MALAYSIAN CERTIFICATION SCHEME FOR HAZARD...

MCS 1/REV.1

MALAYSIAN CERTIFICATION SCHEME FOR HAZARD ANALYSIS AND CRITICAL

CONTROL POINT

GUIDELINES FOR HACCP CERTIFICATION

© Copyright

Food Safety and Quality Division,

Ministry of Health Malaysia

Table of Contents 1. INTRODUCTION ................................................................................................................................ 4

2. DEFINITION…………………………………………………………...…………………………….4

2.1 Adequacy audit ......................................................................................................................... 4

2.2 Audit ........................................................................................................................................... 4

2.3 Auditor ........................................................................................................................................ 4

2.4 Conformance............................................................................................................................. 4

2.5 Non-conformance (NC) ........................................................................................................... 4

2.5.1 Observation ..................................................................................................................... 4

2.5.2 Minor ................................................................................................................................ 5

2.5.3 Major ................................................................................................................................ 5

2.5.4 Serious ............................................................................................................................. 5

2.6 Corrective action request (CAR) ............................................................................................ 5

2.7 Checklist .................................................................................................................................... 5

2.8 Certification ............................................................................................................................... 5

2.9 Compliance ............................................................................................................................... 5

2.10 Compliance audit ...................................................................................................................... 5

2.11 Establishment ........................................................................................................................... 6

2.12 Follow-up audit ......................................................................................................................... 6

2.13 Food premises .......................................................................................................................... 6

2.14 HACCP Plan ............................................................................................................................. 6

2.15 On site-audit .............................................................................................................................. 6

2.16 Pre-requisite programmes (PRP) .......................................................................................... 6

2.17 Surveillance audit ..................................................................................................................... 6

3. OBJECTIVE ......................................................................................................................................... 6

4. SCOPE ................................................................................................................................................. 7

5. BENEFITS ........................................................................................................................................... 7

6. GENERAL REQUIREMENTS FOR APPLICATION ..................................................................... 7

7. NEW CERTIFICATION ...................................................................................................................... 8

7.1 Application Process................................................................................................................. 8

7.2 Fees and auditor expenditure ................................................................................................. 8

8. SURVEILLANCE ................................................................................................................................ 8

8.1 Application Process ................................................................................................................. 8

9. RENEWAL OF CERTIFICATION ..................................................................................................... 8

9.1 Application process .................................................................................................................. 9

9.2 Fees ............................................................................................................................................ 9

10. AUDITING PROCEDURES .............................................................................................................. 9

10.1 Preparation for Auditing ......................................................................................................... 9

10.2 On-site audit .............................................................................................................................. 9

10.3 Follow-up audit ....................................................................................................................... 10

11. EVALUATION PROCESS ............................................................................................................... 10

12. VALIDITY OF THE CERTIFICATE ................................................................................................ 11

13. REAPPLICATION OF NEW CERTIFICATION ............................................................................ 11

14. CERTIFICATION FOR ADDITIONAL PRODUCT(S) ................................................................. 11

15. APPEAL ............................................................................................................................................. 11

16. CONFIDENTIALITY ......................................................................................................................... 11

17. OTHER PROCEDURES.................................................................................................................. 12

17.1 Application of HACCP Certification for Certified Premise with the Different Premise

Name.…………………………………………………………………………………………………………………………………12

17.2 Change in Premise Name ..................................................................................................... 12

17.3 Change in Products Name .................................................................................................... 12

17.4 Application of GMP Certification for MOH HACCP Certified Premise ........................... 13

17.5 Loss/Damage of Certification ............................................................................................... 13

18. WITHDRAWAL OF HACCP CERTIFICATION ............................................................................ 13

19. OTHER CONDITIONS ..................................................................................................................... 13

20. ENQUIRY........................................................................................................................................... 14

21. REFERENCES ................................................................................................................................. 14

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 of 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 from a food premise. The

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 technically competent in the HACCP system and audit, and in a particular

food processing technology or field, formally appointed by MOH.

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:-

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.

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

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 overseas, 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)).

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 and GMP/PRP Manual shall be available with the minimum

content as stated in Appendix 1. The Manual shall be duly signed and dated

by the company management with executive responsibility.

6.7 The HACCP system and GMP/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/.

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 the quotat ion to the appl icant.

*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 Schedule 1 (See Appendix 7)

and the auditor expenditure within one (1) months from the quotation date. All fees

shall be made payable to “SECRETARY GENERAL, MINISTRY OF HEALTH

MALAYSIA”, by bank draft or postal order. Payment by personal or premise

cheque will not be accepted.

8. SURVEILLANCE

The surveillance audit is co ndu c ted to determine wh e t h e r t h e HA C CP

s ys 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 products by importing

countries, customer complaints on products and additional of new processing

line/equipment/building for production of the certified products.

8.1 Application Process

The application for surveillance shall be made in written to MOH.

