CAPA and Risk Pocket Cards

CLEAR Use CLEAR to close a CAPA without hand-waving. Flip for the five closure prompts. Correction or corrective action? Both may be needed, but they are not interchangeable. The CAPA is done because the training record is complete. Use when completion evidence is being mistaken for effectiveness evidence. Your line Training completion proves the action happened. Effectiveness needs future process evidence, such as no repeat defect in the next defined sample or time window. Completion is not recurrence prevention. It separates implementation evidence from effectiveness evidence and asks for a measurable future check. What makes an FMEA-style risk priority high?…

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