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Universitas Pasundan

FSSC 22000-based
Food Safety Management System
Awareness

Food Safety System Certification (FSSC)


22000

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International Standard for Food Safety System

Hazard HACCP is the most recognizable and


acceptable food safety system

Food Safety System

There are a lot of Food Safety


standards based on HACCP Codex
Food Safety System
is needed to prevent
hazard from food

ISO 22000:2005  to harmonize on a global level the


requirements for food safety management for businesses
within the food chain
22000
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International Standard for Food Safety System

ISO 22000:2005  is it the best standard for


Food Safety Management System?

ISO 22000:2005 does not


specify requirements for PRP!

ISO 22000
Certified

HACCP
Communication

?
PRP

System Management

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ISO 22000
HACCP
Communication
PRP
PRP
(PAS 220)
ISO 22003
System Management

Manufacturers that are already certified against ISO


22000 will only need an additional review against BSI
PAS 223 to meet this certification scheme

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FSSC 22000 version 3


Additional Requirement

1. Specifications for services


The organization in the food chain shall ensure that all services
(including utilities, transport and maintenance) which are provided and
may have an impact on food safety:
a. shall have specified requirements,
b. shall be described in documents to the extent needed to conduct
hazard analysis,
c. shall be managed in conformance with the requirements of
technical specification for sector PRPs.
Reference: ISO 22000, clauses 7.2.3.f and 7.3.3

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FSSC 22000 version 3


Additional Requirement

2. Supervision of personnel in application of food safety principles


The organization in the food chain shall ensure the effective
supervision of the personnel in the correct application of the food
safety principles and practices commensurate with their activity.
Reference: ISO 22000, clause 6.2.2

3. Specific regulatory requirements


Organizations seeking certification shall assure that specifications for
ingredients and materials take account of any applicable regulatory
requirements [e.g. control of prohibited substances].

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FSSC 22000 version 3


Additional Requirement

4. Announced, but unscheduled audits of certified organisations


The certification body will participate in a risk based programme of
office audits and announced, but unscheduled, audits of certified
organisations. These audits shall be carried out in accordance to the
GFSI requirements.

5. Management of Inputs
The organization shall implement a system to assure that analysis of
inputs critical to the confirmation of product safety is undertaken. The
analyses shall be performed to standards equivalent to those described
in ISO 17025.

Note: If an additional requirement refers to a subject that also is addressed in one or more of the
standards mentioned in the sections 3.1 and 3.2 of Part I, the applicable clause(s) of these
standard(s) is/are indicated in the reference at the end of the section with the additional requirement.

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Universitas Pasundan

FSSC 22000-based
Food Safety Management System
Awareness

ISO 22000 Requirements

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Clauses of ISO 22000:2005


1 Scope
2 Normative Reference
3 Terms and Definition
4 Food Safety Management System
4.1 General Requirements
4.2 Documentation Requirements
5 Management Responsibility
5.1 Management Commitment
5.2 Food Safety Policy
5.3 Food Safety Management System Planning
5.4 Responsibility and Authority
5.5 Food Safety Team Leader
5.6 Communication
5.7 Emergency Preparedness and Response
5.8 Management Review
6 Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
7 Planning and Realization of Safe Product
7.1 General
7.2 Prerequisite Programs (PRPs)
7.3 Preliminary Steps to Enable Hazard Analysis
7.4 Hazard Analysis
7.5 Establishing The Operational Prerequisite Programs (PRPs)
7.6 Establishing The HACCP Plan
7.7 Updating of Preliminary Information and Documents Specifying the PRPs and The HACCP Plan
7.8 Verification Planning
7.9 Traceability System
7.10 Control of Nonconformity
8 Validation, Verification, and Improvement of The Food Safety Management System
8.1 General
8.2 Validation of Control Measure Combinations
8.3 Control of Monitoring and Measuring
8.4 Food Safety Management System Verification
8.5 Improvement

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4 Food Safety Management System 4 Food Safety Management System


