Food Safety System Certification 22000

Version 4.1 Implementation Course

FSSC 22000 Overview

 Internationally accredited and recognized food safety scheme
 Uses international and independent standards ISO 22000 and ISO/TS 22002-1/ PAS 220
 Fully recognized by Global Food Safety Initiative (GFSI)

FSSC 22000 Requirements

ISO 22000 Food Safety Management System

 Covers management issues or activities of the food supply chain
 Business management tool to identify our impact on the food safety, control/ reduce food
safety hazards, maximize legal compliance, manage food safety risks, reduce costs and
continually improve business performance in line with food safety policy and objectives
 Designed to address food safety systems problems
 ISO 22000 FSMS is more rigorous than most existing GMP/HACCP and demands more
precise control of documentation

Typical Benefits
 Integrates food safety system together with a solid management system
 Increases efficiency of existing system and improves working method
 Promotes a culture of continuous improvement in manufacturing practices
Other Benefits
 Provides recognition throughout the supply chain as single, standard approach to food
safety
 Demonstrates compliance to regulations and legislation on food safety
 Requires continual (scheduled) improvement

Food Safety Elements

 System management
 HACCP principles
 Prerequisite programs
 Interactive communication

Clauses of ISO 22000

1. Scope
2. Normative reference
3. Definition
4. Food safety management system (FSMS)
5. Management responsibility
6. Resource management
7. Planning and realization of safe products
8. Validation, verification and improvement of the food safety management system

NOTE: Clauses 4 to 8 are AUDITABLE

CLAUSE 4.0- FOOD SAFETY MANAGEMENT SYSTEM

4.1 General Requirements- the organization shall establish, document, implement and
maintain an effective FSMS and update it when necessary.

4.2 Document requirements- ISO 22000 calls for documented procedures in 7 areas:
Control of documents, Control of records, Control of non-conformity, Corrective action,
Appropriate handling of potentially unsafe products, Notification of relevant
interested parties in the event of the withdrawal of unsafe products, Internal audit

4.2.1 The FSMS documentation includes: documented food safety policies and
objectives, procedures and records and documents covering the effective design,
implementation & updating/ improvement of the food safety management system

4.2.2 Control of documents

4.2.3 Control of records

CLAUSE 5.0- MANAGEMENT RESPONSIBILITY

5.1 Management commitment- food safety supported by business objectives;
communication of standard, statutory and legal requirements; established food safety
policy; management reviews; availability of resources
 5.2 Food safety policy- a food safety policy should be appropriate to role in chain; meets
statutory, regulatory and agreed customer requirements; communicated, implemented and
maintained; reviewed; addresses communication; supported by measureable objectives

5.3 Food safety management system planning- carried out to meet requirements given in
4.1 and the objectives of the organization that support food safety

5.4 Responsibility and authority- responsibilities and authorizations defined and

communicated within the organization

5.5 Food safety team leader- FSTL shall be responsible for implementing all aspects of the
FSMS

5.6 Communication
5.6.1 External communication- records of all aspects of external communication is
maintained
5.6.2 Internal communication- records of all aspects of internal communication is
maintained

5.7 Emergency preparedness response- procedures for potential emergency situations

and accidents established, implemented and maintained

5.8 Management review

5.8.1 General- regular reviews planned and records maintained which includes:

5.8.2 Review input- follow-up of previous reviews

5.8.3 Review output- decisions and actions related to assurance of food safety,
system improvement, resource needs

CLAUSE 6.0- RESOURCE MANAGEMENT

6.1 Provision of resources- top management shall provide adequate resources to properly
implement and maintain the FSMS

6.2 Human resources

6.2.1 General- food safety team is competent
6.2.2 Competence, awareness, training

6.3 Infrastructure- resources for the establishment and maintenance of the infrastructure
are provided

6.4 Work environment- resources for work environment are provided

CLAUSE 7.0- PLANNING AND REALIZATION OF SAFE PRODUCTS
Hazards:
Biological- bacteria, viruses, parasites

