July 23, 2007 | Mark Paradies

Monday Accident and Lessons Learned: FDA Warning Letter Cites Inadequate Root Cause Analysis

What can inadequate root cause analysis get you? A warning letter from the US FDA and a big headache.

Recent press reports detail the headaches of Srtyker Ireland, LTD and their troubles with the FDA. For more information see these links:

http://www.reuters.com/article/health-SP/idUSN1926664420070619

http://www.fdanews.com/newsletter/article?issueId=10468&articleId=96073

http://www.fda.gov/foi/warning_letters/s6387c.htm

http://www.ryortho.com/NEWSSHORTS/volume3/issue20/06-22-07-NS-FDA.htm

How big a problem is failure to perform adequate root cause analysis in industries regulated by the FDA? A quick search of the FDA’s reading room warning letter database yielded 26 letters in the past 12 months. That’s not an exhaustive study, but it is an indicator. Many medical device manufacturers and drug companies need to do a better job finding and fixing root causes.

Lesson Learned? Think ahead! Get an advanced root cause analysis program in place before the regulator arrives with a letter. Then make advanced root cause analysis a key part of your performance improvement and operational excellence program.

For more information about advanced root causes analysis courses around the world, see:

http://www.taproot.com/courses.php

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