Six Sigma - Overview

Define

Presented by:

Me
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Breakthrough
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Ryan M. Ismail, M.Eng, MBA Methodology
Therapeutic Area Program Manager Y=f(X)
Merck Research Labs
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What is Six Sigma?

v A structured, methodical approach to process /

product improvement and design robustness
v

v All decisions are based on facts and data

v

v A powerful “Tool Box” is used to identify and

eliminate waste through the reduction of
underlying process variability
v

v It is applicable in both Manufacturing and

Transactional (Business) processes
v

v It is implemented through highly trained,

motivated individuals called “Black Belts”
and “Green Belts” from all functions
•
2
Six Elements of Six Sigma

1.Genuine focus on the customer

•The Voice of the Customer (VOC) is the
foundation of the methodology

2.Data- and fact-driven management

•Use data to prove that solutions work and
gains are sustained

3.Process focus
•Improving processes ensures competitive
advantage – delivering real value to
customers
From The Six Sigma Way, by Pande, et al
Six Elements of Six Sigma

4.Proactive management
•Set/track goals, establish priorities, reward fire
prevention

6.Boundaryless collaboration
•Customer-centric; processes transcend
departmental silos

8.Drive for perfection, tolerate failure

•New ideas/approaches involve risk; overcome
fear of mistakes
 T he Six Sigma
Appr oach
Determi
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ed variation Optimi
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Customer Focus Throughout Process d
What is the Definition of

Six Sigma?
Area Under Normal Curve

68% OF DATA FALL WITHIN 1 STANDARD

DEVIATION OF THE MEAN

7
Area Under Normal Curve

95% OF DATA FALL WITHIN 2 STANDARD

DEVIATIONS OF THE MEAN

8
Area Under Normal Curve
99.7% OF DATA FALL WITHIN 3 STANDARD
DEVIATIONS OF THE MEAN

9
3 Sigma Process

LSL Cp = 1.00 USL

LSL

PERFORMANCE 6 σ
Performance
Process
PROCESS 6 σ
10
6 Sigma Process

LSL Cp = 2.00 USL

LSL Cp = 2.00

PERFORMANCE 12 σ
Performance
PROCESS 6 σ Process
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 Process Capability

Performance (VOC) Tolerances

The Tools Develop Process Tolerances
Latitude in Process LSL LCL UCL USL
Capability y

Latitude

6s
12s

− LSL Performance
C = USL = 2
6s Process 12
p
Major Sources of Variability

Poor Skills
Design and
Behaviors

Insufficient
Unstable Parts Measurement System Process Capability
and Material

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 Aver ages vs. Variation
Customer’s Expectations: 8 Day Order to Delivery Cycle
15 Day Span
Existing Process After Conventional
Delivery Cycle Process Improvement
(days) Cycle (days)
20 17
15 2
30 5
10 12
5 4
Average Average 2 5 8 12 17
16 Day Delivery8 Day Delivery
Cycle Cycle Days Early Days Late
We are pleased with our 50% cycle improvement – (-6) (+9)
Customer
however, our customers didn’t feel a thing! Want Date

6 Process Improvement
Delivery Cycle (Days) 2 Day
7 Span
9
9
8
7
8 Day Average
Delivery Cycle 2 7 8 9 17
By attacking variation and reducing span, we
truly met our customer’s expectation for cycle Days Early (-1) Days Late (+1)
time improvement! Customer
Want Date
Customer & Management V iews

•Effectiveness( customer ’ s view ):

meeting customer requirements and
creating ‘ delight ’
ØCustomers feel VARIATION , not averages

•Efficiency ( management view ):

providing streamlined processes ,
minimizing internal costs
ØWin by preventing fires , not
fighting them

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The term “SIX SIGMA”

Acceptance Target Output Acceptance

Limit Limit

3 Sigma Performance
66,807 defects / million 6 Sigma Performance
“Historical Standard” 3.4 defects / million
“World Class”
4 Sigma Performance
6,210 defects / million 2 Sigma Performance
“Current Standard” 308,537 defects / million
“Major League Waste”

Sigma or the Standard Deviation of the process distribution allows us to

determine and communicate the capability of the process.
The “Sigma Level” of a an in-control process is simply the number of standard deviations
of the process distribution that consume 1/2 the allowed tolerance band if the process were
centered around the target value.
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What is a Six Sigma

