Managed Risk Lifecycle

Identified

When the risk or hazard is created, it is in this state. Any CAPA member can create a risk. Any Design Project member can create a hazard.

To promote the risk or hazard to the Evaluated state you must provide values for Probability of Occurrence, Severity, and Risk Reduction Needed. If the value of Risk Reduction Needed is "Yes," you must enter Acceptance Criteria. If the value of Risk Reduction Needed is "No," you must enter the Risk Reduction Not Needed Rationale.

Evaluated

In this state, you can complete the task, provide the details of the control measures taken, and promote the risk or hazard to the Controlled state.

Controlled

After the action plan to control the risk or hazard is implemented, it is promoted to this state.