DFSS and its Deployment at Bausch & Lomb

Presented at WCBF Conference

9-Jun-05

Las Vegas, NV

byJ. Slutsky

World Wide Dir. of DFSS

Bausch & Lomb

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Topics1. Overview of Design for Six Sigma

2. B&L’s DFSS Deployment Plan

3. Mapping DFSS into B&L’sProduct Development Process

4. Roles and Responsibilities

5. Summary

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IntroductionJeff Slutsky

Director of Design for Six Sigma, Bausch & Lomb

World Wide DFSS/Product Development Consultant3M, Samsung, Maytag, Hoover, Westinghouse Air Brake, Trane Air Conditioning, Cummins Engine, StorageTekKorea, Germany, France, England, US, Malaysia

Eastman Kodak/Johnson&Johnson Health CareControl Systems Design Current Product/Manufacturing

Engineering, Senior Systems Development Engineer

Adj. Professor, Rochester Institute of TechnologyGraduate and undergraduate courses in Control Systems and

Product and Production Systems Development

Co-author of the text, “Design for Six Sigma”

Voice: (585) 338-6574

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Overview of DFSS

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What is DFSS?• DFSS is a methodology to be used within a

product development process

• The methodology embeds statistical and non-statistical product development tools & their deliverables into the product development process– The tools deliver reliable and repeatable data in each

phase of the product development process

– The data enables data-based risk assessment and management during and between each phase of the product development process

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The major goals of DFSS are to...

• Ensure tight coupling between the stakeholder needs and the engineered functions intended to fulfill those needs

• Avoiding excellently performing systems that no one wants

• Ensure that the engineered functions are robust to the noises that cause variation in the those functions

• Resulting in consistent performance over the product’s life in the intended-use environment

Goals of DFSS

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The major goals of DFSS are to...

• Ensure that the system is developed following a disciplined, predictable and controllable process

• Allowing data-based management of cost, time, resources and risk

• Smoothing the “bumps” in the development effort experienced by far too many organizations

Goals of DFSS

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Engineering Effort

Phase I Phase II Phase III Phase IV Phase V

Idea

Gen

erat

ion

Fea

sib

ilit

y

Des

ign

/Tec

hn

olo

gy

Tra

nsf

er

Dev

elo

pm

ent

&S

cale

-up

Pro

du

ct L

aun

ch &

Fo

llo

w T

hro

ug

h

Firefighting due to;Insufficient early use of VOM,Poor characterization of Int & Ext Noises

Fix it in the field,Recalls

Extended Effort due to;Feature-Creep (VOC Discipline)Missed/Wrong Features (VOC)Immature TechnologyNarrow Feasibility Scope

VOM- Voice of Manuf

Insufficient effortplaced on technologydevelopment and robustness and VOC

DesiredTypical

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The technical goal of DFSS is 6 standard deviations ()between a critical response’s mean and its upper and lower specification limits

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LSLUSLCp

What Is DFSS?

Functional Capability measured using

LSL66

USL

Target

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What Is DFSS?

Out of Spec. performance

of a 6 function per

million opportunities

When 6 is achieved, Cp = 2 and the following failure rates are to be expected, assuming long term shifts and drifts…

ImprovingCapability 2

3

4

5

6

308,537

66,807

6,210

233

3.4

“Failures” per Million Opp

Nwhere N =Cp

0.66

1

1.33

1.66

2

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DFSS causes a paradigm shift in the way quality is measured and achieved

– A shift from…

Are we in Spec?

to

Are we Precise and Accurate?

What Is DFSS?

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Common View of QualityAre we in spec?

XXXX

Are these two itemsdifferent?

Good

Critical Response

BadBad

XX

Are these two itemsdifferent?

USLLSL

NO! YES!

This view encourages a “just get it to work” and “defect counting” approach

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World Class View of QualityAre we Precise and Accurate?

