Haccp KKM

MCS 1/REV.
KEMENTERIAN KESIHATAN MALAYSIA
MALAYSIAN CERTIFICATION SCHEME

FOR HAZARD ANALYSIS AND CRITICAL
CONTROL POINT
(1ST SEPTEMBER 2015)
© Copyright
Food Safety and Quality Division,
Ministry of Health Malaysia
MCS 1/REV.1
Table of Contents
1. INTRODUCTION ................................................................................................................................ 1
2. DEFINITIONS
2.1 Adequacy audit ......................................................................................................................... 1

2.2 Audit ........................................................................................................................................... 1
2.3 Auditor ........................................................................................................................................ 1
2.4 Conformance............................................................................................................................. 1
2.5 Non-conformance (NC) ........................................................................................................... 1
2.5.1 Observation..................................................................................................................... 2
2.5.2 Minor ................................................................................................................................ 2
2.5.3 Major ................................................................................................................................ 2
2.5.4 Serious............................................................................................................................. 2
2.6 Corrective action request (CAR) ............................................................................................ 2
2.7 Checklist .................................................................................................................................... 2
2.8 Certification ............................................................................................................................... 2
2.9 Compliance ............................................................................................................................... 2
2.10 Compliance audit...................................................................................................................... 3
2.11 Establishment ........................................................................................................................... 3
2.12 Follow-up audit ......................................................................................................................... 3
2.13 Food premises .......................................................................................................................... 3
2.14 HACCP Plan ............................................................................................................................. 3
2.15 On site-audit .............................................................................................................................. 3
2.16 Pre-requisite programmes (PRP) .......................................................................................... 3
2.17 Surveillance audit ..................................................................................................................... 3
3. OBJECTIVE......................................................................................................................................... 4
4. SCOPE…………. ................................................................................................................................ 4
5. BENEFITS …………………………………………………………………………………………………………………………………….4
6. GENERAL REQUIREMENTS FOR APPLICATION ..................................................................... 4
7. NEW CERTIFICATION ...................................................................................................................... 5
7.1 Application Process ....................................................................................................... 5
MCS 1/REV.1
7.2 Fees and auditor expenditure................................................................................................. 5

8. SURVEILLANCE ................................................................................................................................ 6
9. RENEWAL OF CERTIFICATION ..................................................................................................... 7
9.1 Application process .................................................................................................................. 7
9.2 Fees............................................................................................................................................ 8
10. EVALUATION PROCESS ................................................................................................................. 8
11. VALIDITY OF THE CERTIFICATE .................................................................................................. 8
12. REAPPLICATION OF NEW CERTIFICATION .............................................................................. 9
13. CERTIFICATION FOR ADDITIONAL PRODUCT(S) ................................................................... 9
13.1 Application Process ............................................................................................................................ 9
13.2 Fees and auditor expenditure............................................................................................... 10
14. APPEAL ………… ............................................................................................................................ 11
15. CONFIDENTIALITY ......................................................................................................................... 11
16. OTHER PROCEDURES.................................................................................................................. 11
16.1 Application of HACCP Certification for Certified Premise with Different Premise Name
.................................................................................................................................................. 11
16.2 Change in Premise Name ..................................................................................................... 11
16.3 Change in Products Name .................................................................................................... 11
16.4 Application of GMP Certification for MOH HACCP Certified Premise ........................... 12
16.5 Loss/Damage of Certification ............................................................................................... 12
17. WITHDRAWAL OF HACCP CERTIFICATION ............................................................................ 12
18. OTHER CONDITIONS..................................................................................................................... 13
19. ENQUIRY
…………………………………………………………………………………………………………………………………..13
4
20. REFERENCES ................................................................................................................................. 14
MCS 1/REV.1
1. INTRODUCTION
The Malaysian Certification Scheme for Hazard Analysis and Critical Control Point
system (MCS HACCP) describes procedures which apply to food premises in
gaining HACCP certification. The scheme is administered by the Ministry of Health
(MOH), which requires the food premises to set up and implement a HACCP
system that meets the MCS HACCP criteria, followed by the application and
granting of the certification. The certification process includes adequacy,
compliance and any follow-up audits by appointed a n d certified auditors. The
MOH will verify the maintenance of the certified HACCP system through
surveillance audit. The certification is granted for specific food product and is not a
blanket certification for all types of food product w i t h i n a food premise.
2. DEFINITIONS
For the purpose of this scheme, the following definitions shall apply:
2.1 Adequacy audit

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.
2.2 Audit
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.
2.3 Auditor
A person formally appointed by MOH with technical competency in the HACCP
system and audit, including food processing technology.
2.4 Conformance
Conformance means a c t i v i t i e s a r e c a r r i e d o u t a c c o r d i n g t o t h e
e s t a b l i s h e d procedures as laid out in the HACCP Plan and the PRP documents.
2.5 Non-conformance (NC)

