MCS2 MALAYSIAN CERTIFICATION SCHEME FOR HAZARD ANALYSIS AND CRITICAL CONTROL POINT GUIDELINES FOR HACCP COMPLIANCE AUDIT Copyright Food Quality Control Division, Department Of Public Health Ministry of Health Malaysia MOH/K/MAK/13.01(GU)
CONTENTS PAGE Acknowledgement Foreword 1. Introduction 2. Scope 3. Definition 4. Procedure for compliance audit 5. Appointment and registration of compliance auditor 6. Contents of the checklist 7. References 1
ACKNOWLEDGEMENT The Working Group on the Guidelines for Compliance Audit which prepared this Malaysian Certification Scheme consists of the following representatives: Zahara Merican (Chairperson) Mohd Salim Dulatti (Secretary) Yeoh Que Lan Radziah Mohd. Daud Malaysian Agricultural Research and Development Institute (MARDI) Food Quality Control Division, Ministry of Health (FQCD, MOH) Malaysian Agricultural Research and Development Institute (MARDI) SIRIM QAS Sdn. Bhd. Dr. Ayub Mohd. Yatim National University of Malaysia (UKM) NorAiny Mahyuddin Department of Fishery (DOF) Syed Abd. Rahim Syed Abd. Rashid Department of Veterinary Services (DVS) Goh Poh Guat Golden Arches Restaurant Sdn. Bhd. Wee Bee Wah Health Department of Selangor Thayalan Ramadas Health Department of Perak Nor Kamilah Alwi Ch ng Oon Teong Food Quality Control Division, Ministry of Health (FQCD, MOH) Food Quality Control Division, Ministry of Health (FQCD, MOH) 2
FOREWORD The primary aim of the HACCP compliance audit is to provide third party verification that the elements of HACCP and pre-requisite programme have been implemented for purposes of certification under this scheme. This guideline is structured to provide essential information in a standardized, logical and systematic manner for conducting the compliance audit on the HACCP systems, which has been implemented by the food industry. It consists of procedures for conducting the compliance audit and the criteria for the selection of compliance auditors. The procedures are made up of a specific guide which can be combined and customized to meet the specific needs of the auditors. 3
1 INTRODUCTION In recognition of the importance of the HACCP system as a means of identifying and controlling hazards in food, the government, through a committee formed under the Ministry of Health (MOH), developed this HACCP Compliance Audit Guideline. The Guideline for HACCP Compliance Audit is one of the Malaysian Certification Scheme for HACCP System (MCS HACCP) administered by MOH. This guideline is intended to provide transparency to the industry on the HACCP compliance system implemented by MOH. The purpose of the HACCP compliance audit is to provide third party verification that the elements of HACCP and pre-requisite programmes (PRP) have been implemented, for purposes of certification under the MCS. 2 SCOPE The scope of this guideline encompasses the procedures for compliance audit and the criteria for selection of compliance auditor(s). 3 DEFINITION 3.1 Audit (HACCP) 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. 3.2 Auditor A person technically competent in the HACCP system and audit, and in a particular food processing technology or field, formally appointed by MOH. 3.3 Adequacy audit A desk-top/document audit to examine the contents of the HACCP Manual and supportive documents submitted and to verify that all elements of the MCS HACCP has been addressed. 3.4 Certification Procedure by which MOH as the officially recognized body provide written assurance that food safety control and management systems conform to MCS HACCP requirements. 4
3.5 Checklist A list that contains points/elements that may be considered during assessment. It is used as aide-memoire to promote uniformity in assessment. 3.6 Compliance Compliance means the HACCP plan and pre-requisites and their implementation meet MOH MCS requirements. 3.7 Compliance audit 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. It 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. 3.8 Follow-up audit 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. 3.9 On-site audit An audit that is conducted at the auditee's premises. 3.10 Corrective action request (CAR) Non-conformances documented by the auditor which must be satisfactorily addressed or corrected by the auditee. All CARs must be closed before a recommendation for the HACCP Certificate can be made. 3.11 HACCP plan 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. 3.12 Implementation of the HACCP plan The ongoing execution and maintenance of the HACCP plan. 5
3.13 Pre-requisite programme (PRP) 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 1480:1999. 3.14 Conformance Conformance means activities are carried out according to the established procedures as laid out in the HACCP Plan and the PRP documents. 3.15 Non-conformance Non-conformance means activities carried out are not according to the established procedures. 3.16 Categories of non-conformance a) Minor - 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. b) Major - 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 risks without constituting an overall system failure in the area concerned. c) Serious - 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 product. d) Observation - A recommendation given to effect an improvement. 4 PROCEDURE FOR COMPLIANCE AUDIT 4.1 Adequacy audit On receipt of the complete documentations, the auditors conduct an adequacy audit on the HACCP Manual and pre-requisite programme (PRP). The lead auditor collates comments on the adequacy audit; prepare the Adequacy Report on the HACCP 6
