Topic

Corrective and preventive action (CAPA)

The formal quality-system process for investigating a nonconformity, addressing its root cause and recording that the fix was adequate. Required by ISO 13485 and by FDA quality system rules.

Current clusters

build1 publisher

A 90-day inactivity timer closed a CAPA that never got a root cause review

A quality engineer writing on dev.to argues that ISO 13485, EU MDR and FDA guidance all assume an accountable human without listing the approvals an AI may not make, so each site has to write that list itself.

Publishers:dev.to

Reality

Evidence28
Adoption18
Hype gap+12
Incentives45
Confidence40