ACCESS BUSINESS GROUP SUPPLIER AUDIT CHECKLIST

Explanation of Audit Value Ratings

Points Description Full Explanation
NAp Not Applicable or Not Audited The procedure or process is not relevant to the supplier's commodity or the particular facility audited
0 No System The procedure and process is not included in the supplier's system, but was expected to be.
The procedure or process is included in the system but planning and execution both require
1 System Deficient
substantial improvement. The system is documented but not followed.
The system is in place but it is not properly documented or executed. There is a high probability that
2 Improvement Needed
the system will not produce consistent results. Improvements to the process documentation are
required.
The procedure or process is included in the supplier's system. Planning and execution meet these
3 Acceptable requirements. There is a high probability that the supplier's system will produce consistent results.
The system can be manual or electronically automated.
The procedure or process is included in the system. Planning and execution are thorough and
4 Outstanding exceed these requirements. It is certain that the system will produce exemplary results. Although not
required, typically electronic data management is used.

Total Points Available by Audit Sub-System

Points Sub-Section Rating Scale: Score

12 1) Buildings & Facilities Outstanding 95 to 100
15 2) Materials Management Excellent 90 to 94.9
15 3) Quality Control Systems Good 80 to 89.9
11 4) Manufacturing Satisfactory 70 to 79.9
10 5) Packaging & ID Labelling Conditional 50 to 69.9
15 6) Quality Management Systems Unsatisfactory Less than 50
12 7) Personnel & Training
10 8) Purchasing & Customer Service
100 Total

This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement
regarding confidentiality and intellectual property. This document is not to be shared with third parties or with employees outside of normal business conduct
without prior management approval.

QFH006 1 of 1 Effective 10/01/2006

 ACCESS BUSINESS GROUP SUPPLIER AUDIT CHECKLIST - FINAL SCORE
AUDITOR SUPPLIER DATE LOCATION

Total Points Available

Max Points for % of

Section
Points Sub-Section Section Score Sections Available
Points
Reviewed Points
12 1 - Buildings & Facilities NAp NAp NAp NAp
15 2 - Materials Management NAp NAp NAp NAp
15 3 - Quality Control Systems NAp NAp NAp NAp
11 4 - Manufacturing NAp NAp NAp NAp
10 5 - Packaging & ID Labelling NAp NAp NAp NAp
15 6 - Quality Management Systems NAp NAp NAp NAp
12 7 - Personnel & Training NAp NAp NAp NAp
10 8 - Purchasing & Customer Service NAp NAp NAp NAp

100 Total 0.00 0.0 0.0 NAp Audit Score

Auditor's Comments
See cover letter

This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate
agreement regarding confidentiality and intellectual property. This document is not to be shared with third parties or with employees outside of normal
business conduct without prior management approval.

QHF006.1 Effective 05/26/2005

 1-Buildings & Facilities

1 - BUILDINGS AND FACILITIES Score Comments

1.1 Design and Construction

Facility grounds are well maintained including roads, parking lots, grass and drain areas.
There is adequate space provided for orderly placement of equipment and materials to prevent mix-ups and
contamination.
Appropriate environmental controls exist and are maintained (controlled temperature, air filtration, humidity,
lighting, etc...).
All food contact surfaces are made of materials appropriate to the application (i.e. stainless steel vs. aluminum).
All water systems are adequately protected against back flow.
There are adequate hand-washing facilities for rest rooms, break areas and manufacturing areas.
Floors, walls, ceilings, doors and windows are completely sealed to prevent entry of pests.
Loading dock doors are flush to the floor when closed.
There is separation of defined areas and adequate controls to prevent contamination.
Fasilitas yang dipelihara dengan baik termasuk jalan, tempat parkir, rumput dan area
pembuangan.
Ada ruang yang memadai disediakan untuk tertib penempatan peralatan dan bahan untuk mencegah campuran-
up dan kontaminasi.
Kontrol lingkungan yang tepat ada dan dipelihara (suhu terkontrol, filtrasi udara, kelembaban, pencahayaan,
dll...).
Semua permukaan kontak makanan terbuat dari bahan yang sesuai dengan aplikasi (yaitu stainless steel vs.
aluminium).
Semua sistem air terlindung secara memadai terhadap aliran balik.
Ada fasilitas mencuci tangan yang memadai untuk kamar istirahat, daerah istirahat dan daerah manufaktur.
Lantai, dinding, plafon, pintu dan jendela sepenuhnya disegel untuk mencegah masuknya hama.
Pintu Dock pemuatan flush ke lantai saat ditutup.
Ada pemisahan area yang ditentukan dan kontrol yang memadai untuk mencegah kontaminasi.

