IMDR MoQ

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    What is Quality ?

    Usual Responses

    Inspection

    Responsibility of the Quality Control Department

    Measurement Activity Statistics

    Technical Activity

    Support Function

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    Four Phases of MoQ Portion

    Phase 1 History of QualityPhase 2 Foundations for the Management of

    Quality

    Phase 3 Tools for Implementation of Quality

    Phase 4 New Trends in Management ofQuality

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    Phase 1 History of QualityDefinitions of Quality Evolution of Managing for Quality as a Science :

    QC,CWQC,TQC,TQM Definition of TQM

    Phase 2 Foundations for the Management of QualityWorks of the Quality Pioneers :

    Dr. W. Edwards Deming Demings System of Profound Knowledge Demings14 points andDr. Joseph M. Juran The Juran Trilogy , Cost of Quality

    Phase 3 Tools for Implementation of QualityApplication of the 7 QC Tools and Management Tools ( including FMEA , Poka

    Yoke )

    Phase 4 New Trends in Management of QualityISO 9000 Implementation Status of TQM in India

    Four Phases of MoQ Portion

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    The first ever article on Quality as we know it today :The Control of Quality in Manufacturing 1917 by

    George S. Radford

    The first ever book on Quality as we know it today :The Control of Quality in Manufacturing 1922 by

    George S. RadfordThe Second Book : The most seminal bookEconomic Control of Quality of ManufacturedProduct 1931 by Walter A. Shewhart

    The second book by Shewhart : Statistical Methodsfrom the Viewpoint of Quality Control 1938 editedby W. Edwards Deming

    Evolution of Quality

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    1900s Inspection

    1920s Process Control1950s Process Improvement

    1960s Organisational ( Systems ) Improvement

    1970s Business Improvement

    1980s Business Excellence1990s Customer Value Excellence

    2000 Environmental Excellence

    Many now associate Continual Improvement of

    Quality with Meaningful Sustainable

    Development

    Evolution of Quality

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    The total com pos i te product and serv ice ch aracter is t ics of market ing ,

    engineer ing , manu facture , and maintenance through wh ich the produ ctand the serv ic e in use w i l l meet the expectations of the cus tomer

    - Armand V. Feigenbaum

    A produc t or a serv ice possess es Qual i ty i f it helps s omeone l ive better

    mater ial ly and /or otherwise and enjoys a large and sus tainable market

    - W. Edwards Deming

    Qual i ty is def ined as f i tness for purpo se . To be f i t for purpo se , theprodu ct /serv ice must have features that sat is fy custom er needs and mu st be

    delivered free of defic ienc ies.

    - Joseph M. Juran

    Qual i ty is con formanc e to requirements

    - Phi ll ip B. Crosby

    Different Definitions of Quality

    ...degree to whic h a set of in herent character is t ics fulf i ls requ iremen ts

    - ISO 9000 : 2008

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    A people focuss ed management s ystem that

    aims at cont inu al inc rease in cus tomer sat is fact ion

    at c on t inual ly lower cost , wo rking ho r izon tally

    acros s func t ions and departments , invo lv ing allemp loyees and processes , top to bo t tom ,

    extending forwards and backwards to inc lude the

    Supp ly chain as well as the Customer chain.

    Quality Management

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    Quality ofDesign /Redesign

    Quality ofConformance

    Quality ofPerformance

    Customer

    Design Product /Service

    PurposeCreatingCustomer

    Value

    Fundamental Quality Management

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    Deming : The Early Years

    Influence of Walter Shewhart 1920s

    Shewhart enlists the 2 types of mistakes anddevelops the Control Theory to reduce effects ofthese mistakes

    Deming organises a landmark seminar in 1938 on

    Statistics at NYU where Shewhart delivers his 4 daylecture on his Control Theory

    Application of this theory to 1940 US census byDeming results in savings to the tune of $200 million

    Improvement in productivity during the war inAmerica using Shewharts Control Chart

    Sent to lead the 1947 census taking in Japan

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    Deming : The Later Years

    American Response to the use of the Control Chart (

    1942 44 ) and afterward Japanese experience 1950 onwards

    How the West finally took notice 1980 onwards

    Teachings between 1979 1987

    Teachings between 1989 1993

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    The marketplace is now global. Basis for trade between countries will bedefined by Quality

    The customer is all-important. Seek to cultivate long-term relations with your

    customers. Seek to continuously understand consumer needs whendesigning products.

    Quality is determined by managers. The Quality of products and services mus

    reflect consumer needs. Products must be uniform, be consistent, andperform dependably. The Quality of the product cannot be better than the

    intentions and specifications of management. Quality results from the way

    managers lead. Production is a system. The supplier is your partner. Make the supplier a

    partner and an integral part of the system. The customer is also part of the

    system, the most important part of the system.

    The chain reaction. If you improve your processes and product, your costs wi

    decrease and you will capture the market with better Quality and lower prices,thus allowing you to stay in business and provide jobs and more jobs.

    Japan must see itself as a system. There must be trust and cooperation

    throughout all of industry along with government , education and healthcare in

    Japan. A common commitment to cooperation must sweep through Japanlike a Prairie fire

    Deming in Japan 1947 to 1950

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    Production Viewed as a System

    Customers

    Suppliers ofMaterials andEquipment

    Receipt and Testof Materials

    Consumer FeedbackDesign andRe - design

    Distribution

    Production Assembly Inspection

    Tests of Processes , Machines , Methods , Costs

    I believe this Diagram made the difference in Japan.the greatestway I accomplished anything there was through this diagram

    W. Edwards Deming

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    Improve Quality

    Costs Decrease because of less rework, fewer mistakes , fewer delays , snags ;

    better use of machine time andmaterials

    Productivity Improves

    Expand the Market withbetter Quality , Lower

    Price , Diversification , Innovation

    Stay in Business Provide Jobs and more Jobs

    Deming Chain Reaction 1950 ( revised 1988 )

    Improve Qualityfurther

    And so on

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    THE DEMING PRIZE ESTABLISHED IN1950 BY THE JAPANESE UNION OF

    SCIENTISTS AND ENGINEERSPeace and happiness through prosperitywas in fact at the root of my thoughts

    when in 1950, in Japan, I wrote thefollowing inscription on the medal for theDeming Prize, given annually by theDeming Prize Committee to a companythat has successfully and effectivelyadvanced the Quality of their systems :The right Quality and Uniformity are the

    foundations of Commerce, Prosperity, andPeace.Quality brings commerce. It brings

    people together from different parts of theworld, makes friends, and brings respect.. . .Quality does not stand still, however.Invention and design of new products areessential parts of Quality. Design,manufacture, marketing, service, testing,all go on forever in a cycle.

