IFS FOOD VERSION 5 IFS COMPENDIUM OF DOCTRINE



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IFS FOOD VERSION 5 IFS COMPENDIUM OF DOCTRINE ENGLISH VERSION CORRESPONDING TO THE ENGLISH VERSION OF THE IFS FOOD VERSION 5 IFS, July 2008

Content I. DOCTRINE The Doctrine Concept...4 1) Doctrine - definition:... 4 2) Goals of the IFS doctrine:... 4 3) Date of applicability:... 4 4) Review:... 4 Topic 1: Scoring a KO-requirement with N/A...5 Topic 2: Risk analysis...5 Topic 3: CP control point (2.1.3.5.2)...6 Topic 4: Packaging requirements (4.5.3, 4.5.4 and 4.5.5)...6 Topic 5: Clarification about the recommendations for IFS audit durations...7 Topic 6: Clarification about the Annex 1 of the audit protocol regarding the scope determination between IFS Food and IFS Logistic...8 Topic 7: Product scopes for auditors...8 Topic 7.1: Addition of product scope 13 for IFS Logistic audits in the Annex 1 of the IFS Part 3 about product scopes for auditors... 8 Topic 7.2: Clarification for product scope 6: Fruit and Vegetables fresh, dried, chilled and frozen and scope 10: Canned products... 8 Topic 8: Application of IFS Food for wholesalers and cash & carry markets...9 a) Conducting the audit:... 9 b) Field of application of the audit:... 9 c) Auditor competences:... 9 d) Audit duration:... 9 Topic 9: Accreditation and IFS certification process...10 Topic 10: Food defence check-list...10 Redacted by IFS Offices date: 07.08.2008 2

I. ERRATUM Acknowledgements...13 Members of the IFS Working Group...13 Part 1 Audit protocol...13 Chapter 3.2 Follow-up audit... 13 Part 3 Requirements for accreditation bodies and certification bodies and auditors...13 Chapter 2.3 Certification decision... 13 Chapter 3.2 General requirements for auditors when applying for the IFS examinations... 14 Glossary...14 Procedure... 14 Redacted by IFS Offices date: 07.08.2008 3

I. DOCTRINE The Doctrine Concept 1) Doctrine - definition: A doctrine (form the Latin: doctrina) is a generally system of views and statements. The IFS doctrine is a summary of all linguistic and content clarifications of the International Food Standard which have been issued since the standard s publication in August 2007. It is available to certification bodies, food suppliers and all other IFS users. Every element listed in the doctrine complies with the decisions of the IFS Working Group meetings. 2) Goals of the IFS doctrine: 1.) To summarise all interlocking clarifications within the standard which are not purely linguistic. 2.) To summarise and include all linguistic modifications to the standard. 3.) To serve as a basis for the next version of the standard. 4.) To lay down a common interpretation for certification bodies, food suppliers and other IFS users. 3) Date of applicability: The present compendium applies from the 15 th of August 2008. 4) Review: The IFS Working Group and the IFS Review Committee shall review this compendium at least once a year, or more often if necessary. Redacted by IFS Offices date: 07.08.2008 4

Topic 1: Scoring a KO-requirement with N/A A KO can not be scored as N/A (non applicable); it shall only be scored as A, B or D. In the IFS Food, there is one exception to this rule: the KO-requirement 2.1.3.8 about monitoring of CCP might not be applicable according to the company and the products processed. KO n 2: 2.1.3.8: Monitoring system for each CCP. If the company does not have identified any CCP, the auditor shall score this requirement as N/A, and shall give a detailed justification in the audit report why this requirement is not applicable. The company shall verify and document in detail the reasons for the non-applicability of this requirement. Topic 2: Risk analysis In the IFS Food version 5, there are 22 requirements where a risk analysis is mentioned. In the glossary, the risk analysis is defined as A process consisting of three components: risk assessment, risk management and risk communication. This definition comes from the EU Regulation (EC) n 178/2002 but is not relevant for these 22 requirements. In the IFS Food version 5, risk analysis shall be changed to hazard analysis, for all the 22 requirements. The 22 requirements, where hazard analysis applies now, are: 2.3 Record keeping Requirement 2.3.3 3.2.1 Personnel hygiene Requirement 3.2.1.1 Requirement 3.2.1.3 3.2.2 Protective clothing for personnel, contractors and visitors Requirement 3.2.2.5 3.4 Sanitary facilities, equipment for personnel hygiene and staff facilities Requirement 3.4.5 Requirement 3.4.8 4.5 Product packaging Requirement 4.5.5 4.6.2 Exteriors Requirement 4.6.2.3 4.6.4.8 Air conditioning/ventilation Requirement 4.6.4.8.3 4.7 Housekeeping and hygiene Requirement 4.7.1 Requirement 4.7.3 4.9 Risk of foreign bodies, metal, broken glass and wood Requirement 4.9.1 (KO) Requirement 4.9.2 Requirement 4.9.4 Requirement 4.9.9 Requirement 4.9.12 Requirement 4.9.14 Redacted by IFS Offices date: 07.08.2008 5