8.2 Surveillance Fee The premise shall pay the required fee as listed in Schedule 1 (See Appendix 7).

All fees shall be made payable to “SECRETARY GENERAL, MINISTRY OF

HEALTH MALAYSIA”, by bank draft or postal order. Payment by personal or

premise cheque will not be accepted.

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/. The application of renewal procedure is described

in Appendix 6.

9.2 Fees

The premise shall pay the required fee as listed in Schedule 1 (See Appendix 7).

All fees shall be made payable to “SECRETARY GENERAL, MINISTRY OF

HEALTH MALAYSIA”, by bank draft or postal order. Payment by personal or

premise cheque will not be accepted.

10. AUDITING PROCEDURES

10.1 Preparation for Auditing 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. Health State Department

will appoint at least two (2) auditors for surveillance audit

10.2 Compliance Audit Procedure

Compliance audit consist of adequacy and on-site audit. A summary of compliance

audit procedure is shown in Appendix 4.

10.2.1 Adequacy audit

Upon receipt of the complete documentations, the auditors conduct an

adequacy audit on the HACCP Manual and GMP/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 GMP/PRP Manual to

the auditor. On-site audit will be carried out after receiving the updated HACCP

Manual and GMP/PRP Manual.

10.2.2 On-site audit

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

the document and record sha l l be read i ly ava i lab le and the

p rocess ing ac t iv i t ies sha l l be ava i lab le dur ing on -s i te aud i t . The

auditors will present audit finding during the closing meeting.

The premise shall respond to correct ive action requests (CAR’s) issued

within two (2) weeks after the on-site audit. Corrective action shall be taken

http://fosimdomestic.moh.gov.my/

within the stated period as agreed and a maximum of six (6) month will be given

to rectify the CAR. If the s ix (6 ) months period is exceeded without valid

justification, the premise would have to reapply.

10.2.3 Follow-up audit

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.

The lead auditor prepares final recommendation report to the MOH within five

(5) days after all CARs have been closed out.

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.

10.3 Surveillance audit

The MOH w i l l conduct surveillance audits of the certified premises at least once

(1) a year. A summary of surveillance audit procedure is shown in Appendix 5.

10.4 Renewal Audit Renewal audit consist of on-site audit and follow-up audit. A summary of renewal audit procedure is shown in Appendix 9. 10.5 Audit finding

For major and minor NC, if corrective action taken is not satisfactory and/or exceed

the period given, the HACCP certificate shall be suspended for three (3) months

period. The CAR will be closed when corrective action taken is satisfactory. Failure

to rectify the NC shall result in withdrawal of the HACCP certificate.

For serious NC, the HACCP certification will be suspended immediately. Corrective

action shall be taken within the suspended period as agreed in the closing meeting.

Failure to rectify the NC and/or exceed the agreed period, shall result in

withdrawal of the HACCP certificate.

11. EVALUATION PROCESS

The HACCP Certification Committee will conduct a meeting twice (2) 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.

12. VALIDITY OF THE CERTIFICATE

The HACCP Certification awarded shall be valid for three (3) years.

13. REAPPLICATION OF NEW CERTIFICATION

Reapplication for certification shall be necessary, if :

13.1 The certification fee and mileage fee are not paid by the premise within one (1)

months from the issuance date of quotation.

13.2 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.

13.3 The findings of the compliance audit indicate total failure of the HACCP system

(failure to address all the seven HACCP principles)

13.4 The premise doesn’t rectify the CARs within six (6) month from the date of the

on-site compliance audit without valid justification.

13.5 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.

14. 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:

14.1 For MOH HACCP certified premise only

14.2 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.

15. 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.

16. 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.

17. OTHER PROCEDURES

17.1 Application of HACCP Certification for Certified Premise with the 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.

17.2 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

17.3 Change in Products Name

The premise shall submit documents below to the MOH to change the product

name.


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.

17.4 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.

17.5 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

18. WITHDRAWAL OF HACCP CERTIFICATION

The HACCP certification shall be withdraw 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 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

19. 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.

20. 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 Web site : http://fsq.moh.gov.my Email : [email protected]

21. 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.

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

mailto:[email protected]

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).

Appendix 1 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/GMP 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

Documents received

Login to FoSIM Domestik (http://fosimdomestic.moh.gov.my/)

Not

registered berdaftar

Choose the Premise Menu

and complete the registration

Food Premise Registration

Registered

Registered

Applicant

Choose the HACCP/GMP Certification

Choose HACCP New Application

Complete the form and submit

Check for completeness of application

No

Inform

Premise MOH

Yes

Inform applicant for payment

Reject Application

Applicant

No

Payment

Yes

Acceptance of Application

Submission of supporting documents

Not approved

Appoint Certification Audit Team

Conduct Compliance Audit

Evaluation of Auditor’s

Recommendation by

HACCP Certification

Committee

Issuance of HACCP Certificate

Inform Applicant

Approved

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

A.

