Device history reviews

A device history review names the device lot and identifier, carries the record package and links to an operational inspection. The authorized inspector submits the review for that selected record. The workflow checks the operational record, lot, identifier, package and reviewed date, then moves the review from pending through incomplete to approved. The linked inspection gives the quality team a way to find the package from the same case used for inspection decisions.

This record is useful when a reviewer needs to know which lot package was examined. A file alone is hard to place in context. The lot and identifier make the reviewed subject clear, while the operational record connects it to the inspection. The review status tells the team whether the package still needs work or has been approved.

• Identity. The lot and device identifier identify the device scope that the package describes.
• Package. The attachment holds the record material that the inspector submits for review.
• Link. The operational record points to the relevant inspection, so the review can be considered with its requirement checks.

For a final inspection of a manufactured lot, the Inspector selects the inspection, enters the lot and device identifier, attaches the record package and records the review date. If the package needs completion, the review remains in the incomplete state. Once the required material is present and reviewed, the case can advance to approved.

Decide the source of the device lot and identifier before the first operating cycle. Agree which document package the team will attach and how its naming relates to the operational inspection. Identify the person allowed to submit the review and the person responsible for resolving an incomplete package. Keep the reviewed date tied to the actual review, rather than using it as a proxy for manufacturing completion.

Choose a representative final inspection for the pilot. It should have a real subject reference and checks that the reviewer can inspect alongside the device history package. This makes a missing identifier, wrong operational record or incomplete attachment visible during rehearsal.

Create a device history review against a selected inspection. Compare the lot and device identifier with the attached package, then confirm that the operational record is the same inspection the quality team expects to review. Submit the case and inspect the status changes. An incomplete package should bring the case back for completion before the approved state is used.

Ask the Quality Reviewer to open the linked inspection and its checks from the device history case. The reviewer should be able to explain why the package belongs to that inspection and whether the date reflects the actual review. The team can then agree how to handle a revised package without losing the identity of the original case.

• Device history review queue — Pending and incomplete lot packages beside their linked inspections.
• Inspection board — The operational inspection and its current decision state.

See device history review and inspection review.