device history record

Core meaning

A **device history record** (DHR) is the compiled set of manufacturing records that documents how a specific product unit or lot was built, tested, and released, showing it followed the approved device master or product specification.

In regulated industries, the DHR commonly includes:

– Identification of the specific unit, batch, or lot (e.g., serial or lot numbers)
– Reference to the applicable device master record or build specification
– Records of each required manufacturing and inspection step
– Dates, times, and people or equipment performing the work
– Testing and inspection results, including pass/fail decisions
– Records of nonconformances and any rework tied to the unit/lot
– Final release or disposition decision and authorization

A DHR is usually assembled from multiple source systems and documents (MES, LIMS, QMS, equipment logs, paper travelers, labels, and signatures) into a coherent, traceable history for that specific product.

Use in manufacturing workflows

In industrial and regulated manufacturing operations, the device history record is used to:

– Demonstrate that each shipped unit or lot was manufactured and tested according to the approved process
– Provide traceability during investigations, complaints, or recalls
– Support internal quality reviews and external regulatory or customer audits
– Link back to materials, equipment, parameters, and personnel involved in production

Digital execution systems (such as MES or eDHR applications) often capture DHR data in real time, so a complete record can be generated on demand without manual collation.

Boundaries and what it is not

A device history record:

– **Is** the record of *what actually happened* for a specific unit or lot in production.
– **Is not** the device master record (DMR) or product specification. The DMR defines *how it should be made*; the DHR shows *how it was actually made*.
– **Is not** limited to a single document. It may be a compiled set of electronic and paper records, provided they are traceable and controlled.
– **Is not** the same as a batch record in all industries, though the concepts overlap. A batch record usually focuses on process execution for a batch; a DHR is focused on the complete history of a specific device unit or lot.

Common confusion and related terms

– **Device history record vs. device master record (DMR)**: The DMR describes the approved design, materials, and procedures. The DHR documents that a particular unit or lot was manufactured and tested in accordance with that DMR.
– **Device history record vs. batch record**: In some sectors, especially process industries, the primary record is called a batch record. In discrete and regulated device manufacturing, the device history record serves a similar purpose but is tied to device-specific regulations and terminology.
– **Paper DHR vs. eDHR**: The term DHR covers both paper-based and electronic implementations. “eDHR” is often used to emphasize a fully electronic, system-generated history record.

Site context: audit-ready evidence during rate ramps

In the context of audit-ready evidence during a rate ramp, the device history record is the assembled proof that:

– All required process, quality, and configuration steps were completed contemporaneously
– Records are accurate, traceable to people, equipment, and materials, and linked to the correct units or lots
– The full history for any given unit or lot can be retrieved quickly, even under higher production volume and staffing pressure

Operations teams commonly invest in digital data capture and integration so that DHRs remain complete and retrievable without after-the-fact reconstruction.