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    Demings view of Quality

    Begins with meeting real needs of customers ( inuse )

    High degree of Uniformity , predictability

    Beyond mere conformance ( to requirements /specifications )

    Joy in Ownership through Joy in Work

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    Four prongs of Quality

    Innovation in products and services

    Innovation in process

    Improvement of existing products andservices

    Improvement of existing processes

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    Quality aimed at , to meet the needs of the consumer , must be

    stated in terms of specified Quality characteristics that can be

    measured . It is necessary to predict what Quality characteristics

    of a product will produce sat is fact ion in use.

    Quality , however , to the consumer , is no t a set of s peci f icat ion s.

    The Quality of any product is interaction between the product , the

    user , his expectations , and the service that he can get in case the

    product fails or requires maintenance .

    The needs of the consumer are in continual change . So are

    materials , methods of manufacture , and products .

    Quality of a product does not necessarily mean high Quality . It

    means con t inual improvement of the process, so that theconsumer may depend on the uniformity of the product and

    purchase it at low cost .

    ..W. Edwards Deming

    1980

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    People are the most important part of a System .They must work in a System to create value for the

    Customer . The Managers Job is to work on theSystem and continually improve it with help from

    the people and the Customer

    A Managers Job

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    System of Profound Knowledge

    Culmination of Dr. Demings philosophy

    A Theory of Management founded in four different but deeplyinterconnected sciences

    Systems Theory

    Human Psychology

    Statistical Thinking and Methods

    Learning how we learn and Improve

    A tool for the quest of wisdom

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    System of Profound Knowledge

    A different view of events and happenings around us Not as incidences rather as outcomes

    Not isolated rather deeply connected

    Helps us get the complete picture

    A lens with which we view the landscape

    To see things we normally wouldnt see

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    Appreciation for a

    System

    Understanding

    Variation

    Understanding a

    Theory ofKnowledge

    UnderstandingPsychology

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    What Is A System?

    A System is a Network of Interdependent

    components that work together to achieve the Aim of

    the System .

    Every System must have an Aim , Without an Aim

    there is no System

    The Three most important words are

    Network Interdependent

    Aim

    System Thinking

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    System Thinking

    Cause and Effect are not closely related in time orspace

    Outputs are a result of a myriad of inputs

    Inputs affect each other also

    The extent to which inputs affect each other need to bedetermined

    Effect of environment on the inputs need to be studied

    Effect of the inputs on the environment need to be

    studied

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    System Thinking

    Important points about a system :

    Should have an aim . Without an aim there isno system ( as before )

    Aim is for all the components to gain overthe long term

    Aim is to make life better for everyone

    impacted by the System

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    System Thinking

    Pattern Relationships that determine the SystemsCharacteristics

    Structure The Physical Layout of the System

    Processes Activities that take place in the Structure

    Meaning The Purpose of existence of the system

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    Appreciation for a

    System

    Understanding

    Variation

    Understanding a

    Theory ofKnowledge

    UnderstandingPsychology

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    Questioning

    Confirming

    Experimenting

    Hypothesis

    Explorat ionVerif ication

    Improvement

    System of Learning

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    Appreciation for a

    System

    Understanding

    Variation

    Understanding a

    Theory ofKnowledge

    UnderstandingPsychology

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    Appreciation for a SystemUnderstanding that cause and effect are notclosely related in time and space

    Understanding that outputs are the results

    of a myriad of inputs .Understanding the importance of a common

    aim or purpose for the system.

    Understanding a Theory of

    KnowledgeUnderstanding the importance of theory tointerpret observations ( experience ) .

    Understanding the importance of theory and

    practice .

    Understanding how to learn faster .

    Understanding VariationAwareness of the distinction between

    Common and Special Causes of Variationand how to interpret Control Charts

    Learning how to think statisticallyUnderstanding that reducing variation is

    synonymous to increasing Quality .

    PsychologyUnderstanding that people are inherently good -

    they want to do a good job .Understanding that people learn differently , and

    hence think differently . Working on peopleslearning processes rather than exhorting themwould be better .

    Understanding that ranking destroys people .

    Peter Scholtes portrayal of Dr.

    Demings System of Profound

    Knowledge

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    Viewing an event with Theory 1

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    Viewing an event with Theories 1 & 2

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    Viewing an event with Theories 1 , 2 & 3

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    The true picture What was your guess ?

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    D i 14 i t f t

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    Important points to keep in mind:

    Not his philosophy but 14 consequences of his philosophyNot a list of instructions, techniques, check list or

    prescription.

    Vehicles for opening up the mind to new thinking radically

    different ways of managing.Lay the foundation for the transformation a change of

    magnitude never imagined

    "The 14 points all have one aim : to make it possiblefor people to work with joy."

    Demings 14 points for management.

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    Demings 14 points for management.

    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 1

    Create a statement of the aim and purposeof the organisational system.

    It must bring out the long term vision of theorganisation preferably stating how itintends to stay in business through creatingvalue for all those impacted in any way .

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    Appreciation for a System

    Understanding Variation

    Understanding Psychology

    Understanding a Theory of

    Knowledge

    Point 2

    Adopt the new philosophy of win winwhere everybody wins .

    Teach and practise this philosophy with all

    customers , suppliers and competitors .Focus on expanding the market rather thancapturing it .

    Demings 14 points for management.

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    Appreciation for a SystemUnderstanding Variation

    UnderstandingPsychology

    Understanding a Theory ofKnowledge

    Point 3

    Use the system of inspection to understand thegaps in how you perceive a Customerrequirement and how the Customer actuallyperceives it .

    Try to reduce these gaps by first trying tounderstand customer requirements thoroughly then deploy this learning throughout theorganisation .

    Design Quality in .

    Demings 14 points for management.

    f

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    Appreciation for a SystemUnderstanding Variation

    UnderstandingPsychology

    Understanding a Theory ofKnowledge

    Demings 14 points for management.

    Point 4

    Work towards having an arms-around relationshipwith your suppliers .

    Invest in them through education and training sothey can contribute effectively towards the

    organisation .When purchasing , do not focus on price alonewithout a measure of Quality .

    Reduce Variation by practising co-operation with

    your suppliers .

    D i 14 i t f t

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 5

    Look for better ways of understanding andanalysing the processes/systems you work in .

    Keep improving and innovating continually .Systemise this philosophy .

    Find out problems before they find you out .

    Demings 14 points for management.

