Table 2 Risk level classification [19]
Risk priority number (RPN) | Risk category | Decision on admissibility of risk |
|---|---|---|
1–4 | Low | The risk is acceptable. No further action is required |
5–9 | Medium | Risk mitigation measures should be investigated to determine if the risk can be reduced. If the risk cannot be reduced, the risk can be accepted and the decision to accept must be properly documented |
10–16 | High | Risk mitigation procedures are required. If the high risk cannot be reduced, formal acceptance and documentation of the risk by appropriate decision makers (including members of the quality department) is required |