OVERVIEW

OF SIX SIGMA (6) FORPROCESS IMPROVEMENT

Presented by:

Larry Bartkus of

Biosense Webster

and

Matthew Thompson of

FCI Management Solutions

Goals

g Introduction to Six Sigma Description Philosophies Benefits Origin Mythsg Identify the five steps of DMAIC, the core of Six Sigma, and

the logical flow from step to step.g List tools and concepts useful in each step.g Brief introduction to DMADV

Six SigmagDescription

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

23456

Defects per

Million opportunities

Defects per Million

opportunities

308,53766,8076,210

2333.4 .

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 PerformanceSix Sigma Performance

Most Businesses Operate at about 3.5 Sigma

Six SigmagPhilosophies

When defects occur look to the process for the cause. Excellent processes will allow average people to consistently

generate superior results.

gBenefits More loyal and satisfied customers (internal and external) Financial savings through improved efficiency and effectiveness Resolution of chronic problems

gOrigin The late Bill Smith, a reliability engineer at Motorola, is widely

credited with originating Six Sigma and selling it to Motorola'slegendary CEO, Robert Galvin.

gMyths

THE DMAIC METHOD

Overview of the DMAIC Method

IMPROVE

CONTROL

MEASURE

ANALYZE

5

2

3

4

DEFINE

1

Phase 1: DefineGoal

g Define the projects purpose and scope and get background on the process and customer

Outputg A clear statement of the

intended improvement and how it is to be measuredg A high-level map of the

processg A list of what is important to

the customer

IMPROVE

CONTROL

MEASURE

ANALYZE

5 1

2

3

4

Bus

ines

sC

ase

Proj

ect

Char

ter

SIPOC

VOC

QFDDEFINE

Project Charter

Define

DefineDefine MeasureMeasure AnalyzeAnalyze Improve/Improve/InnovateInnovate ControlControl

Product FlowSIPOC

Process OutputInput CustomerSupplier

Planning Level Build Plan Doctors

Quality

Engineering

JCIT

CapacityRequirements

Line Design

ComplianceIssues

Consulting

Improved CycleTimes /WIPReductionsReduced QNCs

Improved Efficiency/Improved Compliance

Shareholders

Quality

Regulatory

ReceiveFinished Goods

Trigger

Cut Work Orderto Line

Sequence WO'sThrough

Single Prod.Line

MarketingForecast

SterilizeRelease

Product toFinished Goods

EXISTING PROCESS FLOW

DefineDefine MeasureMeasure AnalyzeAnalyze Improve/Improve/InnovateInnovate ControlControl

VOICE OF THE CUSTOMER

Identify hidden non-compliance issuesWhy NotCampaign

Reduce QNCs

Create simplified process flow.

Mitigate opportunity for near miss eventsSimplified Product Flow

Eliminate product mix-ups

Compliance to procedures

Consistency between documents

Improved Product Build Documentation

OperationsRapid

Improvement

Documentation mirrors process

Ease of use

Floor associate buy-in to improving the process

Input from floor associates

Reduce process related QNCs by 50%

Reduce near miss eventsfrom 14 in 2004 to 4 (1 per quarter) in 2005

Reduce near miss eventsfrom 14 in 2004 to 4 (1 per quarter) in 2005

Phase 2: MeasureGoal

g Focus the improvement effort by gathering information on the current situation

Outputg Data that pinpoints

problem location or occurrenceg Baseline data on current

process sigmag A more focused problem

statement

IMPROVE

CONTROL

MEASURE

ANALYZE

5

2

3

4

DEFINE

1

BaselineData

Sampling

Gage R&R

PatternsCapability

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 StudyAnalyze

Minutes per Work OrderMaximum = 26.5 min per W/O

8

32.5 2.5 2.5 2 2 2 2

0123456789

Form

046

Form

335

Form

618

Form

621

Form

617

Form

615

Form

633

Form

616

Form

051

Form

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Burst Tester Gage R&R

AnalyzeMeasure Improve ControlDefine

P

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t

P a r t- to - P a r tRe p r o dRe p e a tG a g e R& R

1 0 0

5 0

0

% Co n t r ib u t io n

% S t u d y V a r

S

a

m

p

l

e

S

t

D

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6

4

2

_S= 3 .4 4 7

U CL=5 .4 1 8

LCL=1 .4 7 6

O p e r a to r 1 O p e r a to r 2

S

a

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p

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a

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1 0 0

8 0

6 0

__X= 8 6 .1 0

O p e r a to r 1 O p e r a to r 2

U CL= 8 8 .8 1

LCL= 8 3 .3 8

O p e r a to r sS e ttin g s

O p e r a to r 2O p e r a to r 1N o m ina lM in im umN o m ina lM in im um

1 0 0

7 5

5 0

OperatorsO p e r a to r 2O p e r a to r 1

1 0 0

7 5

5 0

G a ge na m e : G a ge R &R fo r B urst V a lue s (U n iv e rsa l T ra y )D a te o f study :

