PROTOCOL FOR REGISTRATION OF PROCESSING …fsq.moh.gov.my/v5/images/filepicker_users/5ec35272cb-78/Aktiviti/E...MINISTRY OF HEALTH MALAYSIA PROTOCOL FOR REGISTRATION OF PROCESSING

Document No: 01 Revision No: 0 Page: 1 of 41 Effective Date: 23 June 2014

FOOD SAFETY AND QUALITY DIVISION

MINISTRY OF HEALTH MALAYSIA

PROTOCOL FOR REGISTRATION OF PROCESSING

ESTABLISHMENT OF MILK AND DAIRY PRODUCTS EXPORT

TO CHINA

Title: PROTOCOL FOR REGISTRATION OF PROCESSING ESTABLISHMENT OF MILK AND DAIRY PRODUCTS EXPORT TO CHINA


Approved by:

Name: NORAINI BINTI DATO’ MOHD OTHMAN

Designation: Senior Director for Food Safety And Quality

Ministry Of Health Malaysia

Date: 23 June 2014



NO. DATE OF AMENDMENT REVISION NO. AMENDMENT REFERENCE



1. INTRODUCTION :

The safety of milk and dairy 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 to establish food safety control over the milk and dairy products supply chain in order for milk and dairy products produced will be safe for human consumption by complying with the Food Act 1983 and Food Regulations 1985, Food Hygiene Regulations 2009 as well as the importing countries’ requirements. Hence, the ultimate aim of FSQD is to protect and boost Malaysia's reputation as a supplier of safe and good quality milk and dairy products to China. Registration and verification are important steps to ensure that processing establishments continuously meet importing countries’ requirements. It is the responsibility of the processing establishments to ensure compliance to the importing countries’ requirements. The processing establishments shall develop and implement Hazard Analysis and Critical Control Point (HACCP) as the food safety assurance program as one of the requirement to export milk and dairy products to China. In line with the China requirements, a monitoring programme for milk and dairy products is being implemented. The monitoring carried out serves as a measure to ensure the safety of Malaysian milk and dairy products. For the purpose of the monitoring programme, FSQD designs the plan, determines and manages the operational process, which includes product sampling, identification and dispatch to laboratories, data management and analysis and initiation of traceability. Such processing establishments shall obtain the raw milk from processing establishments which have been complied with the requirements imposed by Department of Veterinary Services (DVS) and fulfill the requirement on the food safety so as to ensure that the milk and dairy products are safe for human consumption. Therefore, the processing establishments shall obtain raw milk from sources within the supply chain and verified by Competent Authorities (CAs) i.e. FSQD and DVS. 2. SCOPE

This protocol establishes the mechanism for;

i. registration of the processing establishment; ii. verification of the processing establishment;



3. REGISTRATION 3.1 Types of Registration

MOH maintains and manages list of processing establishment of milk and dairy products to China.

3.2 Registration of Processing Establishments

The FSQD (HQ) shall maintain a registration list of processing establishments. Only processing establishments in the Registration List of Processing Establishment for Export of Milk and Dairy Products to China are permitted to export milk and dairy products to China. The processing establishment shall submit a completed form as follows: 3.2.1 Application Form to the FSQD (HQ) as shown in Appendix 1; 3.2.2 Total Amount of Dairy Product Exported to China as shown in

Appendix 2; 3.2.3 Milk-Based Infant and Follow on Formula (Formula Milk Powder and

Liquid) as shown in Appendix 3 (if applicable); and 3.2.4 Name List of Dairy Product (Except Infant Formula Products)

Processing Establishments Applied to Register in China as shown in Appendix 4.

3.3 Procedures for the Registration of Processing Establishments

3.3.1 Application for Registration

The processing establishment shall submit a completed Application Form as in Appendix 1 to FSQD (HQ).

3.3.2 Application Review

3.3.2.1 The FSQD (HQ) shall review the following documents:

a) Completed Application Form; b) Supporting documents e.g. registration of company, FSQD

(HQ) HACCP certification and others.

