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Operational procedure: Evaluating a supplier food safety assurance program

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1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) staff on the assessment of a regulated party's Supplier Food Safety Assurance Program (SFSAP) for the control of incoming ingredients, materials and non-food chemicals provided through a Supplier Agreement (SA).

An SFSAP and SA's are not mandatory requirements under the Safe Food for Canadians Regulations (SFCR). However, if a regulated party's Preventive Control Plan (PCP) indicates that SA's are used as a control measure, then the SFSAP governing the SA's is to be assessed as part of the PCP.

The procedures outlined below should be used when an assessment of the SFSAP is required. This could be during a preventive control inspection (PCI), as part of a food safety investigation or follow-up to a complaint.

This document is intended to be used in conjunction with other guidance documents as referenced in Section 3.0 of this document.

2.0 Authorities

3.0 Reference documents

4.0 Definitions

Unless specified below, definitions are located in either the:

Supplier
means a person who supplies ingredients, materials and non-food chemicals to a regulated party.
Supplier Agreement (SA)
means a documented agreement between a regulated party and a supplier for incoming ingredients, materials and non-food chemicals to the regulated party. An SA may also be referred to, by industry, as Supplier Quality Assurance (SQA) agreements.

5.0 Acronyms

Acronyms are spelled out the first time they are used in this document and are consolidated in the Food business line acronyms list.

6.0 Operational guideline

An assessment of a regulated party's SFSAP consists of two main components: a review of the regulated party's written procedures for SA's and an on-site inspection (observation, interviews and sampling as required) of incoming ingredients, materials or non-food chemicals. Refer to sub-sections 4.4.1 to 4.4.4 of the Standard Inspection Process (SIP) for further details on how to conduct an inspection.

6.1 Documented procedures / Written program review

6.1.1 Written Program

6.1.1.1 Verify that the regulated party has written procedures for establishing and entering into SA's with suppliers of incoming ingredients, materials or non-food chemicals that are used in, or have a direct impact on, a food commodity, a prescribed activity, or a food processing environment.

Note

The SFSAP may be included in, or be a part of, the regulated party's PCP or be part of another written food quality program.

6.1.1.2 Review the written procedures and verify that they contain the following elements:

Each of these elements will be evaluated individually in subsequent steps (See 6.1.2 – 6.1.8 below).

Note

The Checklist in Appendix 2 may be used as an aid in inspection / assessment of the Supplier Food Safety Assessment Program

6.1.2 Ingredient, material and non-food chemical specifications

6.1.2.1 Verify that, for each ingredient, material or non-food chemical received through an SA, the written program:

6.1.2.2 Verify that the specifications established under step 6.1.2.1 include:

Note

See "Product specifications" section of the industry guidance document: "Supplier Food Safety Assurance Program".

6.1.3 Supplier selection

6.1.3.1 Verify that the written program:

6.1.3.2 Verify that only suppliers that meet the minimum assessment criteria and requirements of section 6.1.3.1 are selected as suppliers under an SA.

Note

See "Supplier selection" section of the industry guidance document: "Supplier Food Safety Assurance Program".

6.1.4 Supplier agreement (SA)

6.1.4.1 Verify that the written program includes procedures for documenting the agreements made between the supplier and the regulated party, such as, what needs to be included in an SA.

6.1.4.2 Verify, from a representative sample of records, that the SA on file include the following information:

6.1.4.3 Verify that each SA is signed and dated by the regulated party and the supplier to acknowledge that both parties agree to the contents of the Agreement.

6.1.5 List of suppliers

6.1.5.1 Verify that the regulated party maintains a list of all suppliers operating under an SA which should include:

6.1.5.2 Verify that the list is up-to-date and amendments are made as required (such as, new suppliers added when selected, suppliers removed when agreements expire, etc.)

6.1.6 Regulated party's verification of the SFSAP

6.1.6.1 Verify that the written program includes procedures for the assessment of the effectiveness of Supplier Agreements (such as, verification that suppliers and the ingredients, materials or non-food chemicals they provide conform to specifications / requirements of the SA and comply with Canadian food legislation).

