chek list haccp - iso 22000 _translate

HAF08.06 CDAN 98/405 SAI Global Limited ABN 67 050 611 642 PAGE 1 OF 14 SAI Global Limited Copyright 2002

SAI Global Checklist

for HACCP / ISO 22.000 Certification Audits

Company Name

Technical Resources:

Address Internal: External:

Audit Date No. of Employees

Licence/App. No

Company Contact Report No

Results Discussed with SAI Global Auditor

SOC No

Products(s)

Product Risk Category (High / Medium / Low)

Process / Package Characteristics (e.g. canned, refrigerated, thermally processed, partially processed, anaerobically packaged, aseptically packaged etc):

Instructions: Evaluate each of the requirements. All deficiencies are detailed on attachment, e.g. NCR, Discrepancy/Observation Sheet.

= Acceptable x = Not Acceptable NA = Not Applicable

Definitions: Codex Alinorm 97/B attached.

Item Requirements Audit

Finding

Attachment

Reference

Quality System Documentation

1. There is a clear, concise controlled and approved quality manual or series of manuals which document procedures specified to control quality and food safety aspects, including Quality Policy/GMP Policy, Procedure/Work Instructions, Forms/Specifications.

Adanya manual mutu yang jelas dan terkontrol atau seri pedoman yang ditetapkan untuk dokumen prosedur pengendalian kualitas dan aspek keamanan pangan, termasuk Kebijakan Mutu / Prosedur Kebijakan GMP, / Instruksi Kerja, Formulir / Spesifikasi

2. Document changes are controlled and authorized by nominated signatory.

Dokumen perubahan dikendalikan dan disahkan serta ditandatangani oleh penaggung jawab

Activity ID

App/Cert

No.



Finding

Attachment

Reference

HACCP System Documentation

3. There is a process flow chart available for identification of critical steps for each product.

Adanya proses flow chart / alur diagram yg tersedia untuk identifikasi dlm mengambil langkah penting untuk setiap produk.

4. The process flow chart clearly numbers the individual steps and cross references any critical step to an applicable HACCP plan.

Aliran proses diagram yg jelas dimana sejumlah tindakan /langkah yang dilakukan oleh individu dan direferensikan silang untk setiap langkah penting tsb untuk perencanaan HACCP yang berlaku.

5. There is an approved clear, accurate HACCP plan for each product.

Adanya perencanaan yg jelas dan disetujui , perencanaan HACCP yang akurat untuk setiap produk.

6. The HACCP plan identifies hazards and critical control points for each critical step.

Rencana HACCP mengidentifikasi bahaya dan kontrol poin kritis untuk setiap langkah penting yang diambil dlm proses produksi,

7. The HACCP plan describes controls and monitoring procedures for critical control points.

Rencana HACCP hrs menggambarkan pengawasan dan pemantauan prosedur untuk titik kontrol kritis

8. The HACCP plan states relevant specifications and tolerances.

Pernyataan bahwa rencana spesifikasi HACCP yang relevan terhadap spesifikasi dan bisa diterima

9. The HACCP plan states corrective action is to be taken if deficiencies in system identified.

HACCP Plan harus menyatakan tindakan korektif harus diambil jika terdapat kekurangan dalam sistem yg telah diidentifikasi.

10. There is documented evidence that corrective action is taken once a deficiency is identified.

Adanya bukti dokumen yg telah didokumentasikan menyatakan bhw tindakan korektif diambil sekali dan kekurangannya hrs diidentifikasi.

11.

12. Any changes to the HACCP plan are controlled and authorized by nominated signatory.

Setiap perubahan terhadap program HACCP dikendalikan dan disahkan melalui penandatanganan oleh yg berkompeten

Physical Facilities

13. Properly stored equipment, waste and refuse, litter.

Penyimpanan peralatan , limbah dan sampah dengan tepat



Finding

Attachment

Reference

14. Road, yard and parking lot dust controlled.

Jalan, halaman parkir dan debu hrs bisa dikendalikan

15. Grounds adequately drained.

Tanah / lantai harus kering

16. Sufficient space for placement of equipment and storage of materials; aisles and working spaces unobstructed, sufficient width.

