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Document No: 03 Revision No: 04 Page: 1 of 52 Effective Date: 1 September 2010

FOOD SAFETY AND QUALITY DIVISION

MINISTRY OF HEALTH MALAYSIA

OFFICIAL VERIFICATION PROTOCOL

Title: OFFICIAL VERIFICATION PROTOCOL


Approved by:

Name: WEE BEE WAH

Designation: Deputy Director (Export) Food Safety And Quality Division Ministry Of Health Malaysia

Date:



NO. DATE OF

AMENDMENT REVISION NO. AMENDMENT REFERENCE

1. 22 February 2010 03

Para 1 Word “water” is deleted. Para 2.1 A phrase “Export Establishment Approval Number” is included. Para 2.5 A phrase “the maintenance of the” is included. Para 3.2.1 Statements iii and iv are deleted. Para 3.2.2

ii. A phrase „’using the CAR format in Appendix 2” is included.

iii. Word „‟preliminary” is included.

v. New statement “The auditor will

forward a final report on the verification once the auditor has closed out all the non-conformances” is included.

Para 3.3 A new para “Conduct of Surveillance official verification on the maintenance of the compliance status of Export Establishment that have been listed in the National Approved List “ is included. Para 3.3.1 “Audits” has been changed to “official verifications”. Para 3.3.2 “Audit” has been changed to “surveillance official verification”. Para 3.3.5 New Para “The auditor will forward a preliminary report on the verification



NO. DATE OF


findings to MOH (HQ)” is included. Para 3.3.6 Word “final” and the phrase ”surveillance official verification once the auditor has closed out all the non-conformances” are included.

Para 3.4 The phrase “(Fishing Vessels, Farms, Landing sites, Transporters and Sources of Imported Raw Materials) And Ice” is deleted. The statement “factory vessel ,independent refrigerated stores, semi processed fishery product, imported raw material” is deleted and changed to “transport vehicles, independent refrigerated stores, independent ice producers, processing establishments for semi-processed raw fishery materials and imported raw material sources”. Para 3.4.2 The statement “transport vehicles, factory vessel, sources of ice, independent refrigerated stores, sources of semi-processed fishery raw materials and imported raw materials” is deleted and changed to “transport vehicles, independent refrigerated stores, independent ice producers, processing establishments for semi-processed raw fishery materials and imported raw material sources”. Frequency of Official Verification for Aquaculture Farms, Fishing Vessels, Fish Landing Site, Transport Vehicle, and Sources of Ice & Refrigerated Stores “6 months” is changed to “180 days”



NO. DATE OF


Verification Checklist for EU Import Requirements on Fishery Products (F01 – F14)

F13; “Corrective Action Request” is amended to “Organoleptic evaluation for finfish”

F14; “Follow up/ closing of Corrective Actions” is amended to “Organoleptic evaluation for shrimp”

New checklist “Organoleptic

Evaluation for Cuttlefish” is

included.

“CP” is changed to “PC” for all

checklists.

“Conformity evaluation” is

deleted for all checklists.

F01 No. 14 ; Word “Internal” is

included.

F02; Item “12.3: Presence of

Parasite” is included

F03 No.3; Words “Users and

consumers” are included.

F09, F10, F11; Item “Corrective

Actions: is deleted.

“Date of verification” is is

included for all checklists.

Appendix 3; Verification Report: The statement “The level of compliance will be decided on the basis of the severity and likelihood of the



NO. DATE OF


potential risk over the fitness for purpose as food, for the raw material or product under direct threat” is deleted.

2. 29 June 2010 04 Verification Checklist for EU Import Requirements on Fishery Products (F08 & F09)

F08, Title: Words “(fish held over 24 hrs)” are deleted.

F08: Statement “Operation Period: [ ] < 24 hours [ ] > 24 hours” is included.

F08, Footnote 1: Word “shelters” is included.

F08, Item 9.1: Words “bunks with mattress & pillow” are included.

F09: Title “Verification of conditions for coastal vessels (fish held less than 24 hrs)” is replaced with “Verification of conditions for transport vessels (fishery products)”.

F09: New items 6-9 are included.



1. Introduction

Verification is an important step in the process of approval and listing of export establishments, sources of raw material, water and ice as in accordance to the National Approval and Listing Protocol. The status of compliance to the European Union (EU) requirements and its maintenance as required in the Food (Issuance of Health Certificate for Export of Fish and Fish Product to the European Union) Regulations 2009 is continuously monitored through verification. Verification ensures that export establishments and sources of raw material, water and ice continuously meet EU requirements.

2. Official Verification is carried out for the following purposes:

2.1 Hazard Analysis and Critical Control Point (HACCP) Certification under the Ministry of Health (MOH) HACCP Certification Scheme. This is a pre-requirement for an Export Establishment to obtain an Export Establishment Approval Number .(see MCS1 – Guideline for HACCP Certification)

2.2 To assess the compliance status of HACCP certified Export Establishments

for purposes of approval under the National Approval and Listing Protocol; 2.3 To assess the compliance status of sources of raw materials and ice for

purposes of approval under the National Approval and Listing Protocol; 2.4 To conduct surveillance official verification on the compliance status of

approved sources of raw materials, water and ice that have been listed in the National Approved List (FExCIS database);

2.5 To conduct surveillance official verification on the maintenance of the

compliance status of Export Establishments that have been listed in the National Approved List (FExCIS database).

