CAPA Closure Criteria: The Six Things That Have to Be True Before \"Closed\" Means Anything
A CAPA marked closed is a claim, not a fact. Containment recorded, corrective action recorded as a system change, effectiveness criteria written as a record instead of a checkbox, verification marked verified against evidence, an independent reviewer, and a recurrence window sized to the part, not the calendar. What the platform enforces for each, in practitioners' own words, and where the automatic recurrence chase is real but scoped.
PFMEA Rescoring: How Do You Prove a Corrective Action Actually Lowered Risk?
A PFMEA gets built, signed off, and filed. Six months later a corrective action closes against one of its failure modes, and nobody updates the RPN. Here is how a rescore workflow locks severity, recalculates occurrence and detection, and produces a before and after risk number a PFMEA spreadsheet cannot generate on its own.
CAPA Effectiveness Metrics: The KPIs That Tell You Corrective Action Is Working
Closing CAPAs on time tells you nothing about whether problems stop coming back. This is the small set of CAPA effectiveness metrics that does: recurrence rate, repeat findings, aging and cycle time, reopen rate, and escape rate, how to define each one so it cannot be gamed, and how to wire them into management review under ISO 9001 clause 9.3.2 and IATF 16949 clause 9.3.2.1.
CAPA Effectiveness Verification: How to Prove a Corrective Action Actually Worked
Most CAPAs close before anyone confirms the fix held. This is what corrective action effectiveness verification requires under ISO 9001 and IATF 16949 clause 10.2.1, how to set objective acceptance criteria, how long to keep the CAPA open, and the audit findings that catch a verification that was a signature instead of a number.
8D vs CAPA: What's the Difference and When to Use Each
8D and CAPA are not the same thing. 8D is a problem-solving methodology. CAPA is a quality system requirement under IATF 16949. Conflating them causes audit findings and customer rejections.