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Free tool · NC/CA/PA decision logic

The Triage Tree

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.

Try it yourself

Walk one issue through

The whole tree, at a glance

You either react to an existing issue or anticipate one

yes no no yes no yes yes no Proactive analysis Quality event (reactive) Potential for future nonconformities? Fails to meet requirements? Is the risk acceptable? (harm × occurrence rate) Is the risk acceptable? (harm × occurrence rate) Preventive action Keep trending Correction* only Correction* + Corrective action

*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.

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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.