QMPI Reference Standard

Table of Contents

1. Purpose
2. Scope
3. Definitions
4. Authorities
5. Reference Standard Requirements
   • Element 1: Licence Holder Responsibilities
   • Element 2: Product Sourcing Plan
   • Element 3: Pre-requisite Plan
   • Element 4: Product Safety Assessment Plan
   • Element 5: Product Compliance Plan
   • Element 6: Verification and Maintenance of the QMPI Plan
   • Element 7: Record and Document Control
6. Template Forms

Appendix A – References
Appendix B – Criteria for an Acceptable Supplier Quality Assurance Agreement
Appendix C – Guidelines for the Use of Electronic Records and Signatures

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1. Purpose

The purpose of this document is to define the regulatory requirements for the documentation and application of a Quality Management Program for holders of a Quality Management Program Import Licence.

2. Scope

This Regulatory Reference Standard is designed for use by QMPI Licence Holders when designing, developing and implementing their Quality Management Program. The contents of this standard are mandatory for all QMPI importers.

This standard is used by CFIA Inspectors to assess a QMPI Licence Holder's compliance when carrying out Regulatory Verification activities.

3. Defintions

Service Provider – A company or person that does not form part of the licence holders organization but is employed or contracted to provide a specified service. Service providers may include, but are not limited to, companies or persons who provide technical advice or expertise, product inspections, laboratory analysis, product storage, brokering or freight forwarding.

Quality Management Program – A fish inspection and control system that includes procedures, inspections and records for the purpose of verifying and documenting the processing of fish and the safety and quality of fish processed in, exported from or imported into Canada.

QMPI Licence Holder – The holder of a QMPI licence issued in accordance with subsection 6.1(1.1) of the Fish Inspection Regulations. An alternative term for QMPI Licence Holder is QMPI importer.

QMPI Reference Standard – The standard that sets out the requirements for the documentation and application of a QMPI Licence Holder's Quality Management Program. The QMPI Reference Standard is consistent with the requirements of the Fish Inspection Regulations.

QMPI Plan – A document describing the controls applied by a QMPI importer to meet the requirements of the Fish Inspection Regulations.

4. Authorities

The authority for the control and inspection of fish is provided by:

• Fish Inspection Act (R.S.C., 1985. c.F-12)
• Fish Inspection Regulations (C.R.C. 1978 c.802, as amended)
• Canadian Food Inspection Agency Fees Notice, Part 16
• Food and Drugs Act and Food and Drug Regulations (as it relates to food)
• Consumer Packaging and Labelling Act and Consumer Packaging and Labelling Regulations (as it relates to food)

The CFIA also takes into consideration the requirements of other Canadian Acts and Regulations applicable to the inspection of food.

5. Reference Standard Requirements

Element 1: Licence Holder Responsibilities

Intent:

Management commitment is critical to being able to successfully develop, implement, and maintain a QMPI plan. To effectively implement a Quality Management Program, management must identify a person responsible for the Quality Management Program and ensure that all personnel performing the functions of the program are qualified for their assigned tasks and responsibilities.

Reference Standard Requirements:

1. Person Responsible [FIR 6.1(3)(e)(i)]

The name, business address, business telephone number, and title of the person responsible for implementing and maintaining the quality management program must be identified.

2. Roles, Responsibilities and Qualifications [FIR 6.1(3)(e)(xii) and 6.6]

The QMPI plan must describe the roles and responsibilities of all persons or service providers assigned functions of the quality management program and identify how they are qualified, experienced or trained to perform each function. Training and qualifications of all persons must be adequate for their assigned role and duties.

Acceptable ways to describe the roles, responsibilities, training and qualifications of persons or service providers includes using a variety of the following tools:

• an organization chart;
• a description of the manager's accountability;
• a description of each person or service provider's responsibilities;
• a record of training or experience acquired by each person or service provider that qualifies the person to perform the designated QMPI activities;
• a record of accreditation or similar recognition by a nationally or internationally recognized academic, food processing or standards organization;
• a written agreement (e.g., Supplier Quality Assurance) for service providers that identifies the responsibilities they are employed to perform.

