Page 1 - September, 2007 Quality Management for the Business Professional [email protected] Quality Development Series Quality Management for the Business.

Page 1 - September, 2007Quality Management for the Business Professional [email protected]

Quality Development SeriesQuality Management for the Business Professional

Quality Expo DetroitJune 12, 2008

Page 2 - June, 2008Quality Management for the Business Professional [email protected]

Introduction

Executive summary

Over 20 years of enterprise systems, change management, innovation management, and product development experience. Former IT executive at Volkswagen.

Sr. Associate with Booz Allen Hamilton helping clients plan and manage complex, global enterprise systems programs

Develop recommended approaches for benefits realization, change management, global program structures, innovation management and business transformation.

Certified Management Consultant (CMC) since 1995.

Education

MBA, Conrad L. Hilton School of Management, Loyola Marymount University (Management with emphasis on International Business)

BS in Aerospace Engineering with minor emphasis in Economics, Henry Samueli School of Engineering and Applied Science, University of California at Los Angeles (UCLA)

Adjunct faculty member, University of Michigan – Dearborn, Graduate School of Management, Department of Management Studies (Marketing Policy and Product Development).


Agenda

Introductions / Administratia / Ice Breaker Overview of Program and Expectations

■ Module 1: Introduction – A History of Quality■ Module 2: Survey of Quality Management Systems

Break during exercise■ Module 3: Quality Management Concepts for

Business Professionals Adjourn


Learning Objectives

1. Reduce anxiety around quality concepts.2. Increase understanding of quality vocabulary and

concepts.3. Introduce the concept of a quality process.4. Understand the kinds of quality standards that exist.5. Understand key differences in quality readiness,

compliance, and certification.6. Introduce change management and validation

concepts, including communication planning.7. Review popular management concepts dealing with

quality.8. Provide resources you can use tomorrow.


Ice-breaker / Quiz

Where in the world:■ Who you are■ What you do■ Where you are from■ Why you are here


Agenda

Module 1: Introduction – A History of Quality Module 2: Survey of Quality Management Systems Module 3: Quality Management Concepts for

Business Professionals


Quality Fundamentals

Definition■ Quality refers to the distinctive characteristics or

properties of a person, object, process or other thing. Such characteristics may enhance a subject's distinctiveness, or may denote some degree of achievement or excellence.

■ ISO 9000 defines quality as "degree to which a set of inherentcharacteristic fulfils requirements".


Modern History of Quality

After the United States entered World War II, quality became a critical component of the war effort. The armed forces initially inspected virtually every unit of product; then to simplify and speed up this process without compromising safety, the military began to use sampling techniques for inspection, aided by the military-specification standards and training courses.

The Japanese quality revolution after World War II welcomed the input of Americans Joseph M. Juran and W. Edwards Deming and rather than concentrating on inspection, focused on improving all organizational processes through the people who used them.

By the 1970s, U.S. industrial sectors such as automobiles and electronics had been broadsided by Japan’s high-quality competition. The U.S. response, emphasizing not only statistics but approaches that embraced the entire organization, became known as total quality management (TQM).


Quality Vocabulary and Concepts

Today, total quality has given way to many kinds of standards, guidelines and working documents all intended to support quality in the manufacture of products and delivery of services in different industries.

ISO 9000

ISO 9001:2000

AS 9000

QS 9000TS 16949ISO 14000

21 CFR Part 11

TL 9000

IWA 1

CAPA


Quality Vocabulary and Concepts

A quality management system, is composed of the following general components:

■ Processes■ People■ Management■ Customers■ Services and / or Products■ and value.

How we define a “quality system” has undergone change over the years but it begins with the intent to offer a product or service to one or more customers.


How Product Development Happens

Source: Hoffman, et. al.


