COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT …fsq.moh.gov.my/v6/xs/dl.php?filename=a3826e831390e57a9ac604576aae5246… · Listing for Export of Fish and Fishery Products

Document No: 01 Revision No: 01 Page: 1 of 62 Effective Date: 15 June 2015

FOOD SAFETY AND QUALITY DIVISION

MINISTRY OF HEALTH MALAYSIA

COMPLIANCE LISTING AND

VERIFICATION PROTOCOL FOR

EXPORT OF FISH AND FISHERY

PRODUCTS TO COUNTRIES

OTHER THAN EUROPEAN

UNION

Title: COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT OF FISH AND FISHERY PRODUCTS

TO COUNTRIES OTHER THAN EUROPEAN UNION


Approved by:

Name: NORAINI BINTI DATO’ MOHD OTHMAN

Designation: Senior Director for Food Safety and Quality Division Ministry Of Health Malaysia

Date: 15 June 2015




NO. DATE OF

AMENDMENT REVISION NO. AMENDMENT REFERENCE

1. 15 JUNE 2015 1

Changed the whole protocol Revision 0,

Effective Date 16 March 2015




1. Introduction : The safety of fish and fishery products has, and continues to attract international attention from both consumers and importing countries. This raises the need for food destined for export to be managed under systems that effectively control the hazards that can compromise food safety. This provides a sound basis for Food Safety and Quality Division

(FSQD), Ministry of Health (MOH) as the Competent Authority for food safety, working jointly with other Competent Authorities (CAs) i.e. the Department of Fisheries (DOF) and Fisheries Development Authority of Malaysia (LKIM), MOH to establish food safety control over the fish and fishery products supply chain in order for fish and fishery products produced will be safe for human consumption by complying to the Food Hygiene Regulations 2009 as well as the importing countries’ requirements. Hence, the ultimate aim of the CAs is to protect and boost Malaysia's reputation as a supplier of safe and good quality fishery products to world markets. Compliance listing and verification are important steps to ensure that processing establishments continuously meet importing countries’ requirements. It is the responsibility for the processing establishments to ensure compliance to the importing countries’ requirements. The processing establishments shall develop and implement a food safety assurance program as the minimum requirement to export the fish and fishery products and shall otherwise comply with the food safety assurance program required by the importing countries. 2. Scope This protocol establishes the mechanism for compliance listing and verification of processing establishments, middlemen and traders involved in the exportation of fish and fishery product to countries other than the European Union (EU). 3. COMPLIANCE LISTING

3.1 Types of Compliance Listing

i. FSQD (HQ) maintains and manages compliance listing of:

a. processing establishments; b. middlemen; and c. traders (exporters which do not have any processing establishment

but export fish and fishery products supplied by listed processing establishments)

3.2 Compliance Listing:

3.2.1 Processing Establishments The FSQD (HQ) shall maintain a compliance list of processing establishments. Only processing establishments in the Compliance List are permitted to export fishery products to countries other than the EU. The processing establishment shall submit a completed Application Form to the FSQD (HQ) as shown in Appendix 1.




3.2.2 Middlemen The FSQD (HQ) shall maintain a compliance list of middlemen. Only middlemen in the Compliance List are permitted to supply fishery raw materials to the processing establishments in the Compliance List. The middlemen shall submit a completed Application Form to the FSQD (HQ) as shown in Annex 1 of Appendix 1.

3.2.3 Traders The FSQD (HQ) shall maintain a compliance list of traders. Only traders in the Compliance List are permitted to export fishery products to countries other than the EU. The traders shall submit a completed Application Form to the FSQD (HQ) as shown in Appendix 2.

3.3 Procedures for the Compliance Listing of :

3.3.1 Processing Establishments 3.3.1.1 Application for Compliance Listing

The processing establishment shall submit a completed Application Form to the FSQD (HQ) as shown in Application Form for the Compliance Listing of Processing Establishment for Export of Fish and Fishery Products (Appendix 1).

3.3.1.2 Application Review

The FSQD (HQ) shall ensure that the following documents are submitted: i. Completed Application Form; ii. Food Safety Assurance Programme Certificate (if any); and iii. Any other appropriate supporting documents. After ensuring the completeness of the documents, FSQD (HQ) shall forward the above documents to designated Food Technologist(s) assigned as auditors to carry out the compliance verification. The designated Food Technologists include Food Technologists from Food Safety and Quality Division of the relevant State Health Department, Food Technologist from relevant District Health Office and Food Technologist from other state or HQ.

3.3.2 Middlemen 3.3.2.1 Application of Compliance Listing The middlemen shall submit a completed Application Form to the FSQD (HQ) as shown in Application Form for the Compliance Listing




of Processing Establishment for Export of Fish and Fishery Products (Annex 1 of Appendix 1).

3.3.2.2 Application Review

The FSQD (HQ) shall ensure that the following documents are

submitted: i. Completed Application Form; and ii. Any other appropriate supporting documents. After ensuring the completeness of the documents, FSQD (HQ) shall forward the above documents to designated Food Technologist(s) assigned as auditors to carry out the compliance verification. The designated Food Technologists include Food Technologists from Food Safety and Quality Division of the relevant State Health Department, Food Technologist from relevant District Health Office and Food Technologist from other state or HQ.

3.3.3 Traders 3.3.3.1 The traders shall submit a completed Application Form to the FSQD (HQ) as shown in Application Form for the Compliance Listing of Traders for Export of Fish and Fishery Products (Appendix 2). 3.3.3.2 The FSQD (HQ) shall ensure that the following documents are

submitted: i. Completed Application Form; and ii. Any other appropriate supporting documents. After ensuring the completeness of the documents, FSQD (HQ) shall forward the above documents to designated Food Technologist(s) assigned as auditors to carry out the compliance verification. The designated Food Technologists include Food Technologists from Food Safety and Quality Division of the relevant State Health Department, Food Technologist from relevant District Health Office and Food Technologist from other state or HQ.




4.0 VERIFICATION

4.1 Verification is carried out for the following purposes:

i. To assess the compliance status of processing establishments, middlemen and traders involved in the exportation of fish and fishery product to countries other than the European Union (EU); and

ii. To conduct surveillance verification on the maintenance of the compliance status of processing establishments, middlemen and traders involved in the exportation of fish and fishery product to countries other than the European Union (EU).

4.2. The assessment of the compliance status of Processing

Establishments, Middlemen and Traders

The following official verification procedures shall be performed:

4.2.1 Document Review

The designated Food Technologists assigned as auditors by FSQD (HQ) to carry out the compliance verification shall review the documents stated in 3.3 prior to conducting the compliance verification.

4.2.2 Compliance Verification for Compliance Listing for processing establishments, middlemen and traders

i. Official on-site verification will be performed by the assigned auditors using

the relevant checklists (Appendix 3-7). ii. The auditors will discuss the verification findings, and issue corrective action

requests (CARs) using the CAR format in Appendix 8-9 for non-conformances together with the completed verification checklist to the management of the processing establishments, middlemen and traders at the closing meeting.

iii. The lead auditor will forward a preliminary report on the verification findings

to FSQD (HQ) within five (5) working days from date of compliance verification.

iv. Corrective actions shall be undertaken on the non-conformances by the

processing establishments, middlemen and traders within the agreed time frame by auditors and processing establishments, middlemen and traders. Follow-up audits shall be carried out, where necessary.

v. The lead auditor shall submit a final report on the compliance status of the

processing establishments, middlemen and traders based on the verification




findings to FSQD (HQ) within five (5) working days from the date of all CARs have been closed out.

vi. The FSQD (HQ) shall review the report and decide on the compliance

status of the application. The FSQD (HQ) shall notify the outcome of the compliance status to the processing establishments, middlemen and traders. The successful applicant shall be entered into the Compliance Listing for Export of Fish and Fishery Products.

vii. The processing establishments, middlemen and traders are given a

maximum of one (1) year from the first on-site audit for all corrective action to be closed out. If the one (1) year period is exceeded, the company would have to reapply (unless valid justification can be provided).

viii. The compliance status of the processing establishments, middlemen and

traders will be based on the following criteria:

(a) For local aquaculture fishery products: Processing establishments and middlemen shall be able to ensure that raw materials are obtained from aquaculture farms that have been registered with the DOF. If processing establishments sourced raw materials from middlemen, the middlemen should be able to prove that the source of raw material supplied to the establishment is from aquaculture farms that have registered with the DOF.