Critical Response

This view requires a statistical approach focused on the mean and variance of a system’s functions

USLLSL

Loss in Quality

Qualitydiminishes as we move off target and asvariationincreases

Target

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B&L’s DFSS Deployment Plan

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DFSS Deployment

•The purpose of the deployment…

to imbed the use of the methods, tools and best practices of DFSS in the development of all appropriate B&L products and manufacturing processes

not to replace methods, tools or best practices currently in place… unless doing so is an improvement

•Full deployment is expected to take three to five years

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How Deployment Will Proceed

•Deployment will proceed both top-down and bottom-up

Corporate Deployment- Top-DownCEO and down mandate corporate-wide adherenceMultiple, concurrent corporate-wide training wavesCorporate media “blitz”Empowerment of a DFSS Steering Committee

Project Deployment- Bottom-UpSelection of a few pilot projectsTraining of the project membersSuccess stories collected and publicized

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•Corporate Deployment- Top-DownPro: Gets the word out to allCon: Can be perceived as another “program of the

month” being forced upon everyone.Lasts only as long as pressure is applied

•Project Deployment- Bottom-UpPro: Builds trust in the tools and methods “in the

trenches” where organic and sustainable design culture change is rooted

Con: Support may not exist from above for the extra time and effort that learning and using the new tools will require

How Deployment Will Proceed

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• I’ve found the best approach to be…

•Some Top-Down•A Director of DFSS position has been created and filled• Corporate-wide awareness will occur through intranet website, monthly internal newsletters, etc.•DFSS statements come from the CEO and down

•Mostly Bottom-Up•Selection of a few current projects•Team members are assigned DFSS roles and responsibilities•Team members are trained•Project reviews and gate reviews are conducted•Success stories are publicized to fuel the next wave of projects

How Deployment Will Proceed

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The Corporate Deployment Path

The “corporate path” involves several key ingredients:

1. An unwavering requirement that DFSS become a product development core competency

2. A corporate-wide DFSS Steering Committee staffed by senior management

3. Mapping DFSS into the company’s existing product development management process

Do you have one?

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The Corporate Deployment Path

• The Steering Committee determines, implements & maintains B&L’s policies and procedures regarding the deployment, governance and steady-state use of DFSS

• The probability of a successful DFSS deployment can be predicted from the intensity of the Steering Committee’s actions and behaviors

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Steering Committee Members

Dir DFSS

VP RD&E

Dir New Prod Dev/Proj Mgmt

Program Directors

VP Human Resources

Dir New Business Technology

Category Leaders Marketing

VP Engineering

Global Supply Chain

VP Quality

VP Regulatory

VP R&D

VP Surgical R&D

Lens&Lens Care

RD&E VP Pharma

RD&E VP Research

VP Clinical Affairs

Dir Proj Admin/Finance

Corp CommunicationsB&L University

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The Project Deployment Path

The “project path” involves three efforts…

1. Project selection and kickoff-

– Apply selection criteria to candidate projects– Assess the likelihood of rework– Make selection with the Steering Committee– Assign DFSS roles & responsibilities to members– Align the project’s development phases to the DFSS

development phases

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The Project Deployment Path

2. Training the project members-

– Bring in DFSS training and consulting partners– Align training schedules to people and the project– Begin Champion training– Begin Green (GB) & Black Belt (BB) Training– Students are required to show how they used the

DFSS tools during each week of training

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The Project Deployment Path

3. Project management, technical support, gate reviews and termination

– Project Managers, Team Leaders and Champions ensure that…

• The DFSS tools are being used by the team• The DFSS development process is being followed• DFSS gate reviews are being conducted• Data from DFSS tool use are used to create the

gate review deliverables• Timely and competent help is provided to the Belts• The project is brought to an orderly close

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The Project Deployment Path

Projects will continually be selected until…

A critical mass of DFSS personnel have been trained

Project Managers, Team Leaders and Champions have achieved the experience and discipline to carry out data-based DFSS Gate reviews

Eventually, DFSS projects would no longer exit

It’s…

“just the way we do product development”

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Key Ingredients for Success

• Senior and middle management demand an unwavering requirement that DFSS become a product development core competency

• Resources must be allocated to achieve this.