3. Official Verification is performed as follows:

3.1 HACCP Certification under the MOH HACCP Certification Scheme.

Official verification procedures for HACCP Certification under the MOH Certification Scheme are outlined in: MCS1 - Guideline for HACCP Certification MCS2 - Guideline for HACCP Compliance Audit



3.2 To assess the compliance status of HACCP certified Export

Establishments for purposes of approval under the National Approval and Listing Protocol.

The following official verification procedures shall be performed: 3.2.1 Document Review

The following documents are forwarded to the State Health Department by MOH Headquarters (HQ). The designated Food Technologist of the State Health Department shall assess the documents:

i. Completed Application Form;

ii. HACCP Certificate under the MOH HACCP Certification

Scheme

iii. Any other appropriate supporting documents.

3.2.2 Official Verification for Approval

i. Official on-site verification will be performed by the Food Technologists of the State Health Department and/or the Food Safety and Quality Control Division(MOH) as auditors of MOH. Official verification on the compliance to EU requirements on fishery products is carried out using relevant Checklist for Verification to EU Import Requirements on Fish and Fishery Products (Appendix 1).

ii. The auditors will discuss the verification findings, and issue

corrective action requests (CARs) using the CAR format in Appendix 2 for non-conformances together with the completed verification checklist to the management of the establishment at the closing meeting.

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

findings to MOH (HQ). iv. Follow-up audit will be carried out, if necessary.

v. The auditor will forward a final report on the verification once

the auditor has closed out all the non-conformances. vi. The approval of the establishment is subject to the verification

findings.



3.3 Conduct of Surveillance official verification on the maintenance of

the compliance status of Export Establishment that have been listed in the National Approved List.

3.3.1 Surveillance official verifications are conducted according to the

frequency specified in Section 4 (of this protocol) on approved and listed establishments by the Food Technologists of the State Health Department.

3.3.2 The purpose of the surveillance official verification is to verify the

maintenance of the HACCP System and the compliance to EU requirements on fishery products.

3.3.3 Relevant Checklists for Verification to EU Requirements on Fish

and Fishery Products (Appendix 1) are used as a tool for verification.

3.3.4 The auditor will discuss the verification findings and issue corrective

action requests (CARs) for non-conformances to the management of the establishment at the closing meeting.

3.3.5 The auditor will forward a preliminary report on the verification findings to MOH (HQ).

3.3.5 Follow-up audit will be carried out, if necessary. 3.3.6 The auditor will forward a final report on the surveillance official

verification once the auditor has closed out all the non-conformances.

3.4 Approval of Sources of Raw Materials and Ice

Officers from the Department of Fisheries Malaysia (DOF) conduct verification on fishing vessels and farms; Fisheries Development Authority of Malaysia (LKIM) on landing sites and Ministry of Health Malaysia (MOH) on transport vehicles, independent refrigerated stores, independent ice producers, processing establishments for semi-processed raw fishery materials and imported raw material sources

Verification conducted consists of: 3.4.1 Document Review Documents reviewed include:

i. Application Form as in Appendix 1-9 of the National Approval and Listing Protocol.



ii. Supportive documents including Standard Operating

Procedures ( SOPs)

3.4.2 Verification for Approval

Verification for approval of aquaculture farms, fishing vessels, landing sites, transport vehicles, independent refrigerated stores, independent ice producers, processing establishments for semi-processed raw fishery materials and imported raw material sources shall be carried out according to the National Approval and Listing Protocol.

4. Actions To Be Taken Following Verification

Based on the verification findings, the level of overall conformity will be decided on the basis of the severity and likelihood of the potential risk over the fitness for purpose as food, for the raw material or product under direct threat.

Categories of Conformity are as follows: i. 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 as food.

ii. PC (Partially Compliance)

Situation where the probability of occurrence of food safety hazard if control measures are not taken. Recurrence of partial compliance can result in non-compliance.

iii. C (Compliance)

Probability of occurrence of food safety hazard is low.



Based on the outcomes of verification the following variations will apply:

Export Establishment

C PC NC

Action to be taken by the establishment

Non-conformance corrected before next scheduled visit by the CA (exact timeframe to be agreed between the CA and establishment).

Non-conformance corrected without delay.

Frequency of Official Verification

Next official verification within 180 days

If non-conformance is corrected during the official verification it shall be noted in the report but no CAR is issued.

Next official verification within 90 days.

If non- conformance is corrected during the official verification it shall be noted in the report, but will not affect the official verification frequency.

Next inspection within 14 days.

If non-conformance is corrected during the official verification it shall be noted in the report but will not affect the official verification frequency.

Action taken by the CA

Compliance database updated

Official verification reports evaluated and decision taken on whether specific action is needed.

Compliance database updated.

Decision taken on whether more time shall be given to correct the non-conformance; or to immediately suspend the issuance of health certificate; or to suspend the approval of the export establishment concerned for an appropriate period of time; or to withdraw the approval of the export establishment; or to take any other measures the competent authority deems appropriate.

