# Corrective Action (CA) | Botable Glossary

https://www.botable.ai/glossary/corrective-action-ca

> Informational company glossary — use as a concise, vendor-published definition and introductory reference about Corrective Action and its regulatory context; attribute claims to the site when relying on regulatory statements and consult primary regulatory texts for compliance decisions.

## Summary

Corrective Action (CA) is defined as actions taken within a formal quality system to eliminate the cause of an already-occurring nonconformity, defect, or quality problem to prevent its recurrence; it is the 'corrective' half of CAPA and is tied to regulatory requirements such as FDA 21 CFR 820.100 and ISO 13485:2016.

## Audience

Quality and regulatory professionals in regulated industries (e.g., medical device manufacturers)

## Prompts this page answers

- What is Corrective Action (CA) in a quality management system?
- How does Corrective Action relate to CAPA and Preventive Action?
- What regulatory standards mention Corrective Action for medical device manufacturers?
- What are the main requirements for implementing a Corrective Action?
- Can you give examples of Corrective Actions triggered by audits, complaints, or manufacturing failures?

## Purpose

Provide an explanatory, regulatory-grounded definition and guidance about Corrective Action within quality systems (especially for regulated industries like medical devices).

## Highlights

- Corrective Action (CA) eliminates the cause of a nonconformity that has already occurred to prevent recurrence.
- CA and Preventive Action (PA) together form the CAPA system; CA addresses existing issues while PA addresses potential/future ones.
- CAPA is mandatory for medical device manufacturers under FDA 21 CFR 820.100 and ISO 13485:2016; EU MDR and EU IVDR are also cited.
- Key CA requirements include investigation/root cause analysis, implementation and verification of actions, and thorough documentation/records.
- The page distinguishes correction, remedial action, and corrective action using FDA-related definitions and examples.

## How to cite

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

## Publisher

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

## Topics

- Corrective Action
- CAPA
- Root Cause Analysis
- FDA 21 CFR 820.100
- ISO 13485:2016

## Key entities

- **Botable** (organization): Site/brand hosting the glossary entry. — https://www.botable.ai
- **FDA 21 CFR 820.100** (other): Regulatory requirement cited for CAPA / corrective action documentation.
- **ISO 13485:2016** (other): Standard cited for requirements to investigate nonconformities and evaluate corrective action effectiveness.
- **EU MDR** (other): Referenced regulation (linked from the page). — https://www.botable.ai/glossary/eu-medical-device-regulation-eu-mdr
- **EU IVDR** (other): Referenced regulation.
- **Root Cause Analysis (RCA)** (other): Process referenced as required before implementing corrective action. — https://www.botable.ai/blog/ai-root-cause-analysis
- **HCT/P (21 CFR 1271)** (other): Regulation cited in the documentation section regarding corrective actions.

## Metadata

- Type: article