    D i 14 i t f t

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 6

    Training must not only focus on how the job isdone but also the purpose of the job beingcarried out .

    Everyone must know how they are contributingto the entire system . Training must also aim atcreating learners .

    This forms the basis for continual improvement

    and motivates intrinsically .

    Demings 14 points for management.

    D i 14 i t f t

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 7

    Create Leaders . Managers are no longer justplanners/instruction-givers . They must be leaders.

    People are the most important part of a System .

    They must work in a System to create value for theCustomer . The Managers Job is to work on the

    System and continually improve it with help fromthe people and the Customer by leading people ,

    coaching them and counselling them in a non-judgmental manner .

    Demings 14 points for management.

    D i 14 i t f t

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 8

    Create a climate of openness , trust and two-waycommunication .

    People must not be afraid to voice their problems/ constraints they are facing thatprevent them from doing a better job .

    Demings 14 points for management.

    Demings 14 points for management

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 9

    Encourage systems thinking in the organisationwhere everybody focuses on creating value for thecustomer and not just meetingdepartmental/sectional objectives .

    Optimise the efforts of everyone do notmaximise individual efforts .

    Demings 14 points for management.

    Demings 14 points for management

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 10

    Do not create a superficial leadership culture byusing impressive-sounding but shallow slogans,posters and exhortations and arbitrary numericaltargets.

    A genuine leadership culture focuses on improvingthe work environment so that people areintrinsically motivated to do productive work and,if useful, create their own slogans and posters .

    Demings 14 points for management.

    Demings 14 points for management

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 11

    Do not attempt to manage the organisational systems andprocesses solely by irrelevant and arbitrary measuressuch as quotas and targets . These are merely singledimensional aspects of very multi-dimensional entities

    Instead, encourage systems thinking i.e. understandingand establishing interdependencies between the differentparts of the system and thus looking beyond theblinkered view presented by quotas, numerical targets andobjectives.

    Deming s 14 points for management.

    Demings 14 points for management

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 12

    Develop a sense of ownership in everyemployee working in the system so thats/he could take pride and joy in the work

    they do .

    They must feel one with their work thus

    creating results themselves .

    Deming s 14 points for management.

    Demings 14 points for management

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 13

    Encourage learning . Develop learners .People are the only living parts of anorganisation . For an organisation to grow fastand move in the right direction , it is essential

    that people are growing and learning .Pay is not as much a motivator as learning is .Continual learning leads to Continualinnovation and improvement .

    Deming s 14 points for management.

    Demings 14 points for management

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    Appreciation for a SystemUnderstanding Variation

    Understanding PsychologyUnderstanding a Theory of

    Knowledge

    Point 14

    Create a structure and a system in theorganisation that embodies all of the aboveprinciples .

    Nurture relationships . Extend the

    boundaries of the organisation to includeall those impacted .

    This will result in long term profits beyond

    measures and long term survival .

    Deming s 14 points for management.

    Create a constancy of purpose towardimprov ement of product and service,

    with the aim to be come competitive and

    to stay in busine ss and to provide jobs

    Eliminate slogans, exhortations, andtarge ts for the work force demanding

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    Appreciation for a System

    Knowledge of Psychology

    Knowledge of Variation

    A Theory of Knowledge

    to stay in busine ss, and to provide jobs.

    Break down barriers between departments.People in research, design, sales, and

    production must work as a team, to foresee

    problems of production and in use thatmay be e ncountered with the product or

    service.

    Remove barriers that rob people ofpride of workmanship.

    Adopt the new philosophy of win win. Weare in a ne w economic age. Western

    management must awaken to thechallenge, must learn their responsibilities,and take on leadership for change.

    Cease dependence on massinspe ction to achieve quality.

    Eliminate the need for

    inspection on a mass basis bybuilding quality into the

    product in the first place.

    a)Eliminate work standards (quotas) on thefactory floor. Substitute leadership.

    b)Eliminate management by objective.Eliminate management by numbers,numer ical goals. Substitute leadership.

    Institute training on the job.

    targe ts for the work force demanding

    zero defects and new levels of

    productivity.

    Drive out fear so that everyonecan work e ffectively for the

    company.

    Adopt and institute leadership. Theaim of leade rship should be to help

    people and machines do a better job.

    Institute a v igorousprogramme of

    education and self-

    improvement.Improv e constantly andforever the system of

    production and service, to

    improv e quality andproductivity, and thus

    constantly decrease costs.

    End the practice of awardingbusiness on the basis of price tag

    alone . Instead, minimise total cost.

    Move toward a single supplier for

    any one item, in a long-termrelationship of loyalty and trust.

    Take action to accomplish the transformation.

    The Product . Your own

    t t f th P d t

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    tests of the Product

    in the laboratory and in

    simulations of use .Testof the Product in

    service .

    Training of Customer .Instructions for use . Training of

    Repairmen . Service . Replacementof Defective Parts . Availability ofParts . Advertising and Warranty :

    What did you lead the Customer

    to expect ? What did your

    Competitor lead him to expect ?

    The Customer and the way he

    uses the Product . The way heinstalls it and maintains it . For

    many products , what the

    Customer will think about your

    Product a year , three years , five

    years from now is important .

    The Three Corners of Quality

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    1. Idea for placing importance on Quality

    2. Responsibility for Quality

    3. Research

    4. Standards for Designing and

    Improvement of Products

    5. Economy of Manufacturing

    6. Inspection of Products

    7. Expansion of Sales Channels

    8. Improvement

    1.Design the Product (with appropriate

    T t )

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    Customer

    Tests)

    2.Make it, test it in the

    Production Line and

    in the Laboratory

    3. Put it on the

    Market

    THE DEMING WHEEL

    manufacturer the user andthe non user

    Plan a change or a testaimed at improvement

    Act - Adopt the change ,or abandon it ,

    th h th l

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    Do - Carry out the changeor test ( preferably on asmall scale )

    Study the results .What went wrong?What did we learn?

    or run through the cycleagain

    Impact Traditional view of quality Enlightened view of Quality

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    Products Manufactured GoodsAll products and services

    whether for sale or not

    ProcessesManufacturing or visibleprocesses

    All processes

    Viewed as A technological opportunity A Business opportunity

    Customer Clients who buy products All those impacted

    Evaluation

    Conformance to

    specifications, procedures,

    standards

    Responsiveness to

    Customer needs, extent to

    which Customer value is

    created

    Improvement Departmental Companywide

    Initiatives led by The Quality Manager Top Management

    Freedom from Features that lead to

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    Deficiencies

    Less Waste

    , Less

    Scrap

    LowerCosts

    Less

    Warranty

    Costs

    Less

    Cycle

    Time

    Increase in Profits

    Customer Satisfaction

    Increased

    Demand

    Increased Market

    Share

    IncreasedPrice

    Freedom from

    Deficiencies

    Features that enhance

    Customer satisfaction

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    Deficiencies

    Reduction in errors

    Reduction in wastes Reduction in failures

    at the Customers end

    ( field failures )

    Reduction in

    inspection and tests

    Reduction in

    Response times

    Increase in yield and

    capacity Increase in delivery

    performance

    Customer satisfaction

    Increased Customer

    Base Increased Market Share

    Premium Price

    The Juran Trilogy

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    QualityImprovement

    %

    of

    Defects

    5

    10

    15

    20Quality Planning

    Sporadic

    Spike

    Quality Control

    Lessons Learned

    Determining

    theCostofQuality,

    Wherearewerigh

    tnow?

