Corrective and preventive action is where a quality system either learns or repeats itself. This hub connects the reference material, the maturity model, the assessment and the practical guidance.
CAPA is judged on whether the problem stopped, not on whether the record closed.
The requirement, the failure modes and the primary sources.
02 · AssessScore this domain and see where it sits against the others.
03 · PositionWhat each level looks like, and what moves you up one.
04 · If it is urgentFirst actions, evidence to preserve and what not to do.
Quality assurance and the system as a whole
“Did the action remove the cause, and can we show it?”
Effectiveness criteria defined before implementation, checked against real data afterwards. Where retraining recurs against similar events, the record documents a pattern rather than a set of incidents.
Laboratory, testing and analytical data
“Are laboratory events feeding the same system?”
OOS and OOT outcomes should enter the CAPA system on the same terms as production events, and laboratory root causes need the same evidential standard.
Production, process and the floor
“Is the process still generating the failure?”
Where the design invites the error, a training action is a delay rather than a correction. Investigation also consumes production and engineering time, so recurrence is capacity spent twice.
Certification and batch release
“What does an open action mean for certification?”
Where a batch is affected by an unresolved deviation, Annex 16 sets expectations and the rationale for certifying must be documented.
Requirements, dossier and authority expectations
“How will this read to an inspectorate?”
Overdue actions are visible in your own records, and a repeat finding is treated far more seriously than a first because it shows the previous correction did not work.
The GMP Health Index scores seven quality-system domains and maps each to a maturity level. It calculates in your browser and keeps history on your device only.