Six Sigma in the Pharmaceutical Industry: Understanding, ...

Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics:
I have all the books written by John McConnell. The detail he provides is enableing me to begin a consulting business. I had the pleasure of being one of his students while working for a Pharmaceutical company in Indiana called Eli Lilly and Co. I began using his teachings there and have used them for the company for 15 years while working there. I also began teaching his program to many others in the manufacture of Human Insulin. We made many improvements using the techniques from his books and was able to save millions of dollars. One of our Directors also made a review of his work on an ealerlier book. (you can see this review on his website) There are many books on this subject. However, his works are written so well anyone can read his work and begin to put it in practice and should begin seeing results in short order. You can read the other books on the subject but if you want something you can get your team to understand quickly then read this book. Your bottom line will thank you for it. Oh, if I could make one recommendation....Mr. McConnell should have left off the words in his title, "for the Pharmaceutical Industry". The information in this book can and has helped many different kinds of businesses. If anyone would like to ask me personally about his work you can write me at Alan Hall

Missed opportunity:
This is the first time I've ever felt compelled to review a book on Amazon. It's too bad that a book whose editorial purports to introduce the concepts of Six Sigma to the pharmaceutical industry gets it mostly wrong. The book deals mostly with statistical process control which is only one of the tools in the Six Sigma practioners arsenal and although the industry could certainly benefit from control charts, this emphasis on control is terribly old fashioned and not in keeping with the principles of ICHQ8 and FDA's "GMP for the 21st Century Initiative," both of which emphasize process understanding. Why then doesn't the book talk about those tools that give real process understanding such as Design of Experiments? The book poo-poo's the Critical Process Parameter selection approach as being "half hearted and dismal," but doesn't explain the process for systematically identifying the factors that contribute to variation. For example, the "Laboratory Variability Reduction" project proposed in the book doesn't even mention Gage R & R studies and even DMAIC gets short shrift. This book may be good for someone interested in nice stories about quality, but most readers unfamiliar with Six Sigma will come away thinking that the emphasis should be on control rather than process improvement. A dismal and half-hearted effort undeserving of the title the book bears.