Operational procedure: Evaluating a supplier food safety assurance program
On this page
- 1.0 Purpose
- 2.0 Authorities
- 3.0 Reference documents
- 4.0 Definitions
- 5.0 Acronyms
- 6.0 Operational guideline
- 6.1 Documented procedures / Written program review
- 6.1.1 Written program
- 6.1.2 Ingredient, material and non-food chemical specifications
- 6.1.3 Supplier selection
- 6.1.4 Supplier Agreement (SA)
- 6.1.5 List of suppliers
- 6.1.6 Regulated party's verification of the Supplier Food Safety Assurance Program (SFSAP)
- 6.1.7 Maintenance of the SFSAP
- 6.1.8 Records
- 6.2 On-site ingredient, material and non-food chemical inspection
- 6.3 Determining compliance
- 6.1 Documented procedures / Written program review
- 7.0 Appendices
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
- Safe Food for Canadians Act (SFCA)
- Safe Food for Canadians Regulations (SFCR)
- Food and Drugs Act (FDA)
- Food and Drug Regulations (FDR)
3.0 Reference documents
- Industry guidance - Incoming ingredients, materials and non-food chemicals
- Industry guidance - Supplier Food Safety Assurance Program
- Standard Inspection Process (SIP)
- Food preventive control and traceability inspection – Compliance verification of a system
4.0 Definitions
Unless specified below, definitions are located in either the:
- Integrated Agency Inspection Model (iAIM) - Glossary of terms (Annex F)
- My CFIA Glossary of terms
- Safe Food for Canadians Regulations - Glossary of key terms
- 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:
- specifications for incoming ingredients, materials or non-food chemicals received through SA's
- a supplier approval process for determining the suitability or acceptability of a specific supplier
- a documented and signed SA between the supplier and the regulated party
- a master list of all suppliers that provide ingredients, materials or non-food chemicals to the regulated party under an SA
- verification procedures to assess the effectiveness of SA's
- procedures for the regular maintenance of SA's and the SFSAP including deviation procedures and corrective actions when issues are identified, and
- records
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:
- identifies and establishes food safety specifications or requirements, and acceptance or rejection criteria
- in addition to food safety specifications, identifies regulatory, functional, technical or operational requirements or criteria
6.1.2.2 Verify that the specifications established under step 6.1.2.1 include:
- name / identification of the ingredients, materials or non-food chemicals received
- description of the ingredients, materials or non-food chemicals received
- specifications, criteria or requirements for the ingredients, materials or non-food chemicals, for example:
- supplier uses approved or acceptable agricultural chemicals, non-food chemicals, pest-control products and other materials
- supplier uses approved or acceptable procedures (for example, manufacturing or production methods, lab methodologies, calibration methods)
- date and signature of person responsible for maintaining the specifications document
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:
- establishes minimum criteria that suppliers must meet for consideration under an SA
- includes a description of how potential suppliers are assessed and selected for an SA
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:
- the full names and addresses of both parties to the agreement
- names and positions of the persons of all parties responsible for maintenance of the Agreement
- scope of the Agreement (which ingredients, materials or non-food chemicals are covered)
- specifications that must be met (refer to section 6.1.2)
- terms and conditions that the supplier is expected to meet, including ongoing assurance that ingredients, materials or non-food chemicals meet specifications or requirements through Certificates of Analysis (COA's), Letters of Continuing Guarantee (LOCG's), Letters of No-Objection (LONO's) from Health Canada or other similar documents (see Appendix 1 for further information on COA's and LOCG's)
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:
- information on the supplier and on the ingredient(s), material(s) or non-food chemical(s) provided as required
- date and signature of person responsible for maintaining the list
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:
- the name or position of the person responsible for carrying out the verification
- the frequency that verification activities will be carried out
- the activities that will be carried out to perform the verification
- the procedures that will be used to complete the verification activities
- Identification of the records and documents that will be maintained
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:
- verification procedures are being implemented as intended and are effective
- appropriate actions are being taken when the supplier, ingredient(s), material(s) or non-food chemical(s) do not meet specifications of the SA or do not comply with Canadian legislation (See section 6.1.7.2)
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:
- supplier approval lists
- ingredient, material or non-food chemical specifications
- SA between supplier and the regulated party
- Certificates of Analysis (COA's) and Letters of Continuing Guarantee (LOCG's), Letters of No-Objection (LONO's) or other equivalent documents
- verification records
- deviations and corrective action records
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:
- supplier is on the regulated party's List of suppliers operating under an SA
- regulated party has specifications, criteria or requirements for the ingredient, material or non-food chemical
- regulated party has a current SA for the ingredient, material or non-food chemical which is signed and dated by both parties
- if identified as terms and conditions of the SA, regulated party has a COA, LOCG or LONO from Health Canada on file for the selected ingredient, material or non-food chemical lot or shipment; or other documentation related to analysis or assurance, as described in the SA (see Appendix 1 for further information on COA's and LOCG's)
- regulated party has records for verification of the supplier, ingredient, material or non-food chemical (supplier inspection/audit, food product or input sampling, etc.)
- regulated party has a record of any deviation issues, appropriate follow-up and corrective actions
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:
- visual inspection of incoming ingredients, materials or non-food chemicals in storage
- interview of employees responsible for implementation of the SFSAP
- interview of employees responsible for verifying ingredient, material or non-food chemical SA controls
- sampling and analysis or appropriate testing (such as, temperature) of ingredient, material or non-food chemical
- observation of employees completing documentation
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:
- name and address of the supplier
- name and address of the manufacturer / producer of the ingredient, material or non-food chemical, if not the same as the supplier (for example, foreign ingredient provided by a broker / distributer)
- name of the ingredient, material or non-food chemical
- ingredient, material or non-food chemical identification - lot number(s) or lot code(s) for traceability purposes
- testing or analysis that was performed (including methodologies used) and results obtained
- name and address of person that performed the testing / analysis (for example, accredited lab)
- confirmation that test results meet acceptance criteria
- confirmation that the ingredient, material or non-food chemical meets specification and requirements set out in the SA
- signed and dated by the person certifying the results
An LOCG or equivalent document should include the following information:
- name and address of the supplier
- name of the ingredient, material or non-food chemical provided
- intended use or application of the ingredient, material or non-food chemical and conditions under which the ingredient, material or non-food chemical is to be used, applied, or delivered
- any precautions for the use, application or delivery of the ingredient, material or non-food chemical
- a statement / commitment from the supplier that the ingredient, material or non-food chemical is not adulterated or contaminated and meets specifications or requirements of the SA and Canadian food legislation (SFCA and SFCR; FDA and FDR)
- a commitment from the supplier that the LOCG or equivalent document will be reviewed and updated on at least an annual basis, or anytime there is a change to the ingredient, material or non-food chemical provided
- signed and dated by the supplier
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
- Box regulated party has written procedures for establishing and entering into supplier agreement (SA) with suppliers of incoming ingredients, materials or non-food chemicals
Ingredient, material or non-food chemical specifications
- Box food safety specifications or requirements, and acceptance or rejection criteria identified for each ingredient, material or non-food chemical
- Box regulatory, functional, technical or operational requirements or criteria identified for each ingredient, material or non-food chemical
- Box specifications also include:
- Box name / identification of ingredient, material or non-food chemical
- Box description of ingredient, material or non-food chemical
- Box requirements of the supplier (for example use of approved materials, approved or acceptable procedures, methodologies, etc.)
