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

Six Sigma: What Does it Mean

2
2.5
Six Sigma Measurement

Defects per Million opportunities

308,537
158,686

30% 16% 6%

3
3.8

66,807
10,724

1%
.6%

4 5 6

6,210 233 3.4

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

Six Sigma Performance

99% Good (3.8 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

99.99966% Good (6 Sigma)

Seven articles lost per hour 1.7 incorrect operations per week One short or long landing every five years 68 wrong prescriptions per 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 CONTROL

1 DEFINE 2 MEASURE

4 IMPROVE

3 ANALYZE

Phase 1: Define
Goal Define the projects purpose and scope and get background on the process and customer Output 1 5 A clear statement of the DEFINE CONTROL intended improvement and how it is to be measured 4 2 A high-level map of the 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

Planning Engineering Quality JCIT Marketing Forecast

Capacity Requirem ents Line Design Com pliance Issues Consulting

Level Build Plan Im proved Cycle Tim es /WIP Reductions Reduced QNCs Im proved Efficiency/ Im proved Com pliance

Doctors Shareholders Quality Regulatory

Receive Finished Goods Trigger

Cut Work Order to Line

Sequence WO's Through Single Prod. Line

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

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

Ease of use Documentation mirrors process Operations Rapid Improvement Improved Product Build Documentation Consistency between documents Compliance to procedures
Reduce process related QNCs by 50%

Reduce QNCs

Eliminate product mix-ups

Simplified Product Flow

Mitigate opportunity for near miss events Create simplified process flow.

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

Define

Measure

Analyze

Improve/ Innovate

Control

Phase 2: Measure
Goal Focus the improvement effort by gathering information on the current situation

5
CONTROL

1
DEFINE

Output 4 Data that pinpoints 2 IMPROVE problem location or MEASURE occurrence Baseline data on current 3 process sigma ANALYZE A more focused problem statement

D M A

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 7 6 5 4 3 2 1 0
6 rm 04
Lenth of time in Minutes

2.5

2.5

2.5

33 5

61 8

62 1

61 7

61 5

63 3

61 6 rm Fo

rm

rm

rm

rm

rm

rm

Fo

Fo

Fo

Fo

Fo

Fo

Fo

Form

Fo

rm

05 1

Burst Tester Gage R&R

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

Components of Variation
100
% Contribution % Study Var

Burst By Settings ( Operators )

100 75 50 Settings Operators

Percent

50

Gage R&R

Repeat

Reprod

Part-to-Part

Minimum Nominal Operator 1

Minimum Nominal Operator 2

S Chart by Operators
6 Operator 1 Operator 2 UCL=5.418 _ S=3.447 LCL=1.476 100 75 50

Burst by Operators

Sample StDev

4 2

Operator 1 Operators

Operator 2

Xbar Chart by Operators

Operator 1 Operator 2

Sample Mean

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

80

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
Individual Value
UCL=1.9437 1.8 1.6 1.4 LCL=1.2472 1 2 3 4 1.2 1.3 1.4 1.5 1.6 1.7 1.8 _ X=1.5955
LSL

C apability H istogr am S pecifications LS L 1.13

M oving Range C har t

Moving Range
0.4 UCL=0.4278

Nor mal P r ob P lot A D : 0.350, P : 0.255

0.2

__ MR=0.1309 LCL=0 1 2 3 4 1.2 1.5 1.8 2.1

0.0

Last 4 O bser vations

1.68

C apability P lot Within S tDev 0.116076 Cp * C pk 1.34 Within O v erall S pecs O v erall S tDev 0.102049 Pp * P pk 1.52 C pm *

Values

1.60 1.52 1 2 Observation 3 4

DMAI2C

Process Capability Ring 20 Current Marking Method

Process Capability Sixpack for Prod. Ring20
Xbar and R Chart
170.45 170.20 Mean=170.1 169.95 169.70 Subgr 0 0.9 1 2 3 4 5 6 7 8 9 10 UCL=0.9050 LCL=169.7
169.6 170.0 170.4

Capability Histogram
UCL=170.4

Mean

Normal Prob Plot

Range

0.6 0.3 0.0 R=0.3515

LCL=0 169.5 170.0 170.5

Last 10 Subgroups
170.4

Values

170.2 170.0 169.8 0 1 2 3 4 5 6 7 8 9 10

Within StDev: 0.207647 Cp: 0.80 Cpk: 0.70 Overall StDev: 0.191131 Pp: 0.87 Ppk: 0.76

