Accreditation Criteria for FSSC 22000 CBs

Accreditation Criteria for FSSC 22000 CBs KAB-R-18 3.5 food safety management system (FSMS) set of interrelated or interacting elements to establish p...

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KOREA ACCREDITATION BOARD

Accreditation Criteria for FSSC 22000 CBs Document No.: KAB-R-18 Issue No.: 2 Issue Date: April 15, 2015

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Foreword

1. This document prepared by KAB specifies the criteria for accreditation of FSSC certification bodies. CBs that wish to obtain and maintain accreditation for FSSC 22000 shall comply with this criteria and other accreditation procedures set out be KAB.

2. Organizations that provide certification for FSSC 22000 in accordance with this criteria shall be accredited by KAB as an FSMS certification body and meet all the requirements of ‘FSMS CB Accreditation Criteria (KAB-R-13)’ unless it is specified otherwise in the criteria.

3. This criteria is subject to modification as GFSI (Global Food Safety Initiative) and FFSC (Foundation for Food Safety Certification) change the certification scheme or specifications. In addition, if GFSI and FFSC set out additional speicifications or guides, FSSC 22000 certification bodies shall meet them.

See the FFSC website (http://www.fssc22000.com)

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Contents

1. Scope 2. Normative references 3. Terms and definitions 4. General requirements 5. Resource requirements 6. Certification process requirements

[Annex A] Additional requirements - Packaging and Feed [Annex B] Additional GFSI requirements [Annex C] Additional FFSC requirements [Annex D] Format of the audit report [Annex E] Guidance Notes

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1. Scope This criteria is designed for the accreditation of FSSC 22000 CBs. CBs that wish to be accredited for FSSC 22000 shall meet all the requirements of this criteria and ‘FSMS CB Accreditation Criteria (KAB-R-13). If there are any difference between them, this criteria takes precedence over the other. If there is any difference between this critera and guides published by the FFSC for clear application of FSSC 22000 certification requirements, or when those gudies should be applied before an announcement on changes to this criteria, they can be applied before such an announcement through KAB’s notification.

2. Normative references

2.1 For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

- FSSC 22000 Certification scheme (FFSC: Foundation for Food Safety Certification, Version 3.1) - GFSI Guidance Document - IAF MD Series - ISO 22000 Food safety management systems -- Requirements for any organization in the food chain - ISO/TS 22002-1 Prerequisite programmes on food safety -- Part 1: Food manufacturing - ISO/TS 22003 Food safety management systems -- Requirements for bodies providing audit and certification of food safety management systems - ISO/TS 22004 Food safety management systems -- Guidance on the application of ISO 22000:2005 - ISO/IEC 17000 Conformity assessment -- Vocabulary and general principles - ISO/IEC 17021 Conformity assessment -- Requirements for bodies providing audit and certification of management systems - BSI PAS 222 Prerequisite programmes for food safety in the manufacture of food and feed for animals - BSI PAS 223 Prerequisite programmes and design requirements for food safety in the manufacture and provision of food packaging

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2.2 Together with this criteria, the following documents apply to accreditation activities:

FSMS CB Accreditation Criteria (KAB-R-13) Guide on Application for Accreditation - Management System CBs (KAB-G-01) Procedure for Handling Complaints and Appeals (KAB-P-20) KAB Accreditation Advisory (KAB-A-01 and KAB-A-02) Requirements and guidance documents published by the FFSC GFSI Guidance Documents

3. Terms and definitions In this document, the terms set out in KS Q ISO/IEC 17000:2007, KS A ISO/IEC 17021:2011, KS Q ISO TS 22003:2009, ISO/IEC 17021:2007, FSSC 22000 certification scheme (Part I – IV), guidance documents published by GFSI and FFSC apply as well as the following:

3.1 food safety concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use

3.2 food chain sequence of the stages and operations involved in the production, processing, distribution, storage and handling of a food and its ingredients, from primary production to consumption

3.3 food•feed safety hazard biological, chemical or physical agent in food•feed, or condition of food•feed, with the potential to cause an adverse health effect on humans or animals

3.4 hazard analysis and critical control point (HACCP) system which identifies, evaluates and controls hazards which are significant for food safety

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3.5 food safety management system (FSMS) set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives, used to direct and control an organization with regard to food safety

3.6 prerequisite programme (PRP) 〈food safety〉 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

3.7 operational prerequisite programme (operational PRP) PRP identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards to and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment

3.8 critical control point (CCP) 〈food safety〉 step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level 3.9 Food Any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be, ingested by humans. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment and live animals which are offered to the customer or consumer and intended for preparation and consumption by the consumer. (Cosmetics, tobacco, substances used only for medications are excluded)

3.10 Food defence The process to ensure the security of food and drink and their supply chains from all forms of intentional malicious attack including ideologically motivated attack leading to contamination or supply failure.

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3.11 certification process Activities performed by a CB to determine if an organization meets the FSSC 22000 certification requirements including application, evaluation, certification decision, renewal and the use of certificate/logo/mark.

3.12 FFSC Foundation for Food Safety Certification

3.13 GFSI Global Food Safety Initiative

3.14 Certification scheme A set of certification process requirements to ensure the conformity to performance standards included or referenced in the scheme. In addition to performance standards, mandatory documents for CBs and ABs that accredit CBs can be included in the scheme.

3.15 The Board of Stakeholders (the Board) A group of stakeholder representatives including food safety experts within the scope of the certification scheme.

3.16 Major nonconformity Nonconformity set out in ISO/IEC 17021, 9.1.15b 1) failure to fulfil one or more requirements of the management system standard, or 2) a situation that raises significant doubt about the ability of the client's management system to achieve its intended outputs;

3.17 Minor nonconformity Any other nonconformities set out in ISO/IEC 17021, 9.1.15c

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3.18 Normative document Normative documents in the scheme are expressed as requirements.

4. General requirements

4.1 The requirements for the certification of organizations for FSSC 22000 include ISO 22000: Food Safety Management System requirements, sector PRPs, and the additional requirements of FSSC 22000 scheme’s Part I (requirements for certified organizations), 3.3

4.2 CBs for FSSC 22000 shall comply with the requirements of ISO/IEC 17021, ISO/TS 22003 and FSSC 22000 certification scheme published by the FFSC.

4.3 Certification bodies shall take all measures required to evaluate an organization conformity to the applicable certification standards and meet other requirements related to the FSSC 22000 certification scheme.

4.4 Certification requiremtns for FSSC 22000 are specified in FSSC 22000 certification scheme, Part I, 3. published by the FFSC.

4.5 Additional requirements for the development and the implementation of the FSSC 22000 certification system are set out in this document.

4.6 A CB for FSSC 22000 accredited by KAB shall provide information on its accrdiatation status to the FFSC and shall notify the Foundation of suspension or withdrawal of the accreditation directly without delay.

4.7 Design of the certificate 4.7.1 The design of the certificate will be similar to the certificates that are issued by the awarding CB. Notwithstanding this, the certificates shall include the following information: a) name and address of the organization (site) which food safety system is certified; b) period of validity; initial, reissue and valid until

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c) relevant signatures and positions of signatories; d) scope, expressed in terms of categories, sectors, production processes, products animal production and sites; e) date of the certification decision

4.7.2 Furthermore, the certificate shall contain the following standard text:

A. The food safety management system of (name and place) has been assessed and complies with the requirements of: FOOD SAFETY SYSTEM CERTIFICATION 22000 Certification scheme for food safety systems including ISO 22000:2005, “name of applicable technical specification for sector PRPs” and additional FSSC 22000 requirements. B. This certificate is applicable for the certification scope (). C. This certificate is provided on the base of the FSSC 22000 certification scheme, version 3.2, published on 26 February 2015. D. The certification system consists of a minimum annual audit of the food safety management systems and a minimum annual verification of the PRP elements and additional requirements as included in the scheme and “name of applicable technical specification for sector PRPs”.

4.8 Certification logo Organizations may not display the FSSC 22000 certification logo or mention possession of a FSSC 22000 certificate on their products. The logo (copyright) is allowed to be used on the issued certificates if the certification is conducted in accordance with all requirements of this scheme.

Reference: Conditions for the use of the logo which can be found on the FSSC 22000 website.

4.9 Changes in the certification scheme New information or changes with regards to the requirements in the FSSC 22000 scheme shall be communicated by the CBs to those parties involved, such as certificate holders and auditors (auditors and experts), within a period of 2 months.

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4.10 Appeals and complaints The CB shall have arrangements for appeals and complaints. Clauses 9.7 and 9.8 of ISO/IEC 17021 apply.

4.11 Conflicts of interest

The certification body shall require all staff involved in the certification process to sign a contract or agreement which clearly commits them to: I. Complying with the rules of the organization, with particular reference to confidentiality and independence from commercial or personal interests. II. Declaring any issues in relation to personal conflicts of interests.

4.12 ISO/IEC 17021 The certification body shall clearly document and make known to its employees all requirements in ISO/IEC 17021 related to personnel.

4.13 Full application of the FSSC 22000 certification scheme The certification bodies are responsible for the full application of the certification scheme and have to observe the regulations and directives issued by the Board.

4.14 Duration of certification The maximum validity of the certificate is three years. Reassessment has to take place in time to ensure that recertification is granted before the expiry date of the certificate (clause 9.4 of ISO/IEC 17021).

4.15 Register of certified organizations The Foundation will keep a register with the names and certification information of the certified organizations. This register will be made publicly available on the website of the Foundation. The CBs will submit the following information to the Foundation in a format as agreed in the contract between the Foundation and the CB: • name and location of the certified organization

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• scope of the certification • date of the initial certification • expiry date of the certificate • in case of suspension or withdrawal; the date of suspension or withdrawal

This information shall be submitted by the CB to the Foundation within 4 weeks after the delivery of the certificate. The CB shall agree in the certification agreement with the organization that this information will be submitted by the CB to the Foundation and this information will be made public.

4.16 Auditor registration system The scheme owner shall have in place an auditor registration system for every scheme specific auditor employed by a certification body. The details of the auditor’s qualifications, training, experience and scope of activity in relation to the scheme’s product categorization shall be held and maintained within this register. The scheme owner will register approved auditors and shall ensure that the certification body has a system to update the auditors’ details, where appropriate. The certification body shall register qualified auditors with the Foundation and update the register at least once per year.

4.17 Distribution of audit reports The certification body shall provide a written report for each audit. The audit team may identify opportunities for improvement but shall not recommend specific solutions. Ownership of the audit report shall be maintained by the certification body. The content of audit reports is to be treated confidentially by the CB. At discretion of the contracted client audit reports may be made available to authorized parties.

