Every claim a company makes about a finished device has to be supported by records that connect the design, the supplier, the production lot, the inspection results, and the release decision. Two documents anchor that chain.
First article inspection records establish that a part can be manufactured to spec before production scales. The device history record establishes that each subsequent unit actually was. For medical device manufacturers, traceability is not a feature of the quality system. It is the quality system.
Why First Article Inspection Matters More Than It Looks
A first article inspection is the first formal verification that a manufacturing process can produce a part meeting all dimensional, material, and functional requirements. It is performed at the start of a new production run, after significant process changes, or when a new supplier is qualified. The output is a documented comparison between design intent and what the supplier or production line actually produced.
In low-stakes manufacturing, FAI is sometimes treated as paperwork. In medical device manufacturing, it is one of the most important risk-reduction activities a company can perform. A successful FAI confirms three things at once: the specification is manufacturable, the supplier or production line can produce it, and the inspection method itself can detect deviations.
The Handoff From FAI to Production
A complete FAI is only useful if its results carry forward into production. This is where many companies lose the thread. The report sits in a quality folder or a supplier file, while production operates from work instructions and a separate set of drawings. When a deviation is approved during FAI, the approval may not propagate into the production specification. For companies operating with paper-based or fragmented systems, this handoff is one of the most common sources of audit findings.
Building the Device History Record Unit by Unit
Once production begins, the device history record takes over. Required under FDA 21 CFR Part 820.184, the DHR documents the manufacturing history of each unit or batch of finished devices. A complete record typically includes:
- Manufacturing dates, quantities produced, and quantities released for distribution
- Acceptance records demonstrating the device met specifications
- Primary identification labels and unique device identifiers (UDIs)
- Supplier certificates of analysis tied to the components used
- Signatures and dates from personnel performing and approving each step
A well-constructed DHR is more than a compliance artifact. It is the operational record that allows a company to investigate complaints, conduct recalls, and improve processes over time.
Electronic Records and the Connected Approach
Electronic device history records, often called eDHRs, capture manufacturing data automatically as production occurs. Operators confirm steps in the system. Inspection results are recorded against the unit. Supplier certificates are linked to the components used. The record is built in real time, not assembled after the fact.
The deeper value comes when the eDHR sits within a connected platform that also holds the design history file, the device master record, supplier records, and complaint history. A reviewer signing off on release can see the design intent, the manufacturing spec, the actual production records, and any open quality issues from one screen rather than five.
Common Failure Modes Auditors Look For
Experienced FDA inspectors know where the gaps usually live. Common findings include FAI records that do not match the current drawing revision, approved deviations during FAI that are not reflected in production work instructions, DHRs missing acceptance records or UDI information, inconsistencies between the device master record and the DHR for the same product, supplier certificates referenced but not attached, and release decisions made without documented review of the complete record.
Traceability as a System, Not a Document
Companies that consistently pass audits share a common trait. They do not manage traceability as a series of documents. They manage it as a system. Each record points to every other record that depends on it or supports it. Changes propagate automatically. Reviews happen in workflow, with electronic signatures and audit trails. The entire chain, from first article inspection to final release, exists as a connected whole rather than a set of folders. For manufacturers facing the FDA’s Quality Management System Regulation (QMSR) transition, this connected approach is no longer optional.
