Six Sigma is a data-driven approach to process improvement that aims to reduce defects. It uses statistical methods and the DMAIC framework (Define, Measure, Analyze, Improve, Control) to identify and address root causes of defects. The document provides an overview of Six Sigma, including its goals of reducing costs and improving customer experience. It also describes the five steps of DMAIC and some of the tools used in each step, such as process mapping in Define and data collection/analysis in Measure and Analyze to identify problems and root causes.

1. OVERVIEW
OF SIX SIGMA (6σ) FOR
PROCESS IMPROVEMENT
Presented by:
Larry Bartkus of
Biosense Webster
and
Matthew Thompson of
FCI Management Solutions

2. Goals
 Introduction to Six Sigma
– Description
– Philosophies
– Benefits
– Origin
– Myths
 Identify the five steps of DMAIC, the core of Six Sigma, and
the logical flow from step to step.
 List tools and concepts useful in each step.
 Brief introduction to DMADV

3. Six Sigma
Description
– “… Six Sigma is a quality program that, when all is
said and done , improves your customer’s
experience, lowers your costs, and builds better
leaders.” Jack Welch CEO GE
– Six Sigma is a proven set of tools and tactics used
for process improvement, reduction of defects, and
improved quality
– Six Sigma uses data and statistical analysis to
zero in on root causes
– Six Sigma can be applied to any process

4. 2
3
4
5
6
σ
Defects per
Million
opportunities
308,537
66,807
6,210
233
3.4 .
3σ to 6σ - 20,000 Times Improvement ... A True QFL
Six Sigma
Measurement
Six Sigma: What Does it Mean
30%
6%
.6%
3.8 10,724 1%
2.5 158,686 16%

5. 99.99966% Good (6 Sigma)
•20,000 lost articles of mail per hour
•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
•Seven articles lost per hour
•1.7 incorrect operations per week
•One short or long landing every
five years
•68 wrong prescriptions per year
99% Good (3.8 Sigma)
Six Sigma Performance
Most Businesses Operate at about 3.5 Sigma

6. Six Sigma
Philosophies
– When defects occur look to the process for the cause.
– Excellent processes will allow average people to consistently
generate superior results.
Benefits
– More loyal and satisfied customers (internal and external)
– Financial savings through improved efficiency and effectiveness
– Resolution of chronic problems
Origin
– The late Bill Smith, a reliability engineer at Motorola, is widely
credited with originating Six Sigma and selling it to Motorola's
legendary CEO, Robert Galvin.
Myths

7. THE DMAIC METHOD

8. Overview of the DMAIC Method
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1

9. Phase 1: Define
Goal
 Define the project’s purpose
and scope and get
background on the process
and customer
Output
 A clear statement of the
intended improvement
and how it is to be
measured
 A high-level map of the
process
 A list of what is important to
the customer
IMPROVE
CONTROL
MEASURE
ANALYZE
5 1
2
3
4
DEFINE

10. Project Charter
Define

11. Define Measure Analyze
Improve/
Innovate
Control
Product Flow
SIPOC
Process OutputInput CustomerSupplier
Planning Level Build Plan Doctors
Quality
Engineering
JCIT
Capacity
Requirements
Line Design
Compliance
Issues
Consulting
Improved Cycle
Times /WIP
Reductions
Reduced QNC’s
Improved Efficiency/
Improved Compliance
Shareholders
Quality
Regulatory
Receive
Finished Goods
Trigger
Cut Work Order
to Line
Sequence WO's
Through
Single Prod.
Line
Marketing
Forecast
Sterilize
Release
Product to
Finished Goods
EXISTING PROCESS FLOW

12. Define Measure Analyze
Improve/
Innovate
Control
VOICE OF THE CUSTOMER
Input from floor associates
Why Not
Campaign
Identify “hidden” non-compliance issues
Floor associate “buy-in” to improving the process
Ease of use
Documentation “mirrors” process
Operations
Rapid
Improvement
Improved
Product Build
Documentation
Consistency between documents
Compliance to procedures
Reduce QNC’s
Eliminate product mix-ups
Simplified
Product Flow
Mitigate opportunity for “near miss” events
Create simplified process flow.
Reduce process related
QNC’s by 50%
Reduce near miss events
from 14 in 2004 to 4
(1 per quarter) in 2005
Reduce near miss events
from 14 in 2004 to 4
(1 per quarter) in 2005