1.2 Construction and Maintenance

Non-toxic and corrosion-resistant materials such as stainless steel are being used around the process.
Seams are well bonded and smooth.
Lubricants and chemicals used for operation of equipment are approved for food grade applications.
A preventative maintenance program developed and implemented for major equipment.
Weighing, measuring, monitoring, and testing equipment critical for ensuring quality should be calibrated
according to written procedures, established schedules and using certified or traceable standards.

Bahan non-beracun dan tahan korosi seperti stainless steel sedang digunakan di sekitar proses.
Jahitan baik terikat dan halus.
Pelumas dan bahan kimia yang digunakan untuk pengoperasian peralatan disetujui untuk aplikasi Food Grade.
Sebuah program pemeliharaan preventif dikembangkan dan diimplementasikan untuk peralatan utama.
Penimbangan, pengukuran, pemantauan, dan peralatan pengujian yang penting untuk memastikan kualitas harus
dikkalibrasi sesuai dengan prosedur tertulis, jadwal yang ditetapkan, dan penggunaan standar yang bersertifikat
atau dapat dilacak.

1.3 Pest control program

A documented pest control program is in place.
Building exterior is protected from rodent and pest entry.
Map with locations of all traps identified
The pest control program includes frequent inspections.
The supplier maintains and enforces written procedures for the application of pesticides.
All chemicals used in pest control are accurately labeled and stored securely
The facility audits PCO performance
Sebuah program pengendalian hama
didokumentasikan ada di tempatnya.
Bangunan eksterior dilindungi dari hewan pengerat dan hama masuk.
Peta dengan lokasi dari semua perangkap diidentifikasi
Program pengendalian hama mencakup pemeriksaan yang sering dilakukan.
Pemasok mempertahankan dan memberlakukan prosedur tertulis untuk penerapan pestisida.
Semua bahan kimia yang digunakan dalam pengendalian hama secara akurat diberi label dan disimpan dengan
aman
Audit fasilitas kinerja PCO

1.4 Cleaning & Sanitation

There is a written and comprehensive plant and equipment sanitation program.
Facility and equipment maintenance ensures safe manufacture of wholesome foods.
There are written operating procedures or work instructions.
Brushes and other utensils used for cleaning food contact surfaces are controlled and clearly identified.
Measures are in place to verify and monitor the effectiveness of cleaning methods.
Cleaning and sanitization procedures are validated and well-documented as such.
Cleaning and usage logs established for major equipment to include: dates, products, lots#, person who used,
person who cleaned.
Hoppers, tanks and similar food receptacles must be properly covered.
A chemical control program manages the use, storage, and handling of non-food chemicals at the manufacturing
facility. Ada yang tertulis
dan komprehensif pabrik dan peralatan sanitasi program.
Pemeliharaan fasilitas dan peralatan memastikan pembuatan aman dari makanan sehat.
Ada prosedur operasi tertulis atau instruksi kerja.
Kuas dan peralatan lain yang digunakan untuk membersihkan permukaan kontak makanan dikontrol dan
diidentifikasi dengan jelas.
Tindakan berada di tempat untuk memverifikasi dan memantau efektivitas metode pembersihan.
Prosedur pembersihan dan sanitasi divalidasi dan didokumentasikan dengan baik.
Pembersihan dan penggunaan log didirikan untuk peralatan utama untuk memasukkan: tanggal, produk, lots#,
personil yang menggunakan, personil yang membersihkan.
Hopper, tank, dan wadah makanan sejenis harus ditutupi dengan benar.
Sebuah program pengendalian kimia mengelola penggunaan, Penyimpanan, dan penanganan bahan kimia non-
makanan di fasilitas manufaktur.

BUILDINGS AND FACILITIES - SUBSYSTEM SCORE NAp

This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.

