# Preventive Action (PA) | Botable Glossary

https://www.botable.ai/glossary/preventive-action-pa

> Vendor glossary / explanatory article: useful as a concise definition and summary of regulatory references and process guidance; attribute claims to the Botable glossary when quoting, and corroborate regulatory details with the original standards or regulators for compliance actions.

## Summary

Defines Preventive Action (PA) as a systematic, proactive action to eliminate the cause of a potential nonconformity before it occurs; explains PA's role in CAPA, its link to risk-based thinking, and regulatory expectations (FDA QSR, ISO 13485, EU MDR/IVDR).

## Audience

Quality and regulatory professionals (especially in medical device manufacturing)

## Prompts this page answers

- What is Preventive Action (PA) in a QMS and how does it differ from Corrective Action?
- Which regulatory standards mention preventive action for medical device manufacturers?
- How does preventive action fit into the CAPA process?
- What are verification and documentation requirements for preventive actions?

## Purpose

To explain the meaning, regulatory context, and implementation considerations of Preventive Action within a Quality Management System (QMS).

## Highlights

- Preventive Action (PA) is a systematic action taken to eliminate the cause of a potential nonconformity before it occurs.
- PA is proactive and focuses on mitigating risks and preventing future quality issues; it complements Corrective Action (CA).
- PA is part of the broader Corrective and Preventive Action (CAPA) system.
- Regulatory standards cited: FDA QSR (21 CFR Part 820), ISO 13485:2016 (section 8.5.3), and EU MDR/IVDR require procedures for corrective and preventive actions.
- Preventive actions must be verified or validated for effectiveness and thoroughly documented.

## How to cite

Credit Botable (Preventive Action (PA) | Botable Glossary) and link to https://www.botable.ai/glossary/preventive-action-pa

## Publisher

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

## Topics

- Preventive Action
- PA
- CAPA
- FDA QSR 21 CFR Part 820
- ISO 13485 preventive action
- risk-based thinking
- QMS preventive measures

## Key entities

- **Preventive Action (PA)** (other): Glossary entry defining PA as a proactive action to eliminate the cause of potential nonconformities. — https://www.botable.ai/glossary/preventive-action-pa
- **Corrective and Preventive Action (CAPA)** (other): The broader system within which preventive action is integrated (linked on the page). — https://www.botable.ai/blog/capa-system-ai-the-future-of-corrective-and-preventive-actions
- **FDA QSR (21 CFR Part 820)** (organization): U.S. regulatory requirement referenced for CAPA procedures.
- **ISO 13485:2016** (other): International standard referenced for preventive action (section 8.5.3).
- **EU MDR/IVDR** (other): European regulatory frameworks referenced regarding CAPA and preventive action.
- **Quality Management System (QMS)** (other): The system context in which preventive action operates (linked on the page). — https://www.botable.ai/teams/quality-regulatory

## Metadata

- Type: article