4.18 Exchange of information At least once per year, the CBs are obliged to provide the Board with all relevant information relating to the application and the functioning of the FSSC 22000 scheme. This information shall be made anonymous so that confidentiality with respect to organizations is assured.

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4.19 Implementation of regulations The CBs are required to ensure that the regulations which are decided by the Board are included in their existing system documentation within a period of two months. Certification bodies are required to control these documents according to their own document control procedures.

5. Resource requirements 5.1 Work experience of auditors

Concerning the requirements on work experience of the auditors in ISO/TS 22003, clause 7.2.4.4, the following is added: a) The allowance to reduce the required five years of total work experience by one year if the auditor has completed appropriate post secondary education, is not applicable; b) The competence of auditors shall be reestablished every 3 years.

Reference: ISO/TS 22003 clause 7.2.4.4

5.2 Auditor training

5.2.1 Training program 5.2.1.1 A training program for each auditor will incorporate: a) an assessment of knowledge and skills for each field and sub field and assignment of fields of evaluation; b) an assessment of knowledge of food safety, HACCP, PRP’s and to have access to, and be able to apply relevant laws, regulations and codes; c) a period of supervised training to cover the assessment of food safety management systems, PRPs and HACCP, specific audit techniques and specific category knowledge; d) for extension of auditor scope for new categories the requirements of ISO/TS 22003, clause 7.2.4.5 apply;

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e) a documented sign off of the satisfactory completion of the training program by the appointed supervisor; f) a plan for continued training to keep the auditors up to date with the best practices and relevant regulatory and statutory developments in the sector(s) where they perform audits. In order to maintain category and scheme knowledge, auditors shall be required to carry out a minimum of 5 on-site GFSI Recognized audits at different organizations each year; g) instructions for the auditor to maintain written records of all relevant training undertaken. Reference: ISO/TS 22003, clause 7.2.4.5 and ISO/IEC 17021, clause 7.2.8

5.2.2 Food safety training The training in HACCP principles, hazard assessment and hazard analysis shall have a duration of at least 2 days/16 h. The food safety management training shall also include specific elements of the sector(s) in which the auditor conduct audits like raw materials, processes, products, risks and legislation and prevailing code(s) of hygiene. Reference: ISO/TS 22003, clause 7.2.4.2

5.2.3 Audit training 5.2.3.1 The training prescribed in section 7.2.4.3 of ISO/TS 22003 shall also cover: a) audit techniques for food safety systems as described in Part I of this scheme; b) the content of this scheme including the standards and technical specification to which is referred. The training in audit techniques shall have a duration of at least 1 week/40h.

Reference: ISO/TS 22003, clauses 7.2.6 and 7.2.4.3

5.3 Audit experience 5.3.1 For qualification the requirements of ISO/TS 22003 apply. In addition to ISO/TS 22003 auditors need to have knowledge of the delivery requirements of FSSC and knowledge of the content of the technical specification for sector PRPs. The certification body shall define how to ensure that this requirement is met.

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5.3.2 The total supervised training against this scheme shall include a successful completion of supervised training in practical assessment of this standard through 10 audits or 15 audit days at a number of different organizations.

5.3.3 Previous experience in ISO 22000 and/or GFSI recognized audits is considered to be applicable for meeting the practical assessment training requirements.

Reference: ISO/TS 22003, clause 7.2.4.5

6. Certification process requirements 6.1 Defining the scope of the certification 6.1.1 When defining the scope, the CB shall indicate for each location the name of the food chain category and the specific sector as specified in Annex A of ISO/TS 22003 and clause 2 of Part 1.

Reference: ISO/TS 22003, clause 9.1.1 and FSSC 22000 guidance document on certification scopes.

6.2 Duration of audit and audit reporting 6.2.1 In addition to the onsite audit time and preparation and reporting time as stipulated in ISO/TS 22003, clause 9.1.4. and Annex B, the CB shall depending of the size of the organization add half to one day for the audit and reporting of the establishment and implementation of the PRPs as stipulated in section 6 of this appendix. This additional time is as well required for an initial, surveillance and renewal audit. Details of the duration of the audit shall be incorporated In the audit report.

Reference: ISO/TS 22003, clauses 9.1.2 and 9.1.4 and Annex B

6.3 Requirements for audit of PRPs

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6.3.1 The CB shall assess whether the organization has established and implemented and maintains the necessary PRPs according to the requirements of section 3.2 of Part I. Of all requirements it shall be assessed to what extent the requirements are fulfilled.

6.3.2 The specific requirements for which the necessary PRP is not established or is not effective in controlling the introduction of food safety hazards (as specified in clause 7.2.1 of ISO 22000) shall be identified. In order to verify if the PRPs are met a plant tour shall be part of the audit.

Reference: ISO/TS 22003 clauses 9.2.3.1.1 and 9.2.3.1.2, 9.2.3.1.4, 9.2.3.1.5 and 9.2.3.2

6.4 Requirements for the audit reports 6.4.1 Additional to the items for the audit and certification reports as stipulated in ISO/TS 22003, clauses 9.1.7 and ISO/IEC17021, clauses 8.2.3, 9.2.3.1.2, the audit and certification report shall identify the following: a) Name and description of the company to which the organization belongs (name, legal entity and address of headquarters); b) Date of previous audit and name of CB conducting the previous audit c) Details of existing certificates; d) Overview of relevant changes to documentation, requirements, processes and products since the last audit; e) Registered complaints on Food Safety and reports to concerning government; f) List of key personnel present at the audit; g) Evidence that the client representative has seen the report and has accepted any NCs raised and provided an appropriate response;.Description of the assessment of the identification by the organization of the food safety hazards to be controlled and the selection of the appropriate (combinations of) control measures for relevant hazards in the operational PRPs or in the HACCP plan; h) The audit of the PRP requirements (specified in Part I, section 3.2) shall be reported separately according to the requirements in section 8 “Audit report of PRPs” in this Annex and attached to the audit report;

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i) Results and the conclusions of the audit per clause of the normative standard or technical specification (specified in Part I, section 3.1) and per additional requirement (specified in Part I, section 3.3); j) Overview of nonconformities and minor nonconformities together with the corresponding clause number of the normative standard or technical specification (specified in Part I, section 3.1 and 3.2) or the number of the additional requirement (specified in Part I, section 3.3); k) Expiry date of the certificate.

6.4.2 The Board may decide on more specific requirements for reporting. In the result section of the report conformance of compliance or noncompliance shall be indicated. In case of nonconformance details shall be provided. Non applicable clauses shall be motivated. In the summary section positive evidence of confirming compliance shall be provided.

Reference: ISO/TS 22003, clauses 8, 9.1.7 and 9.2.3.1.4 and ISO/IEC 17021, clauses 8.2.3, 9.2.3.1.2 and 9.2.5.1

6.4.3 Audit report format The audit report shall cover all elements described in the format as indicated in Part II, appendix IIB (ISO 22000, PRPs and additional requirements) in order to confirm that all requirements are assessed and reported.

6.5 Criteria for nonconformities and certification decision

6.5.1 The CB is required to establish and maintain criteria as a reference against which a nonconformity and minor nonconformity is determined, in accordance with the definitions in this scheme.

6.5.2 Food organizations can only qualify for granting certification on the basis of this scheme if: - the CB has not revealed any outstanding nonconformities and

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- the CB has reviewed and accepted the planned corrections and corrective actions for minor nonconformities.

Reference: ISO/IEC17021, clause 9.1.9, 9.1.15 and 9.2.5.2 and ISO 19011, clause 6.2.2.

6.6 Requirements for initial certification

6.6.1 Stage 1 includes all requirements of 9.2 of ISO/TS 22003 and shall be performed at the client premises in order to evaluate the preparedness of the organization for stage 2. During the initial certification audit (stage 1 and 2) all requirements of this scheme shall be evaluated. This includes ISO 22000, the applicable technical specification for sector PRPs and additional FSSC requirements (clause 3.3 of Part I). Stage 2 includes a comprehensive site tour and shall cover a representative number of product lines, categories and sectors covered by the scope. The site tour shall include the review of implementation of all CCPs and Operational PRPs and shall include a representative sampling of the PRPs. The tour shall include all areas that might influence food safety. Where comparable activities / processes take place it is allowed to sample.

Reference: ISO/TS 22003, clause 9.1.2

6.7 Requirements of the surveillance audits

6.7.1 During the surveillance activities and surveillance audit all scheme requirements from ISO 22000, relevant PRP documents and FSSC 22000 will be reviewed. Surveillance audits shall be carried out and reported as described in the scheme document “Guidance Notes on Surveillance Audits” which is available on the website. Reference: ISO/IEC 17021, clauses 9.3.

6.8 Notification of factors affecting the certification

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6.8.1 The CB shall have arrangements in place with certified organizations for the timely notification in the event that the organization becomes aware of legal proceedings with respect to product safety or legality, or in the event of a product recall. The organization shall immediately, at least within 3 working days, make the CB aware of the situation. The CB in turn shall take appropriate steps to assess the situation and any implications for the certification, and shall take any appropriate action. The CB shall have procedures in place to ensure the integrity of certification following such notification.

6.9 Requirements for additional audits

6.9.1 The CB shall undertake additional surveillance audits in the event that there is evidence or suspicion of nonconformity within the certified organization.

6.10 Requirements for recertification

6.10.1 All requirements given in ISO/IEC 17021 clause 9.4 apply. The recertification shall include a full assessment and reporting of all requirements.

6.11 Risk based office audits The CB will participate in a risk based programme of office audits and announced, but unscheduled, audits of certified organisations. These audits shall be carried out in accordance to the GFSI requirements.

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[Annex A] Additional requirements auditors

1. Auditor competence - Packaging

1.1 A primary qualification, a degree or higher certificate in packaging technology and a relevant certificate recognised by the scheme owner in food technology, food hygiene or related science subject OR a primary qualification in food technology, food safety/ hygiene or related science subject and a certificate in packaging technology that is recognised by the scheme owner. Experience is required in the specific sectors of packaging manufacture: a) plastics b) paper and board c) metal d) glass.

1.2 Food auditor with a packaging certificate A primary qualification in food technology, food safety/ hygiene or related science subject and a certificate in packaging technology that is recognised by the scheme owner. The training organization needs to demonstrate to the Foundation that the training (live or on-line) is delivered by a WPO recognized training organization (including post-training examination) which include the following minimum requirements which have to be verified by the CBs: a) Basics of Packaging Principles & Concepts b) Packaging Legislation, Standards and Regulations c) Packaging Materials (Plastics, Paper & Board, Metal, Glass) Manufacturing d) Specifics to Packaging of Food Products – Food related Hazards e) Quality / Food Safety Control and Testing f) Printing Processes and Printing Inks g) Packaging Recycling h) Design of Packaging Materials

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1.3 Auditor with packaging certificate and food experience/knowledge A primary qualification, a degree or higher certificate in packaging technology and a relevant certificate recognised by the scheme owner (the Foundation) in food technology, food hygiene or related science subject.

