Dr. Brian Nummer PhD

FOOD-SAFETY.GURU

Verification & Validation

The concepts of verification and validation leave most beginner food safety professionals confused.  On top of that there are two different aspects to verification and validation.  The first is related to specific food safety procedures (CCPs, GMPs, SOPs, etc) and the second is a global view.  Is the entire food safety system working?

Specific

•    Monitoring: Are the operations being done as intended? (present)
•    Verification: Was the work done according to the food safety plan? (past)
•    Validation: Are the plan criteria (e.g. critical limits) based on science?

Global

•    Monitoring: Is the entire operation being observed and assessed? (present)
•    Verification: Is all of the work done according to the food safety plan? (past)
•    Validation: Is the plan as a whole effective? (past and future)

FSMA Preventive Controls requires that Process Control CCP critical limits be validated by referencing the science or safe harbor (federal performance standard).  No other Preventive Control programs REQUIRE validation.  This includes allergens.  The FDA has not set threshold levels of allergen residuals.  On the global level, FSMA PC requires an effectiveness check (a) at the documentation stage, (b) just after the roll-out stage, and then (c) every three years.

Opposite to FSMA PC, most GFSI schema based on ISO 22000 and PAS 220 standards require formal validation of CCPs and operational prerequisite programs (oPRPs). In addition, cleaning and sanitizing programs must also be validated. Organizations must properly design, document, implement and maintain prerequisite programs, even if the standard does not specify a validation requirement for this part of the food safety system.

Process Validation focuses on the collection and evaluation of scientific, technical and observational information to determine whether control measures are capable of achieving their specified purpose (outcome or target) in terms of hazard control. Global Validation involves measuring an entire system’s performance against a desired food safety outcome.

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