Non-conformance means activities carried out are not in accordance to the
established procedures. Categories of non-conformance are:-
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2.5.1 Observation
A recommendation given to affect an improvement.
2.5.2 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.
2.5.3 Major
A significant deviation from planned requirements MS1480, 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.
2.5.4 Serious
A severe deviation from planned requirements MS1480, 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.
2.6 Corrective action request (CAR)

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.
2.7 Checklist
A list that contains points/elements that may be considered during assessment. It is
used as aide-memoire to promote uniformity in assessment.
2.8 Certification
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
2.9 Compliance
Compliance means the HACCP plan and pre-requisites and their implementation
meet MCS HACCP requirements.
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2.10 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 a u d i t t o a s c e r t a i n f u l l c o m p l i a n c e w i t h MCS HACCP
c r i t e r i a a n d requirements.
2.11 Establishment
Any premises comprising groups of people and facilities that are involved in the food
preparation, processing, manufacturing, packaging, storage, transportation,
distribution, handling or offering for sale or supply in any sector of the food chain.
2.12 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.
2.13 Food premises

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, re-
processing or re-packing or re-conditioning of any food.
2.14 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.
2.15 On site-audit
An audit that is conducted at the auditee's establishment.
2.16 Pre-requisite programmes (PRP)

PRP shall mean the universal steps or procedures that control the operational
conditions within a food establishment allowing for environmental conditions that are
favorable to the production of safe food as describe in the MS1480 or other related
document.
2.17 Surveillance audit

On-site audit of HACCP certified food premises by surveillance auditor(s) to verify
the effective and continuous maintenance of HACCP system.
2.18 Auditor expenditure

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Auditor expenditure are including airfares, food, accommodation, mileage and other
cost incurred by the auditor(s) for compliance and follow-up onsite auditing will be
borne by the company.
3. OBJECTIVE
The objective of the scheme is to grant formal recognition to food establishment

that have effectively implemented and maintained the HACCP system for their
food product(s).
4. SCOPE
This guideline describes the requirements for food establishments to obtain and
maintain the HACCP certification from MOH.
5. BENEFITS
The benefits of a certified MOH HACCP system are as follows:

5.1 To facilitate and expedite the issuance of Health Certificate which is not
dependent on end product testing.
5.2 To reduce the frequency of regulatory inspection on food premises and
sampling.
5.3 To enhance safety of food produced by food premises.
5.4 To fulfill global requirements on food safety including the application for
Approval Number for the exporting of fish and fishery products to European
Union.
5.5 To promote the acceptance, both in Malaysia and abroad, of food produced
from food premises with certified HACCP system.
5.6 To improve marketability of the certified product.
5.7 To gain recognition by use the HACCP logo upon certification.
6. GENERAL REQUIREMENTS FOR APPLICATION
Food premises applying for HACCP Certification shall fulfill

the following requirements:
6.1 Premises shall be licensed with local authorities.
6.2 Premises shall be registered with Ministry of Health Malaysia via online system
at http://fosimdomestic.moh.gov.my/
6.3 Premise is registered with the Companies Commission of Malaysia
(Suruhanjaya Syarikat Malaysia (SSM)).
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6.4 The HACCP system shall be developed based on the Malaysian Standard
1480 - Food Safety according to Hazard Analysis and Critical Control Point
(HACCP) System and any other requirements imposed by the importing
country/countries.
6.5 GMP/PRP system shall be in place and documented based on the Malaysian
Standard 1514 - Good Manufacturing Practice (GMP) for Food and any other
requirements imposed by the importing country/countries.
6.6 The HACCP a nd PRP Manual shall be available with the minimum content
as stated in Appendix 1, Contents of HACCP and PRP Manual. The Manual
shall be duly signed and dated by the company management with executive
responsibility.
6.7 The HACCP system and PRP system should have been implemented for a
minimum of three (3) months prior to application.
7. NEW CERTIFICATION
7.1 Application Process

