Managing Product Risk File Uses and Misuses

Uses and misuses are added to product risk files to capture the Risk Planning information required to meet regulatory requirements. Product uses and misuses capture the intended uses and possible misuses for a product.

From the Product Risk File record, click Other Actions > Manage Product Use/Misuse.
Result: The Manage Product Use/Misuse window is displayed.
Click the drop down button and select the type of intended use or misuse to be added to the product risk file, such as Intended Use or Foreseeable Misuse. For information on configuration, see Risk Use and Misuse Types.
Enter a description of the product use/misuse.

NOTE: Each combination of Product, Type, and Description must be unique.

Click the drop down button and select the status of the product use/misuse being added to the product risk file, such as Active or Inactive. For information on configuration, see Risk Statuses.

NOTE: By default, when a use or misuse is added, the status is Active. To deactivate a use or misuse for a product risk file, access the existing uses and misuses for the product risk file by following step one and selecting Inactive as the Risk Status. The use or misuse will remain visible in the product risk file with a status of Inactive. Uses and misuses can be reactivated by following step one and selecting Active as the Risk Status.

Click the Submit button.
Result: The use or misuse has been added to the product risk file.