Quality Event Management and the CAPA System Part 3: Effectiveness Checking

June 30, 2014

In the conclusion of this CAPA series, MasterControl Partner Ken Peterson explains the methodology behind ensuring your corrective action does what you intended it to do. As part of your effectiveness checks, he provides a very detailed overview of verification and validation, what the difference is between them, and why they’re both important.

Verification is done before you implement the corrective action. It’s meant to provide assurance that the corrective action will work as intended. This might involve using a prototype to test out the corrective action before it’s put in place in the real environment. Validation makes sure the corrective action works once it’s gone live. This is where companies should collect the quality data to ensure the solution works and indicate if there are any other processes in the organization that need to be changed as well.

Ken Peterson wraps up the series with questions to help viewers plan their effectiveness checks. He also warns against some of the most frequent verification and validation mistakes.

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