Quality Management. Systems OPRE

80 

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O P R E 6364 1

Quality Management

Systems

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O P R E 6364 2

Topics to cover:

‰

Elements of TQM

‰

ISO 9000 family of standards (then and now)

‰

QS 9000

‰

The Baldrige

and Deming Awards

‰

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O P R E 6364 3 Evolution of QA Methods… Inspection Six Sigma… DOE Quality Mgmt Systems Taguc h i 1930 1940 … 1975 1985 1990 1995 2000 SPC

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What does the term

Quality

really mean?

Quality

is the ability of a product or

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Historical Summary

Q

uality Assurance

–Art

is an sh ip • O

ne person / common purpose among tasks

C

loseness of producer and consumer

Industrial revolution •

Long supply chains

U

nskilled labor (division of labor) –M

ass production

U

niform quality

Loss of understanding of purpose

E

li Whitney and Henry Ford

C

onsumerism: a response

Q

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Total Quality

Total Quality Management

– W hat does total mean? • E ntire organization • A

ll products and processes

A

ll aspects (management, design, control)

N

ot a

flavor of the month

(i.e., typical management fad)

Long term perspectives

C

onsider the Japanese

C

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Costs of Quality

• F ailure Costs

-costs incurred by defective

parts/products or faulty services.

Internal Failure Costs –

C

osts incurred to fix problems that are detected

before the product/service is delivered to the customer.

E

xternal Failure Costs A

ll costs incurred to fix problems that are detected

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Costs of Quality (contd)

A

ppraisal Costs A

ll product and/or service inspection costs.

P

revention Costs A

ll TQ training, TQ planning, customer

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Quality Cost: Traditional View

Cost per good unit of product

0

100%

Quality level (q)

Optimum quality level

Total quality costs

Internal and external failure costs

Minimum total cost

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Quality and Competitiveness

Increased revenue

Improved competitive position

Increased market share

Higher prices Reduc

ed

cost o

f

operations

Increased defect-free output

Increased profits

Continuous Quality Improvement

or Cost-Rou te Ben e fits Market-Route Ben e fits 3-7

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Quality Cost Minimized at Zero Defects

Cost per good unit of product 0

100%

Quality level (q)

Optimum quality level

Total quality costs

Internal and external failure costs

Minimum total cost

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Taguchi's Quality Loss Function

Target

τ

Loss ($)

Customer's Tolerance Band

Loss

L Any deviation from target causes a loss to society

d

Lower

Spec Limit

Upper

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Quality and Competitiveness

V

alue of Quality

Impacts of quality efforts on performance

M

arket share and profitability

• C ustomer satisfaction •Q ua lit y •C os ts • E mployee relations

D

irectly related to ROI

S

ix Sigma programs have proven the value of

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Total Quality Management

Principles

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How do Customers see Quality

Performance

-m

ain characteristics of the

product/service

Aesthetics

-appearance, feel, smell, taste

Special features -extra characteristics • Conformance

-how well product/service conforms to

customer’s expectations • Safety -Risk of injury • Reliability -consistency of performance

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Dimensions of Quality (Cont’d)

Durability

-useful life of the product/service

Perceived Quality

-indirect evaluation of quality (e.g.

reputation)

Service after sale

-handling of customer complaints

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Determinants of Quality

Service

Design

Ease of

use

Conform-

ance

to

design

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Consequences of Poor Quality

Recall that Quality is… The ability of a product or service to consistently meet

or

exceed customer expectations

Not meeting Quality is…

Loss of business

:

Poor designs or defective products or services can results in loss of business

Liability:

Damage

or injures resu

lting

from faulty design

Productivity

:

Productivity and quality

are of te n c lo se ly relate d Costs: Poor quality

increases certain costs incurred by the

organizat

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Responsibility for Quality

T

op management

•D

es

ig

n

P

rocurement

P

roduction/operations

Q

uality assurance

P

ackaging and shipping

M

arketing and sales

C

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Ethics and Quality

S

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Quality Gurus

Edward Deming – P lan -D o-Check – A ct; statistical methods – F

ourteen Points for Transformation Management

J. M Juran

M

anagerial Practices, Training, Cost of Quality

Armand Feigenbaum

T

otal Quality Control, “hidden plant”

