Wednesday, April 3, 2013

Verification Vs. Validation



I have found that these above terms are very easy to get confused.  They do look similar and can mean similar things. From www.thefreedictionary.com they are defined as:

verification [ˌvɛrɪfɪˈkeɪʃən]
n
1. establishment of the correctness of a theory, fact, etc.
2. evidence that provides proof of an assertion, theory, etc.
 
val·i·date (vl-dt)
tr.v. val·i·dat·ed, val·i·dat·ing, val·i·dates
1. To declare or make legally valid.
2. To mark with an indication of official sanction.
3. To establish the soundness of
 
In simple terms - verification are the tests on the product.  It is the daily/hourly/consistent "on the floor" testing that is documented, reviewed, and used to ensure the product is OK to ship.  Validation is a check on the system that is being used to test your products. The time period on validation can be yearly, monthly, quarterly, whichever time period has been designated as appropriate for the what you are auditing.

 In terms of Quality - Verification is the Quality Control and Validation is the Quality Assurance (for more on QA vs. QC see my blog posted March 21, 2012).  To verify - you are checking temperatures, hold times, pH levels - essentially recording the "proof" that your product is OK.  To validate - you are checking personnel training, the machines, the process steps - are the procedures being done as written.  Both of these duties / procedures need to be done and kept straight when you are in a GFSI program.
 
Quick example:   To verify a donut coming out of an oven you would test exit temps, or look at the number of off spec end temps for a month.   To validate the process you would check for oven cold spots, training logs, or even customer complaint logs.
 

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