3 of 10
 2-Materials Management

2 - MATERIALS MANAGEMENT Score Comments

2.1 General Controls

There should be written procedures describing the receipt, identification, quarantine, storage, handling, sampling,
testing, and approval or rejections of materials.
There should be a system for control of GMO/non-GMO allergens.
Appropriate environmental controls exist and are maintained (controlled temperature, air filtration, humidity,
lighting, etc...).
Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials.
Materials should be purchased against an agreed specification, from a supplier, or suppliers, approved by the
quality unit(s)).
Harus ada prosedur tertulis yang menjelaskan penerimaan, identifikasi, karantina, Penyimpanan, penanganan,
sampling, pengujian, dan persetujuan atau penolakan materi.
Harus ada sistem untuk kontrol GMO/non-GMO alergen.
Kontrol lingkungan yang tepat ada dan dipelihara (suhu terkontrol, filtrasi udara, kelembaban, pencahayaan,
dll...).
Produsen intermediat dan/atau api harus memiliki sistem untuk mengevaluasi pemasok bahan kritis.
Bahan harus dibeli terhadap spesifikasi yang disepakati, dari pemasok, atau pemasok, disetujui oleh unit kualitas

2.2 Traceability
Lot trace system with distinctive lot number for all raw materials, in-process materials, finished goods, and
packaging components.
Establish and document First-in/First out(FIFO) procedures for all materials and goods.
Kemampuan telusur lot dengan nomor lot yang khas untuk semua bahan baku, bahan dalam proses, barang jadi,
dan komponen kemasan.
Menetapkan dan dokumen pertama-in/First Out (FIFO) prosedur untuk semua bahan dan barang

2.3 Storage
Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-
contamination.
- Temperature and humidly
- Containers designed to protect against adulteration.
- Store and/or control rejected materials in segregated facility so as to prevent usage.
- Warehouse area is clean and orderly - 18" perimeter is maintained.
- Materials should be re-evaluated, as appropriate, to determine their suitability for use (e.g., after
prolonged storage or exposure to heat or humidity).
Material harus ditangani dan disimpan dengan cara untuk mencegah
degradasi, kontaminasi, dan kontaminasi silang.
-Suhu dan kelembaban
-Containers dirancang untuk melindungi terhadap pencampuran.
-Menyimpan dan/atau mengendalikan bahan yang ditolak di fasilitas terpisah untuk mencegah barang tersebut
digunakan.
-Daerah gudang bersih dan tertib-18 " perimeter dipertahankan.
-Bahan harus dievaluasi ulang, yang sesuai, untuk menentukan kesesuaian mereka untuk digunakan (misalnya,
setelah penyimpanan yang berkepanjangan atau terpapar panas atau kelembaban).

MATERIALS MANAGEMENT - SUBSYSTEM SCORE NAp

This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.
 3-Quality Control Systems

3 - QUALITY CONTROL SYSTEMS Score Comments

3.1 Process Quality Control Plan (Packaging / Raw Materials)

A developed plan exists indicating inspection frequency, # of samples & required tests
Procedure for OOS results, how is this info related to production, what is done with product
Systems are in place to ensure that you have and are following the most current customer specification.
Does QC have a product standard reference system?
Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?
Are product retains kept (finished, raw material, packaging) for a minimum of shelf life + 1 year?
Sebuah rencana dikembangkan ada menunjukkan frekuensi inspeksi, # dari sampel & diperlukan
tes
Prosedur untuk hasil OOS, bagaimana info ini terkait dengan produksi, apa yang dilakukan dengan produk
Sistem berada di tempat untuk memastikan bahwa Anda telah dan mengikuti spesifikasi pelanggan terbaru.
Apakah QC memiliki sistem referensi standar produk?
Apakah ada cukup sumber daya (orang yang berkualitas, peralatan pengujian, dll) untuk secara memadai
melakukan fungsi ini?
Apakah produk mempertahankan disimpan (selesai, bahan baku, Kemasan) untuk minimal umur simpan + 1
tahun?

3.2 Incoming Quality Control

A developed plan exists indicating inspection frequency, of samples & required tests.
Procedure exists for handling out of specification (OOS) results.
Does QC have updated product specifications?
Are customer product standards available and used?
Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?
Pengembangan
untuk menunjukkan frekuensi inspeksi, dari sampel & diperlukan tes.
Ada prosedur untuk menangani hasil yang keluar dari spesifikasi (OOS)
Apakah QC telah memperbarui spesifikasi produk?
Apakah standar produk pelanggan tersedia dan digunakan?
Apakah ada cukup sumber daya (orang yang berkualitas, peralatan pengujian, dll) untuk secara memadai
melakukan fungsi ini?

