectives, targets and programmes) and environmental performance is readily available to employees on notice board, or is published on the intranet or newsletters.

Employees with enquiries / complaints regarding to the EMS and/or environmental issues of COMPANY NAME shall inform their Function / Departmental Manager. The designated member of EMS Committee representing each division shall maintain a log for the relevant enquiries / complaints. Depending on the nature and scope of the enquiry / complaint, the EMR shall determine the corresponding action and maintain relevant records to demonstrate the response / corrective actions taken.

For external communication, the environmental policy is available at the office and company web page. All internal and external enquiries / complaints / communications shall be discussed and reviewed during the EMS Committee meeting and the decision shall be recorded on meeting minutes.

The EMS Committee may discuss and decide whether to communicate externally about its significant environmental aspects, the decision shall be documented in the meeting minutes. If the decision is to communicate, the EMS Committee shall establish and implement a method(s) for this external communication, e.g. publish environmental report.

Relevant procedure : EP-07 Enquiry / Complaint / Nonconformity Handling

4.4.4 Documentation

(ISO 14001 Standard Clause 4.4.4)

The Environmental Management System documentation encompasses four levels as described below :

The first level is the Environmental Management System Manual (this document) which includes COMPANY NAME’s environmental policy (specifying the principal objectives and environmental commitments of COMPANY NAME), and a broad description of how COMPANY NAME addresses the ISO 14001 requirements. The EMS Manual serves as an interface to interpret the relationship between COMPANY NAME’s EMS and the ISO 14001 Standard. An individual document of Objectives, Targets and Programmes is developed based on the company’s environmental policy. It demonstrates the company’s environmental commitment on continual improvement in environmental performance.

The second level is the Environmental Procedures (EPs), which include all procedures that COMPANY NAME shall follow as specified in the ISO 14001 Standard. These procedures provide a detailed description of the EMS elements and

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define who should do what, how and when. Appendix A shows the relationship between various environmental procedures and the ISO 14001 Standard clauses. Register of Environmental Aspects, and Register of Legal and Other Requirements are derived from the procedures and act as the foundation of the EMS which the company subscribed to.

The third level is the Environmental Instructions (EIs), which are operational control procedures or instructions, with defined responsibilities, to control the identified significant environmental aspects associated with COMPANY NAME’s operations and activities.

The fourth level is Environmental Records, which arise from the implementation of the Environmental Management System Manual, Environmental Procedures and Environmental Instructions. Environmental Records include various checklists, reports and meeting records, etc, as defined in each Environmental Procedure and Environmental Instruction.

4.4.5 Control of Documents

(ISO 14001 Standard Clause 4.4.5)

The essences of EMS documentation controls are:

* they shall be reviewed, revised as necessary and approved for adequacy by authorized personnel;

* that current version of relevant documents shall be available at all locations where operations essential to the effective functioning of the environmental management system are performed;

* that documents of external origin determined by the organization to be necessary for the planning and operation of the EMS are identified and their distribution controlled;

* obsolete documents shall be promptly removed from all points of issue and use, or are otherwise assured against unintended use; and

* any obsolete documents retained for legal and / or knowledge preservation purposes shall be suitably identified.

COMPANY NAME shall ensure that documentation is legible, dated (with dates of revision) and readily identifiable, maintained in an orderly manner, and retained for a specified period. COMPANY NAME shall establish, implement and maintain a procedure for the creation and modification of the various types of documents and the respective responsibilities for such creation and modifications.

Relevant procedure : EP-04 Control of Documents

4.4.6 Operational Control

(ISO 14001 Standard Clause 4.4.6)

COMPANY NAME shall establish, implement and maintain operation control procedures to manage its significant environmental aspects.

COMPANY NAME shall ensure that all operations and activities, carried out by COMPANY NAME’s employees or contractors, that are associated with the significant aspects are properly controlled, and that appropriate operational control procedures, in terms of Environmental Procedures (EPs) and Environmental

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Instructions (EIs), are communicated to personnel whose tasks may result in significant environmental aspects. COMPANY NAME shall influence its staff and contractors by communicating its environmental policy and other relevant EPs and/or EIs to them.

Relevant instruction : EI-xx

4.4.7 Emergency Preparedness and Response

(ISO 14001 Standard Clause 4.4.7)

COMPANY NAME shall establish, implement and maintain a procedure to identify potential emergency situations and responses to such situations in order to prevent and/or mitigate environmental impacts that may associate with them.

COMPANY NAME shall review and revise its emergency preparedness and response procedures, in particular after the occurrence of accidents or emergency situations.

COMPANY NAME shall also periodically test the procedure and the preparedness where practicable.

Relevant procedure : EP-05 Environmental Emergency Preparedness and

Response

4.5 Checking

While implementing the EMS, COMPANY NAME shall monitor and measure the key characteristics of its operations and activities on a regular basis. These results shall be recorded together with nonconformity and the corrective action and preventive action. As part of the checking process, a periodic audit on the EMS shall provide a basis for management review.

4.5.1 Monitoring and Measurement

(ISO 14001 Standard Clause 4.5.1)

COMPANY NAME shall establish, implement and maintain procedures to monitor and measure, on a regular basis, the key characteristics of its operations and activities that have significant impacts on the environment. This shall include procedures for tracking of performance, applicable operational controls and conformity with the company’s objectives and targets, as well as the calibration and maintenance of monitoring equipment. The information of environmental monitoring shall be documenting.

Relevant procedure : EP-06 Environmental Monitoring and Evaluation of

Compliance

4.5.2 Evaluation of Compliance

(ISO 14001 Standard Clause 4.5.2)

To meet the company’s commitment to compliance, COMPANY NAME shall regularly monitor and evaluate the compliance status of the applicable environmental legal requirements (section 4.5.2.1) and other requirements (section 4.5.2.2) that the company subscribes to. The records of the results of the periodic evaluations shall be retained.

Relevant procedure : EP-06 Environmental Monitoring and Evaluation of

Compliance

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4.5.3 Nonconformity, Corrective Action and Preventive Action

(ISO 14001 Standard Clause 4.5.3)

Continual improvement of the EMS can be achieved by identifying nonconformity, correcting nonconformity, and preventing nonconformity from occurring again. Regarding nonconformity and its subsequent corrective / preventive action, COMPANY NAME shall establish, implement and maintain a procedure which defines the responsibilities and authorities to:

* handle and investigate nonconformity;

* take action to mitigate the impacts caused;

* initiate and complete corrective and preventive actions;

* ensure that the corrective or preventive actions taken to eliminate the causes of actual and potential nonconformity are appropriate to the magnitude of problems and commensurate with the environmental impacts encountered;

* record the results of corrective and prevention actions taken;

* review the effectiveness of corrective action and preventive action taken;

* implement and record any changes in the documented procedures resulting from corrective and preventive action; and

COMPANY NAME shall also ensure that any necessary changes are made to environmental management documentation.

Relevant procedure : EP-07 Enquiry / Complaint / Nonconformity Handling

4.5.4 Control of Records

(ISO 14001 Standard Clause 4.5.4)

Records shall be maintained to keep track of COMPANY NAME’s environmental performance, to demonstrate conformity to the requirements of the EMS, legal compliance, and to maintain audit trails in accordance with the requirements of ISO 14001 Standard, and the results achieved.

COMPANY NAME shall establish, implement and maintain a procedure to denote the identification, storage, protection, retrieval, retention and disposition of environmental records, to ensure that such records are legible, identifiable, and traceable to the activity, product or service involved, and that they are stored and maintained in such a way that they are readily retrievable and protected against damage, deterioration or loss. The retention period of each type of environmental records shall be specified.

Relevant procedure : EP-08 Control of Records

4.5.5 Internal Audit

(ISO 14001 Standard Clause 4.5.5)

COMPANY NAME shall plan, establish, implement and maintain a programme and

procedures to carry out periodic environmental management system audits to:

a) determine whether or not the environmental management system:

* conforms to planned arrangements for environmental management including the requirements of ISO 14001; and

* has been properly implemented and maintained;

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b) provide audit results and information for management review for environmental improvement.

The audit programme, including the schedule, shall be based on the environmental importance of the activities concerned and results from previous audits. The audit procedures cover the audit criteria, scope, frequency and methods, as well as responsibilities and requirements for conducting audits and reporting results and retaining associated records.

COMPANY NAME shall conduct EMS audits on a regular basis. Timely site environmental audits are required to ensure appropriate preventive actions being taken as planned, and corrective actions being carried out on a timely basis.

Relevant procedure : EP-09 Internal Audit

4.6 Management Review

(ISO 14001 Standard Clause 4.6)

The “plan-do-check-act” cycle shall require the top management of COMPANY NAME to act and review the environmental management system periodically to ensure its suitability, adequacy and effectiveness.

Before the Review, the EMR shall schedule for the management review and inform all the participants, and gather all relevant records/requirements (such as change in legal requirements) and prepare a summary report (if necessary) for discussion.

The (Top Management), EMR and DEMR together with the EMS Committee shall take part in the annual management review. They shall assess the work done in the past year in environmental management and evaluate the existing EMS with respect to changes in legislation, concerns of interested parties, (BUSINESS ACTIVITIES), technology and product requirements, and lessons gained from previous experience, etc.

Topics to be discussed in the management review shall include but not be limited to:

* review of the environmental policy, objectives, targets, and programmes;

* review of legal compliance and compliance with other requirements (including contractor compliance on COMPANY NAME’s activities);

* environmental aspects of activities and their disclosure to public;

* findings of the internal audits;

* review of nonconformities and the status of corrective/preventive actions;

* communications from external interested parties, including complaints;

* areas for improvement with respect to environmental performance;

* adequacy of emergency preparedness and response;

* changing circumstances, including developments in legal and other requirements related to its environmental aspects,

* identify the need for modification of the existing EMS in light of the above items, and

* follow-up action from previous management reviews.

The review shall initiate a new “plan-do-check-act” cycle with improvements in COMPANY NAME’s environmental performance and further enhancement of the

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EMS.

Findings from the management review shall be recorded in the meeting minutes and the EMR shall retain it as an EMS record. Maintenance of the records shall be in accordance with EP-08.

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Appendix A Cross Reference of ISO 14001 Requirements* and Sections in the EMS Manual and Environmental Procedures.

ISO Clause

EMS Manual Section No.

EP Ref. No.

4.1 General Requirements

4.1

–

4.2 Environmental Policy

4.2.

–

4.3 Planning

4.3

–

4.3.1 Environmental Aspects

4.3.1

EP-01

4.3.2 Legal and Other Requirements

4.3.2

EP-02

4.3.3 Objectives, Targets and Programme(s)

4.3.3

–

4.4 Implementation and Operation

4.4

–

4.4.1 Resources, Roles, Responsibility and Authority

4.4.1

–

4.4.2 Competence, Training, and Awareness

4.4.2

EP-03

4.4.3 Communication

4.4.3

–

4.4.4 Documentation

4.4.4

–

4.4.5 Control of Documents

4.4.5

EP-04

4.4.6 Operational Control

4.4.6

All EIs

4.4.7 Emergency Preparedness and Response

4.4.7

EP-05

4.5 Checking

4.5

–

4.5.1 Monitoring and Measurement

4.5.1

EP-06

4.5.2 Evaluation of Compliance

4.5.2

EP-06

4.5.3 Nonconformity, Corrective Action and Preventive Action

4.5.3

EP-07

4.5.4 Control of Records

4.5.4

EP-08

4.5.5 Internal Audit

4.5.5

EP-09

4.6 Management Review

4.6

–

* ISO 14001:2004 is referred.

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Appendix B Controlled Document List

Document No.

Document/Form Name

CP-01

Environmental Policy

O&T-YYYY

Objectives, Targets and Programmes

EAR-01

LR-01

EM-01

Environmental Management System Manual

EP-01

Identification of Environmental Aspects and Significance Evaluation

EP-02

Review of Legal and Other Requirements

EP-03

Training

EP-04

Control of Documents

EP-05

Environmental Emergency Preparedness and Response

EP-06

Environmental Monitoring and Evaluation of Compliance

EP-07

Enquiry / Complaint / Nonconformity Handling

EP-08

Control of Records

EP-09

Internal Audit

EI-01

Environmental Office Practices

EI-02

Green Procurement

EI-03

Environmental Practices for Using Company’s Car

EI-04

Waste Management

EI-05

Air Pollution Control

EI-06

Water Pollution Control

EI-07

Noise Pollution Control

EI-08

Resource Conservation

EI-09

Handling and Storage of Chemicals

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Position Classification Standard for

Production Control Series, GS-1152

Table of Contents

SERIES DEFINITION 2

EXCLUSIONS 2

DEFINITIONS 3

OCCUPATIONAL INFORMATION 5

TITLES 7

EVALUATING POSITIONS 9

GRADE CONVERSION TABLE 11

FACTOR LEVEL DESCRIPTIONS 11

FACTOR 1, KNOWLEDGE REQUIRED BY THE POSITION 11

FACTOR 2, SUPERVISORY CONTROLS 13

FACTOR 3, GUIDELINES 14

FACTOR 4, COMPLEXITY 15

FACTOR 5, SCOPE AND EFFECT 17

FACTOR 6, PERSONAL CONTACTS AND FACTOR 7, PURPOSE OF CONTACTS 18

FACTOR 8, PHYSICAL DEMANDS 20

FACTOR 9, WORK ENVIRONMENT 20

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SERIES DEFINITION

This series includes positions involved in the supervision or performance of planning,

estimating, scheduling, and expediting the use of labor, machines, and materials in specific manufacturing or remanufacturing operations that employ mechanical or automated production systems and methods in the fabrication, rebuilding, overhaul, refurbishing, or repair of any type of Government-owned, controlled, or operated equipment, systems, facilities, and supplies. Some positions are involved in the preparation of contract bids that include the preproduction analysis of specific proposed work packages to determine workload capacity, labor, material, services, and machine requirements, etc., to arrive at the most competitive bid. These positions are also covered by this series as they perform the same type of work as positions that are responsible for the preproduction planning for any assigned projects, since the source data used and knowledge applied are the same.

Positions that include only some of the duties and responsibilities of the Production Control Series should not be classified mechanically in this series. In order to include a position in this series, the production control work being performed must reflect the occupational definition as a whole and not just selected or fragmented portions of the duties and responsibilities of the occupation. That is, between the trainee and journey levels, developmental positions must be involved, in varying degrees, with all aspects of the production control program.

EXCLUSIONS

1. Classify positions responsible for the development, analysis, and evaluation of management information systems reports, charts, and graphs from production data that do not have any significant duties or responsibilities for planning all aspects of an integrated system of production control in the Management and Program Analysis Series, GS-0343.

2. Classify positions responsible for planning, coordinating, or evaluating logistical action required to support missions, weapon systems, or other programs, where the paramount requirement is the ability to integrate the separate functions in planning or implementing a logistics management program in the Logistics Management Series, GS-0346. This includes positions that provide logistical program support to the production effort but are not directly responsible for controlling the production process itself.

3. Classify positions responsible for the analysis and improvement of manufacturing processes, methods, procedures, layouts, equipment, and standards that primarily require technical engineering knowledge in the Engineering Technician Series, GS-0802.

4. Classify positions responsible for planning, designing, analyzing, improving, and installing integrated work systems in order to produce products, render services, repair equipment, etc., that require knowledge of the principles and techniques of industrial engineering and pertinent industrial work processes, facilities, methods, and equipment in the Industrial Engineering Technician Series, GS-0895.

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5. Classify positions responsible for planning, evaluating, and maintaining technical surveillance over Government production operations, either in contractor or Government-operated facilities in the Industrial Specialist Series, GS-1150. Positions that have significant production control responsibilities for contractor operations for analyzing, planning, and scheduling specific production operations or workload are included in the GS-1152 series.

6. Classify positions that primarily require a professional knowledge of printing processes and equipment to plan, administer, supervise, review, evaluate, or perform work in connection with the management of a printing program in the Printing Services Series, GS-1654.

7. Classify positions responsible for identifying parts, assemblies, and equipment; determining sources of supply and feasibility of local manufacture; determining availability, interchangeability, and substitution; preparing specifications for procurement and expediting material deliveries; locating alternate sources; or functioning as an equipment technical information resource and providing guidance for the activation or deactivation of equipment in a system in the Equipment Services Series, GS-1670.

DEFINITIONS

Agency: As used in this standard, means Army, Air Force, Navy, DLA, NASA, etc.

"Complex" Product or Project: A complex product or production project is one that requires complex manufacturing or overhaul processes or techniques when:

1. it has component parts, subassemblies, or major assemblies, or undergoes many manufacturing processes and has a great number of characteristics to be controlled or checked;

2. it has envelope or performance-type specifications, a complex design, or a new design subject to engineering changes and modifications concurrent with production;

3. inspection of the item requires complicated setups, involving interrelated dimensions and concentricity requirements, and extremely close tolerances; or

4. inspection of the item requires the use of specially designed intricate calibration and measurement equipment, a practical knowledge of advanced industrial material treatment processes, or intricate or specially designed preservation and packaging techniques.

Some examples of complex items are aircraft, aircraft engines, fire control systems, sophisticated navigation systems, guided missiles, or any items characterized by many

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individual components and subassemblies involving a variety of manufacturing or control operations or processes.

"Less Complex" Product or Project: A less complex product or project is defined as a

type:

1. that has definite specifications and a range of manufacturing processes or commodity characteristics, but relatively few interrelated parts or combinations of factors to be considered;

2. that can be inspected by using a variety of standard precision measuring devices or a somewhat restricted number of sensory determinations; or

3. that is covered by standardized, or less complicated contract clauses; or that requires the use of standard industrial material treatment processes or standard preservation and packaging techniques.

A few examples of less complex products or projects are field or ship gun-type ammunition; some aircraft wheel assemblies; aircraft control surfaces; pumps (feed water/hydraulic/oil); or any items characterized by a limited number of components or subassemblies that require a few different but standardized operations or processes.

Specialized Machines (production): Machines that have been designed for a specific purpose and cannot be used for other purposes without major modification. For example, ammunition depots use a variety of such equipment such as cartridge/shell extractors, and cavity drillers (explosive).

Standard or General Purpose Machines (production): Machines that have not been designed for one particular process or operation, but can be utilized, sometimes with only minor modifications, in a number of different operations. Shipyards and aircraft overhaul and repair activities typically utilize large numbers of general purpose machines. Some examples are drill presses, lathes, turret lathes, milling machines, boring mills, shapers, slotting machines, metal breaks, shears, and balancing machines.

Worker-hours or Worker-days or Worker-years: These terms represent a specific unit of measure for determining the amount of labor required or expended. For example, 560 worker-hours may represent one worker required to do 8 hours of labor every day for 70 days or; it could also represent a different requirement for a variety of trades in two groups of 35 workers each working in two 8-hour shifts for just 1 day (totaling the same 560 hours) to complete the same or different work, but in a shorter period of time.

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OCCUPATIONAL INFORMATION

For the purpose of this standard, the word "product" or "project" is used to identify an item that has been either manufactured, constructed, overhauled, or repaired. When it is completed, it represents an asset that is typically identified with the mission and purpose of the industrial activity. The product or project can be any one of a wide variety of items, of any size, cost, or degree of complexity, ranging from small arms ammunition to a large nuclear-powered aircraft carrier.

Production control is the planning of production in advance of actual operations; establishing the exact route of each individual item, part, or assembly; setting the start and completion dates for each important item and assembly, as well as the finished product; determining the specific type of labor and number of hours required for each phase of the operation; and calculating all the materials, services, and the production schedule lead time required. Many positions that are concerned with current or immediate production are responsible for the preparation and release of necessary work packages and job orders, as well as initiating any appropriate follow up action.

Many large industrial organizations are responsible for highly specialized products with a long production cycle and a lengthy preproduction or advance planning phase (that part of production control work that is done many months to a year or more in advance of the actual production operations). One or more of the production controllers may be responsible for the advance planning phase for production of a very difficult product such as a major overhaul of a large and complex ship, while the current or immediate production control phase is performed by other controllers.

In smaller facilities providing less complex products, the controller may be responsible for the work in both phases. Some activities divide a very large and complex production effort into several major production operations, using different controllers for each major operation who manage both the planning phase and the immediate production phase. Due to the close dependence and vital interaction of both preproduction planning and the immediate production operations, more activities are combining these planning functions. In an overall sense, control over most manufacturing, construction, overhaul, or repair operations is exercised by and through a number of departments or offices. The production control office presupposes that other offices (such as those in engineering, accounting, and procurement) will accomplish their respective daily functions as required and provide information to the control process. The controller may often orchestrate an ongoing team effort of planning, scheduling, procurement coordination, and problem resolution across all the organizations as time and changing priorities dictate.

There are different degrees of difficulty and complexity in production control at Government and contractor industrial activities. Production may range from several worker-hours for a basic product to a complex process that requires several years. An example of a very difficult and

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complex process is an aircraft carrier overhaul. A major overhaul program to extend its service life usually requires several years of difficult and intense work in both the preproduction and the immediate production planning phases.

The full performance level for production controllers will vary from one activity to another depending on the difficulty and the complexity of the product, production methods, and procedures. That level may range from GS-7 up through GS-12. All positions, however, have the same basic duties in common as they all are required to perform almost all of the following functions:

1. prepare production plans for specific projects and operations through the compilation of customer requirements, engineering designs, specifications, and machining process data;

2. compile estimates for different types of skilled labor and the number of worker-hours required for production operations;

3. advise procurement or supply activities on a variety of material requirements and production schedule due dates;

4. schedule and control primary work assignments to manufacturing activities based upon production line or shop capacity, priority, and due date;

5. determine the status of work in progress, time required to complete the job, the availability of materials, tools required, and reassess priorities;

6. expedite jobs in progress by any appropriate means;

7. monitor, record, and report the status of production funding.

Many positions covered by this series are concerned with the construction, overhaul, or repair of relatively large and complex systems or facilities (e.g., aircraft, ships, large ordnance, dry docks, or public works projects) that do not use a production line system. Production shop or contractor personnel normally go to the product to disassemble, overhaul, repair, modify, and provide service and specialized trade operations on-site. They may remove many of the larger assemblies and various components and send them to a variety of different machine shops or other facilities for more specific and sometimes very complex and difficult disassembly, overhaul, and remanufacturing functions.

Many products may appear to be similar because of their class, type, or model, but the overhaul or repair seldom is the same for each product. They often have different wear and usage conditions or operational problems that are identified in their work packages. Thus, modifications and engineering changes made during and after manufacture are seldom alike. Periodically, due to rapid changes in technology or other requirements, some equipment or systems require unexpected modifications, alterations, or improvements. This in turn may cause significant changes in the controller's planning and funding to allow for the additional or changed production procedures, operations, and materials needed to implement and coordinate all the work.

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An increasing number of production controllers are responsible for the preparation of bids for new work since agencies are required to operate their industrial activities in full and direct competition with both private industry and other Government facilities. Many activities must actively solicit new Government business through the formal competitive bid process to provide quality products at the most economical cost.

Some controllers work in industrial activities concerned with products that are produced or overhauled in high volume or have a relatively short production cycle, for example: basic munitions; some types of small arms; electronic and mechanical components of limited complexity; printed matter; or, a wide variety of expendable products. These items usually have a traditional production line operation. The planning and control systems are usually specific, regular, and recurring for the manufacture, modification, or repair of the complete product including any packaging, distribution, or storage. While production complexity of any individual item may be limited, the management of high volume production for a variety of products for numerous customers with different preservation, special packing and shipping requirements, and a variety of conflicting due dates, presents another type of production complexity.

As part of their regular work, some production controllers are required to make unexpected arrangements to transport skilled laborers, machines, and equipment to any site in the world for emergency repairs, or for mission related modifications. The controller must then realign resources and priorities in order to maintain current production schedules to compensate for the loss of these vital production resources.

A few industrial activities have highly complex end products that are one of a kind or research and development prototype products with very limited quantities. Production control at these activities may involve work in which there are limited or no precedents, frequent changes in methods and procedures, few guidelines, requirements for special tools or jigs, or other unique requirements for various materials or services. The controller must closely coordinate production efforts with the designers, make frequent changes in schedules and priorities, and make every effort to control costs.

TITLES

Authorized Titles

The authorized titles established for nonsupervisory positions in this series are:

1. GS-4 -- Production Control Aide

2. GS-5 and GS-6 -- Production Controller

3. GS-7 and above -- Production Controller (specialty)

Supervisory Production Controller is the title for positions that meet the criteria in the

appropriate supervisory guide.

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Specializations

Agencies may use parenthetical titles in accordance with guidance in the Introduction to the Position Classification Standards. We recommend avoiding specializations that are too broad or too narrow. Use of one specialization is more appropriate than use of three or more specializations together, as substantial depth of knowledge in any area is required to warrant use of a specialization in the title. Also, it would not be appropriate to define a specialization in terms of specific product; e.g., (aircraft, C-5). Usually, the required skills and knowledge can be applied to a range of aircraft. The following is a list of suggested parenthetical titles.

Some suggested specializations are:

1. Aerospace - Aerospace systems and subsystems; primary components; and integrated equipment in the areas of fluid and flight mechanics, propulsion and power, materials and structures, including ground support, launch, and aerospace vehicles.

2. Aircraft - Fixed and rotary wing aircraft systems including engines and structural components of the total system such as airframes, wings, rotor heads, stabilizers, and control surfaces; landing and arresting gear; bomb, missile, and torpedo racks, etc.

3. Ammunition - Conventional ammunition and special weapons (e.g., chemical and biological), their components, propellants, and explosive devices and the maintenance of munitions.

4. Automotive - Equipment and components such as cars, trucks, tanks, buses, and special purpose vehicles including track or crawler vehicles, maintenance and material handling equipment, and all component parts and assemblies.

5. Construction - Numerous and complex or long-term Government public works and controlled contractor projects such as airfields, buildings, roads, bridges, ship docks, and flood control projects.

6. Electrical - Electrical machinery, equipment, apparatus, and instruments, including motors, generators, transformers, switches, and controls.

7. Electronics - Electronic equipment and instruments, including radio and television equipment, radar, sonar, navigational computers, external missile guidance equipment, and electro-optical equipment.

8. Mechanical - Machinery, other than electrical, such as engines and turbines; machines and instruments powered by heat or mechanical energy, including steam and internal combustion power plants; industrial equipment; heating and air-conditioning systems; pumps, pipes, and valves; machine tools, and mechanical or marine equipment not included under other specializations.

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9. Missiles - Guided and ballistic missiles, their major components and subsystems including fuel and propulsion systems, boosters, guidance and instrumentation systems, structural components, airframe, and launchers.

10. Nuclear - Reactor cores, pressure vessels and closures, control systems and mechanisms, reactor fuel materials, and all basic systems that are an integral part of a reactor.

11. Ordnance - Mechanical ordnance and accessories, azimuth and elevation mechanisms and motors, sighting and range finding equipment, field and deck guns, machine guns, mortars, and all small arms.

12. Precision Instruments - A wide variety of electronic, electrical, radiological, mechanical, and optical; laboratory, scientific, and engineering instruments; measuring and controlling instruments and timing devices; and range finders not attached to ordnance.

13. Ships - All types of ships, vessels, barges, related marine equipment, and ship systems that are not correctly identified with one of the above specializations.

EVALUATING POSITIONS

Organizational Structure

The organizational placement of production control functions varies considerably among and within most Federal agencies. Generally, larger agencies have highly structured production control organizations, while smaller agencies have less formalized structures. Many production control offices are decentralized and are located at a field installation; some are in or near a contractor's facility; some are at regional facilities; while only a few are part of the agency's headquarters organization. Some production operations are for mission support, while others are for new product manufacturing, or for the purpose of providing specialized product services for a geographical area or for other Government organizations.

There is considerable difference in the degree of difficulty and complexity connected with production operations and procedures from one product and facility to another. Because of this, the organizational location of the production control program, the type or the variety of items being produced or repaired, and the separate or combined functional areas of assignment of preproduction planning and immediate production control should not be assumed to have any automatic grade or factor level implications.