The QMPI Importer must verify that the laboratory scope of accreditation includes all tests they are requested to perform.

Element 2: Product Sourcing Plan

Intent:

To ensure that safe and compliant fish products are imported, QMPI importers must understand the hazard(s) associated with the product and must source product from producers capable of meeting Canadian standards.

To establish a product verification system that provides confidence in product compliance, QMPI importers must have knowledge of their producers' competencies and compliance history.

Reference Standard Requirements:

1. Supplier and Product Selection [FIR 6(1)(a)]

The QMPI plan must identify the types of products imported and how foreign country suppliers are selected to ensure they are capable of supplying products that meet all applicable Canadian standards and requirements.

Acceptable ways to achieve compliance with this requirement include but are not limited to the following:

• Selecting producers that are regulated by a foreign country competent authority and are identified on a list of eligible exporters of fish products;
• Selecting producers that use an audited HACCP-based system in the production of fish products;
• Establishing a Supplier Quality Assurance program that meets the requirements of the Criteria for an Acceptable Supplier Quality Assurance Agreement document (Appendix B);
• Selecting producers that are subject to third party audits by competent authorities or internationally recognized accreditation or certification bodies;
• Establishing an on-site verification process to confirm that processors are operating so as to produce products compliant with Canadian standards.

Element 3: Pre-requisite Plan

Intent:

Pre-requisites are controls that the QMPI importer must establish before implementing a Quality Management Program. Pre-requisite controls are implemented to ensure that all regulatory requirements are followed and imported lots are identified, controlled and subject to appropriate verification activities. An effective Pre-requisite plan is essential to successfully implement a Quality Management Program.

Reference Standard Requirements:

1. Import Notification [FIR 6(2)(e) and 6(2.1)]

QMPI importers' Import Notification System must ensure that CFIA is provided with accurate information for each shipment imported or to be imported into Canada. The system must ensure that each lot of fish contained in a shipment is identified and that the following information is provided to CFIA before importation or within 48 hours after importation:

1. a description of the product;
2. the quantity;
3. the producer;
4. the country of origin;
5. the place where the fish will be held or stored on its entry into Canada;
6. the name, address and telephone number of the importer as declared to the Canada Border Services Agency (CBSA),
7. the importer's licence number;
8. when applicable, the name, address and telephone number of the importer's agent (e.g., broker) providing the notification.

For consistency, CFIA has developed a Fish Import Notification (FIN) form (CFIA/ACIA 5588) with instructions to be used by all importers of fish products.

2. Product Storage [FIR 6.1(1.1) and 22]

The QMPI importer must describe how they will ensure that storage facilities maintain the fish products under sanitary conditions and at the temperature required for product quality and safety. The storage facility must not be a source of contamination for imported products.

3. Lot Identification and Control [FIR 6.1(3)(e)(iii) and (4)(b)]

To ensure that all lots of imported fish are properly assessed and inspected as required, QMPI importers must describe a system to identify, segregate and control every lot of fish imported. The system must ensure that lots are not released until they are assessed, inspected as necessary and an acceptable inspection result is received.

4. Product Distribution Tracking [FIR 6.1(3)(a)]

QMPI importers must provide a written description of the system used to trace fish to its first destination beyond the control of the importer. For each shipment of fish, the following information must be recorded:

1. the name and address of the person to whom each shipment of fish was shipped from the importer;
2. the date on which the fish was shipped.

The QMPI plan must identify the person responsible for maintaining the product identification and distribution system.

5. Product Non-Compliance Investigation [FIR 6.01(1) and 6.1(3)(b)(b.1)]

QMPI importers must investigate any information received that questions the safety of fish products they have imported. This includes information obtained from any source such as the importers' inspection results, consumer complaints, municipal or provincial health authorities, and the CFIA. The method for investigating complaints and product non-compliance information must be described in the QMPI plan.

The QMP importer must maintain a record of all information received that questions the safety of a fish product they imported.
Complaints and information received questioning the safety of a product must be deemed valid if through the investigation the importer determines:

1. they have or may have imported the product in question;
2. the complaint or information concerns a real or potential illness or injury.

