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)
 MCS HACP - Guidelines for HACCP Compliance Audit

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
 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) Malaysian Agricultural Research and Development

Institute (MARDI)

Mohd Salim Dulatti (Secretary) Food Quality Control Division, Ministry of Health
(FQCD, MOH)

Yeoh Que Lan Malaysian Agricultural Research and Development

Institute (MARDI)

Radziah Mohd. Daud 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 Food Quality Control Division, Ministry of Health

(FQCD, MOH)

Ch’ng Oon Teong Food Quality Control Division, Ministry of Health

(FQCD, MOH)

2
 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.

3
 MCS HACP - Guidelines for HACCP Compliance Audit

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
 MCS HACP - Guidelines for HACCP Compliance Audit

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
 MCS HACP - Guidelines for HACCP Compliance Audit

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
 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. 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. Confirm working hours, lunch/tea break arrangements and interim meetings
xiii. Explain the purpose and confirm the arrangements for the closing meeting
between the audit team and the auditee.

4.2.2 Plant visit

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
 MCS HACP - Guidelines for HACCP Compliance Audit

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 Follow-
up 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
 MCS HACP - Guidelines for HACCP Compliance Audit

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.
1
4.11 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
 MCS HACP - Guidelines for HACCP Compliance Audit

xiv. Evidence of Management review

xv. Indication of effective pre-requisite programmes
xvi. 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