Glossary · Evidence, assurance and traceability
Safety evidence
In safety assurance, safety evidence is the records, test results, analyses, approvals, and other artifacts that support a safety claim. Evidence counts only when it is identifiable, controlled and linked to the claim and to the version it applies to.
- Functional safety
- Technical documentation
In one sentence
Safety evidence is the set of records, test results, analyses and approvals that support a safety claim for a specific version.
Example
The safety evidence for a guard interlock on a press includes the PL calculation, the component certificates, the fault injection test report, the signed validation record and the photo of the installed switch.
How it applies
- Evidence: Each item should have an ID, a version, an author, a date and a link to the safety claim it supports. Unlinked files in a shared folder are hard to use as evidence.
- Technical documentation: Much safety evidence ends up in the technical file. Keep it under evidence control so that superseded reports are marked as such.
- Integrated systems: Evidence from suppliers (certificates, safety manuals) must match the delivered variant and version. Check the match at incoming inspection.
- AI and retrieval: Search and AI assistants can surface evidence quickly, but only if metadata such as status and applicability are maintained.
Safety evidence vs. documentation
Not all documentation is evidence. An operating manual is information for the user; a validation report showing that the manual's warnings were reviewed against the risk assessment is evidence.