R e po rte d by : J . C ha nT o le ra nce :M isc:

Co m p o ne nts o f Va ria tio n

S Cha rt by O p e ra to rs

Xba r Cha rt b y O pe ra to rs

Burst By S e ttings ( O p e ra to rs )

Burst b y O pe ra to rs

Ga ge R& R (Ne s t e d) fo r Burs t V a lue s

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

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V

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4321

1.8

1.6

1.4

_X=1.5955

UCL=1.9437

LCL=1.2472

M

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g

R

a

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4321

0.4

0.2

0.0

__MR=0.1309

UCL=0.4278

LCL=0

Observation

V

a

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u

e

s

4321

1.68

1.60

1.52

1.81.71.61.51.41.31.2

LSL

SpecificationsLSL 1.13

2.11.81.51.2

Within

O v erall

Specs

WithinStDev 0.116076C p *C pk 1.34

O v erallStDev 0.102049Pp *Ppk 1.52C pm *

Process Capability Sixpack of C beforeI Chart

Moving Range Chart

Last 4 Observations

Capability Histogram

Normal Prob PlotA D: 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

170.45Xbar 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

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u

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s

169.5 170.5

Capability PlotProcess Tolerance

I I I

I I I

I ISpecifications

Within

Overall

169.5 170.0 170.5

Normal Prob Plot

169.6 170.0 170.4

Capability Histogram

WithinStDev:Cp:Cpk:

0.2076470.800.70

OverallStDev:Pp:Ppk:

0.1911310.870.76

Process Capability Sixpack for Prod. Ring20

DMDMAAII22CC

Phase 3: Analyze

Goalg Identify deep root

causes and confirm them with data

OutputgA theory that has

been tested and confirmed

IMPROVE

CONTROL

MEASURE

ANALYZE

5

2

3

4

DEFINE

1

Process

Analysis

Multi-Vari

Organize

Causes

Hypothesis

TestingRegression

DoE

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

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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 NUMBERA

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Multi-Vari Chart for No ReadingShif 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

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Multi-Vari Chart for Lasso out of RoundnessShif 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

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Multi-Vari Chart for Damaged RingShif 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

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Multi-Vari Chart for Damaged Spine CoverShif t

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

1.0

1.1

1.2

1.3

PART NUMBER

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Multi-Vari Chart for Tip going BackwardsShif t

Benchmarking - InternalS

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Advanced ApplicationsHigh Interactivitye.g. online forms

Knowledge Mgt hubPrimary Communications

VehicleContent Rich

Tier 4Transforming

Features

Tier 1Basic Presence

Basic Company

Information

Tier 3Integrating

CommunitiesAdvanced SearchValue-add tools

Moderate Interactivity

PersonalisationExtensive information

Basic Search

Tier 2Searching

Analyze

Regression Analysis

Analyze

Forecasted Demand08/15/05- 07/15/05

M o nth

G

r

a

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d

T

o

t

a

l

121086420

40000

39000

38000

37000

36000

35000

34000

33000

32000

31000

S 2661.11R -S q 7.0%R-S q(adj) 0 .0%

F itted L ine Plo tG rand T o tal = 3 4329 + 193 .1 Mon th

7% Increase in demand/year

Design of Experiment

AnalyzeMeasure Improve ControlDefine

23 Factorial Design

Factors Low HighTemperature 245 F 260 F

Pressure 55 PSI 90 PSITime 2 SEC 3 SEC

Design of Experiment

AnalyzeMeasure Improve ControlDefine

Hi

Lo0.00000D

New

Cur

d = 0.00000

MaximumBurst Va

y = 94.6429

2.0

3.0

55.0

90.0

245.0

260.0Pressure TimeTemp

[245.0] [75.0] [3.0]

Phase 4: ImproveGoal

gDevelop, pilot, and implement solutions that address root causes.

Outputg 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

Solutions

FMEA

Pilot

Implem

en-

tation

IMPROVE4

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

Add a new hole to apply PU to bond components once they are in place.

PU is applied before the components are in place and is partially removed during installation of components.

Lasso to tip method. Defective bonding of Compression Coil and Lasso Stem

Design a new fixture to hold Nitinol during burnishing.

Current burnishing method is not ergonomic causing associates make defects after some time.

Prep. lasso stem method. Poor burnishing of Nitinol wire.

Train associates on visual acceptance criteria.

Rejection of good product exposes it to damage during rework operations.

Some acceptance criteria are not clear for associates.

