Free tool · NC/CA/PA decision logic
Does every minor quality issue deserve a full-blown CAPA? No — but “no” needs a documented, risk-based rationale. This tree gives you one in four questions or fewer.
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The whole tree, at a glance
*Correction vs. corrective action. A correction is an action to eliminate a detected nonconformity. This includes containment, rework, segregation, etc. A corrective action removes the root cause so it can't come back. They are not the same thing, and many CAPA owners struggle with this concept — which leads to common findings.
The tree decides how far to take a signal. Whether your records back that decision up is the next question — that’s what the CAPA Stress Test toolkit is for. Subscribers get:
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Already know the answer is “our records wouldn’t hold up”? Skip the tools — the NC/CAPA Clarity Assessment is the direct route.