Validation and Verification Procedure

Hello,

I just had my SQF desk audit last week and I got 1 Non conformance for not having a procedure for Validation and another Non conformance for not having a procedure for Verification. I have a Verification and Validation schedule where I explain what the validation & verification activities are, their frequency and who is responsible for those. The auditor said that he was missing the procedure "structure" with scope, responsibilities and procedure itself. My question is, do yo have a generic procedure that covers validation & verification for all the SQF program or do you have a procedure that specifies how to validate & verify each single section of the SQF?

Thank you for your help.

They are both required elements.

Stating why you are doing it on the schedule you are using is after the fact.

Q: What tells you you even need a schedule in the first place? A: The procedure does as well as how to use the form and what to do with it and the information afterwards.

The written (procedure) documentation portion is referenced in 2.5.1.1 & 2.5.2.2.

It is also a very good exercise for the auditor to direct you to the "chapter and verse" of the code for clarification during the audit. I have asked many times for auditors to direct me to the exact point they claim the requirement is made. Some "violations" have been dismissed as they could not find the place (rare) or they misunderstood it themselves.

Always ask for clarification on anything you are unsure about while you have an "expert" there.

My rule of thumb for SQF (mind you, I'm still pretty new to my QA position, let alone SQF!) is "Every procedure must have a corresponding written policy, but not every written policy necessarily needs a procedure". I write a policy for every section of the SQF code and then generate my procedures based off what my policy states. For example, we have a Allergen Policy (2.8.1), but since our facility does not use or store any allergens, we don't have a corresponding procedure. We do have a corresponding training log regarding Allergens that refers back to our Allergen Policy. This has thus far been fine with our auditors.

Good question svelasan,

I have gotten through many audits without a generic procedure - but could theoretically have been hit the same way.

However, as long as the specific validation and verification activities referenced on the validation records and verification schedule have procedures it would make a generic procedure irrelevant.

Often validation is going to refer to some industry standard or scientifically developed procedure from a third party.

-Josh Heinrichs