    Whatdoweneed

    todevelop?

    Original Zoneof

    Quality Control

    New Zone ofQualityControl

    Time

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    Revenue : All the money that a company takes in , in any givenyear

    Costs : All the items which use or take a companys cash to run

    the business

    Assets : Company owned items which can be converted into

    cash

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    Return on Assets =

    Revenue minus Costs

    Assets

    Cost of Quality = Cost of Conformance +

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    Cost of Conformance = Cost of Prevention +

    Cost of Appraisal

    Cost of Non Conformance +

    Cost of Lost Opportunities

    Cost of Non Conformance = Cost of Internal Failure +

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    Cost of External Failure +

    Cost of Exceeding

    Requirements

    Cost of Lost Opportunities = Cost of Lost Opportunities

    Costs of Prevention

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    Costs of Prevention

    Cost of activities that prevent failurefrom happening

    Planning for Quality

    TPM

    Process Design Process Control

    Quality Audits

    Supplier Evaluation

    Training for Quality

    Cost of Appraisal

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    pp

    Cost incurred to determine conformance with

    Customer requirements after the work has been

    completed

    Inspection and Tests ( Incoming , Inprocess and

    Final stages )

    Document Reviews

    Accounts Reconciliation

    Maintaining accuracy of Test Equipment

    Reconciliation of Stocks , Equipment , etc

    Cost of Internal Failure

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    Cost of correcting products or services which do not

    conform to internal customer requirements or are identified

    prior to delivery as not meeting the requirements of externalcustomers

    Failure to meet Customer Requirements and Needs

    Scrap

    Rework

    Missing Information

    Failure Analysis

    100 % Sorting

    Reinspection , retests Changing Processes

    Redesign of Hardware and Software Downgrading

    Cost of Internal Failure

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    Cost of Inefficient Processes

    Variability in Product Characteristics Unplanned Downtime of equipment

    Inventory Shrinkage

    Non value added activities

    Costs of External Failure

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    Costs to correct products or services after delivery to

    the Customer

    Warranty Charges Complaint Adjustments

    Returned Material Allowances

    Penalties ReworkCost of Exceeding Requirements

    Cost of providing Information or Services which are

    not necessary or for which no requirements havebeen established

    Cost of Lost Opportunities

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    Lost Profits due to the company not satisfying or

    being able to satisfy , the requirements of externalcustomers

    Evolution of the Cost of Quality over time

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    Implementation of the Quality Initiative through time

    LO

    C

    NC

    LO

    C

    NC

    LO

    C

    NC

    Quality Goals Identify Customers

    Quality Planning

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    APPLY

    MEASUREMENTSTHROUGHOUT

    Quality Goals Identify Customers

    Identify NeedsTranslate Needs

    Establish Measures Develop Product

    Develop ProcessOptimise Process

    Transfer to Operations

    1. Define the Project

    Quality Planning

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    1. Define the ProjectWhat do we need to bu i ld ?

    2. Identify the Customers .Who w i l l be impacted by ou r efforts ?

    3. Discover Customer Needs .What benef i t do the Customers want ?

    4. Develop the Product / Service .What Product features w il l create that

    benef i t ?

    5. Develop the Processes .How w i l l we produ ce the produ ct features?

    6. Develop Controls / Transfer to Operations .How do we ensu re i t wo rks as designed ?

    C t N d

    Spreadsheets in Quality Planning

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    Custome

    rs

    I

    Customer Needs

    Understanding

    Matrix

    Design

    Matrix

    Process

    Matrix

    Operations

    Matrix

    Cus

    tomerNeeds

    Product Features

    Product

    Features

    Process Features

    Process

    Features

    Process Controls

    ConceptInitiation / Approval

    Programme

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    PRODUCTQUALITY

    PLANNING

    TIMING CHART

    Planning

    Product Design and Development

    Process Design and Development

    Product and Process Validation

    Production

    Feedback Assessment and Corrective Action

    Planning

    Approval Prototype Pilot Launch

    PLAN ANDDEFINE

    PROGRAMME

    PRODUCT DESIGN ANDDEVELOPMENTVERIFICATION

    PROCESS DESIGN ANDDEVELOPMENTVERIFICATION

    PRODUCT

    ANDPROCESS

    VALIDATION

    FEEDBACK ASSESSMENTAND CORRECTIVE ACTION

    The Control Pyramid

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    Informational Controls

    Supervisory Control

    Operator Control

    Automatic Controls

    Error Proofing

    C t l

    What Control means to different people

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    Control

    SubjectsMechanism Decisions

    Operator

    Control

    ProductSpecifications

    Process

    Parameters

    Tools , Gauges ,Fixtures ,

    Templates ,

    Check Lists

    Extent of

    Conformance

    Supervisory

    Control

    ProductCompleteness

    Product

    Usability

    Tests , Checks ,Capabilities of

    Products /

    Processes

    Extent of

    Performance

    ManagerialControl

    Product

    CostingProduct

    Saleability

    Feedbacks , Field

    Intelligence ,Customer

    Surveys

    Extent of Sales, Profits

    Choose the control subject What do we want to regulate ?

    A Negative Approach :

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    A Control Subject emerges out of a Bitter Experience orCatastrophic Failure

    A Positive Approach : ( A Deliberate Effort to unearth

    Control Subjects moving up the Control Pyramid )

    Highly Repetitive Activities ( Fool Proofing and / orAutomation )

    Effect of failures are obvious and localised and losses

    occurring are minor ( Operator Control )

    Coordination , Discipline , Fluidity of Operations , High Risk

    Factors ( Supervisory Control )Matters of Company Performance , Hierarchal or Geographic

    factors , Extensive Analysis , Great Risks ( Informational

    Establish Measures How can these be expressed in termsof units , ratios , indexes etc. ?