Capability Plot
Process Tolerance Within
I I I I I I I

Overall
I

Specifications
169.5 170.5

Subgroup Number

Phase 3: Analyze
Goal
Identify

deep root causes and confirm them with data

5 CONTROL 4 IMPROVE

1 DEFINE 2 MEASURE

Output A theory that has been tested and confirmed

3 ANALYZE

D M A

Multi-Vari Chart for Short in Ring

Shif t
1.34 1.32 1.30 1 2

Multi-Vari Chart for No Reading

Shif t
1.35 1 2 1.30
1.78

Multi-Vari Chart for Lasso out of Roundness

Shif t
1 2 1.68 1.58

1.25

Av erage per WO

Av erage per WO

1.28

Av erage per WO

1.48

1.26 1.24 1.22 1.20 1.18 1.16 D-1237-01-S D-1237-02-S

1.20

1.38

1.15

1.28

1.10

1.18

1.05

1.08

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

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

PART NUMBER

PART NUMBER

PART NUMBER

Multi-Vari Chart for Damaged Ring

Shif t
1.35 1 2 1.30 1.30 1.25 1.35

Multi-Vari Chart for Damaged Spine Cover

Shif t
1 2 1.3 1.25

Multi-Vari Chart for Tip going Backwards

Shif t
1 2

Av erage per WO

1.20

Av erage per WO

1.20

Av erage per WO

1.2

1.15

1.15

1.10

1.10

1.1

1.05 1.05 1.00 1.00 D-1237-01-S D-1237-02-S 1.0 D-1237-01-S D-1237-02-S

PART NUMBER

D-1237-01-S

D-1237-02-S

PART NUMBER

PART NUMBER

Benchmarking - Internal

Strategic Advantage

Tier 4
Transforming

Tier 3
Integrating

Tier 2

Tier 1
Basic Presence

Searching
Communities Advanced Search Value-add tools Moderate Interactivity

Basic Company Information

Personalisation Extensive information Basic Search

Advanced Applications High Interactivity e.g. online forms Knowledge Mgt hub Primary Communications Vehicle Content Rich

Analyze

Features

Regression Analysis
Forecasted Demand 08/15/05- 07/15/05
Fitted Line Plot
Grand Total = 34329 + 193.1 Month 40000 39000 38000
S R-Sq R-Sq(adj) 2661.11 7.0% 0.0%

Grand Total

37000 36000 35000 34000 33000 32000 31000 0 2 4 6 Month 8 10 12

7% Increase in demand/year
Analyze

Design of Experiment 23 Factorial Design

Factors Temperature Pressure Time

Define Measure Analyze

Low 245 F 55 PSI 2 SEC

Improve Control

High 260 F 90 PSI 3 SEC

Design of Experiment

New Hi D Cur 0.00000 Lo Burst Va Maximum y = 94.6429 d = 0.00000

Define Measure

Temp 260.0 [245.0] 245.0

Pressure 90.0 [75.0] 55.0

Time 3.0 [3.0] 2.0

Analyze

Improve

Control

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

5
CONTROL 4 IMPROVE
FMEA

1
DEFINE 2 MEASURE

3 ANALYZE

D M A

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

PROBLEM

BRIEF DESCRIPTION

PROPOSED SOLUTION
Train associates on visual acceptance criteria. Add a new hole to apply PU to bond components once they are in place. Design a new fixture to hold Nitinol during burnishing.

Some acceptance criteria are not clear for associates. Lasso to tip method. Defective bonding of Compression Coil and Lasso Stem Prep. lasso stem method. Poor burnishing of Nitinol wire.

Rejection of good product exposes it to damage during rework operations. PU is applied before the components are in place and is partially removed during installation of components. Current burnishing method is not ergonomic causing associates make defects after some time.

ASSESSING RISK
An Example:
RISK 12. Support Plan not in Place Description

So Solu lutio tions ns

FMEA FMEA

ott ilo P Pil

ne en m n em le p on p l ttiio m tta IIm a

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 golive. 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.) 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.

MITIGATION

RISK LEVEL UPDATED

HIGH 5/2/03

Estimated Cost Benefit

CMM vs. Estimated Cost Avoidance
Cumulative Compliance Risk ($)
Millions

$5 $4 $3 $2 $1
1.6 2 .5

Risk reduction = $1.7 Million

$0 1 2 3 4
Compliance Cost
1 10 100

Capability Maturity Model (CMM) Level

Cumulative Risk ($)

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 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

1 DEFINE 2 MEASURE

CONTROL
4 IMPROVE

3 ANALYZE

D M A

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

Yields Chart is published every week.