Kaor

u Ishikawa

Q

uality Circles, 7 Tools

Philip Cr osb y – Z ero defects

and Quality is free

Genichi T aguchi – D es ign of experiments – Q

uality loss function

R

obus

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Quality Certification

ISO 9000, QS 9000

S

et of international standards on quality

management and Quality assurance, critical to

international Business

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The ISO 9000 Series Standards

ISO 9000 requires companies to document

everything they do that affects the quality of

goods and services.

H

ierarchical approach to documentation of

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International Organization for

Standardization (ISO)

Technical Committee Technical Committee

ISO

National Bodies National Bodies

Committees Trade Orgs Stds Orgs ANSI 176 (Quality) ASQ Auto Z1 User

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Why International Standards?

9

They promote trade and cooperation

9

Product standards allow consumers to

purchase items from different manufacturers

and know those items will perform equally

9

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ISO 9000 Consensus Process

New Work Item Proposal Working Draft Committee Draft Published Standard Final Draft Int’ l Standard

Draft Inter- national

Std

Formal Ballot Formal Ballot Formal Ballot

Formal Ballot Vote to Release

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ISO 9000 Series

ISO 9000

Helps companies determine which standard of ISO 9001, 9002, and 9003 applies

ISO 9001

Outlines guidelines for companies that engaged in design, development, production, installation, and servicing of products or service

ISO 9002

Similar to 9001, but excludes companies engaged in design and development

ISO 9003

Covers companies en

gaged in final inspection

and testing

ISO 9004

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ISO 10000 Series

Quality system auditing guide Quality manual development guide

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The ISO 9001:1994 Clauses

Process Control 15 Handling, Storage, Packaging, Pr es er va ti on & Delivery 19 S erv icing 1 Mana gemen t Responsibility 5 Document & Da ta Control 14 Corrective & Preven tive Action 16 Control of Quality Records 17 Internal Quality Audits 18 Training 20 S ta tistical Techniq u es 2 Quality System Customer 3 Con tract Review 7 Control of Custome r-Supplied Product 4 Design Control Vendor (Sub-Contractor) 6 Pu rchasing Product Contr o l 10 Insp ection & T esting 12 Insp ection & T est Sta tus 8 Product Ident ification & T race ability 9 Proces s Control 11 Insp ection,

Measuring & Test

Equip m ent 13 Control of Non-Conforming Product

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New ISO 9001:2000

Q

uality management system

Put structure in what you do

M

anagement responsibility

Put someone in charge

R

esource management

Provide the resources to achieve goals

P

roduct realization

Design and make it to requirements

M

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The Grand Vision: 2000

9000

Fundamentals An

d Vocabulary

9001

Requirements

9004

Guidelines For Performan

ce

Improvements

10012

Measu

rement Control

19011

QMS/EMS Auditing

¹

Technical Reports on Everything Else

¹

Greater Compatibili

ty

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Third party registration

Registrar Accreditation Board

Registrar Company Course Providers Auditors Customers hire assess certify accredit accredit train

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Registration steps

The

Registrar

will:

R

equest information from you

R

eview your documents (mostly QA manual)

R

eview your application

A

udit your facility

Issue your certificate

C

onduct periodic surveillance

R

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ISO 9000 Registration Process

T

he final audit begins with a review of the

company's Quality Manual, which the

accredited registrar or third party audit team

typically uses as its guide.

