Tag Archives: medical device

Tom Weaver, President, Weaver Consulting
CAPA Corner

Step 1 – Key Investment for Success with a Root Cause Investigation

By Tom Weaver
Tom Weaver, President, Weaver Consulting

In this second of a series of articles on conducting a root cause investigation we explore a key investment every investigator should make: understanding the problem before defining a solution! Unfortunately, investigations often begin by brainstorming possible causes and prioritizing them for further analysis – leading to a trial and error approach resulting in a prolonged, expensive, and often failed investigation. With Step 1 we try to truly understand the performance problem.

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