Work Orders Built

Scrap Produced

Yield Goal

Yield Actual

I-MR Charts of Burst Tester

Universal Tray Packaging (CA Sealer)
In-H 20
115 UCL=113.76 110 _ X=105.88

Individual Value

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 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

LCL=0

Universal Tray Packaging (Juarez Sealer)

In-H 20
110 UCL=109.68

Individual Value

105 _ 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 Burst Values 19 20 21 22 23 24 25 26 27 28 29 30

12 UCL=11.01

Moving Range

__ MR=3.37

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Observation 19 20 21 22 23 24 25 26 27 28 29 30

LCL=0

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 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

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
Team Charter

Opportunity Define

Business Case Opportunity Statement Goal Statement Project Scope Team Selection Project Plan
Generation 1 Generation 2 Generation 3 Vision Product/ Service Generation Technologies/ Platforms

8 Design Review 9 Develop Details 10 Simulation 11 Cost Analysis 12 Design Review 13 Procurement 14 Implementation

Qtr 4, 1999 Qtr 1, 2000 Qtr 2, 2000 Qtr 3, 2000 ID Task Name Sep Oct Nov Dec Jan Feb Mar Apr May JunJulAug Sep 1 ID Customers 2 ID Needs 3 ID CCRs 4 Review 5 Develop Concepts 6 High-Level Design 7 Capability

7 Correlatio n (I) Target goals 3 Characteristic/Measur es (how)(I) Theme 1 Need 1 Need 2 Theme 3 Measures (Hows) Customer needs (Whats) 1 4 Customer Requirem ents (V) Critical process characteristics (Hows) Measures (Whats) House Of Quality #2 6 5 Relationships (What vs. How) (I) How important Targets/Spec s(B)(I) Technical Evaluation (B) Importance (V) Cust omer Rati 2 ng (B) (V)

Measure

Theme 2 Need 3 Need 4

Need 7 Need 8

House Of Quality #1

Need 5

Creative Techniques

White

Red

Black

Blue

Green

Yellow

Analyze
Worke r 1

Start With What You Know

Get Other Perspectives

Non-Linear Thinking

Build on Ideas

Combine Ideas

Compare

Worke rs
Ins pe ctor 1

SYSTEM
Ins p e ctors

P1

M V1 M V2 Valves
Bilge Failure

FAULT TREE
System Failure

Proce s s 1

Ins pe ct 1 Worke r 2 Ins pe ctor 2

Hazard Rate h(t)

Early Failures

Wearou Random Failures t Failures

Card

P2 Bilge
Ins pe ctor 3

Proce s s 2
Re cord e r 1

Ins pe ct 2 Worke r 3

Pumps

Pump Failure

Valve Failure

Re cord e rs
Re corde r 2

Proce s s 3

Ins pe ct 3

RELIABILITY PREDICTION R = RBil X (1 - (1-Rp)2) x

Pump P1 Fails

Pump P2 Fails

Pump V1 Fails

Pump V2 Fails

Time (t)

Card Drop S hop - Proce s s Mod e l

Re corde r 3

(1 -

(1-Rv)2)

DesignProductionDelivery Processes

DesignProductionDelivery Processes

Supporting Processes

Products

Services

Design Elements
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

Verify/Validate
Start

Develop Process Control Plan

Error Proofing and Contingency Planning

Detailed Design Review

Prepare Pilot Test Plans

Items with attribute

Supporting Processes

Products

Services

Design

Type of Design

Type of Design

Discrete

Type of data ?

Continuous

Counting items with an attribute or counting occurrences? Occurrences

Need to detect small shifts quickly?

Yes

No

Within spec limits

Upper Spec UCL

Outside spec limits

No

Equal sample sizes ?

Yes

No

Equal opportunity ?

Yes

Individual measurements Individual measurements or subgroups ? Rational Subgroups Individuals charts EWMA chart

UCL

Transfer

Act Check

Plan Do

Stable
(In control)

Upper Spec

Either/Or

Lower Spec

LCL Lower Spec

LCL

p chart

no chart

u chart

c chart

X, R or s chart

Upper Spec UCL UCL

Do limits look right?

Upper Spec

Yes

Yes

Do limits look right?

Unstable (Not in control )

LCL Lower Spec LCL

Lower Spec

No Try individuals charts

No Try transformation to make data normal

Question & Answer