Proficience-SQAM-Module 9 Introduction To Six Sigma

Module 9 &14: Introduction to statistical
techniques and Six Sigma
14.1 Concept of Six Sigma

14.2 Methodologies
14.3 Six Sigma Structure
14.4 Projects Selection and
Execution
14.5 Reporting
14.6 Case study – only demo
Adopted from the internet - Introduction to Six Sigma-ASQ 2004
SQAM Course, Proficience, IISc 1

Agenda
• Introduction and Course Objectives
• Six Sigma Overview
• The DMAIC Methodology
– Define
• Charter
• Team Tools
– Measure
• Process Map (IPO)
• Prioritization Matrix
• Statistical Process Control
• Capability Analysis
• Measurement System Analysis
Agenda (Continued)
– Analyze
• Failure Modes Effects Analysis (FMEA)
• ANOVA
• Regression
• Multi-Vari Analysis
– Improve
• Design of Experiments (DOE)
– Control
• Effective Control Plans

What is Six Sigma?

What is Sigma?
• A Metric
– Something we can measure for any
process
• Philosophy
– Becomes part of our culture
• Is defined to be the standard
deviation

What is Six Sigma?
A Statistical Metric
Defects per
Ζ Million
opportunities
σ
2 308,537
3 66,807
4 6,210
5 233
6 3.4
What is Six Sigma Performance?
99% Good (3.8σ) 99.99966% Good (6σ)
• 20,000 lost articles of mail per • Seven articles lost per hour
hour
• Unsafe drinking water for • One unsafe minute every seven
almost 15 minutes each day months
• 5,000 incorrect surgical • 1.7 incorrect operations per
operations per week week
• Two short or long landings at • One short or long landing every
most major airports each day five years
• 200,000 wrong drug • 68 wrong prescriptions per year
prescriptions each year

What is Six Sigma?
First Thoughts
• 3.4 PPM defective long term

• Cpk = 2.0
• The customer specs are much wider than my
process capability.
• I always thought 4 sigma (Cpk=1.33) was “good
enough”.
– Sigma - a measure of the statistical variation about a target
value
– Parts Per Million defective - number of units expected to be
found defective in a lot size of 1 million
– CpK - the ability of the process to meet the range and
target specifications (i.e. is the process centered on the
target and in the desired range)
– NO. IT IS MUCH MORE THAN THIS!!!!!!!!
What is Six Sigma ?
A random sampling of definitions
• 6σ is not magic or high tech razzle-dazzle.

• 6σ is a change process.
• 6σ helps organizations make money.
• 6σ identifies and eliminates costs which provide no
value to customers.
• 6σ is a rigorous, focused, and highly effective
implementation of proven principles and techniques.
• 6σ is a management system focused to deliver cash to
the bottom line.
• 6σ is a strategic and tactical system for managing the
whole business.
• 6σ is a systematic methodology that is focused on
achieving significant financial results.
• 6σ is a quality culture of strategies, statistics, and tools
for improving a company’s bottom line.
What Is Six Sigma?
Six Sigma is a highly technical method used by

engineers and statisticians to fine-tune products
and processes. YES AND……….
Six Sigma is a goal of near-perfection in meeting
customer requirements. YES AND ……….
Six Sigma is a sweeping culture change effort to
position a company for greater customer
satisfaction, profitability, and competitiveness.
YES AND ……….

Six Sigma : A Definition
A comprehensive and flexible system for

achieving, sustaining and maximizing business
success. Six Sigma is uniquely driven by close
understanding of customer needs, disciplined use
of facts, data, and statistical analysis, and
diligent attention to managing, and reinventing
business processes.

Six Sigma : 5 Hidden Truths
[#1] Six Sigma encompasses a broad array of

business best practices and skills that are essential
ingredients for success and growth.
[#2] It works just as well in leading an entire
organization as it does a department - it’s scalable.
[#3] Potential gains are equally significant in service
organizations and non-manufacturing activities.
[#4] It is as much about people excellence as it is
about technical excellence.
[#5] Done right, Six Sigma improvement is thrilling
and rewarding.

Six Sigma :Requirements for
Culture Change
• Top-down commitment and involvement

– Actively be involved in project progress
and review
• Measurement system to track progress
– Evaluate the ability to access process
change
• Common well-understood set of metrics tied
to project and organizational strategic plan
• Tough goal setting (reach out!) Think
entitlement!!!!!
– Benchmark best in class
– Provide the required education
Six Sigma : The Projects
• Projects are linked to the Strategic Plan
• Projects prioritized based on value to the
business, resources required, and timing
– Yield improvement (RTY)
– Waste reduction
– Capacity-productivity improvement
– Cycle time reduction
• Inventory
• Days sales outstanding
• Order processing
• Projects selected with leadership buy-in
• Projects are formally tracked
• Team Leader and Management are held
accountable
An Yield Improvement Example :
Card Drop RTY Exercise
• This is a 3-stage process. The goal is to move
20 cards through the process by landing at
least a portion of each card on a “Target”
located on the floor.
• These cards may only move to the next stage
when the any portion of the card lands on the
target surface.
• A card is to be dropped ONE AT A TIME from
shoulder height.
• The card must be dropped from a vertical
position.
• Each operator is to count the total number of
cards dropped at each station.
• The total time SQAM
for Course,
20 “good” cards to go
Proficience, IISc 15
Six Sigma Project Selection
• Scope Projects Properly

A Team document that clearly states the goal.
The project “Y” must be clearly measurable to
maximize success.
The team document should include a from/to
statement clearly stating team goal.
• Basic Qualifications
There is a gap between current and
desired/needed performance
The solution isn’t predetermined, nor is the
optimal solution apparent.

