About Risk Assessment

A risk object contains information about the potential impact of a risk. It also contains a Risk Priority Number that is the product of the severity of the risk and its probability of occurrence.

After a risk is identified, an action plan is devised to control the risk. The acceptance criteria to be satisfied is also provided. Action tasks are created, scheduled, and assigned to CAPA members. The assignee completes the task and provides the details of the measures taken to control the risk.

The lifecycle of a risk consists of three states.

• Identified: When the risk is created, it is in this state. Any CAPA member can create a risk. You must provide the details such as the Probability of Occurrence, Severity, Acceptance Criteria if the value of Risk Reduction Needed is Yes, and Risk Reduction Not Needed Rationale if the value of Risk Reduction Needed is No, to promote the risk to the Evaluated state.
• Evaluated: In this state, you can complete the task, provide the details of the control measures taken, and promote the risk to the Controlled state.
• Controlled: After the action plan to control the risk is implemented, it is promoted to this state.