QUOTED. Feb. 20, 2019. Karl Vahey.
Executive Summary
When a device-maker is trying to figure out what went wrong with a troublesome product, launching a failure investigation is a must. But a firm can find itself in hot water quickly if it kicks off the investigation with a weak or incorrect problem statement, Cardinal Health's Karl Vahey says.
"If you don’t have an accurate problem statement, you’re going to be going after the wrong thing and ultimately implement a corrective action that is not applicable to the problem that you have." –Karl Vahey, VP of Operations Quality, Cardinal Health Inc.
- Find out more: Medtech Tips: First-Rate Problem Statement Key To Failure Investigations, Cardinal Health Quality VP Says
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