When a complaint or product non-compliance investigation indicates that the health and safety concern is valid, the QMPI importer must take appropriate corrective action and maintain the following records:

1. a description of the information;
2. the date and time it was received;
3. the name, address and telephone number of the informant;
4. the method of investigation and the results obtained;
5. the corrective actions taken;
6. the date and time CFIA was notified.

6. Product Safety Notification [FIR 6.01(2)]

QMPI importers must provide CFIA with the results of an investigation or laboratory analysis that indicates that an imported fish product constitutes a potential hazard to the public within 24hrs. The QMPI plan must identify who will be responsible for contacting CFIA and how this will be performed.

7. Product Inspection Reporting [FIR 6.1(3.2) and 6.5(2)(a)(ii)]

The QMPI plan must indicate how the importer will submit inspection results to CFIA according to the following requirements:

1. all non-health and safety product rejections within 5 days of completing the inspection or analysis;
2. at least every 6 months, a report of all evaluations conducted and the results obtained using the 6 month report template provided by CFIA.

6 month reporting periods are as follows:

• October to March – Due by April 15th
• April to September – Due by October 15th

Note: As per element 3, point 6, Product Safety Notification, QMPI importers must notify CFIA of all product health and safety issues with 24 hours.

Element 4: Product Safety Assessment and Management Plan

Intent:

The QMPI program must ensure that imported fish products are safe and do not constitute a hazard to consumers. To achieve this, QMPI importers must have knowledge of the product hazards, know how they are controlled and must take the appropriate steps to manage the product risk.

Reference Standard Requirements:

1. Process Control Documentation [FIR 6.1(3)(c)(d)]

QMPI importers must identify how they obtain, assess and maintain records of process control documents that meet the Guide - Process Control technical Information.

1. For Canned Fish, the QMPI importer must obtain and maintain records of:
   • the name, address and telephone number of the process authority who developed the thermal process used;
   • the container type, size and specifications, style of pack, species packed and if the thermal process utilized has not been published in scientific literature, recognized by CFIA, the sterilizing value (Fо) of the thermal process;
   • a statement in writing signed by the representative of the process authority that attests that the thermal process results in the production of commercially sterile and safe fish products.
2. For Ready-to-Eat fish, the QMPI importer must obtain and maintain records of:
   • the name, address and telephone number of the person who developed the process used;
   • the container type and size, style of pack, the species packed, the type of process, the description of the process; and
   • a statement in writing signed by the person who developed the process or that person's representative that attests that the process results in the production of safe fish products.

Agreements

Process control documents are not required for canned and ready-to-eat products which are from producers listed under an agreement between Canada and a foreign government through which Canada has access to these process control documents. The table Producers for which the process control documents of canned and ready-to-eat products are not required Producers for which the process control documents of canned and ready-to-eat (RTE) identifies the producers to which this applies.

2. Product Hazard Assessment [FIR 6(1)(a)]

The following product characteristics must be assessed to determine which, if any, potential product safety hazards exist:

1. if the product is a novel food or if a new process was used;
2. the method of production (wild or aquaculture);
3. the species;
4. the processing and preservation method and product end-use (Ready-to-Eat or not)

QMPI importers must describe how they will assess each product imported to determine if the product falls within a Product Risk Group or Species Risk Group as identified in the Product Inspection of Imported Fish document.

Other factors that must be considered during the product hazard analysis are identified in the Product Inspection of Imported Fish document.

3. Product Risk Management [FIR 6(1)(a)]

For each hazard identified in the Product Hazard Assessment, QMPI importers must ensure that controls are in place to prevent or reduce the likelihood of the hazard occurring in the imported product. Example of controls may include (but is not limited to) controls implemented by suppliers as indicated in the Product Sourcing Plan or SQA, sourcing from specific harvest areas and controls identified in process control documents.

In lieu of specific controls, the importer may use other information to demonstrate that a potential hazard is not likely to occur in a specific imported product. Examples of other information may include (but is not limited to) the product's history of compliance or scientific evidence.