• A seasoned Director of DFSS should be installed

• Timely and competent help must be provided to the fledgling Belts

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Roles and Responsibilities

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• Successful implementation requires that the right roles are fulfilled by the right people at the right time

• Typical roles already exist in a product development development organization;i.e. Program Directors, Project Managers, Functional Managers, …

• They will take on new DFSS rolesi.e. Green Belts, Black Belts, Champions, Gate keepers, …

• Eventually the roles will blend as DFSS becomes…

“just the way we do product development”

The Players

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Program Directors“Supply” the Program and

the Project Managers

Functional Managers“Supply” the technical

and supportteam members

PDMP Project1

Project Manager

Typical players in a matrix product development environment

Team1

Team Leader

Team Members

Team2

Team Leader

Team Members

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Executives- provide resources and demands that DFSS is a Product Development strategic core competency

Director of DFSS- Plans, implements and oversees all aspects of the deployment, policies and steady state use of DFSS

DFSS Players

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Champions- Roadblock removers to ensure the use of the DFSS tools within each phase of CDOV

CDOV Gate Keepers- Lead the CDOV gate reviews to manage the risk of going forward to the next CDOV phase

Belts- Green, Black, Master, who deploy the DFSS tools within the flow of CDOV

DFSS Players

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The DFSS Players

BlackBelts

GreenBelts

Executives

Dir DFSS

ChampionsMaster Black

Belts

GateKeepers

Executives, MBB and Champions can be Gate KeepersGreen Belts may become Black BeltsBlack Belts may become Master Black Belts

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How They Play Together

• The project players take on the DFSS roles based on

– their hierarchy in the project– their hierarchy in the company– their desire to learn– their previous experience with DFSS

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Program Directors“Supply” the Program and

the Project Managers

PDMP Project1

Project Manager

Team1

Team Leader

Team Members

FunctionalManagers

“Supply” the technicalteam people

DFSS Capability

BlackBelts

GreenBelts

Executives

Dir DFSS

ChampionsMaster Black

Belts

GateKeepers

CEOVP’s

Team2

Team Leader

Team Members

How They Play Together

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Mapping DFSS into…

B&L’sProduct Development Management Process

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The DFSS Development Process

C = Concept Design– Capture of Stakeholder Needs, Needs translation,

Concept Creation, Feasibility & Selection

D = Design Synthesis– Nominal Performance

O = Optimize– Robustness in the presence of stressful noise

V = Verify Product and Process Capability– Production Readiness

B&L is following C-D-O-V

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Mapping the DFSS Tools

Concept Design Optimize Verify

• Critical Parameter Management

• Design for Manufacture and Assembly DFMA

• Design FMEA

• Basic Stats

• Measurement Systems Analysis

• Design of Experiments

• Tolerance Design

• Reliability

• Design of Experiments

• Response Surface Methods

• Robust Design

• Stress Testing

• Reliability Engineering

• Capability Assessment

• Reliability Evaluation

• Control Plans

• Statistical Process Control

• CDOV

• Project Mgt.

• VOC Needs Gathering

• Needs grouping/Prioritizing

• QFD

• Concept Generation

• Pugh Concept Selection

•C = Concept Design

•D = Design Synthesis

•O = Optimize

•V = Verify Product and Process Capability

The DFSS tool set has been mapped into CODV

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DFSS Tools and CDOV MilestonesGathering the VOC

Interviewing, KJ, Affinity Diag, CPM, Sys Eng

Organized & Prioritized Customer Needs QFD, Sys Eng, CPM

Defined Technical Responses Concept Creation, TRIZ, System Architecting, Pugh, CPM, Sys Eng

Concept SelectedSW, Elec, Mech Eng tools, DFx, StatTol, CPM, Sys Eng

Baseline System Designed Robust Design, RSM, Optimization, CPM, Sys Eng

Design Optimized Tolerancing, Capability Assessment, Sys Eng

Design Toleranced

Transfer to Manufacturing

CPM Critical Parameter ManagementKJ Kawakita JiroQFD Quality Function DeploymentTRIZ Theory of Inventive ThinkingRSM Response Surface MethodsDFx Design for “everything”

