QMS, CAPA & Quality System Management worked example

Calibration Compliance Score with severity of an out-of-tolerance instrument of 15 score: a worked example in qms, capa & quality system management

What does the result look like when severity of an out-of-tolerance instrument reaches 15 score? The full calculation is worked below with real intermediate numbers. Use it when calibration compliance in qms, capa and quality system management needs a defensible ranking against other qms, capa and quality system management risks for the next review.

The inputs for this scenario

  • Severity of an out-of-tolerance instrument: 15 score (raised for this scenario; the documented default is 6)
  • Likelihood the instrument drifts out of calibration: 4 score (unchanged)
  • Chance a drift is caught before it affects product: 3 score (unchanged)

Working through the calculation

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

How this compares with the baseline

  • Against the tool's baseline example, where severity of an out-of-tolerance instrument 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.
  • A figure at this level is achievable when severity of an out-of-tolerance instrument is genuinely sustained, not just peaked for a shift. The score is only comparable when every instrument is rated on the identical scale; mixing rating scales or subjective scoring across raters makes the numbers meaningless.

Results at a glance

  • Calibration compliance risk score: 8.15 score (headline result)
  • Calibration compliance severity score: 15 score
  • Calibration compliance occurrence score: 4 score
  • Calibration compliance detection score: 3 score

Run it with your numbers

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

Last reviewed 2026-05-12.