1ISO Workshop on Conformity Assessment, Johannesburg International Organization for Standardization

2ISO Workshop on Conformity Assessment, Johannesburg ISO series by Pauline Jones Former Technical Programme Manager of ISO/TC 34 ISO Regional Workshop on Conformity Assessment 9 and 10 May 2007

3ISO Workshop on Conformity Assessment, Johannesburg Contents Introduction to food safety problems ISO series and TC 34 Codex and HACCP ISO ISO/TS ISO/TS ISO 22005

4ISO Workshop on Conformity Assessment, Johannesburg Food safety Failures in food supply chain can be dangerous and costly. Some 65% of ISO’s food standards (700 to date) deal with analysis and test methods. ISO standards on food safety management systems aim to complement regulatory requirements and assist in reducing weak links in the food supply chain.

5ISO Workshop on Conformity Assessment, Johannesburg Examples of food incidents glass/razor blades in baby food (depressed market ca. £100 million) cross-contamination of Salmonella from raw milk (76 illnesses, one death) contaminated chocolate (245 people ill; £ cost) benzene in bottled mineral water (160 million bottles destroyed: US$ 79 million cost) $

6ISO Workshop on Conformity Assessment, Johannesburg ISO series on food safety management ISO 22000:2005, Food safety management systems -- Requirements for any organization in the food chain ISO/TS 22003:2007, Food safety management systems -- Requirements for bodies providing audit and certification of food safety management systems ISO/TS 22004:2005, Food safety management systems -- Guidance on the application of ISO ISO 22005:2007, Traceability in the feed and food chain -- General principles and guidance for system design and development ISO/TC 34 has prepared a series of international standards on food safety management systems:

7ISO Workshop on Conformity Assessment, Johannesburg ISO Technical Committee TC 34, Food products Standardization in the fields of human and animal foodstuffs animal and vegetable propagation materials terminology, sampling, methods of test and analysis product specifications and requirements for packaging, storage and transport

8ISO Workshop on Conformity Assessment, Johannesburg Participation in ISO/TC 34 Participating members: 45, Observer members: A-liaisons (e.g. CODEX, AOAC, UN/ECE, IH&RA) 5 B-liaisons (e.g. OIV, WHO) with international and regional organizations Experts from more than 20 countries and from six other international organizations took part in the Working Group with 3 new liaisons (e.g. CIES, WFSO)

9ISO Workshop on Conformity Assessment, Johannesburg ISO/TC 34 Liaisons One of TC 34’s most important liaisons is the FAO/WHO Codex Alimentarius Commission When developing a new ISO standard, special care is taken of the relevant Codex documents, each comment of any Codex Committee is taken into consideration during the ISO procedure.

10ISO Workshop on Conformity Assessment, Johannesburg Codex and ISO activities are complementary Codex, as an inter-governmental organization (WHO & FAO) prepares documents to assist governments in their statutory and regulatory work to protect their citizens from health hazards caused by food consumption. ISO, as a non-governmental organization, prepares consensus-based standards on test methods and management systems to assist stakeholders along the whole food chain to fulfil the relevant statutory and regulatory requirements, as well as customer to supplier requirements relating to food an feed products.

11ISO Workshop on Conformity Assessment, Johannesburg HACCP system Hazard analysis and critical control point (HACCP system) was developed in the 1980s by Codex. HACCP plans incorporate issues such as cleaning and general sanitation which are hard to monitor and even harder to validate, e.g. hand-washing. There are often over 20 Critical Control Points (CCPs) per plan. HACCP systems in place with differing requirements and implementations in different countries and for different foodstuffs

12ISO Workshop on Conformity Assessment, Johannesburg Advantages of ISO ISO 22000, Food safety management systems -- Requirements for any organization in the food chain Constitutes an internationally recognized food safety management system standard Incorporates HACCP and goes beyond it Specifies PreRequisite Programmes (PRPs) in lieu of CCPs Identifies Operational PRPs as those PRPs which are essential