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Length of Production Cycle

The number of worker-hours or worker-days required to complete a full production cycle is used by some Government agencies to denote differences between the various levels and types of funded work (e.g., minor versus major overhaul). The length of the production cycle, in itself, does not equate to a particular grade level. The length of the production cycle must be considered in conjunction with the number and variety of processes, procedures, skilled trade personnel, parts, components and materials, and the degree of complexity and difficulty of assembly.

Dollar Value

The total production cost of a product work package or project, by itself, may have little relationship to the difficulty or complexity of the work of the position. Very high dollar production costs could, in some cases, actually represent mostly high cost purchased equipment, components, and materials with only limited plant production activity or assembly costs. In another activity, the same high costs may represent very difficult and complex production processes utilizing considerable skilled labor with a limited amount of purchased equipment. Consequently, dollar value is not considered a valid indicator of project complexity or level of difficulty.

In many Government industrial organizations, the unit of measure for the labor portion of the fund or budget is not in dollars. It is measured or calculated, budgeted, apportioned, and reconciled in worker-hours and worker-days. In many activities, the workers and shops clock or record the exact amount of time spent on each operation they perform against a specific job order. Each shop has its own predetermined labor rate that includes its hourly labor mix plus the shop overhead. The controller utilizes such data for tracking work in progress and when budgeting and allotting those hours and days for new work. The employee must exercise just as much control and responsibility as with any monetary fund. Production controllers may be responsible for managing either type of fund; however, the degree of difficulty and responsibility is usually the same, for the same work, whichever unit of measure is used. The size of the fund, in itself, has no direct grade or factor level impact.

General

Evaluate positions on a factor-by-factor basis, using the factor level descriptions in this standard. Only designated point values may be used. The absence of a factor level description at any particular level does not preclude evaluation of positions at that level. If the work being evaluated exceeds or is lower than any factor level description in this standard, the FES Primary Standard may be used in conjunction with a related FES standard.

Evaluate supervisory positions using the appropriate supervisory evaluation guide.

Various factor levels provide a few examples of products that might be under the responsibility of a production controller. The examples are not meant to be all inclusive, they are only meant

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to establish a general frame of reference for establishing the degree of product/production difficulty and complexity at that level.

GRADE CONVERSION TABLE

Total points on all evaluation factors are converted to GS grade as follows:

GS Grade

Point Range

655-850

855-1100

1105-1350

1355-1600

1605-1850

1855-2100

2105-2350

2355-2750

2755-3150

FACTOR LEVEL DESCRIPTIONS

FACTOR 1, KNOWLEDGE REQUIRED BY THE POSITION Level 1-4 -- 550 Points

At this trainee level, the position requires a practical knowledge of the product and the activity's routine industrial production or civil construction procedures and operations that is sufficient to enable the employee to collect, compile, correlate, and maintain production data from shop records, personnel, and computer sources.

Level 1-5 -- 750 Points

Employees use knowledge of the production organization and established production methods and procedures, labor, and material requirements in order to carry out established production control assignments that range from providing assistance to higher graded production controllers to independent performance of repetitive and uncomplicated production control tasks or projects, e.g., conventional electronic surface and airborne communications systems; mobile field ordnance; or a limited variety of products such as numerous ammunition and explosive devices. These tasks or projects require general knowledge of the product or the project to correlate and analyze a variety of routine production data and processes, prepare outlines for basic production

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schedules, and effectively communicate with and obtain the cooperation and assistance of personnel in other parts of the industrial organization.

Level 1-6 -- 950 Points

Employees use knowledge and experience in the recurring manufacture, overhaul, or repair of products or projects using multiple process production methods and procedures to develop information necessary for the control of a complex product, e.g., numerous skilled trades utilizing a variety of general purpose and specialized machines, tools, equipment, and material to manufacture, remanufacture, or overhaul and assemble products such as large self-propelled ordnance; a complex missile/launcher system; major systems and airframes of fixed and rotary wing aircraft; or a variety of complex and long-term facility repair and construction projects. The employee utilizes a practical knowledge of the industrial activity, its staff and support operations, the purpose and capacities of the machines and equipment, the type and kind of labor required, a variety of material resources and their cost, to plan for and control the production cycle.

The work requires extensive knowledge, understanding, and use of product and manufacturing terminology, data, and standards and how to relate them properly to new projects. The controller utilizes considerable knowledge and experience to observe and analyze production operations to determine if schedules are being followed, if they can be improved, and to determine the causes of production delays.

Level 1-7 -- 1250 Points

Positions at this level require, in addition to the above, a comprehensive and intensive practical knowledge of all the production methods and procedures, machines, and materials; and considerable skill and experience to plan for the future or immediate production control for the manufacture, overhaul, or repair of prototype or very complex products; e.g., spacecraft; combat or strategic fixed wing aircraft; large and very complex weapon systems like a warship or submarine; or responsibility for a number of complex "compartmented zones" of a very large ship (the complete propulsion system is one such zone).

The controller must have knowledge, skill, and experience to prevent or alleviate production delays, scheduling conflicts, the lack of sufficient materials, faulty processes, labor shortages, or skilled trade imbalances. This requires a good working knowledge of the basic requirements and procedures of all departments being coordinated both in and outside of the production area.

The employee must apply a variety of methods to investigate, analyze, plan, and implement corrective action as well as establish effective cost controls for difficult and complex production problems that may occur during the preplanning or the work-in-progress phase. Some production controllers, because of their advanced knowledge and experience, may function as the principal employee responsible for the production control planning for a particular type of product.

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FACTOR 2, SUPERVISORY CONTROLS Level 2-1 -- 25 Points

The supervisor and senior production controllers provide clear, detailed, and specific instructions for all phases of the assignment.

The employee requests information on all situations that are not covered by existing instructions or by guidelines.

Supervisory controls are close for all ongoing and completed work. Work is checked in process and upon completion for accuracy, adequacy, and adherence to instructions and established procedures. Work is reviewed with less frequency as demonstrated proficiency is achieved.

Level 2-2 -- 125 Points

The supervisor makes specific assignments by providing an outline of what is to be done, the degree of quality and accuracy that is expected, and information on deadlines and priorities. The supervisor and senior controller(s) provide additional instructions for new, difficult, or unusual tasks that may include suggested work methods or advice on resources and materials.

The employee uses initiative in carrying out recurring or continuous assignments without assistance but may request help with any deviations, problems, or unusual situations.

Completed work, reports, and procedures are reviewed for technical accuracy and compliance with instructions.

Level 2-3 -- 275 Points

The supervisor assigns responsibility for providing continuous control of production in a specific department or large shop. The supervisor defines the general objectives, priorities, and any changes to project-driven deadlines. The supervisor is available to assist the employee with unusual situations which do not have guidelines or clear precedents.

The controller is expected to analyze the production requirements; plan for the various phases of production and labor requirements; coordinate the job scheduling, materials, and funding; and handle problems and deviations in accordance with instructions, policies, previous training, or accepted practices.

Completed work is usually evaluated for technical soundness, efficient use of resources, resolution of normal production scheduling problems, and efforts made to expedite product completion deadlines.

Level 2-4 -- 450 Points

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The supervisor and the controller confer to set the overall objectives and adjust any conflicting priorities. The controller receives minimal guidance and is expected to analyze, plan, and carry out complex production control tasks independently and resolve most production, labor, machine, and material conflicts or shortages which arise.

The controller plans and coordinates most of the timing and integrated production efforts of many different departments or shops that are responsible for work on various segments of the product. The supervisor is informed of any situations that could impact on long-term production requirements.

The controller may consult with the supervisor to provide information needed by management, to report potentially troublesome situations, or to recommend corrective action in areas that extend beyond the area of the controller's authority. Completed work is reviewed only in terms of effectiveness in meeting and coordinating production requirements and deadlines.

FACTOR 3, GUIDELINES

Level 3-1 -- 25 Points

The employee is provided with specific and detailed guidelines, instructions, and forms for all important aspects of the assignment.

The employee works in strict adherence to the guidelines. Changes or deviations must be approved by the supervisor or a higher level production controller.

Level 3-2 -- 125 Points

The employee uses a variety of detailed guidelines in the form of production control data, worker and machine capabilities, material specifications, technical bulletins, user equipment logs, modification data, drawings, material orders, and historical manufacturing data.

The controller uses judgment to select and apply the available guidelines and all technical data to provide effective production control for the product(s). The controller makes only minor deviations to suit work situations that may arise. When significant deviations from the guidelines are required, the employee seeks guidance from the supervisor or a higher level controller.

Level 3-3 -- 275 Points

Guidelines are available for most assignments but they are not always specific or are not completely applicable to some products, processes, materials, or production operations.

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The controller must use experience and judgment to interpret, adapt, or extend policies, guides, procedures, regulations, and precedents to new or different products and production operations. Since some guides may not be applicable, the employee analyzes the results and makes recommendations for necessary changes. At this level, some positions have responsibility for preparing and testing new product assembly methods, procedures, and guidelines.

Level 3-4 -- 450 Points

At this level, there is a significant lack of definitive or directly applicable guidelines and standard data. The controller usually refers to previous methods, procedural guides, and instructions which cover major production functional areas which are of limited use or application.

The employee exercises a high degree of initiative in searching out sources of information, much of it indirect or obscure, to develop project estimates and plans for control of complex production projects. The controller may depart from traditional criteria, methods, and procedures to develop new ones which may also require proposing new policies to obtain effective results, overcome unusual problems, and meet the individual program and customer requirements.

FACTOR 4, COMPLEXITY

Level 4-1 -- 25 Points

This is a trainee level where most of the assignments are in direct support of the work done by other production controllers.

Most of the tasks are clear-cut and directly related to the production control functions of the organization with few alternatives as to what needs to be done.

The results are monitored by others who use the employee's work products. Assistance is readily available and proficiency is readily achieved in a few months.

Level 4-2 -- 75 Points

At this level, the controller is rotated through a variety of tasks of a developmental nature for the purpose of providing knowledge of, and experience in, a range of standard functions, methods, and procedures for the proper control of material, labor, and funding for production.

As proficiency in basic production control is achieved, the employee is given responsibility for control of the manufacture or repair of a limited variety of items that essentially use the same processes and materials. The production machinery and equipment have been designed to carry out the required production processes, and the workload and labor have been programmed well in advance of the immediate production phase.

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Production control decisions are based upon objective evaluations using current and precedent data for the preparation of work orders, and the sequencing of machine processes, labor, and material allowances that present few problems for products of limited complexity.

Level 4-3 -- 150 Points

At this level, the employee is responsible for the advance planning or the immediate production control for the manufacture, construction, overhaul, or repair of a variety of types of products, of one or more complex products that have numerous components or subassemblies. The product may be a new type of equipment or system, made up of different complex components that require a large portion of the facility's general purpose machines which are adaptable to a variety of operations and processes. The work is programmed on a long-term basis (many months) and production control data are available.

Controllers who are primarily concerned with preliminary or advance planning of production operations make decisions about:

1. the broad span of actions involved (obtaining the materials, engineering data, skilled labor, test, and support equipment; controlling the funding, handling, and storage support; as well as programing the project into the facility workload);

2. selecting the methods which will make the most efficient and economical use of facilities and skilled labor; and

3. time-phasing these actions to obtain optimum efficiency. The controller observes manufacturing operations, monitors applicable reports, determines if production is proceeding according to schedule, analyzes causes for delay, takes corrective action, and makes adjustments to production schedules.

Level 4-4 -- 225 Points

Production controllers at this level are assigned products or projects that are difficult and complex and require the application of a complete range of production control principles, techniques, and methodology to plan and accomplish control over their construction, manufacture, overhaul, or repair. Typical assignments at this level are prototype or developmental equipment, or equipment systems that are composed of a large number of different components and subassemblies, or products that represent long-term depot level major overhaul or repair. Examples include responsibility for a major segment, system, or compartmented zone of a spacecraft or a complex combat or strategic aircraft or ship, or comparable products (e.g., the propulsion system of a large ship or nuclear submarine, the complex fire control and launching systems for sophisticated missiles, or other products of similar difficulty and complexity).

Controllers develop plans prior to the immediate production or availability phase and are faced with difficult problems due to the lack of standard data and guidelines for the equipment or project. Some controllers have to make difficult production planning decisions where there is a

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large amount of technical data and specifications. They exercise considerable judgment in identifying areas that are similar to previous production tasks to establish a framework for initial planning. They conduct research for pertinent information and consult directly with responsible officials to obtain missing technical data, specifications, and design information.

The complexity and individual nature of each product or project and its own special

requirements prevent the use of routine established production plans, methods, and procedures. Long-term overhaul work involves replanning production schedules and preparing justifications for additional funding for unplanned work discovered during the disassembly or tear-down of the product.

Level 4-5 -- 325 Points

Production control assignments at this level include a broad range of duties involving substantial breadth and depth of analysis, and consideration of numerous interrelationships and variables to develop production control plans and programs for very difficult and complex products or projects. Typically, they require multi-year funding and more than a year of preproduction planning and immediate production. The production process requires a wide variety of skilled trades for hundreds of thousands of worker-days to accomplish the project.

The most important function of controllers at this level is the complex coordination of the timing and sequence of: large amounts and wide varieties of materials; hundreds of work orders for the overhaul, modification, removal, repair, and replacement work by many skilled trade shops scattered about the facility and at various contractor locations across the country; and a multitude of requirements for new equipment and materials. Controllers make frequent adjustments to production schedules and prepare justification for additional funding for unplanned work discovered during the disassembly or overhaul of the product.

Examples of this level of complexity are assignments which require the responsibility for both the preproduction planning phase as well as the immediate production control for the major overhaul and repair of a number of large strategic multiengined aircraft or several destroyers; the responsibility for construction of a large ship; the major overhaul of a nuclear-powered submarine; or, the responsibility for the complex long-term major overhaul of any other weapon systems typically requiring 24-36 months of work to complete.

FACTOR 5, SCOPE AND EFFECT

Level 5-1 -- 25 Points

Assignments and tasks are specific, routine, and designed primarily to acquaint the employee with production control work processes and techniques, pertinent product characteristics, and applicable manufacturing, construction, and major overhaul or repair processes.

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While assignments are primarily for training, the accuracy of computations and information given and received are used by others in the work unit. There is little impact or effect beyond the unit.

Level 5-2 -- 75 Points

Assignments are designed to further increase and refine the controller's job-related knowledge and skills, and to provide assistance to higher graded controllers.

They have a direct effect on the planning, estimating, and scheduling of work, materials, and the effective use of labor and machines for the routine production operations of an uncomplicated product or for basic components of a complex product.

Level 5-3 -- 150 Points

The work involves resolving a variety of conventional production problems and situations by the selection or adaptation of formal work methods and procedures, utilizing established or precedent criteria, and production plans.

Results of the work impact the effectiveness of operations of the activity. The goal is to achieve and maintain desired production levels for products that meet or exceed the original specifications and terms of acceptability established by the customer, and are consistent with efficient and economic operations.

Level 5-4 -- 225 Points

At this level, the purpose of the work is to plan, develop, and implement production control programs of considerable breadth and complexity. The work involves establishing criteria, formulating effective production control programs, assessing the effectiveness of production programs, and investigating or analyzing a variety of unusual production problems and conditions.

The work affects a wide range of organizations within the industrial activity, and typically has application to other agency activities that are performing similar work at other locations. Completed assignments have a direct impact on the industrial mission of the agency and the safety and security of personnel in the organization to which the product must be shipped in full operational condition.

FACTOR 6, PERSONAL CONTACTS

AND

FACTOR 7, PURPOSE OF CONTACTS

Match the level of regular and recurring personal contacts with the purpose of contact and credit the appropriate point value using the chart below.

Persons Contacted

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1. Personal contacts are with other employees within the immediate organization or office, and in related production or support units. These include personnel in various occupations such as production foremen, general foremen, engineers, and supply and procurement personnel. Contacts are at work sites and by telephone.

2. Contacts are with other employees in the same agency but beyond the immediate

organization. People contacted are generally engaged in different functions, missions, and kinds of work other than immediate production. They may be in a supporting role such as procurement, supply, budget, etc. Contacts occur within the same agency at regional, district, or field locations. Contacts are made by telephone, through correspondence, and in meetings.

3. Contacts at this level are with individuals from outside the employing agency as well as with agency program heads. They normally take place on the telephone and in person in a moderately unstructured setting. They are significant to the production control effort, and are normally established on a nonroutine basis. Such contacts may include contractors or personnel from other Government agencies who may provide work projects, funding, support services, equipment, machinery, labor, transportation, etc.

Purpose of Contacts

a. The primary purpose is to obtain, clarify, or give facts, status, or technical information about labor, machines, materials, or specific operations concerning the production, overhaul, or repair of a product.

b. Contacts are for the purpose of planning, coordinating, or advising on production efforts, or to resolve production problems by influencing or motivating production or support personnel. They are normally cooperative and have mutual production interests and goals.

c. The purpose at this level is to influence, motivate, and persuade production shop and department supervisory personnel and others in positions of decision making authority to follow a different course of action. Such contacts often arise due to unexpected production material delays, or changes in production methods, procedures, requirements, priorities, etc. The controller must overcome objections of skeptical or uncooperative personnel and may have to negotiate on significant and/or controversial issues to achieve compromise or an alternative solution.

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P U R P O S E

130*

145

110

180

* This combination is probably unrealistic.

FACTOR 8, PHYSICAL DEMANDS

Level 8-1 -- 5 Points

Work for the most part is sedentary with no special physical demands. It may involve some walking, standing, bending, or carrying of light items.

Level 8-2 -- 20 Points

In the course of carrying out production controller duties, the controller is frequently required to stand, walk, and climb in industrial facilities where it is necessary to bend, crouch, stoop, reach, and lift moderately heavy items. The employee may also be required to perform these and other functions in obstructed areas (e.g., in confining or potentially dangerous spaces in or around a ship, aircraft, or submarine under construction, overhaul, or repair).

FACTOR 9, WORK ENVIRONMENT

Level 9-1 -- 5 Points

The employee normally works in an office that involves everyday risks or discomforts which require the normal safety precautions. The area is adequately lighted, heated, and ventilated. Visits to production areas are infrequent and relatively free of hazards to the employee.

Level 9-2 -- 20 Points

The employee works in an office part of the time, but production control duties necessitate regular visits to production areas which involve moderate risks and discomfort and require safety precautions (e.g., working near shielded or contained radiation sources, operating machinery, moving vehicles, and cranes; down in dry docks; on and around scaffolding; or in areas of high noise levels from engine test facilities). Visits take place in all weather conditions. The

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employee may be exposed to strong odors or fumes from paint, fuels, or chemicals used in the work processes. Regular use of safety equipment is an occupational requirement (e.g., hard hat, safety glasses, ear plugs, steel toe safety shoes and other kinds of protective devices).

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2013-2014

DEPARTMENT OF PSYCHOLOGY

GRADUATE

STUDENT

MANUAL

This manual describes departmental procedures that impact graduate students. It is the graduate student's responsibility to understand the procedures in this document, as well as those in the manual for their respective program, and those in the UNT Graduate Catalog. Students are responsible for keeping up with and adhering to changes in departmental or university rules of conduct or procedural rules that occur during their tenure in the graduate program.

Department of Psychology GRADUATE STUDENT MANUAL

UNIVERSITY OF NORTH TEXAS ? 2013-2014 ACADEMIC YEAR

TABLE OF CONTENTS

I. Diversity 1

II. Communications to Students 2

III. Academic Program Advisor 2

IV. Registration 3

V. Departmental Financial Support 3

VI. Non-Departmental Financial Support 5

VII. Degree Plans 6

VIII. Pass-Through Master’s Degree 8

IX. Changing Degree Programs 9

X. Academic Requirements 9

A. General Core Courses 9

B. Practicum Experience 10

C. Minor Area or Related Field 10

D. Concentration Core and Qualifying Ph.D. Exam 10

E. Language Requirement 11

F. Psychological Employment 11

G. Research Requirements 12

H. Thesis and Dissertation 13

I. Internship 17

J. Enrollment Requirements 18

K. Extension of Time Limits 19

L. Graduation 22

XI. Appeal Process 23

XII. Graduate Student Affairs 23

XIII. Academic Integrity 24

XIIII. Forms 25

XIV. Appendices 26

I. DIVERSITY

The Department of Psychology places great value on racial, ethnic, gender, age, and sexual diversity. By having a diverse faculty, staff and student body, the education students receive is enhanced and everyone’s lives are enriched. We are strongly committed to an environment in which diverse individuals feel welcomed and valued for their differences as well as for their similarities. We have no tolerance for harassment or behaviors deemed to indicate prejudice. If potential problems are dealt with immediately, directly and with sensitivity, then this ideal can be pursued in a mutually respectful and straightforward manner. Consequently, we urge you to immediately contact your program director, the department chair, Dean of Students, or UNT’s Office of Equity and Diversity if you become aware of discrimination, harassment or behavior that threatens the freedom, safety and respect deserved by everyone.

Social psychologists often argue that it is not possible to be completely without prejudice. Therefore, to further pursue a diverse and respectful environment, all graduate students are encouraged to engage in introspection or other structured methods to become aware of their own implicit assumptions concerning diversity. As an example of one structured method, you are invited to take a private and confidential version of the Implicit Association Test (IAT) devised by social psychologists. Taking these tests can help us become more self-aware in a variety of ways. Do not take any of these tests without first reading about them on the websites for purposes of informed consent. The IAT can be taken at www.understandingprejudice.org/iat, which has race and gender versions. Another website periodically changes and adds versions. At this time, you can take versions for a variety of social attitudes and mental health issues at www.implicit.harvard.edu/implicit/.

The UNT Multicultural Center is a resource that sponsors programs and activities with the intention of increasing the level of awareness, understanding, and consciousness regarding the under-represented cultures and histories of people of African, Hispanic/Latino, Asian/Pacific Islander, and Native American descents. The Multicultural Center has established the Alton and Renay Scales Ethnic Studies Library, which maintains a basic collection of works relevant to the experiences of African, Hispanic/Latino, Asian, and Native American Peoples. These resources are available to all university students, faculty, and staff for research or general information purposes. The Center also features a lounge area for students, computers and printers for students' use, and a photocopying service for student organizations.

The Psychology Department cooperates with the Office of Disability Accommodation (ODA) to make reasonable accommodations for qualified individuals with disabilities as per the Americans with Disabilities Act and Section 504, Rehabilitation Act. We encourage any qualified student to register with ODA. Requests for accommodation must be presented to the instructor of a class before the 12th class day. If you experience any problems in getting reasonable accommodations, please contact the Psychology Department Chair or the Office of Disability Accommodation.

II. COMMUNICATIONS TO STUDENTS

Students must apprise themselves of departmental and program matters as well as keeping informed of their status in the program. Each student is responsible for facilitating communication in several ways. First, it is the student's responsibility to maintain a current residence address and phone number(s) with the Graduate Coordinator’s office. Every change and/or addition must be done in a timely way through e-mail to Psyc-Grad@unt.edu. Second, students must also check their assigned mailboxes on the 2nd floor of Terrill Hall frequently, except when they are on internship. Third, students must obtain an EagleConnect account for official email. This account can be forwarded to an email account you check more frequently. Obtain an account by going to http://eagleconnect.unt.edu. Fourth, students should periodically inspect the department's web page (http://www.psychology.unt.edu).

Any of these four methods may be used to communicate official information to students. Consequently, each student is responsible for maintaining open lines of communication in all four ways. The department is not responsible for any consequences which result from the student failing to be current with information the department has conveyed.

III. ACADEMIC PROGRAM ADVISOR

The student's advisor has first-level responsibility for the evaluative process, followed by the student's program committee, and lastly by departmental faculty. Students should consult their program director or the Graduate Coordinator if they are unsure which faculty advisor has been assigned to them when they start the first semester of program study.

A. The advisor will aid the student in completing his or her schedule each semester.

B. Evaluations of Student Progress

At least one evaluation per year will be held. Program Committees will evaluate all of their Ph.D. students. The information considered at these meetings will include course grades and examination results, practicum and research team participation, ethical, professional and scholarly behavior, and any other pertinent information concerning a student's performance in the program. Each program has a slightly different procedure and students should check with their program director or program manuals for a complete description of the review process.

The intent of the evaluative review is to apprise students officially of their areas of strength and/or weakness and to assess whether or not the student is making normal progress toward a degree.

IV. REGISTRATION

Students must sign up for classes they intend to take with the Graduate Coordinator so that the department can monitor the size of classes and ensure all will make. If for any reason a student needs/wants to add/drop a class previously requested, they must contact the Graduate Coordinator and make her/him aware of this for the reason stated in the previous sentence. Prior to registration all students must have the courses they are requesting approved by both the student's advisor and Program Director, and the approval forwarded to the Graduate Coordinator at PSYC-GRAD@unt.edu. The registration calendar provides specific procedures and dates for early registration, regular registration, and late registration and payment deadlines http://essc.unt.edu/registrar/index.html. Registration must be done via internet.

V. DEPARTMENTAL FINANCIAL SUPPORT

A. Type and Duration of Support. Departmental teaching assistantships, research assistantships, and teaching fellowships are the primary means of department support for doctoral students. The department is required to provide assistantships to students who have Graduate Assistant Tuition Scholarships (GATS), Toulouse Graduate School Doctoral Fellowships (MDF), or other awards requiring a departmental assistantship for the time period specified in the award. Assistantships are assigned based on department needs. Awards are made for one year at a time and a student may be removed or not be reappointed if performance drops below expectation or for academic reasons. Normally, students should anticipate no more than three years of support if selected (generally prioritizing 2nd and 3rd years) and this is always pending funding. Any support paid through the department such as paid practicum will be counted in the three years. The maximum three-year expectation on support is designed to provide some assistance to most students requesting support during the time they spend in the academic program. Support may be extended for more than three years based on departmental need. This is done on an individual case basis, either due to teaching excellence, department need, or because of unique skills in teaching a given content area.

B. Compensation. Graduate students are paid according to the UNT Graduate Student Pay Schedule (http://vpaa.unt.edu/gradstudsupport.htm), which determines pay based on the academic progression level of the graduate student. Students who have advanced to Doctoral Candidacy are eligible for pay at the highest level. For this reason it is to students’ advantage to advance to doctoral candidacy as soon as possible.

C. Applications. Students will be issued applications from the Psychology Graduate Assistantship Coordinator (PsycCoordinator@unt.edu) upon receipt of their letter of acceptance to a graduate psychology program. Applications for departmental positions may be required each semester.

D. Course Load Requirements. Students who have a departmental assistantship or teaching fellowship have special restrictions placed on the course load they are permitted to carry. The total load of course enrollment and teaching assignment may not exceed 16 semester hours in any long semester. Approval of the Graduate Dean is required for loads in excess of this amount, but approval will not be granted for a combined load in excess of 18 semester hours.

* Teaching fellows or assistants who hold a half-time appointment (i.e., with assigned duties that require twenty hours of work per week) must be enrolled for nine semester credit hours in long terms or three semester credit hours in summer terms.

* Teaching fellows and assistants who hold a quarter-time appointment (i.e., with assigned duties that require ten hours of work each week) must enroll for six semester credit hours in long terms or 3 semester credit hours in summer terms.

E. Satisfactory Progress. Students granted positions are expected to be making normal progress toward their degree, demonstrated by: 1) successfully carrying a minimum of three courses per semester; 2) successfully passing their course requirements while maintaining at least a 3.0 GPA; 3) obtaining positive recommendations from their advisor and practicum supervisor; and 4) receiving a positive recommendation from the faculty supervisor of departmental TAs and TFs

F. Selection Process. Decisions about departmental employment are made by a variety of faculty. 1) Each doctoral program assigns some positions upon admission of doctoral students, 2) Individual faculty have major influence over selections for their research assistant (RA), and 3) Teaching fellow (TF) assignments are made by the TA/TF supervisor with input from students' teaching mentors and the department advisors.