3.3.2.2 The FSQD (HQ) shall record all applications in a central registry.



3.3.3 Verification

Verification is carried out for the following purposes:

i. To assess the compliance status of processing establishments of milk and dairy products; and

ii. To conduct surveillance verification on the maintenance of the

compliance status of processing establishments for purposes of export of milk and dairy products to China.

3.3.3.1 Verification of processing establishment shall be

carried out as follows:

i. The FSQD (HQ) shall assign auditors to carry out the compliance verification of the processing establishment once the application has been reviewed.

ii. Verification of processing establishments shall be

carried out by assigned auditors by using the relevant checklist as in Appendix 5.

iii. The assigned auditors shall report the verification findings to the processing establishment including the non conformances to the processing establishment. The auditors will discuss the verification findings, and issue corrective action requests (CARs) using the CAR format in Appendix 6 for non-conformances together with the completed verification checklists to the management of the processing establishment at the closing meeting.

iv. Corrective actions shall be undertaken on the non-conformances by the processing establishment within the agreed time frame by auditors and processing establishment. Follow-up visits shall be carried out when necessary.

v. CARs shall be closed out not exceeding 6 months from the date of compliance verification or otherwise a new application shall be submitted by the processing establishment provided the corrective actions on the non conformances issued in the previous verification have been undertaken.



vi. The lead auditor will forward a preliminary report on the verification findings and the corrective action request form which has been completed with the corrective action that will be undertaken by the processing establishment and the completion target date to FSQD HQ within 5 working days from date of compliance verification using the specific format as in Appendix 7.

vii. The lead auditor shall submit a final report on the compliance status of the processing establishment based on the verification findings to FSQD HQ within 14 working days from the date of all CARs have been closed out.

viii. The FSQD (HQ) shall review the report and decide on the compliance status of the application. A copy of final report on the verification shall be given to the processing establishment and the successful applicant shall be listed in the Registration List of Processing Establishment for Export of Milk and Dairy Products to China.

ix. The FSQD (HQ) shall forward a request for registration to Certification and Accreditation

Administration of the People's Republic of China (CNCA) for approval.

x. Once the processing establishment is included in the updated CNCA’s Imports of Dairy Production Enterprises Registered Overseas List, the FSQD (HQ) shall forward a written official notification to inform the processing establishment of its approval registration number with a copy sent to the State Health Department.

xi. Upon approval by CNCA, CNCA reserve the right to carry out inspection to the processing establishment.

3.4 Conduct of Surveillance Verification on the Registered Processing Establishment for the Export of Milk and Dairy Products to China

3.4.1 Surveillance verifications are conducted every six (6) months on the registered processing establishment by the assigned auditors.

3.4.2 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 milk and dairy products.

3.4.3 Relevant verification checklists as in Appendix 5 shall be used as a

tool for verification. 3.4.4 The auditors will discuss the surveillance verification findings and

issue corrective action requests (CARs) using the format as in Appendix 6 for non-conformances to the management of the processing establishment at the closing meeting.

3.4.5 The lead auditor will forward a preliminary report on the verification

findings and the corrective action request form which has been completed with the corrective action that will be undertaken by the processing establishment and the completion target date to FSQD HQ within 5 working days from date of compliance verification using the format as in Appendix 7.

3.4.6 Follow-up audit will be carried out, if necessary. 3.4.7 CARs shall be closed within the agreed time frame of not exceeding

30 days. 3.4.8 The lead auditor shall forward a final report on the surveillance

verification to FSQD (HQ) within 14 working days from the date of CARs have been closed out.

3.4.9 In the case of CARs which are not closed out within 30 days e.g.

upgrading of major infrastructures, another agreed time frame shall be given not more than 6 months from the date of the surveillance audit. A Reminder Notice shall be issued by the auditor regarding the unclosed CARs after 4 months from the date of surveillance audit with a copy to FSQD (HQ).

3.4.10 A separate report on the remaining CARs shall be forwarded to

FSQD (HQ) within 5 working days by auditor. 3.4.11 In case of CARs are not closed out, the assigned auditors may

recommend to FSQD (HQ) to suspend the export of milk and dairy products to China by the processing establishment.

