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.
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.
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 | Validation Required? | Why? | Validation 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. While it's largely accepted that a 15 second exposure to 165ºF temps will kill salmonella, it's good to cite a source showing that this control is valid. You can simply link or reference any reputable text which states this fact. | 5D reduction for Salmonella: 15 seconds at 165ºF Table A4.1, “Limiting Conditions for Pathogen Growth” FSPCA Preventive Controls for Human Food 1st Ediiton, 2016 |
| Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature | Yes | You'll need to describe exactly how you know that this combination of controls are effective in controlling specific bacterial pathogens. The validation must be specific to the hazards you are controlling. You can cite a study showing that a certain concentration of bacteria produced by the ferment is effective in limiting the growth of relevant, harmful pathogens. You might also link a source which describes the pH threshold for specific bacteria growth. | For example: pH is an effective limiter for pathogenic bacteria growth in lactic acid producing fermented products if a <4.6 pH is maintained. Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry, Chapter 4 “Preventive Controls” p.27 |
| Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw | Yes | This is a less common type of control (using preservatives to make raw chicken edible) so you would need to make a compelling case that this preservative is effective in eliminating harmful bacteria. You can state the simple facts of the study in one of two sentences and then cite the source. | [cite your source] |
| Chlorine sanitizer used to sanitize dishes | No | Validation is not required for sanitation controls. In this case, it is widely accepted that chlorine is an effective sanitizer. | N/A |
| Items containing peanuts are stored in different-colored containers from non-peanut products | No | Validation is not required for allergen controls | N/A |
This Article is For You if…
∆ You are developing a food safety plan or a HACCP plan.
∆ You are an FDA regulated food facility.
