Implementing Lean Sigma in Pharmaceutical Research and Development: A Review by Practitioners

The authors recount their experience of the implementation of lean thinking and Six Sigma in pharmaceutical development research and development (R&D). Use of Lean Sigma in pharmaceutical manufacturing is widespread and generally noncontentious. Lean Sigma is used successfully to improve the development of new pharmaceutical manufacturing processes. However, the value of the application of lean and Six Sigma ideas to research & development is controversial. Published material is reviewed, and then the methods, tools, barriers and benefits are discussed, with recommendations for implementation of Lean Sigma into an R&D organisation.

[1]  John P. S. Verver,et al.  Lean Six Sigma in Healthcare , 2006, Journal for healthcare quality : official publication of the National Association for Healthcare Quality.

[2]  John Bicheno,et al.  The Lean Toolbox , 1999 .

[3]  Theodore T. Allen,et al.  Six Sigma Literature: A Review and Agenda for Future Research , 2006, Qual. Reliab. Eng. Int..

[4]  J. Liker,et al.  The Toyota Way in Services: The Case of Lean Product Development , 2006 .

[5]  Eric R. Ziegel,et al.  The Complete Guide to Six Sigma , 1999, Technometrics.

[6]  Mary E. Johnson,et al.  Lean and Six Sigma: Not for Amateurs First in a 2-Part Series , 2006 .

[7]  Tony Bendell,et al.  Structuring business process improvement methodologies , 2005 .

[8]  Donald A. Schön,et al.  Organizational Learning: A Theory Of Action Perspective , 1978 .

[9]  M. Ivimey.  Annual report , 1958, IRE Transactions on Engineering Writing and Speech.

[10]  Harold N Weller,et al.  Application of lean manufacturing concepts to drug discovery: rapid analogue library synthesis. , 2006, Journal of combinatorial chemistry.

[11]  Albert Johnson.  Lessons Learned from Six Sigma in R&D , 2006 .

[12]  Jeffrey K. Liker,et al.  The Toyota Production System and art: making highly customized and creative products the Toyota way , 2007 .

[13]  John B. Kidd,et al.  Toyota Production System , 1993 .

[14]  Albert Johnson,et al.  How six sigma improves R&D , 2003 .

[15]  G. J. Hahn,et al.  Six Sigma: 20 Key Lessons Learned , 2005 .

[16]  Peter S. Pande,et al.  The Six Sigma way , 2007 .

[17]  P. Schroeder.  The Goal: A Process of Ongoing Improvement , 1994 .

[18]  J. Cutcher-Gershenfeld,et al.  Lean Thinking , 2019, Encyclopedia of Sustainable Management.

[19]  Geoff Tennant,et al.  Six Sigma : SPC and TQM in Manufacturing and Services , 2001 .

[20]  Mary J. Benner,et al.  Exploitation, Exploration, and Process Management: The Productivity Dilemma Revisited , 2003 .

[21]  K. Lewin,et al.  Defining the 'field at a given time' , 2011 .

[22]  Marianne Philippe,et al.  Application of the Six Sigma concept in clinical laboratories: a review , 2007, Clinical chemistry and laboratory medicine.

[23]  Jeffrey K. Liker,et al.  The Toyota way : 14 management principles from the world's greatest manufacturer , 2004 .

[24]  富野 康日己,et al.  Annual review 腎臓 , 1987 .