Devicemakers Need to Trend Rare Unexpected Events

Devicemakers should not risk warning letters or Form 483s by using the low frequency of a nonconformance as a reason not to track the event. If the average frequency for a nonconformance is extremely low, even one occurrence could be a trend, James Miller, senior quality analyst for core quality systems at Roche Diagnostics, said during an FDAnews webinar.
Devices & Diagnostics Letter