MCS HACCP – Guideline for HACCP Surveillance Audit

MCS4

MALAYSIAN CERTIFICATION SCHEME FOR

HAZARD ANALYSIS AND CRITICAL
CONTROL POINT

GUIDELINES FOR HACCP

SURVEILLANCE AUDIT

Food Quality Control Division, Department of Public Health

Ministry of Health Malaysia
MOH/K/MAK/12.01(GU)
 CONTENTS
Page

Committee Representation

Foreword

1 Introduction

2 Scope

3 Definitions

4 Qualification criteria for surveillance auditor

5 Code of ethics

6 Term and conditions for auditors

7 Registration and appointment of surveillance auditor

8 Procedures for surveillance audit

9 Action on Non-conformance

10 Surveillance audit report

11 Frequency of surveillance audit

12 References

Appendices:

1. Corrective action request (CAR) form

2. Surveillance audit report form

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 ACKNOWLEDGEMENT

The Working Group on the Guideline for HACCP Certification which prepared this
Malaysian Certification Scheme consists of the following representatives :

Mohd. Salim B. Dulatti (Chairman) - BKMM, Kementerian Kesihatan Malaysia

Nor Kamilah bt. Mohamad Alwi (Secretary) - BKMM, Kementerian Kesihatan Malaysia
Lam Ah Chye - FMM
NorAiny Mahyuddin - Jabatan Perikanan Malaysia
Syed Abd. Rahim Syed Abd. Rashid - Jabatan Perkhidmatan Haiwan Malaysia
Wee Bee Wah - Jabatan Kesihatan Negeri Selangor
Thayalan a/l Ramadas - Jabatan Kesihatan Negeri Perak
Wee Kong Heng - MAEH
Foo Mong Keng - Malaysian Agricultural Development
Authority (MARDI)
Radziah Mohd. Daud - SIRIM QAS Sdn. Bhd.
Prof. Madya Dr. Nik Ismail Nik Daud - Universiti Kebangsaan Malaysia
Shamsinar bt. Abdul Talib - BKMM, Kementerian Kesihatan Malaysia
Ch’ng Oon Teong - BKMM, Kementerian Kesihatan Malaysia

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 FOREWORD

The surveillance audit programme managed by the Malaysia Certification

Scheme for Hazard Analysis and Critical Control Point system is designed to
support the food industry which have obtained HACCP Certification under this
scheme.

This guideline is structured to provide essential information in a standardized,

logical and systematic manner when conducting a systematic evaluation on the
HACCP system, which has been implemented by the food industry. It consists of
procedures for conducting the surveillance audit and the criteria for the selection
of surveillance auditors. The procedures are made up of a specific guide which
can be combined and customized to meet the specific needs of the auditors.

This guideline also provides recognition for suitable qualified auditors from the
Ministry of Health who are registered as certified surveillance auditor.

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1 INTRODUCTION

The surveillance audit is part of the Malaysian Certification Scheme (MCS)

for HACCP System administered by the Ministry of Health (MOH). This
guideline applies to auditors conducting surveillance audit on food
premises that have obtained HACCP MCS. The purpose of the
surveillance audit is to verify that the HACCP system is effectively
maintained. The surveillance audit is a systematic evaluation which,
involves on-site observations and records review. One or two appointed
auditors from the MOH will be carried out the surveillance audit.

2 SCOPE

The scope of this guideline is to establish the procedure for conducting

surveillance audit and the criteria for selection of surveillance auditors.

3 DEFINITIONS

3.1 Surveillance audit

On-site audit of HACCP certified food premises by surveillance auditor(s)

to verify the (effective) continuous maintenance of HACCP system.

3.2 Surveillance auditor

An auditor appointed by the MOH to conducts the surveillance audit

4 CRITERIA FOR SURVEILLANCE AUDITOR

A surveillance auditor shall have the following requirements:

4.1 a degree or equivalent qualification with a minimum of three (3) years full
time working experience in the field of food technology/food science or
relevant discipline; or ;

4.2 a diploma or equivalent qualification with a minimum of five (5) years full
time working experience in the field of food technology/food science or
relevant discipline;

4.3 successfully completed and passed the written exam of a MOH

recognized training course on HACCP verification and auditing;

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4.4 be competent in HACCP system where he/she is required to exercise
judgement during an audit with the application of HACCP concepts;

4.5 should be registered and appointed as an auditor by the MOH; and

4.6 be an employee of the MOH.