13ISO Workshop on Conformity Assessment, Johannesburg Reasons for ISO Increasing number of national regulations and controls relating to food safety Food producers have to comply with different requirements depending on the country and customer Retailers are certifying and inspecting food producers and have set a variety of specific criteria (BRC, IFS,…) ISO simplifies the process Requirements of ISO are generic and are intended to be applicable to all organizations in the food chain regardless of size and complexity

14ISO Workshop on Conformity Assessment, Johannesburg Food Chain Interactions Essential: Ensure that the Relevant Food Safety Hazards are identified and adequately controlled at each step within the food chain. Inside the organization With customers With organizations upstream in the food chain With organizations downstream in the food chain With suppliers

15ISO Workshop on Conformity Assessment, Johannesburg Food chain

16ISO Workshop on Conformity Assessment, Johannesburg What does ISO do? ISO specifies the characteristics of a management system designed to  carry out the hazard analysis,  design the HACCP plan,  identify the prerequisite programmes (PRP), and  select the operational prerequisite programmes

17ISO Workshop on Conformity Assessment, Johannesburg Definition of PRP PRP - prerequisite programme basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain suitable for the production, handling and provision of safe end products and safe food for human consumption The PRPs needed depend on the segment of the food chain in which the organization operates and the type of organization. Documents should specify how activities included in the PRPs are managed.

18ISO Workshop on Conformity Assessment, Johannesburg Operational PRPs ISO reorganizes the traditional concept by dividing control measures into two groups (PRPs and CCPs) and introduces the third group, which is the operational PRPs : operational prerequisite programme PRP identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards, or contamination, or proliferation of food safety hazards in the products or in the processing environment

19ISO Workshop on Conformity Assessment, Johannesburg PRPs and operational PRPs PRPs and operational PRPs What are the main differences between PRPs and operational PRPs? Purpose of the control measurePRPOPRP Maintenance the basic hygienic conditions and activities YesNo Controlling hazards identified by hazard analysis and need to be controlled NoYes Validation is requiredNoYes

20ISO Workshop on Conformity Assessment, Johannesburg Categorization of Control Measures Control measures Prerequisite programmes Operational prerequisite programmes HACCP plan and its critical control points Basic conditions and activities. PRPs do not need validation but their effectiveness shall be verified periodically. Control measures identified by the hazard analysis. Both shall be validated and verified.

21ISO Workshop on Conformity Assessment, Johannesburg Validation of control measure combination Validation includes such activities as:  reference to validations carried out by others,  experimental trials to simulate process conditions;  biological, chemical and physical hazard data collected during normal operating conditions;  statistically designed surveys or mathematical modelling  use of a guide approved by competent authorities.

22ISO Workshop on Conformity Assessment, Johannesburg Literature Our plans Are we doing things right ? Verification Are we doing the right things? Validation Our plans Our activities Verification and validation

23ISO Workshop on Conformity Assessment, Johannesburg ISO Overview ISO allows an organization (even small or less developed ones ) to implement an externally developed combination of control measures. ISO can be applied independently of other management system standards. However, it can easily be integrated with existing related management systems.

24ISO Workshop on Conformity Assessment, Johannesburg ISO and ISO 9001 The structure of ISO is aligned with ISO 9001:2000 in order to enhance the compatibility of the two standards for the benefit of the users. Cross-references between ISO and ISO 9001 are provided in Annex A. An organization already certified to ISO 9001 will find it easier to obtain certification to ISO

25ISO Workshop on Conformity Assessment, Johannesburg ISO flowchart Design and Maintenance of Control System Communication Customer requirements Operation of the control system Validation of control system Management Design of control system Production Legislation Science & experience Orders Monitoring of control system Improvement of control system Verification of control system Suppliers and contractors Safe end product Customer satisfaction

26ISO Workshop on Conformity Assessment, Johannesburg Main concepts of ISO Main concepts of ISO Individual organizations are free to choose the necessary methods and approaches to fulfil the requirements of ISO ISO is particularly intended for organizations that seek a more coherent and integrated food safety management system than is normally required by law. It is important to note that certification of an ISO FSMS is a management system certification and not a product certification.

