April 17, 2019 | Mark Paradies

Root Cause Analysis for an FDA Complete Response Letter

The FDA asked for a root cause analysis after a pharmaceutical company submitted a new drug, but there were variations in the drug’s Cmax (maximum concentration), driven by about 5% of the test subjects. (See the article describing the issue HERE.)

What could a company do to analyze this problem? First, they could use a tool taught in our 5-Day TapRooT® Advanced Root Cause Analysis Team Leader CourseChange Analysis. They would develop a list of key factors in the Cmax results and compare the 5% of test subjects with low Cmax to the 95% with normal Cmax. This data could be displayed on a SnapCharT of the drug administration process that would help identify the Causal Factors in the variations in Cmax. These Causal Factors would then be analyzed using the TapRooT® Root Cause Tree® Diagram and Root Cause Tree® Dictionary (part of the TapRooT® Software) to identify the root causes of the drugs Cmax variation among various test subjects.

Want to learn more about Change Analysis, our root cause analysis techniques, and the TapRooT® Software? Attend one of our public 5-Day TapRooT® Advanced Root Cause Analysis Courses. See the list of upcoming courses at this link:


Be confident that you will learn valuable new root cause techniques that will help you find and fix the root causes of quality, safety, and reliability issues. Why can you be so confident? Our guarantee:

GUARANTEE FOR THE 5-DAY TAPROOT® ADVANCED ROOT CAUSE ANALYSIS TEAM LEADER TRAINING: 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.

Investigations, Quality, Root Cause Analysis, Root Cause Analysis Tips
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