Product Development – Risk and Reward

High

HighLowNewness to the Market

Increasing Risk

New

ne

ss

to t

he

Co

mp

an

y In

cre

asi

ng

Ris

k

34% ProductImprovements

20%

23%

9% 4%

10%

Cost Reductions

Repositionings

New Product Lines

New to the world products

Adding to existing lines

Source: Griffin, Abbie, “PDMA Research on New Product Development Practices: Updating Trends and Benchmarking Best Practices, Journal of Product Innovation Management 14 (1997).


The Deming (PDCA) Cycle

Plan. Recognize an opportunity and plan a change.

Do. Test the change. Carry out a small-scale study.

Check. Review the test, analyze the results and identify what you’ve learned.

Act. Take action based on what you learned in the study step: If the change did not work, go through the cycle again with a different plan. If you were successful, incorporate what you learned from the test into wider changes. Use what you learned to plan new improvements, beginning the cycle again.

PLAN

CHECKACT

DO

PDCA

Source: American Society of Quality.


Legend: Value generation

Information flow

The Quality Process – ISO9000:2000

Qualitäts-management

System

Board Responsibility


Management of ResourcesManagement of Resources

ProductrealizationProduct

realization

Measure,Analyze and

Improve

Measure,Analyze and

Improve

CustomerCustomer CustomerCustomer

Satisfaction

RequirementProduct

Continuous improvementof quality management system






realization

Measure,Analyze and

Improve

Measure,Analyze and

Improve


Satisfaction

RequirementProduct



ISO9000:2000 advocated for the

first time a “closed-loop”

process, where the beginning

and the end are with the

customer.


Module 1: Key Concepts

Quality refers to the distinctive characteristics or properties of a person, object, process or other thing.

ISO 9000 defines quality as "degree to which a set of inherentcharacteristic fulfils requirements".

There are many quality standards, guidelines, and working documents for different products and industries.

Modern quality founders such as Deming and Juran spear-headed the quality revolution in Japan and later in the US.

Conventional quality processes are “closed-loop” meaning each process starts and ends with the customer.


Agenda




Development of Successful New Products

Products that don’t solve customer problems or don’t solve them at a competitive cost will fail.

Customer needs are the problems that a person or firm would like to have solved.

Products deliver solutions to customers’ problems.


Successful Product Development

Three issues must be thoroughly examined:

■ Defining the type of new product to launch

■ Establishing how its success will be measured

■ Anticipating potential reasons for possible failure


Managing the Product Lifecycle

The product life cycle- the cycle of stages that a product goes through from birth to death.

Product Lifecycle Management (PLM) is the active management of product information and position through the product life cycle.

Introduction Growth Maturity Decline


Introduction Growth Maturity Decline

Managing the Product Lifecycle

The introduction stage starts when a new product is presented to the market. Initial sales are slow, as potential customers must go through a learning process about the new product and its benefits before they purchase.

The growth stage of the product life cycle characterized by rapidly increasing product demand, new competitors entering the market in response, and rapidly increasing profits for the product varieties that customers decide best meet their needs.

During the maturity stage, sales initially increase but at a slower rate as the market becomes saturated and as competitive pressures reach their peak. Sales and profits typically decline in the latter half of the maturity stage.

Even if new users are found and usage rates are increased, product sales may eventually start a long-term decline, as when a substitute product that offers a superior set of benefits displaces the “old” product.


Legend: Value generation

Information flow

Encore of the Quality Process – ISO9000:2000

Qualitäts-management

System





realization

Measure,Analyze and

Improve

Measure,Analyze and

Improve


Satisfaction

RequirementProduct







realization

Measure,Analyze and

Improve

Measure,Analyze and

Improve


Satisfaction

RequirementProduct



Most quality standards,

regardless of industry

orientation, abide by the “closed-

loop” quality process of

ISO9000:2000.


