Adding Operation Specific Failure Modes

From the SmartSolve Portal Page, click the Home tab.
In the Setup and Policy section, click Setup.
In the Process section, click Operation.
Result: The Operations window is displayed.
Click the arrow for the appropriate operation.
Click Failure Mode.
Result: The Failure Mode tab is displayed.
Click Action > Add.
Result: The Operation Failure Mode entry window is displayed.

Enter the information in the following failure mode fields:

Field	Definition
Failure*	Enter the name of the new failure mode.
Failure Category	Click the drop down button and select the type of failure. This field is used for sorting exceptions and failures. Category is a way to group different failure modes for better reporting.
Description	Enter a description of the new failure mode.
Status*	Click the drop down button and select the status to be associated with the failure mode. ACTIVE - Indicates that the failure mode has occurred recently. INACTIVE - Indicates that the failure mode has not occurred recently. Failures with this status will not be present in the exception created. NEW - Indicates that the failure mode is being recorded for the first time. SUSPECT - SUSPECT is not applicable to CAPA Management.
Exception Type	Click the drop down button and select the type of exception. If no exception type is selected, this field defaults to All.
Exception Sub Type	Click the drop down button and select the sub type of the exception. If no exception sub type is selected, this field defaults to All.
Analysis Code	Zoom to select the analysis code for the failure mode.
Severity*	Click the drop down button and select the default severity of the failure on this particular product/process.
Volume Tolerance	Enter the volume of failures that can be tolerated for the failure mode before action can be taken. Then enter the time within which the failures occur in the Within field.
Occurrence Rating	Click the drop down button and select the default occurrence rating for the risk assessment of the failure mode.
Detection Rating	Click the drop down button and select the default detection rating for the risk assessment of the failure mode.
Count Tolerance	Enter the number of failures that can be tolerated for the failure mode before action can be taken. Then enter the time within which the failures occur in the Within field.
Est. Cost	Enter the estimated cost of the failure. This field is used by the quality team to identify the cost of this failure. Pareto reports can be run in the system to determine the cost and number of failures that are occurring.

Click the Save button.
Result: The new operation specific failure mode has been added.