1.4 FSSC Food Packaging auditor a) Meeting requirements for and qualified as FSSC food auditor; b) Meeting requirements for ISO 22000 auditor for food supply chain category M (reference ISO 22003); c) Has a minimum of 30 hours education in Food Packaging Material technology, potentially being part of the primary or secondary Food Technology education. Records are available showing the training covers for the applicable Packaging Material Type as minimum the knowledge and understanding of: - Characteristics of raw materials, intermediate and finished packaging materials; - The intended use of Packaging Materials and related hazards and risks; - Packaging Material production processes and supporting processes; - Applicable potential food safety hazards, PRP’s, (see also FSSC Packaging Auditor requirements on PAS 223), CCP’s and OPRP’s; d) Has worked for a minimum of 4 years in a food company producing also producing packaging material in a food safety related function.

The qualification is allocated per Food Packaging Material type (glass, metal, plastic, wood) and the described training and experience shall be specific for these packaging material types.

2. Auditor competence Feed

2.1 he auditor shall have post-secondary education in a related field, or equivalent by experience, have completed industry recognised HACCP training, and be trained on the sector specific risk assessments. Also: a) Experience in feed ingredients and their origin b) Work experience or training in the feed and/or food sector

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c) Experience in a quality management environment in the feed/food sector, including audit reporting and communication skills. d) Experience is required in the specific sectors of feed production: - petfood production, - premix production, - thermal processing, - feed/food packaging technology

3. Auditor Competence – Animal production The auditor shall meet the following conditions in full a) a degree in food related or bioscience discipline or, as a minimum, has successfully completed a food related or bioscience higher education course or equivalent b) post-secondary education in agronomy, agriculture or veterinary sciences and, c) a minimum of 2-year work experience in relevant specific sectors of animal production.

4. Design and development processes If applicable, design and development processes have to be clearly described in the scope and on the issued certificate.

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[Annex B] Additional GFSI requirements

1. Introduction

This appendix shows the additional requirements from the global food safety initiative for Certification bodies and Scheme owners who choose accreditation according to ISO/IEC 17021 and ISO/TS 22003.

Most requirements in this addendum are in line with ISO/IEC 17021 requirements; other issues are explicitly included in this scheme. GFSI Requirements that are implicitly met by the scheme and ISO/IEC 17021, however may require additional explanation to guarantee full accordance, are specified below: requirement general

Explanation Where the term Quality Management System is used this may be read as Management System, as used in ISO/IEC 17021.

4.

A quality manual shall be available. In practice this may be a documented system either on paper or in electronic form.

IX

Records shall be available showing the names of subcontractors who are contracted and qualified for delivering the audits

XII

There shall be policy and procedures for appeals, complaints and disputes. The explicit inclusion of disputes is additional to the wording as used in ISO/IEC 17021.

2. Additional GFSI requirements

2.1 As specified in GFSI Guidance Document – 6th edition – version 6.1, Part II Chapter 3 Annex 1: Additional requirements for Certification Bodies and scheme owners choosing accreditation according to ISO/IEC 17021 and ISO /TS 22003

2.1.1 The scheme owner and certification body will recognize the definition of supplier as; ‘the party that is responsible for ensuring that products meet and, if applicable, continue to meet, the requirements on which the certification is based.’

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2.1.2 The certification body shall take all steps required to evaluate conformance with the standard and fully comply with other associated requirements of the of the certification scheme.

2.1.3 The certification body shall operate an effective and fully implemented quality system. The quality system shall be fully documented and used by all relevant certification body staff. Within the certification body there shall be a designated member of staff responsible for the quality system’s development, implementation and maintenance. This designated member of staff will have a reporting role to the organization’s executive and shall also have the responsibility for reporting on the performance of the quality system for the basis of management review and subsequent system improvement.

2.1.4 The required quality system shall be fully documented within a quality manual, which in turn will contain all necessary procedures for compliance. As a minimum, the quality manual shall contain: a) A quality policy statement b) A description of the legal status of the organization, including ownership, and an organizational structure including named individuals their job titles and description of responsibilities. The organizational structure shall include a chart listing each job title and how these functions interrelate through a management structure. Changes in the legal status, management personnel or constitution of the CB shall be notified to the Foundation in a timely manner. c) A list of named individuals employed by the organization which includes their qualifications and full details of their experience. Changes in personnel which may impact the operational effectiveness of the CB shall be notified to the Foundation in a timely manner. d) A description of the management of the certification process including its committee structure, terms of reference and procedures. e) Details of management review policy and procedures. f) Procedures in relation to documentation control

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g) Details of operational and functional responsibilities pertaining to quality defining an individual limits of responsibility and accountability h) Recruitment procedures, i.e. selection, initial training, ongoing training and performance assessment for all relevant certification body personnel. i) A list of all subcontractors and a detailed procedure for their appointment, assessment and their ongoing management j) Procedures for actions in response to nonconformities the effectiveness of agreed corrective and preventative actions taken k) Procedures in relation to the use of the certificate and in the event of the requirement to withdraw or suspend certification the actions taken by the certification body. l) Policy and procedures relating to appeals, complaints and disputes m) Procedures for conducting internal audits and corrective actions arising from internal audits

2.1.5 In the event of significant change which could affect the safety of product, changes to the requirement of the certification scheme standard, change of ownership or management of the supplier or the certification has reason to believe there could be compliance issues in relation to certification, the certification body shall re‐evaluate the supplier(s) to assess compliance with the certification scheme standard. Such cases shall be notified to the Foundation in a timely manner.

2.1.6 The certification body shall make available the following information at all times: a) Authority under which the organization operates b) Statement in relation to its certification system, including information on rules and procedures for granting, maintaining, extending, suspending and withdrawing certification of its clients. c) Evaluation procedures and certification process in relation to the certification scheme

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d) Details of the means of obtaining financial support and fees charged to clients e) Details of the rights and requirements of applicants and clients such as the use of logo and marks and the way in which a client can use information in relation to certification f) Details of complaints, appeals and disputes procedures g) A comprehensive list of all certificated clients against the scope of the certification scheme’s standard

2.1.7 The certification body shall require all staff involved with the certification process to sign a contract or agreement which clearly commits them to a) Complying with the rules of the organization, with particular reference to confidentiality and independence from commercial or personal interests b) Declaring any issues in relation to personal conflicts of interest. The certification body shall clearly document and make known to its employees all requirements in ISO 17021 related to personnel.

2.1.8 The certification body shall hold and maintain records regarding qualifications, training and experience of all staff involved in the certification process. All records shall be dated. The information shall be updated periodically [minimum annually].

2.1.9 The information shall include as a minimum: a) Name and address b) Organisation affiliation and position held c) Educational qualification and professional status d) Experience and training in the relevant fields of competence in relation to the certification categories described in the scheme’s requirements [ISO 22003 Annex 1, Table 1A] e) Details of performance appraisal

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[Annex C] Additional FFSC requirements

1. General 1.1 This annex specifies FFSC’s additional requirements for certification bodies.

1.1.1 Certification bodies shall be accredited by an accreditation body for this criteria including additional requirements set out in [Annex A] to [Annex C] and a food chain scope applicable in accordance with ISO/TS 22003.

2 Rules for Certification Bodies 2.1 Application 2.1.1 When applying for association with the Foundation, the certification body (CB) must specify the required category or categories and sector(s), related to its competence and experience. The applicant CB will agree to meet all applicable requirements of this scheme. The CB will be given written authorization enabling it to use the scheme for certification.

2.2 Accreditation A contract with the CB will only be signed up after it has been accredited. The CB shall be accredited in accordance with the requirements of the scheme FSSC 22000. CBs which have applied for accreditation or for extension of their scope of accreditation to this scheme may certify within the applied scope for a maximum of one year without being accredited, subject to a provisional contract with the Foundation. The application for accreditation or for extension of their scope of accreditation shall be demonstrated with a written confirmation of the accreditation body (AB).

2.3 Application fee An application fee has to be paid to the Foundation before this authorization will be given.

2.4 Implementation of new requirements In the event of the relevant documents in the FSSC 22000 scheme being changed, the Board will give an appropriate period of grace for the organizations to adapt to the

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implementation of the new requirements, unless the legal regulations stipulate a different transition period.

2.5 Annual fee for certified organizations Organizations certified against this scheme will be charged by the CB for an annual fee to the Foundation. The CB will address this obligation in the certification agreement with the organization. The Foundation will decide annually on the amount of this fee. The CBs will be charged at least annually by the Foundation for the total amount of fees of all certificates they have under contract per 31 December of each year.

2.6 Harmonization process The CB is obliged to participate in consultations on the interpretation of the scheme. Once every year there will be a harmonization meeting. In principle a coordinating officer represents the CB during this meeting. Cases will be brought in for discussion. Each CB shall discuss the cases and the results in their own CB with their auditors. A regulation can be set up for the harmonization process.

2.7 Noncompliance with FSSC Scheme Requirements In cases where a CB fails to comply with the requirements set out in the scheme documents, detailed information will be gathered for review by the Board of Stakeholders. The review will normally take place at the next scheduled BoS meeting. If the nonconformance is of a serious nature, the secretary may request a special meeting to deal with matter. The BoS will determine appropriate measures to be taken to deal with the nonconformity.

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[Annex D] Format of the audit report

Note For the requirements for general information in the audit report see ISO/IEC 17021, clause 8.2.3 and relevant items Appendix II A, section 7 “Requirements for the audit reports” In the audit report of PRPs reference can be made to corresponding information in the main audit report.