(b) For local capture fishery products:

Processing establishments and middlemen shall be able to ensure that raw materials are obtained from fishing vessels and landing sites that have been registered/licensed with the DOF and LKIM. If processing establishments sourced raw materials from middlemen, the middlemen should be able to prove that the source of raw material supplied to the establishment is from fishing vessels and landing sites that have been registered/licensed with the DOF and LKIM.

(c) For imported aquaculture/capture fishery products: Shrimps, prawns, crabs and lobsters imported into this country must be accompanied by a Health Certificate issued by the competent authority of the exporting country.




5 Conduct of Surveillance Verification on the maintenance of the compliance status of processing establishments, middlemen and traders that have been listed in the Compliance List

i. Surveillance verifications are conducted every six (6) months on listed processing establishments, middlemen and traders by the assigned auditors.

ii. The purpose of the surveillance verification is to verify the maintenance of

the food safety assurance system in-place and the compliance to the importing countries’ requirements on fish and fishery products.

iii. Relevant verification checklists shall be used as a tool for verification. iv. The auditors will discuss the surveillance verification findings and issue

corrective action requests (CARs) for non-conformances to the management of the processing establishments, middlemen and traders at the closing meeting.

v. The lead auditor will forward a preliminary report on the verification findings

to FSQD (HQ) within five (5) working days from date of surveillance verification.

vi. Corrective actions shall be undertaken on the non-conformances by the

processing establishments, middlemen and traders within the agreed time frame by auditors and processing establishment, middlemen and traders. Follow-up audits shall be carried out, where necessary.

vii. The lead auditor shall forward a final report on the surveillance verification

to FSQD (HQ) within five (5) working days from the date of CARs in para. (iv) have been closed out.

viii. The processing establishments, middlemen and traders are given a maximum of six (6) months from the date of surveillance audit for all corrective action to be closed out. If the six (6) months period is exceeded, FSQD (HQ) may suspend the export of fish and fishery products of the processing establishment, middlemen and traders.

ix. The lead auditor shall immediately recommend to the FSQD (HQ) to

suspend the compliance status of the processing establishments, middlemen and traders if it is found totally not in compliance.




6 Issuance of Corrective Action Request and Reporting Format

i. Issuance of Corrective Action Request (CAR) Corrective action requests shall be issued according to the format specified

in Appendix 8-9. ii. Reporting Format The report of any verification shall be made according to the format specified

in Appendix 10-11.

7 Changes to Compliance List

The processing establishment, middleman and trader that have been listed in the Compliance List shall submit a written request to the FSQD (HQ) to change any details of the processing establishment, middleman and trader such as change of name, address and/or activities. The FSQD (HQ) shall assess whether the requested changes merit a verification activity / audit. If so the FSQD (HQ) shall assign auditors to undertake the verification.

8 Voluntary Delisting of Processing Establishments, Middlemen and Traders

i. Listed processing establishments, middlemen and traders intending to be

delisted from the compliance list shall make a request in writing to the FSQD (HQ).

ii. The processing establishments, middlemen and traders that requested the

voluntary delisting shall not export any product processed on, or after, the date of request for delisting.

9 Delisting of Processing Establishments, Middlemen and Traders by the

FSQD (HQ)

A. Formal delisting from the Compliance List

A listed processing establishments, middlemen and traders shall be delisted from the Compliance List if:

i. The processing establishments, middlemen and traders fails to rectify non-

conformances within an agreed timeframe; and/or ii. The processing establishments, middlemen and traders has stopped

operating for a time period greater than 6 months;

FSQD (HQ) shall notify the affected processing establishments, middlemen and traders in writing of its intention to delist the facility from the Compliance List.




The processing establishments, middlemen and traders shall be given two (2) weeks from the date of notification to appeal against the proposed delisting. If there is no response from the processing establishments, middlemen and traders within the two (2) weeks time limit, the FSQD (HQ) shall delist the processing establishments, middlemen and traders from the Compliance List.

B. Suspension and Reinstatement of Issuance of Health Certificates (if Health

Certification is required by the importing countries)

If the level of compliance in a listed processing establishments and traders is unacceptable, the issuance of Health Certificates for the export of fishery products to the importing countries shall be suspended until a satisfactory level of compliance has been attained within an agreed timeframe. Notification of suspension and reinstatement of issuance of Health Certificates shall be given in writing to the processing establishments and traders with a copy sent to the Food Safety and Quality Division, State Health Department.

C. Communication of Changes

Any changes in the Compliance List shall be communicated in writing to all concerned parties by the FSQD (HQ).




Flow Chart: Assessment of Compliance Status for Export of Fish and Fishery Products

Submission of application (form + supporting documents)

Listing into the Compliance List of for Export of Fish and Fishery Products

Final report reviewed by the FSQD (HQ)

On-site verification performed by the assigned auditors

CARs

Comply

Closed

Not Closed

Yes

No

Lead Auditor forwards a preliminary report to FSQD (HQ)

within 5 working days from date of audit

Follow-up audit shall be carried out, where necessary

Not Listed

Review of application by FSQD (HQ)

Not Complete

Complete




Flow Chart: Surveillance Verification on the Maintenance of the Compliance Status for Export of Fish and Fishery Products

Surveillance verification performed by assigned auditors

(every 6 months)

Lead auditor forwards a preliminary report to FSQD (HQ)

within 5 working days from the date of surveillance audit

Follow-up audit shall be carried out where necessary

Closed

Not Closed

Maintained in the Compliance List for Export of Fish and Fishery Products

CARs (within agreed time frame

of not exceeding 6 months)

Final report reviewed by the FSQD (HQ)

Delisted from the Compliance List

Suspension / Reinstatement of issuance Health Certificate (if required)

Lead auditor forwards a final report to FSQD (HQ) within 5 working days from the

date of CARs be closed




Application Form for Compliance Listing of Processing Establishments, Middlemen and

Traders for Export of Fish and Fishery Products

Contents:

Appendix 1 - Application Form for Compliance Listing for Processing Establishment for

Export of Fish and Fishery Products (CLF-AF/2015 Rev. 1)

Annex 1 of Appendix 1 : Middlemen supply raw materials of fish and fishery

products to processing establishment

Appendix 2 - Application Form for Compliance Listing of Trader in the Export Supply Chain (CLF-AF/2015 (T))




Appendix 1

CLF-AF/2015 Rev. 1

Ministry of Health Malaysia

APPLICATION FORM FOR THE COMPLIANCE LISTING OF PROCESSING ESTABLISHMENT

FOR EXPORT OF FISH AND FISHERY PRODUCTS

1.0 Type of Application (1): New Re-apply

Others, please specify …………………………………………………………..

2.0 Particulars of Applicant 2.1 Name of Applicant: ………………………………………………………………………………………………….……… 2.2 NRIC Number: ………………………………………………………………………………………………………………… 2.3 Name and Address of Company: ……………………………………………………………………………………..... ............................................................................................................................................................. ............................................................................................................................................................. 2.4 Tel. No.: ………………………… 2.5 Fax No.: …………………………… 2.6 H/P No. ……………………...... 2.7 E-mail address: ……………………………………………………………………………………………………………….. 2.8Company Registration Number (ROC): ……………………………………………………………………………….. (Please attach copy of the certificate)

2.9Company Licence Number: .............................................................................................................. (Please attach copy of the licence)

2.10 Address / Location of processing Establishment: ……………………………………………………………………… ………………………………………………………………………………………………………………………………………….

