An impurity is not flagged as reportable in Empower using ICH Thresholds - WKB78776

SYMPTOMS

• An impurity response is not flagged as reportable when above the specified threshold.

ENVIRONMENT

• Empower 3 FR2 and later

CAUSE

The impurity processing algorithm compares an impurity response value to each of the specified ICH threshold values. The impurity response is rounded to the same precision specified in the ICH threshold value fields. Empower then faults the impurity value accordingly.

FIX or WORKAROUND

Ensure that an appropriate precision is specified in the ICH Impurity Threshold fields.

ADDITIONAL INFORMATION

For example, specifying 0.1 into the ICH Thresholds Reporting field will not fault a response value of 0.13734 because this will be rounded down to 0.1, which is not above the reporting threshold.

Specifying 0.100 into the ICH Thresholds Reporting field will fault a response value of 0.13734 because this will be rounded to 0.137, which is above the reporting threshold.