4.1 General Requirements Hanya judul
4.2 Documentation Requirements
4.2.1 General
4.2.2 Control of Documents 4.1 General Requirements
4.2.3 Control of Records
- Organisasi harus punya FSMS
5 Management Responsibility - Harus ada Ruang Lingkup
5.1 Management Commitment
5.2 Food Safety Policy - Eksternal Proses harus diidentifikasi
5.3 Food Safety Management System Planning
5.4 Responsibility and Authority
5.5 Food Safety Team Leader
5.6 Communication
5.6.1 External Communication
5.6.2 Internal Communication 4.2.1 General
5.7 Emergency Preparedness and Response - Apa saja yang harus disertakan dalam Dokumentasi
5.8 Management Review
5.8.1 General FSMS
5.8.2 Review Input
5.8.3 Review Output
4.2.2 Control of Documents
6 Resource Management - Harus ada prosedur pengendalian dokumen
6.1 Provision of Resources - Apa saja yang harus tercakup dalam prosedur
6.2 Human Resources
6.2.1 General tersebut
6.2.2 Competence, Awareness, and Training
6.3 Infrastructure
6.4 Work Environment
4.2.3 Control of Records
- Harus ada prosedur pengendalian record
- Apa saja yang harus tercakup dalam prosedur
tersebut

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5 Management Responsibility
4 Food Safety Management System Hanya judul
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General 5.1 Management Commitment
4.2.2 Control of Documents
4.2.3 Control of Records - Manajemen Puncak harus memiliki komitmen terhadap
FSMS
5 Management Responsibility
5.1 Management Commitment
5.2 Food Safety Policy 5.2 Food Safety Policy
5.3 Food Safety Management System Planning - Harus ada kebijakan keamanan pangan  ditetapkan,
5.4 Responsibility and Authority
5.5 Food Safety Team Leader didokumentasikan, dikomunikasikan
5.6 Communication - Apa saja syarat kebijakan tersebut
5.6.1 External Communication
5.6.2 Internal Communication
- Harus didukung sasaran keamanan pangan
5.7 Emergency Preparedness and Response
5.8 Management Review
5.8.1 General 5.3 Food Safety Management System Planning
5.8.2 Review Input - Harus ada Action Plan untuk FSMS dan untuk masing-
5.8.3 Review Output
masing sasaran
6 Resource Management - Keterpaduan FSMS harus terpelihara jika ada perubahan
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Awareness, and Training 5.4 Responsibility and Authority
6.3 Infrastructure
6.4 Work Environment - Harus ada Job description yang berhubungan dengan
FSMS

5.5 Food Safety Team Leader


- Ketua Tim Keamanan Pangan harus ditunjuk
- Apa saja tanggung jawab Ketua Tim

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4 Food Safety Management System 5.6.1 External Communication


4.1 General Requirements - Harus ada rencana komunikasi eksternal
4.2 Documentation Requirements - Ke siapa saja komunikasi eksternal dilakukan
4.2.1 General
4.2.2 Control of Documents
4.2.3 Control of Records 5.6.2 Internal Communication
5 Management Responsibility - Harus ada rencana komunikasi internal
5.1 Management Commitment - Perubahan apa saja yang harus dikomunikasikan
5.2 Food Safety Policy
5.3 Food Safety Management System Planning
5.4 Responsibility and Authority
5.5 Food Safety Team Leader
5.6 Communication 5.7 Emergency Preparedness and Response
5.6.1 External Communication
5.6.2 Internal Communication - Harus ada prosedur untuk mengelola situasi darurat
5.7 Emergency Preparedness and Response yang berpengaruh terhadap keamanan pangan
5.8 Management Review
5.8.1 General
5.8.2 Review Input
5.8.3 Review Output
5.8.1 General
6 Resource Management
6.1 Provision of Resources
- Management Review harus dilakukan secara rutin
6.2 Human Resources
6.2.1 General 5.8.2 Review Input
6.2.2 Competence, Awareness, and Training
6.3 Infrastructure - Apa saja yang harus jadi input
6.4 Work Environment
5.8.3 Review Output
- Apa saja yang harus jadi output