Reference: ISO/TS 22003, clauses 8, 9.1.7 and 9.2.3.1.4 and ISO/IEC 17021, clauses 8.2.3, 9.2.3.1.2 and 9.2.5.1

1. ISO 22000 Food Safety Management Systems, requirements for organizations throughout the food chain Client name:

Client address:

Date:

Assessor: Conformance Reference: ISO 22000

Yes

No

Remarks

Provide a summary for each ISO 22000 requirement below 4 Food Safety Management System

Summary: 4.1 General requirements 4.2 Documentation requirements 5 Management responsibility Summary: 5.1 Management commitment 5.2 Food safety policy 5.3 Food safety management system planning 5.4 Responsibility and authority

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5.5 Food safety team leader 5.6 Communication 5.7 Emergency preparedness and response 5.8 Management review 6 Resource management Summary: 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment 7 Planning and realization of safe products Summary: 7.1 General 7.2 Prerequisite programmes (PRPs)

7.3 Preliminary steps to enable hazard analysis 7.4 Hazard analysis 7.5 Establishing the operational PRPs 7.6 Establishing the HACCP plan 7.7 Updating of preliminary information and documents specifying the PRPs and the HACCP Plan 7.8 Verification planning 7.9 Traceability system 7.1 Control of nonconformity

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8 Validation, verification and improvement of the FSMS Summary: 8.1 General 8.2 Validation of control measure combinations 8.3 Control of monitoring and measuring 8.4 Food safety management system verification

8.5 Improvement

2. Report on results and conclusion of the audit of PRPs Note The number of the items refer to the sections of the applicable technical specification for sector PRPs. For each item shall be referred to the requirements of technical specification for sector PRPs and to the requirements of applicable legislation, recognized sector codes and customer requirements. + = assessed; OK - = assessed; nonconformity or minor nonconformity. Indicate: NC = nonconformity MNC = minor nonconformity NA = not applicable

Result

3. ISO/TS 22002-1 report 4. Construction and layout of buildings 4.1 General requirements 4.2 Environment 4.3 Locations of establishments

Identification of specific requirement which is not fulfilled

Details of NC or MNC

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Summary Construction and layout of buildings:

5. Layout of premises workspace 5.1General requirements 5.2 Internal design, layout and traffic patterns 5.3 Internal structures and fittings 5.4 Location of equipment 5.5 Laboratory facilities 5.6 Temporary/mobile premises and vending machines 5.7 Storage of food, packaging materials, ingredients and non food chemicals Summary Layout of premises workspace:

6. Utilities – air, water, energy 6.1 General requirements 6.2 Water supply 6.3 Boiler chemicals 6.4 Air quality and ventilation 6.5 Compressed air and other gases 6.6 Lighting Summary Utilities – air, water, energy:

7. Waste disposal

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7.1 General requirements 7.2 Containers for waste and inedible or hazardous substances 7.3 Waste management and removal 7.4 Drains and drainage Summary Waste disposal:

8. Equipment suitability, cleaning and maintenance 8.1 General requirements 8.2 Hygienic design 8.3 Product contact surfaces 8.4 Temperature control and monitoring equipment 8.5 Cleaning plant, utensils and equipment 8.6 Preventive and corrective maintenance Summary Equipment suitability, cleaning and maintenance:

9. Management of purchased materials 9.1 General requirements 9.2 Selection and management of suppliers 9.3 Incoming material requirements (raw/ingredients/packaging) Summary Management of purchased materials:

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10. Measures for prevention of cross contamination 10.1 General requirements 10.2 Microbiological cross contamination 10.3 Allergen management 10.4 Physical contamination Summary Measures for prevention of cross contamination:

11. Cleaning and sanitizing 11.1 General requirements 11.2 Cleaning and sanitizing agents and tools 11.3 cleaning and sanitizing programmes 11.4 Cleaning in place (CIP) systems 11.5 Monitoring sanitation effectiveness Summary Cleaning and sanitizing:

12. Pest control 12.1 General requirements 12.2 Pest control programmes 12.3 Preventing access 12.4 Harbourage and infestations 12.5 Monitoring and detection 12.6 Eradication

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Summary Pest control:

13. Personnel hygiene and employee facilities 13.1 General requirements 13.2 Personnel hygiene facilities and toilets 13.3 Staff canteens and designated eating areas 13.4 Workwear and protective clothing 13.5 Health status 13.6 Illness and injuries 13.7 Personal cleanliness 13.8 Personal behaviour Summary Personnel hygiene and employee facilities:

14. Rework 14.1 General requirements 14.2 Storage. identification and traceability 14.3 Rework usage Summary Rework:

15. Product recall procedures 15.1 General requirements 15.2 Product recall requirements

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Summary Product recall procedures:

16. Warehousing 16.1 General requirements 16.2 Warehousing requirements 16.3 Vehicles, conveyances and containers Summary Warehousing:

17. Product information/consumer awareness

Summary Product information/consumer awareness:

18. Food defence, biovigilance and bioterrorism 18.1 General requirements 18.2 Access controls Summary Food defence, biovigilance and bioterrorism:

Other items required by applicable legislation, recognized sector codes and customer requirements.

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ISSUE No.2

Accreditation Criteria for FSSC 22000 CBs 4. ISO/TS 22002-4 report 4.1 Establishment 4.1.1 General requirements 4.1.2 Environment 4.1.3 Locations of establishment Summary Establishment:

4.2 Layout and workspace 4.2.1 General requirements 4.2.2 Internal design, layout and traffic patterns 4.2.3 Internal structures and fittings 4.2.4 Equipment 4.2.5 Temporary/mobile structures 4.2.6 Storage Summary Layout and workspace:

4.3 Utilities 4.3.1 General requirements 4.3.2 Water supply 4.3.3 Air quality and ventilation 4.3.4 Compressed air and other gases 4.3.5 Lighting Summary Utilities:

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4.4 Waste 4.4.1 General requirements 4.4.2 Waste handling 4.4.3 Drains and drainage Summary Waste:

4.5 Equipment suitability, cleaning and maintenance 4.5.1 General requirements 4.5.2 Hygienic design 4.5.3 Food packaging contact surfaces 4.5.4 Maintenance Summary Equipment suitability, cleaning and maintenance:

4.6 Management of purchased materials and services 4.6.1 General requirements 4.6.2 Selection and management of suppliers 4.6.3 Incoming raw materials Summary management of purchased materials and services:

4.7 Measures for prevention of contamination 4.7.1 General requirements 4.7.2 Microbiological contamination 4.7.3 Physical contamination 4.7.4 Chemical contamination 4.7.5 Chemical migration

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4.7.6 Allergen management Summary measures for prevention of contamination:

4.8 Cleaning 4.8.1 General requirements 4.8.2 Cleaning programmes 4.8.3 Cleaning agents and tools 4.8.4 Monitoring cleaning programme effectiveness Summary Cleaning:

4.9 Pest control 4.9.1 General requirements 4.9.2 Control programmes 4.9.3 Preventing access 4.9.4 Harbourage and infestations 4.9.5 Monitoring and detection 4.9.6 Eradication Summary Pest control:

4.10 Personnel hygiene and facilities 4.10.1 General requirements 4.10.2 Personnel hygiene, cleaning facilities and toilets

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4.10.3 Staff canteens and designated eating and smoking areas 4.10.4 Workwear and protective clothing 4.10.5 Illness and injuries 4.10.6 Personal cleanliness 4.10.7 Personal behaviour Summary Personnel hygiene and facilities:

4.11 Rework 4.11.1 General requirements 4.11.2 Storage identification and traceability 4.11.3 Rework usage Summary Rework:

4.12 Withdrawal procedures Summary Withdrawal procedures:

4.13 Storage and transport 4.13.1 General requirements 4.13.2 Warehousing requirements 4.13.3 Vehicles, conveyances and containers

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Summary Storage and transport:

4.14 Food packaging information and consumer communication Summary Food packaging information and consumer communication:

4.15 Food defence, biovigilance and bioterrorism Summary Food defence, biovigilance and bioterrorism:

Other items required by applicable legislation, recognized sector codes and customer requirements. 5. BSI-PAS 222 report 3. Sites 3.1 General requirements 3.2 Buildings 3.3 Locations 3.4 Locations of sites Summary Sites:

4. Processes and workspaces 4.1 General requirements 4.2 Workflow 4.3 Structures and fittings 4.4 Equipment 4.5 Laboratory facilities

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4.6 Temporary and/or mobile structures and equipment 4.7 Storage of materials Summary Processes and workspaces:

5. Utilities 5.1 General requirements 5.2 Water supply 5.3 Boiler chemicals 5.4 Ventilation 5.5 Air and compressed gas systems 5.6 Lighting Summary Utilities:

6. Waste disposal 6.1 General requirements 6.2 Containers for waste 6.3 Waste management and removal 6.4 Drains and drainage Summary waste disposal:

7. Equipment suitability, cleaning and maintenance 7.1 General requirements 7.2 Temperature control and monitoring equipment 7.3 Preventive and corrective maintenance

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7.4 Measuring devices Summary Equipment suitability, cleaning and maintenance:

8. Management of ingredients 8.1 General requirements 8.2 Selection and management of suppliers 8.3 Incoming material requirements [ingredients/packaging] 8.4 Communications on product/process attributes Summary Management of ingredients:

9. Management of medications 9.1 General requirements 9.2 Prevention of crosscontact 9.3 Storage Summary Management of medications:

10. Prevention of contamination Summary Prevention of contamination:

11. Sanitation 11.1 General requirements

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11.2 Cleaning and sanitizing agents and tools 11.3 Cleaning and sanitizing programmes Summary Sanitation:

12. Pest control 12.1 General requirements 12.2 Pest control programmes 12.3 Preventing access 12.4 Harbourage and infestations 12.5 Monitoring and detection 12.6 Control and eradication Summary Pest control:

13. Personnel hygiene and employee facilities 13.1 General requirements 13.2 Personnel hygiene facilities 13.3 Designated eating areas 13.4 Workwear and personal protective equipment 13.5 Health status 13.6 Personal cleanliness 13.7 Personal behaviour Summary Personnel hygiene and employee facilities:

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14. Rework 14.1 General requirements 14.2 Storage, identification and traceability 14.3 Rework usage Summary Rework:

15. Product withdrawal procedures 15.1 General requirements 15.2 Product withdrawal requirements Summary Product withdrawal procedures:

16. Warehousing and transportation 16.1 General requirements 16.2 Warehousing 16.3 Vehicles, conveyances and containers 16.4 Product returns Summary Pest control:

17. Formulation of products Summary Formulation of products:

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18. Specifications for services Summary specifications for services:

19. Training and supervision of personnel Summary Training and supervision of personnel:

20. Product information Summary Product information:

21. Food defence, biovigilance and bioterrorism 21.1 General requirements 21.2 Access controls Summary Food defence, biovigilance and bioterrorism:

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6. Additional FSSC 22000 requirements Section

Reference: FSSC part 1 appendix 1A

1

Specifications for ervices The organization shall ensure that all services (including utilities, transport and maintenance) which are provided and may have an impact on food safety .

1.1

Shall have specified requirements.

1.2

Shall be described in documents to the extent needed to conduct hazard analysis.

