Concept of Six Sigma in the Pharmaceutical Industry
Main Article Content
Abstract
Six-sigma process that analyses the flaws and shortcomings in a company. It aids a company in producing a quality product at a lesser cost that would satisfy the client. This idea mostly uses two approaches DMAIC, [Define, Measure, Analyz e, Improve, Control] which corrects flaws in current processes, and DMADV [Define, Measure, Analyze, Design, Verify] which starts a new process when the old one entirely fails to accomplish its goals and objective. The tools and techniques used in this article include flow charts, check lists, pareto diagrams, causes and effects diagrams, scatted diagrams, histograms, and statistical process control. Six Sigma's tools and procedures are assessed to determine whether they are being implemented in a way that helps customers. The client benefits, such as improved financial assistance for new development projects, lower prices, quick market deliveries, increased product quality are measured using the key performance indicators. As a result of these characteristics, numerous organizations have adopted six sigma, nevertheless, only a small number of the pharmaceutical companies who are members of the ISSSP [International Society for Six Sigma Professionals] are named, including Baxter, Eli Lilly, Johnson & Johnson, and Novartis. Six sigma deployment is entirely dependent on management and the supporting infrastructure, but it is equally applicable to research and development. It corrects flaws, sets objectives, and specifies how to integrate R&D into corporate objectives. Organizations who have adopted the Six sigma idea in their quest for perfection have seen a 20% increase in profits, 40% growth in market share per year, Costs of production for sales are down 10%. From an average of 35000 faults per million operations to an almost Non existing 3.4 defects per million activities, there has been a drop in defects.
Article Details
This work is licensed under a Creative Commons Attribution 4.0 International License.
References
I. Maria Jernelid, Steven Roan. Six sigma strategy applied to the pharmaceutical industry-How customers benefit. MBA thesis. 2009:58
II. Ankita Bhadoriya, Dr. Gurmeet Singh Chhabra. Six Sigma- A Managerial tool to improve pharmaceutical industry quality. IJRTI,2022;7,(8):12
III. Ankitha George, Aida Mary Joseph, Sreenath Kolencherry, Vishnu Vettekkarma Kodath, Kaliyan Menaka, Britto Durraisingh, Sheik Haja Sherief; Thangavel Shivakumar. Application of Six sigma DMAIC Methodology to Reduce Medication Errors in a major trauma care centre in India. India Journal of Pharmacy Practice.2018;11(4):6
IV. Soham M. Gangal, Mukund R.Mali, Yogesh K. Jadhav, Sneha A. Pachore, Dr. Manure Md Javeed Md Yakub. International Journal of Creative Research Thoughts. IJCRT. 2022;10. (5):8.
V. Acharya SK, Laha A, Acharya PK, Tripathy S. “Applications of Six-Sigma in Pharmaceutical Industries’’ IJRMET Vol. 5, Issue 1, Spl - 1 November 2014 - April 2015 Pp 22-28
VI. Bicheno J. Fishbone flow: Integrating lean, six sigma, TPM and triz. Picsie Books; 2006.
VII. Snee, RD. “Can Six Sigma Boost your company’s growth?”, Harvard Management update, June 2004, pp. 3-5.
VIII. Young, T., Brailsford, S., Connell, C., Davies, R., Harper, P. & Kleain, JH. “Using industrial processes to improve patient care”. British Medical Journal, January 2004, Vol 328 (7432), pp. 162-164.
IX. Studt, T. “Data Management and Analysis Implementing Six Sigma in R&D”, R&D Magazine, August 2002, Vol 3 (3), pp. 21-23.
X. Sewing, AS., Winchester, T., Carnell, P., Hampton, D. & Keighley, W. “Helping Science to succeed: improving processes in R&D”, Drug Discovery today, March 2008, Vol 13(5), pp. 227-233. 12
XI. Marti, F. “Lean Six Sigma Method in Phase 1 Clinical Trials: A practical example”, Quality Assurance Journal, 2005, Vol 9 (1), pp. 35-39.
XII. Johnson, A. “Lessons learned from six sigma in R&D”, Managers at work, March-April 2006, Vol 49 (2), pp. 15-19.
XIII. Gale, SF. “Building frameworks for Six Sigma Success- Case studies- quality management philosophy” Workforce, May 2003, pp.3-5.
XIV. Carley Smith, SW., Dufton, AM. & Altria, KD. “Implementing Lean Sigma in pharmaceutical research and development: a review by practitioners”, R&D Management, 2009, Vol 39 (1), pp. 95-106.
XV. Lewi, PJ. & Smith, A. “Successful Pharmaceutical discovery; Paul Janssens´s concept of drug research” R&D Management, 2007, Vol 37 (4), pp.355-362.