T

he audit team checks to see that the

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ISO 9000 Registration Process

W

hen an organization feels that its

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Timeline for registration

0.0

D

ecide to go for registration

Form a steering committee

0.5

W

rite your QA Manual

Write process procedures

1.0

C

onduct internal reviews

Refine your processes

1.5

C

onduct system audits

Undergo a “mock” audit

2.0

R

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Where to Inspect the Process

R

aw materials and purchased parts

F

inished products

B

efore a costly operation

B

efore an irreversible process

B

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Examples of Inspection Points

Type of business

Inspection points

Characteristics

Fast Food

Cashier Counter area Eating area Building Kitchen

Accuracy Appearance, productivity Cleanliness Appearance Health regulations

Hotel/motel

P

arking lot

Accounting Building Main desk

Safe, well lighted Accuracy, timeliness Appearance, safety Waiting tim

es

Su

permarket

Cashiers Deliveries

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ISO 9000 Registration Process

W

hen the registrar is satisfied with the

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International issues

E

nvironmental management systems

O

ccupational health & safety

R

egulated industries

m edical devices – pharmaceutical – health care

S

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ISO 14000

ISO 14000

-A

set of international standards

for assessing a company’s

environmental

performance

S

tandards in three major areas

M

anagement systems

O

perations

E

nvironmental systems

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ISO 14000

M

anagement systems

S

ystems development and integration of

environmental responsibilities into business

planning

O

perations

C

onsumption of natural resources and

energy

E

nvironmental systems

M

easuring, assessing and managing

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QS 9000

Common Supplier Quality Standard established by the Big Three automakers: Chrysler, Ford, GM.

First introduced in North America in Aug 1994

Consists of : 

Section I ISO 9000 based requirements

Section II Customer-specific requirements

Meeting mandatory requirements for the auto industry

Emphasis on Continuous Improvement and Defect Prevention

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QS 9000 in Summary

• Q

S 9000 emphasizes on meeting customer requirements.

In long run, this will improve competitiveness.

Q

S 9000 put focus on

* Continuous Improvement * Defect Prevention * Reduction of variation and waste

The standard possesses tremendous potential in term of Business Excellent.

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Recognizing Quality

B

enchmarking

Definition: Identifying and documenting

best

practices •

C

ompetitors (OM Princ

iple 4) • O ther industries – S

tart by selecting and benchmarking

own

process

M

etrics: comparis

ons (e.g., LT:Content ratio)

P

ractices: steps, errors, delays, etc.

T

ypical steps summarized in the next slide

C

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The Benchmarking Process: Common Steps

GETTING STARTED

Planning, Organizing, and Managing for benchmarking

PREPARING

TO

BENCHMARK Identify key process. Form team. Understand your own processes.

CONDUCTING RESEARCH Collect information: Who's the best? What to ask?

SELECTING WHOM TO BENCHMARK Establish relationship. Plan to collect and share information.

COLLECTING AND SHARING INFORMATION Surveys Site visits Determine any third parties

ANALYZING

ADAPTING AND IMPROVING Compare data. Plan to surpass. Implement and monitor. Improve.

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Recognizing Quality

Q

uality Awards

Include: •

D

eming Prize (first major award)

• B aldrige A ward (establis hed by Congress) • S tatewide awards –P ro vi de • R

ecognition (shouldn’t be primary goal)

P

ath to improved quality

– B aldrige A ward criteria •

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Quality Awards

Baldrige

Award

Deming Prize

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Malcolm Baldrige

National Quality Award

1.0 Leadership

2.0 Strategic Planning

3.0 Customer and Market Focus

4.0 Information and Analysis

5.0 Human Resource Development and

Management

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Baldrige

Award details

9

A US National Quality Award

9

Started in 1987

9

Awards in three categories –

m

anufacturing, service,

small business –

no more than two awards per

category per year

9

Stresses ‘management by fact’

9

Consists of a three level judging process

9

Is a seven-category, 1000-point scoring system •

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Leadership

• C ontributes 100 points S

enior executive leadership

Q

uality values

M

anagement for quality

P

ublic responsibility

S

ymbolism and Active involvement

Intimate knowledge of how the work actually gets done

Impressive listening skills –

S

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Information and analysis

C

ontributes 70 points S

cope and management of quality data and

information

C

ompetitive comparisons and benchmarks

A

nalysis of quality data and information

M

ust demonstrate fact-based management

Information base must be comprehensive, accessible, and well validated.

