six sigma

1. Auditing of quality assurance and engineering
department
NAME: ABHRA CHAKRABORTY
CLASS: M.PHARM(1ST YEAR)
SUBJECT: AUDITS AND REGULATORY COMPLIANCE

2. CONTENTS
• Introduction to Six Sigma
• History of Six Sigma
• Principles
• Methodologies
• Application
• References

3. INTRODUCTION
Six Sigma is a process that makes use of statistics and data analysis to
analyze and reduce errors or defects. In this process, the purpose is to
improve cycle times while reducing manufacturing defects to no more
than 3.4 defects per million units or events.
CALCULATING SIGMA LEVEL
Organizations and teams can calculate the sigma level of a product or
process using the equation
{(# of opportunities - # of defects)/ # of opportunities}*100= Yield

4. Sigma Level Indicator
Real World Examples in Health Sector:

5. Other Sectors :
On Cyber Monday in 2013, Amazon processed a whopping 36.8 million
orders. Let’s assume that each order error costs the company an average
of $35.
Cost of Amazon order Errors, 5
Total Orders Errors Average Cost per
Error
Total Cost of
Errors
36.8 million 8574.4 $35 $300,104.00
Cost of Amazon order Errors, 6
Total Orders Errors Average Cost per
Error
Total Cost of Errors
36.8 million 125.12 $35 $4,379.20

6. HISTORY OF SIX SIGMA
• Concept of Normal Curve by Carl Friedrich Gauss
• Shewhart’s contribution to statistical process control and control
charts
• Deming’s PDCA or plan-do-check-act cycle
• Continuous Process Improvement: Toyota and Lean
• Motorola’s Focus on Defects
• Jack Welch with General Electric
• Iso Standard of Six Sigma

7. PRINCIPLES OF SIX SIGMA
• Customer-Focused Improvement
• Continuous Process Improvement
• Variation
• Removing Waste
• Equipping People
• Controlling the Process

8. METHODOLOGIES OF SIX SIGMA :
• DMAIC : It is used for projects aimed at improving an existing
business process.
• DMADV : It is used for projects aimed at creating new product or
process designs.

9. APPLICATION OF SIX SIGMA

10. REFERENCES
• SIX SIGMA: A COMPLETE STEP-BY-STEP GUIDE
• What is Six Sigma: Everything You Need to know About it-
Pankaj Kumar
• Shibani, Dr Abdussalam. (2016). The Implementation of Six
Sigma in Construction in China. European Journal of Research
and Reflection in Management Sciences,. 4.

11. THANK YOU