3.3 QC Micro Lab

A developed plan exists indicating inspection frequency, of samples & required tests
Procedure exists for handling out of specification (OOS) results.
Does Micro QC have updated product specifications?
Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?
Is there a documented, effective lab cleaning & sanitization program including environmental monitoring?
Does a documented calibration and maintenance program exist?
Does a validation program exist?
Sebuah rencana dikembangkan ada menunjukkan frekuensi inspeksi, dari
sampel & diperlukan tes
Ada prosedur untuk menangani hasil yang keluar dari spesifikasi (OOS).
Apakah Micro QC telah memperbarui spesifikasi produk?
Apakah ada cukup sumber daya (orang yang berkualitas, peralatan pengujian, dll) untuk secara memadai
melakukan fungsi ini?
Apakah ada didokumentasikan, efektif laboratorium pembersihan & sanitasi program termasuk pemantauan
lingkungan?
Apakah ada program kalibrasi dan pemeliharaan yang didokumentasikan?
Apakah ada program validasi?

3.4 QC Analytical Lab

A developed plan exists indicating inspection frequency, of samples & required tests
Procedure exists for handling out of specification (OOS) results.
Does Analytical QC have updated product specifications?
Are there enough resources (qualified people, testing equipment, etc) to adequately perform this function?
Does a documented calibration and maintenance program exist?
Does a validation program exist?
Does a process exist for maintenance of lab standards?
Does a process exist for the control & documentation of lab reagents?
Establish, validate and document test methods.
Sebuah rencana dikembangkan ada menunjukkan frekuensi inspeksi,
dari sampel & diperlukan tes
Ada prosedur untuk menangani hasil yang keluar dari spesifikasi (OOS).
Apakah QC analis telah memperbarui spesifikasi produk?
Apakah ada cukup sumber daya (orang yang berkualitas, peralatan pengujian, dll) untuk secara memadai
melakukan fungsi ini?
Apakah ada program kalibrasi dan pemeliharaan yang didokumentasikan?
Apakah ada program validasi?
Apakah ada proses untuk pemeliharaan standar Lab?
Apakah ada proses untuk kontrol & dokumentasi reagen laboratorium?
Menetapkan, memvalidasi dan dokumen metode uji.

QUALITY CONTROL SYSTEMS - SUBSYSTEM SCORE NAp

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with third parties or with employees outside of normal business conduct without prior management approval.

5 of 10
 4-Manufacturing

4 - MANUFACTURING Score Comments

4.1 Batch Records

All documents related to the manufacture of intermediates or Active Pharmaceutical Ingredients (APIs) should be
prepared, reviewed, approved and distributed according to a written SOP.
Batch record:
• shall contain list of raw materials, names, characteristics, identification, lot #(s), weights.
• shall include total and theoretical weights/measures, min/max percentage. (Values outside acceptable ranges
require
investigation).
• shall include detailed manufacturing instructions & process control setpoints to assure purity, quality &
consistent composition.
• shall include documentation of each significant step in the manufacturing process.
• shall contain special notes of investigation/deviation from the prescribed process.
• shall be reviewed and approved by Quality Assurance (QA) for each individual batch run.
• shall be retained for at least 1 year after the expiry date of the batch.
Semua dokumen yang terkait dengan pembuatan intermediat atau bahan
farmasi aktif (api) harus dipersiapkan, ditinjau, disetujui dan didistribusikan sesuai dengan SOP tertulis.
Catatan batch:
• harus berisi daftar bahan baku, nama, karakteristik, identifikasi, banyak # (s), bobot.
• harus mencakup bobot/ukuran total dan teoritis, min/Max persentase. (Nilai di luar rentang yang dapat
diterima memerlukan penyelidikan).
• harus menyertakan petunjuk produksi yang terperinci & titik pengaturan kontrol proses untuk memastikan
kemurnian, kualitas & konsisten komposisi.
• harus menyertakan dokumentasi dari setiap langkah penting dalam proses manufaktur.
• berisi catatan khusus penyelidikan/penyimpangan dari proses yang ditentukan.
• akan ditinjau dan disetujui oleh Quality Assurance (QA) untuk setiap individu batch menjalankan.
• akan dipertahankan setidaknya selama 1 tahun setelah tanggal kedaluwarsa batch.

