Frequently asked question
How is CAPA effectiveness different from simply closing a CAPA?
CAPA closure is an administrative status showing that assigned actions were completed. Effectiveness is an evidence-based conclusion that the actions corrected the underlying problem, reduced recurrence risk, and did not create unintended consequences. A…
Answer
CAPA closure is an administrative status showing that assigned actions were completed. Effectiveness is an evidence-based conclusion that the actions corrected the underlying problem, reduced recurrence risk, and did not create unintended consequences. A meaningful effectiveness check should be linked to the original root cause and failure mode, use predefined acceptance criteria, cover an appropriate observation period, and rely on data capable of detecting recurrence. Weak effectiveness checks often reveal that the CAPA logic itself was incomplete, because measuring the wrong indicator cannot demonstrate that the system actually improved.
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