Validation

The application of control measures in the food chain, from primary production, through processing, to consumption, is used to control potential food safety hazards. Validation of control measures demonstrates that they are capable of achieving the intended level of hazard control.

1. What is Validation?

Validation is the process of obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. For example, sanitizer in product wash water is effective in preventing cross contamination.

2. Why is Validation Necessary?

It confirms that the measures being used will control the hazards related to the food product.

3. How is Validation Performed?

Validation focuses on the collection and evaluation of scientific, technical and observational information to determine whether control measures are capable of achieving their specified outcomes. Examples include:

  • Collection of data during operating conditions
  • Scientifically valid experimental data that demonstrates the adequacy of the control measure (e.g. laboratory challenge testing demonstrating log reduction of a specified pathogen)
  • Mathematical models, such as pathogen growth models, to assess the impact of changes in pH and water activity on the control of pathogen growth
  • Reviewing Health Canada guidelines
  • Reviewing processing authority documents, instructions, or research
  • On-site studies, research or historical data
  • Reference to legally defined Critical Control Points (e.g. thermal processing for the pasteurization of milk)

4. Validation vs. Monitoring vs. Verification

Validation is different from monitoring and verification. The table below provides an explanation and comparison of validation, monitoring and verification.

Validation Monitoring Verification
Is this the right thing to do? Does it still work? Are the operations being done as intended? Is what should be done getting done?
Obtaining evidence such as (testing, experimenting, or statistical analysis) to prove the control measure is working effectively The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control Application of methods, procedures, tests and other evaluations (in addition to monitoring) to determine whether a control measure is operating as intended

Example:

New cleaning and sanitation program implemented. Accredited laboratory performs sampling on-site, and microbial analysis to provide evidence that the program is capable of eliminating pathogens

Example:

Each time the cleaning and sanitation procedure is performed, a monitoring device (e.g. ATP swabs) are used to determine the effectiveness of the treatment.

Example:

Supervisor checks monitoring logs regularly to verify monitoring has been done and documented to ensure completeness and compliance to the monitoring requirements. Weekly microbial sampling of cleaned and sanitized surfaces sent to an accredited lab to ensure the program is eliminating pathogens (i.e. operating as intended)


5. Where does Validation Occur?

Validation of control measures occurs at any stage of the food chain. All control measures within the preventive food safety control system, including good manufacturing practices and/or pre-requisite programs, should be validated. Examples include the validation of:

  • Cleaning and sanitizing programs
  • Process water/irrigation water/wash water quality
  • Clean-in-place equipment
  • Cooking process to manufacture ready-to-eat foods
  • Categorization of ready-to-eat foods as per the Health Canada Listeria policy
  • Critical Control Points in a HACCP plan
  • Microbial control interventions for the treatment of carcasses and their parts
  • Thermal or non-thermal processes for foods of plant origin products, such as pasteurization, or canning

6. When is Validation Performed?

Validation is performed at the time a control measure or a food safety control system is designed, or when changes indicate the need for re-validation. Validation of control measures is, whenever possible, performed before their full implementation. All control measures should be validated periodically (for example, once a year).

7. Who Performs Validation Studies?

Producers and processors are responsible for the validation of control measures. A validation team with appropriate expertise and knowledge can be used, but be sure to include representatives who are knowledgeable of the relevant products, manufacturing, storage, distribution and handling processes. This could include people from sanitation, quality assurance, maintenance and engineering.

Governments (e.g. Health Canada) may provide guidance to industry on how to conduct validation studies and how validated control measures may be implemented.

8. Validation - Where to Begin?

You can begin your validation studies by:

  • Referring to scientific or technical literature, previous validation studies or historical data
  • Collecting data during operation
  • Contacting an accredited third party

9. Additional Information

10. Questions? Contact Us

Does your operation take all the necessary steps to ensure your product is safe? Do you follow the best practices to prevent, detect and control risks? We can help you improve upon the good work you are already doing.


For more information:
Toll Free: 1-877-424-1300
E-mail: FoodSafety@ontario.ca


Author: OMAFRA Staff
Creation Date: 7 February 2014
Last Reviewed: 08 June 2018