Postcode :……………………….. District: …………………………………..........State :…………………………........ 2.11 Correspondence Address (if different from para 3.3): . …………………………………………………………. …………………………………………………………………………………………………………………………………………. (1) Tick () where appropriate




3.0 Food Safety Assurance Program in-place

HACCP Implementaion Certification*

GMP Implementaion Certification*

Others, please specify Implementaion Certification*

…………………………………………………………

4.0 Particulars of Food Handlers

4.1 Have all the food handlers been medically examined and vaccinated by a registered medical practitioner in accordance with the Food Hygiene Regulations 2009 ?(1)

Yes No 4.2 Have all the food handlers attended any food handlers training?(1) Yes No If yes, please attach the names of the workers, name and date of training, name of trainer and training institution. (1) Tick () where appropriate

* Please state certification body




5.0 Source of Raw Materials for Fishery Products (1)

5.1 Captured Fishery Product (FP)

No Common Name of FP

Type of Raw Material

(finfish, crustaceans or cephalopods)

Species Registration No. of Fishing

Vessel

Name, Address and Registration No. of Landing Site

Name and Address of Middleman

Please provide the information in a separate annex if the available space is inadequate

5.2 Aquaculture Fishery Product (FP)


Type of Raw Material

(finfish or crustaceans)

Species Name, Address and Registration No. of Aquaculture Farm

Name and Address of Middleman


(1) To be completed where appropriate




5.3 Fishery Product (FP) Processed Using Imported Fishery Raw Material (Including Semi-Processed Fishery Raw Material)(2)


Type of Imported

Fishery Raw

Material

Species Captured Fishery(3)

Aquaculture(3) Country of Origin Foreign Supplier

Name and Address of Processing Establishment


5.4 Fishery Product (FP) Processed Using Locally Produced Semi-Processed Fishery Raw Material


Type of Semi-Processed Fishery Raw Material

Species Name and Address of Establishment Processing Semi-Processed Fishery Raw Material


(2) Application for compliance listing shall be made using “Application Form for the Compliance Listing of Sources of Imported Fishery Raw Materials in the Supply Chain”

(3) Tick () where appropriate




6.0 List of Importing Countries and Products Please specify product(s) to be exported :

No. Name of

Importing Country

Name and Type of Exported Products (finfish,

crustaceans or cephalopods)

Species Processing type /

activity (4) Name and Address

of Importers


(4) RW = raw ; L = filleting ; S = salted; K = smoked ; M = marinated; CN = canned; F = freezing; C = chilling; H = heading; G = gutting; W = wrapping; HT = heat treatment; O = other (please specify)

7.0 Applicant Declaration I , ………………………………………………………………………………. (Name of Applicant) Declare that:

the information supplied in this application is true ;

fully committed to comply with the Food Hygiene Regulations 2009 and

have undertaken necessary measures to comply with the importing countries’ requirements for fishery products.

……………………………….... …………………………… ……………………………….. (Signature of Applicant) (Company Stamp) (Date)

8.0 Please return completed application form to:

Senior Director for Food Safety and Quality Division Ministry of Health Malaysia Level 3, Block E7, Complex E, 62590 Putrajaya Tel. No :03 – 8889 3588 Fax. No :03 – 8889 3815




Annex 1 of Appendix 1

1.0 Middlemen supply raw materials of fish and fishery products to processing establishment

To be filled up by processing establishment or middlemen contracted by processing establishment

A separate form is to be filled for each middleman.

Please provide the information in a separate annex if the available space is inadequate.

i) Particulars of Middleman

Supply to : ………………………………………………..(1) Company Name : ……………………………………………….. Company Registration Number (ROC) : ……………………………………………….. Address : ……………………………………………….. Owner Name : ……………………………………………….. Owner I.C. No. : ……………………………………………….. Tel. No. : ……………………………………………….. Fax No. : ……………………………………………….. Email : ………………………………………………..

1.1 Number of worker(s) : ………………………………………

1.2 Name and NRIC Number of worker(s) :

No. Name NRIC No.


1.3 Name and address of supplier(s) and type of raw material (s) sourced:

No. Name of Aquaculture Farm / Importer

Address of Aquaculture Farm / Importer

Type of raw material (s)


1.4 Address of Fish Collection Centre (s) (if applicable) :

No. Fish Collection Centre Address


(1) Name of processing establishments




1.5 Registration number and type of transport vehicle to be used in the export supply chain:

No. Registration No. of Transport Vehicle Type of Vehicle (2)


1.6 Type of container used to store fishery raw materials: (1) Insulated box Others, please specify ……………………………………………

1.7 Usage of Ice Yes No

(1) Tick () where appropriate (2) Refrigerated truck / covered lorry / others, please specify

2.0 Applicant shall submit documents as follows:

HACCP / GMP Certificate (if the establishment is HACCP / GMP certified); Any other appropriate supporting documents. List of supporting documents: …………………………………………………………. ………………………………………………………….

3.0 Applicant Declaration

I , ………………………………………………………………………………. (Name of Applicant)

Declare that:










Appendix 2

CLF-AF/2015 (T)

Ministry of Health Malaysia

APPLICATION FORM FOR COMPLIANCE LISTING OF TRADER FOR EXPORT OF FISH AND FISHERY PRODUCTS

1.0 Type of Application(1): New Re-apply

Others, please specify …………………………………………………………

2.0 Particulars of Applicant 2.1 Name of Applicant:………………………………………………………………………………………………….…………. 2.2 NRIC Number:…………………………………………………………………………………………………………………… 2.3 Name and Address of Company:…………………………………………………………………………………………… ................................................................................................................................................................. ................................................................................................................................................................. 2.4 Tel. No.: ………………………………2.5 Fax No.: ………………………….. 2.6 H/P No.………………………........ 2.7 E-mail address: ………………………………………………………………………………………………………………….. 2.8 Company Registration Number (ROC):………………………………………………………………………………….. (Please attach copy of the certificate)

2.9 Correspondence Address (if different from para 2.3): . ……………………………………………………………. …………………………………………………………………………………………………………………………………………..... (1) Tick () where appropriate




3.0 Particulars of products to be exported 3.1 Name and address of supplier(s) and name of product (s) sourced:

No. Name of Processing Establishment

Address of Processing Establishment

Name of product (s)


3.2 Registration number and type of transport vehicle to be used in the export supply chain:

No. Registration No. of Transport Vehicle Type of Vehicle (1)


3.3 Address of Finished Products Storage (s) (if applicable) :

No. Name of Finished Products Storage

Address of Finished Products Storage

Type of Finished Products Storage (3)


3.4 Type of container used to store fishery raw materials: (2) Insulated box Others, please specify ……………………………………………

3.5 Usage of Ice (2)

Yes No

(1) Refrigerated truck / covered lorry / others, please specify (2) Tick () where appropriate (3) Cold Room / Warehouse




4.0 Particulars of Food Handlers (Including Drivers)

4.1 Have all the food handlers been medically examined and vaccinated by a registered medical practitioner in accordance with the Food Hygiene Regulations 2009 ?(1)

Yes No 4.2 Have all the food handlers attended any food handlers training?(1) Yes No

If yes, please attach the names of the workers, name and date of training, name of trainer and training institution.

5.0 Applicant Declaration I , ………………………………………………………………………………. (Name of Applicant) Declare that:










Verification Checklist for Processing Establishment

Contents:

FOR EXPORTATION OF FISH AND FISHERY PRODUCTS TO COUNTRIES THAT REQUIRE

IMPLEMENTATION OF GMP ONLY

Appendix 3 - i. GMP Implementation Checklist (AUDIT -9/2014)

FOR EXPORTATION OF FISH AND FISHERY PRODUCTS TO COUNTRIES THAT REQUIRE

IMPLEMENTATION OF HACCP

Appendix 3 -

Appendix 4 -

i. GMP Implementation Checklist (AUDIT -9/2014) ii. HACCP Implementation and Verification Checklist (AUDIT-8/2014) iii. Annex 1 of Appendix 4 : Special Requirements for Export of Fish and

Fishery Products to USA (CLF-CL-USA/2015) (for exportation of fish and fishery products to USA only)

iv. Annex 2 of Appendix 4 : Special Requirements for Export of Fish and Fishery Products to China (CLF-CL-CH/2015) (for exportation of fish and fishery products to China only)

FOR EXPORTATION OF FISH AND FISHERY PRODUCTS TO COUNTRIES THAT DO NOT REQUIRE IMPLEMENTATION OF HACCP AND GMP Appendix 5 - Verification Checklist on the Control of Exportation of Fish and Fishery

Products to Countries that do not Require Implementation of HACCP and GMP (CLF-CL-FHR/2015)




Verification Checklist for Middlemen

Appendix 6 - Verification Checklist for Middlemen (CLF-CL-M/2015)

Verification Checklist for Trader

Appendix 7 - Verification Checklist for Trader (CLF-CL-T/2015)




Appendix 3 AUDIT -9/2014



GMP IMPLEMENTATION CHECKLIST

PREMISE NAME AND ADDRESS:

AUDIT DATE:

INSTRUCTIONS:

Answer the following questions by checking the appropriate box.

C= Compliance NC= Non-Compliance Mjr= Major Mnr= Minor Obs=Observation

1.0 LAYOUT & INFRASTRUCTURE

C NC COMMENTS Mjr Mnr Obs

1.1 Does premise located near to any contamination source? If yes, are the preventive action has been taken to minimize the contamination risk?