Six Sigma : The People
• Champions (Management Sponsor)

– High level, committed to success
– Identify critical business needs to meet goals
• Master Black Belts (Expert & Trainer)
– Provide 6σ technical leadership and statistical
training.
– Mentor and guide black belts
– Facilitate project generation sessions for business
• Black Belts (Team Leader & Mentor)
– Organizational change agents
– Project team leaders
– Mentor for Green Belts
– Facilitates project generation sessions and helps
write project charter
• Green Belts (Team Leader and Team Member)
- Team member and process owner when project
completed.
− 6σ project leaders
Six Sigma Improvement Methodology – D-M-A-I-C
Define
Control
Measure
ACT PLAN
CHECK DO
Improve
Analyze

DMAIC Methodology
• Define :
– Establish project charter and scope
– Determine return, resources, timing
– Ensure management commitment
• Measure :
– Generate process “is” map
– Prioritize project Y’s and document process input variables
– Access critical Y initial capability and measurement system
• Analyze :
– Establish input variable (X’s) ranking via Prioritization matrix
– Evaluate current control system via FMEA
– Gather additional information via passive data collection/analysis
• Improve
– Do active data collection/analysis (DOE’s, etc.) on key inputs
• Control
– Develop/Implement control plans to maintain gains
– Gather long term capability
Key Terms
Y’s
• Key process output variable
• Thought of in terms of performance/defect
measures
X’s
• Key process input variable
• Are a list of variables that influence the
response(s) or Y’s
• Y is a function of the X’s or Y = f(X1, X2, …)
The goal of six sigma is to understand the X’s that control
the Y’s.

Common Six Sigma Mistakes
•Thinking the key to Six Sigma is Statistics, Statistics,

Statistics - NO ! IT IS A MANAGEMENT SYSTEM !!!
•Overemphasis on Cost Reduction
•Failure to address improvement as part of the job
•Ignoring team dynamics as a cause of project failures
•Overreliance on the Black Belt, Six Sigma equals projects
•Not understanding common cause vs. special cause variation
•Failure to apply the concept of the customer internally
•Recognizing management’s involvement not just
commitment
•Ignoring the management of change

The Six Sigma Road
Map
The DMAIC
Methodology

DMAIC Methodology
• Define :
– Establish project charter and scope
– Determine return, resources, timing
– Ensure management commitment
– List of customer (internal & external) requirements
• Measure :
– Generate process “is” map
– Prioritize project Y’s and document process input variables
– Access critical Y initial capability and measurement system
– Baseline data on current process performance
– Revisions/Improvements to project charter
– Access measurement system capability

DMAIC Methodology
• Analyze :
– Establish input variable (X’s) ranking via Prioritization
matrix
– Evaluate current control system via Failure Modes Effects
Analysis (FMEA)
– Gather additional information via passive data
collection/analysis (ANOVA and Multi-Vari)
• Improve
– Do active data collection/analysis (DOE’s, etc.) on key
inputs
• Control
– Develop/Implement control plans to maintain gains (use
FMEA as initial input)
– Gather long term capability documenting before/after
improvement results
Define :
Project Scope
• Identify well-defined Baseline, Goal, and
Entitlement values
• Values must be included for ALL metrics, not just
the one(s) of primary focus for improvement
– The productivity improvements are Operating Income or
Working Capital
• Values are entered as Yearly values, maintaining a
connection to business metrics and measurement
• Values can change throughout the project - make
sure the Charter is updated
Entitlement
• Defines what’s possible - a vision
• Provides a performance level for which to aim
• “Best in class” performance
• Bound by either equipment or engineering

limitations

DMAIC Methodology :
The Tools : Define
• Project Charter : Line of sight to

business unit strategic goals
• Process Map : Map showing high level
and detailed inputs and outputs
• Affinity Diagram – Can identify specific
process for improvement
• Process Perspective : Rolled Throughput
Yield or First Pass Yield
• Stakeholder Analysis (WIFM)
DMAIC Methodology :
The Tools
• Project Charter MUSTS :
– Clarify team expectations
– Clarify team roles
– Define business “pain” or problem
• Improve product RTY from XX to YY
• Reduce product cycle time from XX to YY.
• Decrease defects from process A from XX
to YY
– Identify key milestones and objectives
Affinity Diagram
• Used as a brainstorming tool to

generate ideas for “weakness based”
opportunities.
– What are the main issues preventing us
from implementing six sigma?
– How should a new product be marketed?
– What are our challenges to achieve next
year’s growth objectives?

Affinity Diagram Steps
• State the problem
• Brainstorm ideas/issues by writing ideas on a
sticky note
• EVERYONE writes EACH idea on separate sticky
notes
• Place all notes on the wall.
• In SILENCE, group the ideas by general
categories.
• In group discussion, develop titles for groups.
• (Optional) Vote on top priority issues (3 votes per
person, 9=top priority; 3=2nd priority; 1=3rd
priority. SQAM Course, Proficience, IISc 30
Affinity Diagram Exercise
• What are the main issues preventing

us from implementing six sigma?

Stakeholder Analysis
• Stakeholder analysis identifies key
stakeholders, accesses potential risks or
resistance, and helps plan strategy to
reduce identified gaps.
• Stakeholders are people who have an
interest in a project’s outcome (positive or
negative).
• Stakeholder analysis should be done at the
beginning of a project.

