Criteria for an Acceptable Supplier Quality Assurance Agreement

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Introduction

This document establishes the criteria for an acceptable Supplier Quality Assurance (SQA) agreement between regulated parties and their suppliers. This document is applicable to all parties regulated by the Fish Inspection Regulations. A signed SQA agreement becomes an integral part of the regulated party's quality management program plan.

Scope of a SQA Agreement

For the purposes of the Fish Inspection Program, a SQA is defined as a documented agreement between a party regulated under the Fish Inspection Regulations and a supplier to supply a product or material or to deliver a service in accordance with the conditions as set out in the SQA. The two main components of a SQA agreement are the supplier-based controls and verification of the SQA agreement by the regulated party.

A SQA agreement can be an effective means of control for incoming products or materials (e.g., raw material, ingredients, imported fish products) or delivery of services (e.g., transportation of goods). When such SQA agreements are in place, the regulated party may use the assurances provided by the SQA to make decisions when developing and implementing their quality management program. For example, the frequency of monitoring may be lower or a potential hazard may be deemed not significant because the supplier has procedures, controls and records in place to control the hazard.

Requirements for a SQA Agreement

For a SQA agreement to be successful, a regulated party must develop and implement the following three elements:

  1. a process for determining supplier's suitability as an SQA supplier;
  2. a process for maintaining records and documents associated with the SQA
    agreement; and
  3. procedures to verify the implementation and effectiveness of the SQA.

When a SQA is used to reduce testing frequency or replaces other health and safety monitoring, regulated parties must ensure that suppliers implement controls that are equivalent to Canadian controls for sampling and product testing. When a SQA forms part of the HACCP Plan or is applied to health and safety monitoring, the SQA should be developed consistent with the HACCP principles.

A. Supplier Eligibility

The quality management program must include a description of how the regulated party will determine if a supplier is suitable for an SQA agreement. Regulated parties should use a variety of selection criteria to determine if a supplier is able to comply with the conditions of the SQA and if it has a proven record of compliance.

Suitable examples of selection criteria include using suppliers that:

  • are listed on a foreign country MOU list;
  • are subject to third party audits and can provide audit reports;
  • are certified by a recognized certifying body such as ISO;
  • have records that show a history of providing acceptable products to the Canadian market;
  • have had their products tested by SCC accredited labs with satisfactory results; and
  • have established a cooperative relationship with the regulated party.

Using only one selection criteria is not likely to provide sufficient information to determine eligibility.

B. Documentation and Record Keeping

A SQA agreement must be signed by the regulated party and the supplier to acknowledge that both parties understand and agree on the contents of the SQA.

The documented SQA agreement must include:

  1. the full names, signature and addresses of all parties to the agreement;
  2. the names and positions of the persons responsible for the maintenance of the SQA by both parties;
  3. the scope of the SQA (which input materials or products or services are covered);
  4. the standard applied and specifications of the input material or products, such as microbiological or chemical criteria, labelling requirements or other intrinsic factors such as pH, Aw, etc.;
  5. where applicable, specific production or monitoring procedures which the supplier must have in place;
  6. where applicable, specific analytical tests or inspections which must be conducted, and copies of certificates or records of analysis which must accompany lots;
  7. the verification process in place for the regulated party to verify the effectiveness of the SQA; and
  8. how document version control will be maintained and communicated between parties.

The agreement, records resulting from supplier based controls, verification and corrective action records must be maintained in Canada. As required, these records must be made available to CFIA for the purpose of compliance verification.

C. Verification of Supplier Compliance and Effectiveness of the SQA

The SQA agreement must contain verification procedures conducted by the regulated party, or their representative, to ensure the terms of the SQA are met and are effective. Verification of a SQA agreement must be conducted by a qualified individual.

The SQA document must contain, at a minimum, the following verification information:

  1. the name, qualifications and position of the person responsible for the verification activities;
  2. how the verification will be conducted; and
  3. the frequency of verification activities.

Regulated parties should use a variety of verification tools to assess if the supplier is complying with the conditions of the SQA. Examples of suitable verification activities include:

  • reviewing the suppliers monitoring and verification records;
  • reviewing audit reports produced by third party auditors or foreign country competent authorities;
  • submitting product samples for analysis at an SCC accredited laboratory;
  • on-site verification of activities required by the SQA agreement; and
  • inspecting the product, material or premises for compliance with the standard identified in the SQA.

Where the regulated party concludes that the SQA is not implemented or not effective, immediate action must be taken to prevent the use of non compliant supplies, input materials or final products. The corrective action procedures described in the regulated party's quality management program plan must be initiated to ensure long term corrective actions are implemented and verified.

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

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