13. Phase 2: Measure
Goal
 Focus the improvement
effort by gathering
information on the
current situation
Output
 Data that pinpoints
problem location or
occurrence
 Baseline data on current
process sigma
 A more focused problem
statement
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1

14. D M A I C
• The system to collect information is already
established.
• 100% of Scrap forms from Work Orders for all
products are captured into a Yield Database.
• Scrap form (FORM633) has information as Lot
Number, Date, Shift, Product Number, Defect
Code, Defect Description, Potential Cause, Work
Station ID, Catheter Number, Scrap Quantity, and
is signed by operator and supervisor / engineer.
• Yield Database has information as Product
Number, Date, Lot Number, Description, Lot
Quantity, Reworks, Scrap in Line, and Scrap in QA.

15. Documentation Time Study
Analyze
Minutes per Work Order
Maximum = 26.5 min per W/O
8
3
2.5 2.5 2.5
2 2 2 2
0
1
2
3
4
5
6
7
8
9
Form
046
Form
335
Form
618
Form
621
Form
617
Form
615
Form
633
Form
616
Form
051
Form
LenthoftimeinMinutes

16. Burst Tester Gage R&R
AnalyzeMeasure Improve ControlDefine
Percent
Part-to-PartReprodRepeatGage R&R
100
50
0
% Contribution
% Study Var
SampleStDev
6
4
2
_
S=3.447
UCL=5.418
LCL=1.476
Operator 1 Operator 2
SampleMean
100
80
60
__
X=86.10
Operator 1 Operator 2
UCL=88.81
LCL=83.38
Operators
Settings
Operator 2Operator 1
NominalMinimumNominalMinimum
100
75
50
Operators
Operator 2Operator 1
100
75
50
Gage name: Gage R&R for Burst V alues (U niv ersal Tray )
Date of study :
Reported by : J. C han
Tolerance:
M isc:
Components of Variation
S Chart by Operators
Xbar Chart by Operators
Burst By Settings ( Operators )
Burst by Operators
Gage R&R (Nested) for Burst Values
The total Gage Repeatability and Reproducibility is 12.38%, which is well below the acceptance criteria of less than or
equal to 30% of the Total Variation. Measurement system is acceptable.
The Gage R & R study is able to show that the burst tester is capable of detecting different parts being measured as
shown from the data reported by two different operators measuring the samples.

17. Process Capability-Current
IndividualValue
4321
1.8
1.6
1.4
_
X=1.5955
UCL=1.9437
LCL=1.2472
MovingRange
4321
0.4
0.2
0.0
__
MR=0.1309
UCL=0.4278
LCL=0
Observation
Values
4321
1.68
1.60
1.52
1.81.71.61.51.41.31.2
LSL
Specifications
LSL 1.13
2.11.81.51.2
Within
O v erall
Specs
Within
StDev 0.116076
C p *
C pk 1.34
O v erall
StDev 0.102049
Pp *
Ppk 1.52
C pm *
Process Capability Sixpack of C before
I Chart
Moving Range Chart
Last 4 Observations
Capability Histogram
Normal Prob Plot
A D: 0.350, P: 0.255
Capability Plot

18. Process Capability Ring 20 – Current Marking Method
0 1 2 3 4 5 6 7 8 9 10
169.70
169.95
170.20
170.45
Xbar and R Chart
Subgr
Mean
Mean=170.1
UCL=170.4
LCL=169.7
0.0
0.3
0.6
0.9
Range
R=0.3515
UCL=0.9050
LCL=0
0 1 2 3 4 5 6 7 8 9 10
Last 10 Subgroups
169.8
170.0
170.2
170.4
Subgroup Number
Values
169.5 170.5
Capability Plot
Process Tolerance
I I I
I I I
I I
Specifications
Within
Overall
169.5 170.0 170.5
Normal Prob Plot
169.6 170.0 170.4
Capability Histogram
Within
StDev:
Cp:
Cpk:
0.207647
0.80
0.70
Overall
StDev:
Pp:
Ppk:
0.191131
0.87
0.76
Process Capability Sixpack for Prod. Ring20
DMAI2
C

19. Phase 3: Analyze
Goal
 Identify deep root
causes and confirm
them with data
Output
 A theory that has
been tested and
confirmed
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1

