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

  1. Design History File Audit opens each linked test report and checks it proves its input.
  2. For design quality teams: fourteen links changed overnight.
  3. ISO 13485 asks for criteria and a sample size rationale. Agents check both.
  4. The V for a knee update, each link colored by proof.
  5. Input DI-0312 needs 250 newtons. TR-0881 passed, at 295.
  6. But it tested older parts: rev B inserts, a rev C tray, a rev A tab.
  7. Seraphine opens both pages, and confirms the gap.
  8. Paavo opens the same record himself, reads both pages, and countersigns.
  9. Every signature carries its meaning, on the audit trail.
  10. 386 reports read; 71 links do not prove their input.
  11. Built on Botminds: agents, data, screens and governance on one platform.

The narration as written for the film. Captions are on the player.