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6 Resource Management
4 Food Safety Management System
4.1 General Requirements
Hanya judul
4.2 Documentation Requirements
4.2.1 General
4.2.2 Control of Documents 6.1 Provision of Resources
4.2.3 Control of Records - Harus disediakan sumberdaya yang cukup untuk FSMS
5 Management Responsibility
5.1 Management Commitment
5.2 Food Safety Policy
5.3 Food Safety Management System Planning 6.2.1 General
5.4 Responsibility and Authority - Kompetensi Tim Keamanan Pangan dan orang yang
5.5 Food Safety Team Leader
5.6 Communication
berhubungan dengan FSMS harus sesuai
5.6.1 External Communication - Kalau pakai ahli eksternal, harus ada kontraknya
5.6.2 Internal Communication
5.7 Emergency Preparedness and Response
5.8 Management Review 6.2.2 Competence, Awareness, and Training
5.8.1 General - Kompetensi harus diidentifikasi
5.8.2 Review Input
5.8.3 Review Output
- Harus ada program training untuk orang-orang terkait
- Orang-orang terkait harus peduli
6 Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, Awareness, and Training
6.3 Infrastructure 6.3 Infrastructure
6.4 Work Environment - Infrastruktur yang mendukung FSMS harus tersedia

6.4 Work Environment


- Lingkungan kerja tersedia dengan baik

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7 Planning and Realization of Safe Product 7 Planning and Realization of Safe Product
7.1 General
7.2 Prerequisite Programs (PRPs)
Hanya judul
7.2.1 Establishing, Implementing, and
Maintaining PRPs 7.1 General
7.2.2 The Condition of PRPs
7.2.3 Consideration when Selecting and/or - Proses untuk realisasi produk yang aman harus
Establishing PRPs direncanakan, dikembangkan, dan diimplementasikan
7.3 Preliminary Steps to Enable Hazard Analysis
7.3.1 General
7.3.2 Food Safety Team
7.3.3 Product Characteristics
7.3.3.1 Raw Materials, 7.2.1 PRP harus ditetapkan, diimplementasi, dan dipelihara
Ingredients, and Product-Contact
Materials
(+ gunanya)
7.3.3.2 Characteristic of End
Products 7.2.2 Syarat-syarat PRP
7.3.4 Intended Use
7.3.5 Flow Diagrams, Process Steps, and
Control Measures 7.2.3 Hal-hal yang harus dipertimbangkan saat memilih
7.3.5.1 Flow Diagrams
7.3.5.2 Description of Process Step
dan/atau menetapkan PRP; Contoh-contoh PRP
and Control Measures

7.3.1 General
- Informasi untuk hazard analysis harus tersedia

7.3.2 Food Safety Team


- Tim harus ditunjuk
- Tim harus multidisiplin
- Tim harus punya pengetahuan dan pengalaman yang
sesuai

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7 Planning and Realization of Safe Product


7.1 General 7.3.3.1 Raw Materials, Ingredients, and Product-Contact
7.2 Prerequisite Programs (PRPs) Materials
7.2.1 Establishing, Implementing, and
Maintaining PRPs - Harus dideskripsikan
7.2.2 The Condition of PRPs - Apa saja isi deskripsinya
7.2.3 Consideration when Selecting and/or
Establishing PRPs
7.3 Preliminary Steps to Enable Hazard Analysis 7.3.3.2 Characteristic of End Products
7.3.1 General - Harus dideskripsikan
7.3.2 Food Safety Team
7.3.3 Product Characteristics - Apa saja isi deskripsinya
7.3.3.1 Raw Materials,
Ingredients, and Product-Contact
Materials 7.3.4 Intended Use
7.3.3.2 Characteristic of End
Products - Harus ada deskripsi rencana penggunaan, kemungkinan
7.3.4 Intended Use kesalahan penggunaan, grup pengguna, kelompok khusus
7.3.5 Flow Diagrams, Process Steps, and
Control Measures
7.3.5.1 Flow Diagrams
7.3.5.2 Description of Process Step
and Control Measures 7.3.5.1 Flow Diagrams
- Diagram alir harus dibuat
- Apa saja yang harus ada di dalamnya

7.3.5.2 Description of Process Step and Control Measures


- Harus ada desrkripsi tindakan pengendalian, termasuk yang
berasal dari persyaratan eksternal

