Regulatory Affairs

Hierarchy For Capa Effectiveness

Published 31 May 2018 | By NSF International

Have you ever reviewed an investigation report and wondered whether the proposed corrective and preventive action (CAPA) would be effective? Sometimes, we shrug our shoulders and say, “At least they put something in place”. We all know that the FDA expects us to include an effectiveness check, but do we have enough guidance to make these checks meaningful? NSF suggests that you consider these three questions: 1. What will you measure? 2. When will you measure it? 3. What is your acceptance standard?

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Hierarchy For Capa Effectiveness