27ISO Workshop on Conformity Assessment, Johannesburg Main advantages of ISO Internationally recognized. Auditable. Applicable in varied contexts. Flexible. Easily combinable with other management systems and/or with the HACCP method. Supported by other ISO deliverables (ISO/TS 22003; ISO/TS and ISO 22005).

28ISO Workshop on Conformity Assessment, Johannesburg ISO is widely implemented Although ISO was published only a year ago, it has already been implemented by more than 50 countries, and at least 350 companies have been certified to it.

29ISO Workshop on Conformity Assessment, Johannesburg Potential of ISO International coherence among many GMPs EFSIS Nestlé NQS FAMI-QS GMO ISO 9001 GMP standard for Corrugated & Solid Board IFS GFSI Guide SQF AG 9000 ISO McDonalds system Kraft food system Eurepgap Friesland Coberco FSS DS 3027 BRC-IoP BRC-Food Dutch HACCP Irish HACCP M&S system Aldi system Waiterose system GMP GTP

30ISO Workshop on Conformity Assessment, Johannesburg ISO/TS ISO/TS 22003, Food safety management systems -- Requirements for bodies providing audit and certification of food safety management systems TC 34 needed the assistance of and its liaison organizations, particularly ISO/CASCO and the International Accreditation Forum (IAF). Therefore, a joint working group with ISO/CASCO was established for the elaboration of ISO/TS

31ISO Workshop on Conformity Assessment, Johannesburg Reasons for ISO/TS Certification of a Food Safety Management System (FSMS) provides independent demonstration that the FSMS of the organization  conforms to specified requirements,  is capable of consistently achieving its stated policy and objectives, and  is effectively implemented. ISO/TS gives generic requirements for the certification bodies.

32ISO Workshop on Conformity Assessment, Johannesburg ISO and Conformity Assessment The ISO requirements can be used as the basis of a food safety management system and assessed under Supplier’s Declaration of Conformity, 2 nd party inspection or 3rd party certification ISO/TS adds specific guidance related to assessing compliance with ISO to the requirements for the certification of management systems according to ISO/IEC 17021

33ISO Workshop on Conformity Assessment, Johannesburg Qualifications of FSMS auditors according to product/service category Qualifications of FSMS auditors according to product/service category The FSMS auditors shall have general knowledge of microbiology and chemistry They shall be educated in the food industry category in which they will conduct FSMS audits

34ISO Workshop on Conformity Assessment, Johannesburg Qualifications of FSMS auditors (cont) They shall have successfully completed training in audit techniques based on ISO and in food safety issues relating to FSMS (e.g. ISO 22000) For a first qualification, they shall have performed within the last three years at least 12 FSMS audit days in at least four organizations, under the leadership of a qualified auditor.

35ISO Workshop on Conformity Assessment, Johannesburg Annex A: Food chain categories (1) Category codes CategoriesExamples of sectors AFarming 1 (Animals) animals; fish; egg production; milk production; fishing; hunting; trapping BFarming 2 (Plants) fruits; vegetables; grains; spices; horticulture products C Processing 1 (perishable animal products) meat; poultry; eggs; dairy and fish products D Processing 2 (products with long shelf life at ambient temperature) fresh fruits and fruit juices; preserved fruits; fresh vegetables; preserved vegetables; E Processing 3 (perishable vegetal products) canned products; biscuits; snacks; oils; drinking water; beverages; pasta; flour; sugar; salt FFeed productionanimal feed; fish feed;

36ISO Workshop on Conformity Assessment, Johannesburg Annex A: Food chain categories (2) Category codes CategoriesExamples of sectors GCateringhotels; restaurants HDistributionretail outlets; shops; wholesalers IServices water supply; cleaning; sewage; waste disposal; development of product, process and equipment; veterinary services JTransport and storagetransport and storage KEquipment manufacturingprocess equipment; vending machines; L(Bio)chemical manufacturer additives; vitamins; pesticides; drugs; fertilizers; cleaning agents; biocultures; M Packaging material manufacturing packaging material;

