Glossary · GxP: good practices
Corrective and preventive action (CAPA)
Also known as: CAPA, Corrective action, Preventive action, CAPA system
Corrective and preventive action (CAPA) is the quality system process for investigating nonconformities, deviations, complaints and other quality problems, eliminating their causes to prevent recurrence (corrective action) and eliminating the causes of potential problems before they occur (preventive action). It is required in medical device quality management systems under ISO 13485 and the MDR and in the pharmaceutical quality system described in ICH Q10 and EU GMP.
- GxP
- MDR
- Pharma
In one sentence
CAPA is the quality process for finding the root cause of actual or potential problems and removing it, required in device QMS and pharma GMP.
Example
After several complaints about cracked infusion connectors, a manufacturer opens a CAPA, traces the cracks to a changed molding temperature, corrects the process setting, updates the work instruction, and checks three months of complaint data to verify effectiveness.
How it applies
- Inputs: Nonconforming product, deviations, audit findings, complaints, post-market surveillance data, vigilance cases and trends.
- Steps: Describe the problem, assess its risk, contain it, find the root cause, decide and implement actions, and verify that the actions worked without causing new problems.
- Medical devices: ISO 13485 requires documented procedures for corrective action and for preventive action, and the MDR lists the management of corrective and preventive actions among the quality management system aspects of Article 10(9). Risk decisions link to the ISO 14971 file.
- Pharma: ICH Q10 names the CAPA system as one of four elements of the pharmaceutical quality system, alongside process performance and product quality monitoring, change management and management review.
- Technical documentation: CAPA records show the reasoning, not only the result: evidence for the root cause, the rationale for the actions, links to change control and the effectiveness check. Changes resulting from a CAPA can require updates to the technical documentation, labeling or risk file.
Corrective action vs. correction
A correction fixes the immediate problem, such as reworking or scrapping affected units. A corrective action removes the cause so the problem does not recur. A CAPA closed with a correction alone, or with “retrain the operator” and no evidence of the cause, is a common inspection finding.