5 CODE OF ETHICS

5.1 An auditor shall observe and comply with the following code of ethics :

a) to act professionally, accurately and in an unbiased manner;

b) not to represent or competing interests and to disclose to any client

or employer any relationships that may influence his/her judgement;

c) not to discuss or disclose any information relating conflicting to an

audit to other party unless required by law or authorized in writing
by the auditee and the auditing organization;

d) not to accept any inducement, commission, gift or any other benefit

from auditee organizations, their employees or any interested party
or knowingly allow colleagues to do so;

e) not to intentionally communicate false or misleading information

that may compromise the integrity of any audit or the auditee’s
certification process;

f) not to act in any way that would prejudice the reputation of the
MOH;

g) obtain and assess objective evidence fairly;

h) remain true to the purpose of the audit without fear or favour;

i) perform the audit process without deviating due to distractions;

j) commit full attention and support to the audit process;

k) react effectively in stressful situations;

l) remain true to a conclusion despite pressure to change that is not

based on evidence.

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6 TERMS AND CONDITIONS FOR AUDITORS

An auditor shall :

a) maintain independence, confidentiality and integrity;

b) ensure that confidentiality is maintained for all records and

documents related to the audited company;

c) keep their knowledge and skills up-to-date;

d) not retain or reproduce any records and documentation received

and generated during the course of audit.

7 REGISTRATION AND APPOINTMENT OF SURVEILLANCE AUDITOR

Surveillance auditors will be appointed by the Director of Food Quality

Control Division, MOH, based on the criteria stated in para 4. The Ministry
of Health reserves its rights to revoke the appointment of any surveillance
auditor as and when appropriate.

8 PROCEDURES FOR SURVEILLANCE AUDIT

8.1 Appointment of auditor(s)

The Food Quality Control Division Director will appoint auditor(s) to carry
out surveillance audit.

8.2 Notification of auditee

The surveillance auditor will confirm the time and date of surveillance audit
with the auditee’s management.

8.3 Preparation of checklist

A checklist should be prepared based on the activities under clause 8.4.

The checklist should be according to the scope of the audits.

8.4 Conduct of the surveillance audit

The surveillance audit comprises:

a) entry meeting;

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 b) records review;

c) on-site observation;

d) preparation of audit findings; and

e) exit meeting.

8.4.1 Entry meeting

The entry meeting is held on arrival immediately before the surveillance

audit commences. The auditor(s) will explain the scope and purpose of
the audit, how it will be conducted and the timetable for the audit. The
HACCP coordinator and the company’s top management should be
present at the entry meeting. The auditor(s) will confirm the schedule and
accompanying personal for the on-site visit. The auditor(s) should also
identify the key staff members they will be meeting during the audit.

The company’s management should in brief, inform the auditor(s) about

the latest overview of HACCP implementation in their factory especially if
there are any changes/modifications made to the HACCP system. The
updated versions of HACCP Manual, the pre-requisite programmes,
records and logbooks should be available for review.

8.4.2 Records review

The auditor(s) should :

a) Review of records on the pre-requisite programmes;

b) Verify that food safety objective(s) are being met:

i) review of records on analytical results including those for

regulatory purposes.

ii) review of records on consumer complaints, product recall,

product rejection and other relevant records.

c) Review of records relating to CCPs including review of records on:

i) monitoring

ii) corrective actions

iii) verification

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 d) Review of modifications to the HACCP plan such as (if applicable):

i) changes in raw material

ii) changes in processing parameter or product formulation

iii) installation of any line equipment or modification

iv) changes in packaging or final product handling

v) label changes regarding preparation of the product

vi) new emerging hazard awareness

vii) changes of intended consumer at risk

e) Verify that activities including management review are carried out

as scheduled

f) Verify that continuous training are being conducted

8.4.3 On-site observations

On-site observations will be made to verify that the actual process being
carried out at the factory corresponds with the process flow chart and
procedures documented. The on-site observations of operations should:

a) verify that pre-requisite programmes are effectively maintained.

b) verify accuracy of flow chart and that any changes has been updated.

c) verify CCPs are monitored as required by the HACCP plan.

d) verify processes are operating within established critical limits.

e) verify records are logged in accurately at the time intervals.