Chemical- Natural: mycotoxin, ciguatoxin, shellfish toxins, toxic plant alkaloids; Unintentional or
incidentally added chemicals: pesticides, fungicides, antibiotics, heavy metals, lubricants,
cleaning compounds

Physical- glass, metal, wood

7.1 General: Plan and develop process for safe product

7.2 Prerequisite programs
7.2.1 The facility shall establish, implement and maintain PRPs to assist in
controlling hazards

7.2.2 PRPs shall be appropriate to the organization, size and type of operation and
approved by the food safety team

7.2.3 Consider and utilize appropriate information e.g. regulations, customer

requirements

ISO/TS 22002-1 PREREQUISITE PROGRAMMES ON FOOD SAFETY

Basic conditions and activities necessary to maintain hygienic environment throughout the
food chain
 Construction and lay-out of buildings
 Lay-out of premises and workspace
 Utilities: air, water and energy
 Waste disposal
 Equipment suitability, cleaning and maintenance
 Management of purchased materials
 Measures to prevent cross contamination
 Cleaning and sanitizing
 Pest control
 Personnel hygiene and training
Additional aspects:
 Rework
 Product recall procedures
 Warehousing
 Product information/ consumer awareness
 Food defense, biovigilance and bioterrorism

7.3 Preliminary steps to enable hazard analysis

7.3.1 General- all relevant information needed to conduct the hazard analysis shall
be collected, maintained, updated and documented

7.3.2 Food safety team- appointed and multidisciplinary

 7.3.3 Product characteristics
7.3.3.1 Raw materials, ingredients and food contact materials-
documented of all raw materials, ingredients and product contact

7.3.3.2 Characteristics of end products- characteristics of end products

documented for the conduct of hazard analysis

7.3.4 Intended use- need to consider groups of people/ population that can
consume the product

7.3.5 Flow diagrams, process steps and control measures

7.3.5.1 Flow diagrams
7.3.5.2 Description of process steps and control measures

7.4 Hazard analysis

7.4.1 General- FS team shall conduct hazard analysis
7.4.2 Hazard identification and determination of acceptable levels
7.4.3 Hazard assessment- conducted for each food safety hazard
7.4.4 Selection and assessment of control measures

7.5 Establishing the operational prerequisite programmes (PRPs)

7.6 Establishing the HACCP plan

7.6.1 HACCP Plan- shall be documented
7.6.2 Identification of Critical Control Points (CCPs)
7.6.3 Determination of Critical Limits of Critical Control Points
7.6.4 System for monitoring of control points
7.6.5 Actions when monitoring results exceed critical limits

7.7 Updating preliminary information and documents specifying PRP and HACCP plan

7.8 Verification Planning- Validation: assessment prior operation; Verification: assessment

during and after operation; Monitoring: procedure to detect any failures in the control
measure

7.9 Traceability- consideration should be given to the activities of the organization that
might impact on system complexity

7.10 Control of Non-conformity

CLAUSE 8.0- VALIDATION, VERIFICATION & IMPROVEMENT OF THE FSMS

8.1 General- Plan and implement processes for validation of control measures and
verification and improvement of the system planned

8.2 Validation of control measure combinations

8.3 Control of monitoring and measuring

8.4 Food safety management system verification

 8.4.1 Internal audit
8.4.2 Evaluation of individual verification result
8.4.3 Analysis of results of verification activities

8.5 Improvement
8.5.1 Continual improvement
8.5.2 FSMS updating

ADDITIONAL REQUIREMENTS
 Management of services- all services that may have impact on food safety is carefully
addressed
 Product labelling- product should be labelled according to regulation
 Food defense- should be established to address intentional adulteration of products
 Food fraud prevention- should be established to address adulteration on raw materials
used
 Logo use- FSSC Logo should be appropriately used
 Management of allergens- allergen declaration should be available
 Environmental monitoring- organization shall ensure environmental monitoring program
is in place to verify the effectiveness of cleaning and sanitation programs
 Formulation of products- for cat and dog foods only
 Management of natural resources- for category A only (Farming of animals for meat/ milk/
eggs/ honey

Prepared by:

Gilbert S. Agudo
QA Jr. Manager

Noted by:

Lisette Mendoza
Plant Manager