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I Year – Master of Pharmacy
Pharmaceutical Regulatory Affairs
JSS College Of Pharmacy
Mysuru 570015, Karnataka
What is SixSigma?
• Six Sigma is a Quality Management System.
• Six Sigma is a set of techniques and tools for process improvement.
• It is a measure of quality that strives for near perfection.
• It is a disciplined, data-driven methodology focused on eliminating defects.
• It was developed by Bill Smith at Motorola in 1986.
• Jack Welch made it central to his business strategy at General Electric in
• Today, it is used in many industrial sectors for minimizing errors, reduction
of costs and increase in profit.

process is one in which
of the products manufactured are
statistically expected to be
FREE of defects
(ie defective parts/million)

How SixSigma works?
• Six Sigma seeks to improve the quality of process outputs by
identifying and removing the causes of defects (errors) and
minimizing variability in manufacturing and business processes.
• It uses a set of quality management methods, including statistical
methods, and creates a special infrastructure of people within the
organization ("Champions", "Black Belts", "Green Belts", "Yellow
Belts", etc.) who are experts in these methods.
• Each Six Sigma project carried out within an organization follows a
defined sequence of steps and has quantified value targets, for
example: reduce process cycle time, reduce pollution, reduce costs,
increase customer satisfaction, and increase profits.
Sigma Levels
Sigma Sigma (with Percent Percentage Short- Long-
level 1.5σ shift) defective yield term Cpk term Cpk
1 -0.5 691,462 69% 31% 0.33 –0.17
2 0.5 308,538 31% 69% 0.67 0.17
3 1.5 66,807 6.7% 93.3% 1.00 0.5
4 2.5 6,210 0.62% 99.38% 1.33 0.83
5 3.5 233 0.023% 99.977% 1.67 1.17
6 4.5 3.4 0.00034% 99.99966% 2.00 1.5

7 5.5 0.019 0.0000019% 99.9999981% 2.33 1.83

Belt Hierarchy in SixSigma
These are the people who consider
quality above everything else.
After having worked on at least 10 to 15
High Impact Black Belt projects, a black belt
would then become eligible to become a
People who have undergone Black
Belt training & who have detailed
understanding of Six Sigma concepts.
People who have gone under requisite
training for improvement of project with
support from the Black Belts

People with Basic Knowledge about


SixSigma Doctrine
• Continuous efforts to achieve stable and predictable process results (i.e., reduce process
variation) are of vital importance to business success.
• Manufacturing and business processes have characteristics that can be measured, analyzed,
controlled and improved.
• Achieving sustained quality improvement requires commitment from the entire organization,
particularly from top-level management.
Features that set Six Sigma apart from previous quality improvement initiatives include:
• A clear focus on achieving measurable and quantifiable financial returns from any Six Sigma
• An increased emphasis on strong and passionate management leadership and support.
• A clear commitment to making decisions on the basis of verifiable data and statistical methods,
rather than assumptions and guesswork.

SixSigma Methodologies
Six Sigma projects follow two project methodologies
inspired by Deming's Plan-Do-Check-Act Cycle. These
methodologies, composed of five phases each, bear the
acronyms DMAIC and DMADV.
• DMAIC is used for projects aimed at improving an existing
business process.
• DMADV is used for projects aimed at creating new product
or process designs


The DMAIC project methodology has five phases:
• Define the system, the voice of the customer and their requirements, and the project goals, specifically.
• Measure key aspects of the current process and collect relevant data.
• Analyze the data to investigate and verify cause-and-effect relationships. Determine what the
relationships are, and attempt to ensure that all factors have been considered. Seek out root cause of the
defect under investigation.
• Improve or optimize the current process based upon data analysis using techniques such as design of
experiments, poka yoke or mistake proofing, and standard work to create a new, future state process. Set
up pilot runs to establish process capability.
• Control the future state process to ensure that any deviations from the target are corrected before they
result in defects. Implement control systems such as statistical process control, production boards, visual
workplaces, and continuously monitor the process.
Some organizations add a Recognize step at the beginning, which is to recognize the right problem to work
on, thus yielding an RDMAIC methodology.


The DMADV project methodology, known as DFSS
("Design For Six Sigma"), features five phases:
• Define design goals that are consistent with customer demands and the
enterprise strategy.
• Measure and identify CTQs (characteristics that are Critical To Quality), product
capabilities, production process capability, and risks.
• Analyze to develop and design alternatives
• Design an improved alternative, best suited per analysis in the previous step
• Verify the design, set up pilot runs, implement the production process and hand
it over to the process owner(s).

Similarities Difference
Both the methodologies are used for reducing the number of DMAIC is associated with defining a business process and its
defects to less than 3.4 per million opportunities available for applicability whereas DMADV helps in defining customer needs
such defects to occur. in relation to a product or service.
Both the methodologies use facts and statistical tools for DMAIC is used for measuring the current performance of a
finding solutions to common problems, related to quality. business process whereas DMADV is used for measuring the
customer needs and specifications.
Both the methodologies require the services of Green Belts, In DMAIC, a business process is analyzed to find the root cause
Black Belts and Master Black Belts during the implementation of a defect or recurring problem. In DMADV, a business process
stage. is analyzed for finding options that will help in satisfying the
customer needs and specifications.
Both concentrate on achieving the financial and business In DMAIC, improvements are made in the business process for
objectives of an organization. eliminating or reducing defects whereas in DMADV, an
appropriate business model is designed that helps in meeting
customer requirements.
Both the methodologies require support from a Champion In DMAIC, control systems are put in place to keep a check on
and Process Owner during the implementation stage. future performance of a business process. In DMADV, the
suggested business model is put through simulation tests for
verifying efficacy in meeting customer needs and specifications.
Companies with SixSigma
• 3M • Deere & Company • Northrop Grumman
• Amazon.com • Dell • PolyOne Corporation
• BAE Systems • Denso • Raytheon
• Bank of America • Eastman Kodak Company • Sears
• BD Medical • Evonik Industries • Shop Direct Group
• Bechtel Corporation • Ford Motor Company • Starwood Hotels & Resorts
• Boeing • General Electric

• Caterpillar Inc. • Inventec

• The Vanguard Group

• Computer Sciences • McKesson Corporation

• Unipart
• Motorola
• United States Army
• Convergys
• Mumbai's Dabbawalas
• United States Marine Corps
• Credit Suisse • Wipro
• Six Sigma through the correct application of
statistical tools can reap a company enormous
rewards that will have a positive effect for years
• Six Sigma can be a dismal failure if not used correctly
• A true Six Sigma organization produces not only
excellent product but also maintains highly efficient
production and administrative systems


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