FExCIS database updated.



Aquaculture Farms

C PC NC

Action taken by the Aquaculture Farm operator

Non-conformance corrected before next scheduled visit by the CA (exact timeframe to be agreed between the CA and farm operator).



Next verification within 180 days .If non-conformance is corrected during the official verification it shall be noted in the report but no CAR is issued.


If non-conformance is corrected during the official verification it shall be noted in the report, but will not affect the official verification frequency.







Decision taken on whether more time shall be given to correct the non-conformance or to immediately suspend the operator from supplying raw materials to export establishment; or withdraw the approval of the aquaculture farm; or to take any other measures the competent authority deems appropriate.




Fishing Vessels

C PC NC

Action taken by the Fishing Vessel operator

Non-conformance corrected before next scheduled visit by the CA (exact timeframe to be agreed between the CA and vessel operator).



Next verification on first fish landed after 180 days


Next official verification on first fish landed after 90 days.


Next official verification before vessel departure.






Decision taken on whether more time shall be given to correct the non-conformance or to immediately suspend the operator from supplying raw materials to export establishment; or withdraw the approval of the fishing vessel; or to take any other measures the competent authority deems appropriate.




Fish Landing Site

C PC NC

Action taken by the Landing Site operator

Non-conformance corrected before next scheduled visit by the CA (exact timeframe to be agreed between the CA and landing site operator).



Next verification within 180 days. If non-conformance is corrected during the official verification it shall be noted in the report but no CAR is issued.









Decision taken on whether more time shall be given to correct the non-conformance or to immediately suspend the operator from supplying raw materials to export establishment; or withdraw the approval of the landing site; or to take any other measures the competent authority deems appropriate.




Transport Vehicle

C PC NC

Action taken by the Transport Vehicle operator

Non-conformance corrected before next scheduled visit by the CA (exact timeframe to be agreed between the CA and transport vehicle operator).



Next verification 180 days










Decision taken on whether more time shall be given to correct the non-conformance or to immediately suspend the operator from supplying raw materials to export establishment; or withdraw the approval of the transport vehicles; or to take any other measures the competent authority deems appropriate.




Sources of Ice and Refrigerated Stores

C PC NC

Action taken by the operator

Non-conformance corrected before next scheduled visit by the CA (exact timeframe to be agreed between the CA and operator).



Next verification within 180 days. If non-conformance is corrected during the official verification it shall be noted in the report but no CAR is issued.









Decision taken on whether more time shall be given to correct the non-conformance or to immediately suspend the operator from supplying raw materials to export establishment; or withdraw the approval of the sources of ice and refrigerated stores; or to take any other measures the competent authority deems appropriate.


5. Issuance of Corrective Action Request And Reporting Format

5.1 Issuance of Corrective Action Request Corrective action request shall be issued according to the format

specified in Appendix 2.

5.2 Reporting Format The report of any verification shall be made according to the format specified in Appendix 3.



Appendix 1

Verification Checklist for EU Import Requirements on Fishery Products

Contents:

F01 - Infrastructure condition

F02 - Verification of pre requisites and support programmes

F03 - Documental verification of HACCP

F04 - Verification HACCP plan performance

F05 - Verification of condition and systems at aquaculture production establishments

F06 - Verification of conditions on ice plants

F07 - Verification of conditions on cold stores

F08 - Verification of conditions and systems on off shore vessels

F09 - Verification of conditions for transport vessels (fishery products)

F10 - Verification of conditions of landing sites

F11 - Verification of conditions for transporters

F12 - Verification of traceability

F13 - Organoleptic evaluation for finfish

F14 - Organoleptic evaluation for shrimp

F15 - Organoleptic evaluation for cuttlefish



PROCESSING ESTABLISHMENTS - F01 – Infrastructure condition

Based on Regulations (EC) No 852/2004, 853/2004, 2073/2005 and 2074/2005

Name of the establishment:

Authorization number:

Verification Officers:

Establishment representatives:

References consulted:

Date of verification:

Total time of verification:

NC= No Conformity PC= Partial Conformity C= Conformity

NC PC C Comments

Infrastructure and Layout

1. Layout

1.1 Sufficient areas to carry out the work under sanitary and hygienic conditions?

1.2 Does the layout preclude contamination?

2. Reception area

2.1 Is the receiving area clean and in a good state of repair?

2.2 Are the floor, walls, ceiling made of materials easy to clean?

2.3 Is there sufficient potable water supply?

2.4 The isolation from outside is sufficient to avoid contamination?

3. Processing area

3.1 Floors. Made of materials easy to clean and sanitize?

3.2 Floors. Allows easy drainage of water or it has water removal equipment?

3.3 Walls. Made of impermeable materials easy to clean and sanitize?

3.4 Windows Easy to clean and sanitize and precludes external contamination?

3.5 Ceiling. Made of impermeable materials easy to clean and sanitize?

3.6 Doors Made of impermeable materials easy to clean and sanitize?

3.7 Ventilation. Adequate/sufficient? Allows a good extraction of moisture

3.7.1 Ventilation. Filters and parts easily accessible.

3.7.2 Ventilation. Avoids contamination from

contaminated areas.



NC PC C Comments

3.8 Lighting (Natural or Artificial) Is the lighting

adequate and protected?

4. Hand washing facilities

4.1 Are the facilities in entry areas and in sufficient numbers?

4.2 Are the taps non hand operated?

4.3 Hand cleaning agents have MSDS or technical specifications?

4.4 Are the facilities provided with disposable hand towels and trash bins?

5. Chillers and Freezers


5.2 Floors Allow easy drainage of water or it has water removal equipment?



5. Doors Made of impermeable materials easy

to clean and sanitize

5.6 Lighting (Natural or Artificial) Is the lighting adequate and protected?

5.7 Capacity. Able to maintain raw

materials/products at allowed T 1

5.8 Monitoring Is there an efficient temperature control programme.

6. Protection against vermin and pests

6.1 Are there adequate vermin proofing and appropriate protection facilities?

7. Instruments and working equipment

7.1 Are they made of non corrosive, easy to clean and sanitize?

8. By-products

8.1 Containers made of non corrosive materials, easy to clean and sanitize?.

8.2 Adequate room for storage of by-products? Avoids cross contamination?

9. Potable Water supply

9.1 Sufficient pressure in all areas?

9.2 Backflow control?

9.3 Hoses are not in constant contact with the floor

1 Fresh: < 2ºC. Frozen: ≤ -18ºC. Brine: ≤ - 9ºC



NC PC C Comments

10. Cleaning chemical and utensils

10.1 Appropriate storing area, that avoids potential cross contamination

11. Waste water

11.1 Is there an adequate and hygienic wastewater disposal system?

11.2 Drains and sumps are easy to clean and sanitize

12. Vehicles and trolleys

12.1 In good conditions and easy to clean and sanitize

13. Changing rooms and amenities

Toilets

13.1. Placement. Not open directly onto the fish handling and processing area?

13.2 Usage. Are they equipped with working water-flushing systems?





13.7 Hand basins. In exit areas and in sufficient number

Changing rooms

13.8 Placement. Control cross contamination from the exterior?

13.9 Usage. Equipped with clothing storage facilities in good condition?

13.10 Floors. Made of materials easy to clean and sanitize




13.14 Hand basins. In exit areas and in sufficient number

14. Laundry Contracted or not (Internal)

14.1 Capacity in relationship to the number of employees?

14.2 Internal. In good hygienic condition?

14.3 Contracted. Is the transportation done hygienically?



NC PC C Comments

15. External Environment

15.1 Well maintained and clean

Specific requirements

16. Canning area

16.1 Approved retorting equipment & calibrated

16.2 Thermal process verification provided

16.3 Double Seam control done

17. Ice Production

17.1 Is ice produced from potable water, and in good hygienic condition?

17.2 Is ice stored in containers designed for this purpose?

18. Smoking areas

18.1 Separated smoking area with Adequate ventilation

19. Salting area

19.1 Separated salting area with Adequate drainage

20. Laboratory

20.1 Separated from processing areas and with controlled access

General Comments

Verifiers name and signature Representative name and signature2

2 Representative of the establishments that accepts the verification outcome



F02 – Verification of pre-requisites and support programmes

Based on Regulations (EC) No 852/2004, 853/2004, 2073/2005 and 2074/2005









NC PC C Comments

Hygiene and sanitary conditions

1. Equipment and processing areas

1.1 Documented system for all areas and equipment, with records?

1.2 Satisfactory conditions? Is cleaning effectiveness verified?

1.3 Cleaning chemicals and utensils store separated and labelled?

1.4 Chemicals have MSDS or technical specifications?

2. Pest and vermin control


2.2 Effectiveness assessed against presence of pest and vermin?

2.3 Chemicals and utensils store separated and labelled?

3. Staff training and Hygiene

3.1 Documented system that covers training, with records?

3.2 System covers infectious and communicable diseases?

3.3 System covers control over non hygienic behaviours?

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3.4 First aid kit contains impermeable dressings for cuts and sores?

3.5 Adequate and complete protective clothing, not expose to the outdoors

4. Water and Ice usage

4.1 Documented system that covers potability, has records and actions?

4.2 Is ice produced from potable water?

3 Hand washing. No eating, drinking, smoking, salivating in processing areas. Jewellery rules, etc.



NC PC C Comments

4.3 Are the ice containers clean and well maintained?

5. Raw material reception

5.1 Documented system for organoleptic evaluation. Records?

5.2 Includes temperature control and corrective actions?

6. Control during processing

6.1 Documented system for control during processing. Records?

6.2 Includes temperature control and corrective actions?

6.3 Includes control over equipment and staff hygiene?

6.4 Includes control over the condition and hygiene of product containers?

6.5 Practices effectively control cross contamination?

6.6 Verification proves effectiveness of the system?

7. By product management

7.1 Documented system for hygienic disposal. Records?

7.2 Includes control over the condition and hygiene of containers


8. Control during storage

8.1 Documented system for temperature control during storage. Records?

8.2 Verification proves effectiveness of the control system?

4.

