# Traceability (in QMS) | Botable Glossary

https://www.botable.ai/glossary/traceability-in-qms

> A concise glossary/explanatory resource from Botable: useful for quick definitions and practical points about regulatory expectations; cite the page when referencing its definitions and regulatory summaries and do not treat it as primary regulatory/legal guidance.

## Summary

The page defines traceability in a Quality Management System (QMS) as the systems and records that allow a product or batch to be traced through its lifecycle, explains how Unique Device Identifiers (UDI) and Device History Records (DHR) support traceability, and describes regulatory requirements under the FDA Quality System Regulation (QSR) and the EU Medical Device Regulation (MDR).

## Audience

Manufacturers and quality/regulatory professionals in regulated industries (medical device, pharmaceuticals, biotechnology)

## Prompts this page answers

- What does traceability mean in a Quality Management System (QMS)?
- How does the Unique Device Identifier (UDI) support traceability?
- What documentation is required for traceability in medical device manufacturing?
- What do FDA Quality System Regulations say about identification and traceability?
- How does traceability relate to recalls and risk management?

## Purpose

To explain what traceability means within a QMS, summarise related regulatory requirements (FDA QSR, EU MDR), and describe the documentation and risk-management implications for manufacturers.

## Highlights

- Traceability in QMS is the ability to follow the history, location, or application of a product, part, or material using recorded identification codes (e.g., UDI or control numbers).
- FDA Quality System Regulation (QSR) requires manufacturers to establish and maintain procedures for identification and traceability to ensure finished devices are safe and effective.
- The UDI comprises a Device Identifier (DI, fixed) and a Production Identifier (PI, variable) such as lot, serial number, or expiration date.
- Traceability records must be documented in the Device History Record (DHR), which includes production history, date of manufacture, quantity released, and acceptance records.
- Traceability supports nonconformity/corrective action, links hazards to risk management files (RMF), and is essential for recalls, adverse events, and field safety corrective actions.

## How to cite

Botable Glossary — "Traceability (in QMS)"; link to https://www.botable.ai/glossary/traceability-in-qms

## Publisher



## Topics

- traceability in QMS
- Unique Device Identifier
- Device History Record
- FDA Quality System Regulation
- EU Medical Device Regulation
- UDI DI PI
- risk management file

## Key entities

- **Traceability (in QMS)** (other): Glossary entry defining traceability within a Quality Management System. — https://www.botable.ai/glossary/traceability-in-qms
- **Unique Device Identifier (UDI)** (other): Identifier designed to uniquely identify a device throughout distribution and use; consists of Device Identifier (DI) and Production Identifier (PI).
- **Device Identifier (DI)** (other): The mandatory, fixed portion of the UDI that identifies the specific version or model and the labeler.
- **Production Identifier (PI)** (other): The conditional, variable portion of the UDI that identifies lot/batch, serial number, expiration date, or date of manufacture.
- **Device History Record (DHR)** (other): Record that documents the production history of a finished device, including identification codes, date of manufacture, quantity released, and acceptance records.
- **Risk Management File (RMF)** (other): Formal documentation for risk management that must include traceability linking hazards to risk analyses and controls.
- **FDA Quality System Regulation (QSR)** (organization): Regulatory requirement cited as mandating procedures for identification and traceability.
- **EU Medical Device Regulation (MDR)** (organization): European regulation noted as placing greater emphasis on traceability and verification of UDI assignments.

## Metadata

- Type: article