Awards are usually announced no later than the week prior to registration. Department needs take priority but specific assignments will be based on a student's background, experience, and academic record. For example:

a) statistics or experimental laboratory assistants will generally need to have completed appropriate classes such as Psyc, 5700, 5710, 6810, or 5840.

b) Assessment laboratory assistants will need to have completed appropriate coursework in assessment classes such as Psyc. 5420, 5430, and assessment practicum.

c) In addition to qualifying as a teaching fellow, generally students will need graduate coursework in the area assigned to be taught. Therefore, it is most important that applicants list all of their skills (statistics, testing, group facilitator, etc.) because the department tries to match skills with course requirements. All

other things being equal, a student with relevant skills is more likely to be chosen than a student without those skills. Recommendations from faculty regarding teaching ability and communication skills are given special consideration. Awards are usually made in the fall no later than one week prior to registration. Except in unusual circumstances new awards are not made at the beginning of the spring semester. Due to funding issues, it is not possible to guarantee students spring assignments when they have had an assignment in the fall.

*IF SELECTED ALL TF/TA'S MUST ATTEND A MANDATORY ORIENTATION (Information available on the Toulouse Graduate School website https://tsgs.unt.edu/teaching-excellence-seminar)

G. Teaching Fellows (TFs). Before students will be granted a TF with full responsibility for a course), they must show proficiency in teaching, or demonstrate qualifications based on prior teaching. TFs are only available to students who have demonstrated a high level of performance and are recommended. Often students will serve as teaching assistants (TAs) before being given a teaching fellowship.

H. Paid Practicums. Paid practicums are sometimes available but these are handled by each program and therefore interested students should make application to their respective Program Director.

I. Reapplication. The goal is to meet department needs and to provide financial support for as many doctoral students as possible. Students who have applied for assistantships but who have not been chosen should complete a new application for consideration in subsequent years.

J. Termination ofDepartment Positions. Students may be removed from or not reappointed to TAs, RAs or TFs for non-performance of assigned duties, for violation of department or University rules or APA Ethical Standards, for conviction of a crime, or for other significant reasons.

VI. NON-DEPARTMENTAL FINANCIAL SUPPORT

A. Research assistantships may be available through individual professors holding grants that provide for them. Interested students need to make themselves known to grant-holding professors so that they may be considered for these positions.

B. The UNT Graduate School sponsors financial awards that are open to university-wide competition and make awards annually as funding permits. Check with the Graduate School to see what is available as these change periodically.

C. Psychology graduate students are also eligible to apply for positions with the UNT Housing Office as resident hall directors and other related positions. Applications for these may be obtained from the UNT Housing Office.

VII. DEGREE PLANS

A. Degree plan forms are available from the Graduate School or the office of the departmental Graduate Coordinator (http://www.psyc.unt.edu/graduate-programs/graduate-coordinators-virtual-office).

B. Degree plans must be filed during the semester in which the student accumulates his/her first 12 hours of graduate coursework. Students are bound by the Graduate Catalog currently in force at the time the degree plan is approved by the graduate dean. If the degree plan is done at a later date, the student would be responsible for completing any new requirements added since their entry into the program.

C. Degree plans are developed in consultation with the student's advisor and program director. They are submitted to the Graduate Coordinator’s office and reviewed by the department Chair.

D. Degree Plan Committee:

Students must obtain signatures for their degree plan from their advisor and two other faculty members in order to file the degree plan with the UNT Toulouse Graduate School. The faculty who sign the degree plan will typically serve on the student's thesis/dissertation committee. When the time comes to complete the project, if one or more of the actual committee is different than the original signers on the degree plan, a Change In Degree Plan form must be filed. Students are required to have a minor professor's signature on the degree plan if they select a minor in a department other than psychology.

E. Filing the Degree Plan:

When the degree plan has been filled out and signed by all committee members, it will be taken to the student's program director who must sign the degree plan indicating that he/she concurs with what is stated on the degree plan. The student then brings the original typed degree plan to the Graduate Coordinator. The degree plan will be reviewed, then submitted to the departmental Chair for approval and forwarded to the Dean of the Toulouse Graduate School. After approval by the Graduate Dean, signed copies of the degree plan are returned to the department and placed in the student's file.

F. Degree Plan Changes:

To initiate a degree plan change, the student must first obtain a copy of the Change of Degree Plan Form (http://www.psyc.unt.edu/graduate-programs/graduate-coordinators-virtual-office). The student then indicates changes he/she wishes to make in consultation

with the major professor.

1. For course changes, only the advisor's and program director's signatures are required as well as the department chair.

2. For committee member changes, initials must be from all committee members dropped or added, the student's advisor’s, and the program director’s signatures as well as the department chair.

G. If the thesis/dissertation advisor is of the same program as the student, this person may replace the academic advisor on the graduate degree plan. Students must fill out a Change of Degree Plan Form (http://www.psyc.unt.edu/graduate-programs/graduate-coordinators-virtual-office) to make this change in order to give proper notice to the Graduate School.

H. Prior coursework to meet doctoral program requirements.

1. Students who are admitted to a doctoral degree program in the Psychology Department often have prior graduate coursework that would meet doctoral requirements. Coursework is evaluated in the Psychology Department to determine equivalency to doctoral course requirements. If the coursework is sufficient to meet doctoral program requirements the doctoral course requirement would be waived. Requirements met by prior coursework do not appear on the doctoral degree plan, reducing the number of required hours for the doctoral degree. A maximum of 30 credits can be met by prior coursework; however programs may have other restrictions so consult your program manual. All psychology doctoral degree plans require a minimum of 60 credits taken within the UNT system (or more per program requirements).

2. A student wishing to have coursework evaluated for equivalency should first fill out the Transfer/Course Substitution Request and attach a syllabus from the class previously taken. Once the form is filled out with appropriate attachments, the student must then take it to their program director if the course they are hoping to “transfer” is a program core course, or if it is a department core course to the Graduate Coordinator, who will pass it on to the department chair. If the director/chair deems the course equivalent (though not necessarily identical), he/she will complete the Transfer/Course Substitution Request for the student’s file.

3. Approved courses used to meet doctoral program requirements should be summarized on the Program Requirement Equivalency Record and turned in to the Graduate Coordinator’s office to be kept in the student file.

4. Undergraduate courses taken for graduate credit cannot be used to fulfill graduate

course requirements.

VIII. PASS-THROUGH MASTER’S DEGREE IN PSYCHOLOGY

Students who are admitted to a doctoral degree plan in the Psychology Department, after completing a bachelor’s degree, may receive pass-through master’s degree in Psychology after completing all requirements for the master’s degree while continuing the doctoral program.

A. All of the course work to be credited toward the master’s degree plan must be numbered 5000 or higher.

The Psychology Master’s Degree requires 30 credits selected from the following courses:

PSYC 5010 Human Development (3 cr)

PSYC 5060 History and Systems (3 cr)

PSYC 5090 Social Psychology (3 cr)

PSYC 5420/5430 Assessment I & II (4 cr)

PSYC 5680 Counseling Psychology Methods (3 cr)

PSYC 5640 Cognition and Affect (3 cr)

PSYC 5700/5710 Quantitative Methods I & II (4 cr)

PSYC 5780 Psychopathology (3 cr)

PSYC 5790 Psychophysiology (3 cr)

PSYC 5900/5910 Special Problems (1-4 cr)

PSYC 5950 Thesis (6 cr)

PSYC 6000 Introduction to Psychotherapy (3 cr)

PSYC 6110 Issues in Behavioral Medicine Consultation

PSYC 6200 Advanced Topics Seminar in Psychology (1-3 cr)

PSYC 6300 Theory and Application of Multicultural Psychology

PSYC 6400 Research Methodology Applications

PSYC 6820/6830 Practicum (1-3 cr)

PSYC 6900/6910 Special Problems (1-3 cr)

These are basic departmental requirements. Check the manual for your specific graduate program to see whether a thesis is required. Candidates for a non-thesis master’s degree are required to pass a final comprehensive examination.

B. Apply to the Toulouse Graduate School for admission (http://tsgs.unt.edu/apply) for the master’s degree in Psychology. No application fee is required.

C. Submit a master’s degree plan to the Graduate Coordinator’s office. Once the admission application has been processed by the Graduate School and the student has been officially admitted, the degree plan will be submitted to the Toulouse Graduate School.

D. The student submits an application for graduation

(http://tsgs.unt.edu/academics/graduation) for the semester in which the master’s degree coursework is completed.

IX. PROCEDURE FOR CHANGING DEGREE PROGRAM

Students are admitted for study in a particular degree program in the department. The department recognizes that occasionally a student may wish to change to a different degree program. Any student wishing to make such a change must follow the regular admission procedures. The student is required to file an application for the alternate program by the next application deadline. The alternate program will then review the application as it would any other application.

X. ACADEMIC REQUIREMENTS

A. GENERAL CORE COURSES

These 20 semester hours are required for all Ph.D. programs.

Psyc 5060 - History & Systems (Summer) .3

Psyc 5090 - Social Psychology (Fall & Spring) 3

Psyc 5640 – Cognitive & Affective Bases of Behavior (Fall) 3

Psyc 5700 - Quantitative Methods I (Fall) 4

Psyc 5710 - Quantitative Methods II (Spring) 4

Psyc 5790 - Physiological Psychology (Summer) 3

1. Students who have completed an equivalent course at another university prior to admission to the UNT program should first fill out the Transfer/Course Substitution Request form (http://www.psyc.unt.edu/graduate-programs/graduate-coordinators-virtual-office) and attach a syllabus from the class previously taken. Once the form is filled out with appropriate attachments, the student must then take it to their program director if the course they are hoping to “transfer” is a program core course, or to the Graduate Coordinator, who will then pass it on to the department chair, if it is a department core course. If the director/chair deems the course equivalent (though not necessarily identical), he/she will sign the Transfer/Course Substitution Request for the student’s file.

The department does not award equivalent course credit for prior work experience.

2. Students must receive a grade of "B" or better in all general core courses. Students earning a grade of less than a "B" must repeat the course the next time it is offered. *PLEASE SEE APPENDIX D FOR POLICY ON LOW GRADES

3. Students are required to begin fulfilling general core requirements at the earliest possible opportunity--their first semester of enrollment in the program. Students

entering the program with a master's degree must have completed general core course requirements by the end of the semester in which the student has accumulated 36 semester hours in UNT programs.

4. Before a student can take a course at a university other than UNT, he/she must have written approval from the program director and from the department chair. The approval form may be obtained from the Graduate Coordinator. Once approval is granted the student will need to contact the Program/Project Coordinator for the Council of the Federation in the Graduate School in order to register for the course, otherwise registration will be blocked.

B. PRACTICUM EXPERIENCE

1. Practicum courses are required in programs with an applied orientation. Consult the pertinent program manual for further information.

2. Practicum courses at other institutions are generally not transferable toward the student's UNT degree program. Any questions should be referred to the UNT director of the student's program. (For additional information see

section III., B., 3.).

3. All students enrolled in practicum follow procedures as outlined by their respective program manuals and/or program director.

4. For most programs, practicum experience begins in the first semester of enrollment at UNT.

C. MINOR AREA OR RELATED FIELD

Some programs require a minor or related field. In such programs, the minor or related field consists of a minimum of l2 hours (Students should consult their respective program manual for additional information). A minor area consists of 12 hours in a department outside the psychology department. A related field consists of l2 hours in a specialty within the psychology department. If a minor area is chosen, the student is required to have a minor professor from that department serve on the dissertation committee. If a related field is chosen, the student should check with the Director of that specialty concerning the requirements to fulfill the related field. The student is required to have a professor from the related field specialty on the dissertation.

D. CONCENTRATION CORE COURSES

QUALIFYING PH.D. EXAMINATION IN CONCENTRATION AREA

1. Students cannot take the qualifying Ph.D. examination until they have completed

all general core courses with a grade of "B" or better.

2. All doctoral students are required to take designated courses in their program area (i.e., clinical, counseling, clinical health & behavioral medicine, experimental). These courses comprise the concentration core.

3. After completion of the concentration core, the student must successfully pass the qualifying Ph.D. examination. The requirements for this examination vary according to program areas. Students should refer to their respective program manuals for further details, scheduling, and procedures.

4. Upon completion of the concentration core qualifying exam, students are admitted to candidacy for the doctoral degree by the Graduate Dean.

5. Students cannot propose a dissertation until successful completion of numbers 1 through 4.

E. LANGUAGE REQUIREMENTS

1. The Psychology M.A. degree requires presentation of evidence that the student has a reading knowledge of at least one foreign language, while the foreign language requirement for the M.S. degree maybe waived (See the Graduate Catalogue for details).

F. PSYCHOLOGICAL EMPLOYMENT

Psychological services are regulated by state licensing laws, which allow students to provide psychological services as part of a supervised course of study. Unless a student has a credential that would allow the provision of services to clients, any student providing psychological services must be enrolled in 6820 or 6830 for each internal or external practicum.

Relevant portions of the Act and Rules of the Texas State Board of Examiners of Psychologists are copied below.

Current Rules of Practice

Rule 465.3

(a) Psychologists shall employ or utilize an individual to provide psychological

services, in any setting not specifically exempt under §501.004(a)(1) of the

Psychologists' Licensing Act (the Act), only if:

(1) The individual is licensed by this Board; or

(2) The individual is specifically exempted from licensure requirements by §501.004(a)(2) of the Act, relating to provision of services as part of a

supervised course of study by students, residents or interns pursuing a course of study in a recognized training institution or facility; or, (b) Unlicensed individuals providing psychological services pursuant to §§501.004(a)(2), 501.252(b)(2), or 501.260(b)(3) of the Act must be under the direct supervision of an authorized supervising licensee at all times. All patients or clients who receive psychological services from an unlicensed individual under such supervision must be clearly informed of the supervisory status of the individual and how the patient or client may contact the supervising licensee directly.

Psychologists’ Licensing Act

Sec. 501.003. PRACTICE OF PSYCHOLOGY.

(a) In this section, "psychological services" means acts or behaviors that are

included within the purview of the practice of psychology.

(1) includes providing or offering to provide services to an individual or group, including providing computerized procedures, that include the application of established principles, methods, and procedures of describing, explaining, and ameliorating behavior;

(2) addresses normal behavior and involves evaluating, preventing, and remediating psychological, emotional, mental, interpersonal, learning, and behavioral disorders of individuals or groups, as well as the psychological disorders that accompany medical problems, organizational structures, stress, and health;

(3) includes:

(A) using projective techniques, neuropsychological testing, counseling, career counseling, psychotherapy, hypnosis for health care purposes, hypnotherapy, and biofeedback; and

(B) evaluating and treating mental or emotional disorders and disabilities by

psychological techniques and

procedures; and

(4) is based on:

(A) a systematic body of knowledge and principles acquired in an organized program of graduate study; and

(B) the standards of ethics established by the profession.

G. RESEARCH REQUIREMENTS

1. Thesis is optional for master's degrees although programs may have different requirements. If a student chooses a non-thesis option, he/she substitutes an additional six hours of either coursework or practicum. Refer to your respective program manual or program director for further information.

2. Research requirements vary for the programs. Check your program manual.

3. All doctoral students are required to do a dissertation (12 semester hours).

4. The department has established procedures for investigators using the research subject pool in order to: (a) maintain order in the face of increasing research in the department; (b) assure all researchers equal access to the subject pool; (c) track research going on in the department; and (d) allow staff to know whom to contact when phoned by participants needing information. To have access to the subject pool, the following steps must be followed:

a. Approval for the project must be obtained from the UNT Institutional Review Board (IRB). If you plan to use the department Research Participation Pool Web Site (SONA) to recruit participants for your study include the SONA IRB application with your IRB application (http://www.psyc.unt.edu/undergraduate/undergraduate-research).

b. After obtaining IRB approval, the researcher presents a photocopy of the IRB's approval notification to the Coordinator of the Research Subject Pool. Dr. Kelly (TH347) is currently the departmental Research Coordinator. Information concerning the study including the title of the experiment, the location and time where participants are to report, the number of research credit hours that will be given for participation, the name of the person conducting the experiment, a phone number where the experimenter can be reached or a message left, a general description of the experimental procedure, and the name of the faculty supervisor will be obtained.

c. Once all information is obtained by the Coordinator, the research study will be assigned an experiment number and the researcher will be given access to the online research pool via the Sona system. The researcher will post all of the pertinent information on the system and obtain participants, assign credits, indicate no-shows, etc. through the system.

d. Individuals who fail to follow the required procedures will be denied use of the department's subject pool.

H. THESIS AND DISSERTATION WORK

1. There is a framework of schedule deadlines related to thesis/dissertation work. These deadlines are outlined below and must be followed. Deadlines can be found in the Graduate Catalog and at http://tsgs.unt.edu/academics/graduation. The Graduate School does not make exceptions to its deadlines.

2. The student decides on a general area he/she would like to research. It is the student's 13

responsibility to select a faculty member to direct him/her in the preparation of the research proposal. Students are advised to choose a research director familiar with the particular area the student wishes to research. The remaining committee members are chosen by the student in consultation with the research director.

3. Three committee members are required for thesis or research in lieu of the thesis.

4. Each dissertation committee in the Department of Psychology is to have, as its basic structure, the following: Three persons employed as faculty members by the Department of Psychology or as regular members of a Department of Psychology program committee.

5. If the composition of this thesis, research in lieu of thesis, or dissertation committee differs from the committee that signed the student's degree plan, then the student must fill out a Change of Degree Plan (http://www.psyc.unt.edu/graduate-programs/graduate-coordinators-virtual-office) form requesting the committee member changes.

6. For a dissertation committee, each committee may, but is not required to, have additional members from outside the Department of Psychology. An additional member may be (a) a UNT faculty member from another department; (b) a community professional especially appointed to the committee through the Department of Psychology; or (c) a faculty member from another university especially appointed to the committee through the Department of Psychology. Additional members may not replace the three departmental members. To obtain this university member, the student requests a form from the departmental Graduate Coordinator's office (http://www.psyc.unt.edu/graduate-programs/graduate-coordinators-virtual-office). Signatures of the major professor, program director, and department chair are required to file this form. This university member serves in the same capacity as the departmental committee members and must attend both the proposal and final defense meetings. Programs may place other restrictions on dissertation committee composition, but cannot authorize deviation from the basic structure (e.g., the three departmental faculty) described herein. For example, a program may specify that certain numbers of committee members must be from particular programs, but a program may not authorize committees containing fewer than three departmental faculty members as define above.

7. In consultation with his or her research director, the student develops a specific project that is considered of dissertation magnitude. During this time, he/she also solicits input from the other members of the committee. The student should take care in writing the final proposal draft using the APA Publication Manual. If care is taken, it will not be necessary to make extensive revisions. (As a point of style, the literature review and method sections should be written in past tense; the results and discussion, for the most part, are written in the present tense.)

8. Proposal Defense Meeting

a. When the proposal is in a satisfactory form, the student may schedule a proposal meeting defense with his or her committee to work out any major problems or concerns of committee members.

b. Committee members should have a completed draft of the proposal one week before the proposal meeting.

c. It is the responsibility of the student to arrange a suitable date and time for all members of the committee to meet. Students should also be aware that it is often difficult to schedule committee meetings or defenses during the summer semesters. If members of the committee are not teaching during the summer, they are not expected to attend any meetings.

One week prior to the proposal meeting, the student must contact the main office (TH 316) to reserve a conference room in Terrill Hall or reserve a room in the clinic. The student will then send a word file to Psyc-Grad@unt.edu. A sample of the 2 page file format is included in Appendix A. A hard copy is then placed on the appropriate bulletin board and another copy is given to the graduate coordinator for the student’s file. An announcement will also be emailed to all psychology graduate students and faculty.

d. Upon the committee’s approval of the proposal, the student and research advisor should obtain signatures of all committee members on the proposal signature sheet. These signatures constitute an informal contract protecting the student and committee members. Following the meeting the research advisor outlines and summarizes any modifications made to the research proposal. The Psychology Graduate Coordinator's Office must have a copy of the proposal and the proposal signature sheet. A copy of any modifications made to the proposal must be sent to the candidate and the Psychology Graduate Coordinator.

9. Prior to collecting data, students using human subjects are responsible for clearing their research through the UNT IRB for the Protection of Human Subjects. The Use of Human Subject Form is online. After students have completed the form and obtained approval they should follow procedures outlined under section G. 4, of this Manual if they are using participants from the department's subject pool.

10. If the need arises to make any modifications to the approved design of the project, the student must obtain the approval of the entire committee. This approval should be sought only after consultation with the director.

11. Final Defense Meeting

a. After the project has been executed, the student works with the research director in

drafting the final manuscript of the thesis/dissertation. When the manuscript is considered complete, the student schedules the final defense meeting.

b. Committee members and Department Chair should have a complete draft of the manuscript two weeks before the final defense meeting. The student is responsible for having all aspects of the manuscript in APA/Graduate School form. Each student must plan for sufficient time to complete all of the department requirements before submitting the final version with the chair’s signature to the graduate school. Also see h below.

c. It is the student's responsibility to contact all committee members and arrange a suitable date and time for the final examination. Students should be aware that it is often difficult to schedule final defense meetings during the summer semesters. If members of the committee are not teaching during the summer, they are not expected to attend any meetings. It is the responsibility of the student to inform the Graduate School of the date of the defense and file for graduation so proper forms can be generated. (ie, when you apply for graduation that then generates your defense form)

d. As soon as a date has been confirmed with the committee members, the student checks with the Graduate School at least two weeks prior to defense to make sure that he or she has completed the application for graduation and paid the required graduation fees.

http://www.tsgs.unt.edu/graduation_process/index.htm

e. One week prior to the final defense meeting, the student must contact the main office (TH 316) to reserve a conference room in Terrill Hall or reserve a room in the clinic. The student will then send a word file to Psyc-Grad@unt.edu. A sample of the 2 page file format is included in Appendix A. A hard copy is then placed on the appropriate bulletin board and another copy is given to the graduate coordinator for the student’s file. An announcement will also be emailed to all psychology graduate students and faculty.

f. The decision of the final defense meeting can be pass, pass with specified revisions, continuation until some later time, or fail. The continuation decision means that major questions have been raised about the manuscript such that the committee believes the student needs to address substantive issues and appear again before the entire committee. Pass with specified revisions usually means there were correctable deficiencies. In this situation, the research director summarizes the needed revisions and sends a copy of the summary to the Psychology Graduate Coordinator’s Office and to the student. (Generally, these revisions are made under the supervision of the research director.) Decisions following from the final defense should be determined by vote of the entire examination committee. Once the committee has made their final decision, in order for the Department Chair to sign the final defense form, an electronic copy

(not final) of the dissertation has to have been in the chair’s office at least two weeks prior to the defense or the form will be held until an appropriate time.

g. The student should schedule the final defense meeting with sufficient lead- time to make any needed changes required by the committee before graduate school deadlines. The director is responsible for determining if all necessary changes resulting from the defense have been made.

h. After the Chair has signed the comprehensive examination form, the student may file the manuscript with the Graduate School according to their current requirements.

i. The Graduate School contacts the student when corrections are needed and the thesis/dissertation is ready to be picked up, corrected, and copied.

j. Grades for Thesis/Dissertation: Students enroll in 5950 for thesis and 6950 for dissertation. Credit will be given only for the last 6 semester of thesis and the last 12 semester hours for dissertation. Students receive a grade of PR for "in progress" (or W for "withdraw" if no progress has been made at all). After a student initially enrolls for either 5950 or 6950, continuous enrollment during long semesters is required by the Graduate School until completion of the thesis or dissertation. If the student will be using UNT resources during the summer (e.g., research director's time, computing facilities, etc.) they must enroll in 5950/6950 for one summer session.

I. INTERNSHIP FOR PH.D. STUDENTS

1. Students must have completed all general core courses prior to applying for internship. Students should check their respective program manuals for additional specific requirements.

2. Internship placements are required in all of the Ph.D. programs with the exception of the Experimental Psychology Program.

3. Prior to applying for internship students must complete all general core courses with a "B" or better. The department also expects the completion of comprehensive exam requirement prior to applying for internship because acceptance by internship agencies is greatly reduced otherwise. Students should consult their respective program manual for specific requirements.

4. The final decision about any student's readiness to apply for internship is made by the program director. Application for internship must have prior approval of the student's advisor and program director. Failure to obtain prior approval may result in the student not being allowed to accept an internship.

5. Prior to submitting ranks for internship the student must successfully defend a dissertation proposal. The student should be aware that he/she cannot register for dissertation course credit or defend a dissertation proposal until after all sections of the comprehensive examination have been passed successfully. Students should consult their respective program manual for specific requirements.

6. Internship placement can be highly competitive. The Department and the University give no assurances that every applicant will be placed. According to APPIC, the leading reason that applicants do not obtain an internship placement is their unwillingness to re-locate for internship training. Internship training facilities in the D/FW Metroplex are limited and very competitive. Do not expect to receive placement in the D/FW Metroplex.

J. ENROLLMENT REQUIREMENTS

1. Students may schedule as many as 16 hours during any long semester with the approval of their program. Students who wish to take more than 16 hours must obtain the approval of their program and the Graduate School Dean. Nine semester hours is considered a full-time load by the university for purposes of fulfilling the graduate residence requirement. However, some scholarship awards require a 12 semester hour course load.

2. Graduate students may enroll for no more than 6 hours in each summer term, or for 7 hours if one course is a 4-hour course. Certain courses begin during the first summer term and carry over into the second. In such cases, students may enroll for 9 hours the first term, but only 3 hours for the second term. The extra single hour permitted for lab courses may be taken in either the first summer term or the second term. But this extra hour is not permitted for both summer sessions. Thus the total maximum load for the entire summer is l3 hours. This maximum does not include courses taken during May Minimester

3. Continuous enrollment is expected.

4. All-but-dissertation and all-but-thesis students are required to maintain continuous enrollment in at least 3 hours of research in each Fall and Spring semester until graduation. They are also required to enroll in one semester of Summer if using University resources, including faculty.

5. Students are expected to make normal progress in their degree program. Occasionally students may have reason to take a temporary leave of absence. If such circumstances arise, students should complete a Request for Temporary Leave of Absence (Appendix B) and discuss the matter with their respective program director.

a. The student is responsible for initiating and filing Requests for Leaves. Upon 18

approval, the student must file the Request with the Graduate Coordinator and retain a copy. If more time is needed upon expiration of the Leave, the student should complete another Request and confer with their program director. In the absence of an approved Request, the department uses the following policy:

1. If during any regular (Fall or Spring) semester a masters or doctoral student is not enrolled in any approved coursework, the student is placed on inactive status. After two regular semesters of inactive status, the student is automatically removed from his/her respective degree program (and from the department) as required by the department's leave of absence policy. (See J, 5 below.)

2. A student may be removed from his/her respective program immediately upon receipt of a letter from the student indicating intent to withdraw from the program.

3. A student removed from a degree program who later wishes to resume a degree program must re-apply for admission as would a new applicant.

b. The UNT Graduate School continuous enrollment policy precludes granting Temporary Leaves once a student has commenced enrollment in thesis or dissertation.

c. Leaves of absence do not alter the UNT Graduate School's time limitation policies for work to be credited toward master's or doctoral degrees (i.e., leaves do not extend the time limitations).

d. A student may be removed from a graduate program for failure to make adequate progress or if in the judgment of the program committee the student appears unlikely to succeed professionally, regardless of grades.

K. EXTENSION OF TIME LIMITS FOR MASTER'S AND PH.D. DEGREES

1. University policy, as stated in the Graduate Catalog, sets specific time limitations for students to complete graduate degrees. Time limitations differ for specific degrees, depending on the number of semester credit hours (SCH) required for the degree.

For masters degrees requiring 42 or fewer SCH the time limitation is six (6) years, for those requiring 43-49 SCH it is seven years, and for those requiring 50 or more SCH it is eight (8) years. All work to be credited toward the doctoral degree beyond the master’s degree must be completed within a period of eight years from the date doctoral credit is first earned.

