OVERVIEW

OF SIX SIGMA (6σ) 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 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
 Six Sigma: What Does it Mean
Defects
Defectsper
per
σ
σ Million
Million
opportunities
opportunities

2 308,537 30
%
2.5 158,686 16
Six Sigma
Measurement 3 66,807 %
6%
3.8 10,724 1%

4 6,210 .6%

5 233
6 3.4 .

3σ to 6σ - 20,000 Times Improvement ... A True QFL

 Six Sigma Performance
99% Good (3.8 Sigma) 99.99966% Good (6 Sigma)
• 20,000 lost articles of mail per hour • Seven articles lost per hour

• 5,000 incorrect surgical operations per • 1.7 incorrect operations per week
week

• Two short or long landings at most • One short or long landing every five
major airports each day years

• 200,000 wrong drug prescriptions • 68 wrong prescriptions per year

each year

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

5 1

CONTROL DEFINE

4 2
IMPROVE MEASURE

3
ANALYZE
 Phase 1: Define
Goal

Case s
es
 Define the project’s purpose

Busin

art t
Ch ojec
and scope and get

er
background on the process

Pr
C
PO
and customer SI

Output C
VO
 A clear statement of the 5 1
QFD
intended improvement CONTROL DEFINE
and how it is to be
measured 4
 A high-level map of the
2
IMPROVE MEASURE
process
 A list of what is important to
3
the customer
ANALYZE
 Project Charter

Define
 Product Flow
SIPOC

Supplier Input Process Output Custom er

Capacity
Planning Level Build Plan Doctors
Requirem ents
Im proved Cycle
Engineering Line Design Tim es /WIP Shareholders
Reductions
Com pliance
Quality Reduced QNC’s Quality
Issues
Im proved Efficiency/
JCIT Consulting Regulatory
Im proved Com pliance
Marketing
Forecast

Sequence WO's
Receive Release
Cut Work Order Through
Finished Goods Sterilize Product to
to Line Single Prod.
Trigger Finished Goods
Line

EXISTING PROCESS FLOW

Improve/
Define Measure Analyze Control
Innovate
 VOICE OF THE CUSTOMER

Input from floor associates

Why Not Identify “hidden” non-compliance issues Reduce near miss events
Campaign from 14 in 2004 to 4 (1
per quarter) in 2005
Floor associate “buy-in” to improving the process

Ease of use
Documentation “mirrors” process
Improved
Operations
Product Build Reduce process related
Rapid Consistency between documents QNC’s by 50%
Documentation
Improvement

Compliance to procedures

Reduce QNC’s

Eliminate product mix-ups

Simplified Reduce near miss events
Mitigate opportunity for “near miss” events
Product Flow from 14 in 2004 to 4
(1 per quarter) in 2005
Create simplified process flow.

Improve/
Define Measure Analyze Control
Innovate
 Phase 2: Measure
Goal
 Focus the improvement
effort by gathering
information on the 1
current situation 5
CONTROL DEFINE

Output Baseline
Data
 Data that pinpoints 4 2 Sampling
problem location or IMPROVE MEASURE
occurrence Gage
R&R
 Baseline data on current
3
Patt
process sigma ANALYZE ern
s
 A more focused problem Cap
ab
i li t
statement y
 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.
 Analyze
Documentation Time Study

Minutes per Work Order

Maximum = 26.5 min per W/O

9 8
8
Lenth of time in Minutes

7
6
5
4 3
3 2.5 2.5 2.5
2 2 2 2
2
1
0

Form
 Burst Tester Gage R&R
Gage R&R (Nested) for Burst Values
Reported by : J. C han
G age name: G age R&R for Burst V alues (U niv ersal T ray ) T olerance:
D ate of study : M isc:

Components of Variation Burst By Settings ( Operators )

100 % Contribution
% Study Va r 100
Percent

50 75

0 50
Gage R&R Repeat Reprod Part-to-Part Settings Minimum Nominal Minimum Nominal
Operators Operator 1 Operator 2
S Chart by Operators
Operator 1 Operator 2 Burst by Operators
6
UCL=5.418
Sample StDev

100

4 _
S=3.447 75

2
LCL=1.476 50
Operator 1 Operator 2
Operators
Xbar Chart by Operators
Operator 1 Operator 2

100
Sample Mean

UCL=88.81
_
_
X=86.10
80 LCL=83.38

60

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.

