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Traceability

Design control traceability

Open QMS uses GitHub's native issue-PR linking for design traceability:

Design Input (Issue) → Design Output (PR) → Verification (linked test/PR) → Validation

How to maintain traceability

  1. Create design inputs as issues using the Design Input template
  2. Reference the input issue in your PR using Closes #123 or Fixes #123
  3. Link verification by referencing test results or verification PRs in the design output
  4. The traceability workflow checks that PRs are linked to issues and generates a trace snippet

Traceability matrix

The traceability.yml workflow generates a traceability snippet for each PR showing: - Which issues are referenced - Which files were changed - The PR number

Repository-wide traceability matrix (forward)

A repository-wide traceability matrix walking the full issue/PR linkage graph (and, eventually, the clause-to-artifact bindings published by each regulatory module) is forward work and will ship with the Open QMS generator engine. Until then, the per-PR snippet above plus GitHub's native issue-PR linkage graph are the working traceability surface.