1.3

Shall be managed in conformance with the requirements of technical specification for sector PRPs.

2

Supervision of personnel in application food safety principles.

2.1

The organization shall ensure the effective supervision of personnel in the correct application of food safety principles and practices commensurate with their activity.

3

Specific regulatory requirements

4

Management of inputs

5

Management of natural resources such as water and soil regarding animal production

6

Food defence, biovigilance and bioterrorism

Conformance

Yes

No

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Remarks

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[Annex E] Guidance Notes

1. Guidance on PAS 223

1.1 Guidance on the FSSC scheme with respect to PAS 223 section 18: Food defence, biovigilance and bioterrorism

Competence criteria Bioterrorism is one of the potential hazards that, just like all of the other potential hazards need to be addressed in the manufacturers Hazard Analysis. The auditors have to review if this has been done and if effective control measures are in place. There are no additional qualification requirements required for the auditors.

Where relevant the auditor shall have knowledge of the PAS 96 which gives guidance as to be able to deal with applicable issues properly.

Method for Auditing Biovigilance and Bioterrorism has to be audited within the scope of the certificate. Where relevant the auditor shall have such knowledge as to be able to deal with these issues properly.

1.2 Guidance on the FSSC scheme with respect to PAS 223 section 16: storage and transport Storage and transport are not part of the FSSC scope as a stand alone activity. However manufacturers have to address it in cases where it is part of the organizations own process and when they have agreements with external transport and storage companies. CBs have to review if the manufacturer has addressed this effectively. The PAS 223 covers requirements for storage and transport and to ensure related food safety risks are addressed effectively in the manufacturer’s food safety management system and that CB’s cover this in the audits.

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2. Guidance auditor competence – Packaging Materials

2.1 The KTE [Knowledge, training, Experience] requirements for auditors in the packaging field should be equivalent to the requirements given in ISO 22003 for any other food chain category.

2.2 ISO 17021 Section 7 makes clear that responsibility for determination of competence, and the means by which this is demonstrated, is with the CB: 17021: 7.1.1 “…determine the means for the demonstration of competence prior to carrying out specific functions” 17021: 7.1.3 “The CB shall have documented processes for the initial competence evaluation, and on-going monitoring of competence and performance of all personnel involved in the management and performance of audits and certification, applying the determined competence criteria. The CB shall demonstrate that its evaluation methods are effective. The outputs from these processes shall be to identify personnel who have demonstrated the level of competence required for the different functions of the audit and certification process.

2.3 This means that the CB must interpret the requirements given in ISO 22003 7.2.4 with regard to the packaging category. This is achieved by: a) 7.2.4.1 Education: Applies as written. Use example d] from the list. b) 7.2.4.2 Safety Training: Applies as written. The final para requires the training to be relevant to the industry/category. The CB must specify what it accepts in the case of packaging. c) 7.2.4.3 Audit Training: Applies as written. d) 7.2.4.4 Work Experience: Applies as written. It should be noted that experience in food safety in processing and packing environments may have direct relevance for food packaging safety, whilst the reverse may not apply. The CB must specify what it accepts in the case of packaging e) 7.2.4.5 Audit Experience: Applies as written. It should be noted that the standard allows audit days dealing with ISO9001 in the food industry, as well as other FSMS audits to count toward the required totals. f) 7.2.5.6 Competences: The requirements given in 7.2.4.6.1 through 7.2.4.6.3 are generic and can be applied as written.

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3. Certificate Format Certificate of registration

The Food Safety Management System of Name of Company at

Site Address has been assessed and complies with the requirements of

FSSC 22000 Certification scheme for food safety systems including ISO 22000:2005, “name of applicable technical specification for sector PRPs” and additional FSSC 22000 requirements.

This certificate is applicable for:

Scope Category This certificate is provided on the base of the FSSC 22000 certification scheme, version 3, published 10 April, 2013 (for Food and Pacaging) OR version 3.1, published April 2014 (for Feed). The certification system consists of a minimum annual audit of the food safety management systems and a minimum annual verification of the PRP elements and additional requirements as included in the scheme and the “name applicable technical specification for sector PRPs”.

Certificate of registration No: Certificate number Date of the certification decision: Initial certification date: Reissuing date: Valid until: Authorized by: Position of signatory Issued by: Name and address of certification body. FSSC 22000 Certificate template, Version 17 April 2014

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4. How to use the FSSC 22000 logo

4.1 The use of the FSSC 22000 logo represents achievement of the highest standard. To maintain this, its use and copyright is controlled by the Foundation for Food Safety Certification.

4.1.1 Use of the FSSC logo by Certified Organizations a) FSSC 22000 certified organizations may use the FSSC 22000 logo, but only in conjunction with the mark of its certification body. b) The FSSC logo may be used on the organization’s printed matter, literature, business cards, website and promotional material subject to the design specifications below. c) The FSSC 22000 logo may not be used either on a product, its labeling or its packaging, or in any other misleading manner, so as to suggest that the certification body has certified or approved any product, process or service of a certified organization. d) Mentioning possession of a FSSC 22000 certificate or making any reference such as “Produced in a FSSC 22000 certified company” on a product label is not allowed. e) The certification body will audit the use of the FSSC 22000 logo by certified organizations during every surveillance and re-certification audit. Any nonconformance associated with the use of the logo will require remedial action to correct the use of the logo as well as corrective action for future use.

4.1.2 Use of the FSSC Logo by Certification bodies a) A certification body may use the FSSC 22000 logo once they have entered into a license agreement with the Foundation. This may be a provisional license, when the certification body is not yet accredited, or a permanent license after the certification body has gained their FSSC 22000 accreditation. b) The FSSC 22000 logo may be used by a certification body, but only in conjunction with its own certification symbol on its certificates, printed matter, literature, business cards, website and promotional material associated with its certification activities, subject to the design specifications below. c) The use of the FSSC 22000 logo will be audited by the accreditation body during each surveillance and re- accreditation audit. Any non-conformance associated with

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the use of the logo will require remedial action to correct the use of the logo on issued documents as well as corrective action for future use.

4.1.3 Design a) The FSSC 22000 logo must be reproduced in the specified colors and in a size that makes all features of the logo clearly distinguishable. Color specifications: Light green: Pantone 375 C: CMYK = 41/0/78/0en RGB = 172/202/87 Dark green: Pantone 361 C: CMYK = 69/0/100/0 en RGB = 91/172/38 b) Use of the logo in black and white is permitted when all other text and images are in black and white. c) When used by the licensed certification body or by the certified organization, the size of the FSSC 22000 logo must not differ from the size of the certification bodies’ mark and they must always appear together.

4.1.4 Closing remarks a) If necessary, the FSSC 22000 Board of Stakeholders can review additional requests with regard to the use of the FSSC 22000 logo. Such requirements will be made part of the agreement with the certification body and the certification body will immediately be subject to such requirements. b) The logo can be obtained through the secretariat of the Foundation via [email protected]

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5. FSSC22000 Guidance Notes – Surveillance Audits 5.1 Purpose To provide additional clarity for CB’s on scheme requirements for conducting and reporting surveillance audits. 5.2 Background The scheme requirements for surveillance audits are derived from ISO 17021:2011 and GFSI Guidance Document V6. ISO17021, Section 9.3: [Extract] 9.3.1.1: The CB shall develop its surveillance activities so that representative areas and functions covered by the scope of the management system are monitored on a regular basis, and take into account changes to its certified client and its management system. GFSI GD V6, Section 3.5: [Extract] 3.5.1: The scheme owner shall have a clearly defined and documented audit frequency programme, which shall ensure a minimum audit frequency of one audit per year of an organisation’s facility and has the scope to assess all elements of the scheme’s standard. Clearly, the application of ISO 17021 requirements alone will not fully satisfy the GFSI requirement to assess all elements of the scheme’s standard. 5.3 Reporting Your reports must cover all clauses within ISO 22000, the relevant sector specific PRP document [e.g. ISO/TS 22002-1], and the FSSC scheme requirements. This is achieved through scheme requirements, which mandate a full review of the food safety management system to confirm that on-going compliance is assured. These requirements are described in scheme document part II, “Requirements and regulations for certification bodies”, section 10, and are explained in detail below.

5.4 FSSC22000 surveillance audits

Guidance

on

5.4.1 “During the surveillance activities and surveillance audit the effectiveness of the food safety management system and the compliance with the requirements of ISO 22000, technical specification for sector PRPs and the additional requirements of this scheme (section 3.3 of Part 1) will be reviewed.”

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Guidance: This requires the auditor to consider all of the requirements described in ISO22000, the relevant PRP document [e.g. ISO/TS 22002-1] and the FSSC scheme in a manner sufficient to determine that the overall FSMS continues to comply. The depth of this review is less rigorous than at a certification or recertification audit, but the scope is the same. Appropriate methods of assessment include desk reviews of documentation and interviews with relevant personnel. The surveillance audit must always include the requirements described in ISO 17021, 9.3.2.1. and confirm compliance with ISO 22000, ISO/TS 22002-1 and the additional requirements

5.4.2 “This shall include an examination of the food safety management system documentation on the registration of changes and of the internal communication of changes in the production process, the (origin of) raw materials, the products and product characteristics or in the context in which the food safety system is operating (e.g. changes in legislation, codes of practices, customer requirements) in the period after the previous audit. If any changes are identified by this examination or otherwise, the surveillance audit shall include a full assessment and reporting of the assessment of: •

the documentation requirements, specifically clauses 4.2.1. and 7.3.1 of ISO 22000 and clause 1 of Section 3.3 (Appendix IA) of Part I of this scheme;

• •

the establishment and implementation of the PRPs; the hazard analysis and the operational PRPs and CCPs.”

Guidance: This section implements the detail required by [G] above. The focus is on changes that may have an impact on the food safety management system – as described in the list provided. Where such changes are noted, the depth of the audit becomes more rigorous, to assure that the changes have been appropriately considered, documented [ISO 22000: 4.2.1] and implemented into the hazard analysis process [ISO 22000: 7.3.1]. The additional FSSC scheme requirements relate to cases where the change noted may impact the provision of services or the need for training of personnel. 5.4.3 During surveillance audits it is allowed to sample activities and a number of product lines, categories and sectors covered by the scope. The sampling shall result in a representative review of the scheme implementation.

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Guidance: This section applies in certified establishments where there are a number of different processes, products etc. within the scope. Having established [in 1] that the FSMS as a whole continues to comply, a selection of the processes, product or categories may be made for further examination. The selection must be made in a such a way that it is representative of the FSMS as a whole, and therefore supports the conclusions drawn in [1].