Define Measure Analyze Improve Control

 Process Capability-Current

Process Capability Sixpack of C before

I C har t C apability H istogr am
LSL
UCL=1.9437
S pecifications
Individual Value

1.8
LS L 1.13
_
1.6 X=1.5955

1.4
LCL=1.2472
1 2 3 4 1.2 1.3 1.4 1.5 1.6 1.7 1.8

M oving Range C har t Nor mal P r ob P lot

UCL=0.4278
A D : 0.350, P : 0.255
0.4
Moving Range

0.2 __
MR=0.1309

0.0 LCL=0
1 2 3 4 1.2 1.5 1.8 2.1

L ast 4 O bser vations C apability P lot

1.68 Within Within O v erall
S tD ev 0.116076 S tD ev 0.102049
1.60
Values

Cp * Pp *
O v erall
C pk 1.34 P pk 1.52
1.52 C pm *
S pecs
1 2 3 4
Observation
 DMAI2C
Process Capability Ring 20 – Current Marking Method

Process Capability Sixpack for Prod. Ring20

Xbar and R Chart Capability Histogram

170.45 UCL=170.4

170.20
Mean

Mean=170.1
169.95

169.70 LCL=169.7
169.6 170.0 170.4
Subgr 0 1 2 3 4 5 6 7 8 9 10
Normal Prob Plot
0.9 UCL=0.9050

0.6
Range

R=0.3515
0.3

0.0 LCL=0
169.5 170.0 170.5

Last 10 Subgroups Within Capability Plot

170.4 StDev: 0.207647 Process Tolerance
Cp: 0.80 Within
170.2 Cpk: 0.70 I I I
Values

Overall
170.0 Overall I I I
StDev: 0.191131 Specifications
169.8 Pp: 0.87 I I
Ppk: 0.76 169.5 170.5
0 1 2 3 4 5 6 7 8 9 10
Subgroup Number
 Phase 3: Analyze

Goal
 Identify deep root
causes and confirm 5 1
them with data CONTROL DEFINE

Output 4 2
 A theory that has IMPROVE MEASURE
been tested and
3
confirmed
Do ANALYZE

Pr alys
Reg

An
Testing is

Mult

oc is
Hypothe

Organize
E

Causes

es
r e

i-Var

s
s si
on

i
 D M A I C

Multi-Vari Chart for Short in Ring Multi-Vari Chart for No Reading Multi-Vari Chart for Lasso out of Roundness
Shif t Shif t Shif t
1.34 1 1.35 1.78 1
1

1.32 2 2 2
1.30 1.68

1.30
1.58
1.25
Av erage per WO

1.28

Av erage per WO
1.48

Av erage per WO
1.26 1.20
1.38
1.24 1.15
1.28
1.22
1.10
1.18
1.20

1.05 1.08
1.18

1.16 1.00 0.98

D-1237-01-S D-1237-02-S D-1237-01-S D-1237-02-S

PART NUMBER
D-1237-01-S D-1237-02-S
PART NUMBER
PART NUMBER

Multi-Vari Chart for Damaged Ring Multi-Vari Chart for Damaged Spine Cover Multi-Vari Chart for Tip going Backwards
Shif t
Shif t Shif t
1.35
1
1.35 1
1
2
1.30 2
2
1.30

1.25 1.3
1.25
Av erage per WO

Av erage per WO
Av erage per WO

1.20
1.20
1.2
1.15
1.15

1.10
1.10 1.1

1.05
1.05

1.00
1.0
1.00
D-1237-01-S D-1237-02-S
D-1237-01-S D-1237-02-S
PART NUMBER D-1237-01-S D-1237-02-S
PART NUMBER
PART NUMBER
 Benchmarking - Internal

Tier 4
Strategic Advantage

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

Features
Analyze
 Regression Analysis
Forecasted Demand
08/15/05- 07/15/05
Fitted Line Plot
Grand Total = 34329 + 193.1 Month
S 2661.11
40000
R-Sq 7.0%
R-Sq(adj) 0.0%
39000

