Overview on validation and verification for the food industry
June 23, 2017
Once a company in the food industry has determined how it’s going to keep its facilities spic and span, there are two steps which must be continuously revisited in order to ensure sanitation procedures don’t fall short: validation and verification.
Verification is often described as making sure sanitation methods are being implemented correctly. Validation, then, is making sure the best sanitation methods are being used in the first place.
The Food Safety Modernization Act (FSMA), the most comprehensive reform of food safety laws in the U.S. in over half a century, has shifted the focus from a reactive response to contamination to a preventive one.
As such, food companies that operate in the U.S. are revisiting their environmental monitoring programs in order to ensure that their validation and verification programs will keep them up to par with the FSMA’s requirements for such processes.
Validation and verification programs often feature three primary components: ATP sanitation monitoring, allergen monitoring (when allergens are present in a facility) and pathogen monitoring.
While in many cases across the world, facilities are required by law to implement validation and verification procedures, rarely is the exact protocol to be used specified. Because of variation between facilities, processes, and products produced, the specifics of the procedures needed to ensure cleanliness are very different from one facility to another.
That’s why the U.S. Food and Drug Administration (FDA), for example, does not define specific factors associated with developing an environmental monitoring program. Instead, they are required to “be adequate for their intended purpose.”
Validation
Validation is not interchangeable with verification. Food Safety Tech further identifies two types of validation: process validation, which “addresses manufacturing activities and controls to prevent product hazard and contamination,” and method validation, which “addresses the analytical methods used to verify the physical, chemical or microbiological properties of a product.”
Process validation involves making sure that food production processes, such as pasteurization, work correctly. For the most part, pasteurization is a well-understood, effective method of killing pathogens. However, when new elements are introduced to any food production process, validation is needed. Novel applications, ingredients and product reformulations may introduce new risk areas that need to be checked.
Whether new elements are introduced or not, validation (and verification, too) should be re-evaluated regularly.
Quality Assurance Magazine identifies a few major steps for validation: determining the methods, selecting a surrogate or pathogenic microorganism, identifying worst-case scenarios, executing the validation study with a qualified expert, collecting and analyzing data and preparing a validation report.
Once a food manufacturer knows that a kill-step in its process consistently and effectively removes a specific pathogen, it must then make sure that the method used is validated for both a specific product and a specific facility.
Verification
Verification is defined by the FDA as “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.”
The FSMA’s focus on prevention increases the importance of Adenosine triphosphate (ATP) testing, as such tests provide facility personnel with an indication that corrective action is needed to prevent contamination. A through verification program would, therefore, consist of both ATP testing to verify the effectiveness of cleaning, and pathogen and food allergens (if necessary) testing to verify the absence of adulterants.
If environmental testing detects a contaminant on a product contact surface, then the facility may consider conducting end-product testing to determine if the product was contaminated. Various detection systems can be used to accomplish this including lateral flow, molecular and DNA based solutions.
Upon inspection, the FDA will ask for documents showing the implementation of the food safety plan, the hazards that has been identified, sanitation standard operating procedures, how hazards have addressed and records relating to validation and verification.
Quality Assurance Magazine outlines that validation reports should include contact information, background information about the product, parameters studied, equipment used, methods used, microbial strains used, results, dates and other information that may be important.
For more information about best practices for food allergen validation and verification as well as a complete line of Neogen’s environmental monitoring products, click here.
Verification is often described as making sure sanitation methods are being implemented correctly. Validation, then, is making sure the best sanitation methods are being used in the first place.
The Food Safety Modernization Act (FSMA), the most comprehensive reform of food safety laws in the U.S. in over half a century, has shifted the focus from a reactive response to contamination to a preventive one.
As such, food companies that operate in the U.S. are revisiting their environmental monitoring programs in order to ensure that their validation and verification programs will keep them up to par with the FSMA’s requirements for such processes.
Validation and verification programs often feature three primary components: ATP sanitation monitoring, allergen monitoring (when allergens are present in a facility) and pathogen monitoring.
While in many cases across the world, facilities are required by law to implement validation and verification procedures, rarely is the exact protocol to be used specified. Because of variation between facilities, processes, and products produced, the specifics of the procedures needed to ensure cleanliness are very different from one facility to another.
That’s why the U.S. Food and Drug Administration (FDA), for example, does not define specific factors associated with developing an environmental monitoring program. Instead, they are required to “be adequate for their intended purpose.”
Validation
Validation is not interchangeable with verification. Food Safety Tech further identifies two types of validation: process validation, which “addresses manufacturing activities and controls to prevent product hazard and contamination,” and method validation, which “addresses the analytical methods used to verify the physical, chemical or microbiological properties of a product.”
Process validation involves making sure that food production processes, such as pasteurization, work correctly. For the most part, pasteurization is a well-understood, effective method of killing pathogens. However, when new elements are introduced to any food production process, validation is needed. Novel applications, ingredients and product reformulations may introduce new risk areas that need to be checked.
Whether new elements are introduced or not, validation (and verification, too) should be re-evaluated regularly.
Quality Assurance Magazine identifies a few major steps for validation: determining the methods, selecting a surrogate or pathogenic microorganism, identifying worst-case scenarios, executing the validation study with a qualified expert, collecting and analyzing data and preparing a validation report.
Once a food manufacturer knows that a kill-step in its process consistently and effectively removes a specific pathogen, it must then make sure that the method used is validated for both a specific product and a specific facility.
Verification
Verification is defined by the FDA as “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.”
The FSMA’s focus on prevention increases the importance of Adenosine triphosphate (ATP) testing, as such tests provide facility personnel with an indication that corrective action is needed to prevent contamination. A through verification program would, therefore, consist of both ATP testing to verify the effectiveness of cleaning, and pathogen and food allergens (if necessary) testing to verify the absence of adulterants.
If environmental testing detects a contaminant on a product contact surface, then the facility may consider conducting end-product testing to determine if the product was contaminated. Various detection systems can be used to accomplish this including lateral flow, molecular and DNA based solutions.
Upon inspection, the FDA will ask for documents showing the implementation of the food safety plan, the hazards that has been identified, sanitation standard operating procedures, how hazards have addressed and records relating to validation and verification.
Quality Assurance Magazine outlines that validation reports should include contact information, background information about the product, parameters studied, equipment used, methods used, microbial strains used, results, dates and other information that may be important.
For more information about best practices for food allergen validation and verification as well as a complete line of Neogen’s environmental monitoring products, click here.
Category: Food Safety