ISO 22000 Food Safety Management System Simon Leung

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Nowaday , food safety…

� New buzz words: BSE, E-Coli outbreaks, C3H6N6, Di(2-ethylhexyl) phthalate

� On the Retailer association CIES : top of mind survey in 2004 and 2005 => Food Safety (1st concern)

� Media and politican : extensive coverage of food safety stories

� On people’s minds: Consumer nervousness

� On Governments’ mind: Increasing regulatory pressure

� In operation mind: Increasingly complex global supply chains ??

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The Catastrophe .of large dairy company

-A large Japanese dairy group has suffer from food poisoning , the result is ..

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And their consequences

� 14,000+ people suffered from vomiting and diarrhea

� Product recalled

� Retailers refuse to stock any of the company’s products

� 21 factories temporarily closed

� 30% drop in share value

� Sales drop from $US13.2b to $US11.5 b

� Profit goes from $US230m profit to negative $US538m

� Downgrading of credit rating

� 1,300 people loss their job (20% reduction)

� Executive salaries cut by 30%

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Ensuring Food Safety means managing a supply chain...

...that is:

� Global

� Complex

� Non competitive

� Moving and changing ALL the time

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Proliferation of standards in the Supply Chain

• HACCP - based on Codex Alimentarius Guidelines, USFDA 21 CFR part 110,123, Singapore standard (SS 444), Canadian Food Inspection Agency’s Food safety Enhancement Program (FSEP) ETC.

• HACCP Accredited – RVA scheme

• SQF/BRC/IFS- Retailer scheme, based on HACCP and ISO 9001:2008

• Eurepgap

• GMP/GTP/GHP/GDP- good hygiene practice

• Non security standards – Organics, FairTrade, etc.

Storage, Retail and Distribution

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� Traceability ? => No overall product control

� Total Supply Chain control? => No overall management

� Communications ? => No overall reaction capability

� Mutual recognition? => Confusion and over-work

Food supply chain management systems are not integrated

GrowerValue

adding #1Storage

Transport#2

Value adding #2

Transport#1

Transport#3

Packaging

Sale

CleaningServices

EurepgapISO9000

BRCISO9000

IFSInternalQMS

GMPHACCP

IFS

ISO9000 GTP

HACCP

CoC FSCBRC

ISO9001

Audits bycustomer

Food ChainElement

ManagementSystem

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The problem...

� Multiple systems – client(2nd party) / Certification body (3rd party)

• Often (always?) focusing on the same thing

• Countless audits, procedures, documents, manuals etc.

• Lack of recognition of any single scheme

� High costs of setting up and maintaining multiple systems for producers, transformers, retailers AND clients

� Confusion, both internal and external

� Continued disruption of business

� High costs passed to consumers AND reducing overall profits

� Small producers driven out of business due to too high costs

� Consumers confused regarding the value of “quality / security labels”

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The food supply chain need …

ONE Management Systems that cover all management issues / activities of the food supply chain

• Integrating the approach to food safety over business processes

• Mutual recognition (if possible) of existing standards

• Can be traceable in supply chain system

• Recognized and implementable throughout the supply chain

• Based on an auditable standard allowing compliance verification

• Single management system planning / review session

• Communication food hazard/risk through out the supply chain

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• Management responsibility ( Commitment, policy, objective, resource, documentation etc)

• Hazard management: recognized HACCP approach and other hazard management system

• Traceability– Product items

– Through the whole value chain

• Communication– between all elements of the system

– down to the consumer

An effective integrated food safety system must cover...

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ISO 22000 the answer….

Goals

� To harmonize at a global level the requirements for food safety management throughout the food chain

� To be used by organizations that seek more focused, coherent and integrated food safety management system than normally required by law.

