OVERVIEW

OF SIX SIGMA (6) FOR

PROCESS IMPROVEMENT
Presented by:
Larry Bartkus of
Biosense Webster
and
Matthew Thompson of
FCI Management Solutions
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
Six Sigma
Description
Six Sigma is a quality program that, when all is
said and done , improves your customers
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

2
3
4
5
6

Defects per
Million
opportunities
308,537
66,807
6,210
233
3.4
.
3 to 6 - 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%
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
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
THE DMAIC METHOD
Overview of the DMAIC Method
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1
Phase 1: Define
Goal
Define the projects 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
Project Charter
Define
Define Measure Analyze
Improve/
Innovate
Control
Product Flow
SIPOC
Process Output Input Customer Supplier
Planning Level Build Plan Doctors
Quality
Engineering
JCIT
Capacity
Requirements
Line Design
Compliance
Issues
Consulting
Improved Cycle
Times /WIP
Reductions
Reduced QNCs
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
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 QNCs


Eliminate product mix-ups
Simplified
Product Flow
Mitigate opportunity for near miss events
Create simplified process flow.
Reduce process related
QNCs 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
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
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.
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
F
o
r
m
0
4
6
F
o
r
m

3
3
5
F
o
r
m

6
1
8
F
o
r
m

6
2
1
F
o
r
m

6
1
7
F
o
r
m

6
1
5
F
o
r
m

6
3
3
F
o
r
m

6
1
6
F
o
r
m

0
5
1
Form
L
e
n
t
h

o
f

t
i
m
e

i
n

M
i
n
u
t
e
s
Burst Tester Gage R&R
Analyze Measure Improve Control Define
P
e
r
c
e
n
t
Part-to-Part Reprod Repeat Gage R&R
100
50
0
% Contribution
% Study Var
S
a
m
p
l
e

S
t
D
e
v
6
4
2
_
S=3.447
UCL=5.418
LCL=1.476
Operator 1 Operator 2
S
a
m
p
l
e

M
e
a
n100
80
60
_
_
X=86.10
Operator 1 Operator 2
UCL=88.81
LCL=83.38
Operators
Settings
Operator 2 Operator 1
Nominal Minimum Nominal Minimum
100
75
50
Operators
Operator 2 Operator 1
100
75
50
Gage name: Gage R&R for Burst V alues (Univ ersal Tray )
Date of study :
Reported by : J. Chan
Tolerance:
Misc:
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.
Process Capability-Current
I
n
d
i
v
i
d
u
a
l

V
a
l
u
e
4 3 2 1
1.8
1.6
1.4
_
X=1.5955
UCL=1.9437
LCL=1.2472
M
o
v
i
n
g

R
a
n
g
e
4 3 2 1
0.4
0.2
0.0
__
MR=0.1309
UCL=0.4278
LCL=0
Observation
V
a
l
u
e
s
4 3 2 1
1.68
1.60
1.52
1.8 1.7 1.6 1.5 1.4 1.3 1.2
LSL
Specifications
LSL 1.13
2.1 1.8 1.5 1.2
Within
Ov erall
Specs
Within
StDev 0.116076
Cp *
Cpk 1.34
Ov erall
StDev 0.102049
Pp *
Ppk 1.52
Cpm *
Process Capability Sixpack of C before
I Chart
Moving Range Chart
Last 4 Observations
Capability Histogram
Normal Prob Plot
AD: 0.350, P: 0.255
Capability Plot
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
M
e
a
n
Mean=170.1
UCL=170.4
LCL=169.7
0.0
0.3
0.6
0.9
R
a
n
g
e
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
V
a
l
u
e
s
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
DMAI
2
C
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
D M A I C
D-1237-02-S D-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
A
v
e
r
a
g
e

p
e
r

W
O
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 NUMBER
A
v
e
r
a
g
e

p
e
r

W
O
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
A
v
e
r
a
g
e

p
e
r

W
O
1
2
Multi-Vari Chart for Lasso out of Roundness
Shif t
D-1237-02-S D-1237-01-S
1.35
1.30
1.25
1.20
1.15
1.10
1.05
1.00
PART NUMBER
A
v
e
r
a
g
e

p
e
r

W
O
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
A
v
e
r
a
g
e

p
e
r

W
O
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
A
v
e
r
a
g
e

p
e
r

W
O
1
2
Multi-Vari Chart for Tip going Backwards
Shif t
Benchmarking - Internal
S
t
r
a
t
e
g
i
c

A
d
v
a
n
t
a
g
e


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
Regression Analysis
Analyze
Forecasted Demand
08/15/05- 07/15/05
Month
G
r
a
n
d

T
o
t
a
l
12 10 8 6 4 2 0
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
Design of Experiment
Analyze Measure Improve Control Define
2
3
Factorial Design
Factors Low High
Temperature 245 F 260 F
Pressure 55 PSI 90 PSI
Time 2 SEC 3 SEC
Design of Experiment
Analyze Measure Improve Control Define
Hi
Lo
0.00000
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 Time Temp
[245.0] [75.0] [3.0]
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
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.
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.