4.18 Allergens and specific conditions for production Requirement 4.18.3 5.1 Internal audits Requirement 5.1.1 (KO) 5.6 Product analysis Requirement 5.6.4 5.7 Product quarantine and product release Requirement 5.7.1 5.9 Management of incidents, product withdrawal, product recall Requirement 5.9.4 Clarification This hazard analysis shall be understandable by the auditors. This can be done in written format e.g. within the HACCP-hazard analysis concerning e.g. personal hygiene, cleaning and disinfection etc. but also in the form of other evidences which shall be clear for the auditors. The 4 requirements, where the hazard analysis was already mentioned, remain valid and do not have to be modified: 2.1.3.5 Conduct a hazard analysis for each step Requirement 2.1.3.5 Requirement 2.1.3.5.1 4.3 Product development Requirement 4.3.1 4.4 Purchasing Requirement 4.4.4 Topic 3: CP control point (2.1.3.5.2) IFS requirement 2.1.3.5.2: For all steps, which are not defined as CCP s but as CP s, the company shall implement, maintain and document specific preventive measures. New wording: IFS requirement 2.1.3.5.2: For all steps, which are not defined as CCP s but as CP s, the company shall implement, maintain, monitor and document specific preventive measures. Topic 4: Packaging requirements (4.5.3, 4.5.4 and 4.5.5) All the suppliers are responsible, at their own level, for the products (food products and/or packaging) they supply and shall ensure that the IFS Food requirements about packaging apply to them. If the company uses a new packaging at any step of the production process, there shall be a recheck of all the concerned IFS requirements. IFS requirement 4.5.3: Certificates of conformity or evidence shall exist for all packaging in direct contact with food to demonstrate that they are suitable for use. This applies for packaging in direct contact with raw materials, semi-processed and finished products. This includes containers, conveyor belts in production areas for semi-processed products. Redacted by IFS Offices date: 07.08.2008 6

If no certificates of conformity are available (e.g. for old containers, old conveyor belts), evidences, via the hazard analysis, shall be provided. IFS requirement 4.5.4: All packaging or packaging equipments shall be suitable for its intended use and shall have been tested for possible contamination and hazards (interactions) towards products and consumers. Adequate up-to-date test reports shall exist. Test reports shall be available for all packaging materials which can have negative impact on food, according to the hazard analysis. The packaging suppliers shall, where appropriate, provide information about the intended use of the packaging. It is recommended to provide results of migration tests. The test reports should be based on the simulations undertaken in accordance with EU Regulations (EC) n 1935/2004 and (EC) n 2002/72 and the EU Directive (EC) n 85/572 or be based on the on site packaged food products. IFS requirement 4.5.5: Based on a risk analysis hazard analysis, the company shall verify the capability of the packaging material for each relevant product (e.g. organoleptic tests, storage tests, chemical analysis). Additionally to the requirement 4.5.4, audited companies should test their product packaging on their own products. The reaction of the real product can indeed be clearly different from the reaction of those used in the test simulations. Furthermore, in case of change of use of the packaging, the company shall test it on their own products. Topic 5: Clarification about the recommendations for IFS audit durations The chapter 5.3 of the audit protocol provides a system for estimating the time needed for an audit. It is described, among other, that: Minimum 1.5 days for a company characterised by: < 100 personnel and < 2 products from a single product group and < 10,000 m² constructed site area and < 2 production lines plus 0.5 days for the production of the audit report. The symbol used shall be instead of <, for all the requirements. Additional time will be required in the following cases: - 0.5 days for every additional 100 personnel and/or - 0.5 days for every additional 2 products of a single product group and/or - 0.5 days for every additional constructed 10,000 m² of the site and/or - 0.5 days for every additional 3 production lines. Redacted by IFS Offices date: 07.08.2008 7

