O P R E 6364 1
Quality Management
Systems
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
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
–Artis 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 0100%
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 meetor
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 – Fourteen 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 9000Helps 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
¹Technical 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
• QS 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 documentingbest
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 STARTEDPlanning, 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
9A 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 –Senior 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 –Product 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 –Determining 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 • Close 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
–Quality 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 rainingO
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Deming’s 14 Points (II)
•
T
he 14 Points (Continued)
–Supervision (leadership) –Fear – 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 –Ensuring 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 aO
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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
•Top 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.htmlSWOT 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
