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FDA Reader: Simplifying Food Regulation

Posts tagged title verification vs validation
Verification vs. Validation
Verification vs. validation.png

What You Need to Know:

Verification means conducting a review to confirm a process was performed correctly. Verification answers the question "How do you know it actually happened?"

Example: A manager in a cookie factory reviews production records to confirm that the cookies were baked to the temperature described in the recipe.

Validation refers to the requirement that a food processor use scientifically proven methods to control a hazard. Validation answers the question "How do you know it works?"

Example: A food safety manager collects scientific research to demonstrate that the cooking temperature used in the recipe is effective in eliminating harmful bacteria in the raw product.

Why Verification and Validation are Important:

Both verification and validation are required or else food-safe outcomes may not be achieved.


Validation Without Verification...

Hand washing with soap is a valid method for removing dirt/grime from hands. However, if verification does not occur and employees do not actually wash their hands, then it doesn't matter how scientifically-proven the strategy is.

Verification Without Validation...

Hand washing without soap is not a valid method for cleaning hands. Even if a manager verifies that hand washing is occurring as required, it doesn't matter because hand washing without soap is not a valid method for cleaning hands.


Verification

Verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

21 CFR 117(c)(1)(i)

Examples of Verification

  • Reviewing cooking records to confirm the required temperature and cook time was reached

  • Reviewing refrigeration records to confirm food was held sufficiently cold

  • Observation that employees are following good food-handling practices

  • Calibrating thermometers - this verifies that they are reading properly

  • Sampling your own product for pathogens to verify that your process was faithfully performed

  • Environmental monitoring - testing your production space for pathogens living on surfaces, in drains, etc.

  • Supplier Verification - reviewing a supplier's records to confirm they are faithful to their food safety practices and claims.

When is Verification Required?

All records which monitor a preventive control must be verified within 7 days of their creation.

All corrective action records must be reviewed within 7 days of their creation.

Other verification records, such as instrument calibration, product testing, and environmental monitoring, must be verified "within a reasonable amount of time" as determined by the producer.

Who Conducts Verification?

All verification activities must be performed by a preventive controls qualified individual.

Examples of Verification

Example of Preventive Control Verification Required? Why? Verification Example
Cooking Chicken to a temp of 165ºF as a preventive control to reduce the hazard of Salmonella Bacteria Yes The cook step is a preventive control. Therefore, the production record containing the cook temp/time must be verified A manager reads the cook log and confirms that all chicken cooked that day was cooked to 165º
Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature Yes Low pH is a preventive control applied to stop bacteria growth. Therefore, the pH records must be verified. A manager reviews the daily production records to confirm the pH was below the required threshold in all batches. If there is a deviation, the manger verifies that the appropriate corrective action was taken.
Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw Yes This is a preventive control and must be verified A manager confirms that the appropriate level of preservative was used to render the product safe. Additionally, in such a high-risk scenario, it may be advisable to test the chicken for pathogens.
Chlorine sanitizer used to sanitize dishes Possibly Depending on the nature of the product, it may not be a requirement to verify that the appropriate concentration of sanitizer was used. Manager verifies a record showing that the sanitizer was tested and the chemical concentration fell into the designated range.
Items containing peanuts are stored in different-colored containers from non-peanut products No There is no requirement to verify the implementation of storage practices to mitigate an allergen concern, although it may be a good idea. A manager may inspect storage spaces occasionally to confirm that practices are being followed to avoid allergen contact.

Validation:

Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

21 CFR 117(c)(1)(i)

When is Validation Required?

You are required to validate every preventive control you are implementing. This means that if you use cooking as a means to kill bacteria, then you need to show that the time and temperature are a valid method for killing that bacteria type. This can often be achieved by referencing FDA guidance materials.

You are not required to validate the following types of preventive controls:

  • Sanitation Preventive Controls

  • Food Allergen Controls

  • Recall Plan

Who Conducts Validation?

All validation activities must be performed by a preventive controls qualified individual.

Examples of Validation

Example of Preventive Control Verification Required? Why? Verification Example
Cooking Chicken to a temp of 165ºF as a preventive control to reduce the hazard of Salmonella Bacteria Yes The cook step is a preventive control. Therefore, the production record containing the cook temp/time must be verified A manager reads the cook log and confirms that all chicken cooked that day was cooked to 165º
Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature Yes Low pH is a preventive control applied to stop bacteria growth. Therefore, the pH records must be verified. A manager reviews the daily production records to confirm the pH was below the required threshold in all batches. If there is a deviation, the manger verifies that the appropriate corrective action was taken.
Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw Yes This is a preventive control and must be verified A manager confirms that the appropriate level of preservative was used to render the product safe. Additionally, in such a high-risk scenario, it may be advisable to test the chicken for pathogens.
Chlorine sanitizer used to sanitize dishes Possibly Depending on the nature of the product, it may not be a requirement to verify that the appropriate concentration of sanitizer was used. Manager verifies a record showing that the sanitizer was tested and the chemical concentration fell into the designated range.
Items containing peanuts are stored in different-colored containers from non-peanut products No There is no requirement to verify the implementation of storage practices to mitigate an allergen concern, although it may be a good idea. A manager may inspect storage spaces occasionally to confirm that practices are being followed to avoid allergen contact.