Cukupnya ruang untuk penempatan peralatan dan penyimpanan bahan; gang dan ruang kerja yg tdk mengganggu aktivitas serta cukup lebar.

17. Proper construction: floors, walls and ceilings; clean.

Konstruksi yang pantas / sesuai : lantai, tembok dan langit-langit hrs bersih

18. Fixtures, ducts and pipes placed to preclude drippage or condensate contaminating product.

Peralatan, saluran-saluran dan pipa yg ditempatkan jgn sampai mencemari produk.

19. Adequate lighting: work stations, hand washing areas, dressing or locker rooms, water closets, break rooms and storage areas.

Pencahayaan yang memadai di ruang kerja, tempat mencuci tangan , atau kamar ganti, WC, ruang istirahat dan tempat penyimpanan

20. Light fixtures over processing and packaging areas safety type or equivalent.

Lampu dan peralatan pencahayaan yg diletakkan di atas area pengolahan hrs terjamin keamanan nya

21. Adequate ventilation provided to minimize odours, noxious fumes, odours and condensate in processing operations.

ventilasi yang memadai hrs ada untuk meminimalkan bau, asap berbahaya, bau dan kondensat dalam proses produksi

22. Effective screening or other protection provided against birds, animals, vermin, etc.

Efektif penyaringan atau perlindungan lainnya yang diberikan terhadap burung-burung, binatang, kutu, dll

23. Product in process adequately protected: if sealed system, free of leaks or other sources of contamination, hooded, screened, covered, etc.

Produk dalam proses ; perlindungannya hrs memadai : jika sistem tertutup, bebas dari kebocoran atau sumber lain yg bisa terkontaminasi, tertutup, disaring, ditutup

24. Processing, packaging and storage rooms not directly connected to room(s) used for domestic household purposes.

Pengolahan, pengepakan dan gudang tidak secara langsung terhubung ke kamar yang digunakan untuk keperluan rumah tangga dlm pabrik



Finding

Attachment

Reference

Sanitary Facilities and Control

25. Product water supply from approved, properly located, protected operated and accessible source; safe, sanitary quality; conforms at all times with applicable laws and regulations.

Produk air bersih di supply oleh pihak yg kompeten , lokasi /sumbernya sesuai persyaratan, penyedia air yang dilindungi sumber airnya , aman, kualitas sanitasi sesuai dengan undang-undang dan peraturan yang berlaku. .

26. Operations water supply meets same requirements as product water supply.

pasokan air untuk produksi memenuhi persyaratan yang sama seperti pasokan air produk.

27. Locker and break rooms: separate from plant operations and storage areas, doors self-closing, clean and sanitary; refuse container(s) provided, packaging, wrapping materials and processing supplies absent.

Locker dan kamar istirahat : terpisah dari operasi pabrik dan tempat penyimpanan, pintu otomatis buka tutup, bersih dan sanitasi; kontainer yg ditolak / tdk dipakai diberikan kemasan / bahan pembungkus

28. Sewage disposal and plumbing adequately installed and maintained.

pipa pembuangan kotoran hrs memadai dan sdh diinstal dan terpelihara

29. Floor drainage adequate where subject to flooding type cleaning or where normal operations discharge on the floor.

Lantai drainase yang memadai dan rata pada saat dibersihkan tdk ada air yg tergenang

30. Toilet and changing facilities: adequate, hand washing and disinfectant facilities provided, sanitary, doors self-closing, do not open directly into processing areas, hand washing signs provided in appropriate language, separated change rooms.

Toilet dan fasilitas berubah: cukup, cuci tangan dan fasilitas yang disediakan disinfektan, sanitasi, pintu yg tertutup, tidak terbuka langsung ke area pengolahan, tanda-tanda cuci tangan disediakan dalam bahasa yang sesuai, perubahan kamar ganti,



Finding

Attachment

Reference

31. Hand washing facilities: adequate, convenient, provided at each location where employees are required to wash, sanitize and dry hands, hot and cold or tempered water provided, sanitary towels or dryers provided.

