Device History Record (DHR) Review and Lot Release Checklist
The device history record is where a lot proves it was built as specified. The reviewer who signs the release is the last check before product leaves the building, and errors in records are among the most common findings in inspections. This checklist keeps the review consistent and focused on the items that can actually stop a release.
0 of 30 items complete
13 critical items still open - these are the highest-risk gaps.
Identification and quantities
Materials and traceability
Process records
Inspection, test and acceptance
Sterilization, packaging and labeling
Deviations and final disposition
Any critical item that is not satisfied stops the release until resolved. Use the checklist as a review aid, not a replacement for your device history record procedure. FDA's QMSR incorporates ISO 13485:2016 by reference, so record content is also defined by clauses 4.2.5 and 7.5.1.
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How to use the checklist
Work through the groups in order for each lot. Start with identification and quantities because errors there can invalidate the whole record. Move through materials, process, inspection and sterilization, and finish with open deviations and the release signature. Mark each item as satisfied, not applicable, or an issue, and write the issue on a defect log so it can be corrected by the original author with the proper correction method rather than by the reviewer.
- Review the record on paper or screen in one sitting where possible
- Never correct entries for the operator; return them with a note
- Use a second reviewer for implantable or high-risk devices
- Track record error types for training and trending
What the record must contain
Under the former 21 CFR 820.184, the device history record covers dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records showing the device was made per the device master record, the primary identification label and labeling, and any device identification and control numbers. ISO 13485 clause 7.5.1 carries the same intent, requiring a record for each device or batch that provides traceability and identifies the amount manufactured and approved for distribution. Always follow your own procedure and customer quality agreement for any additional content.
Using the review for improvement
Count the issues found per record over time. A high rate of blank fields points to a form design or training problem, while recurring calibration lapses point to equipment control. Right-first-time record rate is a useful management metric, and electronic batch records can enforce completeness by making fields mandatory. Compare the cycle time of the review with your shipping schedule, since long record reviews are a common cause of late shipments, and consider review by exception for validated, stable processes.
Common mistakes
Reviewers sometimes sign after only checking the final test result, missing that a step was performed out of sequence or with expired material. Another is allowing the production supervisor to review their own record. Late entries without explanation, missing initials and unreconciled labels are repeat findings. Finally, do not release against an open nonconformance on the assumption it will be closed later. The release decision must reflect the status of the lot at that time.
Frequently Asked Questions
Who is allowed to review and release a device lot?
A person designated in your procedure, with authority and training for the task, who did not perform the production steps being reviewed. Many companies reserve final release for quality assurance and require a second review for sterile or implantable devices.
Can I release product before the DHR is fully reviewed?
Not under a compliant procedure. The release decision depends on evidence in the record that the lot was made and accepted as specified. Some processes use staged review during production, but the final review must precede release.
How should I handle a missing signature?
Do not let the reviewer sign for the operator. Return it to the author, who may add a late entry if they remember the activity and can justify it, or raise a nonconformance if the step cannot be verified. Document the decision.
Is an electronic DHR treated differently?
The content requirements are the same. Electronic records and signatures also need controls such as validation, audit trails, access control and, in the US, the expectations of 21 CFR Part 11 where applicable to your records.
If your records are already in an ERP or MES, we can add automated completeness checks so exceptions are flagged before the reviewer opens the file.
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- AI-Powered ERP for Medical Device ManufacturingMedical device ERP with DHR: how the Device History Record is built from work orders, lots, inspections and signatures, plus Part 11 and UDI needs.
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