From Deviation to CAPA
Decide when a deviation needs correction, preventive action, or formal CAPA based on root cause and recurrence risk.
The fork One reconciliation issue is resolved, but history suggests drift. The team must decide whether this is event correction or system learning. Root-cause escalation Impact -> Cause -> Recurrence -> CAPA Use evidence to avoid both under-escalation and CAPA overload. The CAPA route is justified when root cause or recurrence risk points beyond the single event. Step 1 Immediate Impact The missing carton is found empty in waste. What comes before deciding CAPA? Step 2 Root Cause The same room has two similar issues this quarter. Which root-cause path is strongest? Now You Try Fresh Application A lab misses…
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