Tempat cuci tangan: memadai, nyaman, disediakan pada setiap lokasi di mana tenaga kerja wajib untuk mencuci, membersihkan dan tangan kering, panas dan dingin hrs disediakan, pembalut atau pengering disediakan.

32. Waste disposal: proper receptacles with covers, removed promptly from areas, cleaned and disinfected if reused.

Limbah pembuangan: wadah yang tepat dengan penutup , dibersihkan dan didesinfeksi jika digunakan kembali

Sanitary Operations

33. Product contact surfaces (utensils, pipes, equipment, etc.) clean and adequately sanitized at appropriate frequency.

permukaan kontak Produk (peralatan, pipa, peralatan, dll) yang bersih dan cukup dibersihkan pada frekuensi yang tepat.

34. Product contact surfaces maintained free of scale, oxidation and other residue. Presence of any unsanitary condition corrected immediately.

Permukaan Produk yg mempunyai kontak langsung harus terpelihara dari oksidasi dan residu lain. Bila Ada kondisi tdk sehat segera diperbaiki.

35. Product packaging (containers, seals, etc.) purchased and stored sanitary manner. Examined before use; handled, dispensed and used in sanitary manner. Washed, rinsed and sanitized as needed.

Produk kemasan (kontainer, segel, dll) yang dibeli dan disimpan dengan cara sanitasi. Diperiksa sebelum digunakan; ditangani, ditiadakan dan digunakan dengan cara saniter. Dicuci, dibilas dan dibersihkan seperlunya.

36. Processing and packaging done in a sanitary manner.

Pengolahan dan pengemasan dilakukan secara saniter. .

37. Cleaning operations conducted in a manner to preclude contamination of product contact surfaces.

Pembersihan yang dilakukan sedemikian rupa untuk mencegah kontaminasi permukaan kontak produk.



Finding

Attachment

Reference

38. Only toxic materials necessary for maintaining sanitary conditions, plant and equipment or for use in laboratory testing and processing operations are used and stored in plant. Materials are identified and used as intended.

Hanya bahan beracun diperlukan untuk dijaga kondisi sanitasinya , pabrik dan peralatan atau untuk digunakan dalam pengujian laboratorium dan kegiatan pengolahan yang digunakan biasanya disimpan di pabrik. Material diidentifikasi dan digunakan sebagaimana dimaksud.

39. Pest control system procedures implemented and pesticides used in accordance with label directions, restrictions. Verification system for effective pest control. Procedure includes corrective actions and corrective actions documented.

prosedur pengendalian sistem Hama diimplementasikan dan pestisida yang digunakan sesuai dengan petunjuk label, pembatasan. Verifikasi sistem untuk pengendalian hama yang efektif. Prosedur mencakup tindakan koreksi dan tindakan korektif dan sdh didokumentasikan.

40. Non-product contact surfaces of equipment free of accumulated dust, dirt and other debris.

Non-produk / peralatan yg berhubungan langsung kontak permukaan bebas dari akumulasi debu, kotoran dan puing-puing lainnya.

Equipment

41. Equipment suitable for use, designed and of such materials to be cleanable and properly maintained. Design precludes adulteration of product with lubricants, foreign objects, contaminated water, steam or compressed air.

Peralatan yang cocok untuk digunakan, didesain dan bahan tersebut harus dibersihkan dan dipelihara dengan baik. Desain menghalangi pemalsuan produk dengan pelumas, benda asing, yang terkontaminasi air, uap atau udara terkompresi.

42. Product contact surfaces are of nontoxic and nonabsorbent materials, can be adequately cleaned and sanitized.

permukaan yg kontak langsung thdp Produk bahan tdk beracun dan nonabsorbent, cukup dibersihkan dan disterilkan

43. System and storage tanks closed to exclude all foreign matter, filtered vents provided, filters readily cleanable or replaceable elements.

Sistem dan tangki penyimpanan tertutup untuk mengecualikan semua benda asing, ventilasi disaring disediakan, elemen filter mudah dibersihkan atau diganti.



Finding

Attachment

Reference

Raw Materials And Ingredients

44. Purchase specifications available, used and met before acceptance.

Spesifikasi pembelian tersedia , digunakan dan sesuai sebelum barang diterima.

45. Vendors pre-certified.

Vendor pra-bersertifikat.

46. Certificates of analysis / conformance required prior to accepting

Sertifikat analisis / kesesuaian yang dibutuhkan sebelum menerima

Raw Material Receiving

47. Carrier inspection performed.

Carrier dilakukan pemeriksaan

48. Lot testing performed.

Lot dilakukan pengujian.

49. Inspection for temperature, sanitation and visual absence of hazards.

Inspeksi untuk suhu, sanitasi dan tidak adanya visual dari bahaya.

50. Contamination likely from incoming goods assessed.

Kemungkinan kontaminasi dari barang masuk harus dinilai / dipertimbangkan

51.

Raw Materials and Ingredient Storage

52. Acceptable conditions in storage areas (sanitation, construction, equipment, etc.).

penerimaan kondisi di daerah penyimpanan (sanitasi, konstruksi, peralatan, dll).

53. Environment conditions monitored (temperature, humidity).

Lingkungan dimonitor kondisinya (suhu, kelembaban).

54. Containers dated; covered; in good condition.

Wadah yg sdh diberi tanggal; ditutupi; dalam kondisi baik

55. Proper rotation of ingredients.

rotasi bahan tepat

56. Ingredients on HOLD segregated.

Bahan pada HOLD dipisahkan



Finding

Attachment

Reference

57. Packaging materials properly stored.

Bahan kemasan disimpan dengan benar

Raw Material Prep / Staging

58. Temperature / time controlled.

Temprature / suhu waktunya telah di control

59. Employee hygiene.

Kesehatan / kebersihan karyawan

60. Prevention of cross-contamination.

Penjegahan kontaminasi silang

61. Environmental sanitation.

Sanitasi lingkungan

62. Physical hazard removal.

penghapusan bahaya fisik

63. Proper handling implemented.

Penanganan yang tepat diterapkan

64. Proper rework handling.

Penanganan Tepat ulang

65. Packaging materials inspected.

Bahan / material untuk pengemasan telah di inspeksi

Processing

66. Cook time / temperature monitored.

Waktu / suhu pemasakan sudah dimonitoring

67. Chill time / temperature monitored.

Waktu pendinginan / suhu dipantau

68. Formulation control implemented.

Formulasi kontrol diimplementasikan

69. pH control implemented.

Ph control telah diimplementasikan

70. Preservatives, low water activity or other preservation factors used.

Pengawet, aktivitas air yang rendah atau faktor pelestarian lain yang digunakan.

71. Chemical hazard prevention, removal or destruction.

Pencegahan bahaya kimia, pemindahan atau perusakan



Finding

Attachment

Reference

72. Physical hazard prevention or removal (magnet, metal detector, de-stoner, etc.).

pencegahan bahaya fisik atau penghapusan (magnet, detektor logam, de-Stoner, dll).

73. Personnel hygiene.

Petugas kebersihan

74. Cleaning and sanitation: procedures and frequencies recorded, records maintained of agents used including dosage rates and contact times.

Pembersihan dan sanitasi: prosedur dan frekwensi dicatat,catatan yg dibuat dari bahan yg digunakan termasuk tingkat dosis dan waktu kontak

Corrective actions documented.

Dokumentasi dari corrective action yg telah dilakukan,

75. Prevention of cross-contamination.

Pencegahan kontaminasi silang

76. Proper food handling implemented.

Penanganan proses food secara tepat

77. Proper rework handling implemented.

Penanganan yg tepat proses pekerjaan berulang/rework

78. Allergen handling procedures in place.

Prosedur penanganan allergen secara tepat

79. Equipment maintenance in place.

Perawatan peralatan yg ada di tempat / lokasi

80. Hold / release procedures in place and product identified.

Menerbitkan prosedur atas produk yg telah teridentifikasi

81. Representative product samples taken at appropriate intervals and locations during production to assure uniformity and effectiveness of treatment process. Analysis methods approved by relevant authority.

Sample produk yg mewakili produk yg diambil selama interval waktu dan lokasi selama proses produksi untuk menjamin keseragaman efektivitas proses perawatan . metode analisis di approved oleh orang yg diberi otoritas,



Finding

Attachment

Reference

82. Records maintained of samplings: date, water, product type, production code, results and maintained for specified time. Current certificates or notifications of approval authority on file.

Catatan yg dibuat dari sampling ; tanggal, bahan cair, tipe produk, kode produksi, dan hasilnya dimaintain / dipelihara untuk jangka wkt tertentu. Sertifikat yg saat ini ada atau surat pernyataan dari yg diberi otoritas sesuai dengan yg ada di file,

83. Records maintained of volume produced, date produced, lot code used. Data2/ record yg sdh ada dan di maintainmengenai volume produksi, kode produksi yg dipakai,

Post Processing Handling (Human Handling, Conveyors, Chillers and Freezers,

Post Process Cutting and Slicing, Fabrication and Packaging)

Penanganan pasca pengolahan ( penangan oleh manusia, conveyor, chillers dan pendingin )

Proses pasca pemotongan dan pengirisan, fabrikasi dan pengemasan

84. Primary packaging containers and closures nontoxic.

Container tempat penyimpanan dan penutupnya dipastikan tdk beracun

85. Packaging and sealing monitored. Containers visually or electronically inspected.

Proses Pengemasan dan penyegelan harus dimonitor . memeriksa container secara visual dan elektronik

86. Prevention of cross-contamination including shipping containers.

Pencegahan kontaminasi silang termasuk pengapalan container tsb

87. Temperature and time controlled.

Pengawasan atas temperature / suhu dan waktu

88. Equipment sanitation implemented.

Mengimplementasikan sanitasi atas peralatan yg digunakan

89. Environmental sanitation implemented

Mengimplementasikan sanitasi lingkungan

90. Employee hygiene.

Kebersihan karyawan

91. Food handling.

Penanganan makanan


Identifikasi Bahaya fisik

93. Storage conditions.

Kondisi penyimpanan

94. Coding / Tracking clear and in place.

Pemberian kode / nomor yg jelas pada setiap tempat



Finding

Attachment

Reference

95. Proper rework handling to avoid recontamination of product equipment or packaging.

Penanganan ulang yg tepat untuk menghindari kontaminasi atas peralatan produk atau pengemasan

96. Hold / release procedures in place and product identified.

Menerbitkan prosedur di lokasi dan identifikasi produk

Storage, Distribution and Use by Consumer

Penyimpanan , distribusi, dan penguunaan oleh konsumen


Menghilangkan bahaya fisik

98. Temperature / time control.

Suhu / pengontrolan waktu

99. Stock Rotation.

Rotasi atas stok

100. Sanitation in storage.

Sanitasi dalam penyimpanan

101. Temperature control in distribution.

Pengontrolan suhu dalam distibusi produk

102. Sanitation in distribution.

Sanitasi dalam pendistribusian produk

103. Coding / Tracking clear and in place.

Pemberian kode / pelacakan secara jelas di lokasi

104. Instructions on container clear and in place.

Petunjuk yg jelas dalam container yg ada di lokasi

Customer Preparation, Cooking and Handling of Product and of Unused Portions

Persiapan customer, pemasakan dan penanganan produk dan bagian2 yg tdk digunakan

105. Storage instructions on container.

Instruksi penyimpanan di kontainer

106. Shelf-life instructions on container.

Masa berlaku container

107. Cooking instructions on container.

Instruksi ttg pemasakan di container

108. Leftover handling instructions on container.

Instruksi sisa penanganan kelebihan produksi pada container

109. Instruction on what to do if product received damaged, found spoiled or is otherwise found defective.

Intruksi ttg apa yg akan dilakukan apabila produk yg diterima rusak , atau ditemukan cacat