The application shall be made via online system at http://fosimdomestic.moh.gov.my/.
Flow chart for application of new certification/ additional product(s) is described in
Appendix 2.
The premise shall submit the documents according to the checklist as in Appendix 3,
HACCP Certification Scheme New/ Added Product Application Checklist within two
(2) weeks after submission of online application. MOH will verify the completeness of
the application and issu e th e qu ot a t ion to t he ap p lica n t.
*A registered company can have more than one establishment. The address can be
the same or different from one another. Choose only the establishment(s) that needs
to apply for HACCP Certification.
7.2 Fees and auditor expenditure
The premise shall pay the required fee as listed in Appendix 4 within one (1) month
from the quotation date. Certification for new application fee and auditor expenditure
fee shall be made payable to “SECRETARY GENERAL, MINISTRY OF
HEALTH MALAYSIA”, by bank draft or postal order separately. Payment by
personal or company cheque will not be accepted.
7.3 Auditing Procedure
7.3.1 Compliance audit consist of adequacy and on-site audit. Flow chart for
compliance audit is shown in Appendix 5.
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7.3.2 MOH will seek approval from Finance Department to use auditor expenditure
fee after receiving payment from premise.
7.3.3 MOH will appoint a t l e a s t two (2) auditors for the audit. The names of
the auditors will be made known to the premise by letter. For compliance
audit the MOH will send the applicant’s documentations to the audit team.
Audit arrangements will be made between the lead auditor and the
applicant.
7.3.4 Upon receipt of the complete documentations, the auditors conduct an
adequacy audit on the HACCP Manual and PRP Manual. The lead auditor
collates comments on the adequacy audit and prepares the Adequacy
Report on the Manual for the premise. The applicant must submit updated
HACCP Manual and PRP Manual to the auditor.
7.3.5 On-site audit will be carried out after receiving the updated HACCP Manual
and PRP Manual. The lead auditor contacts the premise for the on-site
compliance audit appointment and sends out an audit plan to the premise
and the auditor(s). A l l t h e d o c u m e n t a n d r e c o r d s h a l l b e r e a d i l y
a v a i l a b l e a n d t h e p r o c e s s i n g a c t i vi t i e s s h a l l b e a v a i l a b l e
d u r i n g o n - s i t e a u d i t . The auditors will present audit finding during the
closing meeting.
7.3.6 The premise shall respond to co r re ct i ve action requests (CAR’s) issued
within two (2) weeks after the on-site audit. Corrective action shall be taken
within the stated period as agreed and a maximum of six (6) month will be
given to rectify the CAR. If the s i x ( 6 ) m o n t h s period is exceeded without
valid justification, the premise would have to reapply. Follow up audit shall be
carried out within two (2) weeks after all CARs have been rectified by the
premise. Follow up audit can be on-site a u d i t a n d / or document audit.
7.3.7 The lead auditor prepares final recommendation report to the MOH within
five (5) days after all CARs have been closed out.
7.3.8 The premise is given a maximum of one ( 1 ) year from the first on-site
audit for all the audit process to be completed and all corrective action to be
closed out. If the one (1) year period is exceeded, the premise would have
to reapply.
8. SURVEILLANCE
The surveillance audit is c o n d u c t e d b y H e a l t h S t a t e D e p a r t m e n t at least

once (1) a year to determine w h e t h e r t h e H A C C P s y s t e m i s b e i n g
maintained. The frequency of the audits will vary according to the need and more
frequent audit will be conducted based on the recommendation of the compliance
audit report and on cases such as rejection of p ro d u c t s by importing countries,
customer complaints on products and additional of new processing
line/equipment/building for production of the certified products.
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8.1 Surveillance Fee
The premise shall pay the required fee as listed in Appendix 4. Surveillance fee
shall be made payable to “STATE HEALTH DIRECTOR”, by bank draft or
postal order. Payment by personal or company cheque will not be accepted.
8.2.1 Health State Department w i l l conduct t h e surveillance audits. Flow chart

for surveillance audit is shown in Appendix 6.
8.2.2 Health State Department will i n f o r m t h e p r e m i s e f o r s u r v e i l l a n c e
audit and payment
8.2.3 H e a l t h S t a t e D e p a r t m e n t w i l l appoint a t l e a s t two (2) auditors
for the audit upon receiving payment from premise. The names of the
auditors will be made known to the premise by letter.
8.2.4 Audit arrangements will be made between the lead auditor and the
applicant. A l l t h e d o c u m e n t a n d r e c o r d s h a l l b e r e a d i l y
closing meeting.
valid justification, the premise would have to reapply.
8.2.6 Follow up audit shall be carried out within two (2) weeks after all CARs
have been rectified by the premise. Follow up audit can be on-site
a u d i t a n d / or document audit.
9. RENEWAL OF CERTIFICATION
Certification is subject to renewal f o r every three (3) years. Application for renewal
of certification shall be made as early as six (6) months before expiry date.
9.1 Application process

Application for certification renewal shall be made v i a online system at
http://fosimdomestic.moh.gov.my/. Flow chart for application of renewal certification
is described in Appendix 7.
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9.2 Fees
The premise shall pay the required fee as listed in Appendix 4. Renewal fee shall
be made payable to “SECRETARY GENERAL, MINISTRY OF HEALTH
MALAYSIA”, by bank draft or postal order. Payment by personal or company
cheque will not be accepted.
9.3.1 MOH will appoint a t l e a s t two (2) auditors for the audit upon receiving
application and payment from premise. The names of the auditors will be
made known to the premise by letter. Flow chart for renewal audit is shown
in Appendix 8.
9.3.2 Audit arrangements will be made between the lead auditor and the
applicant. A l l t h e d o c u m e n t a n d r e c o r d s h a l l b e r e a d i l y
closing meeting.
valid justification, the premise would have to reapply.
9.3.4 Follow up audit shall be carried out within two (2) weeks after all CARs
have been rectified by the premise. Follow up audit can be on-site
a u d i t a n d / or document audit.
10. EVALUATION PROCESS
The HACCP Certification Committee will conduct a meeting once (1) in a 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
and members of the committee will consist of officers from the FSQD.
11. VALIDITY OF THE CERTIFICATE
The HACCP Certification awarded shall be valid for three (3) years.
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12. REAPPLICATION OF NEW CERTIFICATION
Reapplication for certification shall be necessary, if :

