⚠️ Quality Risk Management
FMEA / RPN Risk Matrix Calculator
Build a Failure Mode and Effects Analysis (FMEA) table aligned with ICH Q9 Quality Risk Management. Score Severity (S), Occurrence (O), and Detection (D) on a 1–10 scale. The Risk Priority Number (RPN = S × O × D) is calculated automatically.
| Process Step | Failure Mode | Effect of Failure | Cause of Failure | Current Controls | S 1–10 |
O 1–10 |
D 1–10 |
RPN | Recommended Action |
|---|
Risk Heatmap
Add rows and score them to see the risk heatmap
Scoring Guide (ICH Q9)
Severity (S)
1–2Negligible / Minor
3–4Low — slight harm
5–6Moderate — patient risk
7–8High — regulatory issue
9–10Critical — recall / death
Occurrence (O)
1–2Very unlikely (once in lifetime)
3–4Low (once/year)
5–6Moderate (monthly)
7–8High (weekly)
9–10Almost certain (daily)
Detection (D)
1–2Almost certainly detected
3–4High chance of detection
5–6Moderate detection
7–8Low detection chance
9–10Cannot be detected
RPN = S × O × D
RPN < 50: Acceptable · 50–100: Monitor · 101–200: Action required · >200: Immediate action
Reference: ICH Q9 Quality Risk Management; FDA Process Validation Guidance (2011)
RPN < 50: Acceptable · 50–100: Monitor · 101–200: Action required · >200: Immediate action
Reference: ICH Q9 Quality Risk Management; FDA Process Validation Guidance (2011)