# Quality event | Botable Glossary

https://www.botable.ai/glossary/quality-event

> A vendor-hosted glossary entry that explains regulatory concepts and processes; useful as an explanatory reference but not a substitute for primary regulatory texts. Attribute claims to Botable and cross-check regulatory requirements (e.g., 21 CFR Part 803) against official FDA guidance when making compliance decisions.

## Summary

A Quality Event is any occurrence affecting the quality, performance, or conformity of a product, process, or system that typically triggers investigation and action within a Quality Management System (QMS). The page explains examples (nonconformities, deviations, complaints, audit findings), the role of CAPA, MDR reportable events under FDA 21 CFR Part 803, and management, documentation, and remedial actions such as 5-day reporting and recalls.

## Audience

Quality and regulatory professionals in medical device and related industries

## Prompts this page answers

- What is a quality event in a medical device Quality Management System (QMS)?
- Which types of incidents trigger CAPA in medical device manufacturing?
- What makes a Quality Event reportable under FDA 21 CFR Part 803 (MDR)?
- What documentation and timelines are required when a reportable medical device event occurs?

## Purpose

Define and explain the concept of a 'Quality Event' (particularly in medical device/regulatory contexts) and how such events relate to CAPA, MDR reporting, and QMS documentation.

## Highlights

- A Quality Event is any occurrence involving quality, performance, or conformity of a product, process, or system that triggers investigation and action within the QMS.
- Quality Events include nonconformities, deviations, audit findings, and customer complaints and often trigger the Corrective and Preventive Action (CAPA) process.
- MDR reportable events (21 CFR Part 803) are Quality Events that reasonably suggest a device caused or contributed to death or serious injury, or certain malfunctions.
- Manufacturers must document evaluation, investigation, CAPA activities, complaint files, and determine when events meet FDA reporting criteria.
- Serious reportable events that necessitate remedial action require a manufacturer report no later than 5 work days after awareness.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/quality-event

## Publisher



## Topics

- quality event
- Corrective and Preventive Action (CAPA)
- MDR reportable event
- medical device quality
- QMS complaint handling

## Key entities

- **Quality Management System (QMS)** (other): Referenced as the system where quality events trigger investigation and action. — https://www.botable.ai/blog/quality-management-system
- **Corrective and Preventive Action (CAPA)** (other): Described as the process triggered by many quality events. — https://www.botable.ai/blog/unlock-capa-management-ai-chatbot-insights
- **21 CFR Part 803 (MDR)** (other): U.S. FDA medical device reporting regulation referenced on the page.
- **Botable** (other): The website hosting the glossary entry. — https://www.botable.ai

## Metadata

- Type: article