Getting to the Root of Quality Problems in Pharma.

2 min read

My compliments to Agnes Shanley, the Senior Editor for BioPharm International, on her outstanding article from January 2020 (A. Shanley, “Getting to the Root of Quality Problems” BioPharm International 33 (1) 2020).   One of the best articles I have read on the state of root cause analysis (RCA) in any industry.  It was tremendously insightful and comprehensive.  You can read the whole article HERE.


The article covered topics such as understanding the cost of poor quality, rooting out sources of bias in root cause analysis (RCA), trending and analysis of available data, and the need for leading metrics and key performance indicators. The insights were right on target and I encourage those interested in RCA to read the entire article.

The section of particular importance to me referred to the need for better RCA training in Pharma.  In particular, her sources mentioned the need for “advanced training in the techniques and critical thinking for investigators, and application of proven RCA tools such as mapping, brainstorming, cause-and-effect, and Five Whys.” I couldn’t agree more that critical thinking is fundamentally important to complex problem solving, as that is precisely what I teach in our BlueDragon workshops. However, the second part of that quote belies the lack of knowledge and understanding of RCA concepts in many industries.

From anecdotal data, I sense that Healthcare and Pharma are lagging behind industries such as Energy and Aerospace. For example, the use of Five Whys and Fishbones as RCA tools is like getting around in a horse and buggy while your neighbor is driving a Ferrari.  “Five Whys” is not a methodology or a tool in itself, but rather a simple building block…a way to capture cause and effect that is about 60 years old, and the term was coined in the 70’s at Toyota. The Fishbone was developed by Dr. Kaoru Ishikawa in the 1940s, almost 80 years ago. It is also not a good tool for analyzing issues except for those with the lowest level of significance and complexity.   These examples reflect the sad state of RCA knowledge and training across several industries, not just Pharma. 

In 30 years as a RCA practitioner, I’ve had the good fortune to take many courses and conduct hundreds of assessments and causal analyses of varying degrees of severity and complexity.  This experience has allowed me to create a Lean, Agile, scalable, efficient and accurate methodology that eliminates much of the wasted time, energy and bias encountered during traditional RCAs.  I am actively seeking a path to bring that expertise to Pharma, healthcare and other industries that would like to enter the age of Artificial Intelligence (AI) with stronger critical thinking and complex problem solving-skills; life skills that will not be replaced by AI anytime soon.

Once again, compliments to Agnes Shanley, the Senior Editor for BioPharm International, on her outstanding article.

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