Traceability, Serialization & Lot Genealogy worked example

Traceability Audit Readiness with impact severity if traceability fails an audit of 15 score: a worked example

This scenario runs the traceability audit readiness calculation on the strong side: impact severity if traceability fails an audit of 15 score, with every other input held at its documented default. Use it when traceability audit readiness in traceability, serialization and lot genealogy needs a defensible ranking against other traceability, serialization and lot genealogy risks for the next review.

The inputs for this scenario

  • Impact severity if traceability fails an audit: 15 score (raised for this scenario; the documented default is 6)
  • Likelihood of a traceability gap occurring: 4 score (unchanged)
  • Ability to detect gaps before the auditor does: 3 score (unchanged)

Working through the calculation

  • Applying the documented formula (Traceability audit readiness risk score = traceability audit readiness severity score × traceability audit readiness occurrence score × traceability audit readiness detection score) to the inputs above produces each figure below.
  • At this operating point the engine returns 8.15 score for traceability audit readiness risk score, the number this scenario is built around.
  • At this operating point the engine returns 15 score for traceability audit readiness severity score.
  • At this operating point the engine returns 4 score for traceability audit readiness occurrence score.
  • At this operating point the engine returns 3 score for traceability audit readiness detection score.

How this compares with the baseline

  • Against the tool's baseline example, where impact severity if traceability fails an audit sits at 6 score and the headline result is 4.55 score, this scenario comes in 79.12% above the baseline at 8.15 score.
  • Use it during audit prep, after a near-miss traceability escape, or when triaging which genealogy gaps to close first with limited resources. Treat this as a target state: the delta against the baseline quantifies what the improvement is worth before you commit to chasing it.

Results at a glance

  • Traceability audit readiness risk score: 8.15 score (headline result)
  • Traceability audit readiness severity score: 15 score
  • Traceability audit readiness occurrence score: 4 score
  • Traceability audit readiness detection score: 3 score

Run it with your numbers

  • Every input above is editable in the live Traceability Audit Readiness calculator, which recalculates instantly and can be shared with the inputs intact.

Last reviewed 2026-05-12.