Sterilization & Sterile Barrier Manufacturing worked example

Compliance Documentation with documentation defect severity rating of 15 score: a worked example in sterilization & sterile barrier manufacturing

Push documentation defect severity rating up to 15 score and the picture changes. This example computes every intermediate figure at that operating point. Use it when compliance documentation in sterilization and sterile barrier manufacturing needs a defensible ranking against other sterilization and sterile barrier manufacturing risks for the next review.

The inputs for this scenario

  • Documentation defect severity rating: 15 score (raised for this scenario; the documented default is 6)
  • Documentation defect occurrence rating: 4 score (unchanged)
  • Documentation defect detection rating: 3 score (unchanged)

Working through the calculation

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

How this compares with the baseline

  • Against the tool's baseline example, where documentation defect severity rating 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.
  • It computes a Risk Priority Number for a compliance documentation failure mode by multiplying its severity, occurrence, and detection scores. The value of this scenario is the size of the gap it exposes: that gap, priced out over a year, is the budget you can justify spending to close it.

Results at a glance

  • Compliance documentation risk score: 8.15 score (headline result)
  • Compliance documentation severity score: 15 score
  • Compliance documentation occurrence score: 4 score
  • Compliance documentation detection score: 3 score

Run it with your numbers

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

Last reviewed 2026-05-12.