12.1 The certification fee and auditor expenditure are not paid by the premise within
one (1) months from the issuance date of quotation.
12.2 There is a delay of more than three (3) months on the part of the applicant to
agree with the date for compliance audit from the date of audit team appointed.
12.3 The findings of the compliance audit indicate total failure of the HACCP system
(failure to address all the seven HACCP principles)
12.4 The premise doesn’t rectify the CARs within six (6) month from the date of the
on-site compliance audit without valid justification.
12.5 Any of the CARs is not closed out within one (1) year, without a valid justification,
from the date of the on-site compliance audit.
13. CERTIFICATION FOR ADDITIONAL PRODUCT(S)
Application for HACCP certification of additional product(s) shall follow the same procedure
as application for new certification. The application shall be made via online system at
http://fosimdomestic.moh.gov.my/. Food premises wish to apply for HACCP certification of
additional product(s) shall fulfill the following requirements:
a. For MOH HACCP certified premise only

b. Involved additional of new facility (processing line, machinery etc) for the production
of new product(s) within the same HACCP certified premise.
However, for the new plant within the same address, the premise shall apply for new
certification. Flow chart for application of new certification/ additional product(s) is
described in Appendix 2.
13.1 Application Process
The application shall be made via online system at http://fosimdomestic.moh.gov.my/.

The application procedure is described in Appendix 2.
The premise shall submit the documents according to the checklist as in Appendix 3
within two (2) weeks after submission of online application. MOH will verify the
completeness of the application and issue th e qu o ta t io n t o t h e a p p lican t .
*A registered company can have more than one establishment. The address can be
the same or different from one another. Choose only the establishment(s) that needs
to apply for HACCP Certification.
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13.2 Fees and auditor expenditure
The premise shall pay the required fee as listed in Appendix 4 within one (1)
month from the quotation date . Certification for additional products fee and
auditor expenditure fee shall be made payable to “SECRETARY
GENERAL, MINISTRY OF HEALTH MALAYSIA”, by bank draft or postal
order separately. Payment by personal or premise cheque will not be accepted.
13.3.1 Auditing procedure for HACCP certification of additional product(s) shall

follow the same procedure as compliance audit which consist of adequacy
and on-site audit. Flow chart for compliance audit is shown in Appendix 5.
13.3.2 MOH will seek approval from Finance Department to use auditor expenditure
fee after receiving payment from premise
13.3.3 MOH will appoint a t l e a s t two (2) auditors for the audit. The names of
the auditors will be made known to the premise by letter. For compliance
audit the MOH will send the applicant’s documentations to the audit team.
Audit arrangements will be made between the lead auditor and the
applicant.
13.3.4 Upon receipt of the complete documentations, the auditors conduct an
adequacy audit on the HACCP Manual and PRP Manual. The lead auditor
collates comments on the adequacy audit and prepares the Adequacy
Report on the Manual for the premise.
13.3.5 The applicant must submit updated HACCP Manual and PRP Manual to the
auditor. On-site audit will be carried out after receiving the updated HACCP
Manual and PRP Manual. The lead auditor contacts the premise for the on-
site compliance audit appointment and sends out an audit plan to the premise
and the auditor(s). A l l t h e d o c u m e n t a n d r e c o r d s h a l l b e r e a d i l y
closing meeting.
valid justification, the premise would have to reapply. Follow up audit shall be
carried out within two (2) weeks after all CARs have been rectified by the
premise. Follow up audit can be on-site a u d i t a n d / or document audit.
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13.3.8 The premise is given a maximum of one ( 1 ) year from the first on-site
audit for all the audit process to be completed and all corrective action to be
closed out. If the one (1) year period is exceeded, the premise would have
to reapply.
14. APPEAL
Technical Committee will be empowered to make decisions on any appeal lodged against
any application or certification. The appeal panel will consists of members who are
independent of the certification process, to ensure impartiality and prevent conflict of
interest.
15. CONFIDENTIALITY
It is the policy of the MOH to require its staff members and auditors to maintain
confidentiality of information and documentation belonging to any organization. The
auditor must not to disclose any information or documents obtained during the audit to the
third party, without the approval of the organization, except as required by the laws.
Auditors are also required to abide by the Ministry Code of Ethics for Auditors.
16. OTHER PROCEDURES
16.1 Application of HACCP Certification for Certified Premise with Different