Product Risk Management measures must be considered when establishing appropriate testing requirements and frequencies as part of the Product Compliance Plan.

Element 5: Product Compliance Plan

Intent:

The intent of the Product Compliance Plan is to ensure that imported fish meets the minimum requirements for product safety, quality, ingredients, additives, packaging material and labelling.

Reference Standard Requirements:

1. Product Standards and Inspection Plan, [FIR 6.1(3)(e)]

QMPI importers must identify standards and implement inspection activities for each of the following sections:

1. Product safety and quality (including ingredients and additives);
2. Packaging materials;
3. Labelling and code marking.

The following information must be included for each section:

A) The Standard

The standard may be the CFIA standard as set out in the Fish Products Standards and Methods Manual, sections of applicable Regulations, or a standard equivalent or more rigorous than these. The standard must outline the accept/reject criteria which identifies compliance (e.g., sensory standard, micro standard, mercury standard, drug residue tolerances etc.).

A copy of the standard must be included or, when the standard is published by the Government of Canada, it may simply be referenced. In either case, the standard must be readily available in printed or electronic format to those responsible for assessing products.

i. For acceptable product safety and quality, the standard identifies the minimum compliance requirements to ensure that imported fish is not tainted, decomposed or unwholesome and that it meets all applicable sections of the Fish Inspection Regulations for safety and quality.

Ingredients must be documented and acceptable for food use. Ingredient acceptability can be substantiated by several methods including:

• a manufacturer's attestation;
• documentation from a recognised government or non-governmental authority;
• ingredients that are commercially prepared and labelled for food use; or
• results of analysis from an accredited laboratory;

When product additives are used, their identity and concentration must be in compliance with the Food and Drug Regulations. Guidance on additives for fish and fish products for sale in Canada is included on the CFIA Internet site, in the Guide to Additives Permitted in Fish and Fish Products.

ii. For packaging materials, the standard identifies the minimum compliance requirements to ensure that all packaging material is acceptable for food use. All packaging materials must be new, clean and sound and approved for food use. Packaging material must not impart any undesirable chemical or physical substance to the food.

The acceptability of packaging material must be documented. Packaging acceptability can be substantiated by several methods including:

• a manufacturer's attestation;
• documentation from a recognised government or non-governmental authority;
• packaging that is commercially prepared and labelled for food use; or
• packaging material listed on CFIA's Reference Listing of Accepted Construction Materials, Packaging Materials and Non-food Chemical Products;

iii. For labelling and code markings, the standard identifies the minimum compliance requirements to ensure that the labelling and coding of all fish products meets the requirements of the Fish Inspection Regulations and is not false, misleading or deceptive. The standard must also identify requirements to ensure that labelling is legible and includes any species or product specific requirements of the regulations. Labelling required for the safe storage and consumption of the product must also be identified in the standard.

B) The Product Inspection Plan

QMPI importers must develop a Product Inspection Plan to verify that their imported products comply to the standards and meet all applicable regulatory requirements. The Product Inspection Plan must include a minimum frequency of product inspection of 5%, which can be modified to reflect product sourcing controls.

As a minimum the Product Inspection Plan must result in:

1. testing 100% of products on the Mandatory Inspection List (MIL);
2. testing of products on the Enhanced Inspection List (EIL) as per the conditions of the EIL;
3. random testing of other lots at the established frequency.

The QMPI importer must establish product inspection frequencies that are appropriate for each product and supplier. The frequency of inspection must be based on the Product Risk Management measures. Established frequencies of less than 5% must be linked to the Product Sourcing Plan, SQA programs, additional information or other controls that provide reasonable assurances of product compliance. If the importer's Product Inspection Plan requires that an inspection be performed, the importer must ensure the product is tested for all applicable analyses.

The QMPI plan must describe the product sampling procedures that ensure sample collection is random, representative, and performed in a manner that prevents contamination or loss of lot identity.

Inspections performed as part of the Product Inspection Plan must be performed in Canada and must be done by laboratories that are accredited by the Standards Council of Canada (SCC) for the specific analysis.