1.2 Are premises free of harborages and/or breeding places for rodents, insects and other pests

1.3 Is adequate drainage provided to avoid contamination of facilities and products

1.4 Is sufficient space provided for placement of equipment, storage of materials and for production operations

1.5 Are floors, walls and ceilings constructed of easily cleanable materials and kept clean and in good repair

1.6 Are food and food contact surfaces protected from contamination from pipes, etc., over working areas

1.7 Are food processing areas effectively separated from other operations which may cause contamination of food being processed

1.8 Are food products and processing areas have adequate lighting and protected against contamination from breakage of light bulbs and other glass fixtures

1.9 Is air quality and ventilation adequate to prevent contamination by dust and/or other airborne substances

1.10 Are doors, windows and other openings protected to eliminate entry by insects, rodents and other pests




1.11 Changing Room/Area

Does the changing room/area provided - Auditor shall refer to FHR Reg.26. “There shall be provided changing room, where necessary, for the use of a food handler in food premises”

Does the room/area adequate and appropriate - Changing room cannot use as a rest room/pantry.

1.12 Water Supply

Are the water supply came from the source that comply with regulations and analyzed.

Are the water supply facility designed to prevent the contamination/cross contamination

1.13 Is the sewage disposal system adequate

1.14 Is the plumbing adequately sized, designed, installed and maintained in a manner to prevent contamination

1.15 Storage

Does all the raw material, packaging material and finished product have been stored in separate storage rooms or have a clear separation and arranged properly

- Product balance/product transfer from original packaging need to be properly labeled.

Does the storage area clean and properly maintained - Clearly separate the WIP/recycle/rework product.

1.16 Does the sanitation facility adequate and proper

1.17 Storage of food chemical (ingredient) - Must be label and separated

2.0 EQUIPMENT AND UTENSILS

C NC COMMENTS

Mjr Mnr Obs

2.1 Are all utensils and equipment constructed of adequately cleanable materials and suitable for their intended uses

2.2 Is the equipment designed and used in a manner that precludes contamination with lubricants, contaminated water, metal fragments, etc.

2.3 Is the equipment installed and maintained so as to facilitate the cleaning of equipment and adjacent areas

2.4 Food-contact surfaces shall be corrosion-resistant when in contact with food.

2.5 Each freezer and cold storage compartment used to store and hold food capable of prevent the growth of microorganisms shall be monitored with calibrated thermometer, temperature measuring device, or temperature-recording device.

2.6 Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment




shall be treated in such a way that food is not contaminated with unlawful indirect food additives.

2.7 Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.

- Use of recycle non food container is prohibited (when necessary – based on risk)

- Dedicated container shall be used.

3.0 SANITARY FACILITIES AND CONTROLS

C NC COMMENTS

Mjr Mnr Obs

3.1 Toilet

Provided, equipped and maintained clean and in good repair.

- Toilet doesn’t open directly to the processing area

- 1 toilet for 10 workers

Maintaining the facilities in a sanitary condition. - Hose inside the toilet cannot touch the floor

Keeping the facilities in good repair at all times.

Providing self-closing doors. - Only for the main door / buffer zone

Providing doors that do not open into processing area areas where food is exposed to airborne contamination

3.2 Are adequate hand washing and/or sanitizing facilities provided where appropriate

- Hand washing facilities shall be hand free operated

3.3 Is all refuse properly stored and protected where necessary from insects, rodents and other pests and disposed of in an adequate manner

4.0 MAINTENANCE AND SANITATION

C NC COMMENTS

Mjr Mnr Obs

4.1 Is responsibility for overall plant sanitation specifically assigned to competent individual

4.2 Testing procedures shall be used where necessary to identify sanitation failures or possible food contamination

4.3 Are the building, facility, utensil and equipment kept clean and in good condition

4.4 Cleaning and sanitation program

Does the premise have written procedure and training on cleaning and sanitation for all equipments

Does the cleaning and sanitation procedure appropriate and conducted according to schedule

Does the cleaning chemical used according to the procedure

- Procedure for mixing / liquidate the cleaning chemical

Does the Cleaning and sanitation program have been followed accordingly




Is cleaning of facilities and equipment conducted in such a manner as to avoid contamination of food products

Does the company conducted any testing to monitored the effectiveness of the cleaning program

Are detergents, sanitizers, hazardous materials and other supplies used in a safe and effective manner

Are cleaning compounds and hazardous materials kept in original containers, stored separate from raw materials and locked in designated area.

- Designated person in charge.

4.5 Cleaning / Maintenance tools

Tools are suitable with the intended use and maintained - Including spare part, mop, new filter etc

Stored properly at the designated area

Made from the materials that is easy to cleaned

4.6 Equipment- Maintenance and Calibration

Does the premise have the maintenance program and schedule as well as calibration program and schedule

Does the preventive maintenance has been followed

Are there any written protocols including the method and calibration frequency for the equipment

- Include Work Instruction, SOP etc

Calibration and maintenance conducted by the trained workers

Are there any sign where the maintenance and calibration program has been postponed without valid justification

4.7 Pest Control Program

Pest Control program conducted internally or externally or both?

- If conduct by external, internal monitoring must be conducted in between.

Do the treatment, trap location and monitoring frequency are adequate and suitable at the premise

Does the pest control program has been followed

Does the Pest Control layout accurate

Does the Pest control program effectively implemented - No bait inside processing area

- Proper location of insect killer

- Record changing of UV light for insect killer

- Insect killer not installed in the processing area

Are the processing areas maintained free of insects, rodents and other pests

Are insecticides and rodenticides used and stored so as to prevent contamination of food




4.8 Waste Management

Does the waste management is suitable and implemented effectively

- Does the premise have the waste mgmt program and schedule

- Procedure and record for external waste collector

- Condition of waste area free from pest harborage

Does the grease trap and garbage trap adequate and suitable?

- Grease trap not located in processing area

Refuse bin are adequate and appropriate - Closed and hand free dustbin

- Temporary dustbin not allowed

- Separate dry and wet refuse

Does the refuse bin are cleaned and sanitize at regular frequency to minimize the contamination risk

There are facility to clean the refuse bin near the waste area (e.g. water pipe)

4.9 Sewage management

Does the sewage system designed and built in a way that prevent the connection to the others waste system

- No septic tank in processing and food storage area

The sewage system doesn’t enter directly into the processing area unless it has been control to prevent the contamination.

4.10 Utensils and equipment

Cleaned and sanitized at intervals frequent enough to avoid contamination of food products

Food-contact surfaces used for manufacturing shall be in a sanitary condition.

Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food.

4.11 Are utensils and portable equipment stored so as to protect them from splash, dust and other contamination

5.0 PROCESSES AND CONTROLS

C NC COMMENTS

Mjr Mnr Obs

5.1 Raw materials and ingredient

Raw materials unload from the transport in a way that prevents the contamination to the raw materials and packaging material.

Raw Material and packaging materials received at the proper area

Adequately inspected, processed as necessary and stored to assure that only clean, wholesome materials are used

- PIC conducted visual inspection need to be trained




Raw materials and other ingredients shall comply with company specification

- Company spec followed food act and food reg / Codex, Regulatory body, Food Hygiene etc.

Are there any safety and quality procedure control implemented to the received raw material.

Supplier’s guarantee or certification. - Guarantee letter with supporting doc / data

- CoA / MSDS / CSDS from supplier

Control of thawing process - Thawing procedure

- Time & temperature control

5.2 Storage of raw material and finished good

Raw materials and finished good stored in appropriate temperature

Raw materials and finished good has been handled and stored in a way that can prevent the damage and contamination

There are stock control procedure to monitor the incoming and outgoing of raw material and finished goods

- FIFO and FEFO etc

Raw material and finished goods were stored 20 cm from floor and 15cm from the wall and label

5.3 Are any important food safety parameter measured and recorded (temperature/time/pressure etc)

5.4 Is ice, water and steam (where used) manufactured from potable water and stored and handled in a sanitary manner

- Water use from the storage tank need to have control measure

5.5 Food processing

Conducted in a manner to prevent contamination and minimize harmful microbiological growth.

Cross-contamination on raw materials or others ingredients from personnel and environment

5.6 Are the preventive action adequate to prevent the risk of physical, chemical and microbiological contamination

5.7 Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food.

- Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.