2. The primary purpose of time limitations is to ensure that the student is current in the field of study at the time the degree is awarded. Furthermore, time limitations increase the likelihood that the student will move through the work required for the degree in a timely fashion.

3. UNT recognizes that situations may arise that preclude a student from completing the degree within the prescribed time period. Students will be granted extensions only under very special and extenuating circumstances. These include, but are not limited to, personal and family illness, financial issues, or other circumstances over which the student has no control. Full-time employment will not alone be sufficient grounds for an extension.

4. Policy Governing Requests for Extension

a. The Toulouse School of Graduate Studies will consider requests for extensions based on recommendations by the Graduate Curriculum Committee of the College of Arts and Sciences. In turn the Graduate Curriculum Committee may recommend that the request be granted if it is satisfied that:

i. the student has made a diligent and good-faith effort at satisfying the requirements for the degree within the specified time limit;

ii. there are circumstances beyond the student's control that will prevent completion of the degree within the specified time limit;

iii. there is clear and convincing evidence that the student is up to date in his or her major field of study;

iv. the request has the support of the department chair and the student's major professor or chair of the appropriate departmental committee.

5. Request for Extension of Time Procedures

a. Prior to the time limit for receiving the degree, the student desiring an extension should make a request in writing to the Department Chair. Except in highly unusual circumstances the student should initiate this request before the seventh year.

Master's and Doctoral Degrees

Requests for extension of time to complete master's and doctoral degrees are

accomplished by completing a copy of the Request for Time Extension (Master's or Doctoral).

http://www.tsgs.unt.edu/downloads/forms/extension-masters.pdf

http://www.tsgs.unt.edu/downloads/forms/extension-doctoral.pdf

Instructions for the Request for Time Extension are repeated below:

1. Complete a copy of the Request for Time Extension (Master's or Doctoral).

2. Include a detailed time line determined by you and validated by signature and date of your major professor containing steps to completion of the degree within the requested time extension (see Page 3-4 of this form).

3. Obtain signatures on the application for extension from:

1. the Major Professor

2. the Program Coordinator or Director

3. the Department Chair

4. the College or School Dean

5. the Graduate Dean signs after final review.

4. Include letters from:

1. Student (indicating justification and requested terms/conditions of extension request.)

2. Major Professor (clearly stating what additional coursework is needed; if none is needed, explain how the student is current in coursework; spell out the terms/conditions of the extension request.)

3. Program Coordinator (endorsing a & b above; may provide additional information)

4. Department Chair (endorsing a, b, & c above; may provide additional information)

5. Attach a copy of the student's form entitled "The Graduate School Graduate Admission Evaluation Form."

6. Include transcripts of all work toward this degree. (Unofficial copies are fine. Printouts from EIS are not OK.)

7. Include current degree plan with grades.

8. Include resume showing student ID#, place of employment, position and title, work/professional experience, etc.

b. Upon considering the request, the Arts and Sciences Graduate Curriculum Committee may recommend to the Graduate Council that the extension be granted, denied, or it may take any of several actions, such as requiring additional courses to replace those that are out-of-date, requiring the student re-take the comprehensive examination, or stipulating other appropriate measures to ensure the student is current in the field.

L. GRADUATION

To facilitate completion of details needing attention to meet all UNT and Department requirements for graduation, students must attend to the following at least two weeks prior to applying for graduation:

1. Students must apply for graduation with the Toulouse School of Graduate Studies prior to the Graduate School's published deadline.

2. Check degree plan for accuracy. Students must be sure all required courses have been completed and done in the time frame/limit allowed by the Graduate School. Any deficiencies must be removed and a Change in Degree Plan form must be completed and filed before the appropriate deadline for applying for graduation.

3. Students are responsible for checking to be sure all incompletes ("I" grades) are removed by Graduate School deadlines for graduation. Incompletes in organized classes cannot be removed after one calendar year has passed.

4. Students are responsible for insuring that an evaluation letter for internship completion is mailed to the Program Director and that the incompletes ("I" grade) in internship are actually removed prior to the deadline for the graduation ceremony for which they have applied. This is an especially important item when the student is off-campus. The deadline for having this completed is usually about 2-2 %2 months before commencement.

5. Students must insure that the results of their final thesis/dissertation defense or master’s oral examination is filed with the graduate school prior to the published deadline for the expected graduation date. This deadline is usually about 2-2 %2 months before commencement. The defense meeting would need to be scheduled at least a few weeks before the deadline.

6. All keys must be turned in prior to graduation; including keys to the building and the TA/TF cubicles. Do not give a key to another student for any reason. Graduation is blocked if keys are not turned in to the Key Control Office. Turn in all keys when you leave for internship. Report any lost keys immediately. You are responsible for the costs of a lost key.

7. Notify Graduate Coordinator (or Program Director) of address changes and employment obtained after graduation. Often information regarding professional issues arises which we need to communicate to our graduates and various alumni reports need to be completed.

X. APPEAL PROCESS

Students may appeal program committee decisions relating to their graduate standing. The process described in this section is to be used to appeal decisions other than those for which a specific procedure has been developed. For example, the course grade appeal process as described in the Graduate Catalog is to be used when a student wishes to contest a grade in a specific course. Also, on occasion there may be reason to separate a student from his/her program for other than academic reasons and in this instance the procedures described in Appendix C of this Manual are to be used.

The first level of appeal is to the program committee itself. If the student is not satisfied with the program committee's response to an appeal then the student can appeal to the Department Chair.

If the Chair cannot resolve the matter between the student and the program committee, then the next level of appeal is to a three-person ad hoc departmental committee, formed and coordinated by the department chair. One member will be chosen by the student; another member will be chosen by the program committee. These two members together will decide on the third member from the department, who will serve as chair of the ad hoc committee. If the first two members cannot arrive at a mutually agreeable choice for a third member, the chair will select the third member.

The ad hoc committee will require written statements from each participant in the dispute. Judgments are rendered on the basis of these written statements, upon other evidence submitted in support of these statements, and, if deemed necessary by the ad hoc committee, upon an oral hearing. If an oral hearing is necessary, the procedure will be determined by the ad hoc committee. At the end of their deliberations, the committee must make a recommendation to the program committee. All records in the case will be filed with the Chair of the Department.

Either party to the dispute can make further fairness appeals based on procedural violations or lack of fairness, first to the College of Arts and Sciences and ultimately to the Graduate School.

XI. GRADUATE STUDENT AFFAIRS

A. All psychology graduate students are eligible and encouraged to become members of Graduate Association of Students in Psychology (GASP). Some graduate students will also meet the requirements for Psi Chi, the national honor society.

B. The purpose of GASP is to help the graduate students meet their professional, scholastic, 23

and personal needs. GASP is a vehicle for graduate students to present their concerns and input to the department and its graduate programs. It also serves as a point of contact for social interaction among students and between faculty and students.

C. GASP publishes a newsletter several times each year to disseminate information to students about the department.

D. For further information, students are encouraged to contact the current GASP officers.

E. Student rights are protected by procedures for filing a grievance as outlined by procedures in the Graduate Catalogue and by the appeal process described in section X of this manual.

F. Student Advocates. Faculty and those with administrative roles in the department are available to help you address concerns or problems. However, because there maybe circumstances where students have concerns or complaints they are reluctant to share with their Advisor or others in official administrative roles, the department identifies two faculty members to be Student Advocates, one female and one male. The Student Advocates are available to help you problem-solve and access resources; they will hold your identity and details of your concern in confidence to the extent they are able under UNT policies, the ethical guidelines of our profession, and state and federal law. These individuals are appointed to serve a 3-year term by the Chair, who invites all of the graduate students to recommend faculty members for this position through GASP. Those in official administrative roles in the department (Program Directors, Chair, Clinic Director, Graduate Advisor) and Assistant Professors are not eligible for the position. The two faculty members, one female and one male, who receive the most votes are considered to have the students' endorsement for appointment as Student Advocate. Student Advocates will be identified on the Faculty Directory.

XII. Academic Integrity

A strong university is built upon the academic integrity of its members. As an intellectual enterprise, it is dependent upon trust, honesty, and the exchange of ideas in a manner that gives full credit and context to the sources of those ideas. UNT’s policy on the Student Standards of Academic Integrity is designed to uphold these principles of academic integrity. It protects the rights of all participants in the educational process and validates the legitimacy of degrees awarded by the university.

The policy covers categories of academic dishonesty such as cheating, plagiarism, forgery, fabrication, facilitating academic dishonesty, and sabotage. It includes descriptions of infractions, penalties and procedures. In the investigation and resolution of all allegations of student academic dishonesty, the university’s actions are intended to be corrective, educationally sound, fundamentally fair, and based on reliable evidence. The full policy (18.1.16) is available online at policy.unt.edu, where it can be located by searching for either title or number.

XIII. Forms

Most forms can be found on the department webpage at http://www.psyc.unt.edu/graduate-programs/graduate-coordinators-virtual-office.

* Transfer/Course Substitution Request

* Pass Through Master’s Degree Application

* Master’s Degree Plan

* Doctoral Degree Plan

* Doctoral Candidacy Student Form

* Change in Degree Plan

* Designation of Outside member for Dissertation Committee

* R53 Request for Posting Special Title/Topic/Subject – Special Problems

* Advising Clearance Form

Appendices

Appendix A

Procedure for Proposals and Defenses

Student Theses/Research in Lieu of Thesis/Dissertations

1. Student is cleared by Major Professor to schedule a proposal or final defense. (Remember: The chair must

have a copy of the final dissertation for two weeks before signing defense form. Review copies of theses/6610s

are not necessary.)

2. Student coordinates an agreed-upon date and time for the meeting.

3. Student contacts main office (TH 316) to reserve 344, 346, or 348 or reserves a room in the clinic.

4. Student sends a Word file to Psyc-Grad@unt.edu. The 2 page file format is:

Page 1

Specifiy Thesis/Research in Lieu of Thesis or Dissertation Proposal or Defense

Title

Student Name

Date

Time

Location

Major Professor: Typed Name

Committee Members:

Typed Name

(the lines after the name of each person are to allow this to function as the signature sheet indicating approval)

Put the Abstract on Page 2

5. The Graduate Coordinator has one hard copy placed on the correct bulletin board.

6. The Graduate Coordinator is given a hard copy to for department records and the student’s file.

7. The Graduate Coordinator emails the announcement to all graduate students (using their UNT email address) and to faculty.

8. After the proposal or defense, student gives the Graduate Coordinator a copy of the first page with the signatures. Students should also keep a copy.

Appendix B

PSYCHOLOGY DEPARTMENT

UNIVERSITY OF NORTH TEXAS

REQUEST FOR TEMPORARY LEAVE OF ABSENCE

____Requests a leave of absence from

the degree program for the following reasons:

The leave is schedule to begin and to terminate ____.

This request for leave is (approved disapproved).

Student Program Director

Date Date

Department Chair

Date

1. The original request should be filed with the graduate secretary.

2. The student should retain a copy of the Request.

3. If further time is need upon expiration of the leave, the student is responsible for filing further requests. Failure to obtain extension of expired leave may lead to the student being removed from the program in accord with procedures described in the Graduate Student Manual.

Appendix C

Page 1 of 2

Graduate Student Discipline Policy

Faculty and the Chair are charged with ensuring graduate students in psychology uphold the highest academic and professional standards. Students are responsible for knowing, understanding, accepting and following APA’s Ethical Principles as well as local policies and procedures imposed by UNT, by the Toulouse School of Graduate Studies, by the College of Arts and Sciences, by the Psychology Department, and by the graduate program that accepted the student. UNT’s Code of Student Conduct and Discipline is in the Graduate Catalog and on their website. The graduate programs and department also may impose sanctions for conduct covered in these policies. Unfortunately, it is sometimes necessary to discipline a graduate student and, in rare instances, the breach is sufficiently serious to separate the student from the program.

1) Cases of a student’s alleged academic or professional misconduct are turned over to the Program Director who gathers information as needed then notifies the student of the complaint by a written memo either on paper or by email. Mutually, they set a time to discuss and attempt to resolve the matter.

2) If, after the discussion, the Program Director believes there may be substance to complaint or believes further investigation is warranted in order to clear the student, she or he will inform the Program Committee and the student. A meeting of program faculty (without graduate student representatives) will be called to address the matter no sooner than two weeks from the date of notification.

3) The student may submit written material to the program faculty no fewer than three days prior to that meeting. This written material should describe the student’s perspective on the matter at hand. The Program Director should also provide a written description of the issue to program faculty no fewer than three days prior to the meeting.

4) At the meeting, program faculty will decide how to proceed. For fairly minor problems, they may decide to impose an appropriate sanction. For example, if they believe a student committed a fairly minor act of plagiarism they may require the student to provide a research paper about how to avoid plagiarism. In contrast, if they believe a more serious transgression may have occurred, they will become a fact-finding body. If they become a fact-finding body, the Program Director will leave the meeting and any faculty member who may have personal involvement in the situation will also recuse him/herself.

5) As a fact-finding body, the program faculty will function as do grievance and appeal committees for faculty issues in CAS and at UNT. They will first (i.e., at this initial meeting) determine the appropriate process to address the matter ensuring due process to the student. If a client or outside entity is involved, they will also decide their process with considerations of fairness, timeliness and due process for that entity. They will identify a ”fact-finding chair” who will notify the student and relevant other(s) of the process and time line.

Page 2 of 2

Student Discipline

6) The fact-finding committee will meet and follow the procedures it sets out. The formal, decision-making meeting must be held so that no longer 25 work days lapse between notification of the process and a final, written decision. As with similar committes for faculty, decisions are made by a simple majority of members present for the committee hearing. At this meeting, the fact-finding committee will also decide whether to infom the graduate school and/or the office of students’ rights and responsibilities of the situation and their determination.

7) Through its chair, the fact-finding committee will notify the student and relevant other(s) in writing of its final determination within 25 word days. If this committee finds the student committed misconduct, a description of the sanction to be imposed will be included.

8) Adverse decisions may be appealed through the Department Chair to the Graduate Committee of the department on substantive and/or procedural grounds. The Graduate Committee may decide to uphold the previous decision or conduct a second fact-finding process and either agree with the previous decision or return it to the program committee for reconsideration. This committee, too, will have 25 work days with which to make its determination and notify the student and program in writing.

9) If the Graduate Committee decides to send it back to the program for reconsideration, they will provide a written description of their perspective or with the new information they discovered. At this point, the Program Committee fact finding body will reconvene and reconsider the matter. This will be done within 10 days and a final report will be made to the student and to the Graduate Committee.

10) If the student remains dissatisfied with the decsion and sanction, s/he may make an appeal to the Dean of the Graduate School. Procedures may be found in the Graduate Catalog, Graduate School website and by contacting the Dean’s office directly.

Appendix D

Policy on Graduate Student Grades

Effective June 2009

The Graduate School states:

Graduate students must maintain a B average on all courses that receive graduate credit, whether or not the courses are to be applied toward a graduate degree. Grades of D and F will not apply towards any graduate degree but will be computed in the GPA.

Procedures for the Department of Psychology

1. A graduate student shall be dismissed from the program when they have received three grades less than a B in their coursework.

2. The first time a student receives a C, D, or F, in a course(s) on their degree plan, that course must be repeated within a year of earning the original grade of C or lower, and a grade of B or better obtained to make up the deficit.

The student has responsibility for informing the Program Director of the grade and discussing factors affecting their academic performance. The student and Program Director should develop a plan for the student to make up the deficit and address any academic concerns.

3. When a student has a second grade that is below a B, remediation within the student’s program will be necessary.

Remediation Plan: the student is permitted to continue in the program pursuant to successfully completing a specific written plan of remediation prescribed by the program faculty.

Graduate Student Guidelines

The Interdisciplinary

Graduate Program in

Immunology

A subprogram of the Biomedical Science Graduate Program at the University of Iowa Roy J. and Lucille A. Carver College of Medicine

Revised August 1, 2017

Table of Contents

Program Leadership 1

Academic Calendar 1-2

Guidance 3

Formal Coursework 3

Required Courses 3-4

Electives 4

Minimum Number of Credits for Ph.D. Degree 6

Grade Requirements 6

Laboratory Rotations 6-7

Immunology Seminars 7

Teaching Requirements 7

Other Immunology Events 7

IDP Plan 7-8

Comprehensive Examination 9-12

Overview 9-11

Spring Comprehensive Exam Schedule 11-12

Autumn Comprehensive Exam Schedule 12

Dissertation Research 12-14

The Ph.D. Dissertation 14

Vacations 14-16

Revised August 1, 2017

IMMUNOLOGY GRADUATE PROGRAM STUDENT GUIDELINES

THE UNIVERSITY OF IOWA

In addition to the Graduate College Manual of Rules and Regulations, this handbook is for use by the Immunology Graduate Students to clarify Immunology Program-specific policies. The document lists the program leadership, course requirements, laboratory rotation policies, Immunology Journal club and seminar, Comprehensive exam format and schedule, and Dissertation committee guidelines.

I. PROGRAM LEADERSHIP:

Program Director:

Dr. Steven Varga 3-532 BSB 335-7784

Executive Committee Members:

Dr. Steven Varga 3-532 BSB 335-7784

Dr. Gail Bishop 2296 CBRB 335-7945

Dr. John Colgan 3270 CBRB 335-9561

Dr. Lee-Ann Allen D154 MTF 335-4258

Dr. Kevin Legge 1028 ML 335-6744

Dr. Jon Houtman 2210 MERF 335-7780

Graduate Studies Committee Chair:

Dr. John Harty 3-530 BSB 335-9720

Admissions Committee Chair:

Dr. Vladimir Badovinac 3-550 BSB 384-2930

Comprehensive Exam Committee Co-Chairs:

Dr. Lee-Ann Allen D154 MTF 335-4258

Dr. Thomas Waldschmidt 335-8223

Curriculum Committee Chair:

Dr. John Colgan 3270 CBRB 335-9561

Seminar Committee Chair:

Dr. Thomas Waldschmidt 1038 ML 335-8223

Program Administrator:

Paulette Villhauer 354 MRC 335-7748

Program Assistant:

Karina Escobedo 354 MRC 335-6512

Bhuvana Parampalli 354 MRC 384-4470

II. 2017 -2018 ACADEMIC CALENDAR:

Fall semester 2017:

First day of classes August 21

Last day of classes December 8

Close of Finals week December 15

Spring semester 2018:

First day of classes January 16

Last day of classes May 4

Close of Finals week May 11

Summer Rotation June 5 – August 18

Fall Rotation August 21 – November 10, 2017

Winter Rotation November 13, 2017 – February 9, 2018

Spring Rotation February 12 – May 4, 2018

Registration for Fall, Spring, and Summer semesters are performed through the program office during the early registration period.

III. GUIDANCE:

The Graduate Studies Committee is charged with overseeing the progress of all graduate students at all stages of their training. Incoming first year students are assigned a primary advisor from the Graduate Studies Committee who will advise the student on courses, lab rotations, and all other aspects of their education. Soon after arriving on campus, the students will meet with either the chair of the Graduate Studies Committee or their assigned advisor to discuss their specific interests, course work, and laboratories for rotations. In addition, the Graduate Studies Committee may occasionally meet with students to discuss their academic progress. When a student completes their rotations and enters a laboratory to perform dissertation work, the faculty member in charge of the laboratory will assume the role of advisor. The Graduate Studies Committee will however, continue to oversee the students' academic and research progress. The Graduate Studies Committee is also available to the student for advice should problems or questions arise.

IV. FORMAL COURSE WORK:

Immunology graduate courses are offered not only to teach students the current concepts and paradigms within the field, but to emphasize the scientific approaches and methods used to attain this understanding.

NOTE: It is expected that the great majority of graduate students will follow the prescribed curriculum. However, it is recognized that circumstances may arise that require a student's course of study to be altered. Therefore, a student may ask the Graduate Studies Committee for permission to amend the curriculum requirements.

A. Required Courses:

Graduate Immunology and Human Disease IMMU:6247 (4 sh – Fall year 1). This course provides an overview of the important principles and key concepts in immunology including the induction of the innate and adaptive immune systems, the molecular events that control immune cell activation and the function of the immune system in infection and pathophysiological events. Offered fall semester only. Required of all first year students.

Graduate Immunology IMMU:6201 (3 sh – Spring year 1). This course emphasizes the purpose and design of experiments, and how their interpretation has led to current concepts in immunology. Sessions take the form of background presentation by the lecturer followed by analysis of primary research papers. Participation by students in the form of discussion and responding to questions is a key goal. Required of all first year students.

Basic Biostatistics and Experimental Design PCOL:5204 (1 sh – Fall year 1). This course is designed to provide a brief overview of the theory of experimental design and data analysis in the biological sciences for graduate-level students. At the completion of this module, students will feel comfortable identifying the types of analyses that are available for common types of data generated in the biomedical sciences, and will be empowered to critically review the statistical methods used in published studies.

Principles of Molecular and Cellular Biology BMED:5207 (3 sh – Fall year 1).

The goals of this course are to familiarize new graduate students with important principles and key concepts in contemporary molecular and cellular biology; to help students develop the skills required to critically evaluate current research publications; and to familiarize students with the experimental techniques utilized to test specific hypotheses. These goals will be achieved through formal lectures on specific topics and discussions focus on evaluation of published research papers (recent or classical). Students are encouraged to ask questions for clarification and to seek out individual faculty members for additional assistance when needed.

Students will take 3 sh of elective credits. The following courses are suggested; others may be substituted with prior approval of the Graduate Studies Committee. These are either a 3 sh course or a 5-week 1-credit module on various areas of cellular and molecular biology, taught for graduate-level students. MSTP students are exempt from this requirement, but may elect to take any modules they wish. The MSTP students are not exempt from taking the 1 module of Biostatistics.

Introduction to Protein Structures BIOC:7251 (1 sh)

Transcription, RNA MCB:6215 (1 sh)

Inflammatory Cell Signaling and Targeted Cancer Therapy MCB:6240 (1 sh)

Growth Factor Receptor Signaling MCB:6225 (1 sh)

Cell Cycle Control MCB:6226 (1 sh)

Cell Fate Decisions MCB:6227 (1 sh)

Mechanism of Cellular Organization MCB:6220 (3 sh)

Enzymes, Carbohydrates, Nucleic Acids, and Bioenergetics BIOC:7252 (1 sh)

Metabolism 1 BIOC:7253 (1 sh)

Metabolism 2 BIOC:7254 (1 sh)

Metabolism 3 and Biosignaling BIOC:7255 (1 sh)

Molecular Biology BIOC:7256 (1sh)

General Histology for Graduate Students; ACB:8121 (4 sh)

Microscopy for Biomedical Research; ACB:5218 (3 sh)

Graduate Bacteria and Human Disease; MICR:6259 (3 sh)

Graduate Molecular Microbiology; MICR:6260 (3 sh)

Graduate Viruses and Human Disease, MICR:6267 (4 sh)

Biology & Pathogenesis of Viruses; MICR:6268 (2 sh)

Ion Channel Pharmacology; PCOL6207 (1 sh)

G-proteins and G-protein Coupled Receptors; PCOL6208 (1 sh)

Steroid Receptor Signaling; PCOL6209 (1 sh)

Graduate Microbial Genetics; MICR:6270 (3 sh)

Pathogenesis of Major Human Diseases; PATH:5270 (3 sh)

Translational Histopathology; PATH:5260 (3 sh)

Integrated Topics in Infectious Disease MICR:7217 (1 sh)

Introduction to Biostatistics BIOS:4120 (formerly BIOS:5110) (3 sh)

Advanced Topics in Immunology; IMMU:7221. (3 sh – Fall year 2). Graduate Immunology is a prerequisite, although MSTP students, who have taken MS1 Immunology, may elect to take Advanced Topics for credit in either year 1 or year 2. This course, taught during the Fall semester, is split into three sections with each section proctored by a different faculty member. The goal is for each instructor is to present the seminal papers in one area of immunologic expertise. This is done through the use of primary research papers and student presentations. Second year students are required to take this course for credit. Subsequently, students are required to attend an additional two sections as exemplars for younger students, and to

enhance their knowledge of a wider variety of immunologic topics. These two sections need not be taken during the same semester, but can be spread out during the ensuing years. This will enable students to choose two areas which are of particular interest to them. While participating in these additional modules, advanced students will be asked to lead discussions, and demonstrate proper presentation and critique of papers.

Immunology Graduate Student Seminar; IMMU:6211 (1 sh awarded during the fall semester and the spring semester each year). During both the Fall and Spring semesters, all graduate students will attend, and will present their research data under the supervision of the Immunology Program faculty. This exercise is designed to foster oral communication skills and collaboration among graduate students. Faculty evaluators will provide student presenters with useful written and oral feedback on their presentations.

BMED:7270 Scholarly Integrity/Responsible Conduct of Research 1 (0 sh)

BMED:7271 Scholarly Integrity/Responsible Conduct of Research 2 (0 sh)

Courses entitled Scholarly Integrity/Responsible Conduct of Research 1 and 2 are required for all graduate students in Immunology. These courses are designed to expand on and advance training in the principles of scholarly integrity and responsible conduct of research (SI/RCR). As a prerequisite, all individuals taking these courses will have completed basic SI/RCR training through completion of CITI online, web-based training. Following verification of successful completion of all required CITI module, graduate students must complete the 2-semester sequence (BMED:7270, BMED:7271) for meeting full SI/RCR training requirements per the CCOM Office of Graduate & Postdoctoral Studies and their respective departments and programs. Individuals may start the series in either the Fall or Spring semester and complete the series in the following semester (e.g., Fall > Spring; or Spring > Fall series). The workshops emphasize small group discussions and foster ongoing conversations that explore important aspects of the ethical and responsible conduct of scholarly research. Case studies are assigned that cover all core competency areas emphasized by NIH – data acquisition, management, sharing & ownership; conflict of interest & commitment; human subjects; animal welfare; research misconduct; publication practices & responsible authorship; mentor/trainee responsibilities; peer review; collaborative science; financial management; research safety; responsibility to society.

Writing a Scientific Proposal; IMMU:6241:0001 (1 sh – Fall year 2). The goal of this course is to teach the skills of scientific writing, using the highly relevant vehicle of scientific proposal preparation. This skill is crucial in many future scientific careers, not restricted to academic research. Students will practice skills of hypothesis and rationale formulation, experimental design, and the ability to present ideas clearly and convincingly in a concise format. During the course, each student will prepare a proposal that can subsequently be submitted to external funding agencies.

B. Elective Courses:

Students will take 3 sh of elective credits. Any student would have the option to take additional approved electives, on a case-by-case basis, in consultation with the student’s advisor and the Curriculum Committee. Course of study will be approved

and supervised by the Graduate Studies Committee until a dissertation advisor and dissertation committee has been chosen.

C. Minimum Number of Credits for the Ph.D. degree – 72:

It is anticipated that most students will complete classroom work (except for Immunology Graduate Student Seminar and two additional modules in Advanced Topics) by the end of the 3rd semester. Other credits required by the Graduate College for the Ph.D. can be fulfilled by research laboratory course credits. The minimum number of credits required for the Ph.D. degree (coursework plus laboratory) is 72.

D. Academic Progress:

An Immunology Program Graduate Student shall be sent a written notification if, after completing 9 sh (at least 6 sh of which carries a letter grade other than S/U) of graduate coursework at The University of Iowa, the student’s cumulative grade-point average falls below 3.00. The student will then have one semester to raise their grade point average above 3.0. Two consecutive semesters of a cumulative grade point average of less than 3.0 will lead to a dismissal from the program due to a failure to make satisfactory academic progress. In addition, any Immunology Program Graduate student who earns a grade below a B minus in the core Immunology Program courses of: Graduate Immunology and Human Disease, Graduate Immunology, and/or Writing a Scientific Proposal will be required to retake the course(s) the next semester that it is offered. If the student again earns a grade of less than a B minus, the student will be dismissed from the program due to failure to make satisfactory academic progress. The student must also make satisfactory progress during laboratory rotations with at least 2 of the 3 rotation mentors indicating that the student had performed satisfactorily during the rotation as indicated on the rotation evaluation form. It should be noted that this policy is separate from the general Graduate College policy regarding academic probation (Section IV.B.), and will be enforced for Immunology Graduate Program students independently of the Graduate College policy.

