Document & Record Controls
Document and record controls are foundational to the QMSR quality system. They ensure that the correct version of documents is in use and that manufacturing history can be traced and verified.
Key documents and records in the QMSR
Device Master Record (DMR) — § 820.181
The DMR is the compilation of records containing the procedures and specifications for a finished device. It is the reference document set — it defines what the device should be and how it should be made.
The DMR must include or reference:
- Device specifications (design drawings, formulations, component specifications)
- Production process specifications and procedures
- Quality assurance procedures and specifications
- Packaging and labelling specifications
- Installation, maintenance, and servicing procedures
The DMR must be documented, dated, and signed by a designated individual.
Device History Record (DHR) — § 820.184
The DHR is the compilation of records for each manufactured batch, lot, or unit. It demonstrates that the device was manufactured in accordance with the DMR.
The DHR must include:
- Dates of manufacture
- Quantity manufactured and released
- Acceptance records (inspection and test results)
- Primary identification label and labelling used
- Equipment identifications used
- Batch or lot numbers of components used
DHRs must be retained for the design and expected life of the device — at minimum 2 years from the release date.
Quality System Record (QSR) — § 820.186
General quality system activities and documentation must be maintained, including management reviews, training records, and audit results.
Document control requirements — § 820.40
All documents required by the QMSR must be controlled. Document control procedures must address:
| Requirement | Description |
|---|---|
| Document approval | Documents must be reviewed and approved before issue |
| Document availability | Correct versions must be available at point of use |
| Obsolete documents | Must be promptly removed from use and identified |
| Change control | Changes must be reviewed and approved by the same function that approved the original; changes communicated to affected personnel |
| Retention | Retention periods must be defined for all record types |
Common FDA 483 findings in document control
- Current revision documents not available at the point of use
- SOPs referencing documents that have been revised without the SOP being updated
- Obsolete documents still accessible to production personnel
- Change records lacking adequate justification or approvals
Official resources
For devices with indefinite or unknown expected life (e.g., implants, prosthetics), DHRs must be retained for at least 5 years from date of release, or according to a manufacturer-defined retention period that is justified and documented in the quality system. Consult product-specific FDA guidance for retention recommendations.