CHECKLIST FOR APPLICATION FORM

Please tick *Yes (√) / No (X)

Applicant

Officer

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 B.

CHECKLIST FOR MINIMUM CONTENTS OF HACCP MANUAL AND SUPPORTIVE DOCUMENTS


Applicant Officer

1. Company & Food Safety Policy

Company profile

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

7. Hazard Analysis Worksheet

8. HACCP Plan Summary

9. Overall Verification Activities & Schedule

10. Summary of Pre-requisite Programmes

Annex C.

CHECKLIST FOR MINIMUM CONTENTS OF PRP/GMP 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 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 (Att : HACCP Certification Unit) The application will be processed once completed documents are received. Failure to submit the documents will affect your application. ____________________________________________________________________ FOR OFFICER USE Status : COMPLETE REJECT KIV Note : _________________________________________________________________________ ________________________________________________________________________ Processed By : .................................................... (Signature and Official Stamp) Date :

Appendix 4

FLOW CHART FOR COMPLIANCE AUDIT

MOH to seek approval from finance department

MOH to appoint the audit team to conduct the audit

Auditor to prepare adequacy audit report within five (5) days after receipt of documents and submit to the premise

Auditor to contact premise within two(2) weeks after adequacy audit to agree on the date for on-site audit

Premise to respond within two

(2) weeks and completion of CARs

within six(6) month

Auditor to prepare init ial audit

report within five (5) days after on-

site audit date.

Auditor to contact auditee within

two(2) weeks after completion of

CARs to agree on date for follow-up

audit

Adequacy audit

On-site audit

CARs

Response to CARs

Initial on-site audit report

Follow-up audit (if applicable) (onsite audit and/or documents audit)

Appointment of audit team

B

Approval to use auditors expenditure

Auditor to prepare f inal audit report within five (5) days after closed-out of all CARs

Final Audit Report and Recommendation


Recommendation by

HACCP Certification

Committee


Inform Applicant

Surveillance Audit

Not approved

Approved

B

Appendix 5

FLOW CHART FOR SURVEILLANCE AUDIT

Health State Department to appoint the audit team to conduct the audit

Auditor to contact premise to agree on the date for on-site audit

Premise to respond within two (2) weeks and completion of CARs w i t h i n s t a t e d p e r i o d (maximum six (6) month)



site audit date

Auditor to contact auditee within two

(2) weeks after completion of CARs

to agree on date for follow-up audit



On-site audit

CARs

Response to CARs


Follow-up audit (if applicable) (Onsite audit and/or documents audit)


Appendix 6

FLOW CHART FOR APPLICATION OF RENEWAL CERTIFICATION

Payment received.

Login to FoSIM Domestik

(http://fosimdomestic.moh.gov.my/)

Applicant

Choose the HACCP/GMP Certification

Choose HACCP Renewal Application

Complete the form and submit.

MOH


Submission of payment


Conduct Renewal Audit

Approved

Surveillance Audit


Recommendation by

HACCP Certification

Committee


Inform Applicant

Not approved

Details as in Appendix 6

Appendix 7

Schedule 1 : HACCP Certification Cost 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 certified company (separated)

2,750.00 2,550.00

Surveillance 1,800.00 1,800.00

Item Peninsular Malaysia, (RM)

Sabah & Sarawak, (RM)

Auditor expenditure* 3,420.00 4,040.00

Definition: 21.1.1.1 Big Industry (BI) : Comprises 150 full time workers with an annual sale

turn-over of RM25 million

21.1.1.2 Small and Medium : Comprises less than 150 full time workers with an

annual sale Industry (SMI) turn-over of not more than RM25 million Note:

(*) Auditor expenditure is applicable for new application and certification for additional products. It’s includes airfares, food, accommodation, mileage and other cost incurred by the auditor such as follow-up audit.

Appendix 8

FLOW CHART FOR APPLICATION OF SURVEILANCE AUDIT

Formal letter request for audit surveillance

Applicant

Submission of payment


Inform Health State Department

Health State Department


Conduct Surveillance Audit

CAR

Final Audit Report

Inform Applicant

Inform MOH

Details as in Appendix 5

Payment received.

MOH

Appendix 9

FLOW CHART FOR RENEWAL AUDIT

MOH to appoint the audit team to conduct the audit

Auditor to contact premise to agree on the date for on-site audit

Premise to respond within two (2) weeks and completion of CARs w i t h i n s t a t e d p e r i o d (maximum six (6) month)



site audit date

Auditor to contact auditee within

two(2) weeks after completion of

CARs to agree on date for follow-up

audit



On-site audit

CARs

Response to CARs


Follow-up audit (if applicable) (onsite audit and/or documents audit)


B

Not approved

Approved

B


Recommendation by

HACCP Certification

Committee


Inform Applicant

MALAYSIAN CERTIFICATION SCHEME FOR HAZARD...

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