ACCREDITATION SCHEME FOR MANAGEMENT SYSTEMS CERTIFICATION BODIES

SAC HACCP DOCUMENT NO 2 MANAGEMENT OF FOOD SAFETY BASED ON HACCP (HAZARD ANALYSIS AND CRITICAL CONTROL POINT) Requirements for a HACCP based Food Management System

December 2010 The SAC Accreditation Programme is managed by SPRING Singapore All rights reserved

CONTENTS Page Foreword Introduction 1 2 3 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 5 5.1 5.2 5.3 6 7 7.1 7.2 8 9 9.1 9.2 9.3 9.4 Scope of Application Reference Publications Definitions Management Responsibility Food Safety Policy Scope of the HACCP System Tasks, Responsibilities and Authorities HACCP Management Representative HACCP Team(s) Resources Management Review Internal Audit System Requirements General HACCP Analysis Pre-requisite Programme (PRP) Guidelines for the Application of the HACCP System Validation and Verification Validation Verification Monitoring and Measuring Documentation requirements General HACCP Manual Control of Documents Control of Records 3 5 5 5 6 7 7 7 8 8 8 9 9 9 10 10 10 10 10 11 11 11 12 12 12 12 13 13

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Foreword This document was first prepared in November 2005 by the Project Team for developing an accreditation scheme for certification bodies operating Hazard Analysis and Critical Control Point (HACCP) Certification. The Project Team was appointed by the Council Committee for Management Systems and Product (CCMP), under the direction of the Singapore Accreditation Council (SAC). The project team comprises the following members: Name Chairman Members Mr Ong Eng Chan Mr Heng Hoon Jee Organisation CCMP Representative of Certification Bodies in Singapore CCMP Agri-Food & Veterinary Authority of Singapore Singapore Institute of Food Science and Technology Singapore Manufacturers Federation

Mr John Woo Mr Koh Boon Liang

Mrs Ser-Low Wai Ming Dr Siew Teck Woh

Mr Wong Mong Hong Singapore Food Manufacturers Association Secretariat Ms Chang Kwei Fern Mr Phua Kim Chua Mr Mukhtar Singh Singapore Accreditation Council Singapore Accreditation Council Singapore Accreditation Council

Certification bodies which wish to use this document to certify food organisations must be accredited by SAC for compliance with ISO/IEC 17021 and SAC HACCP Document No 1 - Requirements for HACCP Auditing Methodology and Criteria for Auditors. In addition, the certification bodies shall be based in Singapore and are not allowed to use overseas certification bodies as foreign critical locations. Food organisations who wish to seek certification are required to implement the requirements of this document.

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The accreditation scheme for certification bodies is managed by the Singapore Accreditation Council. In preparing the document, reference was made to the following publications: Codex Alimentarius: Recommended International Code of Practice General Principles of Food Hygiene CAC/RCP 1-1969, Rev 4-2003 Requirements for a HACCP based Food Safety System Compiled by the National Board of Experts HACCP, The Netherlands, September 2002 SS 444 Hazard Analysis and Critical Control Point (HACCP) system and guidelines for its application SS ISO 9001 Quality management systems - Requirements

SAC would like to give due acknowledgement for the use of information from Requirements for a HACCP based Food Safety System compiled by the National Board of Experts HACCP, the Netherlands in the preparation of this document.

Notes 1. This document is subject to periodic review to keep abreast of technological changes and new technical developments. 2. Compliance with this document does not exempt users from legal obligations 3. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies

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Introduction This document specifies requirements for a HACCP management system consisting of 2 main elements - management and HACCP system. This document specifies a generic set of requirements. An operational HACCP based food safety system should as a minimum comply with these requirements. This document does not contain requirements on legislation and contracts with customer. These legislative requirements and contract arrangements shall be observed by the individual food organisation. The certification of food organisations to this document does not necessarily imply that the food safety organisation has a continual good performance record in food safety. A certified food safety organisation should be committed to maintain and continually improve its food safety performance.

Scope of Application

The requirements in this document have been specified for use in auditing operational HACCP systems (HACCP based food safety systems) which ensure the safety of foodstuff during preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale or supply in any sector of the food chain. The requirements are applicable to all private, public, profitable or nonprofitable food business organisations which wish to design and implement an effective food safety management system, regardless of type, size and product. The scopes to be certified shall be defined by the food organisations and agreed by the certification bodies. A food organisation is hereinafter referred to as the organisation.

Reference Publications

Publications referred are listed in the appropriate clauses of this document. In addition reference is also made to SS ISO 9000, Quality Management systems - Fundamentals and vocabulary.

