The Pharmaceutical Journal
Vol 280 No 7491 p256
1 March 2008

Persuasive text on reducing variation in the manufacturing process

‘Six sigma in the pharmaceutical industry: understanding, reducing and controlling variation in pharmaceuticals and biologics’, by Brian K. Nunnally and John S. McConnell. Pp 224. Price £49.99. London: CRC Press; 2007. ISBN 978 1420054392

Nunnally and McConnell are men with a mission. To understand the mission, one needs to grasp the concept of six sigma — the proposition that variation in any aspect of a product or process should be such that the specification is six times the standard deviation for that process. That is, the reduction of variation is all.

The mission is to convince sceptical managers in the industry that this goal is the essential prerequisite for high-quality, low-cost, high-profit products, coupled with customer satisfaction, even though managers are often more concerned with cost reduction in their individual departments.

The first part of the book explains the mission and the concepts — with a warning that entrenched views are difficult to change even when evidence is overwhelming. It cites Semmelweis’s problems with the medical establishment in Austria as a historical example.

The authors then move on to case studies in the pharmaceutical industry and more technical chapters on the use of control charts. Readers who understand the title are probably already converted. The authors’ task is to attract the attention of those who do not and then persuade them this goal of reducing variation should be at the heart of the whole manufacturing process, as it is in other highly successful industries.

The book’s approach of short, focused chapters will help them succeed. I hope they do.


Joseph Chamberlain
(an independent pharmaceutical editor and writer, and formerly editor of the Journal of Pharmacy and Pharmacology)