Project?
SIX SIGMA PROJECTS

"All improvement takes place

project by project and in
no other way."
Dr. Joseph M. Juran

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What Is a Six Sigma Project?
T he overall goal of the Six Sigma Initiative
is to significantly improve customer
perceived value and company’s profitability.
Projects that fit that criteria are le gitimate
ØSix Sigma pr ojects should be linked to the
projects.
highest levels of str ate g y and be in dir ect
suppor t of specific WW business and cor e
pr ocess objectives.
Ø
ØSix Sigma pr ojects should be definable and
mana geable in scope with high pr obability of
completion in four to six months, or less.
Ø
ØA Six Sigma pr oject should of fer a significant
oppor tunity for r eduction in Cost of Poor Quality
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(COPQ), in addition to impr oving such things as
What Is a Six Sigma Project?

• There are five phases of Six Sigma

methodology:
•
1. Define (D)
2. Measure (M)
3. Analyze (A)
4. Improve (I)
5. Control (C)


 Together it is called DMAIC

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 The Six Sigma Roadmap
Six Sigma Road Map – DMAIC
A Structured Approach: Pick the Right Projects

Define
Ø Identify Potential Projects
Ø Evaluate Projects
Ø Prepare Problem and Mission Statement
Ø Goals and Objectives

DMAIC Characterize the Process and Measure the

Process Characterization
Performance
Ø Cost of Poor Quality (COPQ)
Ø Map the Process

Measure
Ø Define the Key Process Input Variables (KPIV)
Define Ø Define the Key Process Output Variables (KPOV)
Ø Measurement System Analysis (MSA) to validate the
measurement system
Ø Identify Potential Failure Modes and Effects (FMEA)
Me

Ø Measure baseline performance

Con

Ø Defect rates
asu

Ø Process capability

SIX SIGM
trol

re

Identify Critical Process Variables

Breakthrough
Analyze

Ø Develop hypotheses for text – potential X’s

Methodology Ø Plan for Data Collection

reakthrough
Breakt Ø Analyze Data

Process Optimization
Ø Confirm Determinants of Process Performance
Y=f(X)
Y=f(X) Establish Prediction Model and Optimize
Improve

the Process
Ø Plan Design of Experiments
Im lyze Ø Screen to Identify Critical Few Causes
pr a
ov An Ø Establish Cause-Effect Relationship
e Ø Optimize Process
Hold the Gains
Control

Ø Design Controls

Hold The
Ø Document Improved Process

Gains
Ø Establish final control plan 21
Ø Implement Controls
Ø Monitor Effectiveness of Controls
What Is a Six Sigma Model?
• Taken together, they are referred to as the DMAIC
process of quality improvement.
• The Six-Sigma methodology is based on simple
yet powerful model,
 y=f(x)
•
• where y represents the key process outputs
• x represents key process inputs that strongly
effect the output
• function, “f” represents the relationship between
the inputs and outputs.

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 Six Sigma Toolbox
•Mistake Proofing •Problem Statement
•5s / TPM / PM •Mission Statement
•Validation (IQ, OQ, PQ) •Project Team
•Updated FMEA •Initial COPQ
•Updated Process Map
•Control Plan
DEFINE
•SOP and Training CONTROL
•Statistical Process Control
•Project Impact •Process Mapping
•Documented Savings •Cause and Effect Diagram
MEASURE •Cause and Effect Matrix
•Process FMEA
IMPROVE •List of Theories to Test
•MSA
•Data Collection Plan
•Baseline Data
•Active Experimentation (DOE):
•Response Surface ANALYZE
Designs
•Method of
Steepest Ascent •Passive Data Collection:
•Optimization •Run Charts
•Active Experimentation (DOE): •Pareto Charts
•Factorial Designs •Histograms and
•Factor Pareto Dotcharts
Charts •Box plots
•Main Effects •Defect Concentration
Charts Plots
•Interaction Charts •Scatterplots and
- Marginal Plots 23
-
•
Phase 1: DEFINE

•Purpose: To accurately describe the

problem, define project success, and to
commit the resources necessary to solve
the problem.
•
•Deliverables:
•Problem statement
•Mission statement and project scope
Define

