NC/CA/PA decision logic

The Triage Tree

Does every minor quality issue always deserve a full-blown CAPA? The answer is no — but you always need to evaluate the situation, risk-based. Walk one issue through and see where it lands.

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.

Try it yourself

Walk one issue through

This is the logic for deciding how far to take a single signal. Whether your real records actually follow it is a different question, and it's the one an auditor asks. That's what a NC/CAPA Clarity Assessment answers.

Georg Digel Medical Device (ISO 13485) · NCs & CAPAs