20. D M A I C
D-1237-02-SD-1237-01-S
1.34
1.32
1.30
1.28
1.26
1.24
1.22
1.20
1.18
1.16
PART NUMBER
AverageperWO
1
2
Multi-Vari Chart for Short in Ring
Shif t
D-1237-01-S D-1237-02-S
1.00
1.05
1.10
1.15
1.20
1.25
1.30
1.35
PART NUMBERAverageperWO
1
2
Multi-Vari Chart for No Reading
Shif t
D-1237-01-S D-1237-02-S
0.98
1.08
1.18
1.28
1.38
1.48
1.58
1.68
1.78
PART NUMBER
AverageperWO
1
2
Multi-Vari Chart for Lasso out of Roundness
Shif t
D-1237-02-SD-1237-01-S
1.35
1.30
1.25
1.20
1.15
1.10
1.05
1.00
PART NUMBER
AverageperWO
1
2
Multi-Vari Chart for Damaged Ring
Shif t
D-1237-01-S D-1237-02-S
1.00
1.05
1.10
1.15
1.20
1.25
1.30
1.35
PART NUMBER
AverageperWO
1
2
Multi-Vari Chart for Damaged Spine Cover
Shif t
D-1237-01-S D-1237-02-S
1.0
1.1
1.2
1.3
PART NUMBER
AverageperWO
1
2
Multi-Vari Chart for Tip going Backwards
Shif t

21. Benchmarking - Internal
StrategicAdvantage
•Advanced Applications
•High Interactivity
e.g. online forms
•Knowledge Mgt hub
•Primary Communications
Vehicle
•Content Rich
Tier 4
Transforming
Features
Tier 1
Basic Presence
Basic
Company
Information
Tier 3
Integrating
•Communities
•Advanced Search
•Value-add tools
•Moderate Interactivity
•Personalisation
•Extensive information
•Basic Search
Tier 2
Searching
Analyze

22. Regression Analysis
Analyze
Forecasted Demand
08/15/05- 07/15/05
Month
GrandTotal
121086420
40000
39000
38000
37000
36000
35000
34000
33000
32000
31000
S 2661.11
R-Sq 7.0%
R-Sq(adj) 0.0%
Fitted Line Plot
Grand Total = 34329 + 193.1 Month
7% Increase in demand/year

23. Design of Experiment
AnalyzeMeasure Improve ControlDefine
23 Factorial Design
Factors Low High
Temperature 245 F 260 F
Pressure 55 PSI 90 PSI
Time 2 SEC 3 SEC

24. Design of Experiment
AnalyzeMeasure Improve ControlDefine
Hi
Lo0.00000
D
New
Cur
d = 0.00000
Maximum
Burst Va
y = 94.6429
2.0
3.0
55.0
90.0
245.0
260.0
Pressure TimeTemp
[245.0] [75.0] [3.0]

25. Phase 4: Improve
Goal
 Develop, pilot, and
implement solutions
that address root
causes.
Output
 Identification of
planned, tested
actions that should
eliminate or reduce
the impact of the
identified root causes
CONTROL
MEASURE
ANALYZE
5
2
3
DEFINE
1
FMEA
IMPROVE
4

26. D M A I C
•Improvement team created with members of
Quality, Production, Engineering and R&D areas
to propose and evaluate ideas.
•Brainstorming tool was used to gather ideas on
how to solve the problems identified.
•Ideas were evaluated per following criteria:
feasible, high impact, easy, low cost, and quick.
•Following tables summarizes solutions agreed
by consensus of the improvement team.

27. D M A I C
PROBLEM BRIEF DESCRIPTION PROPOSED
SOLUTION
Some acceptance criteria
are not clear for
associates.
Rejection of good product
exposes it to damage during
rework operations.
Train associates on
visual acceptance
criteria.
Lasso to tip method.
Defective bonding of
Compression Coil and
Lasso Stem
PU is applied before the
components are in place and
is partially removed during
installation of components.
Add a new hole to
apply PU to bond
components once
they are in place.
Prep. lasso stem method.
Poor burnishing of
Nitinol wire.
Current burnishing method is
not ergonomic causing
associates make defects after
some time.
Design a new
fixture to hold
Nitinol during
burnishing.