This rule is in any case an and rule, which means that 0,5 days should be added each time one of the above mentioned requirement is fulfilled. For example: For a company which has 200 employees, with 2 production lines (with 2 products per line) and 20,000 m² of constructed site area, the audit duration is: Minimum 1,5 days Additional 0,5 day for the 100 personnel more Additional 0,5 day for the 10,000m² more In total: 2,5 days. Topic 6: Clarification about the Annex 1 of the audit protocol regarding the scope determination between IFS Food and IFS Logistic Regarding the application of IFS Logistic: IFS: When the food processing company has its own logistic and/or transport department/activities (storage and distribution), it is included in the IFS Food, under the specific sub-chapter about transport or storage. If the logistics platform owned by the food processing company is situated in the same location as the company, and if the company or the customer wishes to get this platform IFS Logistic certified, an IFS Logistic audit can be performed. In this case, the following requirements shall be fulfilled: - the logistics platform is only used for prepacked products, - in case of 2 certificates (Food and Logistic), the respective scopes of each audit and certificate shall be clearly defined, - the requirements of IFS Food concerning transport and storage shall be anyway evaluated during the IFS Food audit, - an IFS Food audit of the food processing company shall anyway be performed; IFS Logistic is an additional audit, - All relevant documents shall be located at the platform. Topic 7: Product scopes for auditors Topic 7.1: Addition of product scope 13 for IFS Logistic audits in the Annex 1 of the IFS Part 3 about product scopes for auditors In the chart of the Annex, the scope 13. Logistic is added. Topic 7.2: Clarification for product scope 6: Fruit and Vegetables fresh, dried, chilled and frozen and scope 10: Canned products Auditors who are approved for scope 10 and who audit companies which produce canned vegetables, vegetables condiments and/or canned fruits are allowed to perform audits for scope Redacted by IFS Offices date: 07.08.2008 8

6 but the contrary does not apply. That means auditors who only have the approval for scope 6 can not perform audits for scope 10, even if the audit concerns canned fruit and vegetables. Topic 8: Application of IFS Food for wholesalers and cash & carry markets a) Conducting the audit: The IFS Food version 5 check-list applies completely, the audit is completely undertaken and the audit report is generated at the end. The non-applicability ("N/A ) of a requirement shall be justified. b) Field of application of the audit: The audit and the certification apply to the overall activities of the company. The area of application is categorised under the new IFS product category 19, "Wholesale / Cash & carry". This new product category 19, "Wholesale / Cash & Carry" may be used for all types of wholesale activities and wholesale companies that handle unpacked products, e.g. weighting, measuring, filling and refilling, stamping, printing, packing, cooling, freezing, deep-freezing, thawing, storing, safekeeping and transporting. In practice, all cash & carry markets as well as many other wholesale companies which handle unpacked products are concerned by this category. c) Auditor competences: To be approved as an auditor for IFS product category 19 Wholesale / Cash & Carry, the auditor shall always have the professional competence and the approval for IFS auditor scope 1 (meat, poultry and meat products) or for IFS auditor scope 2 (fish and fish products; raw, cooled and frozen). d) Audit duration: Basically, the requirements of the IFS for the determination of the audit duration shall be used. Possible reasons for time reductions may be allowed, but shall be justified and documented. In companies where no processing activities take place, many IFS requirements are not as complex, in terms of their application and auditing, as in cases of real processing plants (e.g. requirements applicable to recipes, to process validation, to prevention of contamination). Therefore, in the frame of the applicable IFS audit duration rules, reduced audit duration may be anticipated. In the case of companies with several premises or establishments and central headquarters, the audit begins in the headquarters with the verification of the centrally controlled processes. In such cases, each individual establishment must anyway be audited. In each establishment, checks are made to ensure that the centrally controlled processes are correctly implemented and applied on site and whether the corresponding information is available. If the central control is effective (e.g. as regards hygiene, traceability, internal audits, Redacted by IFS Offices date: 07.08.2008 9

