Available online at www.ijpab.

com

ISSN: 2320 – 7051

Int. J. Pure App. Biosci. 2 (5): 132-138 (2014)

Review Article

INTERNATIONAL JOURNAL OF PURE & APPLIED BIOSCIENCE

Six Sigma: An Emerging Approach in Pharma Industry

Pallavi T. Kare1*, Neha J. Bhor1, Snehal E. Bhusare1 and Rakesh A. Chaudhari2
1
Department of pharmaceutics, MVP Samaj’s College of Pharmacy, Nashik
2
Department of Quality Assurance Technique, MVP Samaj’s College of Pharmacy, Nashik
*Corresponding Author E-mail: [email protected]

ABSTRACT
Six Sigma as a powerful business strategy has been well recognised as an imperative for achieving and
sustaining operational and service excellence. Six sigma has made a huge impact on industry but still the
academic community lags behind in its understanding of this powerful strategy. In other words, six sigma
lacks a theoretical understanding and hence it is our responsibility as academicians to bridge the gap
between the theory and practice of six sigma. Six sigma methodology utilises the tools and techniques for
fixing problems in business processes in a sequential and disciplined fashion. Each tool and technique
within the six sigma methodology has a role to play and when, where, why and how these tools or
techniques should be applied is the difference between success and failure of a six sigma project. Six
sigma utilises the concept of statistical thinking and encourages the application of well-proven statistical
tools and techniques for defect reduction through process variability reduction methods.

Key words-Six Sigma, DPMO, DMAIC Methodology, DMADV Methodology, Process Management.

HISTORY:3
Six Sigma is a set of tools and techniques/strategies for process improvement originally developed by
Motorola in 1981, credit for coining term "Six Sigma" is given to Bill Smith a Motorola engineer
(Summers 2006). In the early and mid-1980s, Motorola engineers decided that the traditional quality
levels for measuring defects in thousands of opportunities didn't provide enough information. A new
standard of measuring the defects per million opportunities was developed and thus created the
methodology and needed cultural change associated with it. Six Sigma became well known after Jack
Welch made it a central focus of his business strategy at General Electric in 1995. The Six Sigma
program was center around manufacturing and operational productivity gains. Honeywell's Six Sigma
model had been modified and expanded to be used for the market place and business .Six Sigma today
has been used in different sectors of industry.

INTRODUCTION:4
Today pharmaceutical companies are faced with demanding tasks such as adjustment to the unstable and
turbulent market in times of economic crisis, as well as aiming to meet the needs of their users in
maintaining their health. In order to meet all requests and requirements and respond to the challenges
these companies are struggling to find ways to reduce internal costs and cycle times by providing high
quality services to users, through innovative design and efficient response to the unexpected increase in
demand for certain products. However, balancing between the desire to reduce costs, on one side and
innovative design, on the other is very difficult. Six Sigma was developed based on preceding Quality
Management concepts such as Total Quality Improvement, Quality Control and Zero Defects.The
methodology measures a process in terms of defects, uses statistical tools to identify the vital factors that
matter most for improving the quality of the process and attempts to eliminate defects.

Copyright © October, 2014; IJPAB 132

Pallavi T. Kare et al Int. J. Pure App. Biosci. 2 (5): 132-138 (2014) ISSN: 2320 – 7051
Pharmaceutical manufacturers are looking in Six sigma principles for significant improvement of
operational efficiency and quality, while facilitating compliance. To ensure a strong position in the
market and to provide competitive advantage they are looking to increase the efficiency of their
operational and manufacturing processes – optimizing resources, improving efficiency, reducing waste
and controlling inventory. Current developments in the pharmaceutical industry are in favor that it is now
an ideal time to turn to the principles of Six Sigma.

Six sigma: 7, 8, 10
The term "six sigma process" comes from the notion that if one has six standard deviations between the
process mean and the nearest specification limit, practically no items will fail to meet specifications. This
is based on the calculation method employed in process capability studies. Capability studies measure the
number of standard deviations between the process mean and the nearest specification limit in sigma
units, represented by the Greek letter σ (sigma). As process standard deviation goes up, or the mean of the
process moves away from the center of the tolerance, fewer standard deviations will fit between the mean
and the nearest specification limit, decreasing the sigma number and increasing the likelihood of items
outside specification.Six Sigma aims to have processes where the mean is at least 6σ away from the
nearest specification limit.

The widely accepted definition of a six sigma process is one that produces 3.4 defective parts per million
opportunities (DPMO). A process that is normally distributed will have 3.4 parts per million beyond a
point that is 4.5 standard deviations above or below the mean (one-sided Capability Study). This implies
that 3.4 DPMO corresponds to 4.5 sigmas, not six as the process name would imply. This can be
confirmed by running on Quik Sigma or Minitab a Capability Study on data with a mean of 0, a standard
deviation of 1, and an upper specification limit of 4.5. The 1.5 sigmas added to the name Six Sigma are
arbitrary and they are called "1.5 sigma shift". The higher sigma level, the smaller probability level of
defects occurs in products.
In a Capability Study, sigma refers to the number of standard deviations between the process mean and
the nearest specification limit, rather than the standard deviation of the process, which is also measured in
"sigmas". As process standard deviation goes up, or the mean of the process moves away from the center
of the tolerance, the Process Capability sigma number goes down, because fewer standard deviations will
then fit between the mean and the nearest specification limit. [7]
The process capability have bell shape curve, which has higher value at center while lower value at both
proximity. The process capability is combined effect of
1. Inadequate process capability.
2. .Inadequate measurement capability.
3. Supplied material variation.
4. Inadequate process control.
Copyright © October, 2014; IJPAB 133
Pallavi T. Kare et al Int. J. Pure App. Biosci. 2 (5): 132-138 (2014) ISSN: 2320 – 7051
When all these four factors combine, effect falls within LSL (Lower Specification Limit) &USL (Upper
Specification Limit) the process is said to be capable. When the combine effect of four factors falls below
LSL and above causes defect in the process and which is not desirable. When defects are detected in
process, there are two options either reject it or rework on it. Both the options are expensive in terms of
money& time.

Definitions of six sigma: 1, 2, 9,14

• Six Sigma is an organized and systematic method for strategic process improvement and new product
and service development that relies on statistical methods and the scientific method to make dramatic
reductions in customer defined defect rates.[2]
• Six Sigma is a methodology of continuous improvement aimed at reducing defects by using the
model Define-Measure-Analyze-Improve-Control (DMAIC), which is further developed through the
Design for Six Sigma, which is based on creating a robust design that meets customer requirements.
• Six Sigma is a formal methodology for measuring, analysing, improving, and then controlling or
locking-in processes. This statistical approach reduces the occurrence of defects from a three sigma
level or 66 800 defects per million to a Six Sigma level or less than four defects per million (Bolze,
1998).
• Six Sigma is a comprehensive, statistics-based methodology that aims to achieve nothing less than
perfection in every single company process and product (Paul, 1999).
• Six Sigma is a disciplined method of rigorous data gathering and robust statistical
analysis to pinpoint sources of error and ways of eliminating them (Harry and Schroeder, 1999).
• Six Sigma as an information-driven methodology for reducing waste, increasing customer
satisfaction, and improving processes, with a focus on financially measurable results (As defined by
Minitab in Goh, 2002).

Goals of Six Sigma: 4, 6

Improving customer satisfaction
• Accelerating process cycle times and time-to market
• Reducing defects
• Controlling variation and improving predictability
• Reducing costs – without "unintended consequences"
• Improving end-to-end process management and measurement
• Offers potential to refine current approaches to supply chain improvement.
• Project-oriented methodology for solving problems using statistical tools; allows to compare
different processes according to the sigma levels The quality improvement system, aimed at reducing
errors and maintaining them at a low value, "Six sigma", meaning DPMO (DPMO = Defects per
Million Opportunities)
• improved effectiveness and efficiency of processes, including e-commerce17.

Six Sigma Methodologies: 5

Six Sigma has two key methodologies: DMAIC and DMADV. DMAIC is used to improve an existing
business process. DMADV is used to create new product designs or process designs in such a way that it
results in a more predictable, mature and defect free performance.

DMAIC Methodology: 13
DMAIC is a closed-loop process that eliminates unproductive steps, often focuses on new measurements,
and applies technology for continuous improvement.
Copyright © October, 2014; IJPAB 134
Pallavi T. Kare et al Int. J. Pure App. Biosci. 2 (5): 132-138 (2014) ISSN: 2320 – 7051

• Define the problem

Define

• Measure the process by gathering data

Measure

•Analyze
Analyze the data and look for any cause-effect
cause effect relationships by paying close attention to
key variables (Six Sigma thinking revolves around the equation Y = f(x))
Analyze

•Improve
Improve the process by using the results of the data analysis as a guideline
Improve

•Control
Control the process through regular monitoring; a control plan should be developed in case
Control the problem reoccurs

Table 1. Tools and Technique DMAIC Six Sigma

Steps Key Process Tools and Technique Deliverable
Define customer and customer Project charter Project charter
requirements General problem
Define Define the process map and map the Cause and effect diagram Identification
process to business plot Business process and plot
Define the general problem Process map Process mapping to
Define the project timeline SIPOC business plot
Create data collection plan Data collection matrix Data needed
Collecting and comparing data to Measurement system Accuracy of measurement
Measure determine problem and process analysis (MSA) system and process
capability Process capability analysis Process capability in
purpose to meet customer
requirement
Analyzing data and process to determine Cause and effect diagram Root
Root-cause problem
process variance Pareto analysis Root
Root-cause prioritization
Analyze Analyzing the root-cause
cause problem Control chart (current
Create the priority of root-cause
root problem condition)
as the improvement target Scorecard
FMEA (current
condition)
Create potential alternative solution Control chart (current Potential risk
Improve Select and create prioritization of condition)
alternative solution The cause and effect of risk
Test the solution FMEA (after improvement)
Implement the solution
Control Create process control plan Control plan Stability control and
Implement the process control plan process output

Copyright © October, 2014;; IJPAB 135

Pallavi T. Kare et al Int. J. Pure App. Biosci. 2 (5): 132-138 (2014) ISSN: 2320 – 7051
DMADV Methodology:

•Define
Define the problem
Define

•Measure
Measure the process by gathering data
Measure

•Analyze
Analyze the data and look for any cause
cause-effect
effect relationships by paying close attention to
key variables (Six Sigma thinking revolves around the equation Y = f(x))
Analyze

•Improve
Improve the process by using the results of the data analysis as a guideline
Design

•Control
Control the process through regular monitoring; a control plan should be developed in
Improve case the problem reoccurs

Implementation Of Six Sigma:: 6,19

There are three basic elements to Six Sigma:
● Process improvement
● Process design/re-design
● Process management

Each of the above three elements is examined in more detail below.

Process improvement
The purpose of process improvement is to eliminate the root causes of performance deficiencies in
processes that already exist in the organization . These performance deficiencies may be causing real
problems for the organization, or may be preventing it from working as efficiently and effectively as it
could.

Process design/re-design:
Sometimes simply improving existing processes iiss not enough, and, therefore, new processes will need to
be designed, or existing processes will need to be redesigned. There are several reasons why this could be
necessary:
● An organisation may choose to replace, rather than repair, one or more of its core
core processes.
● An organisation discovers, during an improvement project, that simply improving an existing process
will never deliver the level of quality its customers are demanding.
● An organisation identifies an opportunity to offer an entirely new product or service.

Process management-
Because it requires a fundamental change in the way an organisation is structured and managed, process
management is often the most challenging and time consuming part of Six Sigma.
Copyright © October, 2014;; IJPAB 136
Pallavi T. Kare et al Int. J. Pure App. Biosci. 2 (5): 132-138 (2014) ISSN: 2320 – 7051
In general, process management consists of:
● Defining processes, key customer requirements, and process “owners”.
● Measuring performance against customer requirements and key performance indicators.
● Analysing data to enhance measures and refine the process management mechanisms.
● Controlling process performance by monitoring process inputs, process operation, and process outputs,
and responding quickly to problems and process variations.