28. Solutions
FMEA
Pilot
Im
plem
en-
tation
Solutions
FMEA
Pilot
Im
plem
en-
tation
RISK 12. Support Plan not in Place
Description IntegWare does not want to put Biosense Webster in a position of being overly reliant for day-to-day
level 1 support of the system after go-live. IntegWare typically suggests that we assume the role of a
second level support for a limited number of hours per month. IntegWare suggests it is typical for
Day-to-Day (level 1) support will be a highly resource consuming task for three-six months after go-
live. To use IntegWare for this might be an ineffective usage of the customer's resources. The
project ownership should be transferred to the customer if at all possible.
It would be a better usage of the customer’s resources to ask IntegWare to implement higher value-
added initiatives in PDM (such as developing PART/BOM configuration management features, JDE
integration, etc.)
MITIGATION To mitigate this risk, we have discussed a support concept at BWI. This will be a combo function
between Doc services (they will handle basic application admin functions) and IM who will handle IT
functions.
Still need to setup support contract for IntegWare to support system.
Celeste has added to the schedule a support contract for level 2 support from IntegWare.
RISK LEVEL HIGH
UPDATED 5/2/03
ASSESSING RISK
An Example:

29. AnalyzeMeasure Improve/ ControlDefine
Estimated Cost Benefit
100
10
1
CMM vs. Estimated Cost Avoidance
$0
$1
$2
$3
$4
$5
1 2 3 4 5
Millions
Capability Maturity Model (CMM) Level
CumulativeCompliance
Risk($)
Cumulative Risk ($) Compliance Cost
Risk reduction
= $1.7 Million
1.6 2 .5

30. Pilot/Pilot Plan
AnalyzeMeasureDefine Control
Used Japan Custom line as a pilot
- Medium size production line
- Minimize the production Impact
– Kanbans Cards
– Signals, Lights
– Performance Measures
Improve/

31. Phase 5: Control
Goal
 Use data to evaluate both the
solutions and the plans
 Validate that all changes adhere to
all operating company change
control, GMP, and compliance
requirements
 Maintain the gains by
standardizing processes
 Outline next steps for on-going
improvement
Output
 Before-and-After analysis
 Monitoring system
 Completed documentation of results,
learnings, and recommendations
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1

32. D M A I C
•All new tooling, processes, clarifications, and
visual aids documented in PIs.
•Creation of MOPXXX with all the quality criteria
for Variable Lasso Deflection and Contraction
performance.
•MOP003 updated with reference to new created
MOPXXX.
•PU quality criteria documented in WSS001 and
available in QA workbenches.

33. D M A I C
•Yields Chart is published every week.
Work Orders
Built
Yield
Goal
Scrap
Produced
Yield
Actual

34. I-MR Charts of Burst Tester
AnalyzeMeasure Improve ControlDefine
Burst Values
IndividualValue
302928272625242322212019181716151413121110987654321
115
110
105
100
_
X=105.88
UCL=113.76
LCL=97.99
Observation
MovingRange
302928272625242322212019181716151413121110987654321
10
5
0
__
MR=2.97
UCL=9.69
LCL=0
Universal Tray Packaging (CA Sealer)
In-H20
Burst Values
IndividualValue
302928272625242322212019181716151413121110987654321
110
105
100
95
_
X=100.72
UCL=109.68
LCL=91.76
Observation
MovingRange
302928272625242322212019181716151413121110987654321
12
8
4
0
__
MR=3.37
UCL=11.01
LCL=0
Universal Tray Packaging (Juarez Sealer)
In-H20

35. Lessons Learned
• Culture shock
• Resources
• Scope creep / Identifying the critical few
• Management buy-in of change of policies
• Time management & deliverables challenges
• J&J Goals too high for small operating company (CMM
goal of Level 3 per J&J Corp Strategy)
• Difficult to measure compliance

36. Project Closure
Improvement must be continuous, but individual
initiatives and project teams come to an end.
Learn when it’s time to say goodbye.
Effective project closure weaves together the themes
of:
– Project purpose.
– Improvement methods.
– Team skills and structures.
Develop managerial systems to capture learnings and
enable the organization to address system issues.
Documentation and recognition are two critical aspects
of project team closure.
Celebrate!

37. DMAIC Pathway

38. New product Development - DEx Roadmap - DMADV
• DEFINE – Develop the Business Case, Scope & Charter the Project
• MEASURE – Gather & Quantify Design Inputs (Customer, Technical, Business,
Regulatory)
• ANALYZE – Develop and Investigate Conceptual Designs
• DESIGN – Develop Detailed Product/Service/Process Designs
• VERIFY/VALIDATE – Confirm design outputs meet design input requirements and
ensure specifications conform with intended uses and users; Scale-up manufacture and
release the product or scale-up and implement the new process; Finally, transfer to
process owners
Verify/
Validate
DesignAnalyzeMeasureDefine

39. Opportunity
Define
Measure
Analyze
Design
Verify/Validate
Transfer
DEx Methodology
IDTask Name
1 ID Customers
2 ID Needs
3 ID CCRs
4 Review
5 DevelopConcepts
6 High-Level Design
7 Capability
8 DesignReview
9 DevelopDetails
10Simulation
11Cost Analysis
12DesignReview
13Procurement
14Implementation
SepOctNovDecJanFebMarAprMayJunJulAugSep
Qtr 4, 1999Qtr 1, 2000Qtr 2, 2000Qtr 3, 2000
Business Case
Goal Statement
Project Plan
Opportunity Statement
Project Scope
Team Selection
Team Charter
Generation1Generation2Generation3
Vision
Product/
Service
Generation
Technologies/
Platforms
Theme 1
Need 1 Need 2
Theme 2
Need 3 Need 4
Need 5
Theme 3
Need 7
Need 8
1
Customer
Requirem
ents
(V)
3
Characteristic/Measur
es (how)(I)
Target goals
7
Correlatio
n (I)
2
Cust
omer
Rati
ng
(B)
(V)
4
Relationships
(What vs.
How)
(I)
6
5
Importance(V)
How important
Targets/Spec
s(B)(I)
Technical Evaluation
(B)
Measures
(Hows)
Customerneeds
(Whats)
House
Of
Quality
#1
Critical
processcharacteristics
(Hows)
Measures
(Whats)
House
Of
Quality
#2
Creative Techniques White Red Black Blue Green Yellow
Start With
What You
Know
Get Other
Perspec-
tives
Non-Linear
Thinking
Buildon
Ideas
Combine
Ideas Compare
FAULT TREE
SYSTEM
RELIABILITY PREDICTION
System
Failure
Pump
P1
Fails
Pump
P2
Fails
Pump
V1
Fails
Pump
V2
FailsR = RBil X (1 - (1-Rp)2) x
(1 - (1-Rv)2)
PumpsBilge Valves
P1
P2
V1M
V2M
Bilge
Failure
Pump
Failure
Valve
Failure
Time (t)
HazardRate-
h(t)
Random Failures
Early
Failures
Wearou
t
Failures
Process
2
Process
1
Process
3
Worker 1
Inspector 1
Worker 2
Inspector 2
Worker 3
Inspector 3
Recorder 3
Recorder 2
Recorder 1
Card
Inspect 1
Inspect 2
Inspect 3
Card Drop Shop - Process Model
Recorders
Workers
Inspectors
Develop
Process
Control Plan
Error
Proofing and
Contingency
Planning
Detailed
Design
Review
Prepare Pilot
Test Plans
Act Plan
Check Do
Start
Type
of data
?
Counting
items with an
attribute or counting
occurrences?
Equal
sample
sizes
?
Equal
opportunity
?
Continuous
Yes
No
Yes
Rational
Subgroups
Discrete
Yes
No
No
Do limits
look right?
Try individuals charts
Need to
detect small shifts
quickly?
Individual
measurements
or subgroups
?
Do limits
look right?
YesNo
Either/Or
No
Yes
Individual
measurements
Occurrences
Items with
attribute
p chart
Try transformation to make data normal
no chart u chart c chart X, R or s chart
Individuals
charts
EWMA
chart
Unstable
(Not in control)
Stable
(In control)
Within spec limits
Upper Spec
Lower Spec
Upper Spec
Lower Spec
UCL
LCL
UCL
LCL
Outside spec limits
Upper Spec
Lower Spec
Upper Spec
Lower Spec
UCL
LCL
UCL
LCL
Type of Design
Products
Services
Design-
Production-
Delivery
Processes
Supporting
Processes
Type of Design
Design Elements
Products
Services
Design-
Production-
Delivery
Processes
Supporting
Processes
1. HW Products
2. SW Products
3. Services
4. Analyses
5. Information Systems
6. Processes and Methods
7. Human Resources
8. Site Facilities
9. Equipment Tools
10. Materials Supplies
11. Sales Marketing
12. Other Non-Technical

40. Question & Answer