Quality Development Series

1
Quality Development Series

• Quality Management for the Business Professional
• Presented byWilliam Newman - Adjunct Professor,
  University of Michigan
• Quality Expo National Manufacturing Week
• Rosemont (Chicago), IL
• September 25, 2007

2
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

3
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.

4
Ice-breaker / Quiz

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

5
Agenda

• Module 1 Introduction A History of Quality
• Module 2 Survey of Quality Management Systems
• Module 3 Quality Management Concepts for
  Business Professionals

6
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".

7
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 Japans 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).

8
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
TL 9000
ISO 90012000
CAPA
9
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.

10
How Product Development Happens
Source Hoffman, et. al.
11
Product Development Risk and Reward
Source Griffin, Abbie, PDMA Research on New
Product Development Practices Updating Trends
and Benchmarking Best Practices, Journal of
Product Innovation Management 14 (1997).
12
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 youve 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.

Source American Society of Quality.
13
The Quality Process ISO90002000
Legend
Value generation
Information flow
ISO90002000 advocated for the first time a
closed-loop process, where the beginning and
the end are with the customer.
14
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.

15
Agenda

• Module 1 Introduction A History of Quality
• Module 2 Survey of Quality Management Systems
• Module 3 Quality Management Concepts for
  Business Professionals

16
Development of Successful New Products

• Products that dont solve customer problems or
  dont 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.

17
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

18
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
19
Managing the Product Lifecycle
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.
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.
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.
Introduction
Growth
Maturity
Decline
20
Encore of the Quality Process ISO90002000
Legend
Value generation
Information flow
Most quality standards, regardless of industry
orientation, abide by the closed-loop quality
process of ISO90002000.
21
More Terminology Quality Core Tools

• APQP Advanced Product Quality Planning
• The overall governing product readiness
  operating model for most repetitive manufacturing
  industries
• PPAP 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
  risk
• 8D Eight-D
• A problem solving approach used to perform
  corrective action
• CAPA Corrective Action, Preventative Action
• A problem analysis approach similar to 8-D used
  in high tech

22
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?)

23
Product Development vis-à-vis TS16949 (APQP)
2) Product Design Design FMEA PreliminaryB
ill of Materials Specification Design
collaboration Control Plan(Prototype)
1) Concept Phase RFQ / Businesscase Developme
nt Plan Regulations (Laws, Standards,
Objectives) Continuous Improvement
3) Process Design Process FMEA Routing
creation Process flow diagram Statistical
process Control (SPC) Control plan(Model)
4) Validation Planning and production under
real-life conditions Control plan for series
production and inspection plan Process
audit Production partapproval process(PPAP)
5) Product Launch Quality Inspections
during Production Requalification tests Proces
s optimization
Review SOP Release
Review/ Approval
Review Pre-ProductionRelease
Review/ Approval
Define type of APQP
24
A Typical Quality Management System (QMS)
APQP

• Analysis
• Know-How
• Methods

Quality Circle
FMEA
QM Plan
Corrective measures (8D)
Defects
Planning
Realization
Production
Product
25
Industries, and their standards, are blending

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

Delphis move into consumer electronics(XM
satellite radio) and medical productsmeans those
products may need to satisfymore than one set of
industry standards.
26
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.

27
Example Internal Audit Program
COMPLETEDCORRECTIVEACTIONS?
YES
VOLKSWAGEN DE MÉXICO
NO
INITIATE PROGRAM
REVIEW AUDITFINDINGS
Lead Responsibility
MAJORCORRECTIVEACTIONS?
Management
Third-party
PROGRAM MANDATE
NO
AUDITFINDINGS
QMO
YES
CONDUCT TRAINING
PARTICIPATEAND AUDIT
DEFINE PROJECT RECOVERY PLAN
TOOLS KNOWLEDGE
28
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
  managementprogram?

29
Ice-breaker

• Three lies and a truth
• Tell the class three lies anda truth.
• Class participants vote onwhich is the truth.
• One point for each correct guess.
• Participant with the most points (correct
  guesses) wins a prize!

30
Module 2 Key Concepts

• 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.

31
Agenda

• Module 1 Introduction A History of Quality
• Module 2 Survey of Quality Management Systems
• Module 3 Quality Management Concepts for
  Business Professionals

32
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!

33
Examples of Quality Initiatives in Business
Benefit Potential
34
Managing the Transition
A New Beginning
The Neutral Zone
Letting Go
William Bridges, Managing Transitions
35
How Change Is Accepted
16 resistors
34 late majority
34 early majority
13.5 early adopters
2.5 innovators
William Bridges, Managing Transitions
36
Why People Resist Change
Certainty I know this change is bad for me!
Uncertainty I think that this change will be bad
for me!
Feelings I dont feel good about this change
Skepticism I strongly doubt that any good at all
will come of this
. . . Understand that the organization is
composed of groups with different needs and
agendas . ..
37
Influence and Communication
Think
Awareness/
Need/
Need
awareness
Commitment/
Understanding/
Feel
understanding
Commitment
Capability/ Action
Do
38
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.

39
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.
40
Business Processes in Quality

• Management
• Business
• Support

Source American Society of Quality.
41
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.

42
Module 3 Key Concepts

• 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.
  Dont bite off more than you can chew!

43
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.

44
Summary and Discussion
45
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/

46
Credentials

• Mr. Newman has over 20 years experience in
  management, marketing and sales helping
  companies go to market quickly and profitably.
  During his career, he has worked for and leda
  variety of management consulting, information
  technology, and engineering services firms. His
  industry expertise spansmanufacturing,
  government, utilities, transportation, and
  healthcare industries.
• Mr. Newman holds a Bachelors Degree in
  Aerospace Engineering with a minor in Economics
  from the Henry Samueli School of Engineering at
  UCLA, and an MBA in Management with an emphasis
  in International Business from the Conrad Hilton
  School of Business at Loyola Marymount
  University.
• Mr. Newman serves as an adjunct professor with
  the University of Michigan Dearborn Graduate
  School of Management in the area of Marketing
  Policy and Product Development. He earned the
  Certified Management Consultant designation in
  1995, and has been a qualified ASQ trainer since
  2000. He is a sought-after speaker and
  facilitator on the topics of New Product
  Introduction (NPI) and innovation management.
  His research includes The Annual Innovation and
  Technology Survey and The Six Secrets of Highly
  Innovative Companies. Mr. Newman may be reached
  at wnewman_at_umd.umich.edu.