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    Create a Sensor How can these measures be captured in a

    timely manner ?Establish Standards What are the instances which will

    warrant concern ( indicators ) ?

    indicate normalcy ?

    Measure continual performance ( frequency ) Decidewhere , who , when and how to measure actual performance

    Compare to Established Standards Decide on who does

    this and how this is to be done

    Take action on the difference Is the difference pronouncedso as to precipitate a systemic change , process change ,

    task change , etc ?

    Process Sensor Goal1

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    Actuator Umpire

    2 3

    4

    5

    1 Sensor plugged into the Process to evaluate actualperformance

    2 Sensor reports performance to the Umpire

    3 Umpire compares performance to Goal

    4 Umpire reports difference to the Actuator

    5 Actuator alters process to bring output in line with goals

    Set standards for

    Control and

    Improvement

    Communicate Standards

    Information on value delivered and unmet Customer needs

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    Input Transformation Output Customer Value( other stakeholders )

    P

    DS

    A

    ReworkContr

    ol

    Feed back information on

    performance , study

    relationships among measures

    of performance throughout thesystem , and take action to

    improve

    Control Nomina Measur Uni Senso

    Frequency

    ofLocation of Criteria

    Action

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    Control

    Subject

    Nomina

    l

    Measur

    e

    Uni

    t

    Senso

    r

    of

    measuremen

    t

    Measuremen

    t

    for

    action

    Action

    taken

    1. Form a Quality Council2. Analyse the Symptoms

    3 Theorise as to the causes

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    3. Theorise as to the causes

    4. Test the Theories

    5. Establish the causes6. Stimulate the establishment of

    a remedy7. Test the Remedy under

    Operating conditions8. Establish controls to hold thegains

    1 5 : The Diagnostic Journey

    6 8 : The Remedial Journey

    Breakthrough in Attitude

    Demonstrated Control

    at the new levelBreakthrough in

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    DiagnosticJourney

    RemedialJourney

    Holding the

    Gains

    Breakthrough in

    Organisation

    Mission Statement

    and Team Charter

    Identified Root Causes

    Breakthrough inCultural Patterns

    Results

    Juran on Quality Improvement

    Project Definition andOrganisation

    1. List and Prioritise Problems

    2. Define Project and Teams

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    Juran on Quality Improvement

    Diagnostic Journey

    3. Analyse Symptoms

    4. Formulate Theories of Causes

    5. Test Theories

    6. Identify Root Causes

    Remedial Journey

    7. Consider Alternative Solutions

    8. Design Solutions and Controls

    9. Address Resistance to Change

    10. Implement Solutions andControls

    Holding the Gains11. Check Performance

    12. Monitor Control Systems

    The Progression from Philosophy to Action

    QC T l d M T l

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    Philosophy W. Edwards Deming

    Structure and Approach Joseph M. Juran

    Frameworks Just in Time , ISO 9000 ,

    Baldrige Criteria

    Methods SPC , QFD , DOE , QIT

    QC Tools and Management Tools

    Demings contribution to the Field of

    Statistics

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    Distinguishing between Enumerative and Analytical

    StudiesEnumerative

    Number crunching exercises data collection ,

    assimilation and presentation

    Analytical

    Application of the Control Theory , Scientific

    Method and Subject Matter Knowledge tounderstand the situations which led to the data

    being generated in other words study of the

    Common & Special Cause Variation

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    Common Causes Variation

    Variation that exists in a system due toinherent properties of the system itself ( its

    design ) or the way its managed...

    Special Cause Variation

    Variation that exists in a system due to

    some external factors factors not a part ofthe system but alien to it...

    Conventional Data Interpretation

    C h

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    Common approaches are :

    comparison to specifications ormanaging by the last data point

    Common Traps in use of Figures alone :

    Too little attention to matters forwhich figures are not available. Forcing wrong figures (due to fear). Misuse and abuse of figures

    Data presentationShewharts Rule One when presenting Data :

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    Data should always be presented in such a way that preserves

    the evidence in the data for all the predict ions that m ight bemade from these data .

    In short the following questions need to be asked :

    Who collected the data ?

    How were the data collected ?

    When were the data collected ?

    Where were the data collected ?

    What do these values represent ? And if the data are computed values , how were the

    values computed from the raw inputs ?

    Has there been a change in formula over time ?

    Shewharts Rule Two when presenting data

    Data presentation

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    Whenever an average , range or h istog ram is used tosummarise data , the summary should not m islead the

    user into taking any action that the user would not t ake

    if the data were presented in a time series.

    In short :

    No comparisons must be made between pairs of

    values except as a part of a broader comparison . Use time Series graphs to present values in their

    context .

    Shewharts control chart approach

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    Control chart : a time series graph witha central line (average), UCL & LCL

    Shewhart gave a simple practical wayof calculating limits

    Focus on process instead of each value hence yields insight andunderstanding.

    Shewharts control chart approach

    The Control Chart is an Operational

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    pDefinition of a process in a state ofStatistical Control

    Not based on laws of probability

    Not a test of Statistical significance

    Empirical laws laid down by Shewhart on May16th 1924 that have stood the test of time

    Control Charts:Some Relevant Points

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    Different types of charts for differentsituations but XmR & XbarR are most used.

    Unstable processes : unpredictablechanges; no significant changes in stable

    processes.

    Control ChartThe methodology

    A) Th X R h t

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    A) The XmR chart.

    Useful for one at a time data

    Can be used with 15 20 observations

    Can also be used with 7 observations but tointerpret with care !!

    Control ChartThe methodology

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    A) The XmR chart (continued). For X chart (individual values).

    Upper Natural Process Limit=Xbar+2.66*Rbar.

    Lower Natural Process Limit=Xbar-2.66*Rbar.

    16.0 15.8 15.7 15.9 16.2

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    16.2 16.4 16.5 16.2 16.0

    15.7 16.1 15.5 15.1 16.0

    16.1 15.7 16.0 16.0 15.5

    16.4 15.9 16.3 16.2 16.6

    15.9 16.1 15.6 15.8 15.8

    16.84

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    15.11

    15.97

    Th Xb R h t

    Control ChartThe methodology

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    The XbarR chart

    For Xbar chartMake Subgroups

    Calculate Average and Range for each sub group

    Calculate grand average of average ( X double bar

    ) and range ( R bar )

    Upper Natural Process Limit=Xdbar+A2*Rbar.

