Operational guideline: Inspection of evidence showing that control measures are effective

On this page

• 1.0 Purpose
• 2.0 Authorities
• 3.0 Reference documents
• 4.0 Definitions
• 5.0 Acronyms
• 6.0 Operational procedure
  • 6.1 Determine the depth of inspection activities required
  • 6.2 Verify that the source of the evidence of effectiveness is specified
  • 6.3 Verify that the validation study shows that an alternative control measure is effective
  • 6.4 Seek subject matter expertise as required
  • 6.5 Verify that the control measures are implemented and effective
  • 6.6 Complete the inspection case
• 7.0 Appendices
  • Appendix 1 – Verification of validation checklist

1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on the process to follow and inspection activities to perform when verifying if the control measures used by a food business are effective.

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

The guidance outlined below should be used when, in the course of an inspection of a preventive control plan, the inspectorate is verifying that validated control measures are being applied.

2.0 Authorities

• Safe Food for Canadians Act (SFCA)
• Safe Food for Canadians Regulations (SFCR)

3.0 Reference documents

• Cleaning and sanitation program
• Compliance verification system – Verification task procedure
• Evidence showing a control measure is effective
• Operational guideline – Food regulatory response guidelines
• Preventive controls for food businesses
• Standard inspection procedures (SIP) overview
• Standard regulatory response process (SRRP) overview

4.0 Definitions

Unless specified below, definitions are located in either the:

• Safe Food for Canadians Regulations: Glossary of key terms
• Integrated Agency Inspection Model (iAIM): Glossary of terms (Annex F)
• My CFIA glossary of terms

Quantitative

Expressible in terms of quantity; involving the measurement of quantity or amount.

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 guidance

Control measures recognized in an industry guidance^Footnote 1 document published by the Canadian Food Inspection Agency (CFIA) are considered to have already been validated as effective (pre-validated control measure) when used by a food business under the same conditions as described in the guidance. However, when new or alternative control measures are used, the food business must validate that these control measures are effective. The industry guidance document Evidence showing a control measure is effective provides guidance to industry on the regulatory requirements for validating control measures and how to gather and document the evidence. The industry guidance should be consulted when carrying out inspection activities to assess if a food business is using validated control measures.

6.1 Determine the depth of inspection activities required

The nature of the control measure and the source of the evidence determines the depth of inspection required to verify that a food business is using effective control measures and is in compliance with SFCR 47(2) and SFCR 89(1)(c)(i) and (ii). Consistent with a risk-based approach, more in-depth inspection is required for control measures targeting significant hazards and when a control measure has not been previously validated. Conversely, evidence for hygiene-based control measures (based on good hygienic practices) does not require such in-depth review because those practices are already known to be effective. Table 1 describes the inspection activities to conduct depending on the nature of the control measure.

Once the type of control measure and depth of inspection activities have been determined, proceed with the relevant activities by applying the processes described below.

6.2 Verify that the source of the evidence of effectiveness is specified

When the review conducted in step 6.1 indicates to verify that the source of the evidence is specified, verify that the evidence identifies:

1. the food item(s) being subjected to the control measure
2. the control measure being applied (for example, what type of process, the processing parameter, at what point in production it is applied to the product)
3. the source of the evidence (for example, CFIA, Codex Alimentarius Committee, a process authority, in-house personnel)

As per SFCR 89(1)(c)(i) and (ii), if a food business is required to prepare, keep and maintain a preventive control plan (PCP), the evidence that the control measure is effective must be documented in the plan. Although some food businesses are exempt from the requirement to prepare, keep and maintain a PCP, they must still comply with the requirements of SFCR 47(2) which requires all food businesses to use control measures shown by evidence to be effective.

Compare the evidence to other information available concerning the product (for example, product description in the PCP, copy of the label) and controls (for example, production records, process description). Use Table 2 to determine if the source of the evidence is properly specified.

6.3 Verify that the validation study shows that an alternative control measure is effective

When the review conducted in step 6.1 indicates to verify that the validation study shows that the alternative control measure is effective, verify that:

• the validation documentation contains all information required according to the industry guidance: Evidence showing a control measure is effective, or
• if the food business used guidance from another acceptable source (that is, provincial governments, industry associations, international partners, or academic) to guide their validation exercise, the validation documentation contains the information identified in that guidance

Use the Verification of validation checklist in Appendix 1 as a tool to guide the inspection of the documentation. The checklist does not need to be completed or maintained as a record for each inspection; however, it may prove useful to help identify potential gaps in the evidence or questions to ask of subject matter experts, if required.

6.4 Seek subject matter expertise as required

After reviewing the validation information for a control measure, consult subject matter experts if support is required to determine compliance. In particular, seek subject matter expertise from the Operational Guidance and Expertise (OGE) Division when evaluating validation information for any new or alternative control measures designed to address a specific hazard.

When seeking advice from subject matter experts, first identify any potential issues and missing information as well as any specific questions for which guidance is required. To seek subject matter expertise, use the established communication channels to submit an electronic Request for Action Form (e-RAF) that includes, where possible, the information identified on the checklist in Appendix 1.