3.4.12 The lead auditor shall immediately recommend to the FSQD (HQ) by

submitting a written report with recommendation to suspend the compliance status of the processing establishment if it is found totally not in compliance.



3.5 Changes To Registration List

The processing establishment that has been listed in the Registration List shall submit a written request to the FSQD (HQ) to change any details of the processing establishment. 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.

3.6 Voluntary Delisting of Processing Establishment

3.6.1 Listed processing establishment intending to be delisted from the

Registration List for Processing Establishment of Milk and Dairy Products to China shall make a request in writing to the FSQD (HQ).

3.6.2 The processing establishment that requested the voluntary delisting

shall not export milk and dairy products from the date of request for delisting.

3.7 Delisting of Processing Establishment by the FSQD (HQ)

3.7.1. Formal Delisting from the Compliance List

A listed processing establishment of milk and dairy products shall be delisted from the Registration List if:

i. The processing establishment of milk and dairy products fails to

rectify non-conformances within an agreed timeframe; ii. The processing establishment of milk and dairy products has

stopped operating for a time period more than 6 months; iii. The processing establishment of milk and dairy products did not

export to China for a time period more than 18 months.

FSQD (HQ) shall notify the affected processing establishment in writing of its intention to delist the facility from the Registration List. The processing establishment 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 establishment within the two (2) weeks time limit, the FSQD (HQ) shall delist the processing establishment from the Registration List.



3.7.2. Communication of Changes

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



Flow Chart: Assessment of Compliance Status of Processing Establishment for Export of Milk and Dairy Products to China

Submission of application (form + supporting documents) by

Processing Establishment

Listing of processing establishment into the Registration List for Export of Milk and Dairy Products to China

Final report reviewed by the FSQD (HQ)

On-site verification performed by the assigned auditors

CARs

Comply

Closed

Not Closed within 6

months

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

Review of application by FSQD (HQ)

Not Complete

Complete

The lead auditor shall submit a written report with

recommendation for listing of the processing establishment to

FSQD (HQ)

The FSQD (HQ) shall review the report

Notify applicant

Terminate

The FSQD (HQ) shall forward a request for registration to

CNCA for approval

Comply

Yes

No Notify applicant



Flow Chart: Surveillance Verification on the Listed Processing Establishment for the Export of Milk and Dairy Products to China

Surveillance verification performed by assigned auditors

(every 6 months)

CARs (within agreed

time frame of not exceeding 30

days)

Lead auditor forwards a preliminary report FSQD (HQ) within

5 working days from the date of surveillance audit

Follow-up audit shall be carried out where necessary

Closed

Not Closed Agreed time frame not more than 6 months from the date of

surveillance audit (e.g. major upgrading)

Maintained in the Registration List for Export of Milk and Dairy Products to China

Final report reviewed by the FSQD (HQ)

Delisted from the Registration List

Suspension / Reinstatement of issuance Health Certificate (if HC is required)

Reminder notice for unclosed CARs after 4 months from the date of surveillance audit with a copy to

FSQD (HQ)

Report on the remaining closed CARs to FSQD (HQ) within 5

working days

Lead auditor forwards a final report to FSQD (HQ) within 14 working days from

the date of CARs be closed

CARs Closed

Yes

No



APPENDIX 1 Form CND/E/1-2014

Ministry of Health

APPLICATION FORM FOR LISTING OF PROCESSING ESTABLISHMENT FOR EXPORT OF MILK AND DAIRY PRODUCTS TO CHINA

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

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

2.0 Product (1): Infant formula and follow up formula powder Others, please specify…………………………

3.0 Particulars of Applicant 3.1 Name of Applicant: …………………………………………………………………………………………… 3.2 NRIC Number: …………………………………………………………………………………………………… 3.3 Name and Address of Company: ………………………………………………………………………… ............................................................................................................................................... ............................................................................................................................................... 3.4 Tel. No.: …………………………3.5 Fax No.: …………………………3.6 H/P No. …………………… 3.7 E-mail address: ………………………………………………………………………………………………… 3.8 Company Registration Number (ROC): ………………………………………………………………… (Please attach copy of the certificate)

3.9 Correspondence Address (if different from para 3.3): .………………………………………… …………………………………………………………………………………………………………………………… ............................................................................................................................................... 3.10 Supporting Documents (please attach e.g. license, any certification etc.):………………… ----------------------------------------------------------------------------------------------------------------- (1) Tick () where appropriate



4.0 Information on Sources of Raw Milk:

No Name of

processing establishment

Address of processing establishment

Country of processing

establishment

Name of Raw Milk

Type or raw milk

(√ where applicable)

Import Approval

No. by DVS Powder Liquid

I hereby, based on my knowledge and the information gathered to this date, certify that

the above statements are all correct without prejudice.

