Device History Record Procedure
Compile and review the production records for each medical device work order with this editable Device History Record (DHR) Procedure and related forms. It guides batch or lot documentation, acceptance results, labeling and identification records, review of incomplete entries and authorization of final release into finished goods.
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Supplied as three editable Microsoft Word documents (the procedure and two forms) in a digital download.
Work-order production records and release review
The Device History Record (DHR) Procedure governs the process of compiling and completing documentation made part of the DHR. Completion of the Device History Record, and associated DHR checklists, becomes documented evidence that the device batch / lot has been manufactured in accordance with the Device Master Record (DMR).
The device history record assembles evidence for each lot, batch or unit: manufacturing steps performed, acceptance results, quantities, identification or labeling information and final release status. The procedure links those records to the controlled device master record and addresses review of incomplete or discrepant entries before release. This lets a reviewer trace a finished device to the specifications and operations that applied when it was built.
The revised procedure references ISO 13485:2016 and FDA QMSR record requirements in 21 CFR 820.35.
Related production documentation
For checks before the next work order begins, see the Line Clearance Procedure.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Production Records, Line Clearance and Shipment for workflow guidance, a checklist and common mistakes.