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7.4 Hazard Analysis


7.4.1 General
7.4.1 General
7.4.2 Hazard Identification and - Hazard analysis harus dilakukan
Determination of Acceptable Level
7.4.2.1 Identification of Hazard
7.4.2.2 Consideration when 7.4.2.1 Bahaya harus diidentifikasi mulai RM, proses, sampai
Identifying The Hazard
7.4.2.3 Determination of distribusi
Acceptable Level
7.4.3 Hazard Assessment 7.4.2.2 Hal-hal yang harus dipertimbangkan saat identifikasi
7.4.4 Selection and Assessment of Control
Measures bahaya
7.5 Establishing The Operational Prerequisite
Programs (PRPs)
7.6 Establishing The HACCP Plan 7.4.2.3 Untuk tiap bahaya harus ditentukan acceptable level-
7.6.1 HACCP Plan nya (+ hal-hal yang jadi pertimbangan)
7.6.2 Identification of Critical Control Points
(CCPs)
7.6.3 Determination of Critical Limits for
Critical Control Points 7.4.3 Hazard Assessment
7.6.4 System for Monitoring of Critical
Control Points - Harus dilakukan hazard assessment berdasarkan
7.6.5 Actions when Monitoring Results kemungkinan terjadinya dan tingkat keparahan
Exceed Critical Limits
7.7 Updating of Preliminary Information and
Documents Specifying the PRPs and The HACCP Plan 7.4.4 Selection and Assessment of Control Measures
7.8 Verification Planning
- Tindakan pengendalian harus ditentukan dan dikategorikan
untuk dikendalikan dengan OPRP atau HACCP Plan

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7 7.5 Establishing
Planning
7.1
The
and Realization
General
Operational
of Safe Product Prerequisite Programs (PRPs)
7.2 Prerequisite Programs (PRPs)
7.2.1 Establishing, Implementing, and Maintaining PRPs 7.8
Tabel Operational PRP
7.2.2 The Condition of PRPs
7.2.3 Consideration when Selecting and/or Establishing PRPs
7.3 Preliminary Steps to Enable Hazard Analysis
No. 7.3.1 Bahaya
General OPRP Monitoring Koreksi Langsung Tindakan Koreksi Tanggung Jawab Verifikasi Dokumentasi
7.3.2 Food Safety Team
(Tindakan dan Wewenang
7.3.3 Product Characteristics
Pengendalian)
7.3.3.1 Raw Materials, Ingredients, and Product-Contact Materials
7.3.3.2 Characteristic of End Products
7.3.4 Intended Use
7.3.5 Flow Diagrams, Process Steps, and Control Measures
7.3.5.1 Flow Diagrams
7.3.5.2 Description of Process Step and Control Measures
7.4 Hazard Analysis
7.4.1 General
HACCP
7.4.2 Hazard Identification and Determination of Acceptable Level
7.4.2.1 Identification of Hazard
OPRP? Plan?
7.4.2.2 Consideration when Identifying The Hazard
7.4.2.3 Determination of Acceptable Level
7.4.3 Hazard Assessment
7.4.4 Selection and Assessment of Control Measures
7.5 Establishing The Operational Prerequisite Programs (PRPs)
7.6 Establishing The HACCP Plan
7.6.1 HACCP Plan
7.6.2 Identification of Critical Control Points (CCPs)
7.6.3 Determination of Critical Limits for Critical Control Points
7.6.4 System for Monitoring of Critical Control Points
7.6.5 Actions when Monitoring Results Exceed Critical Limits
7.7 Updating of Preliminary Information and Documents Specifying the PRPs and The HACCP Plan
7.8 Verification Planning