•Project team

Me
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•Approved COPQ Methodology
Y=f(X)
•Project plan and timeline
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Six Sigma Toolbox – Define

•Problem Statement
•Mission Statement
•Project Team
•Initial COPQ
D EFINE
CONT ROL

MEASURE

IMPROVE

ANAL Y ZE

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Project Assignment / Selection

Definition of Six Sigma Projects

•

•Definable and manageable

•

•High probability of completion in less than six

months
•

•Significant opportunity for reduction in Cost

of Poor Quality (COPQ)
•

•Improve customer satisfaction, capacity, and

top-line growth

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Prepare a Problem / Mission
Statement
•Define the scope of your project in the Problem /
mission statement
•

•Example: Effective Problem Statement

•Our company’s procedure for shipping replacement parts
takes ten days longer on average than our major
competitors take.
•
•This statement is:
•Specific: It names a particular process and states the
problem.
•Observable: Evidence of the problem can be obtained from
internal reports and customer feedback.
•Measurable: Shipping time is measured in days.
•Manageable: The problem is limited to one type of shipping
procedure.
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Cost Of Poor Quality (COPQ)

Theory of:
Waste Customer Returns
“Tip of an Iceberg” Rejects
Testing Costs Inspection Costs

• Rework Recalls

•A few costs are

Customer Allowances
easy to see like Excessive Overtime
Billing Errors Late Paperwork
the part above the Pricing or Premium Freight Costs
Excessive Field
waterline Services Expenses Lack of Follow-up
on Current Programs

• Planning Delays Excess Inventory

Expediting Costs
Development Cost Unused Capacity
•Many more costs of Failed Product
Complaint
Handling Time with Dissatisfied
Customer
are hidden below Overdue Receivables
Excessive
System Costs
the water. Excessive
Employee Turnover
Incorrectly Completed
• Lost Sales
Sales Order

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Define COPQ
• COPQ are the costs that would disappear if every
task was always performed without deficiency
 (Source: Juran Institute Inc.)

•
• COPQ are the cost of failures including costs of
insuring quality in manufacturing, delivering,
and servicing of the products.
•
• The three major COPQ categories:
• Appraisal / Inspection Cost
• Internal Failure Costs
• External Failure Costs

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 Phase 2: MEASURE
•Purpose:
•To characterize the process as it currently existsand to focus
the project by narrowing the range of potential causes. To
evaluate current measurement systems and ensure
measurement capability. Define and develop a data
collection strategy.
•Deliverables:
•Process Map
•Cause and Effect Diagram
•CE-Matrix of prioritized KPIV’s
Define
•Process FMEA
•Data collection plan

Me
Con

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•Measurement system analyses (MSA) Breakthrough

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Methodology
•Baseline measurement data Y=f(X)
•Process Capability
•List of Theories to test
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•First draft of preliminary control plan 30

Six Sigma Toolbox - Measure

•Process Mapping
•Cause and Effect Diagram
•Cause and Effect Matrix
DEFINE •Process FMEA
CONTROL •List of Theories to Test
•MSA
•Data Collection Plan
MEASURE •Baseline Data
IMPROVE

ANALYZE

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Data Collection Plan

• Purpose: Generate data to learn about

• The Process
• The Measurement System (Note: The measurement
system must be suitable for the task at hand)
•
• Steps:
• Develop forms/spreadsheets necessary to collect the data.
• Record the process inputs
• Measure and record the output (i.e; frequency or days)
• Present the data (graphically) and analyze the output (Why is
there so much variation?)

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 Define and Measure

Measurement Systems Analysis

(MSA)
•
•Understanding how much variability comes from your
gage or measuring device.
•
•Reducing the variation, if possible, so that variation
observed is from the process.

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Measurement System

Examples


•
• Weights Check (weight)
• Part tolerance (distance)
• UV measurement (absorbance)
• Analytical tests (concentration)
• Torque testing (force)
• Visual inspection (labels, color, etc.)
• Functional performance (activity, days, etc.)
• Others? ____________________

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Where does Total System
Variation Occur?