handling of complaints), a reduction of the required audit time could be a result. Further factors of reduction of the audit time can be the use of the same auditor for the audit of the central headquarters and the audits of the premises, or the performance of the audit of the premises by an auditor who has some other comparable knowledge of the centrally controlled processes. Topic 9: Accreditation and IFS certification process As indicated in different chapters of the IFS Food version 5, the whole IFS certification process is entirely and exclusively linked to the rules of the EN 45011 accreditation norm. Thus, as mentioned in the EN 45011 accreditation norm for general certification process, the IFS certification includes the following mandatory steps: - performing an IFS audit, - redacting and evaluating the IFS audit report, - making the certification decision and issuing the IFS certificate. In case of withdrawal or suspension of the EN 45011 accreditation of the scope of IFS for the certification body, the whole certification process is stopped and the certification body is not allowed to issue any IFS certificates anymore. In particular, the certification body can not issue IFS certificates from the date of withdrawal or suspension, even for the audits which have been already performed but which are still in the certification process (redaction of the report, certification decision, etc.). Part 1 / Chapter 2.1 Purpose and contents of the audit protocol Only those certification bodies that are accredited to EN 45011 / ISO IEC Guide 65 for the scope of IFS, and which have signed an agreement with the standard owners, may perform audits against the International Food Standard and may issue IFS certificates. The IFS requirements relating to certification bodies are clearly described in Part 3 of this document. Part 3 / Chapter 2.2 Signing of contract with the proprietors of the IFS After having gained IFS accreditation to EN 45011, the certification body shall, in order to be allowed to perform IFS audits and to issue IFS certificates, sign a final contract with the proprietors of the IFS. The certification body is not authorised to perform IFS audits (except the first witness assessment during the accreditation process) and to issue IFS certificates before having signed this contract. Topic 10: Food defence check-list Due to the food defence which is a regulatory requirement in the USA to be applied by the food industry, the IFS has decided to include these requirements into the standard, as an optional check-list. The food defence is the result of all taken specified food security measures to protect production sites, food related materials and finished goods from intentional harm including crime and terrorism. The food defence check-list below is not an obligation for the food industry, but an option, only if they want to show their customers that they also consider this topic. The numbering of the requirements of this check-list corresponds to the continuing of IFS Food Standard, version 5, which means the chapter 6 in the Part 2 of the standard. The evaluation of these requirements is based on the evaluation laid down in the IFS Food Standard: each requirement can be scored with A, B, C or D depending on the fulfilment of the requirement. The Major non-conformity can as well be used if needed. Redacted by IFS Offices date: 07.08.2008 10