Once a laboratory has released a sample record of analysis for a lot, the QMPI Importer must not have the samples re-tested or submit subsequent samples for analysis except under the conditions of a re-inspection. Re-inspection of a lot is permitted only when the following conditions have been met:

• the identity of the fish or containers of fish has been preserved,
• the fish or containers of fish do not have in or upon them any poisonous or harmful substance, and
• the fish or containers of fish have not been previously reinspected.

A reinspection decision is final.

2. Controls, Corrective Actions and Records [FIR 6.1(3)(e)]

a) Control Measures

Controls measures describe what procedures or activities a QMPI importer implements when a product is imported to ensure that it meets all the requirements of the QMPI program.

Examples of control measures are activities such as (but not limited to):

• checking that complete and up-to-date process control documents are on file when a canned or ready-to-eat product is imported;
• checking that imported products meet the conditions of the Product Sourcing Plan including Supplier Quality Assurance Agreements;
• control of products throughout the product evaluation and inspection decision making process;
• implementing a process for reviewing product inspection results and making final product release or reject decisions.

b) Corrective Actions

These actions must include both fixing the immediate problem and preventing the problem from happening again. This section must describe how all product not meeting the standard is identified, segregated and dealt with in an appropriate manner (export from Canada, disposal, culled/reworked if appropriate). It must also describe the corrective actions to prevent future importations of non-compliant product.

c) Record-keeping System

This part of the QMPI plan must describe the record keeping system for control measures, inspection results and corrective actions.

The corrective action record must record a description of the product deviation, the standard that was not met, the corrective action taken, the person(s) responsible for the action and the date the action was taken.

A copy of all forms used must be included.

Element 6: Verification and Maintenance of the QMPI Plan

Intent:

The QMPI Plan is a dynamic document. Verification is a systematic and comprehensive approach to ensure continuous maintenance and improvement of the QMPI Plan. The main objective of verification is to confirm that the QMPI meets the needs of the importer in importing a safe, wholesome and fairly traded product.

Reference Standard Requirements:

1. Routine Verification Requirements

QMPI importers must implement a process to verify that the QMPI plan and controls are being implemented a described in the QMPI plan. This section of the QMPI plan must describe how routine verifications will be performed, how often and by whom.

The routine verification activities must include:

1. verifying that all in-house controls are being implemented as designed and are functioning effectively.
2. verifying that service providers are delivering the assigned service(s) and implementing assigned controls as described in the QMPI plan.

Examples of routine verification activities include: conducting visual observations of activities, performing mock recalls and reviewing records of control measure activities, inspection results, corrective actions, and consumer complaints.

If the results of verification activities indicate that controls are not being implemented or are not effective, the QMPI importer must implement corrective actions to fix the immediate problem and prevent re-occurrence. QMPI importers must identify how they will record verification activities and corrective actions (when applicable).

2. Annual Review Requirements [FIR 6.1(3.2)(4)(e)]

The QMPI plan must describe how the QMPI importer assesses all elements of the QMPI plan to determine if the plan is being implemented as written and if it effectively ensures that all QMPI regulatory requirements are being met. To conduct an effective annual review, the QMPI importer must:

1. conduct a review of the written QMPI plan to confirm that the program is complete and reflects the controls necessary for the imported products and foreign country processors. The review must verify that all controls identified in the QMPI plan are still current, complete and accurately reflect what is being implemented;
2. ensure that all aspects of the implementation of the QMPI plan has been verified during the year;
3. carry out corrective actions when verification indicates the program is not implemented or effective and maintain records of annual review activities and corrective actions (if applicable).

3. QMPI Plan Amendments [FIR 6.1(3.2)(4)(d)]

Amendment must be accepted by CFIA prior to implementation.

Element 7: Record and Document Control

Intent:

Records must be maintained to ensure they are easily accessible for review when required.

Reference Standard Requirement:

1. Location of Records [FIR 6.1(3)(e)(ii)]

QMPI importers must identify in their QMPI plan the address in Canada where all records and documents relevant to the QMPI program are maintained. All records must be maintained at one location.