6.5 Verify that the control measures are implemented and effective

Within the scope of a PCP inspection, review available documentation, including monitoring and verification records for CCPs, and carry out other inspection activities to assess if:

1. the food business is implementing each control measure in a manner that is consistent with the validation information (or more stringent than the validation); and
2. the control measure, as implemented, is effective in meeting the required outcome and performance criteria

Use Table 3 to identify the provision of SFCR to which a non-compliance may exist.

If inspection activities indicate a potential non-compliance with the implementation or effectiveness of a control measure, conduct follow-up activities as described in the Standard inspection procedure (SIP) or Compliance Verification System (CVS) as applicable. If food was produced using control measures that were not effective, conduct additional inspection or control activities (for example, product recall or seizure and detention) to verify product safety and mitigate risks to consumers. Consult the Standard regulatory response process and the Operational guideline – Food regulatory response guidelines to identify and initiate control actions as required.

6.6 Complete the inspection case

Record the inspection results for evidence of effectiveness of a control measure in the appropriate data system and in accordance with the SIP or CVS.

7.0 Appendix

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

Appendix 1 – Verification of validation checklist

This checklist serves to guide the inspectorate when reviewing validation information. It is not required that all boxes be checked off to conclude that the validation study is adequate; in fact, it is highly unlikely that any one study would include all the options included below.

Although the information is presented in a checklist format with spaces for notes, completing the checklist is optional. However, inspection staff is encouraged to use this tool to help formulate questions or comments when seeking subject matter expertise from the OGE.

1. Confirm the type and depth of evidence needed for the control measure:

   Q1. Is the control measure designed to have a quantitative effect on a specific hazard?

   Box No – these are generally hygiene-based control measures that do not require in-depth validation studies. They must still be effective based on literature search or in-house observations/data. Inspection activities should focus on effective implementation to meet the required outcome. Further consideration of the questions below is not required.

   Box Yes – these are controls for significant hazards. Refer to Q2.

   Q2. Is the control measure based on pre-validated control measures such as:

   Box CFIA guidance document,

   Box publications issued by provincial, national or international governments,

   Box scientific publications, and/or

   Box recommendations from the manufacturer of a processing equipment or packaging material?

   Box Yes, pre-validated by at least one source listed – refer to Q3

   Box No, not pre-validate by any of the sources listed above – This control measure is likely a new or alternative control measure. Refer to part B.

   Q3. Does the documentation (for example: preventive control plan) specify the source of the reference?

   Box Yes – Refer to Q4.

   Box No – the documentation does not adequately demonstrate that the control measure is effective. Unless additional evidence of effectiveness is available, a non-compliance to SFCR 47(2) and/or 89(1)(c)(i) or (ii) may be determined without further assessment.

   Q4. Are the conditions for application of the pre-validated control measure the same in practice as in the specified reference? For example: applied to the same type of product and processing method for which it was designed.

   Box Yes – the documentation is adequate. Inspector may still need to inspect to confirm that the operator is implementing the control measure effectively. However, a more in-depth review of the documented evidence is not required.

   Box No – the documentation may not adequately demonstrate compliance to the requirements for evidence that the control measure is effective. Unless additional evidence of effectiveness is available, a non-compliance to SFCR 47 (2) and/or 89(1)(c)(i) or (ii) may be determined without further assessment.

2. Review of validation documentation for new or alternative control measures:

   Q1. Type of approach: what type of approach does the operator use to obtain evidence that the control measure is effective?

   Box Literature review

   Box Collection of data

   Box Challenge studies

   Box Predictive modelling

   Box Surveys

   Notes:

   Q2. Study design: does the study identify the specific control measure that is being validated?

   Box Yes

   Box No

   Q3. Study design: does the validation study define any of the following parameters/criteria?

   Box Yes

   Box the parameters (for example, internal temperature, pressure, pH, concentration level or fill weight)

   Box the acceptance criteria

   Box the acceptable variability

   Box the limit of precision or confidence level (for example, the ability of a metal detector to detect metal fragments greater than or equal to 0.5 mm at a 95% confidence level)

   Box No

   Q4. Study design: who performed or contributed to the validation study?

   Box In-house

   Box Professional process authority

   Box Accredited laboratory

   Box Academic institution

   Box Other third-party consultant

   Notes:

   Q5: Study design: does the validation documentation identify how each person is qualified or competent for their role in the study?

   Box Yes

   Box No

   Notes:

   Q6. Study methodologies: does the documentation include the following details about the study?

   Box Yes

   Box study start and completion dates

   Box equipment used

   Box type of data collected, such as time, temperature, humidity, moisture content and/or specific microorganisms identified.

   Box statistically based sampling plan, if applicable

   Box test methodology, why the method was selected for the specific food commodity and control measure, the laboratory that conducted the testing and its qualifications

   Box method selected for analyzing study results

   Box reference to challenge study guidelines, as applicable.

   Box No

   Q7. Analysis of results: which of the following are analyzed to support the findings in the validation study?

   Box All of the scientific, technical and observational information and results from the study, including, as applicable:

   Box process records

   Box test results

   Box certificates of analysis

   Q8. Analysis of results: does the analysis in the validation study show that the hazard is consistently addressed and makes a conclusion regarding the effectiveness of the control measure?

   Box Yes

   Box No

   Notes:

   Q9. Analysis of results: is the analysis based on the worst case scenario?

   Box Yes

   Box No

   Notes: