Glossary · Evidence, assurance and traceability
Evidence package
In safety assurance, an evidence package is a controlled set of related evidence supporting a claim, function, risk control, or change. It bundles the items, their versions and their links so that a reviewer can assess them together.
- Technical documentation
- Verification
In one sentence
An evidence package bundles the controlled, versioned evidence for one claim, safety function, risk control or change.
Example
The evidence package for a modified guard on a CNC machine contains the impact analysis, the updated risk assessment entry, the new drawing, the retest report and the revised manual topic, all with versions.
How it applies
- Evidence: Define the expected contents per package type (safety function, change, release) so that missing items stand out.
- Change control: Every significant change should produce a package: what changed, why, what was re-verified and which documents were updated. This is the practical output of change control.
- Technical documentation: Packages feed the technical file and support audit readiness. Reference items rather than copying them, so that there is one controlled version.
- Integrated systems: For integrated lines, packages may include supplier evidence. Check that each item matches the delivered version.
Evidence package vs. technical file
The technical file is the complete documentation required by machinery law for a product. An evidence package is a smaller, focused set for one claim or change, and many packages together support the file.