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Mapping the DFSS Tools

• B&L has a Product Development Management process (the PDMP)

• It specifies the deliverables needed to satisfy areas such as Quality, Regulatory and Clinical Affairs

• It is mainly used at the project manager’s level and above

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CEO, VP’s, Directors, Regulatory, Quality, …

“Customers” of the PDMP deliverables

Phase II

Feasibility

Phase III

Dev & scale-up

Phase IV

Des/Tech Xfer

Phase V

Production, Launch,

Follow-Thru

PDMP Phase-Gate Process

Phase I

Idea generation

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Mapping the DFSS Tools

• The PDMP specifies the high level “What’s” for product development management

• It does not specify the tools and methods (the How’s) used at the tactical level of product development

• CDOV fills this gap and is mainly used at the project manager’s level and below

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Mapping the DFSS Tools

• Mapping the DFSS tools to the PDMP establishes a tight coupling between reliable, repeatable data and the PDMP deliverables

• Gate review project go/alter/kill decisions can then be made based on reliable, repeatable data

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TOOL-CDOV-PDMP Linkage

DFSS Tool Use

Project Tasks

CDOV Deliverables

PDMP Deliverables

Tools > Tasks > CDOV Deliverables > PDMP Deliverables

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TOOL-CDOV-PDMP Linkage

Tool useproduces Data

Data are transformedinto information

Information is transformedinto CDOV Deliverables

Information is transformedinto CDOV Deliverables

CDOV Deliverablesare transformed into PDMP Deliverables

CDOV Deliverablesare transformed into PDMP Deliverables

A DFSS Tool used within a task of the project plan

i.e FMEA

A DFSS Tool used within a task of the project plan

i.e FMEA

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Mapping the DFSS Tools

• Embedding CDOV into the PDMP provides the project teams with the tools and a structured method for meeting many of the PDMP deliverables

• The PDMP incorporates the CDOV data and deliverables into its deliverables to manage the overall product commercialization effort

• Eventually, CDOV may disappear, once its tools and deliverables are fully integrated into the PDMP

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CDOV Mapped into PDMP

Phase II

Feasibility

Phase III

Dev & scale-up

Phase IV

Des/Tech Xfer

Phase V

Production, Launch,

Follow-Thru

PDMP Phase-Gate Process

Phase I

Idea generation

Design Optimize Verify

CDOV Phase-Gate Process

Concept

PDMP Gate reviews

CDOV gate reviews

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Producers of CDOV data through DFSS tool use

Project Manager

Team1

Team Leader

Team MembersDFSS Tools

Team2

Team Leader

Team MembersDFSS Tools

CDOV

PDMP Project1

PDMP

CEOVP’s

DirectorsRegulatory

Quality..

A “customer” of the CDOVdata and deliverables

“Customers” of thePDMP deliverables

Translate them into PDMPDeliverablesManages/OrganizesCDOV data and deliverables

Other sources ofinformation forthe PDMP

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Summary

• DFSS helps to ensure system development following a disciplined, predictable and controllable process

• DFSS causes a paradigm shift from “Are we in Spec?” to “Are we Precise and Accurate?”

• Senior and middle management must demand an unwavering requirement that DFSS become a product development core competency

• Resources must be allocated to achieve this.

• A seasoned Director of DFSS should be installed

49

Summary

• Timely and competent help must be provided to the fledgling Belts

• Successful implementation requires that the right roles are fulfilled by the right people at the right time

• Mapping the DFSS tools to the PDMP establishes a tight coupling between reliable, repeatable data and the PDMP deliverables– Gate review project go/alter/kill decisions can then be made

based on reliable, repeatable data

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All DFSS material based on the book;

“Design for Six Sigma in Technology and Product Development”

Creveling, Slutsky, Antis,

Prentice-Hall, 2003, ISBN 0-13-009223-1

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Thank You