Finding

Attachment

Reference

Personnel

110. Overall sanitation of plant and personnel under supervision of assigned individual.

Secara keseluruhan sanitasi atas tanaman dan karywan dibawah pengawasan orang yg kompeten

111. Personnel with disease in communicable form excluded from work in any capacity where there is reasonable possibility of product contamination or transmittal to other individuals.

Karyawan yg mengidap penyakit menular tdk diperkenankan bekerja dimana kemungkinan bisa memberi kontaminasi pada produk dan orang lain .

112. Personnel practices: clean outer garments worn, personal cleanliness exhibited, effective hair restraints used, no tobacco used in any form, no eating at work stations, permitted jewellery only worn, illness reported to management

Kegiatan karyawan: pakaian luar yg dikenakan hrs bersih, termasuk kebersihan barang pribadi, pengkunciran rambut bagi wanita, tdk menggunakan tembakau dlm bentuk apapun, tdk makan di tempat kerja, perhiasan bisa dipakai, yg menderita penyakit dilaporkan ke management.

Auditing & Corrective Action

113. System for auditing GMP

System audit GMP

114. Corrective action taken in response to GMP nonconformances

Melakukan corrective action dan rsepon terhadap NC dari GMP

115. GMP being practised.

Telah mengimplementasikan GMP

Audited by Date

A Non-Conformance Report (Q256) or a System Failure Report (QEF09) must be completed for each critical or major deficiency and attached to this report. A Discrepancy/Observation Sheet (Q0473) can also be used as an attachment.

1. For AQIS audits, refer Schedule 7 of Export Control Orders for defect categories.

2. For VMA refer HAP06. Related Documents: 1. For the checklist relevant to the elements of ISO 9001/9002 audited, refer to the QEC System

Audit Checklist (Q3006) for all elements. 2. For further details of AQIS requirements, refer to AQIS Export Control (Processed Food)

Orders Schedules 2 and 3.


3. SQF 2000.

4. A Guide to the Implementation and Auditing of HACCP-SCARM Report No. 60.

5. HACCP Plan Review Checklist - HAF 03. 6. Other Regulatory Requirements, such as ANZFA Food Standards Code and appropriate State

Health/Food Acts and regulations.


Definitions

The following definitions have been taken from the Codex Alimentarius Commission Alinorm 97/13: Annex 1 to Appendix 2. It should be noted that these definitions are in the final stages of adoption by Codex.

AQL Acceptable Quality Level of a sample lot measured by inspection and tested against predetermined objective criteria (see Critical Limits).

Control (verb) To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP Plan.

Control (noun) The state wherein correct procedures are being followed and criteria are being met.

Control Measures Actions and activities that can be used to prevent or eliminate a food safety hazard or

reduce it to an acceptable level.

Corrective Actions

Actions to be taken when the results of monitoring at the CCP indicate a loss of control.

CCP See Critical Control Point.

Critical Control Point

A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical Limit A criterion which separates acceptability from unacceptability.

HACCP A system which identifies, evaluates and controls hazards that are significant for food safety.

HACCP Plan A document prepared in accordance with the principles of HACCP to ensure control of hazards that are significant for food safety in the segment of the food chain under consideration.

Hazard A biological, chemical or physical agent or factor with the potential to cause an adverse health effect.

Hazard Analysis The process of collecting and evaluating information on hazards and conditions to decide which hazards and conditions are significant for food safety and therefore should be addressed in the HACCP plan.

Monitoring The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.

Step A point, procedure, operation or stage in the food chain, including raw materials, from primary production to final consumption.

Verification The application of methods, procedures and tests, in addition to those used in monitoring, to determine compliance with the HACCP plan, and/or whether the HACCP plan needs modification