Premise Name
The premise shall follow the same procedure as new application and the MOH
shall conduct audit according to the new application procedure.
16.2 Change in Premise Name
The premise shall submit documents below to the MOH to change the premise
name:
a. A written request
b. Original copy of HACCP Certificate(s)
c. A copy of new Premise License from Local Authority
d. A copy of new food premise registration certificate from MOH
The MOH shall assess whether the requested changes merit an official
verification visit. If so, the MOH shall assign the auditor(s) to undertake
verification. Once approved, a new HACCP certificate will be issue by the MOH
with a copy sent to the relevant State Health Department
16.3 Change in Products Name

The premise shall submit documents below to the MOH to change the product
name.
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b. A copy of HACCP Certificate(s)

c. HACCP Manual : Product Description, Process Flow, Hazard Analysis
Worksheet, HACCP Plan Summary
verification. Once approved, a supporting letter shall be issued with a copy sent
to the State Health Department.
16.4 Application of GMP Certification for MOH HACCP Certified Premise

The premise shall submit the GMP Application via online system and the MOH
shall assess whether the application merit an official verification visit. If so, the
MOH shall assign the auditor(s) to undertake verification. Once approved, GMP
Certificate will be issue by the MOH. The premise shall follow any rule
established for HACCP Certified Premise.
16.5 Loss/Damage of Certification

The premise shall submit documents below to the MOH to change the premise
name:
b. Original copy of HACCP Certificate(s) (if any)
verification. Once approved, a new HACCP certificate will be issue by the MOH
with a copy sent to the relevant State Health Department
17. WITHDRAWAL OF HACCP CERTIFICATION
The HACCP certification shall be withdrawn from the company if:
a. The premise fails to fulfill the requirements as describe in the guidelines

b. The premise has fully stopped operating or doesn’t operating for a time period
greater than six (6) months.
c. The premise has voluntarily requested withdrawal of its HACCP Certification.
d. There is a change in location of the HACCP certified premise.
e. There is a delay of more than three (3) months on the part of the applicant to agree
with the date for renewal audit from the date of HACCP Certificate.
f. Food products is contravened with the Food Act 1983
MOH shall notify the affected the premise in writing to withdraw the HACCP Certification
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with a copy sent to the State Health Department. The premise shall not use the MOH
HACCP Logo at any product produced by the premise
18. OTHER CONDITIONS
All the HACCP certified holders are subjected to the following condition:-
a. The HACCP Certificate and Logo shall not be transferred nor shall its content be
altered.
b. Any changes to the name or address of the factory or premises, certification scope
or anything related thereto shall be informed in writing to the Senior Director of Food
Safety and Quality, Ministry of Health (MOH) for further action. Certification will be
automatically void shall factory or premises ceased.
c. The Certificate holder shall at all times be subject to inspection, monitoring and
enforcement conducted either by MOH.
d. The Certificate holder shall be held responsible for any abuse or misappropriation of
the Certificate. Any loss or damage of the Certificate shall immediately be informed
in writing to the Senior Director of Food Safety and Quality, MOH.
e. The use of the Certificate is subject to the laws and regulations that are currently in
force in the country.
f. The Certificate remains the property of Ministry of Health Malaysia. The Certificate
may be withdrawn or terminated at any time if there is violation of any laws or
regulations that are currently in force.
g. The use of the Logo is only allowed for food product that is being produced in the
premise as stated in the Certificate.
19. ENQUIRY
Further information on this scheme can be obtained from:

Food Safety and Quality Division,
Ministry of Health Malaysia,
Level 4, Menara Prisma
No 26, Jalan Persiaran Perdana
Presint 3, 62675, Putrajaya
Tel : 03 – 8885 0797

Fax : 03 – 8885 0769
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Web site : http://fsq.moh.gov.my

Email : fqc-division@moh.gov.my
20. REFERENCES
21.1 Codex Basic Food Hygiene Texts/Annex to CAC/RCP 1-1969, Rev.3

.Codex
21.2 Alimentarius (1997).
21.3 Food Act 1983 and Food Regulations 1985, Malaysia.
21.4 Guidance on Regulatory Assessment of HACCP Report of a Joint
FAO/WHO Consultation on the Role of Government Agencies in Assessing
HACCP, Geneva (1998).
21.5 Laboratory Accreditation Scheme of Malaysia. Department of Standards
Malaysia.
21.6 Malaysian Standard MS 1480:2007. Food Safety According to Hazard
Analysis and Critical Control Point (HACCP) System (1st Revision).
Department of Standards Malaysia. (2007).
21.7 Guidelines on Good Hygiene Practice for Small and Medium Scale Food
Industry Towards HACCP (2002).
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Appendix 1
CONTENTS OF HACCP AND PRP MANUAL
A. MINIMUM CONTENTS OF HACCP MANUAL
1. COMPANY & FOOD SAFETY POLICY