Signature: ______________________________

Name: ______________________________

Date: ______________________________

Company stamp :_________________________

Please return complete application form to:

Senior Director Food Safety and Quality Division Ministry of Health Level 3, Block E7, Complex E, 62590 Putrajaya. Tel. No:03-88833558/3557 Fax No:03-88893815 Email: [email protected]



APPENDIX 2

*TOTAL AMOUNT OF DAIRY PRODUCT EXPORTED TO CHINA Please classify the total amount of dairy goods exported to China in the last 2 years (if applicable).

Product Category

Total amount of dairy product exported to China (104 tons)

Year of ×× Year of ××

Milk powder (excluding milk-based infant and follow up formula powder)

milk-based infant and follow up formula powder

Pasteurized milk

Sterilized milk

Modified milk

Other disinfection milk

Fermented milk

Flavoured fermented milk

Whole milk powder

Partly skimmed milk powder

Sweetened milk powder

Skimmed milk powder

Flavoured milk powder

Formula milk powder

Fortified formula milk powder

Other milk powder

Butter

Cream

Other milk fat

Condensed milk

Sweetened condensed milk

Evaporated milk

Other condensed milk

Cheese

Hard cheese

Other cheese

Demineralized whey powder

Whey powder

Whey protein concentrate

Other whey powder

Other milk and milk product * Extract from Annex 1- CNCA’s Questionnaire of Overseas Manufacturer Registration Management for Exported Dairy Products



APPENDIX 3

Annex 3

Milk-based Infant and Follow on Formula (Formula Milk Powder and Liquid)

Overseas Production Enterprise Registration Application Form

NOTE: This application on foreign dairy products producing, processing and storage is

required by CNCA for evaluation and registration to export dairy products to China. All

information must be submitted in Chinese or English. Application data content should

be true and accurate to avoid misleading and delays. Please provide any additional

information to support your application.

Part I General Information About the Enterprise

A General Information

1.Production enterprise

Registered name (actual production organization):

Registered address (actual production address):

Registration number (if applicable):

2.Contact person:

Telephone:

Fax:

E-mail:

3. Registration (approval) authority:

4.If the actual address of the producer differs from the address on the business licence,

please provide the name, address, telephone number, fax number, email and other contact

details of the production enterprise which is liable for the products exported to China,

specifying the relationship between the producer which is liable for products exported to

China and the actual production enterprise.

5 Date of plant establishment:

6.Total area:

7.Total building area:

8. Please provide layout of workshops, division of clean area, people flow and logistic as

attachment.



9 Name of products to be exported to China:

Serial No. Product type① Applicable

age bracket②

Packaging

form③

Registered

trademark④

①Product type: Complete it according to “infant formula milk powder”, “infant formula

liquid milk”;

②Applicable age bracket: for example, 0-6 months etc;

③Packaging form: for example, paper box with inner package, can with inner package, can

without inner package etc (please provide details about inner and outer packaging forms)

④Registered trademark: please provide registered trademark approved by competent

authorities

10. Please provide the actual production quantity of final products of infant and follow on

formula in the past 2 years (ton/year).



B. Production Information

1. Please choose the production process from the list below and provide a clear processing

flow chart in the form of attachment:

□Wet-mix process

□Dry-mix process

□Combined process

For definitions of wet-mix, dry-mix and combined processes, please refer to the Hygienic

Operation Specification for Infant Formula Milk Powder (Codex Alimentarius Commission,

CAC/RCP66-2008).