    Lower Natural Process Limit=Xdbar-A2*Rbar.

    7 10 11

    4 2 5

    6 3 8

    9 8 12

    7 8 6

    A2 for n = 3 is 1.02

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    7 8 6

    5 5 86 3 6

    8 4 6

    5 5 6

    10 9 12

    6 12 10

    7 9 10

    4 6 7

    6 5 5

    5 7 7

    4 4 3

    7 4 8

    15 18 19

    7 5 3

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    10.14

    4.02

    7.08

    Control Chart used where the Sample size is the Same

    nP Chart

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    UCL = nP + 3

    LCL = nP - 3

    nP = Average Number of Rejections

    P = Overall Proportion of Rejects

    ExampleA lot of 50 pieces were being produced per worker per day ina factory . The following rejects were observed every day for

    each worker . Draw a Control Chart and state your

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    each worker . Draw a Control Chart and state your

    conclusions .

    WorkersDay

    1 2 3 4

    Worker 1 9 11 7 8

    Worker 2 6 11 11 9

    Worker 3 12 7 5 5

    Worker 4 11 10 13 9

    Worker 5 14 8 9 11

    Worker 6 4 11 12 12

    nP = Average Rejections = Total number of Rejections/ Total number of attempts

    = 225 / 24 = 9.38

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    P = Overall Proportion of Rejects = Total number ofRejections / total number produced

    = 225 / 24*50 = 225 / 1200 = 0.188

    Now

    UCL = nP + 3 LCL = nP - 3

    = 9.38 + 3

    = 9.38 + 3(2.76)

    = 9.38 + 8.27

    = 17.66

    = 9.38 - 3

    = 9.38 - 3(2.76)

    = 9.38 - 8.27

    = 1.11

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    Control Chart used where the Bulk Sample isthe Same

    c Chart

    c = Average Number of Blemishes

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    UCL = c + 3 LCL = c - 3

    An officer from the NHAI provided the following data for the

    number of potholes found for every 10 kilometres over a stretch

    of 150 kilometres on the Mumbai Nasik Highway . Draw a c Chartand state your conclusions

    Sample 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

    Potholes 2 4 1 1 4 5 2 1 2 3 4 3 5 2 1

    c = Average Number of Blemishes = Total number of blemishes / Totalnumber of Samples

    = 40 / 15 = 2.667

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    UCL = c + 3 LCL = c - 3

    = 2.667 + 3

    = 2.667 + 4.889

    = 7.567

    = 2.667 - 3

    = 2.667 4.889

    = -2.222

    LCL = 0

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    Total Rejection Percentage

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    Percentage of Shifting

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    Total Rejection Percentage

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    Percentage of Shifting

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    Total Rejection Percentage

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    Percentage of Shifting

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    Welder No. 6 in need of attention .

    Upon examination it was found that his eyes

    needed treatment

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    XmR chart for failures of Lube Oil System on LoadBox/Road Trial for rebuilt locomotives of DCW/PTA

    (Limits are calculated based on values from Jan 2004-Dec

    2005)

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    Use of Beta Blocker 2

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    Use of Beta Blocker 1

    The following data were collected by an Production Manager in aFertiliser Company . The data represent pH values of a certain

    chemical used to make the fertiliser . Compute the Control Limits of

    the process if the XmR method is used .If the Specification Limits are set at 9 4.5 , what will be the values of

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    8.7 9.6 12.6 9.5

    11.3 9.9 8.9 10.6

    8.5 8.4 9.0 9.3

    7.8 10.2 8.3 8.6

    10.4 9.2 10.3 10.18.8 9.1 9.4 9.6

    Cp , Cpl and Cpu ?Suppose the Manager wants to implement the Six Sigma approach inthis process , what will the limits become ?

    The Flow of the data collected is from left to right .

    What are the instances in a Control Chartthat warrant attention?

    One point outside the control limits

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    Seven points in a row all above / below

    average

    Seven points in a row all increasing /

    decreasing.

    THE CONTROL CHART IS NO SUBSTITUTE

    FOR THE BRAIN

    Benefits of Control Charts

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    For all levels worker to CEO Prediction of performance

    Assessing effect of improvements

    Common language Local or management action

    Immense benefits by use at top levels

    Quality Tools

    Flow Diagram

    Management Tools

    Inter relationship Diagram

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    g

    Pareto Charts

    Cause & Effect

    Diagrams

    Run Charts

    Control Charts

    Scatter Diagram

    p g

    Matrix Charts

    Failure Modes and Effects

    Analysis

    Flow Diagram

    ( Cost of Quality )

    ( 5 Why )

    Cost of Quality Example

    The following costs were recorded in an organisation .

    Arrange them under different heads of the Cost of Quality

    as appropriate .

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    Defective Stock Returned from Customer Rs 1,50,000

    Repairs to Product Rs 4,50,000

    Collect Scrap Rs 10,000

    Waste Scrap Rs 2,00,000

    Consumer Adjustments Rs 6,00,000Downgrading Products Rs 1,00,000

    Incoming Inspection Rs 1,00,000

    Laboratory Testing Rs 1,75,000

    Spot Check Inspection Rs 3,50,000

    Local Plant Training Rs 5,00,000

    Corporate Training Rs 2,00,000

    SolutionCost of Non conformance

    External Failure

    Defective Stock Returned from Customer Rs 1,50,000

    Repairs to Product Rs 4,50,000

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    Consumer Adjustments Rs 6,00,000Internal Failure

    Downgrading Products Rs 1,00,000

    Collect Scrap Rs 10,000

    Waste Scrap Rs 2,00,000

    Cost of ConformanceAppraisal

    Incoming Inspection Rs 1,00,000

    Laboratory Testing Rs 1,75,000

    Spot Check Inspection Rs 3,50,000

    PreventionLocal Plant Training Rs 5,00,000

    Corporate Training Rs 2,00,000

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    Quality Tools

    Flow Diagram

    Management Tools

    Inter relationship Diagram

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    Pareto Charts

    Cause & Effect

    Diagrams

    Run ChartsControl Charts

    Scatter Diagram

    Matrix Charts

    Failure Modes and Effects

    Analysis

    Flow Diagram ( Cost of Quality )

    ( 5 Why )

    Project Definition andOrganisation

    1. List and Prioritise Problems

    2. Define Project and Teams

    3. Analyse Symptoms

    4. Formulate Theories of Causes

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    Juran on Quality Improvement

    Diagnostic Journey5. Test Theories

    6. Identify Root Causes

    Remedial Journey

    7. Consider Alternative Solutions

    8. Design Solutions and Controls9. Address Resistance to Change

    10. Implement Solutions andControls

    Holding the Gains

    11. Check Performance

    12. Monitor Control Systems

    Scatter Plots of Data with Various CorrelationCoefficients

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    A Manager in Britannia wanted to find out the relationship between heat

    and compressed air pressure for the process of curing cookies . Hedecided to investigate this using a Scatter Plot . He gathered the following

    data . Draw a Scatter plot for him and state your conclusions .

