Distinguish CAPA action completion from effectiveness evidence using ICH Q10 and PDCA logic.
CAPA closure is a proof point. A CAPA is not finished when the action is installed. It is finished when the organization can show the action reduced the weakness that caused or allowed the issue. ICH Q10 frames CAPA as a quality-system element, and PDCA explains why: plan from root cause, do the change, check whether the process improved, and act on what the check shows. Training, SOP updates, and new checks are often necessary. They are not automatically effective. If the root cause was unclear ownership, the check must prove ownership changed. If the root cause was a poorly…
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