V. LABORATORY ROTATIONS:

Prior to selecting a laboratory for dissertation work, students are expected to perform three laboratory rotations, with each rotation being approximately 12 weeks in duration. During the first semester, a student should become acquainted with the research interests of the faculty members in the Program. This learning process will be facilitated by faculty presentations in Immunology Graduate Student Seminar during the Fall semester. Students are also encouraged to meet with specific faculty to discuss their research programs. Students can then make an informed decision about their laboratory rotations, with the guidance and approval of their advisor and the Graduate Studies Committee. At the latest, students should begin their first rotation within the first week of graduate study). MSTP students and students with M.S. degrees (which include a research-based dissertation), may be excused from one rotation. Students having difficulty choosing a laboratory for dissertation work may perform a fourth rotation. The rotations are graded as either "Satisfactory" or "Unsatisfactory". This grade is based upon a number of criteria including attendance and work habits. It is important to note that when not in classes or seminars, the students are expected to spend the remaining

portion of the day in the laboratory. Without a strong commitment to the rotation project, it is difficult to fulfill the purpose and aims of the rotation. A "satisfactory" grade is required in each of the laboratory rotations. If a "satisfactory" grade is not obtained in one of the rotations, an additional rotation will be assigned. Failure to obtain a "satisfactory" grade in the extra rotation will result in the student being placed on academic probation. After each rotation, an evaluation by the faculty member of the student and by the student of the faculty member will be submitted to the Graduate Studies Committee.

VI. IMMUNOLOGY SEMINAR:

The Immunology program oversees a weekly seminar series. During the school year, the weekly Immunology seminar features a number of well-known Immunologists from around the country, as well as Immunology program faculty. Although seminar is not part of the formal curriculum, students are expected to attend.

VII. TEACHING REQUIREMENTS:

All incoming students will have a one-semester teaching requirement. A variety of courses are available in several Departments, and the Program leadership will place students in courses based upon interest, expertise, and scheduling.

VIII. OTHER IMMUNOLOGY EVENTS:

In addition to classes and seminar, a number of other events are available for graduate students. A Program highlight is informal dinners scheduled with most of the visiting scientists who present in the Immunology seminar series. Typically, this dinner is held at a faculty member's home, and is attended by only students, postdoctoral fellows, and the visiting speaker. These dinners are designed for the benefit of the students, and are an excellent opportunity to personally meet outstanding scientists, and "pick their brains" on contemporary issues. Aside from Immunology seminar, a number of other meetings are available. These include focused or topic-oriented journal clubs, seminars in other departments (e.g. - Microbiology or Physiology seminar series), and Ph.D. dissertation defense seminars. All graduate students are strongly encouraged to affiliate themselves with a journal club and to become a regular participant. Students are also strongly encouraged to join the Center for Immunology & Immune-Based Diseases at The University of Iowa (https://www.medicine.uiowa.edu/immunology/), which sponsors an annual Research Retreat each year in August, as well as a monthly Research In Progress series. Collectively, these events are not only key for one's education, but are important in getting to know all of the other immunologists on campus, and fostering scientific collaborations.

IX. Individual Development Plan (IDP):

The IDP is a tool to assist trainees with career and professional development. The IDP provides a platform for trainees to identify professional goals, assess competencies relevant to these goals, and develop a plan to achieve specific objectives related to their career goals. The trainee-developed IDP becomes a platform for discussion with their Ph.D. mentor, to foster communication important for the trainee’s professional development. The process is interactive and reiterative to ensure training success and satisfaction. Several steps are involved in the development, implementation, and revision of the IDP. The trainee and mentor are active participants, working together to

design a plan that helps the trainee meet goals identified in the IDP. The process involves identification of short-term objectives, with clear expectations and milestones that address long-term career goals.

Basic steps for Trainee

1. Conduct a self-assessment

a. Define your time commitment to various components of the graduate experience.

b. Assess your skills and interests.

c. Use outside resources to get feedback on your skills, strengths, and weaknesses. The following self-assessment tools provide a nice resource for this self-assessment.

http://myidp.sciencecareers.org

www.apsarchive.org/download.cfm?submissionID=7365

2. Survey opportunities with mentor

a. Identify career opportunities that interest you.

b. Define differences between your current skills and additional skills needed for your identified career objectives.

c. Prioritize areas for development and discuss strategies for addressing objectives with your mentor.

3. Write/update your IDP, share it with your mentor, and review together

a. Identify specific skills that you need to develop in the short-term (e.g. 1-2 years)

b. Define strategies to develop each skill. Use the “SMART” principle:

i. Specific - is it focused and unambiguous?

ii. Measureable - define metrics to know whether the objective is achieved.

iii. Action-oriented - identify concrete steps to achieve the objective.

iv. Realistic - is the strategy feasible?

v. Time bound - define a deadline.

c. Discuss draft with mentor

4. Implement the plan, and revise as needed (at least annually)

a. Review your plan with your mentor on a regular basis.

b. Revise as necessary.

Basic steps for Mentor

1. Be familiar with training requirements and opportunities.

2. Discuss opportunities with trainee.

3. Review your trainee’s IDP and help revise. Provide written comments at the end of this document.

4. Establish regular periods for IDP review and revision, as needed.

X. COMPREHENSIVE EXAMINATION:

A. Overview:

The purpose of the comprehensive exam is to evaluate whether students have successfully acquired the skills and competence to continue on to the research and dissertation phases of the Ph.D. program. Two essential skills that will be evaluated are:

1. The ability to learn and understand the state of knowledge in an area of inquiry, identify a significant knowledge gap in that area, formulate a hypothesis or hypotheses to test, and design an effective approach to testing the hypothesis(es).

2. The ability to communicate clearly with other scientists orally and in writing.

Each student taking the Comprehensive examination in a given cycle will prepare a single abstract of an original research proposal, to be submitted to the examining committee according to the schedule outlined below. The abstract must describe a proposal that does not overlap in major approach or topic with the student’s dissertation research, or any other ongoing projects in the dissertation lab. The abstract will have 0.5” margins and no smaller than 11 point Arial font type and is limited to 2 single-spaced pages (references not included in the 2 page limit). The student must not consult with his/her dissertation advisor during this process, except to ask an opinion about potential overlap of a topic. The Abstract will consist of a Rationale, explaining the context of the area of focus, and the significance of the question(s) to be addressed, and Specific Aims, which briefly outline the major experimental approaches (not the detailed Methods) to be taken in the project. Students are encouraged to review abstracts and Rationale/Aims pages of grants of their mentors or senior postdoctoral fellows as examples for what sort of information this should contain, while they prepare their own documents.

The examination committee for the student will then determine a) if the abstract topic is appropriate as non-overlapping and b) if the abstract is scientifically sound, and could potentially serve as the basis for a defensible research proposal. Three outcomes are possible.

1) The abstract is judged acceptable; the student may begin work on the written proposal.

2) The topic of the abstract is acceptable, and the committee believes that the abstract could potentially lead to a defensible proposal, but first requires revision. If the needed revisions are substantial, part or all of the examining committee will convene a meeting with the student, to discuss the nature of the revision needed. The student will receive a written summary of the deficiencies in the abstract and the revisions required. A revised abstract will be due one week after this summary is sent to the student. The student will have one opportunity to revise the abstract so it forms a suitable basis for the written proposal.

3) The abstract is judged fatally flawed. The student will be informed in writing of the basis for the committee’s decision, and will be instructed to prepare a new abstract on a different research topic. The second abstract will be due 3 weeks after this notification. If the second abstract cannot be revised to a level of acceptability, the student will be considered to have failed the first attempt at the Comprehensive examination, and must wait a minimum of 4 months before a second attempt.

After the abstract is accepted, the student will be given 4 weeks to complete and submit the written comprehensive exam proposal. The oral defense will be scheduled 10-14 days after the exam is submitted, depending on availability of the committee members. The comprehensive exam will be written in the form of an NIH style pilot grant proposal based on the abstract and instructions from the Comprehensive Exam.

Committee. The proposal will be limited to 15 double-spaced pages or less, with 0.5 inch margins and 11 point Arial font type. No more than 3 pages of this total can be devoted to specific methodological details. Rather than list all the details of specific protocols, students are urged to refer to published literature whenever possible, and instead focus on why a method was chosen, and its strengths and limitations that impact data interpretation. References and figures will not count in the 15 page limit, but together cannot constitute more than five pages.

Comprehensive exam abstracts and proposals should be the result of the student’s own ideas. Students may discuss their abstracts and proposals with other students and postdoctoral fellows. They are also allowed to consult faculty other than their dissertation advisers for questions regarding specific techniques, as well as general knowledge questions. However, they cannot ask faculty to review their rationale or Aims, or provide experimental design details. It should be emphasized that no matter who provides advice, the student is responsible for whatever is in his/her proposal, regardless of what any other scientist may offer as an opinion. “Dr. ____ said so” is NOT an excuse for incorrect information or flawed reasoning. The description of the exam as “comprehensive” means that the student should have a clear understanding of the state of knowledge that underlies the rationale upon which the proposal is built. When published papers are used as the basis for designing further experiments, be sure such papers are read thoroughly and carefully (not just the Abstract).

Primary advisors should excuse themselves from any administrative committee deliberations (other than the Dissertation Committee) which directly concern their students. Administrative committees will communicate directly with students. Advisors should not act as an intermediary in this process. If an Advisor feels compelled to raise a concern about a decision by an administrative committee, he/she should contact the Program Director.

The Comprehensive Exam Committee will hear the student's defense, which will be a brief oral presentation of the background, rationale, specific aims, and experimental approach. The student may use visual aids, such as PowerPoint slides or transparencies, which are specifically related to the presentation of the proposal. However, no additional reference material will be allowed in the room during the

defense. The student’s presentation will be followed by questions from the Comprehensive Exam Committee on the content of the oral defense and of the written proposal. All proposals submitted by the required deadline will be defended orally if they are readable. The Comprehensive Exam Committee, at its discretion, can direct a student to write a new proposal if the proposal submitted is significantly substandard.

The outcome of the comprehensive examination will fall into one of the three following categories:

1. The student passes and will be permitted to continue to work toward the Ph.D.

2. The student passes with reservation and will be given an opportunity to eliminate the reservation according to specific instructions from the examining committee. If the student is asked to make written revisions the student should provide a point-by-point response to the written critique provided by the committee and highlight the changes made in the revised document.

3. The student fails

It is anticipated that most students will take their comprehensive exam in the second semester of their second year. MSTP students who joined the dissertation laboratory at the beginning of the first year of graduate study may begin the Comprehensive Exam process in September of the second year of graduate study. If the first attempt is failed, a student may begin the examination process again no sooner than 4 months after the first exam is taken, according to the regulations of the Graduate College. If a student fails to pass after two attempts, the student will not be permitted to remain as a Ph.D. candidate.

Failure to take the Comprehensive Exam by the end of the fifth semester will, unless a specific exception is granted by the Graduate Studies Committee, result in a grade of "Incomplete" for the student's research for that semester. Exceptions must be fully explained and justified in a letter to the Chairperson of the Graduate Studies Committee. This letter will also be made part of the student's file. If the grade of "Incomplete" is not removed by the end of the next full semester, it will be changed automatically to an "F" and the student will be required to leave the program.

B. Spring Comprehensive Exam Schedule:

A typical Ph.D. student who spends Year 1 in the Program performing required coursework and 3 laboratory rotations will begin the Comprehensive Exam process in February of the second year of graduate study.

February 1: Deadline for abstract submission.

February 8: Deadline to notify students if the abstract is acceptable (with or without modification) by the Comprehensive Exam Committee, or

whether an entirely new abstract is needed.

February 15: Deadline for submission of revised abstract, if appropriate.

February 29: Deadline for submission of new abstract, if first abstract was judged fatally flawed.

The remainder of the timeline will follow the same approximate schedule as for the first abstract, if a second is required. Note: As soon as an abstract has been accepted, the Program Office will contact the committee members to schedule a meeting. The student will be given 4 weeks to complete and submit the NIH style grant proposal following notification of acceptance of the abstract. The proposal must be turned into the Program Office for distribution to the committee. The oral defense will be scheduled within 2 weeks of proposal distribution, whenever possible.

C. Autumn Comprehensive Exam Schedule:

A MSTP student who joined the dissertation laboratory at the beginning of the first year of graduate study may begin the Comprehensive Exam process in September of the second year of graduate study.

September 15: Deadline for submitting an abstract.

The remainder of the timeline will be similar in intervals and decision points to that

outlined above for the Spring schedule.

Note: As soon as an abstract has been accepted, the Program Office will contact the committee members to schedule a meeting. The student will be given 4 weeks to complete and submit the NIH style grant proposal following notification of acceptance of the abstract. The proposal must be turned into the Program Office for distribution to the committee.

NOTE: The guidelines are written to promote uniform schedules and uniform treatment of graduate students. However, exceptions are to be made in the case of illness, family crisis, or other serious circumstances that may interfere with a student's ability to follow the schedule outlined above.

XI. DISSERTATION RESEARCH:

By or before the beginning of the third semester (usually the fall semester of the second year), the student should choose a laboratory in which to do research. The faculty member from that laboratory will serve as the student's research advisor. If the research advisor selected by the student has not mentored a student through successful completion of the Ph.D. degree, the student and advisor must additionally select a Mentor of Record. Any Immunology Program faculty member who has mentored a student who achieved the Ph.D. degree is eligible to serve as Mentor of Record. The research advisor must submit the name(s) of the suggested Mentor of Record for final approval by the Graduate Studies Committee. The Mentor of Record should be selected as soon as possible after the student has chosen the research advisor. The Mentor of Record will serve as the chairperson of the student’s

dissertation committee. Together the student and the student’s research advisor will select a Dissertation committee for the student prior to completion of the third semester of graduate study and submit these selections to the Graduate Studies Committee for approval. The Dissertation committee will consist of at least five members, including the student’s research advisor. At least four members of the committee will be members of the Immunology Graduate Program. The fifth faculty member may be from outside the Program, but must have an appointment in a Ph.D.-granting program/department. Unless the student has a Mentor of Record (who in that case will serve as Chair), the Dissertation Committee will elect a chairperson (who will not be the research advisor).

The Dissertation Committee will meet with the student at least once each year to review the plan of study and to receive a written report of research progress prepared by the student. The first of these meetings must be held within one year of passing the Comprehensive exam. All subsequent annual reports and Dissertation committee meetings must be completed within one month of the anniversary date of the student's passing the Comprehensive exam. The purpose of this yearly meeting is to determine whether the student's progress has been appropriate to allow for enrollment in the academic year beginning the following Fall semester. The written report will then be forwarded to the Graduate Studies Committee, and will be made part of the student's record. If the annual written report is not received within 60 days of this anniversary date, the student will receive an "incomplete" for that semester's research (148:231 Research in Immunology). If the student has not submitted a satisfactory report within the next 60 days, the grade will be changed automatically to an F and the student will be required to leave the program. Students with a Mentor of Record must hold meetings between the advisor, student, and Mentor of Record within 3 months of selecting a Mentor of Record and at least once between each annual Dissertation Committee meeting. The Mentor of Record will file a progress report following such meetings.

Each year which follows successful completion of the comprehensive examination, students will present their research to the members of the immunology community at the University of Iowa by giving a research seminar to be scheduled by the seminar committee in consultation with the dissertation committee.

The student or any member of the Dissertation Committee may, with reasonable notice, request a meeting, at other times of the year, in which the student and the Committee members would participate. This is especially encouraged during the latter stages of the student's dissertation work.

The Dissertation Committee will be responsible for administering the final examination, or dissertation defense.

Students are guaranteed stipend and tuition support for 6 years, provided they display satisfactory performance in fulfilling all academic requirements, as well as in the progress of their dissertation research. Support after 6 years is not guaranteed, but the student and mentor may petition the Program to continue support, if satisfactory progress is being made.

It is expected that the dissertation project be of sufficient breadth, depth, and novelty to result in first-author research publications in high quality peer-reviewed journals. A minimum of one peer-reviewed paper must be published or in press prior to the completion of the Ph.D. In addition, a second publication, in which the student is a coauthor on a peer-reviewed article, a review or book chapter must be published or in

press prior to the completion of the Ph.D. The student will not be permitted to schedule a dissertation defense until it has been demonstrated that both of these requirements have been met.

XII. THE PH.D. DISSERTATION:

To be awarded the Ph.D. degree, a candidate must satisfactorily defend the Ph.D. dissertation.

The procedure to be followed by the student regarding the Ph.D. dissertation is as follows:

1. The student's completed or nearly completed research should be presented orally to members of the Dissertation committee for consideration. If the Dissertation committee considers progress to be adequate, the student will be advised to write the dissertation. The style of the dissertation will conform to that presented in the CBE Style Manual.

2. When a draft of the dissertation has been approved by the student's research advisor, a copy will be distributed to each member of the Dissertation committee at least two weeks before the date of the final defense.

3. This draft of the Dissertation must conform to the rules of the Graduate College office and must be presented to said office according to their schedule for that semester.

4. The student will present a public seminar on the dissertation work. All graduate students and faculty in the program will be encouraged to attend. The seminar will be followed by a defense of the dissertation before the student's Dissertation committee. A final draft of the Dissertation will then be prepared incorporating revisions suggested by the committee, and approved by the advisor and the committee.

5. Final corrected copies of the Dissertation must be submitted to the Graduate College office at least ten days before the graduation date.

6. Expenses for typing the dissertation, any illustrative material, and copies of the dissertation, are the responsibility of the student.

7. In addition to the copies required by the Graduate College, the student will present one final copy of the Dissertation to the Program for the permanent library file, and at least one copy to the advisor.

XIII. VACATIONS:

Successful graduate education in the sciences does not begin and end with the usual academic calendar, but rather is a full-time occupation. Reasonable vacation periods are certainly appropriate, but long or repeated absences are generally not permitted. Vacations or any other planned absences should be discussed in advance with the individual in whose laboratory a student is rotating or working.

Policy for Paid Leaves, Holidays, and Unpaid Leaves of Absence: Graduate Students in Biomedical Training Programs under the auspices of the CCOM Office of Graduate and Postdoctoral Studies

(Effective Date 8/24/2016)

Kirschstein-NRSA trainees and fellows are eligible for other types of leave (vacations and holidays, sick leave, parental leave) Please refer to NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf and the revised NIH Parental Leave Policy for NRSAs NOT-OD-16-105 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-105.html

Currently enrolled University of Iowa PhD students with a 25% or more appointment employed as:

* Teaching Assistants (FT19)

* Research Assistants (FR19-01, FR19-02)

* Graduate students appointed on federal training grants or federal fellowships

Paid Leaves

PhD students are entitled to University-designated holidays and up to (15) working days per fiscal year of absence without pay deduction. All paid leave must be scheduled with the approval of the mentor. PhD students may be absent for the University-designated holidays unless the mentor specifically requires the PhD student to work. At such time, the mentor and the PhD student shall schedule alternate paid time off. Mentors will make an effort to minimize holiday work for PhD students and if they require work on a holiday, shall provide PhD student(s) with no less than thirty (30) days written notice, whenever feasible.

University-designated Holidays:

* New Year's Day

* Dr. Martin Luther King, Jr.'s Birthday

* Memorial Day

* Independence Day

* Labor Day

* Thanksgiving Day

* Friday after Thanksgiving Day

* Christmas Day

* A day before or after Christmas Day

Monday will be recognized as a holiday for all holidays occurring on a Sunday and Friday for all holidays occurring on a Saturday.

Any further paid leave should have the additional approval of the DEO/Director, which may be granted without financial support.

Sick Leave

PhD students may be absent due to illness without loss of pay not to exceed (18) days during a twelve month appointment.

If a PhD student has exhausted paid sick leave due to illness, they may request an unpaid leave of absence which will be granted at the sole discretion of the Program and mentor, and subject to any relevant policies of the Graduate College.

Family Illness Leave – PhD students may use available sick leave for care of and necessary attention to ill or injured members of the immediate family or for parental leave including birth and adoption.

Bereavement Leave – PhD students may use available sick leave for three (3) work days when a death occurs in the employee’s immediate family.

PhD programs may grant additional paid leave - Such leaves may be granted provided the Program and mentor determine that the PhD student is able to meet the time and effort obligations reflected in the percentage of appointment over the full term of the student’s appointment.

Unpaid Leave of Absence

A PhD student may be granted an unpaid leave of absence during the term of their appointment, upon request to and at the sole discretion of the Program and mentor.

The Program and mentor shall authorize leave requests in accordance with the provisions of the Family and Medical Leave Act of 1993 for qualifying individuals.

The University of Iowa prohibits discrimination in employment, educational programs, and activities on the basis of race, creed, color, religion, national origin, age, sex, pregnancy, disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, gender identity, associational preferences, or any other classification that deprives the person of consideration as an individual. The university also affirms its commitment to providing equal opportunities and equal access to university facilities. For additional information on nondiscrimination policies, contact the Director, Office of Equal Opportunity and Diversity, the University of Iowa, 202 Jessup Hall, Iowa City, IA, 522421316, 319-335-0705 (voice), 319-335-0697 (TDD), diversity@uiowa.edu.

Graduate Student Guidelines

The Interdisciplinary

Graduate Program in

Immunology

A subprogram of the Biomedical Science Graduate Program at the University of Iowa Roy J. and Lucille A. Carver College of Medicine

Revised June 15, 2018

Table of Contents

Program Leadership 1

Academic Calendar 1-2

Guidance 3

Formal Coursework 3-6

Required Courses 3-5

Electives 5

Minimum Number of Credits for Ph.D. Degree 6

Grade Requirements 6

Laboratory Rotations 6-7

Immunology Seminars 7

Teaching Requirements 7

Other Immunology Events 7

IDP Plan 7-8

Comprehensive Examination 9-12

Overview 9-11

Spring Comprehensive Exam Schedule 11-12

Autumn Comprehensive Exam Schedule 12

Dissertation Research 12-14

The Ph.D. Dissertation 14

Vacations 14-16

Revised June 15, 2018

IMMUNOLOGY GRADUATE PROGRAM STUDENT GUIDELINES

THE UNIVERSITY OF IOWA

I. PROGRAM LEADERSHIP:

Program Director:

Dr. Steven Varga 3-532 BSB 335-7784

Executive Committee Members:

Dr. Steven Varga 3-532 BSB 335-7784

Dr. Gail Bishop 2296 CBRB 335-7945

Dr. John Colgan 3270 CBRB 335-9561

Dr. Lee-Ann Allen D154 MTF 335-4258

Dr. Kevin Legge 1028 ML 335-6744

Dr. Jon Houtman 2210 MERF 335-7780

Graduate Studies Committee Chair:

Dr. John Harty 3-530 BSB 335-9720

Admissions Committee Chair:

Dr. Jon Houtman 2210 MERF 335-7780

Comprehensive Exam Committee Co-Chairs:

Kevin Legge 1028 ML 335-6744

Mary Wilson 401 EMRB 356-3169

Curriculum Committee Chair:

Dr. Ashutosh Mangalam 1080A ML 335-8558

Seminar Committee Chair:

Scott Lieberman 2191A ML 353-4399

Program Administrator:

Paulette Villhauer 354 MRC 335-7748

Program Assistant:

Karina Escobedo 354 MRC 335-6512

Bhuvana Parampalli 354 MRC 384-4470

II. 2018 - 2019 ACADEMIC CALENDAR:

Fall semester 2018:

First day of classes August 20

Last day of classes December 7

Close of Finals week December 14

Spring semester 2019:

First day of classes January 14

Last day of classes May 3

Close of Finals week May 10

Fall Rotation August 20 – November 9, 2018

Winter Rotation November 12, 2018 – February 8, 2019

Spring Rotation February 11, 2019 – May 3, 2019

Registration for Fall, Spring, and Summer semesters are performed through the program office during the early registration period.

III. GUIDANCE:

IV. FORMAL COURSE WORK:

A. Required Courses:

Principles of Molecular and Cellular Biology BMED:5207 (3 sh – Fall year 1).

Introduction to Protein Structures BIOC:7251 (1 sh)

Transcription, RNA MCB:6215 (1 sh)

Inflammatory Cell Signaling and Targeted Cancer Therapy MCB:6240 (1 sh)

Growth Factor Receptor Signaling MCB:6225 (1 sh)

Cell Cycle Control MCB:6226 (1 sh)

Cell Fate Decisions MCB:6227 (1 sh)

Mechanism of Cellular Organization MCB:6220 (3 sh)

Enzymes, Carbohydrates, Nucleic Acids, and Bioenergetics BIOC:7252 (1 sh)

Metabolism 1 BIOC:7253 (1 sh)

Metabolism 2 BIOC:7254 (1 sh)

Metabolism 3 and Biosignaling BIOC:7255 (1 sh)

Molecular Biology BIOC:7256 (1sh)

General Histology for Graduate Students; ACB:8121 (4 sh)

Microscopy for Biomedical Research; ACB:5218 (3 sh)

Graduate Bacteria and Human Disease; MICR:6259 (3 sh)

Graduate Molecular Microbiology; MICR:6260 (3 sh)

Graduate Viruses and Human Disease, MICR:6267 (4 sh)

Biology & Pathogenesis of Viruses; MICR:6268 (2 sh)

Ion Channel Pharmacology; PCOL6207 (1 sh)

G-proteins and G-protein Coupled Receptors; PCOL6208 (1 sh)

Steroid Receptor Signaling; PCOL6209 (1 sh)

Graduate Microbial Genetics; MICR:6270 (3 sh)

Pathogenesis of Major Human Diseases; PATH:5270 (3 sh)

Translational Histopathology; PATH:5260 (3 sh)

Integrated Topics in Infectious Disease MICR:7217 (1 sh)

Introduction to Biostatistics BIOS:4120 (formerly BIOS:5110) (3 sh)

BMED:7270 Scholarly Integrity/Responsible Conduct of Research 1 (0 sh)

BMED:7271 Scholarly Integrity/Responsible Conduct of Research 2 (0 sh)

B. Elective Courses:

and supervised by the Graduate Studies Committee until a dissertation advisor and dissertation committee has been chosen.

C. Minimum Number of Credits for the Ph.D. degree – 72:

D. Academic Progress:

An Immunology Program Graduate Student shall be sent a written notification if, after completing 9 sh (at least 6 sh of which carries a letter grade other than S/U) of graduate coursework at The University of Iowa, the student’s cumulative grade-point average falls below 3.00. The student will then have one semester to raise their grade point average above 3.0. Two consecutive semesters of a cumulative grade point average of less than 3.0 will lead to a dismissal from the program due to a failure to make satisfactory academic progress. In addition, any Immunology Program Graduate student who earns a grade below a B minus in the core Immunology Program courses of: Graduate Immunology and Human Disease, Graduate Immunology, and/or Writing a Scientific Proposal will be required to retake the course(s) the next semester that it is offered. If the student again earns a grade of less than a B minus, the student will be dismissed from the program due to failure to make satisfactory academic progress. The student must also make satisfactory progress during laboratory rotations with at least 2 of the 3 rotation mentors indicating that the student had performed satisfactorily during the rotation as indicated on the rotation evaluation form. Unsatisfactory performance in one or more rotations can lead to dismissal from the program. It should be noted that this policy is separate from the general Graduate College policy regarding academic probation (Section IV.B.), and will be enforced for Immunology Graduate Program students independently of the Graduate College policy.