8.4.4 Preparation of Audit Findings

The auditor(s) should list the key points of the audit findings and where
necessary prepare of CAR(s).

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8.4.5 Entry Meeting

The purpose of the exit meeting is to enable the auditor to present the
findings of auditing and to obtain the acceptance of CAR(s) issued using
the CAR Form (See Appendix 1). Action to be taken on NC(s) is as in Para
9.0

9 ACTION ON NON-CONFORMANCE

9.1 Minor Non-conformance (NC)

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 when it is satisfactorily rectified. Failure to rectify the NC shall affect
the renewal of the HACCP certificate.

9.2 Major Non-conformance (NC)

For major NC, CARs 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 b 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.

9.3 Serious Non-conformance (NC)

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 the withdrawal of the HACCP
certificate.

10 SURVEILLANCE AUDIT REPORT

Reports on surveillance audit findings shall be submitted to the HACCP

Certification Secretariat of the Ministry of Health with a copy to the auditee
(See Appendix 2). A preliminary report shall be submitted immediately
after the surveillance audit. A final report shall be submitted after all the
CARs have been closed out.

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11 FREQUENCY OF SURVEILLANCE AUDIT

The surveillance audit will be carried out at least once in six (6) months.
However, the frequency of the audits will vary according to circumstances
Audits at shorter intervals may be required in cases of rejection of
products and customer complaints and other food safety concern.

12 REFERENCES

Codex Basic Food Hygiene Texts/Annex to CAC/RCP 1-1969, Rev.3

.Codex Alimentarius. (1997).

Certification Criteria for Food Safety Auditors, Edition 3, Quality Society of

Australasia. (1998)

Certified Quality Management Consultant Professional Register, Edition 6.

Quality Society of Australasia (1999)

Food Act 1983 and Food Regulations 1985. Malaysia.

Guidance on Regulatory Assessment of HACCP Report of a Joint

FAO/WHO Consultation on the Role of Government Agencies in
Assessing HACCP, Geneva (1998).

HACCP A Practical Approach. Mortimore, Wallace. (1994).

Malaysian Standard MS 1480:1999. Food Safety According to Hazard

Analysis and Critical Control Point (HACCP) System. Department of
Standards Malaysia. (1999)

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 Appendix 1

Form MCS HACCP-SA(1/00)

MALAYSIAN CERTIFICATION SCHEME FOR HACCP

SURVEILLANCE AUDIT : CORRECTIVE ACTION REQUEST (CAR)

Audit no.: CAR No.: Date :

Food Premises (FP) :

Address:

FT representative(s):

Auditors:

Non-conformance : Observation Minor Major Serious

Signed:__________________________ Signed:__________________________
Company Representative Auditor

Corrective Action

Signed:__________________________ Date :__________________

Company Representative

Audit comments and Close Out

Date CAR Closed Out : _______________ Signed:_______________________

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 Appendix 2

Form MCS HACCP-SA(2/00)

SURVEILLANCE AUDIT REPORT

STATE HEALTH DEPARTMENT OF _____________________________

1. Food Premises :

2. address :

3. Date of Audit :

4. No. of Audit:

5. Product(s) :

6. Scope of Audit:

7. Company Representative(s):

8. Surveillance Members:

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9. Results and Observation:

NO *NON-CONFORMANCE CATEGORY CLOSED-OUT

1
Fill up the table below

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NO *NON-CONFORMANCE CATEGORY CLOSED-OUT

10. Position Statement :

Signature : ______________________________

Name :_______________________________

Position :_______________________________

Date :_______________________________

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