2. Production capacity and equipment

(1) Please list the main production equipments, quantity, designed production capacity;

(2) Please provide the information on production capacity per shift (ton),number of shifts

per day, annual average number of working days;

3.Hygiene and quality management system

□If the Hazard Analysis and Critical Control Point (HACCP) system has been established and

implemented, please provide hazard analysis worksheet and HACCP plan form. If certified

by an accredited third-party certification organization and awarded with HACCP

certificates, please provide the certificate and documentary evidences concerning the

qualification of the third-party organization.

□ If the Food Safety Management System (ISO22000 or other equivalent hygiene and

quality management system) has been established and implemented, please provide

HACCP plans and its preconditions. If certified by an accredited third-party certification

organization and awarded with relevant certificates, please provide the certificate and

documentary evidences concerning the qualification of the third-party certification

organization.

□If none is implemented, please provide hazard source analysis and the corresponding

prevention and control measures.

4. Please specify whether there are isolation and washing (or cleaning) measures between

the production of products with different batch numbers, formulas and varieties;

□Yes, please provide supporting evidence in the form of attachment;

□ No.

5. Please provide environmental monitoring plan for salmonella, enterobactersakazakii and

other enteric bacilli, and air purity testing plan for cleaning work area as well as the latest

two test reports as attachment.

6. Are there any automatic valve arrays in enterprise’s processing workshop? (if applicable)



□No.;

□Yes, please provide the following information.

When there is CIP cleaning during the production, please provide CIP cleaning information

concerning major production equipments:

Item Manufacture

equipment

Chemical name

of the cleaner

Temperature,

concentration, time, flux

Cleaning effect

validation way

When equipments and parts are manually cleaned during the production, please provide the

following information:

Item Manufacture

Chemical

name of the

cleaner

Temperature,

concentration, time, flux

Cleaning effect

validation way

7. Please provide the name of the disinfectant, cleaner and others used in the production

and operation area used by the production enterprise in the form of attachment.

8 Water/ice/steam supply (if applicable)

(1) Water source

□Water for public use

□Water source self-owned by enterprise: whether water from self-owned water sources is

disinfected; if any, please specify the mode of treatment and limiting value for monitoring.

□Ozone treatment

□Chlorination

□Others

(2) Please provide water supply and drainage drawings, indicating water flow direction.

(3) Please provide, in the form of attachment, the plan of monitoring water for production,

ice/steam (if applicable) which directly contact food, including bacteriological examination

items, method, frequency and the latest two test reports.



C. Raw Material Information

1.Please specify the raw materials for infant formula dairy products used by enterprise:

(1)□ Raw milk

①Please specify the Standards for acceptance check of incoming raw milk (including

indicators, maximum level, acceptance check requirements etc);

②type of milk source;

□Milk source owned by enterprise;

□Milk source owned by parent company of enterprise and managed according to relevant

regulations of the country (territory) where it is located;

□ Milk source from dairy farms owned by enterprise through cooperatives

□Milk source which is qualified through evaluation by enterprise or accredited organization,

managed according to relevant regulations of the country (territory) where it is located and

signs milk supply contract covering three years or more with enterprise.

□ other milk source

③Please provide information on the annual raw milk output from milk source (ton): ,

annual supply (ton):.

(2) □Dairy products (whole milk (powder), skimmed milk (powder), whey (powder) etc);

①Standards for acceptance check of incoming raw material (including indicators, maximum

level, acceptance check requirements etc);

②Source of raw material:

□Domestic purchase;

□if not domestic purchase, please provide the country of origin.

2. Please briefly describe the enterprise’s system for examination and approval of raw

material suppliers.



D. Product Traceability and Recall

1. Are there any logos, symbols or number and other items for traceability printed on

product package?:

□Yes; please explain the meaning of the logo, symbol or number for traceability, the

position on the package, and how consumers should use such logo, mark or number etc;

□No.

2.Has the enterprise established a product recall system? If yes, please provide a brief

introduction to the product recall system in the form of attachment.

E. Product Testing

1. Laboratory for finished products release testing:

□Official testing organization:

Laboratory name:

□Third-party testing organization:

Laboratory name:

□Laboratory owned by enterprise

Please provide documentary evidence concerning laboratory testing capacity or its

qualification information in the form of attachment.