Doing a Stakeholder
Analysis
• Develop a “stakeholder table” (see
next slide).
• Do an assessment of each
stakeholders importance to the
project success and their relative
power/influence.
• Identify risks and assumptions which
will affect project design and
success. SQAM Course, Proficience, IISc 33
Stakeholder Analysis Worksheet
Stakeholder Analysis of Present Plans to Improve Plans to Primary Point of

Relationship Relationship Communicate Contact (Internal)

RACI Matrix
• A team tool used to clarify team roles
and pinpoint potential conflicts or gaps
in assignments.
– R = Responsible
– A = Accountable
– C = Consultant
– I = Informed Team Member
Project Task A B C D E
1 R I R C
2 I C R I C
3 R R R I C
4 A C I C
5 R A
The GRPI Tool
• A team evaluation tool which allows a self assessment

to be used for improving team effectiveness.
– Project Goals
• Are they specific, measurable, attainable,
relevant, and timely?
– Team Roles
• Are the team roles and responsibilities defined
and agreed upon?
– Team Processes
• Do we know the project key success factors ; is
there an effective project plan in place ; Do we
have specific metrics linked to the project goals?
– Interpersonal
• Do we have trust, flexibility, sensitivity, and
creativity in communicating with each other?
• Each member of the team is to rank each of these
questions on a 0-100 scale and submit privately for data
analysis. SQAM Course, Proficience, IISc 36
Managing Change For A
Successful Six Sigma Project
• Establish the need for change

• Design change to meet that need
• Identify the impact of the planned change
• Plan how the change will be implemented
• Implement the changes

Change Management Exercise
• Stand up
• Choose a partner
• Take a couple seconds to observe your partner’s
appearance
• Turn around
• Each of you change 5 things about your appearance
– Turn around and face your partner when
finished
• Each person identify the changes your partner
made to their appearance

Key Outcomes of Change Exercise
1. People will feel awkward and self-conscious
2. People will think about what they have to give up
3. People will feel alone, even if others are going
through similar change
4. People are at different levels of readiness for
change
5. People can handle only so much change
6. People will be concerned that resources will be
inadequate
7. Without pressure, people will revert to old
behaviors
Change Management
• The ability to change must be greater than our
resistance.
• We can either increase the force mandating
change (management edict, etc.) or reduce the
level of resistance.

So, how do we
deal with
Resistance?

What is Resistance?
• It is energy in another direction

• It is not necessarily bad
• There is valuable information in it
• It is the energy it takes to stay in the same
place

Faces of Resistance
•Technical Resistance
•Political Resistance
•Organizational Resistance
•Individual Resistance

Technical Resistance
• Perceive that the change will make
you feel inadequate or stupid
• Focuses on highly detailed and
insignificant issues
• To help dissipate, focus on higher
level concepts which encourage
demonstration of competence
Reproduced from “Making Six Sigma Last”, Eckes

Political Resistance
• Perceive that change is a threat or

loss to the status quo
• Focuses on real or perceived loss
• To dissipate, focus on positive
aspects of change and be honest
when dealing with real loss

Organizational Resistance
• Perceive that change initiative

removes sense of control
• As before, sense of loss or
subtraction
• To dissipate, get person involved
such that they feel greater control
and a greater sense of ownership

Individual Resistance
• Stress is at such a level that change

results in emotional and behavioral
paralysis
• May say the right thing but action is
slow
• To dissipate, empathize and off-load
action items

Team Dynamics

Team Performance Model :
Four Stages of Team
Performance
•Forming
• Who are you?
• Why am I here?
• Will you accept me as I am?
• Are there hidden agendas?
•Storming
• Can I trust you?
• Is there group consensus on goals?
• What tasks must the team do?
Team Performance Model :
Four Stages of Team
Performance
•Norming
• How do we manage the team?
• Are conflicts resolved?
• Do we all own responsibility for success?
• Who are our stakeholders how do we resolve
needs?
•Performing
• Are boundaries and limits broken?
• Are activities coordinated?
• Is communication intuitive?
• Is there openness and frank discussion?
Team Management Exercise
• Using your prior knowledge from

teams you have been involved with
during your careers, brainstorm a list
of critical success factors which
enabled those teams to succeed.

DMAIC Methodology Tools :
The Tools : Measure
• Process Maps :
– A graphical illustration of the current
process
– All input and output variables are
documented
– Must be done via team approach
including process owners and
stakeholders
– Helps identify gaps in current process
control which may require immediate
test measurement or capability analysis52
SQAM Course, Proficience, IISc
Process Thinking: S-I-P-O-C
Suppliers Inputs
x x Outputs Customers
x
Process
X’s, Inputs Y’s, Outputs

