Risk evaluation is the process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk for a product. This information is required to meet regulatory requirements.
From the Product Risk File record, click Other Actions > Manage Risk Evaluation. Result: The Manage Risk Evaluation window is displayed.
Click the drop down button and select the product risk level, such as Low or Medium.
Specify whether or not the risk is acceptable. For information on configuration, see Risk Acceptance.
Enter the rationale behind the risk evaluation decision.
Click the Submit button. Result: The risk evaluation has been added to the product risk file. The part is updated with the product risk selected during this evaluation.