37ISO Workshop on Conformity Assessment, Johannesburg Annex B: Audit time Annex B: Audit time Guidance is given on the minimum audit time needed, depending on the food chain category involved, number of employees, number of sites, etc. Minimum audit time for single site, Ts: Ts = D + H + MS + FTE where D is the basic on-site audit time H is the audit days for additional HACCP studies MS is the audit days for absence of relevant management system FTE is audit days per number of employees.

38ISO Workshop on Conformity Assessment, Johannesburg ISO/TS ISO/TS 22004, Food safety management systems – Guidance on the application of ISO ISO/TS was published in 2005.

39ISO Workshop on Conformity Assessment, Johannesburg What is the aim of ISO/TS 22004?  It provides users with explanations that will help in the application of the standard  It provides additional information for small and/or less developed organizations on how to implement certain requirements ISO/TS ISO/TS deals with those parts of ISO which need special attention.

40ISO Workshop on Conformity Assessment, Johannesburg Guidance in ISO/TS The guidance helps: to avoid misinterpretation of ISO 22000; to clarify the meanings of its terms; and to eliminate confusion.

41ISO Workshop on Conformity Assessment, Johannesburg Introduction to ISO/TS The design and implementation of the system are influenced by many varying factors:  the type of food safety hazard;  the products provided;  the processes employed;  the size and structure of the organization. Therefore, only generic guidance can be given.

42ISO Workshop on Conformity Assessment, Johannesburg Guidance for small and/or less developed organizations In an organization with only one or two people in the management structure, an internal audit may be carried out as follows:  The manager steps back from direct involvement in the business operations and tries to be objective about the audit.  Cooperation of another small business allows each to provide the internal audit for the other.  External parties (e.g. chamber of commerce, consultant, inspection agencies) could provide independent auditors.

43ISO Workshop on Conformity Assessment, Johannesburg Assessment and combination of control measures / The guidance in ISO / TS lists the information required to assess the effect of a control measure. More than one control measure is often required to control specific food hazards More than one food safety hazard may be controlled by the same control measure (but not necessarily to the same extent).

44ISO Workshop on Conformity Assessment, Johannesburg ISO Checklist ISO and the ITC have recently prepared a checklist to facilitate the use of ISO 22000, namely ISO – Are you ready? This comprehensive document:  Quotes a part from ISO  Raises a question relating to the quoted part.  If the reply is "Yes" it says “Go to the next question”  If the reply is "No" it says “See guidance below”  Detailed explanation is then given to assist in answering the question. The ISO Checklist comprises a paper version and a CD Rom. It is available in English, French and Spanish.

45ISO Workshop on Conformity Assessment, Johannesburg Traceability ISO 22005, Traceability system in the feed and food chain - General principles and basic requirements for system design and implementation, will be published in 2007 The traceability of food products "from the farm to the fork" is an important requirement of ISO ISO will help food producers and manufacturers to comply with the relevant statutory and regulatory requirements, It will also be an important tool to prove the origin of food.

46ISO Workshop on Conformity Assessment, Johannesburg Use of ISO Choice of traceability system is influenced by regulations, product, its characteristics and customer expectations Implementation by an organization of a traceability system depends on: technical limits inherent to the organization and products cost/benefits of applying such a system.

47ISO Workshop on Conformity Assessment, Johannesburg ISO and Codex ISO complements CCFICS (Codex) “Principles for Traceability/Product Tracing as a tool within a Food Import and Export Inspection and Certification System” ISO does not specify how or when regulators require or apply traceability/product tracing This is the work of Codex CCFICS participated in the ISO Working Group (via nominated expert(s) from Codex)

48ISO Workshop on Conformity Assessment, Johannesburg Thank you for your kind attention!