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ASI Food SafetyJan 16, 2024 11:02:28 AM4 min read

The Difference Between Validation And Verification

Validation vs. Verification in Food Safety: A Complete Guide

In the complex world of food production, the terms "validation" and "verification" are foundational. Yet, they are often used interchangeably, leading to critical gaps in food safety management. Since the introduction of the seven HACCP principles in 1989, understanding and correctly implementing both has been mandatory for preventing safety issues and reducing recalls.[1]

With today's intricate global supply chains and the stringent requirements of the Food Safety Modernization Act (FSMA), a deep understanding of these concepts is more critical than ever. This guide provides an authoritative, in-depth analysis to distinguish these two pillars of food safety, ensuring your HACCP or Food Safety Plan is built on a rock-solid, compliant foundation.

Key Takeaways

  • Validation asks: "Is our plan effective?" It is the process of gathering scientific and technical evidence to prove that your control measures are capable of controlling a specific food safety hazard.[2]

  • Verification asks: "Are we following our plan?" It involves routine checks, tests, and observations to confirm that your validated plan is being implemented correctly and consistently.[2]

  • They are complementary, not interchangeable. You must first validate that your plan can work before you can verify that you are doing the work.

  • Both are legally mandated. Both the USDA and FDA require validation and verification, though the specifics differ. For example, under the FDA, you must validate all process preventive controls.[3]


 

The Core Distinction: Validation vs. Verification

While they are complementary and ongoing processes, validation and verification serve two distinct functions. In short, validation focuses on the design and accuracy of your plan, while verification focuses on the implementation and consistency of that plan.[2]

What is Validation in Food Safety?

Validation is the proof that your plan works in theory.

It's the element of verification that involves collecting and evaluating scientific and technical information to determine if the Food Safety Plan, when properly implemented, will effectively control the identified hazards.[4] You must have documented evidence demonstrating that the preventive controls you've designed will actually control the hazard as intended.

The goal is to answer the question: "Will this control measure, if properly implemented, effectively control the hazard to a specified, safe outcome?"

Methods for Validation Include:

  • Citing scientific principles and data from peer-reviewed journals.[1]
  • Referencing regulatory guidance documents from the FDA or USDA.[1]
  • Using mathematical models to predict hazard control.[1]
  • Conducting in-plant tests and observations to gather internal data.[1]
  • Consulting with food safety experts or Process Authorities.[1]

Example: A food processor determines that cooking a chicken product to an internal temperature of 165°F is a critical control point (CCP) to eliminate Salmonella. The validation would be the scientific literature from the USDA or other studies that proves this temperature is sufficient to destroy the pathogen.

What is Verification in Food Safety?

Verification is the proof that you are following your plan in practice.

It involves the application of methods, procedures, tests, and other evaluations—in addition to monitoring—to confirm that your validated plan is being followed every day.[4][5] Verification confirms that your control measures are operating as intended and that your entire system is in compliance.

The goal is to answer the question: "Are we consistently doing what we said we were going to do?"[2]

Types of Verification Activities Include:

  • Regular calibration checks on essential equipment like thermometers and scales.[1]
  • Targeted product sampling and microbiological testing.[1]
  • Reviewing monitoring records, logs, and other documentation.[1]
  • Visual inspections after cleaning and sanitation procedures.[1]
  • Environmental monitoring for pathogens.[1]
  • Performing internal, second-party, or third-party audits.[1]

Example: Following the same chicken example, the verification would be the daily activities of checking the thermometer's calibration, visually observing that employees are checking the product's internal temperature, and reviewing the temperature logs at the end of the week to ensure there were no deviations from the 165°F target.

When to Re-evaluate and Re-Validate Your Food Safety Plan

Validation is not a one-time event. Your food safety system is a living entity that must adapt to changes in your operations. Re-validation ensures your plan remains effective.

Triggers for Re-evaluation Include:

  • A change in raw materials or a new supplier.[1]
  • A change in your product formulation or manufacturing process.[1]
  • The introduction of new or different equipment.[1]
  • New scientific information or research related to your hazards or controls.[1]
  • A routine reassessment of your HACCP or Food Safety Plan, as required by regulations.[1]

Essential Validation Resources for Food Facilities

The following is a list of highly respected sources that facilities can use to find the scientific evidence needed for validation:

  • Official Methods of Analysis of AOAC International
  • American Public Health Association (APHA) Compendium of Methods for the Microbiological Examination of Foods
  • APHA Standard Methods for the Examination of Dairy Products
  • The Pesticide Analytical Manual (PAM)
  • The Food Additives Analytical Manual
  • The Food Chemicals Codex
  • FDA Bacteriological Analytical Manual (BAM)
  • ORA Laboratory Information Bulletins (LIBs)
  • International Organization for Standardization (ISO) Methods

Ultimately, every food facility bears the responsibility for designing and implementing a food safety management program that is both scientifically effective (validation) and consistently followed (verification). Mastering the distinction between these two concepts is the first step toward achieving robust compliance and producing the safest food possible.

Need help ensuring your food safety plan is both validated and verified? Contact our team of experts today!

 
Source
asifood.com
goktl.com
fsns.com
foodprotection.org
food-safety.com

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