CAPA manages, as one procedure, the corrective action that fixes a problem that occurred and the preventive action that keeps it from recurring.
Find underlying causes
Address the actual issue
Prevent potential issues
Review results and update standards
CAPA manages, as one procedure, the corrective action that fixes a problem that occurred and the preventive action that keeps it from recurring.
When a defect appears, two things must happen: decide what to do with the affected product, and find the cause so it does not come back. The first is correction, the second prevention.
CAPA becomes an empty formality most often because root-cause analysis stops at "operator error". If the structure that allowed the mistake remains, the problem returns. The same happens when the action taken is only a revision to a procedure document.
Effective CAPA checks what happened afterwards. Confirming with data that the same class of nonconformance actually declined after the action is what closes the loop.
Correction disposes of the affected product — rework, scrap or concession. Corrective action removes the cause so it does not recur. Closing a case after correction alone guarantees the problem comes back.
Terms that make more sense read together.
A nonconformance is any product or process that fails to meet a defined requirement. Recordi…
QualityStatistical Process Control (SPC) watches the variation in measured values statistically so …
QualityTraceability is the ability to go from a finished product back to the material, process cond…
What IYULAB provides in this area.
Questions that come up when evaluating CAPA.
No. Select on impact and recurrence. Raising one for everything turns the procedure into paperwork and buries the cases that matter.
5 Whys and cause-and-effect diagrams are common. The method matters less than not stopping at human error and following through to structural cause.
Track the occurrence count of the same type over a defined period after the action. This only works if nonconformance data is classified consistently.
A look at your equipment and current workflow is usually enough to scope it.
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