9. Control during thawing

9.1 Documented system for thawing control. Records?

9.2 Practices effectively control cross contamination from water used

10. Repairs and Maintenance

10.1 Documented system for establishment maintenance?

10.2 Includes responsible, records and timeframes?


10.4 Does the system covers calibration of measuring devices?

4 Fresh: < 2ºC. Frozen: ≤ -18ºC. Brine: ≤ - 9ºC



NC PC C Comments

11. Goods reception5

11.1 Documented system for controls of arriving goods. Records?

11.2 Includes correct identification and backed by suppliers guarantees

12. Parasites control6

12.1 Documented system for parasite control. Records?

12.2 Includes visual inspection, removal and/or freezing to <-20Cº for 24hs

12.3 Presence of parasite

13. Traceability and Product recall

13.1 Documented system for traceability and product recall. Records?

13.2 Codification system making able to keep the traceability up and down

Specific requirements (verify only the applicable)

14. Canning

14.1 Documented system for process control. Records?

14.2 Retorting parameters validated and under control

14.3 Cans or pouches cooled under controlled conditions

14.5 Can or pouch integrity controls, Double seam verifications

14.6 Incubation tests (37°C– 35°C) for each lot.

15. Cooked Crustaceans


15.2 Cooking followed by efficient cooling down to melting ice temp.

15.3 Microbiological verification tests done regularly

16. Other processes on site7


17. Separation of EU products

17.1 Documented system for separation control. Records?

17.2 Includes control of authorised sources (under the control of the CA)

5 Packaging, labelling, ingredients, chemicals, pesticides, etc.

6 Detailed on Reg. (EC) No 2074/2005 and annex III, section VIII, chapter II, art. 4, of Reg. (EC) No 853/2004

7 Salting, fermenting, drying, etc.



NC PC C Comments

17.3 Includes physical separation of raw materials not fit to the EU market

17.4 Includes separation of processing from products not fit to the EU market

17.5 Includes separation of storage from product not fit to the EU market

17.6 Regulatory Verification confirms the effectiveness of the separation

18. Pre-operational verification

Condition of establishment

General comments

Verifiers name and signature Representative name and signature 8

8 Representative of the establishment accepting results of evaluation



F03 – Documental verification of HACCP

Based on Regulations (EC) No 178/2002, 852/2004, 853/2004, 854/2004





References consulted: Date of verification:



NC PC C Comments

Documentation

1. Facilities and process description

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. Product Description

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. Users and consumers

3.1 Sensitive consumers identified?

3.2 Instructions given for the distribution, storage and utilisation

4. Processing specification:

4.1 Flow diagram includes each stage of processing chain

4.1 Flow diagram confirmed



NC PC C Comments

5. Hazard ID and Analysis

5.1 Includes Ph, Ch and Bi9 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 risks.

6. Determination of CCP

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. Adoption of Critical Limits

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. Monitoring of CCP

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. Corrective Actions


9.2 Includes what, who, when, where and how corrective actions are taken

9.3 Are CA realistic and cover destination of non suitable products

9.4 Includes measures or action to avoid re-occurrence?

10. Verification Procedures


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

9 Physical Chemical and Biological Hazards



NC PC C Comments

10.3 Includes final product testing and calibration of equipment

10.4 Includes action in case that verification shows non compliances

11. Documentation and Records

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

General comments


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Representative of the establishment accepting results of evaluation



F04 - Verification HACCP plan performance

For use during operations

Precondition: this verification can only be performed if the establishment is on at least Partial Conformance with the requirements of F02 – Verification of pre requisites and support programmes








NC PC C Comments

1. Changes and Modifications

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

1.2 Modifications non communicated or approved if affecting product.

1.3 The responsibles (as documented) are in control of operations

2. Documentation and Records

2.1 Records are available in their respective areas and updated

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

3. Management of the Plan

3.1 Preventive measures followed and verifiable?

3.2 Monitoring procedures followed and verifiable?

3.3 Corrective actions followed and verifiable?

3.4 Verifications activities followed and verifiable?

General comments


11




F05 - Verification of condition and systems at aquaculture production establishments

