Managing Product Risk File Hazards

Hazards are potential sources of harm. Hazards and failure modes are added to the product risk file to evaluate risk and capture the Risk Analysis information required to meet regulatory requirements.

From the Product Risk File record, click Other Actions > Manage Hazard.
Result: The Manage Hazard window is displayed.
Zoom to select the hazard, such as Allergic Reaction. For information on configuration, see Hazards.
Click the drop down button and select the probability of the hazard occurring, such as Probable. For information on configuration, see Risk Probabilities.
Zoom to select the hazardous situation. For information on configuration, see Hazardous Situations.
Click the drop down button and select the probability of the hazardous situation occurring, such as Occasional.
Zoom to select the harm that could occur from the hazard. For information on configuration, see Harms.

Zoom from the Severity field to specify the seriousness of an injury that can result from a harm (injury, loss, or damage), such as Major. For information on configuration, see Risk Severities.

NOTE: Once all values have been added, the risk is calculated and displayed based on the number attributed to each rating selected: Hazard Probability(rating) x Hazardous Situation Probability (rating) x Harm Severity (rating).

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

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

Click the Add Failure Mode + link to add a failure mode to the product risk file.
Zoom to select the failure mode. Failure modes associated with the part are displayed. For information on configuration, see Failure Mode Setup.
Zoom to select the root cause for the failure mode. Root causes associated with the failure mode are displayed. For information on configuration, see Causes.

NOTE: Each combination of Product, Hazard, Hazardous Situation, Harm, Failure Mode and Root Cause must be unique.

Click the drop down button and select the status of the failure mode 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 failure mode is added, the status is Active. To deactivate a failure mode for a product risk file, access the existing failure mode for the product risk file by following step one and selecting Inactive as the Status. The failure mode will remain visible in the product risk file with a status of Inactive. Failure modes can be reactivated by following step one and selecting Active as the Status.

Click the Submit button.
Result: The hazard has been added to the product risk file.