Conducting a Risk Assessment



  1. 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



  1. 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)