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

2

3

4

56

σσDefects per

Million opportunities

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%

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 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 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

Bu

sin

ess

Cas

e

Pro

ject

Cha

rter

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 /WIPReductions

Reduced QNC’s

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

Input from floor associates

Why NotCampaign

Identify “hidden” non-compliance issues

Floor associate “buy-in” to improving the process

Ease of use

Documentation “mirrors” process

OperationsRapid

Improvement

Improved Product Build Documentati

onConsistency between documents

Compliance to procedures

Reduce QNC’s

Eliminate product mix-ups Simplified

Product FlowMitigate opportunity for “near miss” events

Create simplified process flow.

Reduce process related QNC’s 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: 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

Baseline

Data

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

Lent

h of

tim

e in

Min

utes

Burst Tester Gage R&R

AnalyzeMeasure Improve ControlDefine

Per

cent

Part-to-PartReprodRepeatGage R&R

100

50

0

% Contribution

% Study Var

Sam

ple St

Dev

6

4

2

_S=3.447

UCL=5.418

LCL=1.476

Operator 1 Operator 2

Sam

ple Mea

n 100

80

60

__X=86.10

Operator 1 Operator 2

UCL=88.81

LCL=83.38

OperatorsSettings

Operator 2Operator 1NominalMinimumNominalMinimum

100

75

50

OperatorsOperator 2Operator 1

100

75

50

Gage name: Gage R&R for Burst Values (Universal Tray)Date of study:

Reported by: J . ChanTolerance: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

Indiv

idual V

alu

e

4321

1.8

1.6

1.4

_X=1.5955

UCL=1.9437

LCL=1.2472

Movin

g R

ange

4321

0.4

0.2

0.0

__MR=0.1309

UCL=0.4278

LCL=0

Observation

Valu

es

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

Overall

Specs

WithinStDev 0.116076Cp *Cpk 1.34

OverallStDev 0.102049Pp *Ppk 1.52Cpm *

Process Capability Sixpack of C beforeI Chart

Moving Range Chart

Last 4 Observations

Capability Histogram

Normal Prob PlotAD: 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

Mean

Mean=170.1

UCL=170.4

LCL=169.7

0.0

0.3

0.6

0.9

Rang

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

Valu

es

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

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

Process

Analysis

Mu

lti-Vari

Org

anize

Cau

ses

Hyp

oth

esisT

esting

Reg

ression

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

Av

erag

e pe

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 NUMBERA

ver

age

per

WO

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

Av

erag

e pe

r W

O

1

2

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

Av

erag

e pe

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

Av

erag

e pe

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

Av

erag

e pe

r W

O

1

2

Multi-Vari Chart for Tip going BackwardsShif t

Benchmarking - InternalS

trat

egic

Ad

van

tage

•Advanced Applications•High Interactivity

e.g. online forms•Knowledge Mgt hub

•Primary CommunicationsVehicle

•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 Demand08/15/05- 07/15/05

Month

Gra

nd T

ota

l

121086420

40000

39000

38000

37000

36000

35000

34000

33000

32000

31000

S 2661.11R-Sq 7.0%R-Sq(adj) 0.0%

Fitted Line PlotGrand Total = 34329 + 193.1 Month

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: 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

Solutions

FMEA

Pilot

Implemen-

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

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

Implem

en-

tatio

n

Solutions

FMEA

Pilot

Implem

en-

tatio

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 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 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

Mill

ion

s

Capability Maturity Model (CMM) Level

Cu

mu

lati

ve

Co

mp

lian

ce

R

isk

($

)

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: 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

1C

on

trol

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

Indiv

idual V

alu

e

302928272625242322212019181716151413121110987654321

115

110

105

100

_X=105.88

UCL=113.76

LCL=97.99

Observation

Movin

g R

ange

302928272625242322212019181716151413121110987654321

10

5

0

__MR=2.97

UCL=9.69

LCL=0

Universal Tray Packaging (CA Sealer)I n-H20

Burst ValuesIn

div

idual V

alu

e

302928272625242322212019181716151413121110987654321

110

105

100

95

_X=100.72

UCL=109.68

LCL=91.76

Observation

Movin

g R

ange

302928272625242322212019181716151413121110987654321

12

8

4

0

__MR=3.37

UCL=11.01

LCL=0

Universal Tray Packaging (Juarez Sealer)I n-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 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 – 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/ ValidateVerify/ ValidateDesignDesignAnalyzeAnalyzeMeasureMeasureDefineDefine

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

10Simulation11Cost Analysis12Design Review13Procurement14Implementation

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

Business CaseGoal Statement

Project 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

Customer

Requirements

(V)

3Characteristic/

Measures (how)(I)

Target goals

7

Correlation (I)

2

Custome

rRating(B) (V)

4

Relationships(What vs.

How)(I)

6

5

Impo

rtan

ce

(V)

How importantTargets/

Specs(B)(I)

Technical Evaluation (B)

Measures(Hows)

Cus

tom

er n

eeds

(Wha

ts) House

Of Quality

#1

Criticalprocess characteristics

(Hows)

Mea

sure

s(W

hats

) House Of

Quality #2

Creative Techniques

Experimentation

Proto

typing

Customer Trials

Design PrinciplesBenchmarking

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)

Haz

ard

Rat

e -

h(t)

Random FailuresEarly

FailuresWearou

t Failure

s

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

Re cord e r 1

Card

Ins pe ct 1

Ins pe ct 2

Ins pe ct 3

Card Drop Shop - Proce s s Mod e l

Re cord e rs

Worke rs

Ins p e 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

Pro

du

cts

Ser

vice

s

Des

ign

-P

rod

uct

ion

-D

eliv

ery

Pro

cess

es

Su

pp

ort

ing

Pro

cess

es

Type of Design

Design Elements

Pro

duct

s

Serv

ices

Des

ign-

Pro

duct

ion-

Del

iver

yP

roce

sses

Supp

orti

ngP

roce

sses

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