4.2 Contamination
Any material observed to have insect infestation shall be quarantined and immediately removed from premises.
Effective measures shall be taken to protect against metal and extraneous materials.
Material apa pun yang dapat menyebabkan datangnya serangga harus dikarantina dan
segera dihapus dari lokasi.
Tindakan efektif harus diambil untuk melindungi terhadap bahan logam dan asing.

4.3 General Controls

Identify and record usage of all containers, processing lines & major equipment during production.
Perform filling, assembling, packing, and other operations in such a way that products are not adulterated.
Methods for establishing & monitoring critical process control points should be stated in writing.
Mengidentifikasi dan merekam penggunaan semua kontainer, baris pengolahan & peralatan
utama selama produksi.
Melakukan pengisian, perakitan, pengepakan, dan operasi lainnya sedemikian rupa sehingga produk tidak
tercemar.
Metode untuk membangun pemantauan & titik kontrol proses kritis harus dinyatakan secara tertulis.

4.4 Manufacturing Process Controls

Developed plan indicating inspection frequency, samples, required tests
Procedure exists for Out-of-Specification results. What is done with product?
Are product standards routinely utilized?
Is production set up to meet Customer Specifications and Requirements?
Are there enough resources (qualified people, intermediate and final process checks, etc) to assure the
production of a quality product?
Rencana dikembangkan menunjukkan frekuensi
inspeksi, sampel, tes yang diperlukan
Prosedur yang ada untuk hasil di luar spesifikasi. Apa yang dilakukan dengan produk?
Apakah standar produk digunakan secara rutin?
Apakah produksi disiapkan untuk memenuhi spesifikasi dan persyaratan pelanggan?
Apakah ada cukup sumber daya (orang yang berkualitas, pemeriksaan proses menengah dan akhir, dll) untuk
menjamin produksi produk berkualitas?

MANUFACTURING - SUBSYSTEM SCORE NAp

This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.
 5-Packaging & ID Labeling

5 - PACKAGING AND IDENTIFICATION LABELING Score Comments

5.1 General Controls

Establish and follow procedure for the receipt, storage, handling, sampling, examination & reconciliation of
packaging materials.
Establish and follow procedure to ensure that correct labels, labeling and packaging materials are issued and use.
Menetapkan dan mengikuti prosedur untuk penerimaan, Penyimpanan, penanganan, sampling, pemeriksaan &
rekonsiliasi bahan kemasan.
Menetapkan dan mengikuti prosedur untuk memastikan bahwa label yang benar, pelabelan dan bahan kemasan
yang dikeluarkan dan digunakan

5.2 Label Issuance and Control

Access to the label storage areas should be limited to authorized personnel.
Procedures should be established to reconcile the quantities of labels issued, used, and returned.
Procedures should be established on how to investigate / evaluate any discrepancies found between number of
containers labeled and number of labels issued.
Procedures should be established for the destruction of obsolete and out-dated labels.
Printed labels issued for a batch should be carefully examined for proper identity and conformity to specifications
in the master production record.
A printed label representative of those used should be included in the batch production record.
Akses ke area penyimpanan label harus dibatasi pada personil yang berwenang.
Prosedur harus dibuat untuk merekonsiliasi jumlah label yang dikeluarkan, digunakan, dan dikembalikan.
Prosedur harus ditetapkan tentang cara menyelidiki/mengevaluasi setiap perbedaan yang ditemukan antara
jumlah kontainer berlabel dan jumlah label yang dikeluarkan.
Prosedur harus ditetapkan untuk penghancuran label usang dan keluar-tanggal.
Label cetak yang dikeluarkan untuk batch harus diperiksa dengan cermat untuk identitas yang tepat dan
kesesuaian dengan spesifikasi dalam master dokumen produksi.
Perwakilan label cetak yang digunakan harus disertakan dalam rekaman batch produksi

5.3 Packaging and Labeling Operations

Provide adequate separation between different packaging / labeling operations being carried out simultaneously in
the same area.
Identify packages and ingredients with a lot number that permits determination of history and control of batch.
Examine packaged and labeled products to ensure that they have the correct label and lot.
Ensure that proper line clearance procedures are in place and utilized during changeovers.
Menyediakan pemisahan yang memadai antara berbagai operasi pengemasan/pelabelan yang dilakukan
secara bersamaan di area yang sama.
Mengidentifikasi paket dan bahan dengan banyak nomor yang memungkinkan terekam dan kontrol batch.
Periksa produk dikemas dan berlabel untuk memastikan bahwa mereka memiliki label dan lot yang benar .
Pastikan prosedur pembersihan jalur yang tepat berada di tempatnya dan digunakan selama penggantian