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7.4 Hazard Analysis


7.4.1 General
7.6.1 HACCP Plan
7.4.2 Hazard Identification and - Apa saja yang harus ada di HACCP Plan
Determination of Acceptable Level
7.4.2.1 Identification of Hazard
7.4.2.2 Consideration when 7.6.2 Identification of Critical Control Points (CCPs)
Identifying The Hazard - Untuk setiap bahaya yang dikendalikan dengan HACCP Plan,
7.4.2.3 Determination of
Acceptable Level CCP harus diidentifikasi
7.4.3 Hazard Assessment
7.4.4 Selection and Assessment of Control
Measures 7.6.3 Determination of Critical Limits for Critical Control Points
7.5 Establishing The Operational Prerequisite - Untuk setiap CCP harus ditentukan Critical Limit yang bisa
Programs (PRPs)
7.6 Establishing The HACCP Plan diukur
7.6.1 HACCP Plan
7.6.2 Identification of Critical Control Points
(CCPs)
7.6.3 Determination of Critical Limits for 7.6.4 System for Monitoring of Critical Control Points
Critical Control Points - Untuk setiap CCP harus ditetapkan sistem monitoring
7.6.4 System for Monitoring of Critical
Control Points - Prosedur, instruksi, dan record apa saja yang harus ada
7.6.5 Actions when Monitoring Results
Exceed Critical Limits
7.7 Updating of Preliminary Information and
Documents Specifying the PRPs and The HACCP Plan
7.8 Verification Planning 7.6.5 Actions when Monitoring Results Exceed Critical Limits
- Harus ada rencana koreksi langsung dan tindakan korektif
jika critical limit terlampaui
- Akar masalah harus diidentifikasi

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7.4 Hazard Analysis


7.4.1 General
7.4.2 Hazard Identification and
Determination of Acceptable Level
7.4.2.1 Identification of Hazard
7.4.2.2 Consideration when
Identifying The Hazard
7.4.2.3 Determination of
Acceptable Level
7.4.3 Hazard Assessment
7.4.4 Selection and Assessment of Control
Measures
7.5 Establishing The Operational Prerequisite
Programs (PRPs)
7.6 Establishing The HACCP Plan
7.6.1 HACCP Plan
7.6.2 Identification of Critical Control Points
(CCPs)
7.6.3 Determination of Critical Limits for 7.7 Updating of Preliminary Information and Documents
Critical Control Points
7.6.4 System for Monitoring of Critical Specifying the PRPs and The HACCP Plan
Control Points - Hal-hal yang harus diupdate setelah penetapan OPRP dan
7.6.5 Actions when Monitoring Results
Exceed Critical Limits
HACCP Plan
7.7 Updating of Preliminary Information and
Documents Specifying the PRPs and The HACCP Plan
7.8 Verification Planning 7.8 Verification Planning
- Rencana Verifikasi harus dibuat
- Apa saja yang harus diverifikasi
- Hasil verifikasi dikomunikasikan dan dianalisis

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7.9 Traceability System


7.9 Traceability System
7.10 Control of Nonconformity - Harus ada sistem mampu telusur yang mampu melacak
7.10.1 Corrections produk sampai ke penggunaan material dan tujuan distribusi
7.10.2 Corrective Actions
7.10.3 Handling of Potentially Unsafe
Products
7.10.3.1 General
7.10.3.2 Evaluation of Release 7.10.1 Correction
7.10.3.3 Disposition of - Koreksi langsung harus dilakukan jika critical limit terlampaui
Nonconforming Products
7.10.4 Withdrawals
- Produk yang terpengaruh harus dikontrol

8 Validation, Verification, and Improvement of


The Food Safety Management System
8.1 General 7.10.2 Corrective Action
8.2 Validation of Control Measure Combinations
8.3 Control of Monitoring and Measuring - Tindakan Korektif harus dilakukan jika critical limit
8.4 Food Safety Management System terlampaui atau ada penerapan OPRP yang tidak sesuai
Verification
8.4.1 Internal Audit
8.4.2 Evaluation of Individual Verification
Results
8.4.3 Analysis of Results of Verification 7.10.3.1 General
Activities - Harus ada cara penanganan produk yang tidak aman
8.5 Improvement
8.5.1 Continual Improvement - Produk yang terpengaruh harus ditahan
8.5.2 Updating The Food Safety - Kalau terlanjur keluar, harus ada pemberitahuan dan
Management System
dilakukan penarikan