5.5 Reporting of Surveillance Audits The GFSI requirement is described in section 3.6.4 of the Guidance Document: “The audit report shall include sufficient detail to ensure that it clearly expresses where the site is in compliance, or not in compliance, with the scheme’s standards requirements” The FSSC scheme requirements are described in section 7. These include [extracts]: “Results and conclusions of the audit per clause of the normative standard or technical specification…..” “In the result section of the report conformance of compliance or non compliance shall be indicated. ….. “In the summary section positive evidence of confirming compliance shall be provided “The audit report shall cover all elements described in the format as indicated in Part II, appendix IIB…….in order to confirm that all requirements are assessed and reported” Guidance: The key to meeting this requirement is that appropriate evidence must be provided to support a conclusion of conformance. Whereas non conformance is described in the result column against the individual requirement of the standard, evidence of conformance need not be indicated against each individual requirement, but may be given in a summary which deals with a whole section.

Example – ISO22000 - Non Conformance: A detailed description provided against the relevant individual requirement

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ISO 22000 Reference 4.2 4.2.1 4.2.2

Documentation Requirements General Control of Documents

Yes No X X X

Remarks Version 3 of procedure XXX, dated DDMMYY was in use in the production department. Version 4, dated DDMMYY is shown as

4.2.3 Control of Records X Summary: Narrative text summary of conclusions for section 4.2 as a whole

Example – ISO22000 - Conformance: No detailed remarks needed, a summary is given to support the conclusion of conformance Y N Remarks 4.2 Documentation Requirements X 4.2.1 General X 4.2.2 Control of Documents X 4.2.3 Control of Records X Summary: Food safety policy and objectives reviewed – current and signed by senior management. System documents XX, YY, & ZZ examined – all comply with control requirements. A separate

Example – ISO/TS 22002-1 - Conformance: No detailed remarks needed, a summary is given to support the conclusion of conformance 6. Utilities – air, water, energy 6.1 General requirements + 6.2 Water supply + 6.3 Boiler chemicals NA

No use of steam, thus no boiler chemicals used. An example of the quality monitoring is included

6.4 Air quality ventilation + 6.5 Compressed Air + 6.6 Lighting + Summary Utilities – air, water, energy: Main utilities are water (tap) and air. Quality is well monitored during periodic checks.

Example – ISO/TS 22002-1 – Non Conformance: A detailed description provided against the relevant individual requirement

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Part used containers of Boiler chemicals were stored in the production area when they should have been returned to secure

6.4 Air quality ventilation + 6.5 Compressed Air 6.6 Lighting Summary Utilities – air, water, energy: Narrative text summary of conclusions for section 6 as a whole. E.g. Main utilities are water (tap) and air. Quality is well monitored during

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6. Guidance notes on certifications with more than one location

6.1 General requirement on multi site certification of multiple sites FSSC does not allow the application of multi site certification as described in ISO/TS 22003 and ISO/IEC 17021. Each location requires a separate audit, report and certificate, and will be entered separately on the FSSC database.

6.2 Exceptions FSSC does offer exceptions for three main categories of organizations that have multiple locations and want to apply for certification. The three exception categories are: a) Organizations where some functions pertinent to the certification are controlled by a head office separate to the manufacturing location(s). b) Organizations with different operations at one site. c) Organizations with a ‘split’ process (where one or more process steps take place at a separate location).

6.3 Organizations where some functions pertinent to the certification are controlled by a head office separate to the manufacturing location(s). Functions pertinent to the certification but controlled by a head office separate to the manufacturing location(s) can be for example: a) Procurement policy; b) The approval of suppliers; or, c) Overall responsibility for the group quality management system requirements.

In all cases where functions pertinent to the certification are controlled by a head office or other remote location, FSSC requires that those functions are audited directly in the presence of the person[s] described in the documented FSMS as having responsibility for the functions. This will usually mean that the auditor must attend the head office to conduct that part of the audit. It is strongly recommended that the head office audit is carried out prior to the manufacturing location audit.

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The lead auditor may decide that it is acceptable for the responsible person from the head office to attend the audit at manufacturing site. The conditions under which this will be allowed depends upon local access to required files, records and other evidential material.

6.3.1 Responsibilities An audit of H/O control of functions within the FSMS cannot assess the degree of implementation at manufacturing level. The subsequent audit at the manufacturing site(s) must therefore include a confirmation that the requirements set out by H/O are appropriately incorporated into manufacturing documents and implemented in practice.

6.3.1 Certificate The head office cannot take responsibility for all functions within the scope of the certification, and can therefore not receive a separate certificate. The head office is mentioned on the manufacturing certificate by use of wording such as “An audit was carried out at (name and location of head office) on DDMMYY to assess the following function(s) (describe functions audited at the head office)”.

6.4 Organizations with different operations at one site In cases where more than one manufacturing identity is used but the operations are on one site – for example where a manufacturing operation is named differently to a packing operation, both may, by exception, be considered for certification under a single scope based on one audit, report and certificate provided that: a) they are subject to one audit appropriate to the combined scope; b) they are part of the same legal entity.

6.4.1 Certificate The preferred description on the certificate in such cases is to use the name of the legal entity as the primary name. For example: “XYZ company, operating as ABC processing and 123 packaging, (insert address)”.

6.5 Organizations with a ‘split’ process

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There are occasionally cases where a company has a single manufacturing process that is split between 2 locations. (For example, a part-finished product is moved to a separate location for a specific process step or steps to be carried out, and is then either complete or is returned to the primary location for completion). Such processes may, by exception, be considered for certification under a single scope based on one audit, report and certificate.

Exception may be granted only by application from the CB to the scheme secretariat, including the proposed scope and justification. No agreement should be reached or implied with the client prior to approval from the scheme.

Consideration will be given when: a) Only 2 locations are involved – the primary manufacturing site and the secondary for defined process steps. b) There is clearly one process involved, resulting in a finished product, which is within scheme scope. c) The audit must clearly include all relevant requirements at both the primary and secondary locations, and allow investigations and outcomes to be identified as location specific. d) The secondary site carries out the described process steps solely for the primary site and does not service any other sites or customers. e) The locations are under the same overall food safety management system, and part of the same legal entity. f) The certificate must show the address of both sites, but must clearly identify which is the primary site.

6.6 Dealing with Non-Conformities Where non-conformities are noted in head office or separate manufacturing operations, these must be assumed to have impact on the equivalent procedures at all locations. Corrective actions must therefore address issues of communication across the certified locations and appropriate actions for impacted sites. Such NC’s and corrections must be clearly identified in the relevant section of the audit report.

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7. FSSC 22000 guidance on Appendix IA

The following provides additional information relating to questions arising from the revised requirements

7.1 Appendix 1A item 3 – Specific Regulatory Requirements

“Organizations seeking certification shall assure that specifications for ingredients and materials take account of any applicable regulatory requirements [e.g. control of prohibited substances].”

a) This new requirement is essentially an extension of the requirements given in ISO22000 7.3.3.1, to assure that all applicable statutory and regulatory requirements are identified and incorporated into specifications.

b) ISO22000 7.3.3.1 states “All raw materials, ingredients and product contact materials shall be described in documents to the extent needed to conduct the hazard analysis” and goes on to say “The organization shall identify statutory and regulatory food safety requirements related to the above”.

c) The difference between the ISO requirement and the revised FSSC 22000 scheme text is due to the limitations incorporated in the ISO text:

• The ISO text is limited to information needed to carry out the hazard analysis, and it is therefore possible that some substances may be omitted, and

• The ISO text is limited to identifying statutory and regulatory food safety requirements, not all statutory and regulatory requirements.

d) Requirements that need to be considered for inclusion in the specifications may include, but are not limited to: specific micro requirements, mycotoxin levels,

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glycoalkaloid levels, prohibited colours and/or flavours, maximum or minimum preservative levels and migration potential.

7.2 Appendix 1A item 4 – Announced but unscheduled Audits of Certified Organizations

“The certification body will participate in a risk-based programme of office audits and announced, but unscheduled audits of certified organizations. These audits shall be carried out in accordance to the GFSI requirements.”

a) The question arises as to what is meant by ‘announced, but unscheduled audits of certified organizations’. The GFSI GD Section 2.5.6 gives no further explanation or guidance, but there is a definition given later in the GD that describes: Unscheduled Supplier Audits: Audits planned within a defined programme, but without the allocation of a specific programme date.

b) We have interpreted this as for a given year we will announce to CBs that we will "witness" audit an X number of certified organizations. The dates and locations for these audits will be chosen from the CBs audit schedule (list of audit dates, auditor names and client locations).

7.3 Appendix 1A item 5 – Management of inputs

“The organization shall implement a system to assure that analysis of inputs critical to the confirmation of product safety is undertaken. The analyses shall be performed to standards equivalent to those described in ISO 17025.”

Note: The requirement wording is very specific: it is not about the achievement or maintenance of product safety, but about the confirmation of product safety.

a) Inputs critical to the confirmation of product safety may include any material that is added to the product or used as a processing aid. What makes the input critical is the potential to introduce contamination such as pathogens, aflatoxins, pesticide residues,

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heavy metals etc. or a specific property that affects the product such as pH value or moisture content.

b) Raw and packaging materials will normally be subject to specified requirements and are tested to assure that they present no risk to the product or process. Where testing may not be the norm [for example in the case of water, steam or ice] the organization has to determine if there is potential risk to the safety of the product.

c) In cases where risk is identified [for example, by application of HACCP principles], an appropriate testing protocol must be put in place. The testing must be carried out to standards equivalent to those described in the laboratory accreditation standard ISO17025.

d) This does not mean that the testing has to be carried out by an accredited laboratory, but non-accredited laboratories must be able to demonstrate that they follow the principles of the standard. This will include, but is not limited to use of recognized, validated test methods, calibration of instruments, proficiency testing of analysts, traceability of samples and results etc.

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8. Guidance on non conformity grading, time frame to close NCs and certification conditions This document provides Clarification and Guidance on the grading of the severity of potential non conformities (NCs) arising from an FSSC 22000 Certification audit and defines the time frame required to close NCs.

While the grading of NCs remains the responsibility of the CBs, the aim of this document is to achieve a more uniform agreement between the Foundation and FSSC 22000 licensed CBs in the definition of what constitutes a Minor or Major NC.

8.1 Definitions

Additional clarification on the definition of NCs is taken up in the Features of the FSSC 22000 scheme documents.

• Minor Non Conformity: A failure in a requirement of the Management system which does not impact the capability to achieve the expected outcomes.

• Major Non Conformity: A failure to fulfill one or more requirements of the Management System that raises doubt about the capability of the management system to achieve the expected food safety outcomes in the Food chain or to effectively control the process for which it was intended.