PACKAGING & ID LABELING - SUBSYSTEM SCORE NAp

This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.
 6-Quality Management Systems

6 - QUALITY MANAGEMENT SYSTEMS Score Comments

6.1 Quality Goals

An organizational chart exists which reflects the current reporting structure & responsibilities. Does the organization have an established and maintained quality management unit? There is a management representative with defined authority and responsibility for meeting customer
compliance. Qualified technical personnel are available for design, process, product, and service support. A quality manual has been developed which details the quality system of policies and procedures.Quality manual procedures identify:
• Who is responsible for action?
• What has to be done?
• When are actions required?
The responsibility for updating and revising the quality manual and system is well defined. Company quality objectives are documented, signed and dated. Quality objectives are communicated, understood, and maintained throughout the organization. Written procedures address the
following types of planning:
• Establishment of requirements
• Verification of requirements
• Acceptance procedures
• Quality information systems
• Customer satisfaction
• Change control
Ongoing quality improvements are a part of the plant manager’s objectives. Quality costs are used for evaluating and planning. Documented evidence exists that advanced quality planning activities are reviewed with customers.
Bagan organisasi ada yang mencerminkan struktur tanggung jawab & pelaporan. Apakah organisasi memiliki unit manajemen mutu yang mapan dan terjaga?
Ada perwakilan manajemen dengan kewenangan dan tanggung jawab yang ditetapkan untuk memenuhi kepatuhan pelanggan. Personil teknis yang berkualitas tersedia untuk desain, proses, produk, dan dukungan layanan.
Sebuah manual berkualitas telah dikembangkan yang rincian sistem kualitas kebijakan dan prosedur. Prosedur manual kualitas mengidentifikasi:
• Siapa yang bertanggung jawab untuk bertindak?
• Apa yang harus dilakukan?
• Kapan tindakan diperlukan?
Tanggung jawab untuk memperbarui dan merevisi kualitas manual dan sistem didefinisikan dengan baik.Tujuan kualitas perusahaan didokumentasikan, ditandatangani, dan bertanggal. Tujuan kualitas dikomunikasikan, dipahami, dan dipelihara di seluruh organisasi. Prosedur tertulis
membahas jenis perencanaan berikut:
• Pembentukan persyaratan
• Verifikasi persyaratan
• Prosedur penerimaan
• Sistem informasi berkualitas
• Kepuasan pelanggan
• Kontrol perubahan
Peningkatan kualitas yang berkelanjutan merupakan bagian dari tujuan manajer pabrik. Biaya kualitas digunakan untuk mengevaluasi dan perencanaan. Ada bukti didokumentasikan bahwa kegiatan perencanaan kualitas maju ditinjau dengan pelanggan.

6.2 Effectiveness of the Quality Management Systems

Lead times are measured and tracked
The total cost of quality is tracked
Cycle times measured and tracked
Annual Quality improvement goals are set by top management
Goals are regularly reviewed by top management.
There is a system in place to verify that objectives are met and quality policy is adhered to.
Achievement of quality objectives is a high priority in overall performance reviews.
The quality manual is regularly reviewed, revised, and communicated throughout the organization.
There is a documented and objective process in place to measure and track customer satisfaction.
Lead waktu diukur dan dilacak
Total biaya kualitas dilacak
Siklus kali diukur dan dilacak
Tujuan peningkatan kualitas tahunan ditetapkan oleh manajemen puncak
Sasaran secara teratur ditinjau oleh manajemen puncak.
Ada sistem di tempat untuk memverifikasi bahwa tujuan terpenuhi dan kebijakan kualitas dipatuti.
Pencapaian tujuan kualitas adalah prioritas tinggi dalam tinjauan kinerja secara keseluruhan.
Panduan kualitas secara teratur ditinjau, direvisi, dan berkomunikasi seluruh organisasi.
Ada proses didokumentasikan dan objektif di tempat untuk mengukur dan melacak kepuasan pelanggan.

