Measure process threats with scoring and action priorities. Review matrix zones, residual exposure, and controls. Turn scattered defects into focused quality decisions today fast.
| Failure Mode | Severity | Likelihood | Detectability | Exposure | Weighted RPN | Residual Score | Level |
|---|---|---|---|---|---|---|---|
| Label mismatch | 3 | 2 | 3 | 1.2 | 21.60 | 8.64 | Low |
| Seal integrity drift | 4 | 3 | 4 | 1.8 | 86.40 | 36.29 | Moderate |
| Contamination event | 5 | 4 | 4 | 2.4 | 192.00 | 96.00 | High |
| Critical gauge failure | 5 | 5 | 5 | 3.0 | 375.00 | 225.00 | Critical |
Base RPN = Severity × Likelihood × Detectability
Weighted RPN = Base RPN × Exposure Factor
Residual Factor = (Control Gap × 0.60) + (Coverage Gap × 0.40)
Control Gap = 1 − (Control Effectiveness ÷ 100)
Coverage Gap = 1 − (Inspection Coverage ÷ 100)
Residual Score = Weighted RPN × Residual Factor
Expected Defects = Units at Risk × (Likelihood ÷ 5) × Coverage Gap
Expected Quality Loss = Expected Defects × Cost Per Defect × (Severity ÷ 5)
This model blends classic FMEA logic with control and inspection performance. It helps compare inherent exposure with the remaining risk after existing safeguards are applied.
It estimates inherent and residual quality risk using severity, likelihood, detectability, exposure, controls, and inspection coverage. It also estimates expected quality loss and compares residual risk with your threshold.
Detectability reflects how hard it is to find a defect before release. A higher detectability score raises the base RPN because hidden defects usually create more downstream quality exposure.
Exposure scales the risk when a failure can affect more batches, customers, lines, or products. Use lower values for isolated cases and higher values for widespread process reach.
Weighted RPN shows the size of the unmitigated risk after exposure is considered. Residual risk reduces that value based on current controls and inspection coverage.
The priority index compares residual score with the risk appetite threshold. Values above 100 percent mean the issue exceeds the threshold and should receive stronger action.
Use a threshold aligned with your quality system, customer expectations, regulatory needs, and internal escalation rules. Teams often set lower thresholds for safety or compliance-related defects.
Yes. The outputs provide a documented scoring basis, visible matrix placement, estimated loss, and a clear recommendation. That makes it useful for CAPA discussions and audit evidence packs.
No. You can apply it to service quality, validation gaps, supplier issues, documentation errors, complaint trends, testing failures, and other process risks where scoring is appropriate.
Important Note: All the Calculators listed in this site are for educational purpose only and we do not guarentee the accuracy of results. Please do consult with other sources as well.