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Definitions

For the purpose of this document, the definitions given in SS ISO 9000 and SS 444 and the following shall apply. 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 Note: Food safety is related to the occurrence of food safety hazards (3.8) and does not include other human health aspects related to, for example, malnutrition 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 Note 1: This includes the production of feed for food-producing animals and for animals intended for food production Note 2: The food chain also includes the production of materials intended to come into contact with food or raw materials 3.3 Food Safety Policy Overall intentions and directions of an organization related to food safety (3.1) as formally expressed by top management Pre-requisite Programme (PRP) (food safety) basic conditions and activities that are necessary to maintain a hygienic environment throughout for the food chain suitable for the production, handling and provision of safe end products and safe food for human consumption General control measure A measure to control a specific part of the PRP Specific control measure A measure to control a Critical Control Point Control measure Control measure (food safety) action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level Food Safety Hazard Biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect Note 1: Food safety hazards include food allergens
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3.4

3.5

3.6

3.7

3.8

Note 2a: In the context of feed and feed ingredients, relevant food safety hazards are those that may be present in and/or on feed and feed ingredients and that may subsequently be transferred to food through animal consumption of feed and may thus have the potential to cause an adverse human health effect Note 2b: In the context of operations other than those directly handling feed and food (e.g. producers of packaging materials, cleaning agents, etc), relevant food safety hazards are those hazards that can be directly or indirectly transferred to food because of the intended use of the provided products and/or services and thus can have the potential to cause an adverse human health effect

4 4.1

Management Responsibility Food Safety Policy

Top management shall define and document its food safety policy. The policy shall a) demonstrate its commitment to safe food; b) demonstrate that the organisation is fully aware of its position in the food chain; c) reflect the farm-to-fork approach, starting with the purchase and acceptance of raw materials; d) focus on safety of foodstuff and respond to the expectations and needs of its customers and consumers; and e) include measurable objectives to ensure and improve food safety. Top management shall ensure that the policy is understood, implemented and maintained at all levels in the organisation. 4.2 Scope of the HACCP System

The organisation shall define the scope of the HACCP system. The scope shall comprise that part of the food chain and those activities of the food business for which the organisation is responsible and can be held liable: a) The part of the food chain for which the organisation is responsible begins where the responsibility of the suppliers of raw materials and ingredient ends. The organisations responsibility ends where another organisation in the food chain takes over the responsibility. The scope shall therefore conform to purchase and sales contracts;
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b) All locations and process lines where food is produced and/or stored by the organisation shall be properly indicated and be available for audit; c) All products which are supplied to the market by the organisation, whether processed or handled, shall be properly specified; and d) All subcontracted activities (i.e. outsource services, such as packaging, storage, transport) shall be properly managed. For practical reasons, the total production may be clustered into product groups. However it is important that a) specific differences between individual end products have been critically evaluated; b) production and storage conditions are comparable; and c) important aspects for food safety are identified. A key principle is that no part of the operation of the food business can be excluded from the scope of the HACCP system; all activities shall be available for audit. 4.3 Tasks, Responsibilities and Authorities

The organisation shall provide appropriate documentation with respect to the tasks, responsibilities and authorities of its employees who are in positions which involve handling of food and / or controlling and ensuring safety and suitability of the food. 4.4 HACCP Management Representative

Top management shall appoint a member of management, who irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the HACCP management system are established, implemented and maintained; reporting to top management on the performance of the HACCP management system and any need for improvement; and ensuring the promotion of awareness of customer requirements throughout the organisation. HACCP Team(s)

b)

c)

4.5

The organisation shall appoint a HACCP team whose role is to establish, develop, maintain and review the HACCP management system.

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The HACCP team shall be able to demonstrate its knowledge, expertise and different disciplines available required for the role. Minimum qualification criteria, including required expertise, shall be defined and documented for all members of the HACCP team. In addition, the assignment of tasks, responsibilities and authorities of all team members shall be documented. 4.6 Resources

The organisation shall examine the requests and provide, in a timely manner, all the resources needed by the HACCP team(s) to develop, implement and maintain the HACCP system. When corrective actions, verification results or customers indicate that operational improvements are necessary, the organisation shall examine the issues and, where appropriate, provide adequate resources for improvement. 4.7 Management Review

Top management shall review the HACCP system, at planned intervals, of no more than 12 months, to ensure continuity, suitability, adequacy and effectiveness. The review shall evaluate the need for changes to the HACCP system, including food safety, policy and objectives. The review shall provide evidence of the management commitment to improve the HACCP system and its performance. Records from such review shall be maintained. 4.8 Internal Audit

The organisation shall conduct internal audits at planned intervals to determine whether the food management system a) conforms with the planned arrangements, to the requirements of this document and to the food management system requirements established by the organisation; and is effectively implemented and maintained.

b)

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of the previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

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The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow up activities shall include the verification of the actions taken and the reporting of the verification results.