7.10.3.2 Evaluation of Release


- Dasar-dasar untuk melepas produk yang terpengaruh oleh
ketidaksesuaian

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7.9 Traceability System


7.10 Control of Nonconformity
7.10.1 Corrections
7.10.2 Corrective Actions
7.10.3 Handling of Potentially Unsafe
Products 7.10.3.3 Disposition of Nonconforming Products
7.10.3.1 General
7.10.3.2 Evaluation of Release - Produk yang tidak dapat diterima harus di proses ulang
7.10.3.3 Disposition of atau dimusnahkan
Nonconforming Products
7.10.4 Withdrawals
7.10.4 Withdrawals
8 Validation, Verification, and Improvement of
The Food Safety Management System - Harus ada prosedurnya
8.1 General - Produk yang ditarik harus diamankan
8.2 Validation of Control Measure Combinations
8.3 Control of Monitoring and Measuring
- Perlu dilakukan Mock Withdrawal
8.4 Food Safety Management System
Verification
8.4.1 Internal Audit
8.4.2 Evaluation of Individual Verification
Results
8.4.3 Analysis of Results of Verification
Activities
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Updating The Food Safety
Management System

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8 Validation, Verification, and Improvement of The Food Safety


7.9 Traceability System
7.10 Control of Nonconformity Management System
7.10.1 Corrections Hanya judul
7.10.2 Corrective Actions
7.10.3 Handling of Potentially Unsafe
Products 8.1 General
7.10.3.1 General - Tim Keamanan Pangan harus melakukan validasi [kombinasi]
7.10.3.2 Evaluation of Release
7.10.3.3 Disposition of
tindakan pengendalian serta memverifikasi dan
Nonconforming Products meningkatkan FSMS
7.10.4 Withdrawals

8 Validation, Verification, and Improvement of 8.2 Validation of Control Measure Combinations


The Food Safety Management System - Tindakan pengendalian dan kombinasinya harus divalidasi
8.1 General
8.2 Validation of Control Measure Combinations sebelum implementasi dan jika ada perubahan
8.3 Control of Monitoring and Measuring - Jika hasilnya tidak sesuai, harus dimodifikasi
8.4 Food Safety Management System
Verification
8.4.1 Internal Audit
8.4.2 Evaluation of Individual Verification
Results 8.3 Control of Monitoring and Measuring
8.4.3 Analysis of Results of Verification - Harus ada bukti bahwa metode dan alat ukur memadai 
Activities
8.5 Improvement dikalibrasi, diverifikasi, ditera, dilindungi
8.5.1 Continual Improvement - Jika alat ukur tidak sesuai harus ada tindakan
8.5.2 Updating The Food Safety
Management System
8.4.1 Internal Audit
- Harus ada audit internal yang dilakukan secara berkala

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8.4.2 Evaluation of Individual Verification Results


7.9 Traceability System
7.10 Control of Nonconformity
- Harus ada evaluasi hasil masing-masing verifikasi (7.8)
7.10.1 Corrections - Jika tidak sesuai, harus ada tindakan
7.10.2 Corrective Actions
7.10.3 Handling of Potentially Unsafe
Products
7.10.3.1 General 8.4.3 Analysis of Results of Verification Activities
7.10.3.2 Evaluation of Release
7.10.3.3 Disposition of
- Harus dilakukan analisis hasil verifikasi termasuk audit
Nonconforming Products internal dan eksternal (+ tujuan analisis)
7.10.4 Withdrawals - Hasil analisis  untuk input management review dan
8 Validation, Verification, and Improvement of updating FSMS
The Food Safety Management System
8.1 General
8.2 Validation of Control Measure Combinations 8.5.1 Continual Improvement
8.3 Control of Monitoring and Measuring
8.4 Food Safety Management System
- Top management harus memastikan bahwa keefektifan FSMS
Verification selalu meningkat secara terus-menerus (+ beberapa hal yang
8.4.1 Internal Audit digunakan untuk improvement)
8.4.2 Evaluation of Individual Verification
Results
8.4.3 Analysis of Results of Verification
Activities
8.5 Improvement 8.5.2 Updating The Food Safety Management System
8.5.1 Continual Improvement - Top Management harus memastikan bahwa FSMS terus-
8.5.2 Updating The Food Safety
Management System menerus diperbaharui
- FSMS dievaluasi secara berkala oleh tim
- Dasar-dasar yang digunakan untuk evaluasi dan
pembaharuan
- Hasilnya untuk input management review

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