Solutions
FMEA
Pilot
Im
p
lem
en
-
ta
tio
n
Solutions
FMEA
Pilot
Im
p
lem
en
-
ta
tio
n


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 customers 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:
Analyze Measure Improve/ Control Define
Estimated Cost Benefit
100
10
1
CMM vs. Estimated Cost Avoidance
$0
$1
$2
$3
$4
$5
1 2 3 4 5
M
i
l
l
i
o
n
s
Capability Maturity Model (CMM) Level
C
u
m
u
l
a
t
i
v
e

C
o
m
p
l
i
a
n
c
e

R
i
s
k

(
$
)
Cumulative Risk ($) Compliance Cost
Risk reduction
= $1.7 Million
1. 6 2 . 5
Pilot/Pilot Plan
Analyze Measure Define Control

Used Japan Custom line as a pilot
- Medium size production line
- Minimize the production Impact
Kanbans Cards
Signals, Lights
Performance Measures
Improve/
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
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.
D M A I C
Yields Chart is published every week.
Work Orders
Built

Yield
Goal
Scrap
Produced

Yield
Actual
I-MR Charts of Burst Tester
Analyze Measure Improve Control Define
Burst Values
I
n
d
iv
id
u
a
l V
a
lu
e
30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1
115
110
105
100
_
X=105.88
UCL=113.76
LCL=97.99
Observation
M
o
v
in
g
R
a
n
g
e
30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1
10
5
0
__
MR=2.97
UCL=9.69
LCL=0
Universal Tray Packaging (CA Sealer)
In-H20
Burst Values
I
n
d
iv
id
u
a
l V
a
lu
e
30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1
110
105
100
95
_
X=100.72
UCL=109.68
LCL=91.76
Observation
M
o
v
in
g
R
a
n
g
e
30 29 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1
12
8
4
0
__
MR=3.37
UCL=11.01
LCL=0
Universal Tray Packaging (Juarez Sealer)
In-H20
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
Project Closure
Improvement must be continuous, but individual
initiatives and project teams come to an end.
Learn when its 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!
DMAIC Pathway
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
Design Analyze Measure Define
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
10 Simulation
11 Cost Analysis
12 DesignReview
13 Procurement
14 Implementation
SepOct Nov Dec JanFebMar Apr MayJunJul AugSep
Qtr 4, 1999 Qtr 1, 2000 Qtr 2, 2000 Qtr 3, 2000
Business Case
Goal Statement
Project Plan
Opportunity Statement
Project Scope
Team Selection
Team Charter
Generation1 Generation2 Generation3
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
I m
p o r t a n c e ( V
)
How important
Targets/Spec
s(B)(I)
Technical Evaluation
(B)
Measures
(Hows)
C
u s t o m
e r n e e d s
( W
h a t s ) House
Of
Quality
#1
Critical
process characteristics
(Hows)
M
e a s u r e s
( W
h a t s ) 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
Fails R = RBil X (1 - (1-Rp)2) x
(1 - (1-Rv)2)
Pumps Bilge Valves
P1
P2
V1 M
V2 M
Bilge
Failure
Pump
Failure
Valve
Failure
Time (t)
H
a z a r d R
a t e -
h ( t )
Random Failures
Early
Failures
Wearou
t
Failures Proces s
2
Proces s
1
Proces s
3
Worke r 1 Ins pe ctor 1
Worke r 2
Ins pe ctor 2
Worke r 3
Ins pe ctor 3
Re corde r 3
Re corde r 2
Recorder 1
Card
Ins pe ct 1
Ins pe ct 2
Ins pe ct 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?
Yes No
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
P
r o d u c t s
S e r v i c e s
D
e s i g n -
P
r o d u c t i o n -
D
e l i v e r y
P
r o c e s s e s
S u p p o r t i n g
P
r o c e s s e s
Type of Design
Design Elements P r o d u c t s
S e r v i c e s
D e s i g n -
P r o d u c t i o n -
D e l i v e r y
P r o c e s s e s
S u p p o r t i n g
P r o c e s s e s
1. H\WProducts
2. S\WProducts
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
Question & Answer