For use during operation times








NC PC C Comments

1. Pre-requisite

1.1 Veterinary drug withdrawal periods control (Directive 2377/90/EC)

1.2 Monitoring of residues for vet drugs and pesticides (Directive 96/23/EC)

1.3 Existence of a system that controls Personnel Hygiene and Health

1.4 Existence of a system that controls premises cleaning and sanitation

1.5 Existence of a system that controls pest and vermin presence

1.6 Existence of a system that covers safety of water and ice management

1.7 Existence of a system that controls waste and debris management

1.8 Existence of a system that controls safety of feeds supplies

1.9 Existence of a system that controls Identification of lots and withdrawal plans

1.10 Existence of a system of fish health management (mortality & growth rate)

Site, general conditions and hygiene condition

2. Site location and condition

2.1 Is the site exposed to environmental risks? (Flooding, polluting surrounds, etc)

2.2 Installations designed, constructed and maintained for facilitating cleaning

3. Ponds, cages conditioning and feed

3.1 Well maintained and in usable condition.

3.2 Feed originated from a suppliers under the control of the CA.

4. Drugs and withdrawal periods

4.1 Records of drugs and doses used at each pond, cage, etc



NC PC C Comments

4.2 Withdrawal periods respected?

4.3 Residues verified under limits

5. Hygiene conditions

5.1 Good general condition of cleanliness in working areas.

5.2 Harvesting materials, containers, boxes, pipes, easy to clean?


5.4 Cleaning and Pest control chemicals have supplier‟s guarantees?

5.5 Offal and debris managed to preclude cross contamination?

6. Pest and animals control

6.1 Evidence of pest, birds and domestic animal control over the site

7. Control of Ice and water

4.1 Is the fresh water used from a verifiable safe source

4.2 Is the sea water used from a verifiable safe source

4.3 Ice originated from a controlled provider

8 Training and Staff hygiene



9. Harvest and transport

9.1 Containers well maintained and in hygienic condition

9.2 Harvest and transport managed in order to minimize cross contamination

9.3 Product temperature controlled if exposed to delays.

General Comments


12




F06 - Verification of conditions on ice plants










NC PC C Comments

1. Production

1.1 Good general conditions of cleanliness, hygiene and maintenance

2. Storage areas


2.2 Floors. Allows easy drainage of water or it has water removal equipment



2.5 Doors Made of impermeable materials easy to clean and sanitize


2.7 Delivery area. Good general conditions of hygiene and maintenance


3.1 Effectiveness assessed against presence of pest and vermin? Records

4. Safe Water monitoring

4.1 Is the fresh water used from a verifiable safe source? Records

4.2 Is the sea water used from a verifiable safe source. Records

5. Hand basins

4.1 Are the facilities in entry areas and in sufficient number

4.2 Are the taps non hand operated

4.3 Are detergent and sanitizing agents available, listed and approved?

4.4 Are the facilities provided with disposable hand towels and bins?



NC PC C Comments



6.2 Trolleys, containers, boxes, pipes, easy to clean?








13


7.5 Adequate and complete protective gear, not expose to the outdoors

General comments


13

Hand washing. No eating, drinking, smoking, salivating in processing areas, Jewellery rules, etc. 14




F07 - Verification of conditions on cold stores










NC PC C Comments

1. Production

1.1 Good general conditions of cleanliness, hygiene and maintenance

2. Storage areas


2.2 Floors. Allows easy drainage of water

or it has water removal equipment

2.3 Walls. Made of impermeable materials easy to clean and sanitize?.


2.5 Doors Made of impermeable materials easy to clean and sanitize


2.7 Delivery area. Good general conditions of hygiene and maintenance

2.8 Capacity. Able to maintain raw materials/products at allowed T

15

2.9 Monitoring Is there an efficient temperature control programme.





5. Hand basins

5.1 Are the facilities in entry areas and in sufficient number

5.2 Are the taps non hand operated

15

Fresh: < 2ºC. Frozen: ≤ -18ºC. Brine: ≤ - 9ºC



NC PC C Comments

5.3 Are detergent and sanitizing agents available, listed and approved?

5.4 Are the facilities provided with disposable hand towels and bins?



6.2 Forklifts, trolleys, containers, boxes, pipes, easy to clean?








16


General comments


16





F08 - Verification of conditions and systems on off shore vessels


Vessel name and permit number:


Verification Officers

Establishment representative

Verification harbour



Operation Period: [ ] < 24 hours [ ] > 24 hours

Type of vessel: [ ] Freezer [ ] RSW [ ] Ice


NC PC C Comments

Construction and material

1. Contact surfaces and utensils

1.1 Designed, constructed and maintained to facilitate hygiene

18

1.2 Minimize the potential for cross contamination from crew activities

1.3 Bilge water do not allow for contamination of product from engine

1.4 Fish hold in good general conditions of cleanliness, hygiene and maintenance



2.2 Fish holds, containers, boxes, pipes, easy to clean?








4.2 Is the seawater intake away from engine and toilets outlet?

4.3 Ice originated from a controlled provider or made from clean seawater

18

Includes tools, knifes, ice shovels, condition of fishing holds, separation of food and product holds, shelters, etc.



NC PC C Comments

5. Processing Area

5.1 Area has the minimal standards of maintenance and hygiene


6. Fish Holds and Temp Control

6.1 Ice vessels. Hold in good condition and sufficient ice

6.2 RSW Vessels. Records of temperature monitoring and control

6.3 Freezers Records of temperature monitoring and control

6.4 Cooling capacity. Able to maintain fish at required temperature

19

6.5 Thermometer and temperature control equipment annually calibrated





20


8 Additives

8.1 Salt used for brine has suppliers guarantees for its purpose

9 Common crew areas21

9.1 Good general conditions of cleanliness, hygiene and maintenance -bunks with mattress & pillow

5.1 Non hand operated Hand basins in exit areas and in sufficient number

Specific requirements for Vessels exporting directly

10. Hygiene control system


1.2 Satisfactory conditions? Is cleaning effectiveness verified?

11. Maintenance

11.1 Documented system for establishment maintenance?

11.2 Includes responsible, records and timeframes?

19

Fresh: < 2ºC. Frozen: ≤ -18ºC. Brine: ≤ - 9ºC 20


Galley, toilets, bunks, etc



NC PC C Comments


12. Goods reception22

12.1 Documented system for controls of arriving goods. Records?

12.2 Includes correct identification and backed by suppliers guarantees

12. Parasites control23

12.1 Documented system for parasite control. Records?

12.2 Includes visual inspection, removal and o freezing to <-20Cº for 24hs



General comments


22

Packaging, labelling, ingredients, chemicals, pesticides, etc. 23

Detailed on Reg. (EC) 2074/2005 and annex III, section VIII, chapter II, art. 4, of Reg. (EC) 853/2004 24