•Process variables •Customer requirements
•Inputs to the process •Yield, Waste, Rate
•Essential actions to •On Time Delivery
achieve strategic goals •Economic Profit
•Key influences on •Strategic goal
customer satisfaction •Customer satisfaction
Pande
Six Sigma Process Map :
IPO (Inputs, Process, Outputs)
• The process map is derived from the SIPOC
diagram.
– S: Suppliers
– I : Inputs
– P: Process
– O: Outputs
– C: Customers
• Identifies the current process in terms of inputs,
process, and outputs.
• Provides initial team consensus on all input
variables (X’s) which may affect the process
outputs (Y’s). SQAM Course, Proficience, IISc 54
Steps to Complete the Process
Map
• Gather a cross-functional team which
is familiar with the process.
• At a reasonably high level, list all the
process steps. As a guide, the total
number of process steps should not
exceed six.
• List the outputs for each step.
• List the inputs that cause those
outputs to occur.
DMAIC Methodology :
The Tools
• Measure
– Prioritization Matrix (reducing the
number of X’s to consider for further
evaluation)
– Capability Analysis (Initial baseline
performance)
– Measurement System Analysis (Gage
R&R and %P/T)
– Basic Data Analysis Tools
(histograms, box plots, pareto
diagrams,SQAM
etc.)
Course, Proficience, IISc 56
DMAIC Tools :
Prioritization Matrix
• This is a simplified QFD (Quality Function
Deployment) matrix to rank the importance
of the input variables against the project
and customer requirements
• Key Outputs are scored for their
importance to the project and customer
• Key Inputs are scored based on their
relationship to these outputs
Prioritization Matrix Steps
1. Identify key outputs from the “30,000 ft”
process map
2. Rank order and assign priority factor to
each output (using a 1 to 10 scale)
3. List all process steps and inputs from the
detailed process map
4. Evaluate correlation of each input to each
output using a 0,1,3,9 ranking
– 0 = no correlation ; 9 = strong correlation
5. Cross multiply correlation values with
priority factors and sum for each input (X)
Prioritization Matrix Layout
Rating
Output
Output
Output
Output
Output
Output
Output
Output
Output
Output
Output
Output
Output
Output
Output
Total
Process Step Process Input
1 0
2 0
3 0
4 0
5 0
6 0
7 0
8 0

The Measure Phase :
SPC and Capability
• SPC is a methodology of attaining
and maintaining statistical control
• SPC distinguishes between common
cause and special cause variability
– Common cause variability : Random or
systematic variation inherent in the
system
– Special cause variability : Isolated
and/or related to a specific event
SPC and Capability
• Types of control charts :
– Variables Data
• Individual/Moving Range (I/MR)
• X-Bar/R
– Attributes
• P-Chart (Percent defective, unequal sample size)
• NP-Chart (Number defective, equal sample size)
• C-Chart (Number of defects, constant sample area)
• U-Chart (Number of defects/area, variable sample
area)

Individual/Moving Range
Charts
• Individuals (I) chart presents the
measurements in time order.
– Examples include inventory, sales, number of
accounts receivable.
• Moving Range (MR) chart shows the short-
term variability in the process
– Assesses stability of process variation.
– Moving Range is the absolute difference
between consecutive observations.

I/MR Example
Upper Control
I and MR Chart for C1 Limit
25 UCL=24.14
Indiv idual Value
Average or
20
15 Mean=14.17
10 Center Line
5 LCL=4.195
0
Subgroup 0 10 20 30
Lower
UCL=12.25
Control Limit
Mov ing Range
10
5
R=3.749
0 LCL=0

I/MR Chart
• The I/MR chart is a very powerful

chart because…..
– For almost any distribution:
• +/- 1 standard deviation accounts for
approximately 60-70% of the variation
• +/- 2 standard deviations account for
approximately 90-95% of the variation
• +/- 3 standard deviations account for at
least 98% of the variation

I/MR Chart Control Limit
Calculation
• The centerline is the overall average of the data
(X-Bar)
• The process standard deviation is calculated by
taking the overall moving range and dividing by
an adjustment factor to correct for the moving
range being a biased estimate of the process
standard deviation
– The moving range is the absolute difference between
consecutive measurements
– σ = (Average Moving Range)/d2
– d2 = 1.128 for moving range of size 2
– Control limits are X-Bar +/- 3(σ)
Capability Analysis :
Voice of the Customer vs. Voice of the
Process
• Capability analysis compares how
the process is performing relative to
customer specifications
• Capability ratios are the ratio of
customer spec limits / process
variation
• Typical capability metrics include Cp,
Cpk, Pp, Ppk
Capability
• Cp = (Spec width) / (6s)
– s = R-Bar/d2 from I/MR control chart
• Cpk = Minimum (X-Bar – Tgt)/3s ,
(Tgt-X-Bar)/3s
• Pp = (Spec width) / 6(σ)
– σ = Sqrt (Σ(X-X-Bar)2 / (n-1))
• Ppk = Minimum (X-Bar – Tgt)/3σ ,
(Tgt-X-Bar)/3σ

Class Exercise
• Cut out one paper helicopter
• From a height of 6 feet, drop and
time the helicopter drop 20 times.
• Record the drop times.
• We as a class will enter the data, and
generate I/MR charts and capability
charts.
• Be prepared to discuss outputs and
take aways.
The Measurement Phase :
Measurement System
Analysis
• Objective :
– Validate that the current measurement
system on the project Y (cycle time,
inventory, yield, etc) is good enough to
detect process change.
• Methodology :
– Audits
– Gage R&R Study

Measurement System Analysis :
Audits
• An independent assessment of the current data
collection system. Examples include inventory
reduction, complaint reduction, or sales
effectiveness.
• Select an appropriate sample size. Typical may
be between 10 and 30.
• Have a second source validate the original data.
• Evaluate per cent agreement or use a paired-t-
test.
– A paired-t-test evaluates whether the difference
between each pair of observations (current,audit) is 0.
• Goal is to have at least 70% agreement.
Measurement System
Analysis : Gage R&R Studies
• A formal evaluation involving 2 or more
operators, at least 10 samples, with the
entire experiment repeated.
• The study quantifies both repeatability and
reproducibility.
• % R&R is the observed test method
standard deviation (both repeatability and
reproducibility combined) divided by the
total observed standard deviation of the
study.
• Goal is to have %R&R < 30%.
Measurement System
Analysis
• Is the measurement system generating
reliable data?
– Accuracy : How well does the average of the
measurements represent the true value?
– Repeatability : How consistent are repeated
measurements BY THE SAME OPERATOR on the
same sample?
– Reproducibility : How consistent are DIFFERENT
OPRATORS at measuring the same sample?

