Corrective and Preventive Action (CAPA)

What is a CAPA in a medical device quality system?

A CAPA is the documented process a manufacturer uses to react to quality signals: identifying a nonconformity or potential nonconformity, investigating its cause, implementing action, and verifying that the action worked without introducing new problems. Corrective action addresses the cause of a problem that has already occurred; preventive action addresses the cause of a potential problem. ISO 13485 treats them in separate clauses, and a quality system should apply each concept according to the issue rather than forcing every signal into one workflow.

Where is CAPA required by regulation?

In the United States, CAPA requirements sit in the quality system regulation at 21 CFR Part 820, which since 2 February 2026 operates as the Quality Management System Regulation (QMSR) and incorporates ISO 13485 by reference. In the European Union, corrective and preventive action is part of the quality management system required by the MDR and IVDR. A field safety corrective action may result from a CAPA investigation, but an FSCA is a distinct regulatory action taken to reduce a serious risk from a device made available on the market.

What belongs in a CAPA record?

Auditors generally expect a documented trail: the quality-data source that triggered the CAPA, an investigation proportionate to risk, a root-cause determination where one can reasonably be made, the action taken, verification or validation of effectiveness, and communication of changes to affected people and documents. The record should explain both why the chosen action addresses the cause and how the manufacturer decided that the action was effective.

What is the difference between a correction and a corrective action?

A correction fixes the immediate problem — rework, relabeling or replacing a unit. A corrective action addresses the cause so the problem does not recur. The distinction matters in inspections and in recall terminology: removing a defective lot from the market is a correction or removal, while the process change that prevents the same defect from being produced again is the corrective action. CAPA expectations connect to the United States quality system framework and the European Union MDR quality system requirements.