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SQF Validation Documentation

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Posted 22 June 2016 - 08:10 PM

We are a food packaging printer preparing for our 2nd SQF Level 2 audit and I'm look for suggestions/examples of how others are documenting validation activities (we were brand new to the process when audited last year, so validation was not looked during our 1st audit). What methods are others using to document this? Are there specific forms or formats for this, or is it as simple as a Word document stating 'element found to be in conformance'? The whole application of V&V still has me confused (concept understood, but how to document?)


Thanks for any examples to share!

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Posted 22 June 2016 - 09:05 PM

The format is your consent. We use either word or excel, depending on the validation activity. If we perform in house we have a signature and scan, saving the PDF. For validation completed by an outside lab, we present the certificates from the actual lab. An auditor may ask you to step through the validation process, (i.e., documented test methods, and gauges, calibration record of gauges, results of test, findings and or corrective action records). I hope that makes sense.

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Posted 28 June 2016 - 08:40 PM

This is how I interpret verification vs. validation, however, some people have disagreed with me.


Verification - is it being done according to the standard procedure - frequency, log sheets, correct tools & supplies, etc?

This could be done by signed audits, or supervisors/dept. managers reviewing/auditing the log sheets and signing as evidence they reviewed.

Log Sheets and/or Supervisor signature verify that the procedure is being done.

No audit or review = no guarantee that it is being done (no verification).


Validation - is the standard procedure actually working to control the problem?

Management review of audit trends, corrective actions, non-compliances, customer complaints, test data, etc.

Document the management reviews - who, when, what was decided, correction actions, etc.

No meeting minutes or report = no evidence of validation.


Silly example - employees on each shift do a quality/food safety dance (similar to a rain dance):

Verification - yes, employees are dancing on each shift.  I see them do it every day.

Validation - no, not working.  Still having the same problems.  Dancing is totally invalid (ineffective).


More realistic example - employees required to wash hands at certain times.

Verification - no one is checking if employees are washing their hands.

Validation - already commonly known that washing hands is effective in preventing cross contamination from people to products.

(This may have been part of the reason for the problems that Chipotle's was having).

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