Measurement System
Metrics for Continuous Data
• Precision to Tolerance Ratio :
– P/T = 5.15 (σ ms) /(Specification
Tolerance)
– Note : Only applicable for two sided
specs
• % Gage R&R :
– % R&R = σ ms / σ total X 100

Measurement System
Metrics for Attribute Data
• Accuracy : % agreement with known
standard
• Repeatability : % agreement within
appraisers
• Reproducibility : % agreement
between appraisers

Attribute MSA Sample
Output
Date of study:
Assessment Agreement Reported by:
Name of product:
Misc:
Within Appraiser Appraiser v s Standard
90
80
[ , ] 95.0% CI
80
70 Percent
70
60
60 50
Percent
Percent
50
40
40 30
30 20
20 10
10 0
1 2 1 2
Appraiser Appraiser

Attribute MSA Exercise
• 2 Operators
• 10 Samples
• 4 Different Sodas (Coke, Pepsi, RC,
HEB)
• 2 trials

DMAIC Methodology :
The Tools : Analyze
• Failure Modes Effects Analysis (FMEA)
prioritizes known gaps/risks in current
control system.
• Multi-Vari analysis passively studies
existing process to validate key X’s
determined from the FMEA or discover
hidden X’s using statistics to validate
conclusions.
• Detailed statistical analyses including
tests of means/medians, Analysis of
Variance (ANOVA), and Regression
Analysis. SQAM Course, Proficience, IISc 77
Analyze : Failure Modes and
Effects Analysis (FMEA)
• Identifies the ways in which a product or
process can fail and assigns risk to this
failure mode
• Estimates the risk associated with a
specific cause in terms of customer
requirements and the current detection
system
• Uses the above risks to determine key
gaps in current control systems and
prioritize action
FMEA Procedure
• Assemble a cross-functional team

• For each “X” or critical process input as
determined by the prioritization matrix,
determine the failure mode(s).
• For each failure mode, determine the effect
(result) on the project goal or “Y”.
• Also, for each failure mode, list the potential
causes.
• Identify current controls for each failure
mode/cause.
• Determine the severity (how bad) of the effect,
the frequency (how often) the cause, and how
good is the current control system. It is common79
SQAM Course, Proficience, IISc
FMEA Terms
• Failure Mode
– What went wrong in the process?
• Effects of Failure
– What are the impacts of the failure occurring?
• Cause of Failure
– What are the potential causes of this failure?
• Current Controls
– What controls or procedures exist to prevent
the cause or failure mode?
• Severity, Occurrence, Detection
– Risk Priority Number (RPN)
FMEA :
Risk Priority Number (RPN)
• The output of an FMEA is the Risk Priority

Number which ranks the key gaps and
establishes priority to fix the control system
• RPN is the product of the quantitative ratings
related to the effects, causes, and controls:
• RPN = Severity X Occurrence X Detection

Definition of RPN Terms
• Severity (of Effect) - importance of effect on
project Y or counter measures.
– 1= None; 10=Very Severe
• Occurrence (of Cause) – How often a cause
happens and causes a failure mode.
– 1=Rarely Occurs; 10=Frequently Occurs
• Detection (capability of Current Controls) –
How good is the current system at either detecting the
cause or failure mode
– 1=Easy to detect cause; 10=Not able to detect failure
mode

FMEA Worksheet
P rocess F M E A Number
Failure Mode and Effects Analysis P repared B y
(FMEA) F M EA Date
Key Date R evision Date
C ore Team P age of
A ction R esults
P otential P R esponsibility &

P otential S D R
P otential C ause(s)/ r C urrent R ecommended T arget
P rocess Input E ffect(s) e e P A ctions Taken
F ailure Mode(s) M echanism(s) o C ontrols A ction(s) C ompletion
of F ailure v t N
of F ailure b Date

DMAIC Methodology :
The Analyze Statistical Tools
• Hypothesis Testing
– Assessing Risk
• ANOVA
– Tests for differences in means
– Tests for partitioning variability
components
• Regression
– Establishing linear relationships
between the Y’s and X’s
Hypothesis Testing
• Hypothesis testing assigns risk to aid