    Heat ( Temp) Pressure Heat ( Temp) Pressure

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    22.6 8521.5 111

    23.3 79

    24.5 73

    24.4 79

    25.1 68

    20.4 113

    22.7 90

    24.3 85

    21.7 95

    22.2 110

    21.0 110

    22.1 10720.5 119

    22.3 103

    22.5 91

    23.2 90

    22.6 86

    22.6 98

    22.6 104

    24.6 81

    22.9 94

    22.8 96

    22.4 91

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    Quality Tools

    Flow Diagram

    Management Tools

    Inter relationship Diagram

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    Pareto Charts

    Cause & Effect

    Diagrams

    Run ChartsControl Charts

    Scatter Diagram

    Matrix Charts

    Failure Modes and Effects

    Analysis

    Flow Diagram ( Cost of Quality )

    ( 5 Why )

    Project Definition andOrganisation

    1. List and Prioritise Problems

    2. Define Project and Teams

    3. Analyse Symptoms

    4. Formulate Theories of Causes

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    Juran on Quality Improvement

    Diagnostic Journey 5. Test Theories

    6. Identify Root Causes

    Remedial Journey

    7. Consider Alternative Solutions

    8. Design Solutions and Controls

    9. Address Resistance to Change

    10. Implement Solutions andControls

    Holding the Gains

    11. Check Performance

    12. Monitor Control Systems

    Cause Twig

    C T i l t

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    EFFECT

    Cause Branch

    Cause Twig-let

    Doesnt close

    l

    Wrong size of tap

    with respect to pipeBad Quality Pipe

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    Tap Leaking

    properly

    Washer of

    wrong size

    Tap closed

    too tight

    People not

    aware of problem

    Wrong dimensions

    of diameter given

    Tap does not

    rotate properly

    Threads of

    tap damaged

    Bad Quality tap

    Potatoes washed , peeled ,

    steamed ,

    and mashed to form paste

    Chillies , onion , garlic cut to

    small pieces and added

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    Potato Wada

    Ready

    Gram ground , and

    batter prepared

    Salt , spices added

    for taste

    Oil boiled and kept

    ready for frying

    All ingredients mixed

    together and paste put

    in oil for frying

    The following components of Product Quality werelisted under the different heads by a Quality Circle in an

    organisation implementing TQM . Draw a Cause and

    Effect Diagram to indicate the same .

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    Production : Testability , Repairability , Producibility

    Environment : Toxicity , Flammability , Disposability

    Time : Availability , Durability , Dependability ,

    Reliability , MaintainabilityPhysical : Appearance , Size , WeightSensory : Odour , Taste , Touch

    Use : Transportability , Accessibility , Functionality ,

    Portability , Adaptability , Operability

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    Quality Tools

    Flow Diagram

    P t Ch t

    Management Tools

    Inter relationship Diagram

    M t i Ch t

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    Pareto Charts

    Cause & Effect

    Diagrams

    Run ChartsControl Charts

    Scatter Diagram

    Matrix Charts

    Failure Modes and Effects

    Analysis

    Flow Diagram ( Cost of Quality )

    ( 5 Why )

    Project Definition andOrganisation

    1. List and Prioritise Problems

    2. Define Project and Teams

    Diagnostic Journey

    3. Analyse Symptoms

    4. Formulate Theories of Causes

    5 T t Th i

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    Juran on Quality Improvement

    Diagnostic Journey 5. Test Theories

    6. Identify Root Causes

    Remedial Journey

    7. Consider Alternative Solutions

    8. Design Solutions and Controls

    9. Address Resistance to Change

    10. Implement Solutions andControls

    Holding the Gains

    11. Check Performance

    12. Monitor Control Systems

    Shifting 103660 103660 71%

    Open Underlayer 18367 122027 84%

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    Open Underlayer 18367 122027 84%

    Thread Break 10405 132432 91%

    Loose Stitches 8990 141422 97%

    Wrong Stitches 2822 144244 99%Needle Breakages 1583 145827 100%

    Total 145827

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    A manager of Pizza Hut collects data concerning customercomplaints about delivery and Quality of the Pizza being

    delivered

    Problem Frequency

    Topping stuck to box lid 17

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    Topping stuck to box lid 17Pizza is cold 35

    Wrong topping or combination 09

    Wrong style of crust 06

    Wrong size 04Pizza is partially eaten 03

    Pizza never showed up 06

    Use a Pareto chart to identify the vital few" delivery

    problems.

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    The following data as reasons for a damaged automobile were

    collected by the ARAI to be given to the Automobile Industry tofacilitate designing of the Automobile . Draw a Cause-and-Effect

    Diagram and a Pareto Diagram for the same and state yourconclusions .

    Driver Error : Reckless Driving Poor Judgment Poor ReflexesPoor Training

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    Driver Error : Reckless Driving , Poor Judgment , Poor Reflexes ,Poor Training

    Mechanical Failure : Stuck Accelerator , Ceased Engine , Brake

    FailureSlippery Road : Oil , Water

    Flat Tyre : Nails , Blow out

    Reckless Driving : 15 Water on Road : 4

    Poor Judgment : 11 Nails on Road : 7

    Poor Reflexes : 25 Blow Out : 2Poor Training : 14 Oil on Road : 2

    Stuck Accelerator : 5Ceased Engine : 6Brake Failure : 9

    Quality Tools

    Flow Diagram

    Pareto Charts

    Management Tools

    Inter relationship Diagram

    Matrix Charts

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    Pareto Charts

    Cause & Effect

    Diagrams

    Run ChartsControl Charts

    Scatter Diagram

    Matrix Charts

    Failure Modes and Effects

    Analysis

    Flow Diagram ( Cost of Quality )

    ( 5 Why )

    Project Definition andOrganisation

    1. List and Prioritise Problems

    2. Define Project and Teams

    Diagnostic Journey

    3. Analyse Symptoms

    4. Formulate Theories of Causes

    5 Test Theories

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    Juran on Quality Improvement