System Variation

Part to Part (Actual) Measurement

Measurement Variation
Variation Variation

Long Term Short Term Due to

Process Process Due to Gage
Operator
Variation Variation Issues

Lack of Lack of
Reproducibility Repeatability

Gage Bias

Lack of Stability

Non-Linearity
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Measurement System
Attributes
 A measurement system …


• Should be Accurate
•
• Should be Precise
•
• And should be Stable

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ACCURACY
•Biasis the difference between the observed average
measurement value and the “actual” or “true” value.
Bias is a measure of “lack of accuracy”.
•It is typically the most common and easiest problem
to fix.

TRUE Bad Accuracy,

VALUE Good Precision

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 PRECISION
•PRECISION is the ability to replicate measurements time
after time. LACK OF PRECISION implies VARIABILITY.
•All measurement systems should be repeatable, both
within and between evaluators.

Accurate but not

TRUE Precise
VALUE

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 STABILITY

• All instruments need to be periodically re-

calibrated because ACCURACY
DETERIORATES over time.
• A lack of stability implies a “creeping bias” over
time. Need to run a standard on a regular basis
to ensure there is no degradation or bias in the
measurements.
•
Sept
2001
July 2001

May 2001

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 Phase 3: ANALYZE

•Purpose:
•Through data analysis, narrowing down the trivial many
process variables (X's) to the significant few Key
Process Input Variables (KPIVs / Vital X's).
•
•Deliverables:
•List of Key Process Input Variables (KPIVs)
•Updated Preliminary Control Plan
•Updated list of Theories to Test
Define

Me
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Breakthrough

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Methodology
Y=f(X)

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Six Sigma Toolbox - Analyze

DEFINE
CONT ROL

MEASURE

IMPROVE

ANALYZE

Active Experimentation (DOE): Passive Data Collection:

•Factorial Designs •Run Charts
•Factor Pareto Charts •Pareto Charts
•Main Effects Charts •Histograms and Dotcharts
•Interaction Charts •Box plots
- •Defect Concentration Plots
•Scatterplots and Marginal
Plots 41
-
 Not all inputs are important…….
Only a few will drive the process

Y, X1, ……..,
X15
Characterization

Process Dynamics Unpredictable

Y’s
X’s
Optimization

Unimportant X’s
removed

Important X’s (KPIVs)

discovered and Y = f ( X1, X5, X9 ) 42
controlled
How to determine the KPIV’s

Finding the
KPIV's

Passive Data Active

Acquisition
•From the Batch History Record
•From Machine logs
Experimentation
•From lab experiments
•From modification of business
•Historic data process or manufacturing
conditions

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Analyze Phase

Finding KPIV’s through

•Passive Data Acquisition

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 Passive Data Analysis
Boxplots of CT conce by lot
(means are indicated by solid circles)

3.5
0.06
3.0
0.05

Percentage Rejects
2.5
CT concentration

0.04
2.0
0.03
1.5

0.02
1.0

0.5
0.01

0.0 0.00

lot Date/Time 08/10 08/11 08/16

good
bad

Clare Dyad Cleanliness

Pareto Chart for Packaging Sh

100
100
Dirty
80
Clean

Percent
130 140 150 160 170
60
Count 50
40

20

0 0

rs
Defect D A C C-
D
A-
B B
O
t he

Count
Percent
39
36.8
28
26.4
16
15.1
10
9.4
7
6.6
3
2.8
3
2.8 45
Cum % 36.8 63.2 78.3 87.7 94.3 97.2 100.0
Analyze Phase

Finding KPIV’s through

•
•Active Data Acquisition
•One Factor at a time
•Design of Experiment
•Fractional Factorial
Design

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 Active Data Acquisition
Pareto Chart of the Standardized Effects Multi-Vari Chart for Diameter by Location - Cavity
Part
(response is % C&S, Alpha = .10)

A: Hold Tim 1 2 1 2 1 2 1 2
Location
A B: Mandrel Bottom
B C: Mold Tem
0.252 Middle
D: Force
AB
E: Coil Pos T op

E
0.251
BC

Diameter
AE
DE 0.250
C
AD
0.249
BD
AC
CD 0.248
BE
1 2 3 4
D Cavity
CE

0 Main
1 Effects Plot2 (data means)
3 for OD
Interaction Plot (data means) for OD

2.0 4.5 22
0
30
0
Injection Sp
5.5
8 2.0
4.5
7
4.5

6
OD

3.5
5

Mean
2.5 4

3
1.5
Injection Sp Barrel Tempe 2

220 300
Barrel Tempe

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Phase 4: IMPROVE

•Purpose:
•To optimize the process by determining the relationship
between the Key Process Input Variables (KPIV's) and
the Key Process Output Variables (KPOV's).
•
•Deliverables:
•Determine the f in Y=f(X)
•Updated preliminary control plan Define

