FREE QUALITY TOOL
FMEA Quality Risk Assessment
RPN = severity x probability x detectability
Facility FMEA
Utilities, rooms and facility systems. Record scientific rationale and qualified review.
| Facility / system | Effect | Cause | S | P | D | Initial RPN | Risk | Mitigation | Post S | Post P | Post D | Residual RPN | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| — | — | — |
Enter complete integer ratings within the selected scale and positive thresholds with Medium greater than Low. Invalid scores remain blank, including in exports. RPN is a prioritization aid—not a universal regulatory acceptance threshold. Risk conclusions require context, rationale and qualified approval.
CALCULATION GUIDE
Understand your calculation
Clear inputs, a practical example and the context you need to interpret your result.
How it works
RPN = severity × probability × detectability. Initial and residual ratings are calculated separately for each row.
Inputs and units
Choose a pathway and 1–5 or 1–10 scale. Enter integer ratings within the scale; higher detectability ratings should mean harder detection. Set ordered positive Low and Medium thresholds and document rating rationale.
Worked example
On a 1–5 scale with Low ≤20 and Medium ≤50: S=4, P=3, D=2 gives RPN 24 (Medium). Post-control 4×1×2 gives 8.
Interpreting the result
Scores prioritize discussion; residual scores represent the proposed or verified control basis recorded by the team. CSV retains the chosen pathway and row data.
Assumptions and limitations
Thresholds are configurable examples, not regulatory limits. Equal RPNs can represent different severity. Blank or invalid scores must not be treated as low risk. Changing pathway clears rows after confirmation; export before leaving.