Tip of the Week: Verification vs. Validation

These two terms get misused all of the time, even by professionals. We often hear customers tell us that they have validated their cleaning program when in fact it was only a verification.

So let’s now put this in simple, easy to remember terms…                      

Verification: Are we doing what we say we’re doing?                                       
Validation: Is what we are doing effective?

Here are some real world in-plant examples for both activities to show the difference:

Allergen Changeover

  • Verification: The production line was visibly clean during the pre-operational inspection.
  • Validation: After a protein specific Elisa test for peanuts, the test results showed no protein residue after an allergen changeover on ten different pieces of equipment and the line was visibly clean. Review of the Elisa specific testing for all of the equipment on this line indicated no positive peanut protein tests were found after cleaning in the last six months. The facility has not had any customer complaints for allergen residues being present in non-allergen products. There have been no recalls due to undeclared allergens. No products have been placed on hold for the last six months due to an improper allergen cleaning. Internal audits of the allergen program revealed that proper re-cleaning of equipment that failed the Elisa testing seven months ago took place and the equipment passed the testing after the re-cleaning took place. The sanitation personnel were retrained after this positive test. Further review from the internal audit revealed that all sanitation personnel were properly retrained on allergen cleaning and were able to demonstrate the proper procedures when a piece of equipment failed the pre-operational inspection. 

Finished Product Specification

  • Verification: The finished product is checked and meets all of the quality check requirements.
  • Validation: A review of the daily quality check sheets over the last six months indicated that no products were out of specification. There was one product placed on hold a year ago for improper specifications, and this product was downgraded per company policy. Documentation of the hold was on file and properly filled out. Root cause analysis was provided for this issue and corrective actions were implemented. After these corrective actions were implemented, no further issues were observed with the product. The facility has not had any customer complaints for finished product being out of specification. There have been no recalls for product being out of specification. Internal audits of the finished product specification program have revealed that all personnel were properly trained on finished product specifications and were able to properly determine if a product met specifications.

Parts and Tool Accountability

  • Verification: The maintenance mechanic signed off that all of his parts and tools were accounted for on his work request.
  • Validation: A review of the daily work requests indicated that all of the parts and tools had been accounted for in the last six months of maintenance work. There was one instance where a mechanic lost a screwdriver eight months ago and notified production personnel as required by the policy. This screwdriver was later found by a sanitation employee on top of a cabinet. Documentation of finding the missing tool was properly recorded. There have been no customer complaints for maintenance parts or tools found in finished product. There have been no metal detector rejections involving maintenance parts or tools. There have been no recalls for finished product containing maintenance parts or tools. An internal audit revealed that all maintenance personnel were properly trained on tool and parts accountability and were able to explain what to do if parts went missing.  

How are employees defining verification vs. validation at your facility? To make sure your employees know the difference, ask for a Kill Step Validation Consultation and make sure to ask that the innovative Baking Process Kill Step Calculator is demonstrated.