XVI. Klefsjö, B. and Bergman, B. "Digitization and sustainability issues place higher demands on quality development", Quality from need to use, 2004, Vol 6, pp. 712-713
XVII. Snee, RD. and Hoerl, RW. “The Six Sigma-Beyond the factory floor: Deployment Strategies for Financial Service, Health Car and the Rest of the Real Economy, Person Prentice Hall. 2005,
XVIII. R.B. Elsberry, "Decisions in Imaging Economics", Stanford Libraries, 2000, Vol 3 (2), pp.2-4
XIX. Cortada, JW., Enahoro, H. & Fraser, HE. (2004) Uncovering hidden value in Pharma business processes.
XX. M. S. Charde, R. T. Bande, A. S. Welankiwar, J. Kumar and R. D. Chakole. Six Sigma: A Novel approach to Pharmaceutical Industry. International Journal of Advances in Pharmaceutics. 2013; 2(6): 4
XXI. Elliott W. Liu, “Breakthrough: Do Clinical Research the Six Sigma Way”, SLAS TECHNOLOGY: Translating Life Sciences Innovation, February 2006, Vol 11 (1), pp.27-32.
XXII. Mathieu M. PAREXEL's Pharmaceutical R&D Statistical Source Book 2005/2006. Waltham, MA: PAREXEL International Corporation; 2005.
XXIII. Gupta, Verruchi and Saini, Neeraj and Kamal, Sachdeva and Sharma, Om Prakash and S, Rathore, "Six Sigma in Pharmaceutical industry and Regulatory Affairs: A Review", Journal of Natura, 2012, Vol 2 (1), pp.273-293
XXIV. B Tjahjono*, P Ball, V I Vitanov, C Scorzafave, J Nogueira, J Calleja, M Minguet, L.Narasimha, A Rivas, A Srivastava, S Srivastava and A Yadav. Six Sigma: a literature review. International Journal of Lean Six Sigma. 2010; vol 1(3):31
XXV. Van Iwaarden, J., van Der Wiele, T., Dale, B., Williams, R. and Bertsch, B., “The Six Sigma improvement approach: a transnational comparison”, International Journal of Production Research, 2008, vol. 46, (23), pp. 6739-6758 13
XXVI. Ferrin, D., Miller, M. and Muthler, D., “Lean sigma and simulation, so what’s the correlation? V2”, in: Proceedings of the 2005 Winter Simulation Conference, December 2005, Vol 4 (7), pp. 2011-2015.
XXVII. Brady, J.E. and Allen, T.T., "Six Sigma Literature: A Review and Agenda for Future Research", Quality and Reliability Engineering International, 2006, vol. 22, pp.335-367
XXVIII. Raja, A., “Simple Tools for Complex Systems”, Quality Progress, 2006, vol. 39, (6), pp. 40-44
XXIX. Hagemeyer, C., Gershenson, J. K. and Johnson, D. M.), “Classification and application of Problem solving quality tools”, TQM Magazine, 2006, vol. 18, (5), pp.455-483
XXX. Bunce, M. M., Wang, L. and Bidanda, B., “Leveraging Six Sigma with industrial engineering tools ins crate less retort production”, International Journal of Production Research, 2008, vol. 46, (23), pp. 6701-6719
XXXI. Maciel Junior, H., Batista Turrioni, J., Cesar Rosati, A., Garcia Neto, D., Kenji Goto, F.Fujioka Mologni, J., Machado Fernandes, M., “Application of Design for Six Sigma (DFSS) on an Automotive Technology Development Process”, SAE Technical paper series, 2008, vol 36 (20), pp.8
XXXII. Dumpala, R.L., et al., Six Sigma and Lean Concepts: A Novel Approach to Pharmaceutical Industry. International Journal of PharmaO2. 2020;2(5): pp.0337-0348
XXXIII. Dreachslin, Janice and Lee, Peggy, "Applying Six Sigma and DMAIC to diversity initiatives", Journal of healthcare management/American College of Healthcare Executives, 2007, vol 52(1), pp.361-367
XXXIV. Gamal Aboelmaged, M. Six Sigma quality: a structured review and implications for future research", International journal of quality Reliable and Mangement,2010; Vol. 27(3): pp. 268-317.
XXXV. Prabhakar Kaushik and Dinesh Khanduja, "Utilizing Six Sigma for the pass percentage of students", Educational Research and Review, 2008, vol 5 (9), pp:471-483
XXXVI. Andersson et al., "Importance of vertical and horizontal transmission of west Nile virus by Culex Pipiens in the northeastern United States", The Journal of Infectious Diseases, 2006, vol 194(11), pp.1577-1579
XXXVII. Bañuelas, R. and Antony, J., "Going from six sigma to design for six sigma: an exploratory study using analytic hierarchy process", The TQM Magazine, 2003, Vol. 15 (5), pp. 334-344.
XXXVIII. Antony, Jiju, "Design for Six Sigma: A breakthrough business improvement strategy for achieving competitive advantage", Work Study, 2002, vol 51(2), pp.6-8armaceutical Industries”, IJRMET, 2014; 5: pp22–28
XXXIX. de Koning, H. and de Mast, J., “A rational reconstruction of Six-Sigma’s break through cookbook”, International Journal of Quality & Reliability management, 2006, vol. 23, (7) pp.766-787.
XL. Halliday, RG., Drasdo, AL., Lumley, CE. & Walker, SR. “The allocation of resources for R&D in the world’s leading pharmaceutical companies”, R&D Management 27, Jan 1997, pp.63-77.