6.1.6.2 Verify that the verification procedures referred to in section 6.1.6.1 include:

Note

See "Verification of the SFSAP" section of the industry guidance document: "Supplier Food Safety Assurance Program".

6.1.6.3 Verify, through a representative sample of records, that:

6.1.7 Maintenance of the SFSAP

6.1.7.1 Verify that the written program includes procedures for regular maintenance and updating.

6.1.7.2 Verify that the written program includes deviation procedures for the development and implementation of corrective action when issues are identified. These procedures may be set out in the SFSAP or in the regulated party's PCP.

Note

See "Maintenance of the SFSAP and supplier agreements" section of the industry guidance document: "Supplier Food Safety Assurance Program".

6.1.8 Records

6.1.8.1 Verify that the written program identifies the records which will be kept in relation to SA's, where they will be located, and how long they will be retained.

For example, these records could include:

6.2 On-site ingredient, material and non-food chemical inspection

6.2.1 Selection of ingredient, material or non-food chemical for inspection

6.2.1.1 Select at least one incoming ingredient, material or non-food chemical (for example, ingredient, additive, label, etc.) for assessment against requirements of the SA and Canadian food legislation.

6.2.1.2 If possible, select incoming ingredient, material or non-food chemical, or a supplier that has not been selected before. Any new suppliers or a change in incoming ingredients, materials or non-food chemicals should also be considered for selection.

6.2.2 Documentation / record review

6.2.2.1 For the ingredient, material or non-food chemical selected, verify that all the necessary SA documentation is in place for that specific ingredient, material or non-food chemical:

6.2.2.2 Review records referred to in section 6.2.2.1; verify that records are complete and accurate, and specified frequencies are met.

6.2.3 Ingredient, material or non-food chemical inspection or observation

6.2.3.1 If possible, conduct an on-site inspection of the ingredient, material or non-food chemical selected which could include:

Verify that the regulated party and employees are following procedures set out in the written program and the SA.

6.3 Determining compliance

6.3.1 Compliance decision

6.3.1.1 Based on observations from the documentation review and on-site inspection (as per steps 6.1 and 6.2) determine if the operator has control over sourcing ingredients, materials and non-food chemicals such that they are suitable for their intended use and do not become a source of contamination for food or the food processing environment. For example, incoming ingredients, materials or non-food chemicals meet SA specifications, meet outcome and performance criteria of Preventive Control (PC) Sub-element 1.1a Incoming Inputs and, in turn, meet regulatory requirements (SFCA and SFCR, FDA and FDR). Refer to sections 4.6 and 4.7 of the SIP for further direction on determining compliance.

For general inquiries related to this Operational Guidance Document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).

7.0 Appendices

Appendix 1 - Information that should be contained in Certificate of Analysis (COA), letter of Continuing Guarantee (LOCG) or equivalent document

A COA or equivalent document should include the following:

An LOCG or equivalent document should include the following information:

Note

LOCG's are more generic / broader in nature than COA's. LOCG's are not intended for a specific lot or shipment of ingredients, materials or non-food chemicals; nor based on specific testing or analysis of individual lots or shipments. Rather LOCG's are based on a more in-depth evaluation / assessment / or validation of an ingredient, material or non-food chemical over time (for example, chemical leaching or migration data; chemical and physical characteristics; approval by Health Canada or other jurisdictions – for example, United States of America, Australia or New Zealand, etc.).

Appendix 2 - SFSAP Checklist

This checklist serves to guide the inspectorate when reviewing a Supplier Food Safety Assurance Program. It is not required that all boxes be checked off to conclude that the regulated party's program is adequate. But, may be used to help determine if their overall controls for incoming ingredients, materials or non-food chemicals under a SFSAP are adequate.

Completing the checklist is optional.

Documented procedures / Written program review

Written program
Ingredient, material or non-food chemical specifications
Supplier selection
Supplier Agreement (SA)
List of suppliers
Regulated party's verification of the SFSAP
Maintenance of the SFSAP
Records

On-site ingredient, material and non-food chemical inspection

Selection of ingredient, material or non-food chemical for inspection
Documentation / record review
Ingredient, material or non-food chemical inspection or observation

Determining compliance

Compliance decision
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