� Auditable standard

Prepared by Technical Committee ISO/TC34,Food products

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ISO 22000:2005

1. Scope

2. Normative reference

3. Definition

4. Food safety management system

5. Management Responsibility

6. Resource management

7. Planning and realization of safe products

8. Validation, verification and improvement of the food safety management system

� Annex A: Cross reference with ISO9001

� Annex B: Cross reference with HACCP

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4.1 General Requirements

4.2 Document requirements

4.2.1The FSMS

4.2.2Control of documents

4.2.3Control of records

4.0 Food safety management system

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5.0 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

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5.6 Communication

5.6.1 External communication

5.6.2 Internal communication

5.7 Emergency preparedness response

5.8 Management review

5.8.1 General

5.8.2 Review input

5.8.3 Review output

5.0 Management responsibility

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6.0 Resource management

6.1 Provision of resource

6.2 Human resource

6.2.1 General

6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work environment

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7.0 Planning and realization of safe products

7.1 General :plan & develop process for safe product

7.2 Prerequisite programs

7.2.1 shall establish, implement and maintain PRPs to

assist in controlling

7.2.2 The PRPs shall be appropriate to the organization

,size and type of the operation and approved by the

food safety team

7.2.3 Consider and utilize appropriate information e.g.

regulation ,customer requirement.

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7.3.1 General:

relevant information needed and maintained records

7.3.2 Food safety team

7.3.3 Product characteristics

7.3.4 Intended used

7.3.5 flow diagram, process steps and measures

7.0 Planning and realization of safe products

7.3 Preliminary steps to enable hazard analysis

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7.4 Hazards analysis

7.4.1 General:

Food Safety team shall conduct a hazard analysis

7.4.2 Hazard identification and determination of

acceptable level

7.4.3 hazard assessment

7.4.4 Selection and assessment of control measure

7.0 Planning and realization of safe products

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7.5 Establishing the operation prerequisite programs

Operational PRPs and their control measures shall be documented and shall include the following information

� The identified food safety hazards and their methods of control

� Monitoring procedures including records

� The correctives and corrective actions

� The identification of responsibility and authority

7.0 Planning and realization of safe products

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7.6 Establishing the HACCP plan

7.6.1 HACCP plan - documented for CCP

�Food safety hazards to be controlled

�Control measures

�Critical limits

�Monitoring procedures

�Actions to be taken if critical limits are exceeded

�Responsibility for monitoring

�Records of monitoring

7.0 Planning and realization of safe products

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7.7 Updating if preliminary information and documents specifying the prerequisite programs and HACCP plan

7.8 Verification planning

7.9 Traceability system

7.10Control of nonconformity

7.10.1 Correction

7.10.2 Corrective action

7.10.3 Handling of potentially unsafe product

7.10.4 Withdrawals

7.0 Planning and realization of safe products

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8.0 Validation, verification and improvement

of the food safety management system

8.1General : plan and implement

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

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8.5 Improvement

8.5.1 Continual improvement

8.5.2 Food safety management system updating

8.0 Validation, verification and improvement

of the food safety management system

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ISO 22000, a business management tool to...

� identify your impact on the food safety

� control / reduce food safety hazards

� ensure legal compliance

� manage Food safety risk

� reduce costs thanks to more efficient systems

� continuously improve business performance in line with the food safety policy and objectives.

� Can be implemented to different units in the supply chain

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ISO22000 main benefit: integrated communication

•Producers of pesticides, fertilizers and veterinary drugs

•Food chain for the production of ingredients and additives

•Transport and storage operators

•Producers of equipment

•Producers of cleaning agents

•Producers of packaging materials

•Services providers

• other supplying food chains

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Consumers

Crop producers

Feed producers

Primary food producers

2nd food processors

food producers

Wholesalers

Retailers

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Advantages

� Align with other management system standard e.g. ISO9000

� Integrate with existing related management system requirements

� Utilize existing management system to establish a food safety management system

� Apply independently

� Integrate the principle of HACCP and application steps of CODEX.

� Integrate requirements of existing programs – single audits / single management system

� Provide organization with freedom to choose the necessary method to fulfill the requirements

� Allow small and/or less developed organization to implement an externally developed system

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Advantages

� Demonstrate compliance to regulations and legislation on food safety

� Provide confidence to customers, consumers, stakeholders etc.

� Link food safety to business processes

� Require continuous improvement

� Provide recognition throughout the supply chain as single standard approach to Food Safety

ISO 22000

...is controlled and aligned under internationally recognized accreditation and certification requirements AND...

...can be audited against

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