May 19, 2024 | Mark Paradies

Bad Root Cause Analysis – Common FDA Finding

FDA Warning Letter

Article Says Bad Root Cause Analysis Is a Common Problem

An article about a drug manufacturer’s quality problem said:

Root cause analysis isn’t new, but it is one of the most often misunderstood
quality processes drugmakers must master. In fact, inadequate root cause
analysis is one of the FDA’s most common findings during an inspection.

The article says the publisher can send you a booklet to learn how to perform root cause analysis.

A booklet? You must be kidding.

Would you depend on a booklet for something as important as pharmaceutical quality root cause analysis?

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Amy Teaching a TapRooT® Root Cause Analysis Course

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You don’t want the FDA citing you for bad root cause analysis because you learned a poor technique from a booklet or a YouTube video. Only the best system will do when your pharmaceutical quality is at stake. Learn more about the TapRooT® Root Cause Analysis System today. Then register for one of our courses.

Quality, Root Cause Analysis
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