- Box date and signature of person maintaining specifications
Supplier selection
- Box minimum criteria established for suppliers providing ingredients, materials and non-food chemicals under an SA
- Box description of how potential suppliers are assessed and selected for an SA
- Box only suppliers that meet minimum assessment criteria and requirements are selected as suppliers under an SA
Supplier Agreement (SA)
- Box procedures for documenting agreements made between the supplier and the regulated party (that is to say, what needs to be included in an SA)
- Box from a representative sample of records, SA's on file include the following information:
- Box full names and addresses of both parties to the agreement
- Box names and positions of the persons of all parties responsible for maintenance of the Agreement
- Box scope of the Agreement (which ingredients, materials or non-food chemicals are covered)
- Box specifications that must be met
- Box terms and conditions that the supplier is expected to meet, including ongoing assurance that ingredients, materials or non-food chemicals meet specifications or requirements through Certificates of Analysis (COA's), Letters of Continuing Guarantee (LOCG's), or other similar documents
- Box each SA is signed and dated by the regulated party and the supplier
List of suppliers
- Box regulated party maintains a list of all suppliers operating under an SA which includes:
- Box information on the supplier and on the ingredient(s), material(s) or non-food chemical(s) provided as required
- Box date and signature of person responsible for maintaining the list
- Box list is up-to-date and amendments are made as required (for example new suppliers added when selected, removed when agreements expire)
Regulated party's verification of the SFSAP
- Box procedures for the assessment of the effectiveness of Supplier Agreements (for example verification that suppliers and the ingredients, materials or non-food chemicals conform to specifications / requirements of the SA and comply with Canadian food legislation)
- Box verification procedures include:
- Box name or position of the person responsible for carrying out the verification
- Box frequency that verification activities will be carried out
- Box activities that will be carried out to perform the verification
- Box procedures that will be used to complete the verification activities
- Box Identification of the records and documents that will be maintained
- Box from a representative sample of records, records demonstrate that:
- Box verification procedures are being implemented as intended and are effective
- Box appropriate actions are being taken when the supplier, ingredient(s), material(s) or non-food chemical(s) do not meet specifications of the SA or do not comply with Canadian legislation
Maintenance of the SFSAP
- Box procedures for regular maintenance and updating of written program
- Box includes deviation procedures for the development and implementation of corrective action when issues are identified
Records
- Box identifies records to be kept in relation to SA's, where they are located, and how long they will be retained
On-site ingredient, material and non-food chemical inspection
Selection of ingredient, material or non-food chemical for inspection
- Box select incoming ingredient, material or non-food chemical for assessment against requirements of the SA and Canadian food legislation
- Box select an 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
Documentation / record review
- Box all the necessary SA documentation is in place for the ingredient, material or non-food chemical selected:
- Box supplier is on the regulated party's List of suppliers operating under an SA
- Box regulated party has specifications, criteria or requirements for the ingredient, material or non-food chemical
- Box regulated party has a current SA for the ingredient, material or non-food chemical which is signed and dated by both parties
- Box if identified as terms and conditions of the SA, regulated party has a COA on file for the selected ingredient, material or non-food chemical lot or shipment; has a LOCG on file for the ingredient, material or non-food chemical; or other documentation related to analysis or assurance, as described in the SA
- Box regulated party has records for verification of the supplier, ingredient, material or non-food chemical (supplier inspection/audit, ingredient sampling, etc.)
- Box regulated party has a record of any deviation issues, appropriate follow-up and corrective actions
- Box records are complete and accurate, and specified frequencies are met
Ingredient, material or non-food chemical inspection or observation
- Box conduct an on-site inspection of an ingredient, material or non-food chemical which could include:
- Box visual inspection of incoming ingredients, materials or non-food chemicals in storage
- Box interview employees responsible for implementation of the SFSAP
- Box interview employees responsible for verifying ingredient, material or non-food chemical SA controls
- Box conduct sampling and analysis or appropriate testing (such as, temperature) of ingredient, material or non-food chemical
- Box observe employees completing documentation
- Box regulated party, employees are following procedures set out in the written program and the SA
Determining compliance
Compliance decision
- Box based on observations from the documentation review and on-site inspection determine if ingredients, materials or non-food chemicals meet SA specifications, PCP performance criteria and outcomes and, in turn, meet regulatory requirements (SFCA and SFCR, FDA and FDR)
- Date modified: