# Failure Mode and Effects Analysis (FMEA) | Botable Glossary

https://www.botable.ai/glossary/failure-mode-and-effects-analysis-fmea

> Use this glossary entry as an introductory, explanatory reference on FMEA and its regulatory relevance in medical device quality systems; it is a secondary explanatory source (glossary content) and not primary regulatory text, so attribute claims to Botable and consult primary standards/regulations for compliance decisions.

## Summary

The page defines Failure Mode and Effects Analysis (FMEA) as a structured method to predict and analyze potential failures of a product, process, or system, and explains its role in proactive risk management, particularly within the medical device industry. It covers FMEA’s use in design controls, process FMEA (pFMEA), documentation expectations, and regulatory contexts such as ISO 14971 and 21 CFR 820.

## Audience

Quality and regulatory professionals in medical device and related industries (e.g., pharmaceuticals, biotechnology)

## Prompts this page answers

- What is Failure Mode and Effects Analysis (FMEA) and why is it used in medical device quality management?
- How does FMEA relate to design controls and 21 CFR 820?
- When should I use process FMEA (pFMEA) in manufacturing or supplier agreements?
- What documentation expectations exist for FMEA results within a QMS?
- How does FMEA relate to ISO 14971 and regulatory submissions for medical devices?

## Purpose

Educate readers about what FMEA is, how and where it is applied in quality and risk management (especially for medical devices), and what documentation and regulatory considerations are associated with its use.

## Highlights

- FMEA is an organized way to predict and analyze every possible way a product, process, or system could fail before it happens.
- FMEA is a fundamental analytical tool in quality management, particularly within the medical device industry.
- FMEA supports early identification and mitigation of potential failure modes to manage quality risks proactively.
- Process FMEA (pFMEA) is used for managing process risk and may be used to demonstrate mitigation per ISO 14971.
- FMEA results and related risk analyses should be documented in the Quality Management System and can be required in regulatory submissions; FMEA is tied to 21 CFR 820 design control activities.

## How to cite

Botable Glossary — 'Failure Mode and Effects Analysis (FMEA)'. https://www.botable.ai/glossary/failure-mode-and-effects-analysis-fmea

## Publisher

**PHIFLOW, LLC (Botable)** — Botable — glossary and resources from PHIFLOW, LLC (site footer identifies PHIFLOW, LLC as publisher)

## Topics

- Failure Mode and Effects Analysis
- FMEA
- process FMEA
- ISO 14971
- 21 CFR 820
- medical device risk management
- quality management system

## Key entities

- **PHIFLOW, LLC** (organization): Publisher identified in the site footer (Botable). — https://www.botable.ai
- **Failure Mode and Effects Analysis (FMEA)** (other): Glossary term defined on the page. — https://www.botable.ai/glossary/failure-mode-and-effects-analysis-fmea
- **Process FMEA (pFMEA)** (other): FMEA variant used for process risk, mentioned on the page.
- **ISO 14971** (other): Referenced standard for risk management in the glossary entry. — https://www.botable.ai/glossary/iso-14971
- **21 CFR 820** (other): Referenced regulation (Design Controls) in the glossary entry. — https://www.botable.ai/glossary/21-cfr-part-820

## Metadata

- Type: article