Abstract

A REVIEW ON SIX SIGMA METHODOLOGY: A MODERN APPROACH IN PHARMACEUTICAL MANUFACTURING INDUSTRY

Bhavin D. Pandya*, Shreyash A. Diwakar and Ajay K. Saluja

ABSTRACT

The Six Sigma is a statistical methodology that is used to represent standard deviation and it is an indicator of the degree of variation in a set of measurements or a process. It is used to define problems systematically, provides tools to measure and influential factors and identifies the improvements that can be implemented easily. It is quality management tool. When the use of this technique for a process then process variation reduced to 3.4 DPMO (Defects per million Opportunities). Six Sigma is divided in two sub methods: DMAIC (Define, Measure, Analyze, Improve, Control) is improvement system for existing processes that does not meet specification and DMADV (Define, Measure, Analyze, Design, Verify) is used to develop new processes at Six Sigma level. It works on the three elements i.e., process improvement, process design or process re-design and process management. In pharmaceutical industries, slightest error can have a disastrous and hazardous impact on human health. Six Sigma methodology plays an important role in Pharmaceutical Industries as it results in 99.997 % accuracy rate. Its implementation will be resulted in highly improvised quality products and waste minimization. This review represents the application of Six Sigma methodology in pharmaceutical industries. However, due to increasing competitive market pressures, more and more Pharmaceutical Industries are beginning to adopt process improvement strategies. Hence, Six Sigma is evolutionary promising method used by present manufacturing organizations.

Keywords: Six Sigma, Lean Six Sigma, DPMO, DMAIC, DMADV, problem solving, process improvement, pharmaceutical industry.