2. Please provide, in the form of attachment, the disposal procedures of non-conforming

raw materials, semi-finished products and finished products of the enterprise.

F. Enterprise Location and Plant Environment

1. Please describe the location of the enterprise. Is it located within industrial, agricultural or

residential area? Is it far away from pollution including smell, smoke and dust from livestock

farm, refinery, municipal refuse, chemical plant and sewage treatment plants (please attach

the enterprise location plan in the form of attachment to clearly show the surrounding

environment of the plant area)?

2. Please provide pest and mouse control chart in the form of attachment



G Enterprise Statement

1. The enterprise here declares that the enterprise and nutritional ingredients and additives for infant

formula dairy products to be exported to China by the enterprise comply with relevant Chinese laws,

regulations, food safety standards.

2.The above information and additional materials submitted are authentic and accurate.

Name and position of legal representative

________________________________________________________

Signature of legal representative and company seal and date

________________________________________________________

H. Confirmation by Competent Authority

It is hereby certified that through examination and confirmation, the above materials provided by the

enterprise are authentic and accurate.

________________________________________________________

Name and position of the responsible person

________________________________________________________

Signature of the responsible person and seal of competent department (date)

________________________________________________________



Part II Overview of Enterprise’s Export to China

A. Please describe the relationship among the producer, exporter, importer, the trademark holder

that exports the products to China and the responsible party that exports the products to China.

A.Import information

1 Importer information

Name:

Address:

Telephone:

Fax:

E-mail:

Contact person:

2. Please list the trademarks of products to be exported to China in the form of attachment, clarifying

the trademarks holder that exports the products to China, the country in which the trademarks are

registered and the approval authority, and provide relevant supporting evidences.

3. Please list all the ingredients (formula) information according to the amount added to the products

to be exported to China in the form of attachment.

4. Are there any logos, symbols or numbers for product recall printed on the packages of the products

exported to China?

□ Yes, please explain the meaning of the logos, symbols or numbers for product recall, the position on

the package and how consumers should use the logos, symbols and numbers, etc.

□ No.

5 For infant and follow on formula products exported to China, has the enterprise established or

authorised a third party to establish a complaints platform in Chinese and an inquiry system of product

information?

□ self-owned

□ authorised a third party

Please briefly introduce how to introduce the established complaints platform and the inquiry system

of product information to the consumers. Please give an example on the proceeding procedure when

consumers use the complaints platform and the inquiry system of product information in Chinese.

6 Please provide the licence of independent legal entity, business licence, licence of legal

representatives or identification of the authorised person as well as contact details of the importer or

legal representative of the enterprise in China which is liable for recall in China of products exported to

China according to Chinese laws and regulations.



B Export information

1 Exporter Information

Name:

Address:

Telephone:

Fax:

E-mail:

Contact person:

2. Product information

Please describe the history of products exported to China in the past 2 years in the form below.

Item Product

type①

Applicable age

bracket②

Registered

trademark

Quantit

y (ton)

Date of exporting for

the first time (if

applicable)

①Product type: Complete it according to “infant formula milk powder”, “infant formula liquid milk”;

② Applicable age bracket: for example, 0-6 months etc;



APPENDIX 4

Annex 5

Name List Of Dairy Product (Except Infant Formula Products) Processing Establishments Applied To Register In China

Name of Processing

Establishment

Address of Processing

Establishment

City/ County

State/ Province/

Region

*Type of Establishments

**Product ***Remark

*Type of Establishments: PP-production processing; CS-cold storage; Dry Store **Product varieties to be registered:

Pasteurized milk Butter

Sterilized milk Cream

Modified milk Other milk fat

Other disinfection milk Condensed milk

Fermented milk Sweetened condensed milk

Flavoured fermented milk Evaporated milk

Milk powder Other condensed milk

Whole milk powder Cheese

Partly skimmed milk powder Hard cheese

Sweetened milk powder Other cheese

Skimmed milk powder Demineralised whey powder

Flavoured milk powder Whey powder

Formula milk powder Whey protein concentrate

Fortified formula milk powder Other whey powder

Other milk powder Other milk and milk product

***Remarks: Bovine dairy Goat or Sheep Bovine



APPENDIX 5

MOH.HACCP Audit Checklist – Rev 0/09

CHECKLIST FOR HACCP AUDIT



INSPECTION CRITERIA FOR PRP/GMP

ESTABLISHMENT NAME AND ADDRESS:

DATE INSPECTED:

PRODUCT(S):

NAME AND TITLE OF RESPONSIBLE PLANT OFFICIAL:

TEL. NO.: FAX NO. :

References consulted: MS 1514/MS1480 Total time of verification:

INSTRUCTIONS:

Answer the following questions by checking the appropriate box.

NC= No Conformity PC= Partial Conformity C= Conformity

1.0 LAYOUT & INFRASTRUCTURE

NC PC C COMMENTS

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

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

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

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

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

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

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

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

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

2.0 EQUIPMENT AND UTENSILS

NC PC C COMMENTS

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 supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature measuring device, or temperature-recording device and should be fitted with an automatic control

2.6 Calibration and maintain

2.7 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.

2.8 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.

2.8.1 Vehicles and trolleys (EU Requirement)

In good conditions and easy to clean and sanitize (no

rusty)

3.0 SANITARY FACILITIES AND CONTROLS

NC PC C COMMENTS

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

3.2 Are the water temperatures and pressures maintained at suitable levels for its intended use

3.3 Is the sewage disposal system adequate

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

3.5 Toilet

3.5.1 Provided, equipped and maintained clean and in good repair.

3.5.2 Maintaining the facilities in a sanitary condition.

3.5.3 Keeping the facilities in good repair at all times.

3.5.4 Providing self-closing doors.

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

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

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



3.8 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

3.9 Laundry (EU Requirement)

Contracted or not (To meet requirement for “protective clothing are clean & maintained in a clean area condition”)

4.0 SANITARY OPERATION

NC PC C COMMENTS

4.1 Is the facility kept clean and in good physical repair

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

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

4.4 Are cleaning compounds and hazardous materials kept in original containers, stored separate from raw materials

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

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

4.7 Utensils and equipment

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

4.7.2 Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use

4.7.3 In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surface may have become contaminated.

4.7.4 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.

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

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

5.0 PROCESSES AND CONTROLS

NC PC C COMMENTS

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



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

5.3 Raw materials and ingredients

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

(Specific EU Requirement)

5.3.1.1 Maintain raw materials/products at allowed temperature (Fresh: < 4⁰C/Frozen: -18⁰C/ Brine: -9⁰C)

5.3.2 Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act

(5.3.3 – USFDA Shellfish Specific Requirement)

5.3.3 Source control - Raw Molluscan Shellfish

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

b. harvested from approved growing waters by related authority

c. information on shellstock’s tagging

5.3.4 Supplier’s guarantee or certification.

5.3.5 Control of thawing process

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

5.5 Heat treating acid or acidified foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.

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

5.7 Food processing

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

5.7.2 Records of the process

5.7.3 Cross-contamination on raw materials or others ingredients

5.8 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.



5.9 Control of adulterated food, raw materials, and other ingredients

5.10 Are chemical microbiological or extraneous material testing procedures used where necessary to identify sanitation failures of food contamination

5.11 Are packaging processes and materials adequate to prevent contamination

5.12 Are only approved food and/or colour additives used

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

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

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

5.16 Are finished products stored and shipped under conditions which will avoid contamination and deterioration

5.17 (USFDA Specific Requirement)

Frozen raw breaded shrimp/ lightly breaded shrimp

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

5.17.2 Suitable preservatives (ascorbic acid and antioxidant)

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

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

5.18 By product management (EU Requirement)

5.18.1 Documented system for hygienic disposal.

Records?

