1. INTRODUCTION
1.1. MCS HACCP describes procedures which apply to food premises in gaining HACCP certification
1.2. Administered by the Ministry of Health
1.3. The certification process includes adequacy, compliance and any follow-up audits by appointed of certified auditors
2. REQUIREMENTS FOR APPLICATION
2.1. A. Food premises shall be licensed
2.2. B. Company is registered with the Registrar of Companies (ROC)
2.3. C. Pre-requisite programmes shall be in place and documented
2.4. D. The HACCP Manual shall be available with the minimum content as stated in Appendix 1. The Manual shall be duly signed and dated by the company management with executive responsibility
2.5. E. The HACCP system shall be developed based on the Malaysian Standard MS 1480:2007 (1st Revision) and any other requirements imposed by the importing country/countries
2.6. F. The HACCP system should have been implemented for a minimum of three (3) months prior to application
3. APPLICATION PROCESS
3.1. 6.1 Submission of Application
3.2. 6.2 Acceptance of Application
3.3. 6.3 Fees
3.4. 6.4 Other Expenditure
4. AUDITING PROCEDURES
4.1. 7.1 Preparation for Auditing
4.2. 7.2 Compliance Audit Procedure
4.2.1. 7.2.1 Adequacy audit
4.2.2. 7.2.2 On site-audit
4.2.3. 7.2.3 Follow-up audit (FUA)
5. AUDITOR
5.1. 8.1 Compliance Auditor
5.2. 8.2 Surveillance Auditor
6. EVALUATION PROCESS
6.1. The HACCP Certification Committee will conduct a meeting every month or when the need arises to approve recommendations given by the audit team leader. The meeting will be chaired by the Director of the FSQD, Ministry of Health or appointed officer (Deputy Director / Senior Principal Assistant Director / Principal Assistant Director), and members of the committee will consist of officers from the FSQD. Certification awarded shall be valid for two(2) years
7. MAINTENANCE OF THE CERTIFIED HACCP SYSTEM
7.1. 10.1 Minor Non-conformance (NC)
7.1.1. For minor NC, CAR will be issued and action shall be taken within the stated period as agreed during the exit meeting. A follow-up audit (FUA) will be conducted according to the stated agreed period. The CAR will be closed out when it is satisfactorily rectified. Failure to rectify the NC shall affect the renewal of the HACCP certificate
7.2. 10.2 Major non-conformance
7.2.1. For major NC, CAR will be issued and immediate corrective action shall be taken by the company. A FUA shall be conducted to verify that the corrective action has been taken. If corrective action taken is not satisfactory, the HACCP certificate shall be suspended. Failure to rectify the NC shall result in withdrawal of the HACCP certificate. The CAR will be closed when corrective action taken is satisfactory
7.3. 10.3 Serious non-conformance
7.3.1. For serious NC, the HACCP certification will be suspended immediately. Corrective action shall be taken within the suspended period as agreed in the exit meeting. A FUA shall be conducted to verify the corrective action taken. Failure to rectify the NC shall result in withdrawal of the HACCP certification
8. 11. REAPLLICATION
8.1. a. there is a delay of more than six (6) months on the part of the applicant to agree with the date for compliance audit from the issuance of the adequacy audit report
8.2. b. the findings of the compliance audit indicate total failure of the HACCP system (failure to address all the seven HACCP principles)
8.3. c. any of the CARs is not closed out within one(1) year, without a valid justification, form the date of the on-site compliance audit
9. 16. REFERENCES
9.1. 1. Codex Basic Food Hygiene Texts/Annex to CAC/RCP 1-1969, Rev.3. Codex Alimentarius (1997)
9.2. 2. Food Act 1983 and Food Regulations 1985, Malaysia
9.3. 3. Guidance on Regulatory Assessment of HACCP Report of a Joint FAO/WHO Consultation on the Role of Government Agencies in Assessing HACCP, Geneva (1998)
9.4. 4. Laboratory Accreditation Scheme of Malaysia. Department of Standards Malaysia
9.5. 5. Malaysian Standard MS 1480:2007. Food Safety According to Hazard Analysis and Critical Control Point (HACCP) System (1st Revision). Department of Standards Malaysia. (2007)
9.6. 6. Guidelines on Good Hygiene Practice for Small and Medium Scale Food Industries Towards HACCP (2002)
10. DEFINITIONS
10.1. 2.1 Adequacy Audit
10.1.1. A desk-top/document audit to examine the contents of the HACCP Manual and supportive document submitted and to verify that all elements of the MCS HACCP have been addressed
