SIX SIGMA
"Delivering Tomorrow's Performance Today"
PAWAN KUMAR PORWAL
ASSOCIATE PROFESSOR
DEPT. OF QUALITY ASSURANCE
ISF COLLEGE OF PHARMACY
WEBSITE: - WWW.ISFCP.ORG
EMAIL: PAWANKPORWAL@GMAIL.COM
ISF College of Pharmacy, Moga
Ghal Kalan,nGT Road, Moga- 142001, Punjab, INDIA
2WHAT IS SIGMA ?
 A term (Greek) used in statistics to represent standard deviation from
mean value, an indicator of the degree of variation in a set of a process.
 Sigma measures how far a given process deviates from perfection. Higher
sigma capability, better performance
3WHAT IS SIX SIGMA?
 Six Sigma - A highly disciplined process that enables organizations deliver
nearly perfect products and services.
 The figure of six arrived statistically from current average maturity of most
business enterprises
 A philosophy and a goal: as perfect as practically possible.
 A methodology and a symbol of quality.
4WHAT IS SIX SIGMA?
 A statistical concept that measures a
process in terms of defects – at the six
sigma level, there 3.4 defects per million
opportunities.
But, it is much more!
5
Six Sigma is not:
•A standard
•A certification
•Another metric like percentage
Rather!
•It is a Quality Philosophy and the way of improving performance by knowing
where you are and where you could be.
 Methodology to measure and improve company’s performance, practices
and systems
WHAT IS SIX SIGMA
6WHY SIX SIGMA ?
 Six Sigma emerged as a natural evolution in business to increase profit by
eliminating defects
 The Current business environment now demands and rewards innovation
more than ever before due to:
 Customer Expectations
 Technological Change
 Global Competition
 Market Fragmentation
Five Core Elements of Six Sigma
 Customer Orientation
 Leadership Engagement
 Dedicated Improvement Organization
 Structured Method
 Metric Focus
7
8SIGMA LEVELS
Sigma Level ( Process Capability) Defects per Million Opportunities
2 308,537
3 66,807
4 6,210
5 233
6 3.4
SIX SIGMA – PRACTICAL MEANING
99% GOOD (3.8 Sigma)
 20,000 lost articles of mail per hour
 Unsafe drinking water for almost 15 minutes
per day
 5,000 incorrect surgical operations per week
 Two short or long landings at most major
airports each day
 200,000 wrong drug prescriptions each year
 No electricity for almost seven hours each
month
99.99966% GOOD (6 Sigma)
 Seven articles of mail lost per hour
 One unsafe minute every seven months
 1.7 incorrect operations per week
 One short or long landing every five years
 68 wrong prescriptions each year
 One hour without electricity every 34 years
9
Not very satisfactory!
 Companies should strive for ‘Six Sigma’ quality levels
 A successful Six Sigma programme can measure and improve quality levels across all areas
within a company to achieve ‘world class’ status
 Six Sigma is a continuous improvement cycle
INDUCTION INDUCTION
DEDUCTION DEDUCTION
Data
Facts
Theory
Hypothesis
Conjecture
Idea
Model
Check
Plan
DoAct
Improvement cycle
 The PDCA cycle
Plan
Do
Check
Act
Prioritise (D)
Measure (M)
Interpret
(D/M/A)
Problem (D/M/A)
solve
Improve (I)
Hold
gains (C)
Alternative interpretation
13
SIX SIGMA METHODOLOGY
(It takes money to save money)
 BPMS
 Business Process Management System
 DMAIC (Define, Measure, Analyze, Improve, Control)
 Six Sigma Improvement Methodology
 DMADV(Define, Measure, Analyze, design and verify)
 Creating new process which will perform at Six Sigma
14BUSINESS PROCESS MANAGEMENT (BPM)
SYSTEM:
 BPM strategies emphasize on process improvement and automation to derive
performance
 Combining BPM strategies with sigma six is most powerful way to improve
performance
 Both strategies are not mutually exclusive but some companies produced
dramatic results by combining them.
15
DMAIC
(Define, Measure, Analyze, Improve, Control)
 A logical and structured approach to
problem solving and process improvement.
 An iterative process (continuous
improvement)
 A quality tool which focus on change
management style.