V. LABORATORY ROTATIONS:

that when not in classes or seminars, the students are expected to spend the remaining portion of the day in the laboratory. Without a strong commitment to the rotation project, it is difficult to fulfill the purpose and aims of the rotation. A "satisfactory" grade is required in each of the laboratory rotations. If a "satisfactory" grade is not obtained in one of the rotations, an additional rotation will be assigned. Failure to obtain a "satisfactory" grade in the extra rotation will result in the student being placed on academic probation. After each rotation, an evaluation by the faculty member of the student and by the student of the faculty member will be submitted to the Graduate Studies Committee.

VI. IMMUNOLOGY SEMINAR:

VII. TEACHING REQUIREMENTS:

VIII. OTHER IMMUNOLOGY EVENTS:

IX. Individual Development Plan (IDP):

revision of the IDP. The trainee and mentor are active participants, working together to design a plan that helps the trainee meet goals identified in the IDP. The process involves identification of short-term objectives, with clear expectations and milestones that address long-term career goals.

Basic steps for Trainee

1. Conduct a self-assessment

a. Define your time commitment to various components of the graduate experience.

b. Assess your skills and interests.

c. Use outside resources to get feedback on your skills, strengths, and weaknesses. The following self-assessment tools provide a nice resource for this self-assessment.

http://myidp.sciencecareers.org

https://www.grad.uiowa.edu/individual-development-plan

2. Survey opportunities with mentor

a. Identify career opportunities that interest you.

b. Define differences between your current skills and additional skills needed for your identified career objectives.

c. Prioritize areas for development and discuss strategies for addressing objectives with your mentor.

3. Write/update your IDP, share it with your mentor, and review together

a. Identify specific skills that you need to develop in the short-term (e.g. 1-2 years)

b. Define strategies to develop each skill. Use the “SMART” principle:

i. Specific - is it focused and unambiguous?

ii. Measureable - define metrics to know whether the objective is achieved.

iii. Action-oriented - identify concrete steps to achieve the objective.

iv. Realistic - is the strategy feasible?

v. Time bound - define a deadline.

c. Discuss draft with mentor

4. Implement the plan, and revise as needed (at least annually)

a. Review your plan with your mentor on a regular basis.

b. Revise as necessary.

Basic steps for Mentor

1. Be familiar with training requirements and opportunities.

2. Discuss opportunities with trainee.

3. Review your trainee’s IDP and help revise. Provide written comments at the end of this document.

4. Establish regular periods for IDP review and revision, as needed.

X. COMPREHENSIVE EXAMINATION:

A. Overview:

2. The ability to communicate clearly with other scientists orally and in writing.

1) The abstract is judged acceptable; the student may begin work on the written proposal.

The outcome of the comprehensive examination will fall into one of the three following categories:

1. The student passes and will be permitted to continue to work toward the Ph.D.

3. The student fails

B. Spring Comprehensive Exam Schedule:

February 1: Deadline for abstract submission.

February 8: Deadline to notify students if the abstract is acceptable (with or without modification) by the Comprehensive Exam Committee, or

whether an entirely new abstract is needed.

February 15: Deadline for submission of revised abstract, if appropriate.

February 29: Deadline for submission of new abstract, if first abstract was judged fatally flawed.

C. Autumn Comprehensive Exam Schedule:

A MSTP student who joined the dissertation laboratory at the beginning of the first year of graduate study may begin the Comprehensive Exam process in September of the second year of graduate study.

September 15: Deadline for submitting an abstract.

The remainder of the timeline will be similar in intervals and decision points to that

outlined above for the Spring schedule.

XI. DISSERTATION RESEARCH:

The Dissertation Committee will meet with the student at least once each year to review the plan of study and to receive a written report of research progress prepared by the student. The first of these meetings must be held within one year of passing the Comprehensive exam. All subsequent annual reports and Dissertation committee meetings must be completed within one month of the anniversary date of the student's passing the Comprehensive exam. The purpose of this yearly meeting is to determine whether the student's progress has been appropriate to allow for enrollment in the academic year beginning the following Fall semester. Unsatisfactory progress, as judged by the thesis committee, during the yearly thesis committee meeting can lead to dismissal from the program. The written report will then be forwarded to the Graduate Studies Committee, and will be made part of the student's record. If the annual written report is not received within 60 days of this anniversary date, the student will receive an "incomplete" for that semester's research (148:231 Research in Immunology). If the student has not submitted a satisfactory report within the next 60 days, the grade will be changed automatically to an F and the student will be required to leave the program. Students with a Mentor of Record must hold meetings between the advisor, student, and Mentor of Record within 3 months of selecting a Mentor of Record and at least once between each annual Dissertation Committee meeting. The Mentor of Record will file a progress report following such meetings.

The Dissertation Committee will be responsible for administering the final examination, or dissertation defense.

Students are guaranteed stipend and tuition support for 5 years, provided they display satisfactory performance in fulfilling all academic requirements, as well as in the progress of their dissertation research. Support after 5 years is not guaranteed, but the student and mentor may petition the Program to continue support, if satisfactory progress is being made.

completion of the Ph.D. In addition, a second publication, in which the student is a coauthor on a peer-reviewed article, a review or book chapter must be published or in press prior to the completion of the Ph.D. The student will not be permitted to schedule a dissertation defense until it has been demonstrated that both of these requirements have been met.

XII. THE PH.D. DISSERTATION:

To be awarded the Ph.D. degree, a candidate must satisfactorily defend the Ph.D. dissertation.

The procedure to be followed by the student regarding the Ph.D. dissertation is as follows:

3. This draft of the Dissertation must conform to the rules of the Graduate College office and must be presented to said office according to their schedule for that semester.

5. Final corrected copies of the Dissertation must be submitted to the Graduate College office at least ten days before the graduation date.

6. Expenses for typing the dissertation, any illustrative material, and copies of the dissertation, are the responsibility of the student.

XIII. VACATIONS:

Policy for Paid Leaves, Holidays, and Unpaid Leaves of Absence: Graduate Students in Biomedical Training Programs under the auspices of the CCOM Office of Graduate and Postdoctoral Studies

(Effective Date 3/26/2018)

Kirschstein-NRSA trainees and fellows are eligible for other types of leave (vacations and holidays, sick

leave, parental leave). Please refer to NIH Parental Leave Policy for NRSAs

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-154.html

Currently enrolled University of Iowa PhD students with a 25% or more appointment employed as:

* Teaching Assistants (FT19)

* Research Assistants (FR19-01, FR19-02)

* Graduate students appointed on federal training grants or federal fellowships

Paid Leaves

University-designated Holidays:

* New Year's Day

* Dr. Martin Luther King, Jr.'s Birthday

* Memorial Day

* Independence Day

* Labor Day

* Thanksgiving Day

* Friday after Thanksgiving Day

* Christmas Day

* A day before or after Christmas Day

Monday will be recognized as a holiday for all holidays occurring on a Sunday and Friday for all holidays occurring on a Saturday.

Any further paid leave should have the additional approval of the DEO/Director, which may be granted without financial support.

Sick Leave

PhD students may be absent due to illness without loss of pay not to exceed (18) days during a twelve month appointment.

Bereavement Leave – PhD students may use available sick leave for three (3) work days when a death occurs in the employee’s immediate family.

Unpaid Leave of Absence

A PhD student may be granted an unpaid leave of absence during the term of their appointment, upon request to and at the sole discretion of the Program and mentor.

The Program and mentor shall authorize leave requests in accordance with the provisions of the Family and Medical Leave Act of 1993 for qualifying individuals.

RIKEN 1 Sep 2016

HPC system startup manual (version 1.60)

Document change log

Issue

Date

Change

Modified pages

Notes

12/1/2012

New document

10/22/2013

Added the information of supported OS

10/22/2013

Changed the example 1 for data download

3/4/2014

Added the chapter of Torque/Maui batch job system

3/4/2014

Changed text font

10/2/2014

Changed the example 1 for data download

5/26/2015

Changed the example 4 for browse SACLA Database

10/16/2015

Changed the section 5 for Data handling in SACLA HPC system

9/1/2016

Replacement SACLA HPC system

1 Overview

The high performance computing (HPC) system in the SACLA facility consists of 38 compute nodes, with two 14-core processors per node, for a total of 1064 cores. The theoretical peak compute performance is 34 TFLOPS. The system supports a 2PB shared storage system, managed by the Lustre file system. Nodes are interconnected with Infiniband with a 54 Gbps bandwidth. This manual introduces the startup from account creation to the launch of software installed in the SACLA HPC system.

2 Account creation

After your experiment proposal accepted, a responsible researcher of the SACLA is assigned to your proposal. Contact him by e-mail and request the use of the SACLA HPC system. He will create your account and give the username and password. Note that “/home” directory is limited by quota

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RIKEN 1 Sep 2016

to 100 GB per user. When you are going to use more storage area for a large amount of experimental data and the result data of the analysis, "work” directory can be used. Please talk with your contact researcher for the use of "/work” directory.

3 How to login SACLA HPC system

The access of the SACLA HPC system is limited to be within SPring-8 local network. First of all, you have to connect your computer to the SPring-8 local network by using VPN service. After that, you can login the HPC server through SSH protocol.

[ step 1. Connect the SPring-8 network with VPN service. ]

* Access the web page: https://hpc.spring8.or.jp with a web browser.

* Login the web page of VPN installation service. (Enter your username and password given in Sec. 2)

* Download and install VPN connection software into your computer. Supported OS for VPN service is as follows.

[Windows]

Windows 7, 8, 8.1 & 10 x86 (32-bit) and x64 (64-bit)

[Mac]

Mac OS X 10.8, 10.9, 10.10, 10.11

[Linux]

Red Hat 6, 7 & Ubuntu 12.04 (LTS), and 14.04 (LTS) (64-bit only)

[ step 2. Login SACLA HPC system. ]

* Type “ssh -X [username]@xhpcfep”. The username is given in Sec.2.

* Enter your password given in Sec.2.

4 Batch job system

The queuing system on SACLA HPC system is PBS . You need three main commands to use this

system: qstat, qsub, and qdel.

[qstat]

“qstat” display status of PBS batch jobs, queues, or servers.

[qsub]

“qsub” submits a job. In its simple form you would run “qsub myscript”, where myscript is a shell

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script that runs your job. For those who don't want to write scripts, you can do an

interactive qsub with the -I option. You can also use -X option for enabling X11 forwarding (e.g.

“qsub –I –X –q smp”).

[qdel]

“qdel job_number” deletes your job. You can get information on job_number with “showq”.

5 Data handling in SACLA HPC system

Access the web page: http://xhpcfep.hpc.spring8.or.jp/manuals via VPN service.

6 Installed software List and how to use

The available software is listed below.

[ Hdfview ]

* Login the SACLA HPC system as stated in Sec. 3.

* Type "hdfview” in the terminal window.

[ MATLAB]

* Login the SACLA HPC system as stated in Sec. 3.

* Type “qsub -I -X” in the terminal window.

* Type "matlab” in the terminal window.

Note: The concurrent client number is restricted to be the number of license key RIKEN possess. You MUST close the MATLAB after finish your analysis.

[ ImageJ ]

* Login the SACLA HPC system as stated in Sec. 3.

* Type “qsub -I -X” in the terminal window.

* Type "ImageJ” in the terminal window.

[ FireFox ]

* Login the SACLA HPC system as stated in Sec. 3.

* Type "firefox” in the terminal window.

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Pitt Meadows Economic Development Corporation

Commercial Property Search User Manual

Establish & Activate a User Account 1

Create a Listing . 2

Edit a Listing 3

Delete a Listing . 3

Share Your Listings 3

Establish & Activate a User Account

Step 1 r Provide Contact Information

To establish your account, complete the information in the table below and forward to Pitt Meadows Economic Development Corporation (PMEDC) by:

Tel: 604-465-9481

Fax: 604-465-4986

Email: edinfo@pittmeadows.bc.ca

*indicates required fields

First Name*

Username (NOTE: this will not appear in your listings)

Step 2 - Receive Password

Once PMEDC receives and enters your information into the Property Search Database system, an email will be sent to you from webmaster@pittmeadows.bc.ca titled “New Broker Account.”

This email will contain your “Username” and an automatically generated “Password.”

So it is easy for you to remember your password, it is recommended that you personalize your

password.

Step 3 - Update/Personalize Password

Please note you can continue to use the Username and Password contained in the email you received. If you wish to personalize your password, follow the instructions below.

1. Navigate to the Realtor Login page

http://www.pittmeadows.bc.ca/propertylistings/login.aspx

2. Enter “username”

3. Enter your “temporary password”

4. Click on “LOGIN”

5. Click on (edit)

6. Scroll down to password, clear the field, enter a new password, click on SUBMIT. Make sure you keep this password in a safe place.

7. The following message should appear: Your profile has been updated*

8. From here, you can add a property, or logrout of the system.

*If you experience any difficulties while updating/personalizing your password, please contact edinfo@pittmeadows.bc.ca

Create a Listing

1. Navigate to the Realtor Login page

http://www.pittmeadows.bc.ca/propertylistings/login.aspx

2. Enter “username”

3. Enter your “password”

4. Read the Disclaimer. Please contact edinfo@pittmeadows.bc.ca if you have any questions.

5. Click on “LOGIN”

6. Click on “Add Property”

7. Enter/upload information into applicable fields

8. Once complete, click on “SUBMIT” – your listing is now live.

9. Add additional properties by clicking “Add Property” or click on “LOG OUT”

10. Once you log out, you may wish to visit the site from a visitor’s perspective to ensure the information you uploaded is displayed correctly.

NOTE: Your listing will not expire, therefore it is your responsibility to edit and delete your listing as needed.

Edit a Listing

1. Navigate to the Realtor Login page

http://www.pittmeadows.bc.ca/propertylistings/login.aspx

2. Enter “username”

3. Enter your “password”

4. Click on “LOGIN”

5. Find the listing you wish to edit.

6. Click on Edit on the right hand side of the page.

7. Make necessary changes.

8. Once complete, click on “SUBMIT” – your edited listing will now be live.

Delete a Listing

1. Navigate to the Realtor Login page

http://www.pittmeadows.bc.ca/propertylistings/login.aspx

2. Enter “username”

3. Enter your “password”

4. Click on “LOGIN”

5. Find the listing you wish to delete.

6. Click on Delete on the right hand side of the page.

7. A prompt box will appear asking: Are you sure you want to delete this listing? If so, choose OK.

8. Your listing has now been deleted from the Property Search database.

Share Your Listings

To help market your properties, the City of Pitt Meadows’ website is full of resources including a Community Profile, Site Selector Database, OCP development area information, Key Sector information, and our recently debuted marketing tool, the Property Search Database – let us be your ally in helping you get the exposure your listings deserve and spreading the word that Pitt Meadows is the Natural Place to invest.

Copy, paste, and share this Property Search website with your clients and colleagues today.

Share at: http://www.pittmeadows.bc.ca/propertylistings/default.aspx

Before you share it, be sure to add your properties to the Property Search database!

Add a property at: http://www.pittmeadows.bc.ca/propertylistings/login.aspx

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

Position Classification Standard for Industrial Property

Management Series, GS-1103

Table of Contents

SERIES DEFINITION 2

EXCLUSIONS 2

OCCUPATIONAL INFORMATION 3

TITLES 4

PART I - INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST POSITIONS 5

NATURE OF INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST POSITIONS 5

GRADE-LEVEL COVERAGE 6

CLASSIFICATION FACTORS 6

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-05 7

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-07 8

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-09 9

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-11 12

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-12 16

PART II-INDUSTRIAL PROPERTY CLEARANCE SPECIALIST POSITIONS 20

NATURE OF INDUSTRIAL PROPERTY CLEARANCE SPECIALIST POSITIONS 20

U.S. Office of Personnel Management 1

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

SERIES DEFINITION

This occupation includes positions which primarily require a knowledge of business and industrial practices, procedures, and systems for the management and control of Government-owned property. These positions involve technical work in the administration of contract provisions relating to control of Government property in the possession of contractors, from acquisition through disposition. Also included are positions that involve providing staff leadership and technical guidance over property administration matters.

This standard cancels and supersedes the standard for the Industrial Property Administration Series, GS-1103, which was issued in February 1959.

EXCLUSIONS

Excluded from this occupation are positions which involve:

1. Providing clerical, typing, or stenographic assistance to the property administration staff. Such positions are classified in the appropriate occupation in the General

Administrative, Clerical, and Office Services Group, GS-0300.

2. Negotiating, administering, or terminating contracts to furnish services, supplies, equipment, or other materials to the Government. These positions require a knowledge of market trends and conditions, and the relationships among costs of production, marketing, and distribution. (By contrast, positions in the Industrial Property Management Series, GS-1103, specialize in the administration of contract provisions relating to control of property in possession of contractors.) See the Contracting Series, GS-1102.

3. Auditing contractor accounting systems, including examination of property control records, for adequacy. Such positions are classified in the appropriate occupation in the Job Family Position Classification Standard for Professional and Administrative Work in the Accounting and Budget Group, GS-0500.

4. Performing other technical services requiring specialized knowledge of industrial practices, methods, and facilities other than those relating to management of Government property. See the Industrial Specialist Series, GS-1150; the Production Control Series, GS-1152; and other related occupations in the Business and Industry Group, GS-1100.

U.S. Office of Personnel Management 2

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

OCCUPATIONAL INFORMATION

1. Control of Government property in possession of contractors

Industrial property management specialists insure that contractors comply with contract requirements and procurement regulations pertaining to Government property in possession of contractors.

Individual contracts, including related agreements and understandings, together with procurement regulations, establish the requirements for control of Government property in the possession of contractors. The contractor is directly responsible and accountable for all Government property. Under these provisions, the contractor must:

(a) Establish a system to control, protect, preserve, and maintain Government property in his possession. This system must be reviewed and, if satisfactory, approved by an industrial property management specialist designated as a property administrator.

(b) Maintain and make available required property records and account for Government-provided property. Liability for loss, damage, or excess use of property in a given instance depends upon the circumstances surrounding the particular case and must be determined by the industrial property management specialist.

(c) Require subcontractors who are provided Government property to comply with the provisions of the contract and regulations.

2. Types of Government provided property

Government property is all property owned by or leased to the Government or acquired by the Government under the terms of a contract. Government-provided property includes both Government-furnished property and property acquired by the contractor for the performance of a contract.

Types of Government-provided property include:

! material

! special tooling

! test

! military property

! industrial plant equipment

! plant equipment other than industrial plant equipment

! real property

! scrap and salvage

U.S. Office of Personnel Management 3

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

Each type of property normally requires distinctly different methods for management and control.

3. Property control systems

A property control system is a method of management and control of Government property within a contractor's organization from acquisition through disposition. The property control system generally includes written procedures, records, and physical control (in some cases financial management control) of the different types of property.

It is possible, in large industrial organizations, for more than one property control system

to exist. Each system is separate and distinct from the standpoint of organizational management and supervision, as well as functional and geographical characteristics.

4. Disposition (plant clearance)

Plant clearance includes responsibility, in accordance with the terms of the contract, for disposition of Government-provided contractor inventory remaining in the contractor's plant after change, completion, or termination of a contract. Included are all actions related to the screening, redistribution and disposal of contractor inventory from the contractor's plant or worksite.

Contractor inventory includes:

-- any property acquired by and in the possession of a contractor or subcontractor (including Government-furnished property) under a contract pursuant to the terms of which title is vested in the Government, and in excess of the amounts needed to complete full performance under the entire contract; and

-- any property which the Government is obligated to or has an option to take over under any type of contract as a result either of any changes in the specifications or plans thereunder or of the termination of such contract for subcontract thereunder) prior to completion of the work, for the convenience or at the option of the Government.

TITLES

The approved titles for positions covered by the GS-1103 standard are:

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST

(For nonsupervisory positions concerned primarily with control of Government property in possession of contractors from acquisition through disposition. Some positions may also include responsibility for plant clearance functions. See part I of this standard for additional information.)

U.S. Office of Personnel Management 4

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

INDUSTRIAL PROPERTY CLEARANCE SPECIALIST

(For nonsupervisory positions primarily concerned with the disposal of contractor inventory from a contractor's plant. See part II of this standard for additional information.)

SUPERVISORY INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST and SUPERVISORY INDUSTRIAL PROPERTY CLEARANCE SPECIALIST

(For supervisory positions covered by the General Schedule Supervisory Guide.)

INDUSTRIAL PROPERTY MANAGEMENT OFFICER

INDUSTRIAL PROPERTY CLEARANCE OFFICER

(For managerial positions which exceed Part II of the Supervisory Grade-Evaluation Guide.)

PART I - INDUSTRIAL PROPERTY MANAGEMENT

SPECIALIST POSITIONS

NATURE OF INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST POSITIONS

Industrial property management specialists are concerned with (a) field operations; and (b) staff and program responsibilities.

Field operations positions include:

a. Industrial property management specialists who perform a range of industrial property administration functions over an assigned contract or group of contracts involving property management by one or more contractors. Incumbents of these positions are not responsible for the overall property administration function.

b. Industrial property management specialists who are designated as "Property Administrators" to act as the Government representative in matters pertaining to the administration of the contractor's management and control of Government property. The property administrator has full responsibility for planning and executing the total property management program for all assigned contracts within a specified area or location. He may serve as a resident or nonresident property administrator.

Staff or program positions are concerned with developing, preparing, interpreting, or administering and evaluating programs, methods, techniques and practices relating to control of Government property in possession of contractors.

U.S. Office of Personnel Management 5

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

GRADE-LEVEL COVERAGE

Grade-level criteria in this Standard are directly applicable to nonsupervisory field operations positions of industrial property management specialist in grades GS-5 through GS-12. The absence of criteria for positions above GS-12 does not preclude the evaluation of individual positions in a higher level. For GS-13, the nature of the assignment and the level of responsibility must clearly exceed, in important features, the grade-level characteristics described at GS-12.

Omission of the even grade levels (GS-6, GS-8, or GS-10) does not preclude their use when the duties and responsibilities of a position warrant such classification.

Grade-level criteria in this standard are not directly applicable to staff positions. Staff positions should be established at a grade level commensurate with the level and scope of work performed, and comparable with staff positions in other occupations of like complexity.

CLASSIFICATION FACTORS

Classification criteria for industrial property management specialist positions are described in terms of (a) Nature of Assignments and (b) Level of responsibility.

A. Nature of Assignments

This factor reflects the scope and difficulty of assignments; and the nature and purpose of personal contacts. Work assignments range from single tasks performed in sequence for training purposes to full responsibility for highly complex property control systems.

For positions not designated as "property administrator," grade-level criteria include consideration of the range and difficulty of property administration functions performed, the amount and types of Government-provided property to be controlled, and complexity of the contractor's property control system.

Complexity of the contractor's property control system has a significant impact on the scope and difficulty of the "property administrator" positions. Grade-level criteria at GS-9, 11, and 12 describe characteristics which influence the complexity of a contractor's property control system, and the corresponding effect on the property administrator's assignment. The grade-level criteria include a consideration of:

1. The diversity, variety, and complexity of the contractor's organization rind operations.

-- This feature is considered significant because the property administrator must have a sufficient knowledge of the contractor's operations (including manufacturing methods, materials and processes, organization, management, etc.)

U.S. Office of Personnel Management 6

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

to understand the role of each organizational element or function and its relationship to others in the total property control system.

2. The amount and types of Government property provided the contractor.

-- Each type of property requires distinctly different methods for management. The differences normally relate to processes of acquiring, receiving, recording, protecting, maintaining, using, and disposing of the property. The need to control different types of Government property involved influences the complexity of the property control system and has a direct bearing upon the scope and difficulty of the assignment and the knowledge and abilities required of the property administrator.

3. The difficulty of property administration problems resulting from contractual provisions.

-- This element deals with the extent to which special or unique contractual provisions must be considered in controlling Government property, and the extent to which guidelines and precedents have been established for these situations.

B. Level of Responsibility

This factor reflects the degree of supervision received; the nature of available guidelines; and the nature and complexity of decisions and recommendations. With respect to these elements, positions in this occupation range from training assignments performed under close, step-by-step supervision, to assignments at full working levels that involve independent work, including authority to reach decisions on the adequacy of the contractor's property control system.

The level of knowledge and ability required in property administration work is not discussed separately at each grade level, but is included implicitly in the other classification factors. The degree of knowledge and ability required becomes increasingly greater at each higher grade level.

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-05

This is an entrance or training level. The GS-5 industrial property management specialist receives orientation, formal training, and on-the-job training to acquaint him with the range of duties involved in control of Government property in possession of contractors.

Assignments normally involve standardized and repetitive portions of industrial property functions, performed under specific, detailed instructions. A GS-5 industrial property management specialist typically assists a specialist of higher grade, e.g., by performing routine but increasingly difficult tasks required in the control of Government property.

Personal contacts at this level are primarily to obtain or give factual information needed for routine examination or verification of records.

Level of Responsibility

U.S. Office of Personnel Management 7

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

Work at the GS-5 level is performed under close technical guidance of a higher-grade specialist, or under specific instructions or directly applicable regulations and procedures. Work is reviewed in progress or upon completion of a specific phase for accuracy, completeness, and compliance with instructions, regulations, and procedures and to assess the trainee's potential for more difficult and responsible work at higher grade levels.

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-07 Nature of Assignments

The GS-7 industrial property management specialist typically performs portions of a broader assignment which is the responsibility of an industrial property management specialist of higher grade. He receives on-the-job and formal training to develop a thorough understanding of business management, statistical sampling, and automatic data processing techniques related to management of property control systems.

By comparison with the GS-5 specialist who performs routine tasks under detailed supervision, the GS-7 specialist typically performs assignments such as the following:

-- Surveys assigned portions of a contractor's property control system, or performs other related work, which is limited in terms of the variety of types of property involved or in the complexity of the property control system;

-- Under close technical guidance of a higher grade specialist performs designated portions of system surveys, or other related work, when a greater variety of types of property and a relatively complex property control system are involved.

Typical duties of the GS-7 specialist include, for example:

-- Gathering information and selecting units to be examined in a survey sample.

-- Performing detailed examinations to determine whether contractor records pertaining to Government property are being maintained properly according to the approved property control system.

-- Conducting selective examinations to get information regarding Government property, such as: the reasonableness of consumption, authorized usage, proper storage and identification, proper control of scrap, physical maintenance of equipment, and proper disposition of excess property.

-- Gathering factual information about the circumstances surrounding the loss, damage, or destruction of Government property resulting from contractor operations.

The GS-7 specialist confers with contractor personnel to obtain factual information; to explain and urge correction of clear-cut deficiencies found during system surveys; and to explain

U.S. Office of Personnel Management 8

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

regulations and procedures regarding industrial property administration. He also confers with production, quality assurance, engineering, and other personnel within the agency to ascertain that the Government property is being maintained and used as authorized.

Level of Responsibility

An industrial property management specialist of higher grade makes specific assignments and gives instructions concerning the work to be performed, such as the data to be gathered and the general approach to be used in surveying assigned portions of a contractor's property control system. The supervisor makes spot checks of the work of the GS-7 specialist and is available to

discuss problems which arise during assignments. The supervisor or a higher grade specialist reviews completed work products for conformance with instructions, analytical development, technical accuracy, and validity of recommendations. The supervisor also assesses the GS-7 specialist's ability to take on more complex and responsible work. The GS-7 specialist follows specific guides and precedents. These include contracts and related documents, portions of the procurement regulations, and office instructions.

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-09 Nature of Assignments

GS-9 positions include one or both of the following types of assignments:

I. GS-9 industrial property management specialists who are NOT designated as a "property administrator" perform system surveys, designated portions of system surveys, or other related industrial property functions. These GS-9 work assignments exceed the GS-7 level:

(1) in the complexity of the property control systems and types of Government property involved; and (2) in the broader range and difficulty of property administration duties performed.

The GS-9 specialist performs duties related to complex or highly complex property control systems for which a higher grade property administrator has full responsibility. For example, the specialist:

A. Surveys all categories of the contractor's property control system, or designated portions assigned to him. Categories surveyed include, but are not limited to, the system and procedures for acquiring, receiving, recording, storing, moving, consuming, using, maintaining, taking inventories, and disposing of property.

