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Evidence showing a control measure is effective

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements are being phased in over the following 12 to 30 months. For more information, refer to the SFCR timelines.

Introduction

As a food business operator, describing the control measures you put in place to address each hazard identified in your hazard analysis is an essential part of your food safety system. Equally important is having solid evidence to show that your control measures are actually effective in controlling the hazards. This is often referred to as validation. There are a range of approaches that can be used to obtain such evidence so that you can be confident you are using validated measures. Generally the type and depth of evidence you need will be proportional to the level of risk associated with the hazard(s) being controlled. If your business has a HACCP-based plan implemented, you may already have completed the process to gather this evidence.

Purpose

The Canadian Food Inspection Agency (CFIA) created this document as guidance to help food businesses comply with the requirements of the Safe Food for Canadians Regulations.

It's your choice

You may use other guidance that has been developed by provincial governments, industry associations, international partners, or academic. Always ensure that the guidance you choose is relevant for your particular business, product or products, and market requirements.

What is included

This document outlines the general principles and steps of the process to gather and document evidence that control measures used are validated. The information is based on the Codex Alimentarius document Guidelines for the validation of food safety control measures - PDF (222 kb).

Refer to the Tell me more! section for additional sources of information that may help you obtain evidence on the effectiveness of the control measures applied.

What's not included

Detail related to the tools, techniques, and statistical principles used to validate specific food safety control measures are not included. The process of validation will be unique for each business and will need to be tailored for your particular business, product and market requirements.

Roles and responsibilities

Food businesses are responsible for complying with the law. They demonstrate compliance by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. If a written Preventive Control Plan (PCP) is required, the food business develops a PCP with supporting documents, monitors and maintains evidence of its implementation, and verifies that all control measures are effective.

CFIA verifies the compliance of a food business by conducting activities that include inspection, and surveillance. When non-compliance is identified, CFIA takes appropriate compliance and enforcement actions.

General Principles

The type and depth of evidence needed to show a control measure (or combination of control measures) is effective depends on the nature of the hazard(s) being controlled.

The Process

The process for obtaining evidence on the effectiveness of a control measure requires that you:

  1. know your food, the hazards and control measures
  2. obtain the evidence showing the control measures are effective
  3. document the evidence and where/how it was obtained

1. Know your food, the hazards and control measures

The first step in gathering evidence to show a control measure is effective is to identify and describe the following information which you should already have in your PCP (process and product description, and hazard analysis).

Identify the hazard or hazards that need to be controlled

Describe the hazard(s) in your food and operation for which a control measure is required. For example, Listeria monocytogenes in a ready-to-eat food.

Identify the food safety outcome or target

Identify what the control measures are meant to accomplish. For example, reduce the level of Listeria monocytogenes in a ready-to-eat food to below 100 cfu/g for the duration of the shelf-life.

Note:

Identify the control measure(s)

Identify the control measure(s) used to control the hazard(s) you identified. For example, cooking at "x" degrees Celcius for "y" minutes to achieve a 5-log reduction in numbers of Listeria monocytogenes.

Consider the following:

2. Obtain evidence that shows a control measure is effective

For each control measure:

a. Define the parameters and acceptance criteria

Define:

You can obtain the parameters and criteria from:

b. Determine the approach you will follow to obtain evidence

There is a range of approaches that can be used to obtain the evidence needed to validate the effectiveness of a control measure. The approach depends on the nature of the hazard, the nature of the raw ingredients and product, the type of control measure and the food safety outcome. Some control measures may require that you use multiple approaches. This work can be contracted out to technical experts, as appropriate. The approaches could include:

c. Analyze results to confirm the effectiveness of the control measure

Analyze all of the scientific, technical and observational information and results from the approaches(s) you used, for example process records, test results, certificates of analysis. Based on this assess the ability of your control measure to consistently address the hazard and achieve the intended outcome. Always account for worst case scenarios. In some cases, you may need to conduct statistical analysis to assess the significance of the results or confidence in the control measure to achieve the intended outcome.

Re-validation of a control measures

Several factors could result in the need for you to re-validate a control measure or obtain new evidence on the effectiveness of a given control measure (or combination of control measures). These factors include, but are not limited to:

3. Document the evidence

It is important to document all the relevant information you reviewed and/or obtained as evidence to validate the effectiveness of your control measures. This should include where and/ or how you obtained the evidence. This information is maintained as part of your PCP and should include the following (as applicable):

Keep your evidence current

Your evidence of effectiveness has to be kept up to date and take into consideration changes in formulations, new processing equipment, and emerging new information or processing data.

Tell me more! Further reading

The following references contain information that helps explain food safety controls, demonstrates how to develop them, and provides examples. CFIA is not responsible for the content of documents that are created by other government agencies or international sources.

CFIA references

Other references

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