SixSigma
AKSHAY ANAND MI 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 1995.
• Today, it is used in many industrial sectors for minimizing errors, reduction of costs and increase in profit.
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process is one in which
of the products manufactured are
statistically expected to be
FREE of defects (ie defective parts/million)
99.99966%
SixSigma
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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.
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Sigma LevelsSigma level
Sigma (with 1.5σ shift)
DPMOPercent
defectivePercentage
yieldShort-
term Cpk
Long-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
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Belt Hierarchy in SixSigma
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People with Basic Knowledge about quality.
People who have gone under requisite training for improvement of project with support from the Black Belts
People who have undergone Black Belt training & who have detailed understanding of Six Sigma concepts.
After having worked on at least 10 to 15 High Impact Black Belt projects, a black belt would then become eligible to become a MBB.
These are the people who consider quality above everything else.
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 project.
• 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.
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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
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DMAICThe 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.
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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).
DMADV
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DMAIC vs. DMADVSimilarities Difference
Both the methodologies are used for reducing the number of defects to less than 3.4 per million opportunities available for such defects to occur.
DMAIC is associated with defining a business process and its applicability whereas DMADV helps in defining customer needs in relation to a product or service.
Both the methodologies use facts and statistical tools for finding solutions to common problems, related to quality.
DMAIC is used for measuring the current performance of a business process whereas DMADV is used for measuring the customer needs and specifications.
Both the methodologies require the services of Green Belts, Black Belts and Master Black Belts during the implementation stage.
In DMAIC, a business process is analyzed to find the root cause of a defect or recurring problem. In DMADV, a business process is analyzed for finding options that will help in satisfying the customer needs and specifications.
Both concentrate on achieving the financial and business objectives of an organization.
In DMAIC, improvements are made in the business process for 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 and Process Owner during the implementation stage.
In DMAIC, control systems are put in place to keep a check on 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.
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Companies with SixSigma• 3M
• Amazon.com
• BAE Systems
• Bank of America
• BD Medical
• Bechtel Corporation
• Boeing
• Caterpillar Inc.
• Computer Sciences Corporation
• Convergys
• Credit Suisse
• Deere & Company
• Dell
• Denso
• Eastman Kodak Company
• Evonik Industries
• Ford Motor Company
• General Electric
• Inventec
• McKesson Corporation
• Motorola
• Mumbai's Dabbawalas
• Northrop Grumman
• PolyOne Corporation
• Raytheon
• Sears
• Shop Direct Group
• Starwood Hotels & Resorts Worldwide
• The Vanguard Group
• Unipart
• United States Army
• United States Marine Corps
• Wipro13
Conclusion
• 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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