6.3 Internal Audits

There is a documented procedure for conducting internal quality audits.
Internal audits are conducted semi-annually or scheduled on the basis of status and importance of activity.
Audit includes work environment and general housekeeping.
Internal audit results are documented and brought to attention of management.
There is an established and documented complaint investigation and response program.
Establish and document rework and reprocessing procedure
Corrective actions are timely, recorded, and evaluated for effectiveness.
Ada prosedur didokumentasikan untuk melakukan audit kualitas internal.
Audit internal dilakukan semi-tahunan atau dijadwalkan atas dasar status dan pentingnya kegiatan.
Audit mencakup lingkungan kerja dan tata graha umum.
Hasil audit internal didokumentasikan dan dibawa ke perhatian manajemen.
Ada yang mapan dan didokumentasikan penyelidikan pengaduan dan program tanggapan.
Menetapkan dan mendokumentasikan prosedur pengerjaan ulang dan pengolahan
Tindakan korektif tepat waktu, direkam, dan dievaluasi untuk efektivitas

QUALITY MANAGEMENT SYSTEMS - SUBSYSTEM SCORE NAp

This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared with third parties or with employees outside of normal business conduct without prior management approval.

8 of 10
 7-Personnel & Training

7 - PERSONNEL AND TRAINING Score Comments

7.1 Qualifications and Experience

An organizational chart exists which reflects the most current reporting structure.
Job descriptions throughout the organization include responsibilities for supporting quality objectives.
An adequate number of qualified personnel exist to perform functions in manufacturing, packaging and QA.
Bagan organisasi ada yang mencerminkan struktur
pelaporan terbaru.
Uraian pekerjaan di seluruh organisasi mencakup tanggung jawab untuk mendukung tujuan kualitas.
Jumlah personel berkualitas yang memadai ada untuk melakukan fungsi di bidang manufaktur, pengemasan dan QA.

7.2 Hygienic Practices

Are there hygienic practices in place to protect against contamination of food?
Personnel should wear clean clothing suitable for the manufacturing activity. Additional protective apparel, such as head, face, hand,
and arm coverings should be worn, when necessary.
Any person, by medical examination or supervisory observation, that is shown to have, or appears to have, an illness, or open lesions,
by which there is reasonable possibility of food, food-contact surfaces, or food-packaging materials being contaminated, shall be
excluded from any operations until condition is corrected.
Personnel shall be instructed to report such conditions to supervisors.
Designated areas outside of processing zones have been provided for clothing and other personal belongings (Jackets, cell phones,
bags, radios, CD players, headsets, pagers).
Consumption of food & beverages, chewing of gum, or the use of tobacco products are strictly prohibited in processing areas.
Proper hand washing practices are reinforced with signs posted in breakrooms, production areas, and washrooms.
Written procedures exist which address and include the control and proper supervision of the above practices.
Apakah ada praktik higienis yang harus dilakukan untuk
melindungi terhadap kontaminasi makanan?
Personil harus memakai pakaian bersih cocok untuk kegiatan manufaktur. Pakaian pelindung tambahan, seperti kepala, wajah, tangan,
dan penutup lengan harus dipakai, bila diperlukan.
Setiap orang, dengan pemeriksaan medis atau pengamatan pengawasan, yang terbukti memiliki, atau tampaknya memiliki, penyakit,
atau lesi terbuka, di mana ada kemungkinan yang wajar makanan, permukaan kontak makanan, atau bahan kemasan makanan yang
terkontaminasi, harus dapat dikecualikan dari setiap operasi sampai kondisi dikoreksi.
Personil harus diperintahkan untuk melaporkan kondisi tersebut kepada Pengawas.
Area yang ditunjuk di luar zona pengolahan telah disediakan untuk pakaian dan barang pribadi lainnya (jaket, ponsel, tas, radio,
pemutar CD, headset, pager).
Konsumsi makanan & minuman, mengunyah permen karet, atau penggunaan produk tembakau dilarang keras di bidang pengolahan.
Praktek mencuci tangan yang tepat diperkuat dengan tanda-tanda diposting di breakrooms, daerah produksi, dan kamar kecil.
Ada prosedur tertulis yang alamat dan termasuk kontrol dan pengawasan yang tepat dari praktek di atas.