PROPOSED SOLUTION

BRIEF DESCRIPTIONPROBLEM

Solutions

FMEA

Pilot

Imple

men-

tation

Solutions

FMEA

Pilot

Imple

men-

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 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 RISKAn Example:

AnalyzeMeasure Improve/ ControlDefine

Estimated Cost Benefit

100101

CMM vs. Estimated Cost Avoidance

$0

$1

$2

$3

$4

$5

1 2 3 4 5

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Capability Maturity Model (CMM) Level

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(

$

)

Cumulative Risk ($) Compliance Cost

Risk reduction= $1.7 Million

1.6 2 .5

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/

Phase 5: ControlGoal

g Use data to evaluate both the solutions and the plansg Validate that all changes adhere to

all operating company change control, GMP, and compliance requirements gMaintain the gains by

standardizing processesg Outline next steps for on-going

improvementOutput

g Before-and-After analysisgMonitoring systemg Completed documentation of results,

learnings, and recommendations

IMPROVE

CONTROL

MEASURE

ANALYZE

5

2

3

4

DEFINE

1C

ontrol

Standardize

Document

Monitor

Evaluate

Closure

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

AnalyzeMeasure Improve ControlDefine

Burst Values

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302928272625242322212019181716151413121110987654321

115

110

105

100

_X=105.88

UCL=113.76

LCL=97.99

Observation

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302928272625242322212019181716151413121110987654321

10

5

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__MR=2.97

UCL=9.69

LCL=0

Universal Tray Packaging (CA Sealer)In-H20

Burst ValuesI

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302928272625242322212019181716151413121110987654321

110

105

100

95

_X=100.72

UCL=109.68

LCL=91.76

Observation

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302928272625242322212019181716151413121110987654321

12

8

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__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

gImprovement must be continuous, but individual initiatives and project teams come to an end.gLearn when its time to say goodbye.gEffective project closure weaves together the themes

of: Project purpose. Improvement methods. Team skills and structures.gDevelop managerial systems to capture learnings and

enable the organization to address system issues.gDocumentation and recognition are two critical aspects

of project team closure.gCelebrate!

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/ Verify/ ValidateValidateDesignDesignAnalyzeAnalyzeMeasureMeasureDefineDefine

Opportunity

Define

Measure

Analyze

Design

Verify/Validate

Transfer

DEx MethodologyIDTask Name1 ID Customers2 ID Needs3 ID CCRs4 Review5 Develop Concepts6 High-Level Design7 Capability8 Design Review9 Develop Details

10 Simulation11 Cost Analysis12 Design Review13 Procurement14 Implementation

SepOctNovDecJanFebMarAprMayJunJulAugSepQtr 4, 1999Qtr 1, 2000Qtr 2, 2000Qtr 3, 2000

Business CaseGoal StatementProject Plan

Opportunity StatementProject ScopeTeam Selection

Team Charter

Generation 1Generation 2Generation 3

Vision

Product/ServiceGeneration

Technologies/Platforms

Theme 1

Need 1 Need 2

Theme 2

Need 3 Need 4

Need 5

Theme 3

Need 7

Need 8

1

CustomerRequirem

ents(V)

3Characteristic/Measur

es (how)(I)

Target goals

7Correlatio

n (I)

2

CustomerRating(B) (V)

4

Relationships(What vs.

How)(I)

6

5

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V

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How importantTargets/Specs(B)(I)Technical Evaluation (B)

Measures(Hows)

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(

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Quality #1

Criticalprocess characteristics

(Hows)

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W

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) House Of

Quality #2

Creative Techniques

Experimentation

Proto

typing

Customer Trials

Design PrinciplesBen

chmark

ing

TRIZ

White Red Black Blue Green Yellow

Start With What You

Know

Get Other Perspec-

tives

Non-Linear Thinking Build on Ideas

Combine Ideas Compare

FAULT TREESYSTEM

RELIABILITY PREDICTION

SystemFailure

PumpP1

Fails

PumpP2

Fails

PumpV1

Fails

PumpV2

FailsR = RBil X (1 - (1-Rp)2) x

(1 - (1-Rv)2)

PumpsBilge Valves

P1

P2

V1M

V2M

BilgeFailure

PumpFailure

ValveFailure

Time (t)

H

a

z

a

r

d

R

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-

h

(

t

)

Random FailuresEarly

FailuresWearou

t Failures Proce s s 2

Proces s 1

Proces s 3

Worke r 1Ins pe c tor 1

Worke r 2Ins pe ctor 2

Worke r 3

Inspe cto r 3

Re corde r 3

Re corde r 2

Re cord e r 1

Card

Ins pe c t 1

Inspe ct 2

Inspe ct 3

Card Drop Shop - Proces s Mode l

Re corde rs

Worke rs

Ins pe ctors

DevelopProcess

Control Plan

ErrorProofing andContingency

Planning

DetailedDesignReview

Prepare PilotTest Plans

Act Plan

Check Do

Start

Type of data

?

Counting items with an

attribute or countingoccurrences?

Equalsamplesizes

?

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

Individualmeasurements

OccurrencesItems withattribute

p chart

Try transformation to make data normal

no chart u chart c chart X, R or s chart

Individualscharts

EWMAchart

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

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Type of Design

Design Elements

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1. H\W Products

2. S\W 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

Question & Answer