in statistical decision making.
• Ho : The null or “dull” hypothesis
assumes there are no differences.
The null hypothesis is rejected if
there is sufficient evidence.
• Ha : The alternative or opposite
hypothesis states there is a
difference. SQAM Course, Proficience, IISc 85
Hypothesis Testing Risks
• There are two types of risks in
deciding whether or not to accept a
null hypothesis.
• Type I error or alpha error : The
probability of rejecting the null
hypothesis when it is in fact true.
• Type II error or beta error : The
probability of accepting the null
hypothesis when it is in fact false.
Hypothesis Testing
Decisions
• Determine null hypothesis
– For example, the average of the first sample equals
the average of the second sample.
• Collect appropriate amount of data
• Calculate appropriate signal to noise ratio.
– From above, the test statistic is measuring whether
the difference between the two averages (signal) is
sufficiently greater than the variability of each
sample (noise).
• Make decision based on data and
predetermined risk
– In most software packages, a p-value is used aid in
decision making.
• A p-value is the probability of the observed
result when Ho is true.
– As a general rule, if P is low (less than 0.05), then
there is sufficient evidence to reject the null
Tests for Differences in Means :
The Analysis of Variance (ANOVA)
• Null hypothesis (Ho) : All means are equal
to one another. Note, For ANOVA, the
Response (Y) must be continuous and the
X variable discrete.
• Alternative hypothesis (Ha) : At least one
mean is different than all others.
• ANOVA tests whether or not different
levels of a particular X affects the
response or Y variable.
• ANOVA Assumes the data are from a
reasonably normal distribution and the
residuals are normally distributed.
ANOVA Example :
Helicopter Wing Length
• Null Hypothesis (Ho) : 3 different wing
lengths do not affect flight time.
– ft1 = ft2 = ft3
• The data have already been collected from
a previous experiment.
• Validate assumptions :
– One way to to that is to plot the data using an
I/MR chart when the data are time dependent –
such as monthly sales, weekly accounts
receivable, etc – or as in this case where the
data do represent a time order.
ANOVA : Check for
Normality I -MR Chart of FlightTime by WingLength
WL1 WL2 WL3
UC L=4.395
4
I ndividual Value
3 _
X=2.795
LCL=1.195
1
3 6 9 12 15 18 21 24 27 30
Observation
WL1 WL2 WL3

2.0 UC L=1.966
Moving Range
1.5
1.0
__
MR=0.602
0.5
0.0 LCL=0
3 6 9 12 15 18 21 24 27 30
Observation
Does the data appear to be coming from a normal

distribution?
Is the process stable?
ANOVA : Analysis Output
• One-way ANOVA: FlightTime versus WingLength
• Source DF SS MS F P What is the

•
•
WingLength
Error
2
27
1.056
4.292
0.528
0.159
3.32 0.051
P-Value?
• Total 29 5.349
• S = 0.3987 R-Sq = 19.75% R-Sq(adj) = 13.81%
• Individual 95% CIs For Mean Based on

• Pooled StDev
• Level N Mean StDev -------+---------+---------+---------+--
• WL1 10 2.3403 0.2576 (----------*---------)
• WL2 10 2.6274 0.4011 (---------*---------)
• WL3 10 2.7948 0.4997 (----------*---------)
• -------+---------+---------+---------+--
• 2.25 2.50 2.75 3.00
• Pooled StDev = 0.3987 SQAM Course, Proficience, IISc 91

ANOVA Output : Graphs
Boxplot of FlightTime by WingLength
3.5
3.0
FlightTime
2.5
2.0
1.5
WL1 WL2 WL3
WingLength

ANOVA Class Exercise
• Make three (3) helicopters varying ONLY
ONE OF THE X VARIABLES (wing length,
OR, wing width, OR stem length, etc.)
• Drop each of the three chosen designs 10
times recoding flight time and record the
data.
• After the data has been entered into the
computer, we’ll discuss output and key
take-aways.

Tests for Determining a Linear
Relationship : Regression
Analysis
• Null hypothesis (Ho) : There is no linear
relationship between the response (Y) and the
independent variable (X).
– Note, For Regression, the Response (Y) must be
continuous and the X variable must also be
continuous.
• Alternative hypothesis (Ha) : There is a linear
relationship between the response and the
independent variable.
• Regression assumptions are that the data are
reasonably normally distributed and the
residuals are normally distributed with no
obvious pattern in the residuals.
– A residual is the difference
SQAM between
Course, Proficience, IISc what was 94
Regression Example :
Helicopter Wing Length
• Null Hypothesis (Ho) : There is no linear
relationship between flight time and
wing length
– ∆Y/∆X = 0
– Note that wing length can be viewed as
continuous since we can measure the wing
length.
• The data have already been collected
from a previous experiment.

Regression Example :
Plot the Data
Fitted Line Plot
FlightTime = 2.133 + 0.2272 WL
S 0.392612
3.5 R-Sq 19.3%
R-Sq(adj) 16.4%
3.0
FlightTime
2.5
2.0
1.5
1.0 1.5 2.0 2.5 3.0
WL

Regression Analysis :
The Output
Regression Analysis: FlightTime versus WL
The regression equation is FlightTime = 2.13 + 0.227 WL
Predictor Coef SE Coef T P

Constant 2.1330 0.1896 11.25 0.000
WL 0.22723 0.08779 2.59 0.015
S = 0.392612 R-Sq = 19.3% R-Sq(adj) = 16.4%
Analysis of Variance
Source DF SS MS F P
Regression 1 1.0326 1.0326 6.70 0.015 WHAT IS THE
Residual Error 28 4.3160 0.1541 P-VALUE?
Total 29 5.3487
Regression Analysis
Example:
Output Detail
• The Linear relationship
– Algebra days are Y = MX + B
– Regression output is Y = B + MX
• FlightTime = 2.13 + 0.227 WL
• The R-Squared Statistic
– R-Squared is the per cent of the variation in
the response (Y) that is explained by the
model.
– Statistical packages use the method of “least
squares” which finds the best model which
minimizes the difference between the
observed response and the predicted response.
• R-Sq = 19.3%
SQAM Course, Proficience, =
R-Sq(adj) IISc16.4% 98
Regression Analysis Example:
Output Detail
• The ANOVA Table :
– Analysis of Variance
– Source DF SS MS F P
– Regression 1 1.0326 1.0326 6.70 0.015
– Residual Error 28 4.3160 0.1541
– Total 29 5.3487
– Regression and ANOVA are VERY similar. The ANOVA