1.1. Company profile – including plant location, products(s)/scope to be
certified and export market (if applicable)
1.2. Organization chart – indicating line of responsibilities of team
members and the link to top management
1.3. Food safety management policy
1.4. Plant layout – indicating material flow, employee traffic flow and
sanitary facilities
2. HACCP TEAM & RESPONSIBILITIES
List the name of each team member, their position in the company,
academic/technical qualification and their HACCP job function. Identify the
HACCP coordinator/leader who will coordinate/lead the team.
3. SCOPE OF HACCP PLAN
4. FOOD SAFETY OBJECTIVE(S)
5. PRODUCT DESCRIPTION & INTENDED CONSUMER

5.1. Product Name
5.2. Raw Materials used
5.3. Sensitive ingredients identified
5.4. Reworked material (to be taken as ingredient)
5.5. Important product characteristics, where appropriate
5.6. Process type
5.7. Packaging and labeling
5.8. Shelf-life and storage conditions;
5.9. Handling and distribution
5.10. Intended Use & Consumer
5.11. Where the product will be sold
6. PROCESS FLOW DIAGRAM
7. HAZARD ANALYSIS WORKSHEET
8. HACCP SUMMARY PLAN
9. OVERALL VERIFICATION ACTIVITIES & SCHEDULE

B. MINIMUM CONTENTS OF PRP MANUAL
1. ESTABLISHMENT : DESIGN AND FACILITIES

1.1 Location
1.2 Premises and rooms
1.3 Equipment
1.4 Facilities
2. CONTROL OF OPERATION
2.1 Control of Food Hazards
2.2 Key aspects of hygiene control systems
2.3 Incoming Materials requirements
2.4 Supplier assurance programme
2.5 Packaging and storage
2.6 Water, steam and ice
2.7 Management and supervision
2.8 Documentation and records
2.9 Customer feedback and complaints
2.10 Recall procedures and traceability
3. ESTABLISHMENT : MAINTENANCE AND SANITATION

3.1 Maintenance and cleaning
3.2 Cleaning programmes
3.3 Chemical control
3.4 Pest Control
3.5 Waste Management
3.6 Sanitation systems
4. ESTABLISHMENT : PERSONAL HYGIENE

4.1 Health Status
4.2 Illness and injuries
4.3 Personal cleanliness
4.4 Personal behavior
4.5 Visitors and workmen
5. TRANSPORTATION AND DISTRIBUTION

5.1 General
5.2 Requirements
5.3 Use and maintenance
6. PRODUCT INFORMATION AND CONSUMER AWARENESS

6.1 Batch Identification
6.2 Product information
6.3 Labelling
6.4 Consumer education
7. TRAINING
7.1 Awareness and responsibilities
7.2 Training programmes
7.3 Instruction and supervision
7.4 Refresher training
8. INTERNAL INSPECTION
9. MANAGEMENT REVIEW
Appendix 2
FLOW CHART FOR APPLICATION OF NEW CERTIFICATION/ ADITIONAL

PRODUCT(S)
Login to FoSIM Domestik

(http://fosimdomestic.moh.gov.my/)
Applicant
Complete the form and submit
Submission of supporting documents
Documents received
Inform No Check for

Applicant completeness
of application MOH
Yes
Inform applicant for payment
No
Reject Payment Applicant
Application
Yes
Acceptance of Application
AppointAudit Team
Conduct Compliance Audit

Not
approved
Evaluation of Auditor’s
Inform Recommendation by
Applicant HACCP Certification
Committee
Approved
Issuance of HACCP Certificate

Appendix 3
FOOD SAFETY AND QUALITY DIVISION

MINISTRY OF HEALTH MALAYSIA
HACCP CERTIFICATION SCHEME

NEW / ADDED PRODUCT APPLICATION
CHECKLIST
MCS HACCP appcklist(1/00)

For APPLICANT use
Premise Name
Premise
Address
Submission
Date
Please tick
A. CHECKLIST FOR APPLICATION FORM *Yes (√) / No (X)
Applica Officer
nt
1. Online Application Form
2. A copy of SSM Certificate (Suruhanjaya Syarikat Malaysia)
3. A copy of Premise Licence from Local Authority
4. A copy of Company Audited Account
5. Two (2) copies of HACCP Manual
(Refer to Annex B below for minimum content of HACCP
Manual)
6. Two (2) copies of PRP/GMP Manual
(Refer to Annex C below for minimum content of PRP/GMP
Manual)
Annex Please tick

