1. Quality Management

2. SIX SIGMA TECHNIQUE
An organization cannot do today’s job with yesterdays methods & be in business tomorrow.

3. SIX SIGMA
A highly disciplined process that helps us focus on developing and delivering near-perfect products and services.
The word Six Sigma is a statistical term that measures how far a given process deviates from perfection.
The central idea behind Six Sigma is that if you can measure how many “defects” you have in a process, you can systematically figure out how to eliminate them and get as close to “zero defects” as possible.

4. Introduction to Six Sigma
The term Six Sigma originated from terminology associated with manufacturing, specifically terms associated with statistical modelling of manufacturing processes.
The maturity of a manufacturing process can be described by a sigma rating indicating its yield, or the percentage of defect-free products it creates. 
A six sigma process is one in which % of the products manufactured are statistically expected to be free of defects (3.4 defects per million)

5. Understanding Six Sigma
Degree of variation;
Sigma is a letter in the Greek Alphabet
Level of performance in terms of defects
Statistical measurement of process capability
Benchmark for comparison
Process improvement methodology
It is a Goal
Strategy for change;
A commitment to customers to achieve an acceptable level of performance

6. Sigma is standard deviation and it denotes the % of error in the process

7. Origin and meaning of the term "six sigma process"

8. ORIGIN OF SIX SIGMA Motorola company that invented Six Sigma.
The term “Six Sigma” was coined by Bill Smith, an engineer with Motorola
Late 1970s - Motorola started experimenting with problem solving through statistical analysis
Motorola officially launched it’s Six Sigma program
Motorola saved more than $ 15 billion in the first 10 years of its Six Sigma effort

9. The Growth Of Six SIGMA The company that perfected Six Sigma
Jack Welch launched Six Sigma at GE in Jan,1996
At GE, Six Sigma added more than $ 2 billion to the bottom line in 1999 alone.

10. THE GROWTH OF SIX SIGMA

11. Six Sigma Project methodologies
Methods of Six Sigma
Six Sigma Project methodologies
DMAIC
DMADV
 Used for projects aimed at improving an existing business process
 Used for projects aimed at creating new product or process designs

12. DMAIC and DMADV DMAIC: Define the problem
Measure key aspects of the current process
Analyze the data to investigate and verify cause-and-effect relationships
Improve or optimize the current process based upon data analysis
Control the future state process to ensure that any deviations from target are corrected before they result in defects.

13. Six Sigma Project Methodology
Control
Define
Measure
Analyze
Improve
Establish standards to maintain process;
Design the controls, implement and monitor.
Evaluate financial impact of the project
Identify, evaluate and select projects for improvement
Set goals
Form teams.
Collect data on size of the selected problem,
identify key customer requirements,
Determine key product and process characteristic.
Analyze data, establish and confirm the “
vital few “ determinants of the performance.
Validate hypothesis
Improvement strategy
Develop ideas to remove root causes
Design and carry out experiments,
Optimize the process.

14. DMAIC and DMADV
DMADV:
Define design goals that are consistent with customer demands
Measure and identify CTQs (characteristics that are Critical To Quality)
Analyze to develop and design alternatives
Design details, optimize the design, and plan for design verification
Verify the design

15. Benefits of Six Sigma Generates sustained success
Sets performance goal for everyone
Enhances value for customers;
Accelerates rate of improvement
Promotes learning across boundaries
Executes strategic change

16. Regulatory authorities

17. USDFA FDA is responsible for :
Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
Protecting the public from electronic product radiation
Assuring cosmetics and dietary supplements are safe and properly labeled
Regulating tobacco products

18. USDFA
Advancing the public health by helping to speed product innovations
Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health

19. Offices of USDFA Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Tobacco Products (CTP)
Center for Veterinary Medicine (CVM)
National Center for Toxicological Research (NCTR)
Office of the Commissioner (OC)
Office of Regulatory Affairs (ORA)

20. Offices of USDFA FDA regulates
foods, except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture
food additives
infant formulas
dietary supplements
human drugs
vaccines, blood products, and other biologics
medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers
electronic products that give off radiation, such as microwave ovens and X-ray equipment
cosmetics
feed, drugs, and devices used in pets, farm animals, and other animals
tobacco products

21. Offices of USDFA FDA does not regulate:
advertising (except for prescription drugs, medical devices, and tobacco products)
alcoholic beverages
some consumer products, such as paint, child-resistant packages, baby toys, and household appliances (except for those that give off radiation)
illegal drugs of abuse, such as heroin and marijuana
health insurance
meat and poultry (except for game meats, such as venison, ostrich, and snake)
restaurants and grocery stores
FDA shares the responsibility for regulating these products with other government agencies:
pesticides (FDA, the U.S. Department of Agriculture, and the Environmental Protection Agency regulate these)
water (FDA regulates the labeling and safety of bottled water, while the Environmental Protection Agency develops national standards for drinking water from municipal water supplies)

22. THANK YOU -PHARMA STREET