Root Cause Analysis for the FDA
What does the FDA want when you perform a root cause analysis?
The answer is quite simple. They want you to find the real, fixable root causes of the problem and then fix them so they don’t happen again.
Even better, they would like you to audit/access your own processes and find and fix problems before they cause incidents.
And even better yet, they would like to arrive to perform a FDA 483 inspection and find no issues. Nothing. You have found and fixed any problems before they arrive because that’s the way you run your facility.
How can you be that good? You apply root cause analysis PROACTIVELY.
You don’t want to have to explain and fix problems found in a FDA 483 inspection or, worse yet, get a warning letter. You want to have manufacturing excellence.
TapRooT® Root Cause Analysis can help you reactively find and fix the real root causes of problems or proactively improve performance to avoid having quality issues. Want to find out how? Attend one of our guaranteed root cause analysis courses. See:
I’d suggest one of our public 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Courses to get started. Then have a course at your site to get everyone involved in improving performance.
Want more information before you sign up for a course? Contact us by CLICKING HERE.