Managing Product Risk File Risk Controls

Risk Control is the process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels. Risk Controls and New Risks are added to Product Risk File records to capture the Risk Analysis information required to meet regulatory requirements.

From the Product Risk File record, click Other Actions > Manage Risk Control.
Result: The Manage Risk Control window is displayed.
Enter any information regarding the risk analysis for the risk in the Option Analysis field.
Enter the measure to be taken to mitigate the risk.
Zoom to select the hazard the risk control will mitigate. Hazards entered during Risk Analysis are displayed. Once the hazard is selected, the hazardous situation and harm associated with the hazard default. For information on configuration, see Hazards.

NOTE: Each combination of Product, Risk Control Measure, Hazard, Hazardous Situation, and Harm must be unique.

Click the drop down button and select the status of the risk control as it applies to the product risk file, such as Active or Inactive. For information on configuration, see Risk Statuses.

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

Click the Add New Risk + link.
Enter the new risk.

NOTE: Each combination of Product, Risk Control Measure, Hazard, Hazardous Situation, Harm, and New Risk must be unique.

Click the drop down button and select the severity of the new risk, such as Minor. For information on configuration, see Risk Severities.
Click the drop down button and select the status of the new risk as it applies to the product risk file, such as Active or Inactive. For information on configuration, see Risk Statuses.

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

Enter the residual risk evaluation or risk remaining after the risk control measures have been implemented.
Specify how close the related risk control is to being complete.
Enter the risk benefit analysis or projected benefit of the risk control.
Click the Submit button.
Result: The risk control has been added to the product risk file.