Conducting an Impact Assessment
Conducting a Risk Assessment
- Overview
- While determining the impact of the CAPA a risk assessment may be required
- A risk assessment can be started in the Impact Details section of the CAPA
- How to create a Risk Assessment
Step 1: Choose the checkbox Conduct Risk Assessment? under Impact Details section
Step 2: A button "ASSESS RISK" shall appear, click on the button to start a risk assessment.
Step 3: Clicking on the ASSESS RISK button shall open a new risk assessment in a dialog
- Complete all the mandatory information or refer to the Risk Assessment module for further details
- Submit the Risk assessment and you shall observe that the risk has been added under the impact details section as shown below
- The Risk Indicator and Risk Rating shall be set based on the highest risk assessment (multiple risk assessments can be conducted)