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:
Delivered by email, along with the MedTech CAPA Journal: frameworks for NCs and CAPAs that solve the problem and hold up in an audit. No fluff. Unsubscribe anytime.
Already know the answer is “our records wouldn’t hold up”? Skip the tools. Want my eyes on this?