5.8 Control of nonconformance product, finish product food.

5.9 Are packaging processes and materials adequate to prevent contamination

5.10 Type of packaging materials doesn’t have any reaction to the finished products, suitable and in good condition

- Suitable for intention of use




5.11 Are only approved additives used

5.12 Are products coded to enable positive lot identification, and are records maintained in excess of expected shelf-life

5.13 Are weighing and measuring practices adequate to ensure the declared quantity of contents

- US requirement for net weight of glazing process

5.14 Are labels of products covered during inspection in compliance (submit violative labels as exhibits)

Item need to be check: 1. Appropriate designation of the

food 2. Claims 3. Manufacturer’s name and

address 4. List of ingredient 5. Allergen (If any)

5.15 Water

If the water and ice used as a raw material, does the water used undergo filtration process

Are the suitable filter used

If the water and ice used as raw material doesn’t undergo filtered system, is there other treatment used to ensure the quality and safety of the water

Are the treated water used to clean the packaging materials that have direct contact with food

Is the water supply adequate in quantity and quality for its intended uses

5.16 Steam

Water used in the boiler is inspected regularly and chemical treatment is controlled to avoid contamination

- Contact steam only

Steam produced from treated water and adequate for operation requirement

5.17 Ice

Comply with MOH ice licensed requirement

5.18 Verification of finished product

Sampling and analysis procedure are adequate

Are the analysis conducted in by competent personnel (internal) and certified lab (external)

If the screening device used, what is the sensitivity and is the sensitivity adequate, calibrated and maintain properly?

- Include metal trap, magnetic trap, metal detector, x-ray etc

5.19 Product recall system

Is there any product has been recalled

If Yes, is the system effectively implemented? Provide the record to prove the effectiveness of the recall system

If not, are there mock recall has been conducted. - For HACCP audit only




6.0 PERSONNEL

C NC COMMENTS

Mjr Mnr Obs

6.1 Are personnel with sores, infections, etc., restricted from handling food products

6.2 Do personnel wear clean outer garments, use adequate hair restraints and remove excess jewellery when handling food

6.3 Do personnel thoroughly wash and sanitize hands as necessary

6.4 Do personnel refrain from eating, drinking and smoking and observe good food handling techniques

in processing areas

6.5 Do the officer in charge supervise the personnel’s cleanliness

6.6 Does the personnel undergo health screening and vaccinated

6.7 Worker’s Flow:

Does the worker’s flow follows the procedure and doesn’t permit cross contamination to the product.

6.8 Visitor

Does the proper protective cloth provided to the visitor when entering the process area

- Include maintenance workers, auditors etc.

Does the visitor required to fill in the visitor log book / form

Does the visitor required to fill in the visitor health declaration form before enter the production area

7.0 TRANSPORTATION AND DISTRIBUTION

C NC COMMENTS

Mjr Mnr Obs

7.1 Does the transport suitable and can prevent the contamination to the product

7.2 Does the arrangement in the transport is suitable

7.3 If the transport is used for many different products, does the transport have a clear separation area or have a control to prevent contamination

- Dedicated for carrying food

7.4 Does the cleanliness of the transport is monitored and satisfactory

7.5 If using cold truck/ freezer truck, does the temperature adequate

7.6 Are there any temperature recorded during transportation of the product (for related product only)




8.0 TRACEABILITY

C NC COMMENTS

Mjr Mnr Obs

8.1 Does the finished product have a identification code at the packaging

8.2 Does the identification code follow the procedure

8.3 If the finished product contain active ingredient and its percentage is not identified, does the company have classification letter from MOH to prove that finished product is a food.

9.0 INTERNAL AUDIT

C NC COMMENTS

Mjr Mnr Obs

9.1 Does the internal audit has been conducted - For renewal and surveillance audit only

9.2 Does the checklist and internal audit report are adequate and cover all the element

9.3 Does the corrective action taken for all CAR issued? If not, does the written justification are provided

9.4 If necessary, do the audit has been conducted upon the main raw material supplier and additive supplier to ensure the safety and quality of the product. If no, state why.

- On site audit or questionnaire (oversea supplier)

9.5 Does the frequency of the internal audit adequate

10.0 TRAINING

C NC COMMENTS

Mjr Mnr Obs

10.1 Does all the food handlers have been to the food handler’s training provide by the MOH certified SLPM

10.2 Training schedule provided

10.3 Do the food safety training (HACCP & GMP) training has been given to the top management and the workers

- MS 22000 accepted

10.4 Are there any other training related to the food safety provided to the workers

10.5 Does the effectiveness of the training has been conducted and recorded.

10.6 Does the frequency training given adequate

10.7 Does the training given by competent individual/agency

10.8 Does the worker has been given the training that suit with their job

10.9 Does the training given based on the Training Schedule. If not, explain why.

- Training must follow training schedule (no exception)




EVALUATION OF COMPLIANCE:

LEAD AUDITOR SIGNATURE AND OFFICIAL STAMP

…………………………………………………

AUDITOR(S) SIGNATURE AND OFFICIAL STAMP :

…………………………………………………




Appendix 4

AUDIT-8/2014

FOOD SAFETY AND QUALITY DIVISION MINISTRY OF HEALTH MALAYSIA

HACCP IMPLEMENTATION AND VERIFICATION CHECKLIST

PREMISE NAME AND ADDRESS:

AUDIT DATE:

INSTRUCTIONS:


C= Compliance NC= Non-Compliance Ser= Serious Mjr= Major Mnr= Minor Obs=Observation

1.0 FACILITIES AND PROCESS DESCRIPTION

C NC COMMENTS

Ser Mjr Mnr Obs

1.1 Company/section general description providing sufficient information?

1.2 Compromise: Commitment for HACCP clearly expressed

1.3 HACCP team: Responsibilities documented and updated

1.4 HACCP team: Adequate qualification and experience available

1.5 HACCP team: Documented references and resources utilized

1.6 Personnel: Informed about the objectives of HACCP

2.0 PRODUCT DESCRIPTION

C NC COMMENTS Ser Mjr Mnr Obs

2.1 Products description clear and complete?

2.2 Include origin and specifications of raw material

2.3 Include composition, packaging, distribution, validity, storage condition

2.4 Include additives and/or ingredients in the final product.

3.0 USERS/ CONSUMERS

C NC COMMENTS Ser Mjr Mnr Obs

3.1 Sensitive consumers identified?

3.2 Instructions given for the distribution, storage and utilisation




4.0 PROCESSING SPECIFICATION

C NC COMMENTS

Ser Mjr Mnr Obs

4.1 Flow diagram includes each stage of processing chain

4.2 Flow diagram confirmed

5.0 HAZARD IDENTIFICATION AND ANALYSIS

C NC COMMENTS

Ser Mjr Mnr Obs

5.1 Includes Ph, Ch and Bi1 hazards associated to raw materials

5.2 Includes Ph, Ch and Bi hazards associated to each step of processing

5.3 Hazards evaluated in terms of likelihood and severity

5.4 Includes references, bibliography or external advice used on the analysis

5.5 Identifies potential process and staff variations

5.6 Preventive measures identified to control each relevant risk.

5.7 Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest;

6.0 DETERMINATION OF CCP

C NC COMMENTS

Ser Mjr Mnr Obs

6 1 The Identification is consistent with the identified hazards

6.2 It includes references to methodologies and resources used

6.3 Control measures were identified for each CCP

7.0 ADOPTION OF CRITICAL LIMITS

C NC COMMENTS

Ser Mjr Mnr Obs

7.1 Established for each CCP determined before

7.2 Are the CLs able to be determined simple and routinely during production

7.3 Are limits validated taking into account published/experimental evidence




8.0 MONITORING OF CCP

C NC COMMENTS

Ser Mjr Mnr Obs

8.1 Responsibilities and activities documented for each CCP.

8.2 Includes what, who, when, where and how each CCP is monitored

8.3 Includes verifiable records and identification of the responsibilities

9.0 CORRECTIVE ACTIONS

C NC COMMENTS

Ser Mjr Mnr Obs


9.2 Includes what, who, when, where and how corrective actions are taken on the system and non-conformance products

9.3 Are CA realistic and cover destination of non suitable products

9.4 Includes measures or action to avoid re-occurrence?

10.0 VERIFICATION PROCEDURES

C NC COMMENTS

Ser Mjr Mnr Obs


10.2 Includes what, who, when, where and how verification activities take place

10.3 Includes final product testing and calibration of equipment

10.4 Includes action in case that verification shows non compliances

10.5 Reassessment of the HACCP plan (follow agenda MS1480:2007)

11.0 DOCUMENTATION AND RECORDS

C NC COMMENTS

Ser Mjr Mnr Obs

11.1 Records are documented for each component of the HACCP plan.

11.2 Includes what, who, when, where and how records are taken and stored

11.3 Procedure for the annual plan review adopted and documented




12.0 VERIFICATION OF HACCP PLAN

C NC COMMENTS

Ser Mjr Mnr Obs

12.1 Changes and Modifications

12.1.1 Changes or modification in process -raw materials included in the plan

12.1.2 Modifications non communicated or approved if affecting product.

12.1.3 The responsible (as documented) are in control of operations

12.2 Documentation and Records

12.2.1 Records are available in their respective areas and updated

12.2.2 Records can be traced and reviewed as far as the last regulatory verification

12.3 Management of the Plan

12.3.1 Preventive measures followed and verifiable?

12.3.2 Monitoring procedures followed and verifiable?

12.3.3 Corrective actions followed and verifiable?

12.3.4 Verifications activities followed and verifiable?

EVALUATION OF COMPLIANCE:

LEAD AUDITOR SIGNATURE AND OFFICIAL STAMP

…………………………………………………

AUDITOR(S) SIGNATURE AND OFFICIAL STAMP :

…………………………………………………




Annex 1 of Appendix 4 CLF-CL-USA/2015 Rev. 1

Ministry of Health



SPECIAL REQUIREMENTS

FOR EXPORT OF FISH AND FISHERY PRODUCTS TO USA

ESTABLISHMENT NAME AND ADDRESS:

DATE INSPECTED:

PRODUCT(S):

NAME AND TITLE OF RESPONSIBLE PLANT OFFICIAL:

TEL. NO.:

INSTRUCTIONS:


NC= No Conformity PC= Partial Conformity C= Conformity

PART A : PRE-REQUISITE PROGRAMME

C

NC COMMENTS

Ser Mjr Mnr Obs

1.0 Toilet

Providing self-closing doors

2.0 Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with § 123.11(b) they need not be included in the HACCP plan, and vice versa

3.0 Are single service articles stored, handled, dispensed, used and disposed of in a manner that prevents contamination?

4.0 Source control - Raw Molluscan Shellfish

i. controlling the origin - to comply with microbiological contamination, chemical contamination, natural toxins, and related food safety hazards

ii. harvested from approved growing waters by related authority

iii. information on shellstock’s tagging

5.0 Maintaining refrigerated foods at 45 °F (7.2 °C) or below as appropriate for the particular food involved.

6.0 Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.




C

NC COMMENTS

Ser Mjr Mnr Obs

7.0 Frozen raw breaded shrimp/ lightly breaded shrimp

7.1 Not less than 50/ 65 percent of shrimp material and the methods for determination as follow as prescribe in Para g Part 161.175

7.2 Suitable preservatives (ascorbic acid and antioxidant)

7.3 Antioxidant meets the requirement (21 CFR Ch. 1, Part 182, Subpart D)

7.4 Label of the products meets the USFDA requirement (21 CFR Ch. 1, Part 161.175, Subpart F)

8.0 Conduct supplier audit at least once a year for each supplier

9.0 Verification for drug control in the HACCP plan.

Obtain letter of guarantee from each supplier declaring no unapproved or prohibited drugs or chemicals have been used on the farm

PART B : HACCP IMPLEMENTATION

10.0 Review of monitoring record of CCP within 1 week

11.0 Training – completed training in the application of HACCP principles at least equivalent to that received under standardized curriculum recognized as adequate by the USFDA.

12.0 Competent in developing, reassess, modify and performing record review of the HACCP plan

GENERAL COMMENTS

EVALUATION OF COMPLIANCE

VERIFIERS NAME AND SIGNATURE







Annex 2 of Appendix 4

CLF-CL-CH/2015

Ministry of Health



SPECIAL REQUIREMENTS

FOR EXPORT OF FISH AND FISHERY PRODUCTS TO CHINA


DATE INSPECTED:

PRODUCT(S):


TEL. NO.:

INSTRUCTIONS:



C

NC COMMENTS

Ser Mjr Mnr Obs

1.0 BASIC PRINCIPLES

1.1 Quality management system based on HACCP principles should be established, and implemented with necessary food defense;

2.0 RAW MATERIALS AND INGREDIENTS

2.1 Fish and fishery products should be imported with health certificates or hygiene certificates and certificates of origin issued by the competent authorities of the export country, and should be under the inspection of the competent authorities.

3.0 WORKSHOPS

3.1 Production water directly discharging onto the floors should be avoided; and the waste water from the production should not be discharged from low clean area to high clean area

4.0 TEMPERATURE AND TIME CONTROL

4.1 For histamine formation species group, should control the temperature and time from raw materials to finish according to the characteristics of the product, when necessary, it should test the histamine level.

5.0 STORAGE

5.1 Cooling storage/quick-frozen storage and cold storage should be equipped with automatic temperature recording device, and have a periodic calibration. The temperature in cooling storage shall be controlled between 0’C-4’C; The temperature in cold storage shall be controlled below -18’C; The temperature in quick-frozen storage shall be controlled below -28’C.




C

NC COMMENTS Ser Mjr Mnr Obs

6.0 PERSONNEL HYGIENE

6.1 It shall distinguish the work clothes/hat using different color or marking for clean area and non-clean area/cooked area and uncooked area. Personnel in different processing areas should not go to other non-related areas.

GENERAL COMMENTS






Appendix 5

CLF-CL-FHR/2015

Ministry of Health



CHECKLIST ON THE CONTROL OF EXPORTATION OF FISH AND FISHERY PRODUCTS TO COUNTRIES THAT DO NOT REQUIRE IMPLEMENTATION OF HACCP AND GMP


DATE INSPECTED:

PRODUCT(S):


TEL. NO.:

INSTRUCTIONS:



NC PC C COMMENTS

1 All processing establishments shall:

i. Registration of food premises (Reg. 3, FHR)

Premise shall be registered with Ministry of Health Malaysia

i. Food safety assurance programme (Reg. 9, FHR)

Implement food safety assurance programme in the food premises

ii. Food traceability system (Reg. 10, FHR)

a) Implement one step up and one step down food traceability system at any specified stage of a food chain from production to distribution with written procedure and records in place

iv. Food handlers training (Reg. 11 & 30, FHR)

a) All workers has undergone food handlers training prior to work

b) All food handlers shall obtain valid SLPM training certificate

v. Medical examination and health condition of food handler (Reg. 11 & 31, FHR)

a. All workers has been medically examined and vaccinated by a registered medical practitioner prior to work

b. Any food handler who carrier or suspected or suffering from food-borne diseases shall—

1. not allow to enter processing area or




handle food until being certified medically fit by a registered medical practitioner

2. immediately report to the management pertaining to his health condition

vi. Clothing of food handler (Reg. 32, FHR)

A food handler shall wear :

a. Clean, suitable and light coloured outer overall or

b. Light coloured apron, head cover and footwear

b. The protective clothing shall not be worn other than in food premises and shall be kept in suitable place when not in use

vii. Personal hygiene of food handler (Reg. 33, FHR)

A food handler during processing shall maintain good personal hygiene practices

viii. Duty to keep food premises clean (Reg. 34, FHR)

A food handler shall ensure that food premises where the food is handled are kept clean and free from rubbish, pest, dirt or soot, sweepings, ashes, wastes and cobwebs at all time

ix. Handling of food, appliances, etc. (Reg. 35, FHR)

Food appliances and containers shall be handled in accordance with the following requirements:

1. Prevent food contamination

2. All appliances and containers used in food premises are to be maintained in a good condition, easily cleaned and, where necessary disinfected at all times

3. All appliances and containers made from safe material and easy to clean

4. All appliances and containers are installed in such manner as to allow adequate cleaning

5. Separate food contact surface shall be used for raw clean and raw unclean edible bird’s nest

6. Cleaning activity shall not be carried out while food is being handled

x. Preparing, Packing and Serving of Food (Reg. 36, FHR)

1. Food packaging material and packaging operation provide adequate protection for food products to minimize contamination and prevent damage to the food products from any contamination




2. Food packaging materials are non-toxic and of sufficient strength to resist tearing and puncturing

3. Food packaging materials do not affect safety and suitability of food under the specified conditions of storage and use

4. Adequate and suitable facilities to store packaging material

5. Not use his bare hands to handle any unwrapped food

6. Not use any raw material or ingredient that may be contaminated with parasites, pathogenic microorganisms, toxic, or decomposed or foreign substances which may cause the finished food product unfit for human consumption

xi. Storage of food (Reg. 25 & 38, FHR)

Food shall be stored store food in accordance with the following requirements:

1. Food is not stored in a same storage facility with cleaning agent and disinfectant

2. Different store room for the storage of raw food materials and ingredients and for the storage of processed food materials in all food premises

3. All fittings or equipment used or to be used for the storage of food shall be made from suitable material, permit adequate cleaning and disinfection and adequate space for storage of food.