NOTE 1: in the context of a FSMS, the expected outcome is typically a safe product. NOTE 2: a number of minor non conformities associated with the same requirement or issue could demonstrate a systematic failure and thus constitute a major non conformity. NOTE 3: definition adapted from draft revision of the ISO 17021.

8.2 Audit findings that could lead to a Major NC

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1. Failure to document and implement FSMS requirements effectively. 2. FSMS failure with a direct impact on the safety of the food. 3. Multiple minor failures that cumulatively indicate that the capability of the FSMS to achieve the expected outcomes is in doubt. 4. Failure to resolve any food safety relevant issues in a timely manner. 5. Unresolved minor NCs within the agreed timeframes. 6. Evidence of situation which raises a doubt as to the safety of the food and/or unsafe product without any measure taken to control the concerned potentially unsafe product.

8.3 Time frame to close NCs

8.3.1 If a Minor NC is identified in an audit a proposed corrective action plan is required within 3 months of the audit. Corrective actions should be completed within 12 months after the audit. Implementation / completion of the corrective plan should be reviewed, at the latest, at the next on-site audit.

8.3.2 If a Major NC is identified in an audit, the client must provide objective evidence of a root cause analysis and proposed corrective action plan, agreed on by the CB. This should be provided within 14 days of the audit and the MNC closed within a further 14 days.

8.3.3 The implementation of the corrective actions might take more time depending on the potential severity of the NC. In such cases the corrective action plan must include any temporary measures or controls necessary to mitigate the risk until the permanent corrective action is implemented.

a) A Major NC is automatically raised (on management responsibility & resource allocation) in the event of non-completion of the approved action plan. b) When food safety is at risk this should be reflected in both the wording and grading of the NC and the corrective action plan provided by the client. c) If food safety is at risk, a certificate should be withdrawn within 5 working days (max).

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8.4 Certification conditions An FSSC 22000 Certificate will only be achieved when • all action plans related to the Minor non-conformities have been accepted; • all Major non-conformities have been completed. A repeat audit is required in cases where any non-conformities are not resolved and the certificate not issued within 3 months of the original audit date.

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9. Guidance note on politically unstable areas and war zones

9.1 Introduction Quite often FSSC 22000 is confronted with news about politically unstable regions and regions where a war is going on. As there may be operational FSSC- certified sites in those areas, problems can arise such as:

a) the FSSC certified site ceased to exist because it is destroyed by terrorist acts or acts of war; b) the FSSC certified site is taken over by soldiers or rebels; c) the FSSC certified site is shut down by the (international) head office because the region is not safe; d) the FSSC certified site cannot be audited because the region is not safe to be visited by auditors from the certification body.

The above-described situations all may have negative impact on the integrity of the FSSC certificate.

9.2 This Guidance Note gives binding instruction to the FSSC 22000 Certification Bodies (CBs) on how to deal with these situations.

a) The site is destroyed The Certification Body is informed by the former management of the site or receives the information from another source. If the information is from another source the CB has the obligation to seek for confirmation of the fact from reliable nature. After confirmation of the fact the CB withdraws the certificate and the FSSC secretariat is directly informed in writing, including all relevant details.

b) The site is taken over be soldiers or rebels.

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The Certification Body is informed by the former management of the site or receives the information from another source. If the information is from another source the CB has the obligation to seek for confirmation of the fact from a reliable source. After confirmation of the fact the CB withdraws the certificate and the FSSC secretariat is directly informed in writing, including all relevant details.

c) The head office shuts down the site. The management of the production site or the head office informs the CB. The CB withdraws the certificate and the FSSC secretariat is directly informed in writing, including all relevant details.

d) The site cannot be audited. The CB is responsible for the safety and wellbeing of her auditors. The CB makes the decision that the region is not safe to be visited by an auditor. The decision must be based on official travel advice from recognized national or international authorities.

9.3 The decision has the following consequences for the FSSC 22000 certified site:

a) the surveillance or re-certification audit can be postponed for a maximum 6 months. The actual decided length of the deferral period is established by the CB; b) the CB has to change the status of the certificate into “temporarily postponed”1; c) the postponed audit has to be performed within 2 moths after the end of the deferral period; e) the CB will withdraw the certificate if the audit cannot take place within the abovedescribed time frame.

9.4 The CB has to inform the FSSC 22000 secretariat of her decision immediately, in writing. The information sent to the secretariat must include: • Length of the deferral period; • Evidence that support the decision.

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10. Audit time calculation tool

10.1 Basic audit time calculation FSSC requires that in addition to the on-site audit time and preparation and reporting time as stipulated in ISO/TS 22003:2007 and ISO/TS 22003:2013, clause 9.1.4 and Annex B, the CB shall depending on the size of the organisation add a half to one day, for the audit and reporting of the establishment of implementation of the PRPs as stipulated in FSSC Part II, Appendix II A1, section 6.

This separate additional time is as well required for an initial, surveillance and renewal audit. Details of the motivation of the duration of the audit shall be incorporated in the audit report or audit time calculation sheet.

10.2 The additional FSSC audit time shall be calculated as follows: • Half a day (0,25 on-site plus 0,25 reporting) when the company has less than 250 employees and less than 5 production lines and less than 3 HACCP studies; to, • One day (0,75 on-site plus 0,25 reporting) if one of the conditions described in the first bullet are not met, i.e. 250 employees or more, more than 5 production lines or more than 3 HACCP studies

10.3 Audit time calculation The way of calculating the audit time must clearly be shown in the report or audit time calculation sheet and must match the audit time calculation tool shown in ISO 22003, Annex B (Ts = (D + H + MS + FTE) plus the additional FSSC audit time.

10.4 Organisations with multiple locations FSSC offers exceptions for three categories of organizations that have multiple locations and want to apply for certification. The three exception categories are: a) Organizations where some functions pertinent to the certification are controlled by a head office separate to the manufacturing location(s). b) Organizations with different operations at one site.

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c) Organizations with a ‘split’ process (where one or more process steps take place at a separate location).

For more information please see the guidance note on certification of multiple locations.

10.5 Audit time calculation 10.5.1 Organizations where some functions pertinent to the certification are controlled by a head office separate to the manufacturing location(s)

The minimum time shall be half a day on-site to audit the functions pertinent to the certification at the head office. If the lead auditor decides that it is acceptable for the responsible person from the head office to attend the audit at manufacturing site, no extra audit time is calculated.

10.5.2 Organizations with different operations at one site No extra audit time is calculated

10.5.3 Organizations with a ‘split’ process (where one or more process steps take place at a separate location)

• The minimum audit time shall be half a day on-site at the second location when the location has less than 250 employees and less than 3 production lines and lone HACCP study; to, • Or a minimum of one audit day on-site, at the second location if one of the conditions described in the first bullet are not met, i.e. 250 employees or more, more than 3 production lines or more than one HACCP study

10.6 Upgrade from ISO 22000 to FSSC 22000 When transferring an ISO 22000 certification to FSSC certification, a full stage 1 and 2 audit will not be required to upgrade the ISO 22000 part of the FSMS to FSSC 22000. The certification audit is a Stage 1 and 2 audit combined with a scheduled ISO 22000surveillance audit or re-certification audit. Because the upgrade audit is in fact a certification audit the available audit time must match the re- certification audit time to allow enough audit time to access al the aspects of an upgade/certification audit.

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For more information please see the guidance note on <> link.

10.7 Extended surveillance audit The FSSC certification audit is combined with a scheduled ISO 22000 surveillance audit.

Audit time calculation The minimum certification time should be two-thirds of the initial certification audit time, with a minimum of 0,5 audit days on-site plus the required FSSC additional audit time shown in paragraph 1 of this guidance document.

10.8 Extended re-certification audit. The FSSC certification audit is combined with a scheduled ISO 22000 re-certification audit.

Audit time calculation The minimum certification time should be two-thirds of the initial certification audit time, with a minimum of 0,5 audit days on-site plus the required FSSC additional audit time shown in paragraph 1 of this guidance document.

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11.Guidance transition from ISO 22000 to FSSC 22000 certification

Introduction The FSSC BoS confirmed in May 2014 that when transferring an existing ISO 22000 certification to FSSC 22000, a full stage 1 and 2 audit will not be required to transfer the ISO 22000 part of the FSMS to FSSC 22000. The transition audit shall meet substantive requirements for initial certification audit described in FSSC Part II, Appendix II A1, section 9. The complete transition audit must be performed at the client’s premises.

11.1 Transition from ISO 22000 to FSSC 22000 When transferring an ISO 22000 certification to FSSC certification, a full stage 1 and 2 audit will not be required to transfer the ISO 22000 part of the FSMS to FSSC 22000. The transition audit can be combined with a scheduled ISO 22000-surveillance audit or recertification audit.

11.2 Transfer audit The FSSC 22000 certification audit is combined with a scheduled surveillance audit or recertification audit. The audit report shall clearly specify the audit type “transfer audit from ISO 22000 to FSSC 22000”. The auditor shall also confirm the validity of the existing ISO 22000 certificate. The audit must include ISO 22000, the applicable technical specification for sector PRP’s and the additional FSSC requirements. For audit time calculation see Guidance document on audit time calculation.

11.3 Certificate The newly issued certificate is a FSSC 22000 certificate. The scope shown on the certificate covers the full process. It is not allowed to exclude part of the process within the FSSC 22000 scope of certification. The date of issuing on the certificate is the date of issuing the FSSC certificate. The original date of issuing the ISO 22000 certificate is not shown on the FSSC 22000 certificate.

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11.4 Validity of the certificate The transfer audit will result in a FSSC 22000 certificate with the validity of the existing ISO 22000 certificate. The new validity period cannot be more than 3 years. Examples to illustrate the possible certificate validity as result of the transition audit: 1. Synchronise the FSSC 22000 and ISO 22000 certificate. The FSSC 22000 follows the validity period of the existing ISO 22000 certificate. The ISO 22000 certificate is valid until November 1, 2016 and is not revoked. The FSSC 22000-transition audit is on September 25, 2014. The certification decision is on October 20, 2014. The initial certification date of the FSSC 22000 certificate is October 20, 2014. The FSSC 22000 certificate is valid until November 1, 2016.

2. Issuing a FSSC certificate on its own with a 3-year validity. The ISO 22000 certificate is valid until November 1, 2016 and is not revoked. The FSSC 22000-transition audit is on September 25, 2014. The certification decision is on October 20, 2014. The initial certification date of the FSSC 22000 certificate is October 20th, 2014. The FSSC 22000 certificate validity period is October 20th, 2014 plus three years (example October 19th, 2017 or October 20th, 2017).