38000

37000
Grand Total

36000

35000

34000

33000

32000

31000
0 2 4 6 8 10 12
Month

7% Increase in demand/year

Analyze
 Design of Experiment

23 Factorial Design

Factors Low High

Temperature 245 F 260 F
Pressure 55 PSI 90 PSI
Time 2 SEC 3 SEC

Define Measure Analyze Improve Control

 Design of Experiment

New Temp Pressure Time

Hi 260.0 90.0 3.0
D Cur [245.0] [75.0] [3.0]
0.00000 Lo 245.0 55.0 2.0

Burst Va
Maximum
y = 94.6429
d = 0.00000

Define Measure Analyze Improve Control

 Phase 4: Improve
Goal
 Develop, pilot, and
implement solutions
that address root
5 1
causes.
CONTROL DEFINE
Output
Solutions
 Identification of 4 2
planned, tested IMPROVE MEASURE
FMEA
actions that should
eliminate or reduce Pilot
3
the impact of the ANALYZE
n-
identified root causes lemon
e
p
Im tati
 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 Rejection of good product Train associates on

are not clear for exposes it to damage during visual acceptance
associates. rework operations. criteria.

Lasso to tip method. PU is applied before the Add a new hole to

Defective bonding of components are in place and apply PU to bond
Compression Coil and is partially removed during components once
Lasso Stem installation of components. they are in place.

Prep. lasso stem method. Current burnishing method is Design a new

Poor burnishing of not ergonomic causing fixture to hold
Nitinol wire. associates make defects after Nitinol during
some time. burnishing.
 ASSESSING RISK
So
Solu
lutio
tionnss

FMEA
FMEA

t
PPililo t
--
eenn
emm

An Example:
pplle oonn
m ttaattii
IIm

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
 Estimated Cost Benefit
CMM vs. Estimated Cost Avoidance
Millions
$5
Cumulative Compliance

$4

$3
Risk ($)

Risk reduction
$2 = $1.7 Million

$1
1. 6 2 .5
$0
1 2 3 4 5
Capability Maturity Model (CMM) Level
Cumulative Risk ($) Compliance Cost

1
10
100
Define Measure Analyze Improve/ Control
 Pilot/Pilot Plan

Used Japan Custom line as a pilot

- Medium size production line
- Minimize the production Impact

– Signals, Lights

– Kanbans Cards
– Performance Measures

Define Measure Analyze Improve/ Control

 Phase 5: Control
Goal
 Use data to evaluate both the

St

Cont
an
solutions and the plans

da

rol
Do

rd
 Validate that all changes adhere to E

cu

ize
va

m
all operating company change lu

en
at

t
control, GMP, and compliance Mo e
nit
requirements or
Clos 5 1
 Maintain the gains by u re
standardizing processes CONTROL DEFINE
 Outline next steps for on-going
improvement
4 2
Output
IMPROVE MEASURE
 Before-and-After analysis
 Monitoring system
 Completed documentation of results, 3
learnings, and recommendations ANALYZE
 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 Scrap

Built Produced

Yield
Goal

Yield
Actual
 I-MR Charts of Burst Tester
Universal Tray Packaging (CA Sealer)
In-H20
115
UCL=113.76
Individual Value

110

_
X=105.88
105

100
LCL=97.99

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Burst Values

10 UCL=9.69
Moving Range

5
__
MR=2.97

0 LCL=0

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Observation

Universal Tray Packaging (Juarez Sealer)

In-H 20

110 UCL=109.68

105

Individual Value
_
X=100.72
100

95

LCL=91.76

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Burst Values

12
UCL=11.01
Moving Range

4 __
MR=3.37

0 LCL=0

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Observation

Define Measure Analyze Improve Control

 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 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!
DMAIC Pathway
New product Development - DEx Roadmap - DMADV

Define Measure Analyze Design

Verify/ Validate

• 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
 DEx Methodology
Qtr 4, 1999
Qtr 1, 2000
Qtr 2, 2000
Qtr 3, 2000
Team Charter IDTask Name SepOctNov
1 ID Customers
2 ID Needs
3 ID CCRs
DecJanFebMarAprMayJ unJulAugSep

Business Case
Opportunity Statement
4 Review
5 Develop Concepts
6 High-Level Design
7 Capability
Goal Statement
Project Scope 8 Design Review
9 Develop Details
10Simulation

Opportunity
Project PlanTeam Selection 11Cost Analysis
12Design Review
13Procurement
14Implementation

Generation 1Generation 2Generation 3

Vision

Product/
Service
Generation

Technologies/
Platforms

Define
7
Correlati
on (I)
Target goals
3
Characteristic/Meas
ures (how)(I)

Importance
1 Cust
Theme 1 4

(V)
ome
Need 1 Need 2 Theme 3 Custome r
r 2
Rati
Relationships
Require (What vs. ng
Measures (B)
(Hows) ments How)
Critical (V) How
(I) (V)

Measure

Customer needs
Need 7 process characteristics 6
Theme 2 (Hows) important
Targets/Spe
House

(Whats)
Of cs(B)(I)
Need 3 Need 4 Need 8 Quality House

Measures
5 Technical

(Whats)
#1 Of Evaluation (B)
Quality
#2
Need 5

g
pin
ty Creative Techniques
o to White Red Black Blue Green Yellow
Pr
Design
ing Princip
a rk Exp les
nchm er im
Be enta
IZ tio n Start With Get Other Non-Linear
TR Build on Combine

Analyze
Customer Trials What You Perspec- Thinking Compare
Ideas Ideas
Know tives

Wo rke rs SYSTEM
Wo rke r 1
P1
FAULT TREE
Ins pe ctor 1
Ins p e ct ors
M V1
Proce s s System
In sp e c t 1
1 Work e r 2 Failure

Hazard Rate -
Early Wearou Card In sp e c tor 2
P2 M V2
Failures Random Failures t
Proce s s
Failure 2
Ins pe ct 2

Bilge Pumps Valves Bilge P ump Valve

s Re co rde r 1 Work e r 3

Ins pe ctor 3 Failure Failure Failure

h(t)
Re c or de rs Proc e s s
Re c ord e r 2
3
In sp e c t 3
RELIABILITY PREDICTION Pump Pump Pump Pump
P1 P2 V1 V2
R = RBil X (1 - (1-Rp)2) x Fails Fails Fails Fails

Card Drop Shop - Proc e ss Mod el

Time (t) R e co rde r 3
(1 - (1-Rv) 2)

Design Type of Design

Type of Design

Supporting
Production-
Products

Processes

Processes
Delivery
Services

Design-
Production -

Supporting
Processes
Processes
Design Elements

Products

Services

Delivery
Design-
1. H\W Prod ucts

2. S\W Prod ucts

3. Services
4. Analyses

5. Information Systems

6 . Process es and M ethods

7 . Human Resources

8. Site \ Facilities

9. E qu ipment \ Tools

10. Materials \ Supp lies

11. Sales \ Marketing

12. Other Non-Technical

Verify/Validate
Start

Develop Error Detailed Prepare Pilot Discrete Type Continuous

of data
Process Proofing and Design Test Plans ?

Control Plan Contingency Review Counting Need to

Yes
Planning items with an
attribute or counting
detect small shifts
Items with quickly?
attribute occurrences? Occurrences

No
Equal Individual
Wit hin spec limits Outside spec limits Equal Yes No Yes
No opportunity measurements
sample ?
sizes Individual
Upp er Spec
? measurements
UCL UC L
or subgroups
?

Transfer
Stable
Act Plan Either/Or
Up per Sp ec

(In control) Rational Individuals

L ower Spe c Subgroups charts

LCL EWMA
LC L
p chart no chart u chart c chart X, R or s chart chart
Check Do
L ower Spec

Upp er Spec

UCL UC L Do limits Yes Yes Do limits

look right? look right?
Up per Sp ec
Unstable
(Not in control )
L ower Spe c No No
LC L LCL
Try individuals charts Try transformation to make data normal
L ower Spec
Question & Answer