Example Risk Analysis for Process Room A100
| Hazard | Sub-Factor Outcome | Probability Score | Severity Score |
|---|---|---|---|
| Temperature | Cold room | 0 | 1 |
| Wet or dry area | Dry area | 1 | 0 |
| Drain | None | 0 | 0 |
| Processing | Open | 0 | 3 |
| Duration of activity | Long | 3 | 3 |
| Cleaning and disinfection | High level | 1 | 0 |
| Distance from final formulation | Two steps removed | 0 | 2 |
| Room occupancy | Medium | 2 | 0 |
| Equipment | Fixed | 0 | 1 |
| Environmental monitoring performance | Standard | 2 | 0 |
| Total scores | 9 | 10 |
Risk Class 2.
Detection method: Medium.