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Food Quality Control Division, Department Of Public Health Ministry of Health Malaysia

MCS HACP - Guidelines for HACCP Compliance Audit

CONTENTS Acknowledgement Foreword 1. 2. 3. 4. 5. 6. 7. Introduction Scope Definition Procedure for compliance audit Appointment and registration of compliance auditor Contents of the checklist References


MCS HACP - Guidelines for HACCP Compliance Audit

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 Dr. Ayub Mohd. Yatim NorAiny Mahyuddin Syed Abd. Rahim Syed Abd. Rashid Goh Poh Guat Wee Bee Wah Thayalan Ramadas Nor Kamilah Alwi Chng Oon Teong 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. National University of Malaysia (UKM) Department of Fishery (DOF) Department of Veterinary Services (DVS) Golden Arches Restaurant Sdn. Bhd. Health Department of Selangor Health Department of Perak Food Quality Control Division, Ministry of Health (FQCD, MOH) Food Quality Control Division, Ministry of Health (FQCD, MOH)

MCS HACP - Guidelines for HACCP Compliance Audit

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.

MCS HACP - Guidelines for HACCP Compliance Audit

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.

SCOPE The scope of this guideline encompasses the procedures for compliance audit and the criteria for selection of compliance auditor(s).

3 3.1

DEFINITION 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.


Auditor A person technically competent in the HACCP system and audit, and in a particular food processing technology or field, formally appointed by MOH.


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.


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

MCS HACP - Guidelines for HACCP Compliance Audit


Checklist A list that contains points/elements that may be considered during assessment. It is used as aide-memoire to promote uniformity in assessment.


Compliance Compliance means the HACCP plan and pre-requisites and their implementation meet MOH MCS requirements.


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.


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.


On-site audit An audit that is conducted at the auditee's premises.


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.


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.


Implementation of the HACCP plan The ongoing execution and maintenance of the HACCP plan.

MCS HACP - Guidelines for HACCP Compliance Audit


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.


Conformance Conformance means activities are carried out according to the established procedures as laid out in the HACCP Plan and the PRP documents.


Non-conformance Non-conformance means activities carried out are not according to the established procedures.


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. 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. 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. Observation - A recommendation given to effect an improvement.



d) 4 4.1

PROCEDURE FOR COMPLIANCE AUDIT 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

MCS HACP - Guidelines for HACCP Compliance Audit

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. ii. iii. iv. v. vi. vii. viii. ix. x. Introduce audit team members Introduce observers (if any), inform purpose and their role Request auditee to introduce themselves Circulate attendance list Inform auditee of Undertakings of Confidentiality by all members of the audit team State the authority of the audit, the scope of the audit, the audit standard and other related documents Confirm the audit programme Give a summary of the methods and procedures to be used to conduct the audits Describe the method of non-conformance reporting and define the terms "minor", "major", "serious" and "observation" non-conformance and their implications 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 Request for a meeting room to be reserved for the audit team's use 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.

xi. xii. xiii.

4.2.2 Plant visit i. ii. Verify process flow diagram on-site Conduct observations on process, procedures and premises.

4.2.3 Document audit comments i. ii. iii. Clarification of adequacy document comments On-site document review Verification of HACCP control chart, on-line monitoring and checking records. 7

MCS HACP - Guidelines for HACCP Compliance Audit

4.2.4 Auditors meeting i. Discuss audit findings.

4.2.5 Exit (Closing) Meeting i. ii. iii. iv. v. vi. vii. viii. ix. 4.3 4.4 4.5 4.6 4.7 Thank auditee for hospitality, cooperation and assistance Circulate attendance list State that the critique is based on objective evidence presented and does not mean that areas not seen or mentioned are considered satisfactory State general impressions Request auditors to give their findings Resolve points raised by auditee Present corrective action requests (CAR) Reconfirm scope of HACCP certification Inform auditee of subsequent action after the on-site audit.

Response by company to CAR(s) issued within 3 weeks. Prepare and send Audit Report to company with a copy to MOH within four (4) weeks after receipt of CAR response. Corrective action and document update by company within six (6) months from on-site audit. Submission of updated document by company to lead auditor and to conduct Followup Audit (FUA), if necessary (Concurrent with 4.5 above) 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. ii. iii. iv. Entry meeting As 4.2.1 (where appropriate) Plant visit Document audit comments Exit Meeting As 4.2.5 (where appropriate) Issuance of new CAR (if any) Closing of completed CAR Close on-site FUA. 8


MCS HACP - Guidelines for HACCP Compliance Audit

4.8 4.9 4.10 4.11 4.12 4.13

Response by company to unsatisfactory corrective actions on previous CAR(s) and new CAR issued (if any) within three (3) weeks. FUA report by FUA auditor to lead auditor within two (2) weeks. Prepare an Interim Report to the company with a copy to MOH within two (2) weeks.

Corrective action and document update by company within six (6) months.

Conduct document audit and further FUA on-site (if necessary). 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 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.



CONTENTS OF THE CHECKLIST 6.1 i. ii. iii. iv. v. vi. vii. viii. ix. x. xi. xii. xiii. HACCP Management commitment Scope of the HACCP plan Appropriate HACCP team established, with appropriate job functions Proper product description and intended use Factory floor layout Process flow chart Proper application of HACCP principles Proper identification of hazards (hazard analysis) Proper selection of critical control points (CCPs) Appropriate critical limits (CLs), monitoring procedures, corrective actions, as well as validation and verification activities Proper documentation and record keeping All regulatory requirements relating to health and safety have been addressed HACCP Internal Audit Reports

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).

MCS HACP - Guidelines for HACCP Compliance Audit

xiv. xv. xvi. 6.2 i. ii. iii. iv. v. vi. vii. viii. ix. x. xi. xii. 7.

Evidence of Management review Indication of effective pre-requisite programmes On-site observations. Pre-requisite for HACCP Premises location, design, construction and maintenance, lighting, ventilation, product flow, waste disposal, factory grounds, employee facilities Supplier control and specifications - supplier guarantee, written specifications Water, steam and ice supply, quality, records Receiving, storage, distribution - Food and non-food, finished product Production equipment - design and installation, maintenance, calibration, records Cleaning and sanitation - sanitation programme, equipment cleaning and sanitizing facilities, records. Personnel - cleanliness and conduct, communicable diseases and injuries Training - hygiene and sanitation, GMP, HACCP, technical Chemical control - procedures, storage, records Pest control - pest control programme and records Recalls - procedures and records Customer complaints.

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).