More Terminology… Quality “Core Tools”

APQP – Advanced Product Quality Planning■ The overall governing product readiness operating model for

most repetitive manufacturing industriesPPAP – Production Part Approval Process

■ A specific approval process in most manufacturing companies to certify a part is ready for assembly

FMEA – Failure Mode Effects Analysis■ Analysis performed generally at the design and manufacturing

process levels to assess product risk8D – “Eight-D”

■ A problem solving approach used to perform corrective actionCAPA – Corrective Action, Preventative Action

■ A problem analysis approach similar to 8-D used in high tech


Other Quality Management Concepts

There have emerged post-”total quality” a variety of programs and techniques. These allow for a series of checks and balances in the organizations appropriate at different stages of the product lifecycle.

On the Shop Floor:• Kanban• JIT• Poke-a-yoke

For Quality professionals:• Statistical Process Control

(SPC)• Measurement Systems

Analysis (MSA)• Production Part Approval

Process (PPAP)• Six Sigma (6)


Product Development vis-à-vis TS16949 (APQP)

Define type of APQP

Review/ Approval

Review/Approval

ReviewPre-ProductionRelease

ReviewSOP Release

1) ConceptPhase

RFQ / Businesscase

Development Plan

Regulations (Laws, Standards, Objectives)

Continuous Improvement

2) Product Design

Design FMEA

PreliminaryBill of Materials

Specification

Design collaboration

Control Plan(Prototype)

3) ProcessDesign

Process FMEA

Routing creation

Process flow diagram

Statistical processControl (SPC)

Control plan(Model)

4) Validation

Planning and production under real-life conditions

Control plan forseries production and inspection plan

Process audit

Production partapproval process(PPAP)

5) Product Launch

Quality Inspections during Production

Requalificationtests

Processoptimization


A Typical Quality Management System (QMS)

Planning Realization Production

PreventiveActions

Analysis

Know-How

Methods

Product

Defects

8D Report Solution DB

Quality Circle

Corrective measures (8D)

APQP

FMEA

QM Plan


Industries, and their standards, are blending

With a trend to enter new markets and industries with a company’s products, similarities and unique differences in quality adherence is encountered.

Delphi’s move into consumer electronics(XM satellite radio) and medical productsmeans those products may need to satisfymore than one set of industry standards.


Readiness, Compliance, Certification

Readiness refers to the ability of an organization to begin to implement a QMS.

Compliance indicates that an organization is following one or more quality standards and guidelines with internal controls via an implemented QMS. This could involve internal audits.

Certification is awarded to a particular site or company division where one or more quality standards and guidelines have been implemented via a QMS and repeatedly audited and validated by a third-party registrar.


Example Internal Audit Program

INITIATE PROGRAM

CONDUCT TRAINING

Lead Responsibility:

Third-party

QMO

Management

PARTICIPATEAND AUDIT

PROGRAMMANDATE

TOOLS &KNOWLEDGE

DEFINE PROJECTRECOVERY PLAN

COMPLETEDCORRECTIVE

ACTIONS?

YES

NO

REVIEW AUDITFINDINGS

MAJORCORRECTIVE

ACTIONS?

YES

NOAUDITFINDINGS

VOLKSWAGENDE MÉXICO


Case Study: Siemens VDO

Read the case study handout on Siemens VDO. You are the management team for the Guadalajara plant operations

and you are considering a quality initiative. Break into teams and discuss the following:

■ What business drivers compelled Siemens to consider this program initiative?

■ How would this serve the customers of Siemens?■ How did the business benefit from a quality management

program?


Ice-breaker

Three lies and a truth:■ Tell the class three lies and

a truth.■ Class participants vote on

which is the truth.■ One point for each correct guess.■ Participant with the most points

(correct guesses) wins a prize!



Quality management systems (QMS) can occur and do occur during all stages of the product lifecycle.

Based on the standard or guideline that you are following there may be requirements in the conceptual design, production planning, validation, and through manufacturing and service.

Depending upon your product or service and the value chain your company operates, you may be subject to one or more quality requirements.

There is a huge investment / reward difference between readiness, compliance, and certification.


Agenda




How Do you Implement Quality in an Organization?

Implementing Quality or any concept in an organization must address the fact that change will happen in the organization.

There are different levels of change in the organization based on quality concepts.