4. Clean, free from contamination, odours, protected from damp, dust or pests and prevented from being in contact with raw material or any other article which may contribute to any contamination of food

5. Food is placed or stacked with a minimum space of:

i. 15 centimeters between the wall of a storage facility and the food stored; and

ii. 20 centimeters above the floor

6. Raw materials is labelled and stored properly

7. Stock is rotated regularly on a “first in first out” basis

iv. Location (Reg. 12, FHR)




Food premises shall be located away from sources of contamination including aeration ponds, septic tanks and waste disposal sites

v. General design (Reg. 13, FHR)

Food premises shall be designed and constructed as such to facilitate cleaning and disinfection

vi. Water supply (Reg. 14, FHR)

a. Adequate supply of potable water and facilities for storage

b. The water supply shall be adequately protected against any contamination

vii. Cleanliness of food premises (Reg. 15, FHR)

a. Food premises shall be maintained at all times in a good, clean and tidy condition and free from harbourage of pest.

b. The cleaning of food premises shall be carried out at least once daily.

c. Adequate facilities for the cleaning, disinfecting and storing of appliances used in food premises. Facilities shall be constructed from corrosion resistant materials and easily cleaned.

d. Shall be provided an adequate supply of suitable cleaning agents, disinfectant and tools to enable regular and proper cleaning of a food premises and appliances used.

e. Every cleaning agent and disinfectant used in the food premises shall be adequately labelled.

viii. Pest control in food premises (Reg. 16, FHR)

a. Food premises shall, free from pest at all time.

b. A pest control treatment shall only be carried out by using a suitable chemical agent and without posing a threat to the safety of food.

ix. Disposal of refuse (Reg. 17, FHR)

a. All food waste, non edible by-products and other refuse shall be—

1. removed from where food is present as soon as possible

2. deposited in closable containers and kept in a good condition, easily cleaned and where necessary, disinfected

b. Adequate provision for storage and disposal of food waste or non edible by-products and




other refuse.

x. Floor surfaces (Reg. 18, FHR)

All floors in food premises shall be made from impervious, non-absorbent, non-toxic materials, maintained in a good condition, easily cleaned and adequately drained, where necessary disinfected

xi. Wall surfaces (Reg. 19, FHR)

All walls in food premises shall be made from impervious, non-absorbent, non-toxic materials, maintained in a good condition, easily cleaned, require a smooth surface up to a height appropriate for a food process, where necessary disinfected

All angles between a wall and a floor in a food premises shall be sealed and coved to facilitate cleaning, where necessary

xii. Lighting (Reg. 20, FHR)

Provided with adequate lighting and does not lead, or cause any contamination of food

xiii. Ventilation (Reg. 21, FHR)

a. A ventilation system in food premises shall be:

1. provided with adequate ventilation and does not lead, or cause any contamination

2. enable filters and other parts readily accessible for cleaning or replacement

b. In place to avoid air flow from contaminated area to clean area

xiv. Ceiling (Reg. 22, FHR)

All ceilings made from suitable material and able to prevent accumulation of dirt and dust

xv. Door (Reg. 23, FHR)

All doors in food premises shall be made from smooth, non absorbent surface, and easily cleaned; self closing system, where necessary disinfected

xvi. Furniture fitting and food contact surfaces (Reg. 24, FHR)

All furniture, fittings and food contact surfaces used or to be used for the preparation, serving, storage, conveyance or distribution of food in any food premises shall be well maintained and kept clean at all times and shall be of impervious material and easily cleaned.

xvii. Changing room (Reg. 26, FHR)

Changing room shall be made available.

xviii. Wash-basin (Reg. 27, FHR)




a. Adequate number of non-hand operated (tap) wash-basin suitably provided.

b. The wash-basin shall, at all times, be:

1. supplied with potable running water;

2. supplied with detergent and hand drying facilities i.e. paper towel or automatic hand dryer

3. kept clean and maintained in a good condition;

c. Separate wash-basin for washing hand and washing food

xix. Toilet room (Reg. 28, FHR)

a. Adequate number of toilets shall be provided.

b. Toilet shall—

1. be provided running water, detergent and hand drying facility or clean roller towels or paper towels at all times

2. be kept clean and properly ventilated

3. not directly open to any room used for storage, production and serving of food

xx. Drainage facility (Reg. 29, FHR)

a. Adequate, made from suitable material, easily cleaned and well maintained.

b. Avoid flow of waste water from dirty to clean area

2. Receiving Of Raw Material

a. Container to carry raw material shall be made from suitable and safe material, easily cleaned and prevent contamination.

3. Unloading and landing of fish (Reg. 42, FHR)

3.1 Unloading and landing of fish:

a. unloading and landing equipment that comes into contact with fish is constructed of material that is easily cleaned and disinfected and maintained in a good condition;

b. avoid contamination of fish by—

(i) carrying out the unloading and landing operations rapidly;

(ii) placing the fish without delay in a protected environment at the temperature specified in subregulation




38(3); and

(iii) not using equipment and practices that may cause unnecessary damage to the edible parts of the fish;

c. area where the unloading and landing of fish is conducted in his food premises is not used for other purposes;

d. any vehicles emitting exhaust fumes that is likely to impair the quality of fish is not allowed to drive through or enter his food premises; and

e. animal is not allowed to enter the food premises.

4. Handling of fresh fish (Reg. 43, FHR)

4.1 A food handler who handles fresh fish shall comply with the following requirements:

a. where chilled or unpackaged fresh fish is not distributed, dispatched, prepared or processed immediately after landing, such fish is –

(i) stored under ice in appropriate facilities; and

(ii) re-icing as often as necessary;

b. packaged fresh fish is chilled to a temperature approaching that of melting ice.

c. the heading and gutting of fresh fish is carried out hygienically;

d. the gutting of fresh fish is carried out as soon as possible after the fish is caught or landed and washed thoroughly with potable water;

e. if gutting of fresh fish is carried out on board of a vessel, clean water is used for washing;

f. the filleting and cutting of fresh fish is carried out in such a manner to avoid contamination or spoilage to such fish;

g. the fillets and slices of fresh fish is not to remain on work tables beyond the time necessary for their preparation;

h. the fillets and slices of fresh fish is wrapped and where necessary, packaged and chilled as soon as possible after its preparation; and

i. melt water from ice in a container used for the carriage or storage of unpackaged fresh




fish is not remain in contact with the fish.

5. Handling of processed crustacean or mollusc (Reg. 44, FHR)

5.1 A food handler shall handle processed crustacean or mollusc in accordance with the following requirements:

a. rapid cooling of the crustacean or mollusc is carried out after cooking and water used for this purpose is potable water or if no other method of preservation is used, the cooling process is continued until a temperature approaching of melting ice is reached;

b. the shelling or shucking of the cooked crustacean or mollusc is hygienically carried out to avoid contamination of such product; and

c. the cooked crustacean or mollusc is frozen immediately, or is chilled as soon as possible to the temperature as specified in subregulation 38(3) after shelling or shucking.

6. Storage of fish (Reg. 45, FHR)

6.1 A food handler shall store fish in accordance with the following requirements:

a. a fresh fish, thawed unprocessed fish, and processed crustacean or mollusc is maintained at a temperature approaching of melting ice;

b. a frozen fish is kept at a temperature below minus 18

0C in all parts of the product;

c. a frozen fish in brine that is intended to be processed as canned food is kept at a temperature below minus 9

0C; and

d. a live fish is kept at a temperature and in a manner that does not adversely affect food safety or its viability.

7. Carriage of fish (Reg. 46, FHR)

7.1 A person who carries fish shall comply with the following requirements:

a. fresh fish, thawed unprocessed fish and processed crustacean or mollusc is maintained at a temperature approaching of melting ice;

b. frozen fish is kept at a temperature below minus 18

0C in all parts of the product; and

c. frozen fish in brine that is intended to be processed as canned food is kept at a




GENERAL COMMENTS



temperature below minus 90C.

7.2 Melt water from ice in a containers used for the carriage or storage of fish is not in contact with the fish.

7.3 Live fish to be sold in a market shall be carried in such a manner that does not adversely affect food safety or its viability.

8. Sale of chilled and frozen fish (Reg. 47, FHR)

8.1 A person who sells chilled and frozen fish shall ensure that–

a. all chilled fish stored, displayed or exposed for sale are kept at a temperature between minus 1°C to 10°C; and

b. all frozen fish stored, displayed or exposed for sale are kept at a temperature below minus 18°C.