7.3 Training Procedures

Have procedures been established and used for identifying training needs? Training procedure(s) shall exist for all levels including part-
time and temporary staff, management, visitors, contract/construction personnel, consultants, government and customer auditors.
Procedures address training schedules such as upon hire, future training requirements, follow up and/or retraining frequencies. Training
effectiveness is evaluated on a periodic basis.
Employee training covers general topics such as cGMP, sanitation, safety, environment, SOPs & MSDS. In addition, training is provided
on specifc work instructions, procedures, equipment operations, or as required to perform a specific job function. Are qualifications and
training records maintained for all personnel? Are the qualifications and experience requirements for trainers defined in the training
procedures?
Training records must be maintained for all personnel and should include: Date, Topic, Name of Instructor, Employee Signatures, Tests,
Quizzes, etc...Specific training requirements are defined for each unique job description or job function.
Apakah prosedur telah dibuat dan digunakan untuk mengidentifikasi kebutuhan pelatihan?
Prosedur pelatihan harus ada untuk semua tingkatan termasuk staf paruh waktu dan sementara, manajemen, pengunjung,
kontrak/personel konstruksi, konsultan, pemerintah dan auditor pelanggan. Prosedur membahas jadwal pelatihan seperti saat
menyewa, persyaratan pelatihan di masa depan, menindaklanjuti dan/atau frekuensi pelatihan ulang. Efektivitas pelatihan dievaluasi
secara periodik. Pelatihan karyawan mencakup topik umum seperti cGMP, sanitasi, keamanan, lingkungan, SOP & MSDS. Selain itu,
pelatihan disediakan pada petunjuk kerja specifc, prosedur, operasi peralatan, atau yang diperlukan untuk melakukan fungsi pekerjaan
tertentu. Apakah kualifikasi dan catatan pelatihan dipelihara untuk semua personil?
Apakah persyaratan kualifikasi dan pengalaman untuk pelatih yang ditentukan dalam prosedur pelatihan?
Catatan pelatihan harus dipertahankan untuk semua personil dan harus mencakup: tanggal, topik, nama instruktur, tanda tangan
karyawan, tes, kuis, dll... Persyaratan pelatihan khusus ditentukan untuk setiap deskripsi pekerjaan yang unik atau fungsi pekerjaan.

PERSONNEL & TRAINING - SUBSYSTEM SCORE

NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared with third parties or with
employees outside of normal business conduct without prior management approval.

9 of 10
 8-Purchasing & Customer Serv.

8 - PURCHASING AND CUSTOMER SERVICE Score Comments

8.1 Purchasing
Is there a system to notify customers of delivery days?
How are they notified? E-mail, fax, phone, mail? Is this documented?
What systems or processes are in place for Cost of Quality (i.e. scrap, reduction, rework, commodity planning)?
An up-to-date organization chart with names/key personnel available.
Apakah ada sistem untuk memberi tahu pelanggan tentang hari pengiriman?
Bagaimana mereka diberitahu? E-mail, Fax, telepon, mail? Apakah ini didokumentasikan?
Sistem atau proses apa yang ada di tempat untuk biaya kualitas (yaitu, memo, pengurangan, pengerjaan ulang,
perencanaan komoditas)?
Bagan organisasi mutakhir dengan personel nama/kunci tersedia.

8.2 Customer Service

Is there evidence of a Customer Service System?
Company contact list.
Is there a process for requesting samples or information?
Who receives and reviews ABG specifications?
Apakah ada bukti sistem layanan pelanggan?
Daftar kontak perusahaan.
Apakah ada proses untuk meminta sampel atau informasi?
Siapa yang menerima dan ulasan ABG spesifikasi?

8.3 General
Are there contingency plans for serious problems (fire, tornado, flood, etc.)?
Is there a system to identify facility, machine, and operational needs for the future?
An established complaint investigation and response program exists
Do you have a recall procedure?
Do you perform mock recalls? On what frequency? Have you performed one recently? What were the results?
Do you have a documented stability program?
Apakah ada rencana kontinjensi untuk masalah serius (api, tornado, banjir,
dll)?
Apakah ada sistem untuk mengidentifikasi fasilitas, mesin, dan kebutuhan operasional untuk masa depan?
Terdapat program investigasi dan tanggapan yang mapan
Apakah Anda memiliki prosedur penarikan?
Apakah Anda melakukan penarikan tiruan? Pada frekuensi apa? Apakah Anda telah melakukan satu baru-baru
ini? Apa hasilnya?
Apakah Anda memiliki program stabilitas didokumentasikan?

PURCHASING & CUSTOMER SERVICE - SUBSYSTEM SCORE

NAp
This document may contain confidential information and is considered proprietary information. Use of this document is covered by the corporate agreement regarding confidentiality and intellectual property. This document is not to be shared
with third parties or with employees outside of normal business conduct without prior management approval.