10.2. 2.2 Audit
10.2.1. An independent, systematic examination of objective evidence, performed by trained personnel, to determine whether the activities of the HACCP systems and the related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve food safety objectives
10.3. 2.3 Auditor
10.3.1. A person technically competent in the HACCP system and audit, and in a particular food processing technology or field, formally appointed by MOH
10.4. 2.4 Checklist
10.4.1. A list that contains points/elements that may be considered during assessment. It is used as aide-memoire to promote uniformity in assessment
10.5. 2.5 Certification
10.5.1. Procedure by which MOH as the officially recognized body provide written assurance that the food safety control and management systems conform to MCS HACCP requirements
10.6. 2.6 Compliance
10.6.1. Compliance means the HACCP plan and pre-requisites and their implementation meet MCS HACCP requirements
10.7. 2.7 Compliance Audit
10.7.1. An activity to obtain evidence that the seven HACCP principles have been effectively applied and the HACCP plan and pre-requisites correctly implemented and that the system can be maintained
10.7.2. Includes adequacy, on-site and follow-up audits. Compliance audit is conducted by means of an independent, impartial and objective audit to ascertain full compliance with MCS HACCP criteria and requirements
10.8. 2.8 Conformance
10.8.1. Conformance means activities are carried out according to the established procedures as laid out in the HACCP Plan and the PRP documents
10.9. 2.9 Corrective Action Request (CAR)
10.9.1. Non-conformances documented request by the auditor which must be satisfactorily addressed or corrected by the auditee. All CARs must be closed before a recommendation for the HACCP Certification can be made
10.10. 2.10 Categories of Non-Conformance
10.10.1. Minor
10.10.1.1. A deviation of the HACCP-based system relative to HACCP procedures and facility sanitation or others which are not likely to reduce materially the facility's ability to meet acceptable sanitation requirements or ensure food safety
10.10.2. Major
10.10.2.1. A significant deviation from planned requirements (MS 1480 : 1999 Malaysian Standard on Food Safety According to HACCP), such that maintenance of safety is inhibited. Major non-conformance represents an unacceptable safety risk without constituting an overall system failure in the area concerned
10.10.3. Serious
10.10.3.1. A severe deviation from planned requirements (MS 1480 : 1999 Malaysian Standard on Food Safety According to HACCP), such that maintenance of safety is impacted. Serious non-conformance represents a very significant omission or failure in the food safety system, one that has a direct and adverse effect on the safety of the product
10.10.4. Observation
10.10.4.1. A recommendation given to affect an improvement
10.11. 2.11 Follow- up Audit
10.11.1. The follow-up activity to obtain evidence that the non-conformances given as CAR are being satisfactorily corrected and implemented and that the HACCP system has been maintained. The follow-up audit can be on-site or document audit
10.12. 2.12 Food Premises
10.12.1. Any building or factory used for or in connection with the preparation, preservation, packaging, storage, conveyance, distribution or sale of any food, or re-labelling, reprocessing or re-packing or re-conditioning of any food
10.13. 2.13 HACCP Plan
10.13.1. A document describing the activities developed in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the product under consideration and its intended use
10.14. 2.14 Implementation of HACCP Plan
10.14.1. The ongoing execution and maintenance of the HACCP plan
10.15. 2.15 On site-Audit
10.15.1. An audit that is conducted at the auditee's premises
10.16. 2.16 Non-Conformance
10.16.1. Means activities carried out are not in accordance to the established procedures
10.17. 2.17 Pre-Requisite Programme
10.17.1. PRP shall mean the universal steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favourable to the production of safe food as describe in the Malaysian Standard 1480: 2007 (1st Revision) or other related document
10.18. 2.18 Surveillance Audit
10.18.1. On-site audit of HACCP certified food premises by surveillance auditor(s) to verify the effective and continuous maintenance of HACCP system
10.19. 2.19 Surveillance Auditor
10.19.1. Appointed auditor under the MOH who conducts the surveillance audit