table provides the P-Value for us to test the null
hypothesis.
– P = 0.015. Hence, we reject the null hypothesis and
conclude there is a statistical linear relationship
between flight time and wing length.
• The standard deviation about the regression
line (S).
– The standard deviation provides an estimate of how
precise our observations were in the study and
provides a guide on how good our predictability of
future flight times will be with these wing lengths.
Regression Analysis
Example :
Validating the Assumptions
Is the Data Normally Distributed? –
Use “Fat Pencil” Test. Is there an obvious
pattern in the residuals?
Residual Plots for FlightTime
Normal Probability Plot of the Residuals Residuals Versus the Fitted Values
99 2
Standardized Residual
90
Percent
0
50
10 -2
1
-3.0 -1.5 0.0 1.5 3.0 2.4 2.5 2.6 2.7 2.8
Standardized Residual Fitted Value
Histogram of the Residuals Residuals Versus the Order of the Data

8 2
Standardized Residual
6
Frequency
0
4
2 -2
0
-3 -2 -1 0 1 2 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Standardized Residual Observation Order

DMAIC Methodology :
The Multi-Vari Analysis
• Objective :
– Validate the key X’s as determined from the
FMEA
• Methodology :
– Passively observe process in its natural state
– Use a survey
• Analysis :
– Use statistical methods to validate
hypothesized relationships (ANOVA,
Regression, Pareto diagrams, etc.)
DMAIC Tools Analyze : Multi-Vari
Passive Data Collection Planning
1. Determine Objective
2. Identify Input and Output Variables to be studied
3. Identify Measurement Systems for each variable
Which should be studied to assure capability?
4. Determine sampling plan
5. Determine data collection, formatting and storage
procedure
6. Describe procedure and settings used to run process
7. Assign and train Team
8. Assign clear responsibilities
9. Outline data analysis to be performed using the
appropriate statistical tool.

Passive Data Collection :
Data Analysis Steps
1. Determine stability and capability.
If the data is time oriented, use an I/MR chart
Otherwise, use a Pareto chart
2. Explore relationships among the variables.
Use ANOVA, Regression or another appropriate
statistical tool
• Draw conclusions: Which input (X) variables are
associated with variability in the output (Y)?

Multi-Vari Key Challenges
• Data only represent one moment in time.
Beware of false hidden relationships.
– Ice cream sales and total car miles driven per
month
• Lack of Planning
– Who will collect what information
– Is it the right information
• KISS
– Do not overanalyze data.

DMAIC Methodology :
The Tools : Improve
• Process simulation
• Advanced statistical tools including
Design of Experiments (DOE) and
response surface methodology.

Design of Experiments
(DOE)
• DOE is an active way to study more
than one X variable at a time and
any corresponding interactions.
• Two level factorial experiments are a
very neat special case of the DOE
family.

Two Level Factorial
Experiments
• Each variable has two levels: low and
high
– Two levels per variable helps minimize the
total number of combinations
• Notation used is 2k
– k represents the number of input variables
– 2 refers to the number of levels of each input
variable
– 23 is an example of a three variable design
with 8 runs
Calculating How Changing the
Level of Each X Affects the Y
Helicopter Flight Time (Sec)
Average
Wide 2.00 2.50
2.25
Wing
Width
1.80
Narrow 1.60 2.00

Difference = 0.45
Wing
Short Long
Length
Or, the mean effect on flight time from changing the wing
length from short to long is 0.45 seconds.
DOE Example : A 23 Experiment
• Null hypothesis (Ho) : Each Independent variable
studied (X) has no effect on the response (Y). Or, the
difference between the response at the high level of X
vs. the low level of X is 0 FOR EACH AND EVERY X IN
THE EXPERIMENT.
– For each X variable : Y (at the high level of X) – Y (at
the low level of X) = 0
• Alternative hypothesis (Ha) : There is a difference in the
response for any of the X’s in the experiment.
• DOE evaluates how EACH X variable affects the
response.
• DOE Assumes the data are from a reasonably normal
distribution and the residuals are normally distributed.
• The response must be continuous but the X’s can be
either continuous or discrete.

DOE 23 Example : The
Data
Wing Length Stem Length Wing Width Flight Time
-1 -1 -1 2.0
1 -1 -1 2.5
-1 1 -1 1.8
1 1 -1 2.4
-1 -1 1 2.4
1 -1 1 2.8
-1 1 1 2.1
1 1 1 2.9
-1 -1 -1 1.9
1 -1 -1 2.6
-1 1 -1 2.0
1 1 -1 2.5
-1 -1 1 2.3
1 -1 1 3.0
-1 1 1 2.1
1 1 SQAM Course, Proficience,
1 IISc 3.1 110
DOE 2 Example : The
3
Analysis
Analysis of Variance for Flight Time (coded units)
Source DF Seq SS Adj SS Adj MS F P

Main Effects 3 2.27500 2.27500 0.75833 75.83 0.000
2-Way Interactions 3 0.04500 0.04500 0.01500 1.50 0.287
3-Way Interactions 1 0.04000 0.04000 0.04000 4.00 0.081
Residual Error 8 0.08000 0.08000 0.01000
Pure Error 8 0.08000 0.08000 0.01000
Total 15 2.44000
DOE is a special case of ANOVA. DOE studies several X’s at the same time
in a systematic way.
P-Value = 0. Hence, for at least one of the X’s, changing from the low level
of that variable to the high level of that variable statistically affected flight
time. But which one(s)?
DOE 2 Example : The
3
Analysis
Estimated Effects and Coefficients for Flight Time (coded units)
Term Effect Coef SE Coef T

