Six Sigma

Title:

Six Sigma Implementation within the Pharmaceutical Industry

I) Introduction

Six Sigma15 is a methodology of continuous improvement today that drives process gains in the operations. With its roots being developed initially by Motorola, and an emphasis on manufacturing process improvement, Six Sigma has been applied successfully in and across organizational functions and industries. This report focuses on the application of Six Sigma methods in three (3) pharmaceutical companies and the business benefits that are realized upon successful implementation.

II) Six Sigma Framework

The key strategy for continuous process improvement in Six Sigma is the methodical identification and control of process factors knows as Key Process Input Variables1. This in turn will ensure that the Key Process Output Variables1 which drives business and operation goals within an organization. The Six Sigma framework is based on a data-driven approach to achieve optimization goals.

The most commonly used concept framework for Six Sigma is the Define, Measure, Analyze, Improve, and Control (DMAIC) principle stages applied to a process1.

Define: Selection and definition of process streams that are critical to the business and require improvements.

Measure: Identify critical process output values that to form a basis for a measurement analysis system. This is to measure process improvement performance.

Analyze: This is process stream mapping to identify key input variables that affect subsequent process activities. The analysis from this stage is critical to the decision making of choosing which optimization process will provide the best benefit.

Improve: The determination and improvement of key process input variables to optimize the process and produce key process output variables that drive business and operation goals.

Control: Controls the key process input variables identified in the preceding stages to achieve sustained improvement...