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CAPA(Corrective and Preventive Action)


Powerful Closed-loop CAPA - Meeting FDA Expectations


Corrective and Preventive Action or commonly known as CAPA is a concept within Good Manufacturing Practice (GMP). Objective of CAPA is to perform a systematic investigation of discrepancies in order to prevent them from resurfacing. Systematic investigation of the failure incident helps to track down the effectiveness and efficiency of implemented CAPA.

Corrective and Preventive Action

CAPA is a key element to QMS which is focused to continual improvement and incessant customer satisfaction. CA or the corrective action, on one hand, is intended to find out the root cause of nonconformance while on the other hand, PA or the preventive action is chalking out a plan to prevent a problem from surfacing again in the future.

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CAPA: Corrective Action - the ISO 9001 Standard Requirements

Corrective action is meant to identify the root cause for the Nonconformity. Once the root cause is identified, motto of the company should be initiating an action to eliminate it: The corrective action. For implementation of successful corrective action, the stepping stone is an efficient documentation as only the documentation will help you to verify whether your corrective action was enough, effective and fruitful.

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CAPA: Preventive action - the ISO 9001 Standard requirements

Preventive action is performed to eliminate potential event that can create nonconformity. While talking about preventive action, we must remember that the nonconformity has not taken place yet and it is a preventive action of identifying and eliminating the cause of nonconformity.

For effective implementation of preventive action, documentation of the process and steps is a must. Only a proper documentation will help you track the effectiveness and sufficiency of the preventive action process.

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CAPA Process

The CAPA process includes application of collected information through a chain of homework, corroboration criteria, and list of related events. Aim of the CAPA action plan is ultimately introducing a process that will correct a faulty event, minimizing a risk and bring an overall change i n the company.

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