Monday Accidents & Lessons Learned: FDA Wants Root Causes of Quality Issues Fixed
Look over recent FDA Warning Letters (http://www.fda.gov/iceci/enforcementactions/WarningLetters/default.htm) to medical device manufacturers, and you will see that about a third of them are issued because of failures of CAPA (Corrective and Preventive Action programs).
The FDA expects medical device manufacturers and drug makers to find the root causes of quality issues, effectively fix them, and monitor them to make sure that the fixes worked.
A key part of a CAPA program is effective root cause analysis. Without effective root cause analysis, problems tend to repeat – and the FDA definitely doesn’t like repeat problems.
What makes effective root cause analysis? That’s a question we’ve been dedicated to answering for over 25 years. We designed the TapRooT® System to include tools to help guide investigators to the root causes of human performance and equipment reliability issues and find effective corrective actions to stop repeat problems from occurring.
Want to see how TapRooT® can help your company find and fix the root causes of quality issues? Then I would recommend attending one of our public 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Courses. See the upcoming public course schedule by CLICKING HERE.
Don’t be afraid that the TapRooT® System won’t work at your company. Our training is guaranteed:
Attend this course, go back to work, and use what you have learned
to analyze accidents, incidents, near-misses, equipment failures, operating issues, or quality problems.
If you don’t find root causes that you previously would have overlooked and if you and your management
don’t agree that the corrective actions that you recommend are much more effective,
just return your course materials/software and we will refund the entire course fee.
It’s that simple. We know TapRooT® will work for you because we’ve seen it work at so many companies in so many industries including pharmaceutical and medical device manufacturers. See success stories from multiple industries at:
But don’t wait. You can’t afford a major finding adverse to quality and a warning letter. And you don’t want to have the course you want to attend fill up before your register (seats are limited in each class). Register today and start applying TapRooT® to improve performance and avoid quality incidents.