Six Sigma history, current status and future horizons

Kriger Biopharmaceutical Career Training Programs www.kriger.com , info@kriger.com

This article has been published by the International Biopharmaceutical Association www.ibpassociation.org

The project is sponsored by KRC CRO and training services ( www.kriger.com ) and ClinQua CRO (www.clinqua.com )

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Manufacturing processes as well as quality control systems are constantly evolving. Some products of this evolution became integrated parts of any manufacturing or quality system. The examples are: Statistical Process Control, Total Quality Management Principals, Creative Thinking Tools and Methodologies such as Failure Mode and Effect Analysis, Cause and Effect Analysis, etc. Leading Role of Mathematical Statistical Methods for manufacturing and quality systems became a requirement for technological developments and manufacturing.
Six Sigma is considered by many experts to be the most advanced contemporary system that integrates many of the previously known methods of quality management and provides certain further improvements.
Some of the first companies that started adopting and developing Six Sigma program in late 80's and early 90's were Motorola, IBM and GE (General Electric). These companies significantly influenced development of Six Sigma philosophy and methodology. Later companies like AlliedSignal and Sony were reporting successful implementations of Six Sigma programs. Currently there are more companies throughout different industries that are using or considering implementation of the Six Sigma programs. Six Sigma is making it’s way into pharmaceutical and biotechnology industries as well. The topics regarding application of Six Sigma Methodology to Pharmaceutical Process and Six Sigma Benefits for Pharmaceutical Manufacturing Environment were addressed at the Center of Pharmaceutical Training Conference that recently took place in Philadelphia (USA) in March, 2004.
Pre-conference workshops were followed by the conference with wide participation from the leading companies and enterprises in pharmaceuticals and biotechnology industries.
FDA’s Quality Systems Approach and Six Sigma for Pharmaceuticals was the main topic of the conference. The conference was attended by professionals in Quality Assurance, Quality Control, Quality Management and Quality Engineering as well as professionals in Operation and Process, Regulatory Affairs and Auditing. The Fundamentals of Six Sigma was presented by Six Sigma Black Belt, Quality/Performance Improvement Specialist from Rockingham Memorial Hospital. Application of Six Sigma Methodology to Pharmaceutical Process was presented by the Director of business management and global training from Wyeth Pharmaceutical. This company case study addressed the successes that Wyeth Pharmaceutical has had in applying Six Sigma tools to resolve and improve processes within their organization. The representative of pharmaceutical Supply Chain Management from IBM Global Services presented the talk “How Six Sigma Benefits a Pharmaceutical Manufacturing Environment”.
Some controversial questions about Six Sigma program exist, questions are being asked about how applicable is this program in different situations and for different types of companies. But Pharmaceuticals and Biotechnology companies as well as other hightech industries demonstrate significant desire to understand Six Sigma and utilize the advantages of this system. This explains deep interest of the main employers in hiring professionals with knowledge about Six Sigma.
This training material is designed to provide basic knowledge about Six Sigma. Upon the completion you will have good overall understanding of the most important aspects of Six Sigma.

Six Sigma Definitions
Six Sigma is a controlled methodology for achieving company’s performance improvement goals. It utilizes methods of statistics as well as qualitative analysis, provides the roadmap and strategy for improvement and development projects.
Very often people have difficulties trying to formulate one universal definition of what is Six Sigma. Indeed Six Sigma implies a number of different inter-related areas and could be defined on different basis and levels.
Overall 3 most distinctive Six Sigma definitions are in the following areas
Six Sigma as a Metrics
Six Sigma as a Methodology
Six Sigma as a Philosophy

Six Sigma as a Metrics.
Definition of Process with “6 sigma” Capability:
The distance from mean of the process to specification limit is 6 standard deviations ( 6s ), this indicates the possibility that less than 3.4 defectives per million are located outside of specification limit.
“Basic Statistics” section will include detailed review of this definition and it’s meaning.
Six Sigma as a Methodology.
Structured problem solving roadmaps, measurement-based tools and strategy focusing on process improvements and variation reduction.
This is accomplished through the use of Six Sigma sub-methodologies such as DMAIC process (define, measure, analyze, improve, control) DMAIC, pronounced “Duh-May-Ick”, usually applies to the improvement projects for the existing systems and processes. Specific Six Sigma methodologies could be applied to a different type of projects for example in case of new process or product development project DMADV methodology (define, measure, analyze, design, verify) is applied.
“DMAIC” section will describe DMAIC process giving an example of Six Sigma methodology.
Six Sigma as a Philosophy.
Focus on reduction of variation in your business and take customer-oriented, data driven decisions. Six Sigma provides businesses with the tools to improve the capability of their business processes. This increase in performance and decrease in process variation leads to defect reduction and vast improvement in profits, employee morale and quality of product.

Six Sigma Organization
Six Sigma practical implementation in the company involves raising Six Sigma specialists called Belts. There are several levels of Six Sigma specialists (Belts).
Typically the highest level of Six Sigma program is being carried by Six Sigma “Champion”.
Six Sigma Champion is responsible for establishing strategy, managing company targets, identifying major projects.
Six Sigma Master Black Belts are responsible for assisting the Champion in identifying major company projects, developing methodologies, training and guiding Black Belt projects.
Six Sigma Black Belts are responsible for carrying out Black Belt projects, training Green Belts and guiding Green Belt projects.
Six Sigma Green Belts are responsible for carrying out Green Belt projects.
Financial Department Representative responsible for verifying BB and GB projects financial benefits is an essential element in Six Sigma organization.
Typically company will establish a Six Sigma Management Office or group for planning and scheduling operations and systems, managing BB and GB project results, conducting evaluations and audits.