The final score of this specific chapter will be shown separately in the IFS audit and is independant from the global IFS Food audit score (chapters 1 to 5). This score can not correspond to the total result of the IFS Food audit. Number Requirements Scoring Description 6. Food Defence & External Inspections 6.1 Defence Assessment 6.1.1 Responsibilities for food defence shall be clearly defined. The responsible person shall be part of key staff or shall have access to the top management team. Sufficient knowledge in this area can be demonstrated. 6.1.2 Analysis about possible internal and external activities with negative influence on the food stuffs handled onsite shall have been performed, documented and risks evaluated. Based on this risk assessment, and based on the legal requirements and identified needs, areas critical to security shall be identified and reviewed regularly, 6.1.3 Sufficient measures shall be taken in order to adequately control identified risks. Incidents shall be notified to one defined position. Measures shall be taken and the efficiency of all measures shall be evaluated regularly. 6.1.4 If legislation makes registration or onsite inspections necessary, this shall be proved. Responsibilities for Site Security and Safety Training and/or Experience within this area is needed Bad activities of all kinds. E.g. risk assessment based on CARVER or other schemes or own systems. Preparation of a food defence plan. Documentation / audit report / registration Implementation of the food defence plan Food safety, commercial register, FDA, Security etc. 6.2 Site Security 6.2.1 If, based on a risk assessment, special areas critical to security have been identified, intrusion of unauthorized persons to this areasshall be prevented by effective measures. e.g.: self closing doors, access only with chip card, permanent staff onsite etc. Note: Protective measures and access control are covered by 4.6.2.4 in IFS Food 6.2.2 Access points shall be permanently controlled or access shall be granted only for authorized persons. 6.2.3 Raw materials stored outside, machinery and materials shall be protected against unauthorized access, if relevant for site security or food defence. 6.2.4 Potential manipulation of from site received and sent goods shall be identified. At outside area stored material as gas cylinder, pesticides, chemicals, cooling plant, as well as silo, pallets with raw material Sealing etc. number e.g. on packing list 6.3 Personal & Visitor Security 6.3.1 Visitors and external service providers on site shall be registered at the time of access. They shall be informed about the rules and controlled adequately. 6.3.2 All employees shall be trained in food defence on a regular basis. The training sessions shall be documented. Limited access and visitors control Training Redacted by IFS Offices date: 07.08.2008 11

Number Requirements Scoring Description 6.3.3 Employment conditions of new staff shall consider security aspects. If necessary and permitted by law, additional background checks for new personnel and/or medical tests shall be performed. 6.4 External Inspections 6.4.1 A documented procedure for interacting with external inspectors and regulatory authorities shall exist. The relevant personnel shall be informed about the procedure and shall apply it. 6.4.2 During supplier audits, no information related to other customers shall be presented. 6.4.3 If the site releases information or materials to customers or regulatory authorities, at least one identical sample or copy shall be retained and stored for an appropriate time. The customer shall be notified when customer owned properties are concerned, especially in case of results of external checks. Security for the employment of new staff: queries by previous employer, police clearance, drug test, medical screenings Procedure for handling supplier audits and rules for the responsibilities, official controls Training Confidentiality of processes, procedures and customer relations Records of examples, documents Information in case customer products are involved Redacted by IFS Offices date: 07.08.2008 12

II. ERRATUM Acknowledgements Members of the IFS Working Group Andrea Artoni Roberta de Natale Cécile Gillard Kaplan Maurizio Garbin Sergio Stagni CONAD, on behalf of ANCD (Associazione Nazionale Cooperative tra Dettaglianti), Italy Auchan, on behalf of Federdistribuzione, Italy Groupe Carrefour, France UNES, on behalf of Federdistribuzione, Italy COOP, on behalf of ANCC (Associazione Nazionale Cooperative Consumatori), Italy The IFS is also pleased to acknowledge the helpful contributions provided by the following persons: Fayçal Bellatif Marion Holette Philippe Leveau Eurofins Certification, on behalf of the French certification bodies, France Provera Alimentaire, France SAI Global France, on behalf of the French certification bodies, France Part 1 Audit protocol Chapter 3.2 Follow-up audit In the second paragraph, the following correction applies: If the major non-conformity is related to process production failure(s), the follow-up audit shall be performed at least 6 weeks after the previous audit and no lather than 6 months after the previous audit. Part 3 Requirements for accreditation bodies and certification bodies and auditors Chapter 2.3 Certification decision In the third paragraph the following correction applies: According to EN 45011, the final certification decision shall only be taken by a person who is directly employed by the certification body shall be taken by the certification body and shall not be subcontracted. Redacted by IFS Offices date: 07.08.2008 13

Chapter 3.2 General requirements for auditors when applying for the IFS examinations The following correction applies: e) Specific and practical knowledge per product scopes auditors apply for At least 10 audits under EN 45011 accreditation and/or second party audits for retailers per scope, or at least 2 years professional experience in the food industry close to food production areas for each applied product scope. The audits shall have been carried out in different companies. Glossary Procedure Procedure shall be implemented and the elaboration of procedures can be done by documents or process description. In the standard, it is precised when a procedure shall be documented or not. IFS, July 2008 Redacted by IFS Offices date: 07.08.2008 14