There are change management techniques and concepts you can learn and use to make your journey less painful than it could possibly be!


Examples of Quality Initiatives in Business

Benefit P

otential

WORKFLOW

RE-DESIGN

BUSINESS PROCESS

RE-ENGINEERING

BUSINESS

TRANSFORMATION


Managing the Transition

William Bridges, Managing Transitions

A «New Beginning»

The «Neutral Zone»

«Letting Go »


How Change Is Accepted

2.5% innovators

13.5% early adopters

34% early majority

34% late majority

16% «resistors»

William Bridges, Managing Transitions


Why People Resist Change

CertaintyI know this change is

bad for me!

CertaintyI know this change is

bad for me!

FeelingsI don’t feel good about this change

FeelingsI don’t feel good about this change

SkepticismI strongly doubt that any

good at all will comeof this

SkepticismI strongly doubt that any

good at all will comeof this

UncertaintyI think that this change

will be bad for me!

UncertaintyI think that this change

will be bad for me!

. . . Understand that the organization is composed of groups with different needs and “agendas” . ..

. . . Understand that the organization is composed of groups with different needs and “agendas” . ..


Influence and Communication

Need/awareness

Commitment/understanding

Awareness/

Need

Understanding/

Commitment

Think

Feel

Do Capability/ Action


Change Process

All change goes through a lifecycle, whether intended or unintended, which generally follows the diagram at right.

You can be pro-active about managing the change process or re-active. The choice is yours and that of your organization.


Some Principles for Initiative Planning

The Uniqueness Principle Whatever the apparent similarities, each problem is unique and requires an approach that dwells on its own contextual needs.

The Purposes Principle Focusing on purposes helps strip away nonessential aspects to avoid working on the wrong problem.

The Solution-After-Next Principle Innovation can be stimulated and solutions made more effective by working backward from an ideal target solution.

The Systems Principle Every problem is part of a larger system. Understanding the elements and dimensions of a system matrix lets you determine in advance the complexities you must incorporate in the implementation of the solution.

The Collective Principle An organization is made of a collective of individuals who hold the solutions to most organizational initiatives.

Source: Variety of sources, including G. Nadler, S. Hibino, Breakthrough Thinking, 1990, Prima Publishing.


Business Processes in Quality

Management

Business

Support

Source: American Society of Quality.


Communication Planning

Some typical sponsorship and communication techniques include:

■Company newsletter / intranet news sites / email

■Focus groups■Fireside chats■Management briefings

The old adage applies:“Tell ‘em what you are going to do,Tell ‘em what you are doing, Tell ‘em what you did.”



There are many quality concepts used across industries, appropriate for different activities across the business.

The best way to implement a quality management system (QMS) is to show the benefit to the people and to the organization through constant and open communication.

Pro-active change management techniques can help to successfully implement a QMS.

There are different levels of change with proportionate levels of resistance to change. Don’t bite off more than you can chew!


Learning Objectives – How did we do?

1. Reduce anxiety around quality concepts.2. Increase understanding of quality vocabulary and

concepts.3. Introduce the concept of a quality process.4. Understand the kinds of quality standards that exist.5. Understand key differences in quality readiness,

compliance, and certification.6. Introduce change management and validation

concepts, including communication planning.7. Review popular management concepts dealing with

quality.8. Provide resources you can use tomorrow.


Summary and Discussion


Resources

The American Society of Quality■ www.asq.org

Automotive Industry Action Group■ www.aiag.org

UofM Medical Center Quality System Public Website■ http://www.med.umich.edu/mqs/

The Juran Institute■ www.juran.org

Delphi Quality / Social Responsibility Web page■ http://www.delphi.com/about/main/social/quality/


Thank you!

Feel free to request a copy of this presentation.

Contact Information:William NewmanUniversity of Michigan – DearbornSchool of Management, Dept. of Mgmt. [email protected] Office: (248) 922-5907

Page 1 - September, 2007 Quality Management for the Business Professional [email protected] Quality Development Series Quality Management for the Business.

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