16PHASES
Phases of Six Sigma are:
 Define specific goals to achieve outcomes, consistent with customers
demand and business strategy
 Measure reduction of defects
 Analyze problems ,cause and effects must be considered
 Improve process on bases of measurements and analysis
 Control process to minimize defects
17DMADV
 Acronym for:
 Define the project
 Measure the opportunity
 Analyze the process options
 Design the process
 Verify the performance
Difference between DMAIC and DMADV
 The DMADV methodology, instead of the DMAIC methodology, should
be used when:
 A product or process is not in existence at your company and one
needs to be developed
 The existing product or process exists and has been optimized
(using either DMAIC or not) and still does not meet the level of
customer specification or Six Sigma level
18
Types of Process Variation
 Chances causes: None traceable to a single major cause,
 Special Cause: Variation is due to differences between people, machines,
materials, methods, etc
 Control charts provide a means for distinguishing between common cause
variability and special cause variability
19
Statistical Process Control
 Control charting is the primary tool of SPC
 Control charts provide information about the
stability/predictability of the process,
specifically with regard to its:
 Central tendency (to target value)
 Variation
 SPC charts are time-sequence charts of
important process or product characteristics
20
Control Chart Example: Patient Falls 21
What To Do: Plan of work phase-I
22
Select three cups with the same sample number (day).
Weigh each on the digital scale
Record the data on the check sheet form and calculate the mean (average)
and report the results to the instructor
Also report the lowest and highest weights for each day. Calculate range =
highest - lowest
Process Capability
 “Process Capability is broadly defined as the ability of a process to meet customer
expectations” (Bothe, 1997)
 Once we have a process in control then we can answer the question of whether
the process is capable of meeting the customer’s specifications.
23
Assessing Process Capability
 Cp, a term used to define process
capability, is mathematically
expressed by:
Cp = (USL-LSL)/6σ
 The figure shows centered
distributions with various Cp levels.
 Cps less than two have visible tails
outside the acceptable limits.
24
Non-Centered Distributions
 If the distribution is off center, the
probability of a bad result
drastically increases. In this case
Cpk is used.
 It is the smaller of
Cpk = (USL – Mean)/ 3σ
Or
Cpk = (Mean - LSL) / 3σ
25
This figure shows the same distributions off-center by 1.5σ. The Cpks are smaller than the corresponding Cps.
This illustrates the need to both control variation and accurately hit the desired mean.
Bad
What To Do: Plan of work phase-II
26
Draw control limits on your chart based on the first 20 samples.
Weigh a new sample (3 cups), record the data on the 2nd check sheet and
calculate the average and range.
Plot the average and range on the charts, and decide if the process is in
control.
If the process goes out of control, stop and investigate the cause using a
fishbone diagram.

SIX SIGMA

  • 1.
    SIX SIGMA "Delivering Tomorrow'sPerformance Today" PAWAN KUMAR PORWAL ASSOCIATE PROFESSOR DEPT. OF QUALITY ASSURANCE ISF COLLEGE OF PHARMACY WEBSITE: - WWW.ISFCP.ORG EMAIL: [email protected] ISF College of Pharmacy, Moga Ghal Kalan,nGT Road, Moga- 142001, Punjab, INDIA
  • 2.
    2WHAT IS SIGMA?  A term (Greek) used in statistics to represent standard deviation from mean value, an indicator of the degree of variation in a set of a process.  Sigma measures how far a given process deviates from perfection. Higher sigma capability, better performance
  • 3.
    3WHAT IS SIXSIGMA?  Six Sigma - A highly disciplined process that enables organizations deliver nearly perfect products and services.  The figure of six arrived statistically from current average maturity of most business enterprises  A philosophy and a goal: as perfect as practically possible.  A methodology and a symbol of quality.
  • 4.
    4WHAT IS SIXSIGMA?  A statistical concept that measures a process in terms of defects – at the six sigma level, there 3.4 defects per million opportunities. But, it is much more!
  • 5.
    5 Six Sigma isnot: •A standard •A certification •Another metric like percentage Rather! •It is a Quality Philosophy and the way of improving performance by knowing where you are and where you could be.  Methodology to measure and improve company’s performance, practices and systems WHAT IS SIX SIGMA
  • 6.
    6WHY SIX SIGMA?  Six Sigma emerged as a natural evolution in business to increase profit by eliminating defects  The Current business environment now demands and rewards innovation more than ever before due to:  Customer Expectations  Technological Change  Global Competition  Market Fragmentation
  • 7.
    Five Core Elementsof Six Sigma  Customer Orientation  Leadership Engagement  Dedicated Improvement Organization  Structured Method  Metric Focus 7
  • 8.
    8SIGMA LEVELS Sigma Level( Process Capability) Defects per Million Opportunities 2 308,537 3 66,807 4 6,210 5 233 6 3.4
  • 9.