U

se benchmarking as a enabler of change, a learning

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Strategic Quality Planning

C

ontributes 60 points S

trategic quality planning process

Q

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Human Resource Utilization

C

ontributes 150 points H

uman resource management

E

mployee involvement

Q

uality education and training

E

mployee recognition and performance

measurement

E

mployee well-being and morale

E

mpower the employees and unleash the full

potential of the work force

Q

uality training involves increased awareness,

problem-solving tools, group

process skills, and

job-specific skills

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Quality Assurance of Products &

Services

C

ontributes 140 points D

esign and introduction of quality products and

services

P

rocess quality control

C

ontinuous improvement of processes

– Q uality assessment – D ocumentation – B

usiness process and support service quality

S

upplier quality

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Quality Results

• C ontributes 180 points P

roduct and Service Quality results

B

usiness process, operational, and support

service quality results

S

upplier quality results

Look for ‘meaning trends’

S

ustained improvements on critical measures over a

period of at least three years

U

se statistical methods to correlate objective quality

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Customer Satisfaction

• C ontributes 300 points D

etermining customer requirements and expectations

C

ustomer relationship management

C

ustomer service standards

C

ommitment to customers

C

omplaint resolution for quality improvement

D

etermining customer satisfaction

C

ustomer satisfaction results

C

ustomer satisfaction comparison

C

ustomer information from a wide range of sources –

focus

groups, surveys, one-to-one meetings, sales visits etc.

M

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The Deming Prize

H

onoring W. Edwards Deming

Japan’s highly coveted award

M

ain focus on statistical quality

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Employee-Driven Quality

T

raining (and education)

Involves •

B

as

ic job skills

T

ools for continuous

improvement, SPC, etc. • C ross-training ( O M Principle 7) – M ust be considered as investment , not expense! – O

ld (and still prevalent) approach Exploit division of labor (hire unskilled) Inhibits pride in workmanship

C

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Employee-Driven Quality

O

rganization

Involves • C

lose supplier/customer (next process) contact

• M ulti-functional teams, e tc. – U

niting workers for constancy of purpose •T

yp ic a l f or m at s – Q uality circles – C

ells and teams (pioneered in manufacturing)

P

roject teams: when work flows are separated

Gangs versu s teams – T

eam training: team dynamics; problem-solving;

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Deming’s 14 Points (I)

F

ocus On Management

Q

uality problems lie with the

system

T

he system is under the control of management

T

he 14 Points

--Not a

Menu!

– C onstancy of purpose – N ew philosophy – M ass inspection – P rice tag – C ontinuous improvement – T raining

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Deming’s 14 Points (II)

T

he 14 Points (Continued)

Supervision (leadership) –Fea

r – B arriers – S logans – Q uotas – P ride in workmanship M anagement • F ront-line – E ducation – O

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Software Quality

• P rocess Quality E

nsuring conformance with user requirements

Identifying defects

M

onitoring the product through its phases of

development

P

roduct Quality Identifying user specified quality needs P

rioritizing quality needs

R

esolving quality conflicts, if any

B

uilding them into the development process

A

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A Step in Assuring Software Quality Analyze need

for quality Convert quality needs to require m en ts Do cu men t SW Quality require m en ts User opinions Criter ia f or good requirements Req spec Derived req’s Quality factors Needs data base Quality conflicts Co st o f qu al it y

Factor and criteria definitions

Level of quality matrix Quality needs data base

Engineering criteria

Traceability

m

atrix

Software qrs

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Approaches to Attain Quality

Traditional Approach to Quality

Control the quality of the product by inspection. Acceptable quality levels (AQL). Some defects will slip through.

World-Class Approach to Quality

The product is only the result of the process

which makes it.

If the process is correct, the product will be good. No need to inspect.