In conducting the survey, the GS-9 specialist performs such duties as:

-- reviewing the contractor's policy, procedures, and instructions;

-- developing flow process data to identify critical processes within the contractor's system;

U.S. Office of Personnel Management 9

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

-- applying statistical sampling techniques to obtain and validate data;

-- determining adequacy of assigned category, identifying uneconomical or inefficient procedures or practices;

-- conferring with contractor personnel to urge correction of noted deficiencies or improvements in the property control system; and

-- developing and submitting to superior a fully documented report covering all survey procedures, findings, and recommended actions.

B. Performs other analytical studies such as:

-- analyzing contractor's procurement to determine reasonable requirements, use and consumption of Government property;

-- examining cases of loss, damage, or destruction of Government property and inventory adjustments, and preparing written findings for the property administrator with recommendations for determination of liability against contractor;

-- determining whether the contractor is using Government property for the purposes authorized by the contract, and whether the contractor is exercising the appropriate degree of care in handling and maintaining Government property;

-- at completion of contract, assuring that all Government property provided under the contract has been accounted for and there are no unresolved questions as to contractor liability.

C. Reviews adequacy of contractor's proposals to modernize property control systems and makes appropriate recommendations to the property administrator. This may include, for example, advising the contractor on acceptability of automated property procedures for record accumulation and retention or inventory controls, electronic data transmission equipment, or other automated property accounting methods.

II. GS-9 specialists who are designated as a' "PROPERTY ADMINISTRATOR." -- These positions exceed the GS-7 level in that they have full responsibility for maintaining surveillance and control over the contractor's management of Government property under a simplified or less complex property control system. The GS-9 specialists typically serve as a nonresident property administrator, with responsibility for an assigned group of contracts involving management of Government property in possession of a number of contractors.

"SIMPLIFIED OR LESS COMPLEX PROPERTY CONTROL SYSTEMS" are usually found when the following characteristics are present:

(1) AMOUNT AND TYPES OF GOVERNMENT PROPERTY CONTROLLED:

! Limited to substantial amounts (e.g., a few to several hundred line items).

! One or several types of property are controlled (e.g., plant equipment or special tooling) under similar methods and procedures.

U.S. Office of Personnel Management 10

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

! Property is stable, nonconsumable, and can be readily identified, segregated, and inventoried

(2) NATURE OF CONTRACTOR OPERATIONS FOR WHICH PROPERTY IS USED:

! Property is used for a narrow or limited range of operations, for example: fabrication, production, or assembly of simple end items, kits, or spare parts.

! The contractor's control of property is typically centralized, with few subordinate or branch accounting records.

! The contractor's activities from acquisition through disposition can be readily reviewed through available records and physical observation.

(3) CONTRACTUAL PROVISIONS:

! Contracts include few or no unique provisions or requiring special control of Government property.

! Guidelines or precedents are usually available for problems encountered.

Functions of a property administrator include, but are not limited to, the following duties and responsibilities:

-- Assisting and directing negotiations with contractors in the establishment of adequate industrial property control systems.

-- Evaluating, and approving or disapproving, contractor's policy, procedures and techniques, and changes thereto, pertaining to management of Government property.

-- Developing, planning, scheduling, or performing system surveys to analyze, test and evaluate the contractor's system for Government property management.

-- Maintaining surveillance over the contractor's property management system to assure that the contractor meets the requirements and obligations of each assigned contract.

-- Disclosing and evaluating conditions of loss, damage, or destruction of Government property, and determining contractor's liability.

-- Evaluating inventory adjustments and approving those determined to be reasonable.

-- Taking other actions with regard to Government property necessary to protect the Government's interest.

-- Resolving property administration questions as necessary with the contractor's management personnel, Government procurement, logistic, and audit agencies, and other concerned Government departments and agencies.

In personal contracts with contractors and other Government agencies and officials, the GS-9 specialist has more authority than the GS-7 specialist to negotiate solutions to problems and reach agreement on matters under discussion. The GS-9 specialist has numerous contacts with contractor personnel to exchange factual data, to secure the contractor's cooperation in correcting deficiencies in the property control system, and to examine and justify the contractor's property

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

control procedures and operations. He coordinates property administration matters with specialists in related fields, such as production specialist, quality control representatives, contracting officers, and other personnel of the concerned Government department or agency.

Level of Responsibility

The GS-9 industrial property management specialist works under the technical supervision of a higher grade industrial property management specialist or supervisor. Unlike the GS-7 specialist, whose work is reviewed as he completes each phase, the work assignments, objectives and methods of accomplishment are usually prescribed for the GS-9 specialist, but are seldom reviewed or controlled while his work is in progress. Guidelines include relevant portions of assigned contracts, procurement regulations, and agency regulations and instructions.

The GS-9 specialist not designated as a property administrator typically works with a greater degree of independence than the GS-7 specialist in performing system surveys and other industrial property duties. Based on his review of survey findings, he is responsible for making an initial decision in the form of a recommendation to the property administrator that the contractor is complying with contractual and agency requirements related to control of Government property.

The GS-9 specialist who serves as a property administrator has responsibility, not delegated to a GS-7 specialist, for planning and accomplishing the property administration functions for contracts or contractor organizations assigned. He approves or disapproves the initial and continuing adequacy of the contractor's property control system. He makes final decisions, on a day-to-day basis, that records, consumption, use, maintenance, etc., of Government property are within the terms of contractual provisions and agency requirements. His completed work is reviewed by supervisory personnel for effectiveness of results obtained and for soundness of judgment. This is accomplished through review of reports, records, and correspondence, or through periodic plant visits.

The GS-9 specialist keeps the supervisor informed of problems in resolving differences with the contractor, and persistent lack of corrective action by the contractor or subcontractors, or unusual or controversial problems.

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-11 Nature of Assignments

Most GS-11 industrial property management specialists serve us a resident or nonresident "PROPERTY ADMINISTRATOR" with full responsibility for the property management program within a specified area or location. Assignments exceed those described at the GS-9 level in that the GS-11 property administrator has responsibility for surveillance and control of the contractor's management of large amounts of Government property (e.g., thousands of line

U.S. Office of Personnel Management 12

Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

items) under a more complex property control system. At GS-11, Government property is more difficult to control because:

-- varied types of property are controlled, with each type subject to different control methods and procedures;

-- the property and property records are maintained in various divisions and organizations dispersed throughout the plant and must be coordinated;

-- problems associated with identification, use, maintenance, and disposition are encountered;

-- contracts include unique or special property provisions requiring the use of experienced judgment in applying established guidelines.

By contrast, the GS-9 property administrator has responsibility for surveillance and control of Government property in possession of a number of contractors with simplified property control systems. At GS-9, Government property is less difficult to control because the more limited amounts or types of property can be controlled under similar methods and procedures. The Government property is stable, nonconsumable, and can be readily identified, segregated, and inventoried. The contractor's acquisition through disposition can be readily reviewed through available records and physical observation. Contracts include few or no unique property provisions.

Other GS-11 specialists serve as a full assistant to a GS-12 property administrator, or perform assignments as described at the GS- 12 level but with more limited responsibility. These GS-11 specialists are not designated as a property administrator, and final determinations and signatory authority are reserved for the designated property administrator.

Characteristic features of resident and nonresident GS-11 property administrators are described below.

A. RESIDENT PROPERTY ADMINISTRATORS at GS-11 have full responsibility for maintaining control over a large amount of Government property where the contractor has a COMPLEX PROPERTY CONTROL SYSTEM, including the following characteristics:

(1) AMOUNT AND TYPES OF GOVERNMENT PROPERTY CONTROLLED:

! Large amounts (e.g., thousands of line items) of Government-provided property are controlled.

! Substantial quantities in each of four or five different types of property are controlled, with each type requiring distinctly different methods for management and control. Types of property include: material; real property; special tooling; special test equipment, industrial plant equipment; other plant equipment, military property; or scrap and salvage.

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

! Property is difficult to control, for example:

-- consumable materials for work in process are difficult to control because of their movable nature; the changes made during production, manufacture, or research processes; the ease of diversion or loss; and the difficulty of taking inventory;

-- other types of property are difficult to control because of problems associated with identification, use, maintenance and disposition (e.g., property is altered during use, or is attached to another piece of equipment, or is subject to spoilage, shrinkage, loss, etc.).

(2) NATURE OF CONTRACTOR OPERATIONS' FOR WHICH PROPERTY IS USED:

! The property is used in diversified industrial operations, or the property is used to produce complex or varied items. Examples may include:

-- research, development, testing, and production of components and parts;

-- manufacture and/or overhaul and repair of complex equipment, such as aircraft, rocket, or missile engines;

-- logistical or supply support services provided for the testing, maintenance, overhaul and/or repair of equipment systems or subsystems.

! The contractor's property control records are maintained in various divisions or organizations dispersed throughout the plant, and must be properly coordinated.

! The contractor's acquisition through disposition of Government property requires an understanding of diversified industrial operations and the different inventory control, purchasing, maintenance, and other methods used to control Government property scattered throughout the plant.

(3) CONTRACTUAL PROVISIONS:

! Terms of contracts include some unique and special property provisions which present difficult property administration problems requiring the use of experienced judgment in the application of guidelines, for example:

-- in the approval of commingling of contractor-owned and Government-owned property;

-- in determining the propriety and reasonableness of the contractor's expenditures for materials and components;

-- in assuring that equipment fabricated from contractor-owned materials is recorded as Government property under the contract for which it was fabricated at the time title passes to the Government.

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

B. NONRESIDENT PROPERTY ADMINISTRATORS at GS-11 have full responsibility for surveillance and control over Government property in a number of contractor plants or specific areas, including in some cases areas outside of the United States. The total assignment includes responsibility for control by the contractors of a large amount of Government property, and may include items in all or most types of Government property. The property control systems in the plants range from "simple" (as described at GS-9) to "complex" (as described above at GS-11).

The complexity and difficulty of the nonresident property administrator's assignments, in total, are comparable to those cited above for a GS-11 resident property administrator. However, all elements of a complex property control system as described above may not be present in any one plant.

By comparison with the GS-11 resident property administrator, the nonresident property administrator typically: (1) may be concerned with control of a lesser amount or variety of types of Government property in any one plant, but he encounters property which is difficult to control and different methods for controlling property from plant to plant; (2) he must understand a diversity of industrial operations; and (3) he must use judgment in interpreting unique or special contract provisions relating to control of Government property.

Personal Contacts: By comparison with the GS-9 property administrator whose contacts deal with the less difficult property control problems, the GS-11 property administrator deals with a variety of top officials of contractor firms on more complex property control program matters with greater potential impact on the contractor's diversified operations. For example, the GS-11 property administrator has personal contacts with:

-- The contractor's top, management and key officials to assure understanding of industrial property management programs, regulations, and contractual requirements; to approve or negotiate changes in the contractor's complex property control system; and to resolve significant problems of noncompliance with the approved property control procedures.

-- The contractor's personnel in financial and property accounting, production, transportation, supply, data processing, and other organizational elements concerned with the control of Government property. These contacts are made to gather information needed to ascertain adequacy of the contractor's property control system and procedures, to exchange factual information, to assist the contractor in maintaining an adequate property control system, to advise contractor personnel regarding unsatisfactory conditions, and to secure corrective action.

-- Other Government representatives, such as production specialists, quality control representatives, contracting officers, audit personnel, etc. These contacts are to coordinate property administration matters, or to clarify or secure information needed to make sound property management determinations.

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

Level of Responsibility

The GS-11 resident property administrator typically receives general administrative supervision at the plant level from a supervisor with broad responsibilities for contract administration, and technical supervision from staff or supervisory industrial property specialists at a regional or district headquarters. The GS-11 nonresident property administrator typically works under the technical supervision of a higher grade industrial property management specialist or supervisor located in a district or field office. In either case, work assignments and objectives are prescribed, but methods of accomplishment are seldom reviewed or controlled while work is in progress.

The GS-11 property administrator has full authority and responsibility for developing plans and accomplishing the total property control program for the assigned contractors. His responsibility exceeds that of a GS-9 property administrator in that:

-- independently he makes decisions to 'approve or disapprove the initial and continuing adequacy of more complex property control systems; and

-- he has greater authority than the GS-9 property administrator in management of the contractor's property control system.

The GS-11 property administrator keeps the supervisor informed on differences with the contractor that he is unable to resolve, or any persistent lack of corrective action by the contractor or subcontractors, and on unusual or unduly complex problems.

The GS-11 specialist who is not a property administrator works with a greater degree of independence than the GS-9 specialist. Final approval, determinations, and signatory authority, however, are reserved for the designated property administrator.

INDUSTRIAL PROPERTY MANAGEMENT SPECIALIST, GS-1103-12 Nature of Assignments

GS-12 industrial property management specialists typically serve as a resident or nonresident "property administrator." Assignments exceed those described at GS-11 primarily in that:

-- Larger amounts and greater varieties of Government property must be controlled. The greater variety and dissimilarity of the materials, equipment, and facilities involved result in an increase in the difficulty of the problems associated with identification, use, maintenance, and disposition of the property.

-- Contractor's control of Government property is diffused among different organizational components. The diversity and complexity of the contractor's operations require a variety of different automated or manual control techniques,

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

procedures, and forms to meet the specific needs of numerous divisions, plant subdivisions, and plant facilities serviced.

-- There is a continuing need to resolve difficult property administration problems relating to unique or special property provisions for which there are no established guidelines or precedents.

Additionally, the scope and complexity of the work assigned at the GS-12 level is such that the GS-12 property administrator typically has some responsibility for the work of lower grade industrial property management specialists. This may include acting as a working leader with responsibility for training, assigning and reviewing the work of a few lower grade specialists. The specialists may be assigned to work with the property administrator on a full-time basis, or may be assigned at periodic intervals to perform designated portions of a systems survey or other related property work for which the GS-12 property administrator is responsible. (NOTE: Positions with supervisory responsibilities exceeding those described here should be evaluated by reference to the General Schedule Supervisory Guide.

Characteristic features of GS-12 assignments are described below:

A. RESIDENT PROPERTY ADMINISTRATORS at GS-12 have full responsibility for maintaining control over a very large amount of Government property where the contractor has a "HIGHLY COMPLEX PROPERTY CONTROL SYSTEM." A highly complex property control system is usually encountered when all of the following characteristics are present:

(1) AMOUNT AND TYPES OF GOVERNMENT PROPERTY CONTROLLED:

! Very large amounts (e.g., tens of thousands of line items) of Government-provided property are controlled. These include:

-- a large amount of consumable materials for work in process; and

-- at least substantial quantities in most of the seven remaining types of property, with each type requiring distinctly different methods for management and control. (Types of property include special tooling; special test equipment; industrial plant equipment; other plant equipment; military property; real property; and salvage and scrap.)

By contrast, the GS-11 property administrator is responsible for control of a large amount (e.g., thousands of line items) of Government property in a plant, including substantial amount in each of four or five different types of property. Government property is more difficult to control than at the GS-11 level because:

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

-- more types of Government property result in a much greater diversity of methods and procedures for controlling property from acquisition through disposition; and

-- the greater variety and dissimilarity of the materials, equipment, and facilities involved result in an increase in the difficulty of problems associated with the identification, use, maintenance, and disposition of the property.

(2) NATURE OF CONTRACTOR OPERATIONS FOR WHICH PROPERTY IS USED:

! The Government property is used for business and industrial operations that are more complex than at GS-11 because of the greater diversity of operations and the greater variety or complexity of items produced. Examples include property control connected with such complex activities as:

-- the research, development, testing, and manufacture of space, aircraft, weapons or other equipment systems or subsystems (by contrast, the GS-11 property administrator controls Government property used for research, development, testing, and manufacture of components or parts); or

-- production and/or overhaul and maintenance of different kinds of equipment systems, subsystems, or specialized products requiring diverse manufacturing processes and plant operations which encompass more than one major commodity or industrial activity, such as the manufacture of several products through complicated chemical processes, plus the fabrication of a variety of other specialized items from numerous parts or components which are Government-furnished, Contractor-acquired, and contractor-fabricated. (By contrast, the GS-11 property administrator is responsible for a property control system used for the production and/or overhaul of similar kinds of systems, subsystems, or complex equipment.)

! Complexity of the GS-12 property administrator's assignment in a plant with such multiple and diverse operations is inherently greater than at the GS-11 level because:

-- the contractor's control of Government property is diffused among many different organizational components or departments;

-- property control under such conditions requires an understanding of (a) the organization, production facilities, and processes of these diverse operations; (b) the general and complex machinery, tools, materials, and other property that are used; and (c) the variety of different automated or manual control techniques, procedures, and

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

forms required to meet the specific needs of numerous divisions, plant subdivisions, plant facilities located in outlying areas, and/or subcontractor operations.

(3) CONTRACTUAL PROVISIONS:

! The contractor's property control system is designed to meet the terms of:

-- numerous contracts which include complex property clauses (e.g., unique or special property provisions included in cost reimbursement, cost-plus-fixed-fee, overhaul and maintenance, fixed-price incentive, or other contracts which present property administration problems); or

-- a continuing major contract, with numerous supplements, which presents many difficult property administration problems (e.g., a contract for contractor operation of a large Government-owned plant to produce different kinds of specialized products requiring diverse manufacturing processes).

! By contrast with the GS-11 property administrator who must use experienced judgment in the application of established guidelines or precedents, the GS-12 property administrator is confronted with property administration problems for which there are no established guidelines or precedents. These problems arise because of the research nature or state-of-the-art complexity of the end product, or from the diversity and complexity of the contractor's operations.

B. NONRESIDENT PROPERTY ADMINISTRATORS at the GS-12 level encounter property control systems in the plants under their surveillance which range in difficulty from "COMPLEX" (as described for a resident property administrator at the GS-11 level) to "HIGHLY COMPLEX" (as described above at GS-12).

The total assignment of a GS-12 nonresident property administrator is comparable in complexity and difficulty to that described for a GS-12 resident property administrator. However, all elements of a highly complex property control system need not be present in one plant. These GS-12 assignments require:

! Control over a very large amount and most types of Government property. A diversity of methods and procedures for controlling dissimilar materials, equipment, and facilities is encountered in the plants under his surveillance.

! Knowledge and understanding of different kinds of diverse and complex industrial and business operations, including a variety of different

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

automated or manual control techniques, procedures and forms to meet the specific needs of the plants under his surveillance.

! A continuing need to resolve difficult property administration problems for which there are no established guidelines or precedents.

Personal Contacts: At the GS-12 level, personal work contacts with top contractor personnel (corporate management) are of extreme importance in achieving acceptance of new property management programs or changes to programs of large scope with substantial impact on the contractor's operations. The other personal contacts of the GS-12 property administrator are similar in nature and purpose to those described at GS-11. Contacts at the GS-12 level exceed those at GS-11 in difficulty primarily because of the broader scope and diversity of the contractor's operations, the complexity of property administration problems, and the greater amount and variety of Government property involved.

Level of Responsibility

GS-12 property administrators work under the same type of supervisory controls as described at the GS-11 level. The essential difference between GS-11 and GS-12 positions is the greater scope and complexity of assignments at the GS-12 level.

PART II-INDUSTRIAL PROPERTY CLEARANCE SPECIALIST

POSITIONS

NATURE OF INDUSTRIAL PROPERTY CLEARANCE SPECIALIST

POSITIONS

Field operations positions include responsibility, in accordance with the terms of the contract, for disposition of Government-provided contractor inventory remaining in the contractor's plant after change, completion, or termination of a contract. Subject to the Government exercising its rights to require delivery of any items of contractor inventory to satisfy known Government requirements, contractor inventory is disposed of by the following methods:

1. purchase or retention, by prime contractor or subcontractor, of contractor-acquired property at cost;

2. return of contractor-acquired property to suppliers;

3. utilization within the Government (through application of prescribed screening procedures);

4. donation to eligible donees;

5. sale (including purchase or retention at less than cost by the prime contractor or subcontractor);

6. donation to public bodies in lieu of abandonment; or

7. abandonment or destruction.

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Industrial Property Management Series, GS-1103 TS-81 August 1969, TS-1 June 1970

Included also under part II are staff or program positions concerned with developing, preparing, interpreting, or administering and evaluating programs, methods, techniques and practices relating to disposition (plant clearance) of Government-provided contractor inventory remaining in the contractor's plant after change, completion, or termination of a contract.

Industrial property clearance specialists must follow certain of the Government regulations and procedures for screening, sale, or disposal of contractor inventory. Knowledge, skills, and abilities to perform these functions are similar to those contained in the Property Disposal occupation, GS-1104. Positions classifiable to the GS-1103 occupation primarily require in addition knowledge of and ability: (a) to apply contract provisions pertaining to Government-provided property in possession of contractors; (b) to evaluate the adequacy of the contractor's procedure, for effecting property disposal actions; and 8 to monitor the contractor's disposition of excess or surplus property.

NOTES TO USERS OF THE STANDARD: Direct application of the criteria contained in Part I of this standard is not intended in classifying plant clearance positions under part II because of the difference in job content. Until classification standards are issued for part II, it is suggested that grade levels for Industrial Plant Clearance Specialist positions be determined by comparison with published standards which are appropriate for the specific duties being performed. Thus:

1. Compare work performed in the actual utilization, redistribution, donation, sale or other disposal of excess or surplus personal property with standards for the Property Disposal Series, GS-1104;

2. Compare work performed in applying contract provisions, in evaluating the adequacy of the contractor's procedures for effecting property disposal, or in monitoring the disposition of excess or surplus property with part I of this standard. Consider, for example, knowledge required of the property or of plant operations, nature and extent of personal contacts with contractor personnel, etc.

U.S. Office of Personnel Management 21

Contract Manufacturing

Arrangements for Drugs:

Quality Agreements

Guidance for Industry

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Center for Veterinary Medicine (CVM)

November 2016

Pharmaceutical Quality/Manufacturing Standards (CGMP)

Contract Manufacturing

Arrangements for Drugs :

Quality Agreements

Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

10001 New Hampshire Ave., Hillandale Bldg., 4th Floor

Silver Spring, MD 20993-0002

Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353

Email: druginfo@fda.hhs.gov

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

and/or

Office of Communication, Outreach and Development

Center for Biologics Evaluation and Research

Food and Drug Administration

10903 New Hampshire Ave., Bldg. 71, Room 3128

Silver Spring, MD 20993-0002

Phone: 800-835-4709 or 240-402-8010

Email: ocod@fda.hhs.gov

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

and/or

Policy and Regulations Staff, HFV-6

Center for Veterinary Medicine

Food and Drug Administration

7519 Standish Place, Rockville, MD 20855

http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Center for Veterinary Medicine (CVM)

November 2016

Pharmaceutical Quality/Manufacturing Standards (CGMP)

Contains Nonbinding Recommendations

TABLE OF CONTENTS

I. INTRODUCTION 1

II. DEFINING THE WHO AND WHAT OF CONTRACT MANUFACTURING 2

III. RESPONSIBILITIES OF PARTIES INVOLVED IN CONTRACT

MANUFACTURING 3

IV. DOCUMENTING CGMP ACTIVITIES IN QUALITY AGREEMENTS 5

A. What Is a Quality Agreement? 6

B. Elements of a Quality Agreement 6

1. Manufacturing Activities 7

2. Change Control Associated With Manufacturing Activities 10

V. ILLUSTRATIVE SCENARIOS 11

A. Owners and Contract Facilities Are Both Responsible for CGMP 11

B. CGMPs Apply to all Contract Facilities, Including Analytical Testing Laboratories 12

C. Owners and Contract Facilities Perform Change Control Activities 13

VI. RECOMMENDATIONS 13

Contains Nonbinding Recommendations

Contract Manufacturing Arrangements for Drugs:

Quality Agreements

Guidance for Industry1

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on

this topic. It does not establish any rights for any person and is not binding on FDA or the public. You

can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.

I. INTRODUCTION

This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.

For purposes of this guidance, we use certain terms with the following specific meanings:

* Current Good Manufacturing Practice (CGMP) refers to requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 501(a)(2)(B), for all drugs and active pharmaceutical ingredients (APIs). For finished human and animal drugs, the term includes applicable requirements under 21 CFR parts 210 and 211. For biologics, the term includes additional applicable requirements under 21 CFR parts 600-680.

* Commercial manufacturing refers to manufacturing processes that result in a drug or drugs intended to be marketed, distributed, or sold.

* Commercial manufacturing does not include research and development activities, manufacturing of material for investigational new drug studies (e.g., clinical trials, expanded access), or manufacturing of material for veterinary investigational drugs. Although this guidance does not explicitly apply to the manufacture of investigational, developmental, or clinical trial materials, FDA believes that quality agreements can be extremely valuable in delineating the activities of all parties involved in contract research and development arrangements. Many of the principles described in this guidance could be applied in pre-commercial stages of the pharmaceutical life cycle.

1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.

Contains Nonbinding Recommendations

* Manufacturing includes processing, packing, holding, labeling operations, testing, and quality unit operations.

* A manufacturer is an entity that engages in CGMP activities, including implementation of oversight and controls over the manufacture of drugs to ensure quality.2

* Quality unit is defined as synonymous with the term quality control unit.3

This guidance covers commercial manufacturing of the following categories of drugs: human drugs, veterinary drugs, certain combination products, biological and biotechnology products, finished products, APIs, drug substances, in-process materials, and drug constituents of combination drug/device products.4 This guidance does not cover the following types of products: Type A medicated articles and medicated feed, medical devices, dietary supplements, or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of the Public Health Service Act and 21 CFR part 1271.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. DEFINING THE WHO AND WHAT OF CONTRACT MANUFACTURING

This guidance describes how contract manufacturing operations fit within the larger scheme of pharmaceutical quality systems. It also presents the Agency’s current thinking on the roles and manufacturing activities of the parties involved in contract manufacturing arrangements. Specifically, this guidance addresses the relationship between owners and contract facilities. For purposes of this guidance, we define owners as manufacturers of APIs, drug substances, in-process materials, finished drug products, including biological products, and combination products. The term owner does not apply to retail pharmacies, drug stores, supermarkets, discount warehouse stores, or other retailers who purchase finished drug products to sell over the counter as a store brand. For purposes of this guidance, we define contract facilities as parties that perform one or more manufacturing operations on behalf of an owner or owners.5

2 See section 501 of the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (Public Law 112-144, title VII, section 711).

3 For quality control unit, see 21 CFR 210.3.

4 Combination product manufacturers can apply this guidance to their quality agreements because they are subject to requirements under 21 CFR part 211 and/or 21 CFR part 820 (see 21 CFR 4.3). In addition to facilitating compliance with requirements under 21 CFR part 211, manufacturers can use quality agreements with contract facilities to demonstrate compliance, in part, with 21 CFR 820.50 (purchasing controls) and with 21 CFR 820.80(b) (receiving acceptance activities) for combination products.

5 A contract facility may also be an owner depending on its role (e.g., when the contract facility is using a subcontractor).

Contains Nonbinding Recommendations

Drug manufacturing encompasses many discrete operations and activities. One manufacturer may perform all operations and activities or may engage an outside party or parties to perform some or all of the operations and activities under contract. Contract facilities perform a variety of manufacturing operations and activities, including but not limited to:

* Formulation

* Fill and finish

* Chemical synthesis

* Cell culture and fermentation, including for biological products

* Analytical testing and other laboratory services

* Packaging and labeling

* Sterilization or terminal sterilization

However, agreements between owners and contract facilities sometimes do not clearly define the CGMP-related roles and manufacturing operations and activities of each of the parties. When all parties clearly understand their CGMP-related roles and manufacturing responsibilities, the owners who use contract facilities, contract facilities that provide services to owners, and, ultimately, patients who take the drugs manufactured under these arrangements may benefit in many ways. Contracting can enhance speed and efficiency, provide technological expertise, and expand capacity.

We encourage entities that engage in manufacturing related solely to drug distribution (e.g., distributors, brokers, private label distributors, own label distributors) to follow the recommendations in this guidance document, as appropriate. Our focus here, however, is on the roles and manufacturing activities of the owner and contract facility.