Manual and PRP for the company with a copy to MOH within four (4) weeks after receipt of documents. 4.2 On-site audit The lead auditor contacts the company for the on-site compliance audit appointment within two (2) weeks after the adequacy audit; and sends out a formal on-site audit programme to the company and the auditor(s). The auditor(s) prepare checklists for the on-site audit. 4.2.1 Entry (Opening) Meeting: i. Introduce audit team members ii. Introduce observers (if any), inform purpose and their role iii. Request auditee to introduce themselves iv. Circulate attendance list v. Inform auditee of Undertakings of Confidentiality by all members of the audit team vi. State the authority of the audit, the scope of the audit, the audit standard and other related documents vii. Confirm the audit programme viii. Give a summary of the methods and procedures to be used to conduct the audits ix. Describe the method of non-conformance reporting and define the terms "minor", "major", "serious" and "observation" non-conformance and their implications x. Request for a guide for each audit group. Inform auditee of the responsibilities of the guide, which include facilitating the execution of the audit plan, acting on request of the auditor and witnessing and noting the performance of the audit on behalf of the auditee xi. Request for a meeting room to be reserved for the audit team's use xii. xiii. 4.2.2 Plant visit Confirm working hours, lunch/tea break arrangements and interim meetings Explain the purpose and confirm the arrangements for the closing meeting between the audit team and the auditee. i. Verify process flow diagram on-site ii. Conduct observations on process, procedures and premises. 4.2.3 Document audit comments i. Clarification of adequacy document comments ii. On-site document review iii. Verification of HACCP control chart, on-line monitoring and checking records. 7
4.2.4 Auditors meeting i. Discuss audit findings. 4.2.5 Exit (Closing) Meeting i. Thank auditee for hospitality, cooperation and assistance ii. Circulate attendance list iii. State that the critique is based on objective evidence presented and does not mean that areas not seen or mentioned are considered satisfactory iv. State general impressions v. Request auditors to give their findings vi. Resolve points raised by auditee vii. Present corrective action requests (CAR) viii. Reconfirm scope of HACCP certification ix. Inform auditee of subsequent action after the on-site audit. 4.3 Response by company to CAR(s) issued within 3 weeks. 4.4 Prepare and send Audit Report to company with a copy to MOH within four (4) weeks after receipt of CAR response. 4.5 Corrective action and document update by company within six (6) months from on-site audit. 4.6 Submission of updated document by company to lead auditor and to conduct Followup Audit (FUA), if necessary (Concurrent with 4.5 above) 4.7 Follow-Up Audit (FUA) FUA can be on-site audit or document audit which will be conducted within two (2) weeks of receipt of request from auditee. 4.7.1 On-site FUA i. Entry meeting As 4.2.1 (where appropriate) ii. Plant visit iii. Document audit comments iv. Exit Meeting As 4.2.5 (where appropriate) Issuance of new CAR (if any) Closing of completed CAR v. Close on-site FUA. 8
4.8 Response by company to unsatisfactory corrective actions on previous CAR(s) and new CAR issued (if any) within three (3) weeks. 4.9 FUA report by FUA auditor to lead auditor within two (2) weeks. 4.10 Prepare an Interim Report to the company with a copy to MOH within two (2) weeks. 4.11 1 Corrective action and document update by company within six (6) months. 4.12 Conduct document audit and further FUA on-site (if necessary). 4.13 When all CARs have been closed out, lead auditor prepares a final recommendation report to MOH with a copy to company within two (2) weeks 5. APPOINTMENT AND REGISTRATION OF COMPLIANCE AUDITOR The compliance auditor will be appointed by MOH based on the criteria specified under the Guidelines for Certification of HACCP Compliance Auditor (MCS 3). MOH reserves the right to revoke the appointment of any compliance auditor if it is deemed necessary. 6. CONTENTS OF THE CHECKLIST 6.1 HACCP i. Management commitment ii. Scope of the HACCP plan iii. Appropriate HACCP team established, with appropriate job functions iv. Proper product description and intended use v. Factory floor layout vi. Process flow chart vii. Proper application of HACCP principles viii. Proper identification of hazards (hazard analysis) ix. Proper selection of critical control points (CCPs) x. Appropriate critical limits (CLs), monitoring procedures, corrective actions, as well as validation and verification activities xi. Proper documentation and record keeping xii. All regulatory requirements relating to health and safety have been addressed xiii. HACCP Internal Audit Reports 1 The company is given a maximum of one year from the first on-site audit for all corrective action to be closed out. If the one year period is exceeded, the company would have to reapply (unless valid justification can be provided). 9
xiv. xv. xvi. Evidence of Management review Indication of effective pre-requisite programmes On-site observations. 6.2 Pre-requisite for HACCP i. Premises location, design, construction and maintenance, lighting, ventilation, product flow, waste disposal, factory grounds, employee facilities ii. Supplier control and specifications - supplier guarantee, written specifications iii. Water, steam and ice supply, quality, records iv. Receiving, storage, distribution - Food and non-food, finished product v. Production equipment - design and installation, maintenance, calibration, records vi. Cleaning and sanitation - sanitation programme, equipment cleaning and sanitizing facilities, records. vii. Personnel - cleanliness and conduct, communicable diseases and injuries viii. Training - hygiene and sanitation, GMP, HACCP, technical ix. Chemical control - procedures, storage, records x. Pest control - pest control programme and records xi. Recalls - procedures and records xii. Customer complaints. 7. REFERENCES Food Act 1983 and Food Regulations 1985, Malaysia. Malaysian Standard MS 1480:1999. Food Safety According to Hazard Analysis and Critical Control Point (HACCP) System. Department of Standards Malaysia. (1999) Codex Basic Food Hygiene Texts/Annex to CAC/RCP 1-1969, Rev.3. Codex Alimentarius. (1997). Guidance on Regulatory Assessment of HACCP Report of a Joint FAO/WHO Consultation on the Role of Government Agencies in Assessing HACCP, Geneva (1998). 10