    SIX SIGMA –PRACTICAL MEANING 99% GOOD (3.8 Sigma)  20,000 lost articles of mail per hour  Unsafe drinking water for almost 15 minutes per day  5,000 incorrect surgical operations per week  Two short or long landings at most major airports each day  200,000 wrong drug prescriptions each year  No electricity for almost seven hours each month 99.99966% GOOD (6 Sigma)  Seven articles of mail lost per hour  One unsafe minute every seven months  1.7 incorrect operations per week  One short or long landing every five years  68 wrong prescriptions each year  One hour without electricity every 34 years 9
  • 10.
    Not very satisfactory! Companies should strive for ‘Six Sigma’ quality levels  A successful Six Sigma programme can measure and improve quality levels across all areas within a company to achieve ‘world class’ status  Six Sigma is a continuous improvement cycle INDUCTION INDUCTION DEDUCTION DEDUCTION Data Facts Theory Hypothesis Conjecture Idea Model Check Plan DoAct
  • 11.
    Improvement cycle  ThePDCA cycle Plan Do Check Act
  • 12.
    Prioritise (D) Measure (M) Interpret (D/M/A) Problem(D/M/A) solve Improve (I) Hold gains (C) Alternative interpretation
  • 13.
    13 SIX SIGMA METHODOLOGY (Ittakes money to save money)  BPMS  Business Process Management System  DMAIC (Define, Measure, Analyze, Improve, Control)  Six Sigma Improvement Methodology  DMADV(Define, Measure, Analyze, design and verify)  Creating new process which will perform at Six Sigma
  • 14.
    14BUSINESS PROCESS MANAGEMENT(BPM) SYSTEM:  BPM strategies emphasize on process improvement and automation to derive performance  Combining BPM strategies with sigma six is most powerful way to improve performance  Both strategies are not mutually exclusive but some companies produced dramatic results by combining them.
  • 15.
    15 DMAIC (Define, Measure, Analyze,Improve, Control)  A logical and structured approach to problem solving and process improvement.  An iterative process (continuous improvement)  A quality tool which focus on change management style.
  • 16.
    16PHASES Phases of SixSigma are:  Define specific goals to achieve outcomes, consistent with customers demand and business strategy  Measure reduction of defects  Analyze problems ,cause and effects must be considered  Improve process on bases of measurements and analysis  Control process to minimize defects
  • 17.
    17DMADV  Acronym for: Define the project  Measure the opportunity  Analyze the process options  Design the process  Verify the performance
  • 18.
    Difference between DMAICand DMADV  The DMADV methodology, instead of the DMAIC methodology, should be used when:  A product or process is not in existence at your company and one needs to be developed  The existing product or process exists and has been optimized (using either DMAIC or not) and still does not meet the level of customer specification or Six Sigma level 18
  • 19.
    Types of ProcessVariation  Chances causes: None traceable to a single major cause,  Special Cause: Variation is due to differences between people, machines, materials, methods, etc  Control charts provide a means for distinguishing between common cause variability and special cause variability 19
  • 20.
    Statistical Process Control Control charting is the primary tool of SPC  Control charts provide information about the stability/predictability of the process, specifically with regard to its:  Central tendency (to target value)  Variation  SPC charts are time-sequence charts of important process or product characteristics 20
  • 21.
    Control Chart Example:Patient Falls 21
  • 22.
    What To Do:Plan of work phase-I 22 Select three cups with the same sample number (day). Weigh each on the digital scale Record the data on the check sheet form and calculate the mean (average) and report the results to the instructor Also report the lowest and highest weights for each day. Calculate range = highest - lowest
  • 23.
    Process Capability  “ProcessCapability is broadly defined as the ability of a process to meet customer expectations” (Bothe, 1997)  Once we have a process in control then we can answer the question of whether the process is capable of meeting the customer’s specifications. 23
  • 24.
    Assessing Process Capability Cp, a term used to define process capability, is mathematically expressed by: Cp = (USL-LSL)/6σ  The figure shows centered distributions with various Cp levels.  Cps less than two have visible tails outside the acceptable limits. 24
  • 25.
    Non-Centered Distributions  Ifthe distribution is off center, the probability of a bad result drastically increases. In this case Cpk is used.  It is the smaller of Cpk = (USL – Mean)/ 3σ Or Cpk = (Mean - LSL) / 3σ 25 This figure shows the same distributions off-center by 1.5σ. The Cpks are smaller than the corresponding Cps. This illustrates the need to both control variation and accurately hit the desired mean. Bad
  • 26.
    What To Do:Plan of work phase-II 26 Draw control limits on your chart based on the first 20 samples. Weigh a new sample (3 cups), record the data on the 2nd check sheet and calculate the average and range. Plot the average and range on the charts, and decide if the process is in control. If the process goes out of control, stop and investigate the cause using a fishbone diagram.