Design History File (DHF) Audit demo
Design quality engineers see which trace links really prove their input, down to a report run on rev B while rev D shipped, with both pages cited. 1:26
What the demo shows
A design history file audit: every linked test report opened and checked against its input
Agents open all 386 linked reports (9,804 pages) for a knee implant update and check five things a link cannot show: the criterion equals the input, the tested revision is the released one, the sample size has a rationale whose sum holds, the result passed, and the report is approved. Of 1,214 links, 1,135 prove their input and 71 do not; 22 requirements have no link. The design quality engineer confirms, the design assurance manager countersigns, a systems engineer answers.
Transcript
- Design History File Audit opens each linked test report and checks it proves its input.
- For design quality teams: fourteen links changed overnight.
- ISO 13485 asks for criteria and a sample size rationale. Agents check both.
- The V for a knee update, each link colored by proof.
- Input DI-0312 needs 250 newtons. TR-0881 passed, at 295.
- But it tested older parts: rev B inserts, a rev C tray, a rev A tab.
- Seraphine opens both pages, and confirms the gap.
- Paavo opens the same record himself, reads both pages, and countersigns.
- Every signature carries its meaning, on the audit trail.
- 386 reports read; 71 links do not prove their input.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.