9. Carriage Of Food (Reg. 56, FHR)

1. A person who carries food shall ensure that a vehicle used in the course of carriage of food-

a. is clean and in a good working condition

b. where necessary, effectively permit the separation of food from non-food items during carriage to prevent any risk of contamination

c. is not used for carrying hazardous, toxic or poisonous item

2. A person who intends to use any vehicle to carry food shall ensure that the vehicle is cleaned after being used to carry different foods or non-food items

3. A person who uses any vehicle to carry food of swine origin (sus scrofa) shall not use the same vehicle to carry any food of non-swine origin




Appendix 6

CLF-CL-M/2015

Ministry of Health



CHECKLIST FOR VERIFICATION OF MIDDLEMAN

COMPANY NAME AND ADDRESS: DATE INSPECTED:

NAME AND TITLE OF RESPONSIBLE MIDDLEMAN:

TEL. NO.:

INSTRUCTIONS: Answer the following questions by checking the appropriate box. NC= No Conformity PC= Partial Conformity C= Conformity

GENERAL COMMENTS



NC PC C COMMENTS

1. Traceability and Product recall

1.1. Suppliers and/or origin clearly identified and verified

1.2. The batch / lot is clearly identified and separated during transportation

1.3. Identification/marks/codes allow tracking of the products (up and down)

1.4. Destination of products identified and data is verifiable

1.5. Suppliers registered with relevant Competent Authority

2. Transportation

2.1. Managed to avoid cross contamination

2.2. Ice usage and Temperature control (if applicable)

2.2.1 Ice originated from a controlled supplier

2.2.2 Handling of ice minimizes potential for cross contamination

2.2.3 Temperature monitoring on refrigerated trucks

2.3. Fuel storage (if applicable)

2.3.1 Separated from catch and ice

3. Training and Hygiene

3.1. Drivers understand the minimal requirements of personal hygiene

4. Storage

4.1 Raw material and finished product stored in appropriate temperature

4.2 Raw material and finished product has been handled and stored in a way that can prevent the damage and contamination




Appendix 7

CLF-CL-T/2015

Ministry of Health



CHECKLIST FOR VERIFICATION OF TRADER

COMPANY NAME AND ADDRESS: DATE INSPECTED:

NAME AND TITLE OF RESPONSIBLE TRADER:

TEL. NO.:

INSTRUCTIONS: Answer the following questions by checking the appropriate box. NC= No Conformity PC= Partial Conformity C= Conformity

GENERAL COMMENTS



NC PC C COMMENTS

1. Traceability and Product recall

1.1. Suppliers and/or origin clearly identified and verified

1.2. The batch / lot is clearly identified and separated during transportation

1.3. Identification/marks/codes allow tracking of the products (up and down)

1.4. Destination of products identified and data is verifiable

1.5. Suppliers listed with FSQD

2. Transportation

2.1 Managed to avoid cross contamination

2.2 Temperature control (if applicable)

2.2.1 Temperature monitoring on refrigerated transport

3. Training and Hygiene

3.1 Worker understand the minimal requirements of personal hygiene

4. Finished Product Storage

4.1 Finished product stored in appropriate temperature

4.2 Finished product has been handled and stored in a way that can prevent the damage and contamination




Appendix 8 AUDIT-10/2014


CORRECTIVE ACTION REQUEST (CAR) FORM

Audit Date : CAR No :

Premise Name and

Address

Premise Representative

Auditor Members

Non-Conformance Report: Observation Minor Major Serious

Applicable Requirement

Objective evidence &

Location

Potential effect of non-

conformances

Premise Representative:

………………………………………………………..

(Signature and Official Stamp)

Auditor(s):

………………………………………………………..


Determination of root cause (To be filled by Premise Representative):

Corrective Action required to fix and prevent recurrence (To be filled by Premise Representative):

Completion target date: Premise Representative:

…………………………………………………………


Follow-up audit comments (Auditors):

CAR Closed out : Yes No

Date :

Auditor(s):

………………………………………………………..





Appendix 9

CLF-CF-FHR/2015

VERIFICATION : CORRECTIVE ACTION REQUEST (CAR)

ON CONTROL OF EXPORTATION OF FISH AND FISHERY PRODUCTS TO COUNTRIES

THAT DO NOT REQUIRE IMPLEMENTATION OF HACCP AND GMP

Audit No: CAR No.: Date:

Processing Establishment

Address/Tel. No.:

Company representative(s):

Auditors:

Non-Conformance Report :

Partial Compliance (PC) Non-Compliance (NC)

Objective evidence & Location

Potential effect of non-

Conformance

Root cause that needs to be

addressed (if any)

Signature:

Name:

Company Representative

Signature:

Name:

Auditors

Corrective Action required to fix and prevent recurrence: (To be completed by the Company)

Completion target date:

……………………..

Signature:………………….

Name:……………………

Company Representative

Signature: ………………….

Name: ……………………..

CA Auditor

Follow-up audit comments

Date Car Closed Out:

……………………………

Signature: ……………………….

Name: ……………………………

CA Auditor




Appendix 10

AUDIT-13/2014


FINAL AUDIT REPORT

Premise Name :

Premise Address :

Audit Date : Follow-up audit :

Product list :

Type of Certification : HACCP / GMP

Type of Audit : Compliance / Surveillance / Renewal / Compliance for Additional product / Verification

Premise Representative :

Auditor Members :

The following attachments form part of this report : Please tick *Yes (√) / No (X) : Auditor Officer

9.1 Audit Summary Report (AUDIT-7/2014)

9.2 Attendance List (AUDIT-6/2014)

9.3 CAR Form (closed-out) (AUDIT-10/2014)

9.4 GMP Implementation Checklist (AUDIT-9/2014)

9.5 HACCP Implementation And Verification Checklist (AUDIT-8/2014) (for HACCP audit)

9.6 Certification Information Form (AUDIT-12/2014) (Not applicable for Surveillance Audit)

9.7 For Compliance /Additional Product Audit :

9.7.1 Adequacy Audit Report (AUDIT-1/2014 )

9.7.2 One (1) set updated HACCP and/or GMP Manual

For Officer Use :

Status : Completed Not Completed Remarks:______________________________________________________________________________________________________________________________________________________




Results and Observations:

The audit work done in accordance with the standard and comprised of the examination of the

monitoring records, verification records, documentation of HACCP and /or GMP program etc. The

summary of the inspection as follow :

Document Inspection:

No Document / Record Date Record

Checked

Comment / Finding

Onsite Inspection :

No Area Comment / Finding

An on-site inspection revealed that the HACCP and/or GMP program were properly maintained

except below :

No Non-Conformance Category Corrective Action Taken Closed Out Date

Position statement:

Recommendation :

Approve/continue the certification. Disapprove for certification Suspension of certification. Revocation of certification.

Signature and Official Stamp :

…………………………………………………

Name :

Date :




Appendix 11

CLF-R-FHR/2015

VERIFICATION REPORT ON CONTROL OF EXPORTATION OF FISH AND FISHERY PRODUCTS TO COUNTRIES THAT DO NOT REQUIRE IMPLEMENTATION OF HACCP AND GMP

1. Name of Processing Establishment:

2. Address :

3. Date of Audit :

4. Audit No. :

5. Product(s) :

6. Scope of Audit :

7. Company Representative(s) :

8. Auditors :

9. Results and Observations2 :

NO. NON-CONFORMANCE CATEGORY

PC / NC

CORRECTIVE ACTION

TAKEN

COMPLETION

TARGET DATE

CLOSED-OUT

2 Fill up the table below




10. (a) Status of Overall Compliance of Establishment (please tick where relevant):

Compliance (C)1 :

Partial Compliance (PC)2 :

Non-Compliance (NC)3 : :

(b) Reasons for Status of Overall Compliance :

----------------------------------------------------------------------------------------------------------------------------- ------

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General Comments/Recommendation:

Signature

Name of Auditor

Position

Date

:

:

:

:

.........................................................................................

.........................................................................................

.........................................................................................

.........................................................................................

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1 C (Compliance) : Probability of occurrence of food safety hazard is low 2 PC (Partial Compliance) : Situation where the probability of occurrence of food safety hazard is high if

control measures are not taken. Recurrence of partial compliance

can result in non compliance. 3 NC (Non-Compliance) : The non compliance subjects the product to an unacceptable level

of exposure to any food hazard that jeopardizes the fitness for

purpose food

Documents

COMPLIANCE LISTING AND VERIFICATION PROTOCOL FOR EXPORT …fsq.moh.gov.my/v6/xs/dl.php?filename=a3826e831390e57a9ac604576aae5246… · Listing for Export of Fish and Fishery Products