5 5.1

System Requirements General

The organisation shall establish, document and maintain a HACCP management system and continually improve its effectiveness in accordance with the requirements of this document. Where an organisation chooses to outsource any process that affects food conformity with requirements, the organisation shall ensure control over such processes. Control of outsourced processes shall be identified within the HACCP management system. 5.2 HACCP Analysis

The organisation (HACCP Management Representative and HACCP team) shall identify, analyse and evaluate all potential food safety hazards that can have an adverse effect on the safety of the products. See definition 3.8. Whenever the operation of the organisation changes in a manner that could adversely affect food safety, all relevant steps of the HACCP analysis shall be updated. 5.3 Pre-requisite Programme (PRP)

The organisation shall make available a complete and actual description of the pre-requisite program (PRP) of the organisation. The procedures for PRP shall be well established, documented, fully operational and integrated in the HACCP system, and be verified. Reference to a PRP shall be made to Codex Alimentarius, General Principles of Food Hygiene: CAC/RCP 1-1969 Rev 4 -2003.

Guidelines for the Application of the HACCP System

The organisation shall make reference to Codex Alimentarius CAC/RCP 11969, Rev. 4 -2003 Recommended International Code of Practice, General Principles of Food Hygiene, Annex Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application or SS 444 Hazard
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Analysis and Critical Control Point (HACCP) System and Guidelines for its Application.

7 7.1

Validation and Verification Validation

Validation is not a part of verification. Validation is a separate activity done before the authorisation of a HACCP plan. The objectives of validation are to ensure that a) hazards originally identified by the HACCP team are complete and correct; and b) these hazards will be effectively controlled under the proposed HACCP plan. To achieve the objectives of validation, it is necessary to review the a) effectiveness and adequacy of the supporting evidence used in the HACCP study; b) general and specific control measures; c) monitoring system; and d) corrective actions.

The validation review shall be conducted for every change in its operation that could impact food safety. The composition of the validation team and the activities undertaken shall be documented. The organisation shall demonstrate satisfactory completion of validation by maintaining relevant validation records. 7.2 Verification

The organisation shall establish, document and implement procedures for verification of the HACCP system. The objective of verification is to determine compliance with the specifications of the HACCP system and to confirm that the HACCP system is working

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effectively through the application of procedures, tests, monitoring and measurement and auditing and other verification methodologies. The organisation shall demonstrate satisfactory completion of verification by maintaining relevant verification records.

Monitoring and Measuring

If monitoring and measuring equipment is used for performance measurement and monitoring, the organisation shall establish and maintain procedures for the calibration and maintenance of such equipment. Where applicable, calibration shall be traceable to appropriate national or international measurement standards. Records of the results of calibration and maintenance processes shall be maintained.

9 9.1

Documentation Requirements General

The HACCP management system documentation shall include a) b) c) d) documented statements of a food safety policy and objectives; a HACCP manual; documentation procedures required by this document; documents needed by the organisation to ensure the effective planning, operation and control of its processes; and records required by this document.

e)

Documentation should be appropriate to the nature and size of organisation and type of activities, the complexity of the processes and their interactions; and the competence of personnel. 9.2 HACCP Manual

The organisation shall establish and maintain a HACCP manual that includes: a) b) the food safety policy of the organisation; the scope of the HACCP management system;

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c)

the documented specifications, procedures and instructions established for the HACCP management system; or reference to them; and a description of the interaction between the processes of the HACCP management system. Control of Documents

d)

9.3

Documents required by the HACCP management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 9.4. A documented procedure shall be established to define the controls needed to a) b) c) approve documents for adequacy prior to issue; review and update as necessary and re-approve documents; ensure that changes and the current revision status of documents are identified; ensure that relevant versions of applicable documents are available at points of use; ensure that documents remain legible and readily identifiable; ensure that documents of external origin are identified and their distribution controlled; and prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. Control of Records

d)

e) f)

g)

9.4

Records shall be maintained as evidence of the operation of the HACCP management system. All records shall be legible and be retained for a specified period of time, depending on the shelf life of the product, statutory and / or customer requirements. Records shall be readily retrievable and maintained under conditions which prevent their loss, damage or deterioration. A documented procedure shall be established to define the controls needed for identification, storage, protection, retrieval, retention period and disposal of records.

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