III. RESPONSIBILITIES OF PARTIES INVOLVED IN CONTRACT MANUFACTURING

Each party engaged in the manufacture of a drug is responsible for ensuring compliance with CGMP for the manufacturing activities it performs.6 For both owners and contract facilities that conduct manufacturing operations, CGMP “includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.”7 Drugs not manufactured in compliance with CGMP are adulterated.8

The FD&C Act also prohibits any person from introducing or delivering for introduction an adulterated or misbranded drug into interstate commerce.9 In addition, it prohibits anyone from the “doing of any ... act with respect to, a ... drug ... if such act is done while such article is held

6 Section 501(a)(2)(B) of the FD&C Act; 21 CFR parts 210 and 211; and 21 CFR part 600.

7Section 501 of the FD&C Act as amended by the Food and Drug Administration Safety and Innovation Act (Public

Law 112-144, Title VII, section 711).

8 Section 501(a)(2)(B) of the FD&C Act.

9 Section 301(a) of the FD&C Act.

Contains Nonbinding Recommendations

for sale ... after shipment in interstate commerce and results in such article being adulterated or misbranded.”10

FDA’s regulations recognize that owners commonly use contract facilities to perform some drug manufacturing activities.11 When an owner uses a contract facility, the owner’s quality unit is legally responsible for approving or rejecting drug products manufactured by the contract facility, including for final release.12 The regulations require that the quality unit’s responsibilities and procedures be in writing and that they be followed.13

Owners can use a comprehensive quality systems model to help ensure compliance with CGMP. A comprehensive quality systems model anticipates that many owners will use contract facilities and calls for quality agreements between owners and contract facilities. Quality agreements should clearly describe the materials or services to be provided, quality specifications, and communication mechanisms between the owner and contract facility. See guidance for industry Quality Systems Approach to Pharmaceutical CGMP Regulations.14

Owners and contract facilities can review FDA guidance documents for recommendations on achieving compliance with CGMP. Various FDA guidance documents describe how quality management principles relate to contract manufacturing operations, including some of the roles and manufacturing activities of contract manufacturing parties.15

The following three ICH guidances for industry contain relevant and valuable CGMP recommendations with respect to contract manufacturing arrangements:

* Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

* Q9 Quality Risk Management

* Q10 Pharmaceutical Quality System

ICH guidance for industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure that contractor sites comply with CGMP for specific operations.16 It also recommends that owners have approved written agreements with contractors that define the manufacturing responsibilities in detail, including the quality measures, of each party. The written agreements should also define considerations for subcontracting; describe how changes to processes, equipment, methods, and specifications will be managed; and permit the owner to audit its contractor’s facilities for compliance with CGMP.

10 Section 301(k) of the FD&C Act.

1121 CFR 200.10(b) and 211.22(a).

12 Ibid.

13 21 CFR 211.22(d).

14 We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

15 See, e.g., guidance for industry Cooperative Manufacturing Arrangements for Licensed Biologics.

16 In ICH Q7, the term company is used rather than owner and is used to refer to an API manufacturer.

Contains Nonbinding Recommendations

ICH guidance for industry Q9 Quality Risk Management offers a systematic approach to quality risk management as part of an effective quality system. It discusses quality risk management principles such as risk assessment, risk communication, and risk review and provides examples of tools that can be used to make effective and efficient risk-based decisions in, for example, auditing and arranging quality agreements with contract manufacturers.

ICH guidance for industry Q10 Pharmaceutical Quality System states that, as part of a pharmaceutical quality system, the owner is ultimately responsible for ensuring that “processes are in place to assure the control of outsourced activities and quality of purchased materials.”17 It indicates that these processes should incorporate quality risk management and include the following critical activities:

* Assessing the suitability and competence of potential contractors before outsourcing operations or selecting material suppliers. This could be accomplished through audits, material evaluations, or other qualification criteria.

* Defining the manufacturing responsibilities and communication processes for quality-related activities of the involved parties. For outsourced activities, these should be in a written agreement.

* Monitoring and reviewing the performance of the contract facility and identifying and implementing any needed improvements.

* Monitoring incoming ingredients and materials to ensure they are from approved sources using the agreed-upon supply chain.

FDA encourages parties engaged in contract manufacturing to implement quality management practices. This guidance is intended to build upon the quality risk management principles and recommendations outlined above and to illustrate key points in developing and executing quality agreements that describe and support contract manufacturing arrangements.

IV. DOCUMENTING CGMP ACTIVITIES IN QUALITY AGREEMENTS

If an owner employs a contract facility for all or part of the manufacturing (including processing, packing, holding, or testing) of a drug or drug product, the owner’s quality unit is responsible for approving or rejecting the contract facility’s product or service.18 The contract facility is also required to comply with statutory CGMP and applicable CGMP regulations, including requirements for its quality unit.19 CGMP regulations require that quality unit activities and procedures be in writing, and that these procedures be followed.20

Implementing a written quality agreement can facilitate compliance with CGMP and, in particular, with 21 CFR 211.22(d), which states that quality unit activities and procedures should be in writing. FDA recommends that owners and contract facilities establish a written quality agreement to describe their respective CGMP-related roles, responsibilities, and activities in drug

17 In ICH Q10, the term company is used rather than owner.

18 Section 501(a)(2)(B) of the FD&C Act; 21 CFR 211.22(a).

19 21 CFR 210.2(b); 21 CFR 211.22(a).

20 21 CFR 211.22(d).

Contains Nonbinding Recommendations

manufacturing. It is important to note that quality agreements cannot be used to delegate statutory or regulatory responsibilities to comply with CGMP. The following sections describe the Agency’s current thinking regarding the documentation of agreed-upon manufacturing activities in a quality agreement, as well as the basic elements of a quality agreement.

A. What Is a Quality Agreement?

A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with CGMP. In general, the quality agreement should clearly state which party —the owner or the contract facility or both —carries out specific CGMP activities. It should cover activities mentioned in section 501(a)(2)(B) of the FD&C Act and, as applicable, those in 21 CFR parts 210, 211, 600-680, 820, and 1271, as well as all other applicable statutory or regulatory requirements. Representatives from each party’s quality unit and other relevant stakeholders should participate actively in the drafting of quality agreements.

Quality agreements should not cover general business terms and conditions such as confidentiality, pricing or cost issues, delivery terms, or limits on liability or damages. FDA recommends that quality agreements be separate documents, or at least severable, from commercial contracts such as master services agreements or supply agreements. Quality agreements may be reviewed during inspections.21

B. Elements of a Quality Agreement

A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under CGMP. A well-written quality agreement will use clear language. It will define key manufacturing roles and responsibilities. It will establish expectations for communication, providing key contacts for both parties. It will specify which products and/or services the owner expects from the contract facility and who has final approval for various activities. Most quality agreements contain the following sections:

* Purpose/Scope —to cover the nature of the contract manufacturing services to be provided

* Definitions —to ensure that the owner and contract facility agree on precise meaning of terms in the quality agreement

* Resolution of disagreements —to explain how the parties will resolve disagreements about product quality issues or other problems

* Manufacturing activities —to document quality unit and other activities associated with manufacturing processes as well as control of changes to manufacturing processes

* Life cycle of, and revisions to, the quality agreement

The owner may consider including the contract facility’s established processes and procedures as part of the quality agreement (for example, by incorporating certain standard operating

21 See section 704 of the FD&C Act.

Contains Nonbinding Recommendations

procedures by reference). Doing so could reduce the risk of misinterpretation or error during manufacturing. The quality agreement should explain how the contractor will report manufacturing deviations to the owner, as well as how deviations will be investigated, documented, and resolved in compliance with CGMP. Quality agreements should state that manufacturing services provided by contract facilities (including laboratories) will comply with CGMP.

From a CGMP perspective, manufacturing activities are the most important element in a quality agreement. The most critical pieces are quality and change control, as described in the following sections.

1. Manufacturing Activities

Quality agreements may document each party’s roles and manufacturing activities with a variety of formats —charts, matrices, narratives, or a combination of these. Regardless of the format, a quality agreement should clearly document which party is responsible for specific activities. No party to a quality agreement may delegate any of its responsibilities to comply with CGMP through the quality agreement or any other means. The quality agreement should cover all of the activities for ensuring compliance with CGMP. Depending on the scope of the contract manufacturing services to be provided, the quality agreement should indicate whether the owner or contract facility (or both) will handle specific activities related to each of the following topics:

a. Quality unit activities

The section of a quality agreement that addresses each party’s quality unit activities should define in detail how the parties will work together to ensure that products are manufactured in compliance with CGMP. Note that assigning quality control or other activities to either the owner or contract facility in the quality agreement does not relieve either party from compliance with applicable CGMP requirements.

In particular, this section of the quality agreement should be clear with respect to product release. Contract facilities are responsible for approving or rejecting the product or results of their manufacturing operations (e.g., test results, finished dosage forms, or in-process materials).22 In addition, owners are responsible for approving or rejecting drugs manufactured by the contract facility,23 including for final release. In all cases, the owner must not introduce or deliver into interstate commerce, or cause to be introduced or delivered into interstate commerce, any drugs that are adulterated or misbranded.24

Within its quality unit activities, a quality agreement should describe how and when the owner and contract facility will communicate with each other, both verbally and in writing. This includes identifying appropriate contact personnel within the owner’s and contract facility’s organization.

22 21 CFR 211.22(a).

23 Section 501(a)(2)(B) of the FD&C Act; 21 CFR 211.22(a).

24 See section 301(a) of the FD&C Act.

Contains Nonbinding Recommendations

Quality agreements should also cover audits, inspections, and communication of findings. The agreement should allow owners to evaluate and audit contract facilities to ensure CGMP compliance for specific operations. This provision should cover both routine quality audits and for-cause audits. The agreement should also set owner and contract facility expectations regarding FDA inspections (pre-approval, routine surveillance, and for-cause) with consideration for the nature of the products to be manufactured and/or services to be provided. It should include the parties’ agreed-upon provisions for communicating inspection observations and findings, as well as relevant FDA actions and correspondence.

Because contract facilities often provide services to multiple owners, the quality agreement should address when, how, and what information the contractor will report to owners about objectionable conditions observed during inspections and audits of the contract facility.

b. Facilities and equipment

This section of a quality agreement should identify the specific site(s) where the contract facility will perform manufacturing operations, including the address of and specific services to be provided at each site. It should indicate which party will be validating processes and qualifying and maintaining equipment and applicable systems relevant to the contracted operations. These include information technology and automated control systems, environmental monitoring and room classification, utilities, and any other equipment and facilities that must be maintained to perform the contracted manufacturing operations in compliance with CGMP. The agreement also should identify which party will approve equipment validation, qualification, and maintenance activities. In addition, it should indicate how the parties will communicate information about preventing cross-contamination and maintaining traceability when a contract facility processes drugs for multiple owners.

c. Materials management

This section of a quality agreement should indicate which party will establish specifications for components as well as which party will establish processes for auditing, qualifying, and monitoring component suppliers. It should also identify which party will conduct required sampling and testing in compliance with CGMP. This section of the quality agreement should address how the parties will ensure appropriate inventory management, including labeling, label printing, inventory reconciliation, and product status identification (e.g., quarantine). The agreement should address how the contract facility will prevent mix-ups and cross-contamination. FDA does not expect the agreement to contain a complete description of the supply chain for each component. However, the agreement should define responsibility for physical control of materials at different points in the manufacturing process. For example, the quality agreement should cover responsibilities for proper conditions for storing and transporting or shipping materials. It should define each party’s roles in storage and transport —whether from the contract facility back to the owner or to another contract facility for further operations. This includes defining activities for monitoring or validating shipping conditions as appropriate.

Contains Nonbinding Recommendations

d. Product-specific considerations

A comprehensive quality agreement may address specific considerations related to individual products. The owner and contract facility might opt to include this information in an appendix, or directly in the body of the quality agreement. In either case, if included, this section of the quality agreement should include the parties’ expectations of each other regarding:

* Product/component specifications

* Defined manufacturing operations, including batch numbering processes

* Responsibilities for expiration/retest dating, storage and shipment, and lot disposition

* Responsibilities for process validation, including design, qualification, and ongoing verification and monitoring

* Provisions to allow owner personnel access to the contract facility when appropriate

The quality agreement also should indicate how owners will transfer knowledge, such as product and process development information, to contract facilities to ensure a drug can be manufactured in compliance with CGMP, and conversely how contract facilities should share with owners product quality information gained throughout the product life cycle. This applies to knowledge about all drugs, including drugs subject to an approved application (e.g., new drug application) and nonprescription drug products marketed under an over-the-counter drug monograph.

Owners that hold an approved drug application should be aware of application and approval requirements that could affect manufacturing activities. Both parties to a quality agreement should share relevant information to ensure compliance with CGMP and other applicable requirements of the FD&C Act.

e. Laboratory controls

The owner and contract facility should both have access to adequate laboratory facilities for testing of their drugs. A quality agreement will help each party meet this need by defining roles and responsibilities for laboratory controls. We recommend the following elements:

* Procedures delineating controls over sampling and testing samples

* Protocols and procedures for communicating all laboratory test results conducted by contract facilities to the owner for evaluation and consideration in final product disposition decisions

* Procedures to verify that both owner and contract facilities accurately transfer development, qualification, and validation methods when an owner uses a contract facility for laboratory testing

* Routine auditing procedures to ensure that a contract facility’s laboratory equipment is

qualified, calibrated, and maintained in a controlled state in accordance with CGMP

Contains Nonbinding Recommendations

* Designation of responsibility for investigating deviations, discrepancies, failures, out-of

specification results,25 and out-of-trend results in the laboratory, and for sharing reports

of such investigations

f. Documentation

The quality agreement should define expectations between the contract facility and the owner to review and approve documents. It also should describe how changes may be made to standard operating procedures, manufacturing records, specifications, laboratory records, validation documentation, investigation records, annual reports, and other documents related to products or services provided by the contract facility. The quality agreement should also define owners’ and contract facilities’ roles in making and maintaining original documents or true copies in accordance with CGMP. It should explain how those records will be made readily available for inspection.

The quality agreement also should indicate that electronic records will be stored in accordance with CGMP and will be immediately retrievable during the required record-keeping time frames established in applicable regulations.

2. Change Control Associated With Manufacturing Activities

Either an owner or a contract facility may initiate changes to processes, equipment, test methods, specifications, and other contractual requirements. Both parties should discuss changes and address them in the quality agreement. There are some changes that owners should review and approve before they are implemented and other changes contractors may implement without notifying the owner. How all changes are managed should be outlined in the agreement, including allocation of responsibilities for conducting validation activities as needed before implementing changes. Additionally, both parties should be aware of those changes that need to be submitted to FDA in a supplement or annual report. The owner and contract facility should carefully consider and agree on the types of changes to report to each other and to FDA and the need for approval from each party’s quality unit and FDA, as applicable. The quality agreement should address expectations for reporting and approving changes to the following:

* Components and/or their suppliers

* Establishment locations

* Manufacturing processes

* Products or product types that use the same production line, equipment train, or facility

* Testing procedures

* Major manufacturing equipment

* Shipping methods

* Lot numbering scheme

* Container closure systems

* Tamper evidence features

25 Refer to the guidance for industry Investigating Out-of Specification (OOS) Test Results for Pharmaceutical Production.

Contains Nonbinding Recommendations

? Product distribution

Various unexpected events, such as manufacturing deviations, complaints, product recalls, adverse event reports, master label changes, field alert reports, and biological product deviation reports, may necessitate changes to processes and procedures. Process improvement projects, process capability analyses, and trending reports may also necessitate changes to processes and procedures. The quality agreement should include the owner’s and contract facility’s expectations for reporting and communication in case of unexpected events and related changes.

V. ILLUSTRATIVE SCENARIOS

The following hypothetical scenarios illustrate common problems in contract manufacturing arrangements and depict ways in which both owners and contract facilities can affect product quality. These scenarios also demonstrate FDA’s current thinking regarding potential ways to resolve problems. The examples provided are not intended to encompass all drug manufacturing problems related to arrangements between owners and contract facilities. Rather, they provide industry and other stakeholders with patterns FDA investigators frequently encounter and analyses of the facts within these patterns.

A. Owners and Contract Facilities Are Both Responsible for CGMP

Case 1: Facilities and Equipment Maintenance and Upkeep at Contract Facility

An FDA inspection of a contract facility that manufactures an injectable drug product for an owner reveals significant objectionable conditions at the contract facility. Most of the objectionable conditions relate to deficient maintenance of facilities and equipment used to manufacture the injectable drug product.

Equipment is broken. Pipes are tarnished, and seals are leaking. In addition, the facility design does not adequately prevent contamination. A quality agreement between the contract facility and the owner states that the owner is responsible for upgrades and maintenance of the facilities and equipment used to manufacture the owner’s product. The owner has failed to provide upgrades and perform

maintenance, and the contract facility continues to manufacture the product under non-CGMP conditions with risk of contamination.

Case 2: Documenting Steps in the Manufacturing Process

A contract facility is manufacturing a prescription drug product for an owner. FDA has approved an application from the owner for this drug. On inspection, FDA observes that the contract facility’s batch records do not accurately reflect the actual manufacturing process because the batch records do not document the addition of reclaimed powder. Despite the fact that the batch records are inaccurate and are therefore not compliant with CGMP, the contract facility claims that its batch records comply with expectations set out in the quality agreement with the owner.

In the cases described above, the owners and contract facilities appear to be in violation of CGMP. A quality agreement cannot exempt owners or contract facilities from statutory or

Contains Nonbinding Recommendations

regulatory responsibilities to comply with applicable CGMP, regardless of whether the quality agreement specifically discusses those CGMP requirements. In case 1, the contract facility violates CGMP requirements by continuing to manufacture on outdated or poorly designed equipment, even though the quality agreement says that the owner is responsible for maintenance and upkeep of the equipment. In case 2, the contract facility violates CGMP by using a batch record that does not accurately reflect the manufacturing process, even though the batch record is consistent with what was set out in the quality agreement.

At the same time, the owner remains responsible for ensuring its products are made in compliance with CGMP even when a quality agreement assigns a particular manufacturing activity to the contract facility. After finding problems at a contract facility, such as the ones described in the cases above, FDA might determine that it is appropriate to inspect the owner. The owner could also be in violation of CGMP related to its failure to oversee the contract facility’s manufacturing activities.

B. CGMPs Apply to all Contract Facilities, Including Analytical Testing Laboratories

Case 3: Unreliable Data in Laboratory Records and Test Results

In this scenario, an owner contracts with a facility for analytical testing services. The contract facility repeatedly reports passing results in its CGMP records when actual analyses indicated failures. The contract facility also fails to report accurate results to the owner, who is the finished drug product manufacturer. When FDA inspects the owner, it finds that despite having a written procedure requiring a site audit of contract facilities every 2 years, the owner has not audited the analytical testing facility.

Case 4: Contracted Analytical Testing Laboratory and Method Validation

An owner contracts with a facility to perform stability testing and other analyses of its newly approved drug. FDA approval and a quality agreement with the owner require the drug to be manufactured using these processes, which are described in the owner’s new drug application (NDA). The contract facility uses an analytical method contained in the NDA but gets several out-of-specification results. Also, the facility’s duplicate sample analyses occasionally point to possible unacceptable variations in drug concentration. The facility investigates the varying results and concludes that the failures are related to the sample preparation techniques but does not clearly identify the problem. Despite this, the contract facility continues to use the noncompliant method to test the product. When FDA inspects the contract facility, it finds that the facility failed to fully investigate the problems and implement corrective actions. The contract facility claims that because it used the owner’s analytical method as specified in the product application, it is not responsible for investigating and implementing corrections related to it.

In both of the cases above, FDA might conclude that the contract facilities are responsible for violating CGMP applicable to the laboratory activities they perform. FDA could also conclude

Contains Nonbinding Recommendations

that the owners are responsible for CGMP violations. Analytical testing laboratories are responsible for operating in compliance with CGMP regardless of quality agreements they may have with owners. They must employ adequate controls to ensure that data and test results are reliable and maintained in accordance with CGMP requirements. It is the owner’s responsibility to review this information from the contract facility to decide whether to approve or reject product for release and distribution.26

No matter who tests the products, the owners’ quality units are ultimately responsible for ensuring that the products are manufactured in accordance with CGMP. A quality agreement does not change that. FDA could cite the owners in cases 3 and 4 further for failing to evaluate, qualify, audit, and monitor their contract facilities.

C. Owners and Contract Facilities Perform Change Control Activities

Case 5: Approving or Rejecting Changes That Affect Product Quality and CGMP Compliance

A contract facility informed the owner about obvious powder segregation issues. The contract facility had attempted to correct the problem by making changes to the equipment, but then determined that the issues could not be fixed without process redesign and component changes. Under their quality agreement, the contract facility could not implement these changes without the owner’s approval. The owner refused to approve the recommended changes, so the contract facility continued manufacturing the product using the flawed process and is therefore not compliant with CGMP.

Case 5 illustrates the responsibilities of both owners and contract facilities when change control issues are in question. Owners may be reluctant to approve changes recommended by contract facilities, even if changes are necessary to continue manufacturing the drug in compliance with CGMP.

VI. RECOMMENDATIONS

Owners and contract facilities can draw on quality management principles to carry out the complicated process of contract drug manufacturing by defining, establishing, and documenting their activities in drug manufacturing operations, including processing, packing, holding, labeling operations, testing, and quality control operations. Accordingly, FDA recommends that owners and contract facilities implement written quality agreements as tools to delineate manufacturing activities for ensuring compliance with CGMP.

26 See, for example, §§ 211.22(a), 211.68, 211.180, 211.188, and 211.194(a).

MANUAL PROSEDUR PERKULIAHA

STKIP PGRI JOMBA NG

2009

Manual Prosedur Perkuliahan

STKIP PGRI JOMBA NG

MP.UPM.STKIP-JB.2009

Revisi

Tanggal

15 Januari 2009

Dikaji ulang

oleh

Tim UPM STKIP PGRI

JOMBA NG

Disetujui oleh

Ketua

Revisi

ke-1

Tanggal

Januari

2009

Manual

Prosedur

Perkuliahan

Disetujui

Oleh

TIM PE NYUSU N DOKUME

Ketua : Dr. Agus Prianto, M.Pd

Anggota : 1. Dr. Munawaroh, M.Kes

2. Drs. Kustomo, M.Pd

3. Drs. Adib Darmawan, MA

4. Susi Darihastining, S.Pd M.Pd

5. Wiwin Sri Hidayati, S.Pd M.Pd

6. Drs. M. Setyowahyu, M.Pd

KATA PEN GA NTAR

Penjaminan mutu akademik merupakan tanggung jawab bersama seluruh warga STKIP PGRI JOMBA NG. Untuk memperlancar pelaksanaan dan kegiatan Penjaminan Mutu Akademik maka Tim UPM STKIP PGRI JOMBA NG menyusun pedoman pelaksanaan Akademik dalam bentuk buku PEDOMAN AKADEMIK. Salah satu buku PEDOMAN AKADEMIK di STKIP PGRI JOMBA NG adalah Manual Prosedur Perkuliahan.

Tujuan dibuatnya Manual Prosedur Perkuliahan adalah untuk meningkatkan efisiensi pelaksanaan perkuliahan dan memberikan kemudahan pada mahasiswa, dosen dan tenaga administrasi dalam pelaksanaan perkuliahan.

Semoga Manual Prosedur Perkuliahan yang telah disusun oleh Tim Penjaminan Mutu STKIP PGRI Jombang dapat dipahami dan dilaksanakan dengan baik oleh dosen, tenaga administrasi dan mahasiswa sehingga dapat memperlancar proses belajar mengajar di lingkungan STKIP PGRI JOMBA NG.

Jombang, 18 Januari 2009 Ketua,

WI NARDI, S.H. M.Hum

I. TUJUAN

1. Meningkatkan efisiensi pelaksanaan perkuliahan.

2. Memberikan kemudahan pada mahasiswa, dosen dan tenaga administrasi/TU dalam pelaksanaan perkuliahan.

II. PIHAK TERKAIT

1. Mahasiswa

2. Tenaga Administrasi/TU

3. Ketua Program Studi

4. BAAK

5. Dosen Tidak Tetap

6. Dosen Tetap.

III. LA NGKAH-LA NGKAH PELAKSA NAA N PERKULIAHA

3.1. Perslapan Perkullahan

Keglatan

Penanggung Jawab

Ketua Program Studi mengadakan rapat persiapan pelaksanaan perkuliahan dengan semua dosen pembina mata kuliah.

Ketua Program Studl

Ketua Program Studi menyusun draft

jadwal perkuliahan.

Ketua Program Studl

Ketua Program Studi menyerahkan draft jadwal perkuliahan ke BAAK.

Ketua Program Studl

Ka.Sub.Bag. Akademik BAAK menyusun

jadwal perkuliahan seluruh program studi, yang memuat daftar nama mata kuliah,

dosen pengampu, hari, jam kuliah, dan

tempat ruang kuliah.

Kasubag Akademlk

BAAK mengumumkan jadwal kuliah.

Kepala BAAK

BAAK membuat jadwal pemrograman per program studi per angkatan.

Kasubag Data

BAAK menerbitkan presensi kuliah sesuai

dengan jumlah mahasiswa yang

memprogram mata kuliah.

Kasubag Data

BAAK menerbitkan jurnal perkuliahan.

Kasubag Akademlk

BAAK bekerja sama dengan UPRT

menyiapkan ruang kelas dan sarana

prasarana yang diperlukan untuk kegiatan kuliah.

Kasubag Akademlk dan Kepala UPRT

3.2. Pelaksanaan Perkuliahan

Kegiatan

Penanggung Jawab

Dosen hadir pada waktu dan di tempat yang telah dijadwalkan dengan membawa presensi kuliah.

Dosen Pembina MK

Dosen memberikan kuliah sesuai dengan alokasi waktu yang ditentukan.

Dosen Pembina MK

Dosen memberikan kuliah sesuai dengan alokasi waktu yang ditentukan.

Dosen Pembina MK

Mahasiswa mengisi presensi kuliah.

Mahasiswa/Ketua Kelas

Mahasiswa menyerahkan jurnal kuliah

kepada dosen untuk diisi sesuai dengan topik perkuliahan.

Mahasiswa/Ketua Kelas

Setelah selesai kuliah mahasiswa

mengembalikan jurnal perkuliahan ke loker BRRK.

Mahasiswa/Ketua Kelas

Setelah selesai kuliah Dosen atau

mahasiswa mematikan LCD.

Dosen/Mahasiswa

LAMPIRAN

Lampiran 1. Contoh Daftar Peserta (Presensi) Kelas

DAFTAR PESERTA (PRESE NSI) KELAS

Matakuliah : Mikro Ekonomi Hari : Selasa

Jam : 07.30 - 10.00 Ruang : Ruang E1

Dosen : Dr.Agus Prianto, M.Pd

Nama

NIM

Tgl.

Firman

0210940017

paraf

Paraf

Paraf Dosen

paraf

Perhatian: Bagi mahasiswa yang namanya tidak tercantum dalam daftar presensi, tidak diijinkan untuk mengikuti kuliah atau ujian untuk kelas inil

Lampiran 2. Contoh Presensi Kegiatan Perkuliahan

JUR NAL KULIAH

SEMESTER GA NJIL/GE NAP 200.../200...

Matakuliah : Mikro Ekonomi

Program Studi : Pend. Ekonomi

Dosen : 1. Dr. Agus Prianto, M.Pd

Hari

Tanggal

Materi

yang

Dibahas

Nama Dosen

TTD DOSEN

TTD MHS

Catatan: Jurnal mengajar dosen harus diisi dengan tertib dan disertai dengan tanda tangan mahasiswa

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Senin, 08 Agustus 2022

LAPORAN PENILAIAN PROGRAM STUDI DAN PEMBELAJARAN

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