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Quality Control Modes a Company can be in

H

eavy use of inspection

• Manufacturing & QC are adversaries • Firefighting • Management by cris

is

• High costs • Lost sales • Loss of competitive position

Detection Mode

V

ery little inspection

• QC is a resource of Manufacturing

-teamwork

• Problem elimination • Smooth operations

-c

ontinual improvement

• Decreasing costs • Increased sales • More competitive

Prevention

Mode

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Operations are a Transformation Process

Inputs

People

Capital

Energy

Materials

Technology

Market and

Environmental

Forces

Transformation

Processes

Goods

Services

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The

Process

Focus

O

peration = Transformation Process

Process inputs •

M anagement • M ethods • M aterials • M achines • M aintenance • P ersonnel • Information •E n er g y – T

ransformation (macro/micro views)

O

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The Process Focus: Contributing Variables

Man agement Main tenance Mea surement Machines Methods Man power Materials Materials Length

Process performance: Quality characteristics

PROCESS: 3-inch machine bolt

THE NEXT

PROCESS

Distribution of bolt lengths

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Managing the Process

P

roblems

R

esult from series of activities (process)

N

ot from single aspect (e.g., physician)

T

herefore, for each product, entire process

needs study for improvement

P

rocess

R

ecall Input/Process/Output model:

Input components change over time

Æ

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Process Improvement and Control

in a nutshell

A

pply Scientific Method

Incorporate Tools

G

eneral tools

C

oarse grained tools

F

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Scientific Method for Process Improvement

1. Identify and define the problem. 2. Study the existing situation;collect necessary data. 3. Generate possible solution alternatives. 4. Evaluate alternatives and choose the preferred one. 5. Implement the improvement and measure results. 6. Evaluate and revise if required. 7. Otherwise, return to step 1 and start again with a

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Tools for Process Improvement

3. Process flowchart. 4. Check sheets and histograms. 5. Pareto analysis. 6. Fishbone charts.

Coarse-grained Tools

General Tools

Fine-grained Tools

7. Fail-safing

(Pokayoke).

8. Design of Experiments (DOE) 9. Scattergrams.

1. Team-building and group-interaction tools. 2. Specific process/technology tools.

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The Six Sigma Methodology

A 4-Step Methodology for Process Improvement Process Characterization 1)

Measure

Identify Project Scope / Goal

Define Key Process Elements

Establish Process Capability

• Validate Measur ement System 2) Evaluate

Benchmark Process Entitlement

Data Analysis

Determine Critical Factors

Process Optimization 3) Improvement • Develop Improv ement Plan • Understand/Optimize Vital Process Elements •

Reduce Variation / Defects

Verify Impact

4)

Control

Implement Long Term Control Plan

Leverage to Similar Products/Processes

Document & Standardize

Measure

Measure

Eva lu

ate lu Eva

ate ImprovementImprovement

Control

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TQM

•T

op management’s direct involvement

S

trong customer orientation

C

ompanywide

participation to meet or exceed

customer expectations; empowerment

S

ystematic problem solving

A

philosophy of Continuous Improvement:

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Obstacles

to Implementing TQM

Lack of

C

ompanywide

definition of quality

S

trategic plan for change

C

ustomer focus

R

eal employee empowerment

S

trong strong motivation

T

ime to devote to quality initiatives

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Obstacles to Implementing TQM

P

oor intraorganizational

communication

V

iew of quality as a “quick fix”

E

mphasis on short-term financial results

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Summary

TQM requires

‰

Top management’s direct involvement

‰

Strong customer orientation

‰

Everyone participates: empowerment

‰

Systematic problem solving

‰

Continuous improvement

¾

TQM is a great foundation, but TQM does not directly relate to business results

¾

Six Sigma is the latest quality management innovation: It is a

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Useful links

http://www.mindtools.com/swot.html

SWOT analysis for strategy development

http://www.iqs.com/Presentations/SALE6108_files/frame.htm

Overview of QS 9000

http://home.att.net/~iso9k1/tqm/tqm.html

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