January 2, 2023 | Mark Paradies

FDA Root Cause Analysis

Pharma Manufacturing - FDA Root Cause Analysis

What Does the FDA Want from Your Root Cause Analysis

What does the FDA want when you perform a root cause analysis?

The answer is simple:

They want you to find the real, fixable root causes
of problems 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 an incident happens.

And even better yet, they would like to arrive to perform an FDA 483 inspection and find no issues. Nothing. You have found and fixed all problems before the FDA arrives.

How can you find and fix problems before the FDA arrives? You must be reactive (good root cause analysis of quality issues) and proactive (find and fix problems before incidents happen). That’s the way you need to run your facility. Can you be that good? YES! 

You don’t want to have to explain and fix problems found in an FDA 483 inspection or, worse yet, get a warning letter. You want to have manufacturing excellence.

Pharmaceutical Manufacturing - FDA Root Cause Analysis

Advanced Root Cause Analysis Can Be Proactive

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.

Before you attend the course, how can you be assured that the course will be worthwhile? Because TapRooT® RCA Courses are GUARANTEED.

GUARANTEE: Attend a TapRooT® RCA 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 and we will refund the entire course fee.

To see the dates and locations for all the upcoming public TapRooT® Courses, CLICK HERE.

Do You Want to Be PROACTIVE?

TapRooT® course - Alex & Marcus

To become proactive, we suggest attending the pre-Summit Course:

Auditing & Proactive Improvement Using TapRooT® RCA

This course is being held on April 24-25, 2023, at the Margaritaville Lake Resort, Lake Conroe, near Houston, Texas, just before the 2023 Global TapRooT® Summit.

You should also attend the Summit. One of the eight Summit Tracks is titled:

CAPA & Continuous Improvement


The Summit is being held at the Margaritaville Lake Resort on April 26-28. Benna Hughes will be the Track Leader for the CAPA & Continuous Improvement Track. The Track sessions include best practice sharing and developing a roadmap to success. Get more information about the CAPA & Continuous Improvement Track by CLICKING HERE.

In addition to the insightful sessions in the track, the Summit has five amazing Keynote Speakers

Summit Keynote Speakers 2023

Another reason to attend the Summit is that you SAVE $300 OFF the pre-Summit Course. If you bring a team, you can save even more…


So, don’t wait! Get registered for an upcoming TapRooT® Course, the Auditing & Proactive Improvement Using TapRooT® RCA Course, and the 2023 Global TapRooT® Summit. We know you will find this investment of your time invaluable.

Quality, Root Cause Analysis, Root Cause Analysis Tips
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