Failure Mode and Effects Analysis Scoring Guidelines Used in the Example Presented in Appendix A. These guidelines have been taken from the ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (9).
| Value | Severity | Occurrence | Detection |
|---|---|---|---|
| 10 | Injury to a patient or employee | More than once per batch | Not detectable by current methods |
| 7 | Cause extreme customer dissatisfaction | Once per batch | All manually inspected |
| 5 | Something likely to result in a complaint | Once per six months | Statistical sampling |
| 3 | Minor nuisance resulting in no loss | Once every one to three years | 100% inspection |
| 1 | Be unnoticed and not affect performance | One occurrence in greater than five years | Obvious or monitored or alarmed |
Interpretation of RPN Values:
RPN >350, High Risk (Minimum -10 S X 7O X5D)–Additional controls must be identified and implemented
RPN 105–350, Medium Risk (Minimum 5S X 7O X 3D)–Additional controls should be considered for implementation
RPN <105, Low Risk–No additional controls are required