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ISO 22000 Food Safety Management System

Simon Leung

Nowaday , food safety


New buzz words: BSE, E-Coli outbreaks, C3H6N6, Di(2On 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 peoples minds: Consumer nervousness On Governments mind: Increasing regulatory pressure In operation mind: Increasingly complex global supply chains ??
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ethylhexyl) phthalate

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

And their consequences


14,000+ people suffered from vomiting and diarrhea Product recalled Retailers refuse to stock any of the companys 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%

Ensuring Food Safety means managing a supply chain...

...that is: Global Complex Non competitive Moving and changing ALL the time

Proliferation of standards in the Supply Chain

Storage, Retail and Distribution

HACCP - based on Codex Alimentarius Guidelines, USFDA 21 CFR part 110,123, Singapore standard (SS 444), Canadian Food Inspection Agencys 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.

Food supply chain management systems are not integrated


Audits by customer Value adding #1 ISO9000 BRC Transport #1 ISO9000 GTP Cleaning Services CoC FSC Packaging BRC Transport #2 Internal QMS Value adding #2
GMP HACCP IFS

Grower

Storage ISO9000 IFS

Transport #3 HACCP

Sale

Eurepgap

ISO9001

Food Chain Element

Traceability ?

=> No overall product control

Management System

Total Supply Chain control? => No overall management Communications ? Mutual recognition? => No overall reaction capability => Confusion and over-work
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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

An effective integrated food safety system must cover...


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

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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. 2. 3. 4. 5. 6. 7. 8. Scope Normative reference Definition Food safety management system Management Responsibility Resource management Planning and realization of safe products 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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4.0 Food safety management system


4.1 General Requirements 4.2 Document requirements 4.2.1The FSMS 4.2.2Control of documents 4.2.3Control of records

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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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5.0 Management responsibility


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

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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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7.0 Planning and realization of safe products


7.3 Preliminary steps to enable hazard analysis 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

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7.0 Planning and realization of safe products


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

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7.0 Planning and realization of safe products


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

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7.0 Planning and realization of safe products


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

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7.0 Planning and realization of safe products


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

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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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8.0 Validation, verification and improvement of the food safety management system
8.5 Improvement 8.5.1 Continual improvement 8.5.2 Food safety management system updating

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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


Crop producers
Producers of pesticides, fertilizers and veterinary drugs Food chain for the production of ingredients and additives Transport and storage operators Producers of equipment

Regulatory authorities

Feed producers Primary food producers food producers 2nd food processors Wholesalers Retailers

Producers of cleaning agents Producers of packaging materials Services providers

other supplying food chains

Consumers

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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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THANK YOU!
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