5.18.2 Includes control over the condition and hygiene

of containers

5.18.3 Practices effectively control cross contamination?

6.0 PERSONNEL

NC PC C COMMENTS

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

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

6.3 Do employees thoroughly wash and sanitize hands as necessary

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

in processing areas



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

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

7.0 SANITATION AND CONTROL PRECEDURE

NC PC C COMMENTS

7.1 Have written sanitation operating procedure and records as below

7.1.1 Water, Ice and steam usage

7.1.2 Cleanliness of food contact surfaces, including utensils, gloves, and outer garments

7.1.3 Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces

7.1.4 Maintenance of hand washing, hand sanitizing, and toilet facilities

7.1.5 Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants

7.1.6 Proper labeling, storage, and use of toxic compounds

7.1.7 Control of employee health conditions

7.1.8 Exclusion of pests from the food plant.

8.0 (EU Specific Seafood Requirement 8.1-8.6)

8.1 Laundry

8.1.1 Contracted or not

8.1.2 Capacity in relationship to the number of employees?

8.1.3 Internal. In good hygienic condition?

8.2 Canning area

8.2.1 Approved retorting equipment & calibrated

8.2.2 Thermal process verification provided

8.2.3 Double Seam control done

8.3 Ice Production

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

8.3.2 Is ice stored in containers designed for this purpose?

8.4 Smoking areas

8.4.1 Separated smoking area with Adequate ventilation

8.5 Salting area

8.5.1 Separated salting area with Adequate drainage



8.6 Laboratory

8.6.1 Separated from processing areas and with controlled access

GENERAL COMMENTS

EVALUATION OF COMPLIANCE

VERIFIERS NAME AND SIGNATURE



Ministry of Health




HACCP IMPLEMENTATION


DATE INSPECTED:

PRODUCT(S):


TEL. NO.: FAX NO. :


INSTRUCTIONS:



1.0 FACILITIES AND PROCESS DESCRIPTION

NC PC C COMMENTS

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

NC PC C COMMENTS

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



NC PC C COMMENTS

3.1 Sensitive consumers identified?

3.2 Instructions given for the distribution, storage and utilisation

4.0 PROCESSING SPECIFICATION

NC PC C COMMENTS

4.1 Flow diagram includes each stage of processing chain

4.2 Flow diagram confirmed

5.0 HAZARD ID AND ANALYSIS

NC PC C COMMENTS

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

NC PC C COMMENTS

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 DE CRITICAL LIMITS

NC PC C COMMENTS

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

NC PC C COMMENTS

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

NC PC C COMMENTS


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

NC PC C COMMENTS


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)

10.6 Review of monitoring record of CCP within 1 week

11.0 DOCUMENTATION AND RECORDS

NC PC C COMMENTS

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

EVALUATION OF COMPLIANCE




Ministry of Health




VERIFICATION HACCP PLAN PERFORMANCE


DATE INSPECTED:

PRODUCT(S):


TEL. NO.: FAX NO. :


INSTRUCTIONS:




OBSERVATIONS 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 responsible (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?

OBSERVATIONS NC PC C Comments

3.4 Verifications activities followed and verifiable?

General comments back page



Evaluation of Compliance




APPENDIX 6

MALAYSIAN CERTIFICATION SCHEME FOR HACCP

CORRECTIVE ACTION REQUEST (CAR)

Audit No: CAR No. Date : 23 JANUARI 2014

Food Premises (FP)

Address/Tel.No

Company representative(s)

Compliance Auditors (CA):

Wan Mohd N

Non-Conformance Report: Observation Minor Major Serious

Applicable

Regulation/Requirement

MS1480:2007, MS1514:2009,

FOOD ACT 1983, FOOD HYGIENE REGULATION 2009

Objective evidence & Location

Potential effect of non-

conformances

Root cause

Signature:

Name:

(Company Representative)

Signature:

Name:

(Auditor/s)

Corrective Action

Completion target date: Signature :...........................

Name :

(Company Representative)

Signature :...........................

Name :

(CA Auditor)

Follow-up audit comments

Date CAR closed out Signature :...........................

Name :

(CA Auditor)



APPENDIX 7

VERIFICATION REPORT

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

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

Compliance (C)3 :

2 Fill up the table below

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



Partial Compliance (PC)4 :

Non-Compliance (NC)5 : :

(b) Reasons for Status of Overall Compliance :

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General Comments/Recommendation:

Signature

Name of Auditor

Position

Date

:

:

:

:

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4 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. 5 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