Traceability, Serialization & Lot Genealogy worked example

Traceability Audit Readiness with impact severity if traceability fails an audit of 3 score: a worked example

Here is what the math looks like when conditions slip. We hold every other input steady and drop impact severity if traceability fails an audit to 3 score, then walk the calculation through step by step. Estimate traceability audit readiness for traceability, serialization and lot genealogy using production-ready inputs so teams can rank risks and decide which issue needs containment, controls, or escalation first.

The inputs for this scenario

  • Impact severity if traceability fails an audit: 3 score (the input this scenario stresses; the baseline uses 6)
  • Likelihood of a traceability gap occurring: 4 score (held at the documented default)
  • Ability to detect gaps before the auditor does: 3 score (held at the documented default)

Working through the calculation

  • The calculation starts from the formula this tool documents: Traceability audit readiness risk score = traceability audit readiness severity score × traceability audit readiness occurrence score × traceability audit readiness detection score.
  • Traceability audit readiness risk score works out to 3.35 score at these inputs, and this is the headline figure for the scenario.
  • Traceability audit readiness severity score works out to 3 score at these inputs.
  • Traceability audit readiness occurrence score works out to 4 score at these inputs.
  • Traceability audit readiness detection score works out to 3 score at these inputs.

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 26.37% below the baseline at 3.35 score.
  • The practical read: the gap between this scenario and the baseline is entirely attributable to impact severity if traceability fails an audit, so recovering it is worth quantifying in dollars before considering equipment or staffing changes. RPN treats the three factors as equally weighted multiplicatively, so a very high severity can be masked by low occurrence — always review high-severity items regardless of total score.

Results at a glance

  • Traceability audit readiness risk score: 3.35 score (headline result)
  • Traceability audit readiness severity score: 3 score
  • Traceability audit readiness occurrence score: 4 score
  • Traceability audit readiness detection score: 3 score

Run it with your numbers

  • To rerun this with your own numbers, open the live Traceability Audit Readiness calculator, set impact severity if traceability fails an audit to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.