From Root Cause to Real Cause

 Let’s face it; nothing new can be said about root cause analysis (RCA). Standard RCA techniques have been around for decades, and before them being documented and referred to as RCA techniques, they were being employed. It is human to ask why. While it may not be human to ask why five times, it is natural to get to the bottom of problems. Unfortunately, in the regulated world of medical device and pharmaceutical manufacturing, there is a temptation to require intense documentation to prove that not only was the real root cause found but that it was accomplished by following strict processes. The emphasis on establishing the work was done often takes away from real RCA and actual problem-solving. Read More.

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