2. Record and Document Maintenance [FIR 6.1(3)]

Copies of all the records (e.g., blank examples) described in the QMPI plan including control measures, verification, corrective action and personnel training records must be included in the QMPI plan documentation.

Records must remain up-to-date, legible, readily identifiable and retrievable. Records must be maintained in a manner which is secure and protects the integrity of the record.

When electronic records are used, specific controls must be developed to control the creation and maintenance of electronic records and electronic signatures. Guidelines for the use of electronic records and signatures are included in Appendix C of this document.

6. Template Forms

1. Fish Import Notification Form (CFIA/ACIA 5588) and Instructions
2. Template 6 month report form
3. Mandatory Inspection List (MIL) update form (CFIA/ACIA 5467)

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Appendix A

References

The following reference tools and documents are useful to QMPI licence holders when developing a program to comply with this standard:

A.1 Fish Inspection Regulations
A.2 Food and Drugs Act and Food and Drug Regulations
A.3 Canadian Regulatory Requirements for Quality Management Program Import Licence Holders
A.4 Guide - Process Control Technical Information
A.5 Product Inspection of Imported Fish
A.6 Fish Products Standards and Methods Manual
A.7 Guide to Additives Permitted in Fish and Fish Products
A.8 Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products
A.9 Questions and Answers – Fish Import Program
A.10 Standards Council of Canada

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Appendix B

Criteria for an Acceptable Supplier Quality Assurance Agreement

See Criteria for an Acceptable Supplier Quality Assurance Agreement.

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Appendix C

Guidelines for the Use of Electronic Records and Signatures

Electronic Records

When QMPI records are created and/or stored using microprocessor technology, these electronic systems can be classified as "open" or "closed" systems. A closed system is an environment where the system access is controlled by the persons who are responsible for the content of the electronic records on the system. An open system is an environment in which the system access is not controlled by the persons who are responsible for the content of the electronic record on the system. For example, an importer has purchased off-the-shelf software to record and store data, and generate reports of product inspection results. If the importer does not have access to the data storage files generated by the software, this system is considered closed. If the importer has access to the content of those data files generated by the software the system is considered open. The distinction between open and closed governs who is responsible for implementing controls to ensure the authenticity and integrity of electronic records. If the system is closed then the software manufacturer is responsible, otherwise the importer is responsible.

When importers use electronic records in place of paper records required for QMPI, they must develop and implement additional controls to demonstrate the reliability of the electronic records.

Importers should be able to demonstrate compliance with the following requirements:

1. Documentation of the computer system operation, maintenance, and modifications is part of the QMPI Plan.
2. Computer systems are validated to ensure their accuracy, reliability, consistency and ability to discern invalid or altered records.
3. Computer systems are able to generate accurate and complete copies of records in a readable text format for inspection purposes.
4. Computer systems contain an adequate means to protect records for accurate and timely retrieval throughout the record retention period. This may include systems to maintain appropriate backup records.
5. Computer systems limit record access to authorised individuals.
6. Computer systems have a rigorous security protocol to ensure that only authorised individuals can use the system, electronically sign a record, access the operation or computer system, alter a record, or perform operations.
7. Management establishes and implements policy that holds individuals responsible and accountable for data recorded and/or actions taken under their electronic signatures.

Electronic Signatures

When a QMPI record is made it should be signed or initialled by the responsible party. Similarly, when an electronic record is created, the computer systems will require identification of the person who created the record, this identification is called the "electronic signature".

When electronic signatures are used in association with QMPI records, the following characteristics should be associated with the electronic signature:

1. The electronic signature contains a unique identifier for the signer, the date and time of signing.
2. The electronic signature is clearly linked with one (or more) electronic record(s).
3. Controls are in place to ensure that electronic signatures and their links to records cannot be removed, copied, or otherwise manipulated.
4. Each electronic signature is unique to only one individual and is not re-used or re-assigned at any time.
5. Identity of persons authorised to use electronic signatures are documented in the QMPI Plan.
   

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Document Type: Regulatory Standard / Status: Version 1
Date: April 1, 2009 / Review Date: March 31, 2010