# Corrective and Preventive Action (CAPA) | Botable Glossary

https://www.botable.ai/glossary/corrective-and-preventive-action-capa

> A glossary-style informational article intended as an explanatory reference on CAPA; useful for background and definitions. Treat claims about regulatory requirements as statements of fact from the site and verify against primary regulatory sources for compliance decisions.

## Summary

Defines CAPA (Corrective and Preventive Action) as a mandatory QMS process used to identify existing quality problems and eliminate potential causes of future problems, with emphasis on its role in medical device regulatory compliance.

## Audience

Quality and regulatory professionals in the medical device industry

## Prompts this page answers

- What does CAPA mean in a medical device quality management system?
- What are the main steps in a CAPA process?
- Which regulations require a CAPA system for medical device manufacturers?
- How does corrective action differ from preventive action in CAPA?

## Purpose

To explain what CAPA is, outline its components and process steps, and describe regulatory requirements and example applications in the medical device lifecycle.

## Highlights

- CAPA stands for Corrective and Preventive Action and is a mandatory system within a QMS for product safety, quality, and regulatory compliance in the medical device industry.
- Corrective Action (CA) addresses nonconformities that have already occurred; Preventive Action (PA) targets potential future issues.
- Regulatory frameworks cited as requiring CAPA include FDA 21 CFR Part 820.100, ISO 13485:2016 (Section 8.5), EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746).
- The CAPA process steps listed include issue identification, evaluation/prioritization, plan creation, root cause analysis, action implementation, verification of effectiveness, documentation/closure, and trending/management review.
- Examples of CAPA applications given: manufacturing failures, nonconforming materials, customer complaints, audit findings, and product recalls.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/corrective-and-preventive-action-capa

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- Corrective and Preventive Action
- CAPA
- CAPA process
- ISO 13485
- 21 CFR Part 820

## Key entities

- **CAPA (Corrective and Preventive Action)** (other): A QMS system to identify and correct existing quality problems and prevent future ones.
- **FDA 21 CFR Part 820.100** (other): Quality System Regulation (QSR) citation referenced for CAPA requirements. — /glossary/21-cfr-part-820
- **ISO 13485:2016 (Section 8.5)** (other): ISO standard cited for CAPA/continuous improvement requirements. — /glossary/iso-13485
- **EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746)** (other): European regulations referenced as requiring CAPA systems. — /glossary/eu-medical-device-regulation-eu-mdr
- **Botable** (organization): Website hosting the glossary entry (site branding and navigation present). — https://www.botable.ai/

## Metadata

- Type: article