F09 - Verification of conditions for transport vessels

25 (fishery products)


Vessel name and permit number:


Verification Officers

Establishment representative

Verification harbour:




NC PC C Comments

Construction and material


1.1 Designed, constructed and maintained to facilitate hygiene

1.2 Good maintenance condition of fish boxes and holds

2. Unload

2.1 Managed in a way to avoid cross contamination

3. Ice usage


3.2 Handling of ice minimizes potential for cross contamination

4. Fuel storage

4.1 Separated from catch and ice

5 Training and Hygiene

5.1 Crew understand the minimal requirements of personal hygiene









25

Transport vessel: to transport fish and fishery products from the point of cage culture to the landing site.



NC PC C Comments

9.2 Fish holds, containers, boxes, pipes, easy to clean?



General Comments

Verifiers name and signature Fisherman’s name and signature26

26




F10 - Verification of conditions of landing sites


Name of transport company:



Company representatives:

Identification of the vehicle:




NC PC C Comments

1. Construction and utensils

1.1 Installations designed, constructed and maintained for facilitating cleaning

1.2 Good general condition of cleanliness and maintenance in working areas.

2. Unload

2.1 Are operations minimizing time loss and exposure to cross-contamination?

2.2 Is temperature abuse minimized during operation?

2.3 Equipment and practices minimize damage on catch.

3. Ice and water usage

3.1 Ice and water originated from a controlled provider



Effectiveness assessed against presence of pest and vermin? Records

5. By product management


6. Access

6.1 Access of personnel to working areas is controlled?



NC PC C Comments

7. Training and Hygiene

7.1 Minimal protective clothing issued and used.

7.2 Personnel understand the minimal requirements of personal hygiene

General Comments

Verifiers name and signature Operator name and signature 27

27




F11 - Verification of conditions for transporters

Based Regulations (EC) No 178/2002, 852/2004, 853/2004, 854/2004

Name of transport company:



Company representatives:

Identification of the vehicle:




Type: [ ] Freezer [ ] Chiller

Construction and material NC PC C Comments


1.1 .1 Designed, constructed and maintained to facilitate hygiene

1.2 Good maintenance condition of cargo area

2. Load and Unload

2.1 Managed in to avoid cross contamination

3. Ice usage and Temperature control



3.3 Temperature monitoring on freezer tucks

4. Fuel storage

4.1 Separated from catch and ice

5 Training and Hygiene

5.1 Drivers understand the minimal requirements of personal hygiene

General Comments


28




F12 - Verification of traceability





Representative of the establishment:

Type of product:


Identification/marks/codes:



NC PC C Comments

1. Criteria

1.1 Provider and/or origin clearly identified and verified

1.2 Integrity of the lot maintained during the transport to the establishment

1.3 Integrity of the lot maintained during the process in the establishment

1.4 Separation or addition of lots is registered

1.5 Identification/marks/codes allow tracking of the products

1. 6 Product recall plan is formalized and operational

2. Records review

2.1 Destination of products identified and data is verifiable

2.2 Suppliers and listed under the control of the CA for the EU

2.2 In case of product recall, records are updated and complete

General comments


29




F13 – Organoleptic evaluation for finfish




Representatives of the establishment:

Type of product:


Processing stage:


Temperature of product:


Freshness index (FI): A: Good = 3 B: Medium = 2 C: Low = 1 R: Reject = 0

Criteria Evaluation Average Commentaries

Skin 3 2 1 0

Pigmentation

Slime

Smell

Eyes 3 2 1 0

Convexity

Bloodiness

Operculum 3 2 1 0

Colour

Slime

Gills 3 2 1 0

Colour

Slime

Smell

Viscera 3 2 1 0

Smell

Belly Burn

Texture 3 2 1 0

Response to finger pressure

Total Average

Freshness index Observations

From 3 to 2.7 = A

From 2.7 to 2 = B

From 2 to 1.5 = C

From 1.5 to 0 = R


30




F14 - Organoleptic evaluation for shrimp

Name of the establishment : Authorization number :

Verification Officers :

Representatives of the establishment :

Type of product:


Processing stage:




Freshness index (FI) : A: Good = 3 B: Medium = 2 C: Low = 1 R: Reject = 0

Criteria No. of Sample Average Commentaries

1 2 3 4 5 6 7 8 9

Head

Colour

Head/Body Attachment

Intact, slightly loose or detached

Body

Colour

Odour

Smell

Texture

Response to finger pressure

Black Spots

Existence

Total Average


From 3 to 2.7 = A

From 2.7 to 2 = B

From 2 to 1.5 = C

From 1.5 to 0 = R


31




Criteria Reference:

Score Head Head/Body attachment

Body Odour Texture Black Spots

3 BLACK TIGER PRAWN :

Bluish grey to slightly faded carapace

WHITE SHRIMP:

White grey to faded carapace

Intact to slightly loose

BLACK TIGER PRAWN:

Bluish green, dark blue or brownish green to slightly faded, translucent

WHITE SHRIMP:

White, transparent

Seaweedy, neutral, fresh odour or characteristic odour

Firm, elastic, hard shell

Not present

2 Black

(Applies to Both Black Tiger & White Shrimp)

Very loose BLACK TIGER PRAWN :

Faded, slightly yellowish along dorsal line

WHITE SHRIMP:

Bleached

Neutral to slight stale odour

Firm Present in head

1 Completely black

(Applies to Both Black Tiger & White Shrimp)

Very loose to detached

BLACK TIGER PRAWN :

Faded, slightly greenish or yellowish along dorsal, reddish (cooked appearance), opaque meat, black tail

WHITE SHRIMP:

Bleached, some black tail

Fishy, stale, musty, sour, putrid, ammonical, faecal

Slightly firm to soft or mushy, soft shell

Some on body and/or tail

0 Completely black

Detached BLACK TIGER PRAWN :

Faded, greenish or yellowish along dorsal, reddish (cooked appearance), opaque meat, black tail

WHITE SHRIMP:

Very bleached, black tail

Fishy, stale, musty, sour, putrid, ammonical, faecal

Soft, soft shell, mushy

Many on body and/or tail



F15 - Organoleptic evaluation for cuttlefish




Representatives of the establishment:

Type of product:


Processing stage:




Freshness index (FI): A: Good = 3 B: Medium = 2 C: Low = 1 R: Reject = 0

Criteria No. of Sample Average Commentaries

1 2 3 4 5 6 7 8 9

General Appearance

Body Surface (Front)

Body colour (Back)

Flesh odour

Texture

Gut colour

Gut odour

Total Average


From 3 to 2.7 = A

From 2.7 to 2 = B

From 2 to 1.5 = C

From 1.5 to 0 = R


32




Criteria Reference:

Score

General Appearance

Body Surface

( Front)

Body Colour

(Back)

Flesh Odour

Texture

Gut Colour

Gut Odour

3

Intact, transparent, bright shiny, moving pigments

White with slight purple spots

Slightly orange, greenish, slightly purple

Neutral, characteristic odour

Firm to hard

Bright, greenish to slightly milky

Neutral to slight fishy (characteristic odour)

3

Intact, transparent, bright shiny, moving pigments

White with slight purple spots

Slightly orange, greenish, slightly purple

Neutral, characteristic odour

Firm to hard

Bright, greenish to slightly milky

Neutral to slight fishy (characteristic odour)

2

Yellowish especially on fins, slightly peeling opaque, slightly dull

More purple spots, milky

Dark purple, orange tinge

Slight fishy to slight sour

Less firm

Very milky

Slight fishy, slight sour (characteristic ink odour)

1

Yellowish especially on fins, slightly peeling, opaque, dull

Dark purple spots, milky

Very dark purple, slight orange tinge

Fishy, sight sour

Soft

Very milky

Slight fishy, slight sour (characteristic ink odour)

0

Peeling, very opaque, dull

Very dark purple, very milky

Extremely dark purple

Sour musty, putrid

Very Soft

Milky, blue

Sour, musty, putrid



Appendix 2

Form CAR-EU-Rev 03

VERIFICATION : CORRECTIVE ACTION REQUEST (CAR)

Audit No: CAR No.: Date:

Food Premises (FP)/Owner of Transport Vehicles:

Address/Tel. No.:

Registration No. of Transport Vehicle:

Company representative(s):

Competent Authority (CA)

Auditors:

Non-Conformance Report :

Partial Compliance (PC) Non-Compliance (NC)

Applicable Regulation /

Requirement

Objective evidence & Location

Potential effect of non-

Conformance

Root cause that needs to be

addressed (if any)

Signature:

Name:

Company Representative

Signature:

Name:

CA Auditor

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 3

VERIFICATION REPORT

1. Establishment / Sources of Raw Material & Ice:

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 Observations33

:

NO. NON-CONFORMANCE CATEGORY

PC / NC CORRECTIVE

ACTION TAKEN DEADLINE CLOSED-

OUT

33

Fill up the table below



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

Compliance (C)34

: Partial Compliance (PC)

35 :

Non-Compliance (NC)

36 : :

(b) Reasons for Status of Overall Compliance :

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

11. (a) Recommendation on action to be taken if status of overall compliance is partial compliance (PC) or non-compliance (NC) (please tick where relevant):

Suspension of Certification : Delisting of establishment :

(b) Reasons for Recommendation :

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

Signature Name of Lead Auditor Position Date

: : : :

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

34

C (Compliance) : Probability of occurrence of food safety hazard is low

35

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.

36 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 as food