Application in Pharma Industry:20

In the past few years, a few pharmaceutical companies started adopting Six Sigma mainly to reduce cycle
time and cost.
The following key strategies are suggested to launch a Six Sigma effort within the pharmaceutical
industry:
• Begin to change the traditional ways of conducting clinical trials by campaigning for the
implementation of needed integration initiatives through the use of Six Sigma with a commitment
from top down leadership.
• Focus on the integration of technology and workflow improvement in meeting challenges and extend
new ventures not possible using conventional isolated implementation of technology or homegrown
process improvement methodologies.
• Provide tested research approaches for the quantitative evaluation of clinical development and
process improvement strategies, the integration of which highly correlates with strong financial
performance.
One success story is on the supplier and material approval process in a packaging division of one
company. The process of identifying and certification of a supplier of packaging materials usually takes
12 months because of the very complex process involved. The Six Sigma team was formed and traced 4
pilot products and focused on the critical paths, analyzed and identified process problems. Using Six
Sigma methodology, they were able to streamline the process and were able to reduce the cycle time from
twelve to five months and realized significant savings20.

REFERENCES
1. Chakraborty, A. and Chuan, K. Total Quality Management and Six Sigma, Intech ltd., 2012, 247-286.
2. Linderman, K. Schroeder, R. G. Zaheer, S. and Choo, A.S. Six Sigma: a goal-theoretic perspective, J
Oper Manag, 21: 193–203(2003)
3. Henderson, K.M. Evans, J.R. Successful implementation of Six Sigma: benchmarking General
Electric Company, Benchmarking: an International Journal, 7: 260-282(2000)
4. Rusko, M. Králiková,R. Application of Six Sigma Method To EMS Design, Faculty of Materials
Science and Technology In Trnava, 30: 39-44(2011)
5. Ratnaningtyasa, D.D. and Surendrob, K. Information Quality Improvement Model on Hospital
Information System using Six Sigma, Procedia Technology, 9: 1166 – 1172(2013)
6. Pokharkar, D. Jadhav, V. Gholve S and Kadam V. Six Sigma: Golden Opportunity for
Pharmaceutical Industry, Int J PharmTech Res, 2: 1160-1164(2010)
7. Janil, P. Chauhan, S. Patel, G. Sant, L. Patel, D. et.al. Sigma six: a quality control tool in pharma
industry, International journal of universal pharmacy and bio sciences, and 2: 59-69 (2013)
8. Antony, J. Banuelas, R. Key ingredients for the effective implementation of Six Sigma program,
Measuring Business Excellence, 6: 20-27(2002)
9. Antony, J. Antony, F.J. Kumar, M. Six sigma in service organizations Benefits, challenges and
difficulties, common myths, empirical observations and success Factors, Int J Qual Reliab Manag,
24: 294-311(2007)
Copyright © October, 2014; IJPAB 137
Pallavi T. Kare et al Int. J. Pure App. Biosci. 2 (5): 132-138 (2014) ISSN: 2320 – 7051
10. Motwani, J. Kumar, A. Antony, J. A business process change framework for examining the
implementation of six sigma: a case study of Dow chemicals, The TQM Magazine, 16: 273-283
(2004)
11. De Feo, J. Bar-El, Z. Creating strategic change more efficiently with a new Design for Six Sigma
process, J Change Manag, 3: 60-80 (2002)
12. www.uwstout.edu/content/lib/thesis/2009/2009faustj.pdf
13. Desai, T.N. Shrivastava, R.L. Six Sigma – A New Direction to Quality and Productivity
Management, Proceedings of the World Congress on Engineering and Computer Science, 2008, 1-6.
14. Brady, J.E. Allen, T.T. Six Sigma Literature: A Review and Agenda for Future Research, Qual.
Reliab. Engng. Int., 22: 335–367 (2006)
15. Antony, J. Some pros and cons of six sigma: an academic perspective, The TQM Magazine, 16: 303-
306 (2004)
16. Tenera, A. Pinto, L.C. A Lean Six Sigma (LSS) project management improvement model, Procedia -
Social and Behavioral Sciences, 119: 912 – 920(2014)
17. OECD, "Improving Value in Health Care: Measuring Quality," Health Policy Studies, 2010.
18. Pande, P. and Holpp, L. What is Six Sigma? McGraw-Hill, 2002, 2-6.
19. http://www.dti.gov.uk/bestpractice
20. Sharma, O.P. Gupta, V. Rathore, G.S. Saini, N.K. Sachdeva, K. Six Sigma in Pharmaceutical
industry and Regulatory Affairs: A Review, Journal of Natura Conscientia, 22(1): 273-293 (2011)

Copyright © October, 2014; IJPAB 138