Hierarchy for CAPA effectiveness

Published: 29-May-2018
Regulatory

Have you ever reviewed an investigation report and wondered whether the proposed corrective and preventive action (CAPA) would be effective? Here NSF propose a CAPA hierarchy to help investigators select an appropriate corrective/preventive action that is most likely to deliver the desired outcome

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?

Click here to read on and access the full pdf.

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