Suspect links: a requirement changed after its test passed
A suspect link is a trace between a requirement and its verification where the requirement changed after the verification last passed. The pass was recorded against an earlier version, so the link can no longer be taken as proof until someone looks at it.
The rule the finder applies
A requirement is changed since verified when its last-changed date is strictly later than the date of its latest passing verification. The same day is not raised. Where several verifications are linked, the latest passing date is the one compared. A blank last-changed date, or a pass with no date, is named as a question on the line and never read as a pass.
Why the standards care
- ISO 13485 7.3.9: Control of design and development changes
- FDA QMSR 820.10: Quality management system requirements: ISO 13485 incorporated by reference
- FDA QMSR 820.35: Control of records: retention, audit trail and the records FDA adds
- AS9100D 8.3.6: Design and development changes
- IATF 16949 8.3.6.1: Design and development changes - supplemental
- ISO 26262 Part 8, 6.4.3: Management of safety requirements
- ISO 26262 Part 8, 8.4.5: Implementing and documenting the change
- IEC 62304 5.6.6: Conduct regression tests
- IEC 62304 5.7.3: Retest after changes
What clears it
Re-verification against the current version, or a recorded decision, with its reason, that the change needs none (an editorial change, for example). Either belongs in the change record, which is where the assessor will look.