CAPA Definitions as Used by FDA and ISO

CAPA definitions and terms can sometimes be confusing. Nearly everyone stumbles over the proper use and application of the CAPA terms of corrections, corrective actions, and preventive actions.

The following CAPA definitions clarify the differences and are consistent with interpretations by FDA and ISO 9000-2008:

Correction: An action taken to eliminate a detected non-conformity. A correction can be made in conjunction with a corrective action. A correction can be rework or regrade, for example.

A corrective action is taken to prevent recurrence of the non-conformity.

Corrective Action: An action taken to eliminate or minimize the cause of a detected non-conformity or other undesirable situation. You can identify more than one cause for a non-conformity. A corrective action is taken to prevent recurrence of the non-conformity.

Preventive Action: An action taken to eliminate or minimize the cause(s) of a potential non-conformity or other undesirable situation. A preventive action is taken to prevent the initial occurrence of a non-conformity.

– Non-conformity: The non-fulfillment of a specified requirement. FDA’s definition also can be found in 21 CFR 820.3.

For further information on FDA and ISO expectations for CAPA systems, attend EduQuest’s training class called The CAPA Compliance Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management.

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