Corrective and preventive action (CAPA)

    In Oversight, quality & inspection

    A CAPA is the structured response to a problem: correct what went wrong, and change something so it does not happen again. The corrective part fixes the immediate issue; the preventive part addresses the root cause. Retraining one person is usually a weak CAPA, because it rarely changes the system that allowed the error.

    Example

    Consent forms were signed on an outdated version. Corrective: re-consent affected participants on the current version. Preventive: add a version check to the visit checklist and remove superseded versions from the site file.

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