Validation

What You Need To Know:

Validation answers the question “How do you know it works?”
You must validate that the preventive controls that you implement actually work.
Validation activities includes using scientific and technical evidence (or conducting your own studies)

Example of Validation: Collecting scientific research, and conducting tests to prove that the cooking temperature in your recipe is effective in killing the harmful bacteria in the product.

Hint: you can find information to validate many food processing practices on the FDA website.

What is 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.

When do I need to validate my preventive controls?

You must validate your preventive controls:

Within 90 days of beginning production or there must be written justification for why if >90 days after production begins.
Whenever a change is made that could impact how a hazard is controlled.
Whenever the food safety plan is reanalyzed.

What Part of My Food Safety Plan Require Validation?

Some parts of your food safety plan do not need to be validated. Sanitation activities, for example, do not need to be validated because most people use a small set of scientifically proven processes (i.e. soap and water, common chemical sanitizers). As a result, there is no need to require each business to prove their sanitation practices actually work.

The following activities do not require validation

Food allergen controls
Sanitation controls
Recall plan
Supply chain program
Other preventive controls if the PCQI prepares the written justification that a validation is not applicable based the nature of the hazard and the preventive control.

This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or identified a hazard that requires a preventive control

Resources

Verification vs. Validation

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Guidance Document, ClarificationNed KleinFebruary 10, 2019food processing facilities, Food Safety Plan, Food safety validation, validation, record keeping, fda regulation, preventive controls, haccp, food producer requirements, title validation, food safety plan, food regulation

Verification vs. Validation

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

		
			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.
				
		SOURCE: Sources

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 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
				

	
		SOURCE: Sources
	

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