P
Constant 2.40000 0.02500 96.00
0.000
Wing Length 0.65000 0.32500 0.02500 13.00
0.000
Stem Length -0.07500 -0.03750 0.02500 -1.50
0.172
Wing Width 0.37500 0.18750 0.02500 7.50
0.000
Wing Length*Stem Length 0.07500 0.03750 0.02500 1.50
0.172
Wing Length*Wing Width 0.07500 0.03750 0.02500 1.50
The P-Values are low (less than 0.05) for Wing Length and Stem
0.172
Length.
Stem Therefore,
Length*Wing Width conclude that each of0.00000
0.00000 these variables
0.02500 statistically
0.00
1.000
affects flight time.
Wing Length*Stem Length*Wing Width 0.10000 0.05000 0.02500 2.00
0.081
DOE 2 Example : The
3
Analysis
• Since DOE is ANOVA but for several X’s at one time, it is
also VERY SIMILAR to regression and the output from a DOE
analysis can be used to predict the response (flight time)
for any combination of the X variables studied (wing length,
stem length, and wing width).
• Note that from the previous slide, the effects and the
coefficients column. The effect is the difference in the
response from the high level of X to the low level of X, or 1
– (-1), a 2 unit change. Regression measures the change in
the response per ONE unit change in X. Hence, the
regression coefficients are half the effect value.
– Y = 2.4 + 0.32 (Wing Length) – 0.075(Stem Length) +

0.19 (Wing Width)
S = 0.1 R-Sq SQAM
= 96.72% R-Sq(adj)
Course, Proficience, IISc = 93.85% 113
DOE Class Exercise
• We are going to run and analyze a 23
design experiment. This requires
making 8 different helicopters.
• The variables to be studied are wing
length, wing width, and stem width.
• We’ll determine who will make each
helicopter, run and analyze the
experiment, and discuss the output.

DMAIC Methodology :
The Tools : Control
• Institutionalize updated process
complete with Standard Operating
Procedures (SOP’s).
• Control charts for critical X’s
• Before/After run chart
documenting improvements
• Mistake Proofing the process
Control Phase
• Control plans (SOP’s) should :

– Be easy to follow.
– Provide corrective action when the X’s
change.
– Have buy-in/support of process owner
– Be audited to insure long term gains

Some References
Joseph M. Juran: Juran’s Quality Handbook

(McGraw-Hill, 1999)
Mikel J. Harry: Six Sigma, A Breakthrough Strategy for Profitability

(Quality Progress, May 1998)
William J. Hill: Six Sigma at Allied Signal, Inc. (Presentation at 1999 Q&P
Research Conference, May 1999)
Jack Welch: Six Sigma, the GE Way
Six Sigma Forum Magazine: www.asq.org/pub/sixsigma
Your favorite Search Engine: search on “Six Sigma”

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Module 9 &14: Introduction to statistical

techniques and Six Sigma

14.1 Concept of Six Sigma

SQAM Course, Proficience, IISc 1

SQAM Course, Proficience, IISc 3

SQAM Course, Proficience, IISc 4

SQAM Course, Proficience, IISc 5

SQAM Course, Proficience, IISc 7

• 3.4 PPM defective long term

• 6σ is not magic or high tech razzle-dazzle.

Six Sigma is a highly technical method used by

SQAM Course, Proficience, IISc 10

A comprehensive and flexible system for

SQAM Course, Proficience, IISc 11

[#1] Six Sigma encompasses a broad array of

SQAM Course, Proficience, IISc 12

• Top-down commitment and involvement

• Scope Projects Properly

SQAM Course, Proficience, IISc 16

• Champions (Management Sponsor)

SQAM Course, Proficience, IISc 18

SQAM Course, Proficience, IISc 20

•Thinking the key to Six Sigma is Statistics, Statistics,

SQAM Course, Proficience, IISc 21

SQAM Course, Proficience, IISc 22

SQAM Course, Proficience, IISc 23

• Defines what’s possible - a vision

• Provides a performance level for which to aim

• “Best in class” performance

• Bound by either equipment or engineering

SQAM Course, Proficience, IISc 26

• Project Charter : Line of sight to

• Used as a brainstorming tool to

SQAM Course, Proficience, IISc 29

• What are the main issues preventing

SQAM Course, Proficience, IISc 31

SQAM Course, Proficience, IISc 32

Stakeholder Analysis of Present Plans to Improve Plans to Primary Point of

SQAM Course, Proficience, IISc 34

• A team evaluation tool which allows a self assessment

• Establish the need for change

SQAM Course, Proficience, IISc 37

SQAM Course, Proficience, IISc 38

SQAM Course, Proficience, IISc 40

SQAM Course, Proficience, IISc 41

• It is energy in another direction

SQAM Course, Proficience, IISc 42

SQAM Course, Proficience, IISc 43

SQAM Course, Proficience, IISc 44

• Perceive that change is a threat or

Reproduced from “Making Six Sigma Last”, Eckes

SQAM Course, Proficience, IISc 45

• Perceive that change initiative

SQAM Course, Proficience, IISc 46

• Stress is at such a level that change

SQAM Course, Proficience, IISc 47

SQAM Course, Proficience, IISc 48

• Using your prior knowledge from

SQAM Course, Proficience, IISc 51

X’s, Inputs Y’s, Outputs

Process Step Process Input

SQAM Course, Proficience, IISc 59

SQAM Course, Proficience, IISc 61