Glossary Item

Although the terminology – Corrective and Preventive Action (CAPA) – comes from FDA regulations, the overall effort to investigate and correct quality issues to prevent recurrence is critical success factor for any quality system. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a CAPA system improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance.

Although there are regulations specifying how FDA regulated companies must implement CAPA, conceptually it is simply defining a business process to ensure that defects and customer complaints are identified, completely documented, and specific action is taken to correct the situation and ensure that it does not re-occur.

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