CHECKLIST FOR MINIMUM CONTENTS OF HACCP
B. *Yes (√) / No (X)
MANUAL AND SUPPORTIVE DOCUMENTS
Applicant Officer
1. Company & Food Company profile
Safety Policy Organization chart
Food safety management policy
Plant layout
2. HACCP Team & Responsibilities
3. Scope of HACCP Plan
4. Food Safety Objective(s)
5. Product Description & Intended Consumer
6. Process Flow Chart
Annex Please tick
CHECKLIST FOR MINIMUM CONTENTS OF HACCP
B. *Yes (√) / No (X)
MANUAL AND SUPPORTIVE DOCUMENTS
Applicant Officer
7. Hazard Analysis Worksheet
8. HACCP Plan Summary
9. Overall Verification Activities & Schedule
10. Summary of Pre-requisite Programmes
Annex Please tick

CHECKLIST FOR MINIMUM CONTENTS OF PRP/GMP
C. *Yes (√) / No (X)
MANUAL
Applicant Officer
1. Establishment : Design and Facilities
a. Location
b. Premises and rooms
c. Equipment
d. Facilities
2. Control of Operation
a. Control of Food Hazards
b. Key aspects of hygiene control systems
c. Incoming Materials requirements
d. Supplier assurance programme
e. Packaging and storage
f. Water, steam and ice
g. Management and supervision
h. Documentation and records
i. Customer feedback and complaints
j. Recall procedures and traceability
3. Establishment : Maintenance and sanitation
a. Maintenance and cleaning
b. Cleaning programmes
c. Chemical control
d. Pest Control
e. Waste Management
f. Sanitation systems
4. Establishment : Personal Hygiene
a. Health Status
b. Illness and injuries
c. Personal cleanliness
d. Personal behaviour
e. Visitors and workmen
5. Transportation and Distribution
a. General
b. Requirements
c. Use and maintenance
6. Product information and consumer awareness
a. Batch Identification
b. Product information
Annex Please tick
CHECKLIST FOR MINIMUM CONTENTS OF PRP/GMP
C. *Yes (√) / No (X)
MANUAL
Applicant Officer
c. Labelling
d. Consumer education
7. Training
a. Awareness and responsibilities
b. Training programmes
c. Instruction and supervision
d. Refresher training
Please submit all the documents above within two (2) weeks after submission of
online application to the address below:
Senior Director
Food Safety and Quality Division
Ministry of Health
Level 4, Menara Prisma
No 26, Jalan Persiaran Perdana
Presint 3, 62675 Putrajaya
(Attn: HACCP Certification Unit)
The application will be processed once completed documents are received. Failure to
submit the complete documents will affect your application.
____________________________________________________________________
FOR OFFICER USE
Status : COMPLETE REJECT KIV
Note :
Processed By :
....................................................
(Signature and Official Stamp) Date :
Appendix 4
HACCP CERTIFICATION FEE
Item BI (RM)1 SMI (RM)2
New application 5,400.00 4,000.00

Renewal 4,000.00 3,000.00
Certification for additional products from 2,750.00 2,550.00
certified company (separated)
Surveillance 900.00* 900.00*
Item Peninsular Sabah & Sarawak,

Malaysia, (RM) (RM)
Auditor expenditure** 3,420.00 4,040.00
Definition:
1. Big Industry (BI) Comprises 150 full time workers with an annual sale
turn-over of RM25 million
2. Small and Medium Comprises less than 150 full time workers with an
Industry (SMI) annual sale turn-over of not more than RM25 million
Note:
(*) Starting from 1st January 2019 surveillance fee is RM1,800.00
(**) Auditor expenditure is applicable for new application and certification for additional
products. It’s includes airfares, food, accommodation, mileage and other costs
incurred by the auditor such as follow-up audit.
Appendix 5
FLOW CHART FOR COMPLIANCE AUDIT
Approval to use auditors’ expenditure MOH to seek approval from finance

department
Appointment of audit team MOH to appoint the audit team to

conduct the audit
Adequacy audit Auditor to prepare adequacy audit

report within five (5) days after
receipt of documents and submit to
the premise
On-site audit Auditor to contact premise within

two(2) weeks after adequacy audit
to agree on the date for on-site audit
CAR Issuance
Premise to r e s p o n d within t w o
Response to CARs (2) weeks and completion of CARs
within six (6) month
Initial on-site audit report Auditor to prepare initial audit

report within five (5) days after on-
site audit date.
Follow-up audit (if applicable) Auditor to contact auditee within

(onsite audit and/or documents audit) two(2) weeks after completion of
CARs to agree on date for follow-up
audit
B
B
Auditor to prepare f in a l a u d it
Final Audit Report and
report within five (5) days after
Recommendation closed-out of all CARs
Not
approved
Recommendation by
Inform HACCP Certification
Applicant Committee
Approved

Appendix 6
FLOW CHART FOR SURVEILLANCE AUDIT
State Health Dept. inform the premise

for surveillance audit & payment
Receive payment
Health State Department to appoint