3. The ISO 22000 certificate is revoked and replaced by a FSSC 22000 certificate. The ISO 22000 certificate is revoked. The FSSC 22000-transition audit is on September 25, 2014. The certification decision is on October 20, 2014. The initial certification date of the FSSC 22000 certificate is October 20th, 2014. The FSSC 22000 certificate validity period is October 20th, 2014 plus three years (example October 19th , 2017 or October 20th,2017)

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12. FSSC 22000 guidance document on certification scopes

Introduction The CBs will register issued certificates in English in the online FSSC 22000 register in a format as agreed in the requirements and the contract between the Foundation and the CB. The certificate shall be registered within 4 weeks of the issue date shown on it.

Certification scopes can and will be reviewed anonymously by a technical expert. When scopes do not meet the FSSC 22000 requirements the responsible CB will be notified by the FSSC 22000 secretary. Any information related to this will be kept confidential, but the FSSC 22000 secretary has the right to notify the Board of Stakeholders if a CB regularly issues certificates with scopes that do not meet the requirements. If a Certification Body has doubts on the scope it is recommended to send the scope to the secretary before publishing it on the certificate.

Please notice that it is not the responsibility of the FSSC 22000 secretary to formulate the scopes. The CB holds full responsibility for this.

For defining the certification scopes the following rules apply:

12.1 Meet ISO 17021 management system certification requirements As FSSC 22000 requires ISO 17021 management system accreditation these requirements are fully applicable. ISO 17021 chapter 8.2, “Certification documents”, defines the requirements for certificates. It is the responsibility of each CB to ensure compliance with these requirements.

12.2 Scope of FSSC 22000 In Part 1 of the scheme documents, chapter 2 defines the scope of FSSC 22000 certification as:

The requirements in this document are set out for the assessment of food safety systems, which ensure the safety of foodstuffs during:

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• Food Manufacturing • Animal Feed Production • Production of Food Packaging and Food Packaging Material • Production of (Bio) Chemicals Note: See scheme document part I, section 2 Scope for more details.

Reference is also made to the ISO 22003 categories (Annex A – Table A1) from which the following categories are: • Fully included: ISO 220003:2007 C, D, E, F and M or ISO 22003:2013 C, D, I • Partially included: ISO 220003:2007 L or ISO 22003:2013 K for which Pesticides, drugs, fertilizers and cleaning agents are excluded • Not included: ISO 22003:2007 A, B, G, H, I, J, K or ISO 22003:2013 A, B, E, F, G, H, J.

12.3 Packaging scope The specific sectors (e.g. plastics, paper and board, metal, glass) of packaging manufacture must be taken up in the scope on the certificate. It must also be clear that the manufactured packaging material is intended for the food industry. Packaging material used for personal care, pharmacy or other uses are not allowed.

For facilities producing food & packaging it is allowed to issue 1 certificate that refers to both ISO 22002-1 and ISO 22002-4 (decision 23 BoS).

12.4 Examples of inclusions and exclusions As the FSSC secretary receives many questions on what is included and what’s not, this document provides some examples.

Some examples of included activities are: • Slaughtering and deboning; • Processing of pet food; including complementary pet food; • Processing of fruits and vegetables;

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• Manufacturing of food ingredient additives like vitamins and emulsifiers; • Manufacturing of dietary food supplements sold for direct consumption; • Any gas which is included in the Codex list of additives (List of Codex specifications for food additives - current version CAC/Misc 6) would be considered within FSSC 22000 scope for certification. In this case ISO 22002-1 will be used. In the scope on the certificate the statement “…used as food ingredient” [or equivalent wording] must be taken up; • Any gas which is included in the Codex list of processing aids as packaging gas (Codex inventory for processing aids - current version CAC/Misc 3) would be considered within FSSC 22000 scheme scope for certification. In this case ISO 22002-1 will be used but the phrase ‘ …used as a food ingredient’ or equivalent will be replaced by an appropriate statement of intended use such as ‘…used as packaging gas’; • For gas re-packagers, while we cannot prevent the use of FSSC if an organization really wants to do so, we suggest that CBs should recommend that they apply ISO 22000 and develop their own PRPs in accordance with Clause 7.2 in ISO 22000; • Packing of “naked” food products (Unpackaged Product); • Manufacturing of Packaging products for presentation like ice-cream wood sticks; • Filling of pre-manufactured products from bulk into trade or consumer packages; • Storage, warehousing & distribution operations [on or off site] may be added to the manufacturing scope in cases where these are • dedicated to the company's own production • included within the audited food safety management system • part of the same legal entity.

Some examples of excluded activities are: • All activities not part of ISO 22003:2007 C, D, E, M, F and L or ISO 22003:2013 categories C,D, I & K; • Processing pharmaceutical ingredients; • Modified atmosphere mixtures for including in sealed food packaging or storage vessel environment; • Farming;

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• Manufacturing of additives and raw materials for food packaging; • Growing of bean sprouts (controlled growing where the sprout itself is the product); • Development and design as separate activity. Unless it is an activity in addition to a processing or manufacturing activity and part of the same legal entity. The development process shall be audited against the applicable FSSC 22000 requirements; • Storage, warehousing, distribution, delivery, supply, dispatch, and sales (offices) on or off site, which are not part of the same legal entity; • Packaging material manufacturing intended to be used in the pharmaceutical, medical or personal care industry.

Additional remarks Based on the ISO 17021 and FSSC 22000 scheme requirements the scopes shall: • Always describe the audited processes and products / product groups. It is recommended to use terminology like processing, manufacturing, packing; • Not be misleading. Any limitations shall be described in the scope; • Not be vague. So instead of “manufacturing of beverages” it shall define what kind of beverages; • Define the main activities and not obvious supporting activities like receiving raw materials, cooking batches of raw materials, human resources etc. unless this is essential to clarify what is meant by the term production; • Not be holding any promotional statements; • Only refer to the processes, products, sites, etc. of the organization that were assessed during the audit; • Combat potential confusion among customers and end users; • Brand names are not recommended. If a client wishes to include a brand name, this is not forbidden but will form a restriction to the validity of the products that are named in the scope; • Terms like “organic” may not be used in the scope.

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• If the term has a specific set of requirements to be met before it can be used, and those requirements are not fully covered by the scope of the FSMS audit, then it can't be used in the scope.

12.5 Examples of correct and incorrect scopes The following examples can be used as guidance for correct and not correct / not complete scopes. These examples were discussed during the yearly FSSC 22000 harmonization meetings for Certification Bodies.

No. 1

2 3 4

Scope description

Acceptable

No Supply of cleaning fluids (detergents and disinfectants) in plastic containers for food industry. Yes Manufacturing of biscuits.

Cooled transport of processed ready to eat salads. Production of chili sauce.

No

Distribution and transport are not part of the present FSSC 22000 scope. ISO 22000 can be applied.

Yes

5

The manufacture of high quality No cereals from ecological grain growing.

6

Production and packing of vegetable oil.

Yes/No

7

Production (pressing, winterization filtering and filling) of olive oil. Production (storage, filling and packing) of olive oil in glass bottles.

Yes

8

Comments and suggestions for improvement Production of cleaning chemicals is not possible within the present FSSC 22000 scope. ISO 22000 can be applied.

Yes

9

The Olive tree® is a producer of No high quality pure olive oil. Products are supplied in glass bottles ranging from 100 ml to 2.5 liters.

10

Production of pasteurized milk and sterilized milk.

Yes

Although this is food production and thus within the scope, subjective terms (high quality, good, high standard etc) shall not be used in a scope. For a company that really produces oil (pressing, extraction) this might fit, however for a company that only fills oil into bottles the term production as such may be misleading and incorrect. In this case it is clear what is meant by production. Parts of production processes may be included as scope for FS 22000 as long as these actually include production steps that change the nature of the product and the scope is limited to these steps. The nature of the production is not clear. Apparently this is only filling (see above). The scope shall clearly identify the applicable steps of the production process and not be a commercial formulation. Use of brands in the scope is not recommended.

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Accreditation Criteria for FSSC 22000 CBs 11

Trade in processed food stuffs.

No

12

The production of liquid canned soups.

Yes

13

Production and packing in glass Yes of ambient stable pickled vegetables

14

Yes The production of natural ripened half-hard cheese. Slicing and packing of cheese in plastic packaging materials, under protected atmosphere. Yes Production of food gases Nitrogen, Oxygen, Argon, Nitrogen Dioxide, Carbon Dioxide, Hydrogen and gas mixtures Yes Filling and distribution of food gasses oxygen, nitrogen, argon, carbon dioxide and mixtures of these

15

16

17

Receive bulk gas and repack into smaller vessels for commercial use

Yes but not recommend

18

Production of dry ice

Yes

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Trade is not included in FS 22000 scope. Even if it had been production of food stuffs this scope would not be accepted since the nature of this products is not clearly identified. The kind of packaging material can add a health risk to the process and/or product. This could mean a “limitation” of the scope by describing the kind of packaging. The kind of packaging material can add a health risk to the process and/or product. This could mean a “limitation” of the scope by describing the kind of packaging. The kind of packaging material can add a health risk to the process and/or product. This could mean a “limitation” of the scope by describing the kind of packaging. Gasses used as food ingredients or as packaging Gas must use appropriate qualifying statements in the scope. (See examples in section 4) The FSSC 22000 scheme definitions mention that food manufacturing is also called food processing. Filling can be seen as a process and would therefore fit in the FSSC scope. Therefore filling of gases is in the scope of FSSC 22000. This activity is regarded as equivalent to a repacker who receives bulk food products and converts to smaller commercial packages. For gas repackagers, while we cannot prevent the use of FSSC if an organization really wants to do so, we suggest that CBs should recommend that they apply ISO 22000 (with regards to the specificity of such process) and develop their own PRPs in accordance with Clause 7.2 in ISO 22000. Dry Ice is solid Carbon Dioxide and can be used to manufacture food products where the carbon dioxide remains in the product. Carbon Dioxide is not a processing aid in this case. Therefore this could also be inside the FSSC scope with the use of ISO 22002-1. To include examples where the processing aid is completely eliminated during the process, so does not appear on the product's list of ingredients - for example, where dry ice is used to create a modified atmosphere or

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temperature in part of the process, but evaporates completely before the process is complete. Any packaging gas on the Codex list [Codex inventory of processing aids CAC/Misc 3] would be considered within scheme scope for certification with the use of ISO 22002-4

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Additional Clause 1. This document enters into force from November 6, 2014.

Additional Clause 1. This document enters into force from April 15, 2015.