Me
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Breakthrough

trol

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Methodology
Y=f(X)

Im ze
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 Six Sigma Toolbox -
Improve

DEFINE
CONTROL

MEASURE

IMPROVE

Active Experimentation (DOE):

•Response Surface ANALYZE
Designs
•Method of Steepest
Ascent
•Optimization

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 Phase 5: CONTROL
•Purpose:
•To maintain the gains through control of the Key Process
Input Variables (KPIV's) and error detection-correction
methods.
•Deliverables:
Define
•Error Proofing / Poka-Yoke
•Safety Issues / OSHA

Me
Con

asu
•5S / TPM / Updated PM Breakthrough

trol

re
Methodology
•Validation (IQ, OQ, PQ) Y=f(X)
•Updated FMEA
•Updated Process Map (Improved Process) I mprov Analy
ze
e
•Training
•Control Plan
•SPC
•Project Impact & Summary (e.g. updated COPQ and
documented process improvement)
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Six Sigma Toolbox - Control

•Mistake Proofing
•5s / TPM / PM
•Validation (IQ, OQ, PQ)
•Updated FMEA
DEFINE
•Updated Process MapCONT ROL
•Control Plan
•SOP and Training
•Statistical Process Control MEASURE
•Project Impact
•Documented SavingsIMPROVE

ANALYZE

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Improve and Control

Poka-yoke
•A Poka-Yoke device is mechanism that
either prevents a mistake from occurring
or makes a mistake obvious at a glance
•

•‘Mistake-Proofing’ is the Anglican

translation of this principle
•

•Several basic principles are consistently

used in Poka-Yoke efforts

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Poka-yoke Device Categories
• Prevention
• Engineer the process or product so that it is
impossible to make the mistake in the first place.
• 3 1/2” floppy disk example.
• Prevention devices eliminate the need to detect or
correct a mistake


• Detection
• A detection device cues the operator when a
mistake has been made. This enables a quick fix.
• Your car has some of these: door ajar, beeps when
key in ignition and door open, seat belt not
fastened.
• Clutch in, or in park before it will start are examples
of prevention devices.

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Poka-yoke Device

Good Poka-yoke Device Characteristics:

•
• Simple and cheap
•
• Part of the process
•
• Placed close to where the mistakes occur

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Example of Mistake Proofing

Fueling area of car has three mistake-

proofing devices:

1. Filling pipe insert keeps larger, leaded-fuel

nozzle from being inserted
2. Gas cap tether does not allow the motorist to
drive off without the cap
3. Gas cap is fitted with ratchet to signal proper
tightness and prevent over-tightening.

Every Day Examples used from John Grout. Go to his website at

mistakeproofing.com for more examples.
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Example of Mistake Proofing

The window in the envelope

is not only a labor saving
device. It prevents the
contents of an envelope
intended for one person
being inserted in an
envelope address to another.

Every Day Examples used from John Grout. Go to his website at

mistakeproofing.com for more examples.

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 Examples of Mistake
Pr oofing

Hungry Jack syrup has a small window near the bottom of the
container that changes from black to clear when heated
revealing the word HOT. This signals that the syrup is warm
and ready to serve.
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Total Productive Maintenance
• TPM is a process focused, team-based effort that
will build quality into manufacturing or service
process steps and by doing so will improve the
overall effectiveness.


• TPM . . .
• Focuses on entire life cycle
• Coordinates all processes in a department
• Involves all associates
• Is implemented through teams
• Maximizes equipment/process effectiveness

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Statistical Process Control (SPC)

Upper control limit

3σ x 3σ x X X

99.73% of X values
will fall inside these limits Lower control limit
3σ x

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Six Sigma Quality Costs

• The Benefits of higher quality are obvious.

However, many believe it costs a lot to
achieve this.
•
• With Six Sigma, it can actually cost less.
Six Sigma looks at attacking all the
“hidden” components contributing to
the Cost of Quality.
•
 (General Electric Company)

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Any Questions, Please?

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Project Management
Humor

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