Appointment of audit team the audit team to conduct the audit
Auditor to contact premise to agree

On-site audit on the date for on-site audit
CAR Issuance
Premise to respond within two

within stated period
(maximum six (6) month)
Auditor to prepare initial audit

Initial on-site audit report report within five (5) days after on-
site audit date
Auditor to contact auditee within two

Follow-up audit (if applicable)
(2) weeks after completion of CARs
(Onsite audit and/or documents audit) to agree on date for follow-up audit
Final Audit Report and Auditor to prepare f in a l a u d it

Recommendation report within five (5) days after
closed-out of all CARs
Appendix 7
FLOW CHART FOR APPLICATION OF RENEWAL CERTIFICATION
Login to FoSIM Domestik

(http://fosimdomestic.moh.gov.my/)
Choose the HACCP/GMP Certification
Choose HACCP Renewal Application Applicant
Complete the form and submit.
Submission of payment
Payment received.
Acceptance of Application
Appoint Audit Team
Conduct Renewal Audit
Details as in
Not Appendix 9
approved
Evaluation of Auditor’s MOH
Committee
Approved

Appendix 8
FLOW CHART FOR RENEWAL AUDIT
Receive application & payment
MOH to appoint the audit team to

Appointment of audit team conduct the audit
Auditor to contact premise to agree

On-site audit on the date for on-site audit
CAR Issuance
Premise to respond within two

within stated period
(maximum six (6) month)
Auditor to prepare initial audit

Initial on-site audit report report within five (5) days after on-
site audit date
Auditor to contact auditee within

Follow-up audit (if applicable)
two(2) weeks after completion of
(onsite audit and/or documents audit) CARs to agree on date for follow-up
audit
Auditor to prepare f in a l a u d it
Final Audit Report and report within five (5) days after
Recommendation closed-out of all CARs
B
B
Not
approved
Committee
Approved

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MCS 1/REV.

KEMENTERIAN KESIHATAN MALAYSIA

MALAYSIAN CERTIFICATION SCHEME

2.1 Adequacy audit ......................................................................................................................... 1

7.2 Fees and auditor expenditure................................................................................................. 5

2.1 Adequacy audit

2.5 Non-conformance (NC)

2.6 Corrective action request (CAR)

2.10 Compliance audit

2.12 Follow-up audit

2.13 Food premises

2.14 HACCP Plan

2.16 Pre-requisite programmes (PRP)

2.17 Surveillance audit

2.18 Auditor expenditure

The objective of the scheme is to grant formal recognition to food establishment

The benefits of a certified MOH HACCP system are as follows:

6. GENERAL REQUIREMENTS FOR APPLICATION

Food premises applying for HACCP Certification shall fulfill

7.1 Application Process

7.2 Fees and auditor expenditure

7.3 Auditing Procedure

The surveillance audit is c o n d u c t e d b y H e a l t h S t a t e D e p a r t m e n t at least

8.1 Surveillance Fee

8.2 Auditing Procedure

8.2.1 Health State Department w i l l conduct t h e surveillance audits. Flow chart

9.1 Application process

9.3 Auditing Procedure

10. EVALUATION PROCESS

11. VALIDITY OF THE CERTIFICATE

12. REAPPLICATION OF NEW CERTIFICATION

Reapplication for certification shall be necessary, if :

13. CERTIFICATION FOR ADDITIONAL PRODUCT(S)

a. For MOH HACCP certified premise only

13.1 Application Process

The application shall be made via online system at http://fosimdomestic.moh.gov.my/.

13.2 Fees and auditor expenditure

13.3 Auditing Procedure

13.3.1 Auditing procedure for HACCP certification of additional product(s) shall

16. OTHER PROCEDURES

16.1 Application of HACCP Certification for Certified Premise with Different

16.3 Change in Products Name

b. A copy of HACCP Certificate(s)

16.4 Application of GMP Certification for MOH HACCP Certified Premise

16.5 Loss/Damage of Certification

17. WITHDRAWAL OF HACCP CERTIFICATION

The HACCP certification shall be withdrawn from the company if:

a. The premise fails to fulfill the requirements as describe in the guidelines

18. OTHER CONDITIONS

Further information on this scheme can be obtained from:

Tel : 03 – 8885 0797

Web site : http://fsq.moh.gov.my

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

CONTENTS OF HACCP AND PRP MANUAL

A. MINIMUM CONTENTS OF HACCP MANUAL

1. COMPANY & FOOD SAFETY POLICY

2. HACCP TEAM & RESPONSIBILITIES

3. SCOPE OF HACCP PLAN

4. FOOD SAFETY OBJECTIVE(S)

5. PRODUCT DESCRIPTION & INTENDED CONSUMER

6. PROCESS FLOW DIAGRAM

7. HAZARD ANALYSIS WORKSHEET

8. HACCP SUMMARY PLAN