SOP
851-01

Corrective and Preventive Action

FR-851-01-01 CAPA Form and FR-851-01-02 CAPA Log

Outlines the corrective and preventive action process to identify and implement changes required to ensure and maintain the continued suitability, adequacy and effectiveness of the QMS. It defines the requirements for collecting and analyzing information based on appropriated statistical methodology for corrective and preventive actions, from detection and reporting of nonconformities, through the investigation, correction, corrective or preventive action and checking of effectiveness after implementation. Applies to nonconforming and potentially nonconforming raw materials, product in process, final product, customer complaints or feedback, manufacturing process nonconformance as well as QMS nonconformances.

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