CAPA Program: Segregation of CA's and PA's

Written by Brian Graeff, Brian Graeff LLC ; Benoit Prince, SOLABS ; Philippe Gaudreau, SOLABS Monday, 21 November 2011 18:12

CAPA is a well-known cGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence. CAPA is not just a procedure; it is a system of very different, but interrelated activities.

The acronym "CAPA" is currently used in the regulated industries, but the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action. A good CAPA program should differentiate actions in the following manner:

When a quality event is identified (such as a nonconformity), the organization will determine the significance, risk of the nonconformity and the potential of recurrence. Once this has been determined, the organization may decide that the nonconformity has little associated risk or is unlikely to recur. In such cases, the organization may decide only to carry out a correction. Should the nonconformity recur during manufacturing or after product has been delivered to a customer, it is an indication that an improvement action is likely to be required. In either case, a Quality Management System (QMS) requires that corrective action(s) be carried out with the aim of preventing recurrence. Corrective actions (CAs) may be quite simple, or as complex as redesigning the manufacturing process.

Organizations may also encounter situations that have not actually caused a nonconformity, but may bring one in the future. Such situations call

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