    Diagnostic Journey 5. Test Theories

    6. Identify Root Causes

    Remedial Journey

    7. Consider Alternative Solutions

    8. Design Solutions and Controls

    9. Address Resistance to Change

    10. Implement Solutions and

    Controls

    Holding the Gains

    11. Check Performance

    12. Monitor Control Systems

    Left house late

    Watch not

    properly set

    Carelessness

    Traffic Jam

    Clutch wire

    broken

    Too many

    gear changes

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    Late coming to

    College

    Tyre Punctured Too many potholes

    Stepney also

    punctured

    Bad Roads

    Quality Tools

    Flow Diagram

    Pareto Charts

    Management Tools

    Inter relationship Diagram

    Matrix Charts

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    Pareto Charts

    Cause & Effect

    Diagrams

    Run ChartsControl Charts

    Scatter Diagram

    Matrix Charts

    Failure Modes and Effects

    Analysis

    Flow Diagram ( Cost of Quality )

    ( 5 Why )

    Project Definition andOrganisation

    1. List and Prioritise Problems

    2. Define Project and Teams

    Diagnostic Journey

    3. Analyse Symptoms

    4. Formulate Theories of Causes

    5. Test Theories

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    Juran on Quality Improvement

    g y

    6. Identify Root Causes

    Remedial Journey

    7. Consider Alternative Solutions

    8. Design Solutions and Controls

    9. Address Resistance to Change

    10. Implement Solutions and

    Controls

    Holding the Gains

    11. Check Performance

    12. Monitor Control Systems

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    A

    A1 A2

    a1 a2 a3 a4 a5

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    B

    B1

    B2

    b1

    b2

    b3

    b4

    Interrelationships

    Counterpart Characteristics

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    Relationships between

    Attributes andCounterpart Characteristics

    Attributes

    Voiceo

    fthe

    Customer

    Prior

    ity

    Compe

    titive

    Evalua

    tion

    Priorities of Characteristics

    Design Attributes

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    Features ProcessSteps Operational

    ConditionsQuality

    Plan

    House of QualityDesign

    Matrix ProcessMatrix

    Operational

    Matrix

    Control

    Matrix

    Project Definition andOrganisation

    1. List and Prioritise Problems

    2. Define Project and Teams

    Diagnostic Journey

    3. Analyse Symptoms

    4. Formulate Theories of Causes

    5. Test Theories

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    Juran on Quality Improvement

    6. Identify Root Causes

    Remedial Journey

    7. Consider Alternative Solutions

    8. Design Solutions and Controls

    9. Address Resistance to Change

    10. Implement Solutions andControls

    Holding the Gains

    11. Check Performance

    12. Monitor Control Systems

    Quality Tools

    Flow Diagram

    Pareto Charts

    Management Tools

    Inter relationship Diagram

    Matrix Charts

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    Cause & Effect

    Diagrams

    Run ChartsControl Charts

    Scatter Diagram

    Failure Modes and Effects

    Analysis

    Flow Diagram ( Cost of Quality )

    ( 5 Why )

    Three Ways to Reduce Variation and ImproveQuality

    Control the Process :Eliminate Special

    Cause Variation

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    Improve the System :Reduce effect of

    Common Cause Variation

    Anticipate Variation :Design Robust

    Processes andProducts

    QualityImprovement

    Robustness An Underused Concept

    Reduce the effects of uncontrollable variation in

    Product design

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    Product design

    Process design

    Management practices

    Anticipate variation and reduce its effects

    Robust Products are Designed in

    Anticipation of Customer Use

    User-friendly computers and software

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    User friendly computers and software

    Low maintenance automobiles

    Speed Breakers

    Instruments for home use

    Product and Process Robustness

    Product Performance is insensitive to variations in

    conditions of manufacture, distribution, use anddisposal.

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    p

    Process Performance is insensitive touncontrollable variations in process

    Inputs Transformations activities steps

    External factors

    Process Robustness Analysis

    Identify Those Uncontrollable Factors that Affect

    Process Performance Weather

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    Weather

    Customer Use of Products

    Employee Knowledge, Skills, Experience, Work Habit

    Age of Equipment ( Can be controlled through TPM )

    Design the Process to be Insensitive to the

    Uncontrollable Variations in the Factors

    Robustness in Management

    Develop strategies that are insensitive to economic

    trends and cycles

    Design a project system that is insensitive toPersonnel changes

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    Personnel changes

    Changes in project scope

    Variation in business conditions

    Respond to differing employee needs

    Adopt flexible work hours

    Provide customised benefits

    Enable personnel to adapt to changing business

    needs

    Why FMEA ?

    Helps to recognise and evaluate the potential failureof a product / process and its effects

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    Helps to identify actions which could eliminate orreduce the chance of a potential failure occurring

    Helps to document the process better

    Definition of FMEA

    FMEA is an Analytical Technique utilised as a

    means to assure that , to the extent possible ,Potential Failure Modes and their associated causes

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    Potential Failure Modes and their associated causes/ mechanisms have been considered and addressed.

    Important Terms

    Analytical Technique

    Method of analysing and understanding

    P t ti l F il M d

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    Potential Failure ModeThe manner in which a Component , Subsystem orSystem could potentially fail to meet the design /

    process intent

    Causes / MechanismsIndication of Design / Process weakness , theconsequence of which is the Failure Mode

    Purpose of FMEAFMEA seeks to :

    Identify the possible failure modes and

    mechanisms Effects or Consequences that Failure Modes

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    Effects or Consequences that Failure Modes

    may have on performance

    Methods of detecting the identified Failure

    Modes Subsequent possible means for Prevention

    The net results of an FMEA study are action plans forelimination orpossible m it igationof the Failure

    Modes

    Two types of FMEA

    Design FMEA Primarily used when designing /f l ti

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    formulating

    Process FMEA Primarily used when creating a

    process

    Features of Design FMEA

    Aiding in the objective evaluation of Designrequirements and Design alternatives.

    Increasing the probability that Potential Failuremodes and their effects on System and End Use haveb id d i th D i / D l t

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    been considered in the Design / DevelopmentProcess.

    Developing a list of Potential Failure modes ranked

    according to their effect on the Customer thusestablishing a priority system for designimprovements and development testing.

    Providing future reference to aid an analysing fieldconcerns , design changes and developing advanced

    designs.

    Features of Process FMEA

    Identifies potential product related process failuremodes.

    Identifies the potential manufacturing or assembly

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    Identifies the potential manufacturing or assemblyprocess variables on which to focus controls foroccurrence,reduction or detection of the failureconditions.

    Documents the results of the manufacturing orassembly process.

    The First Step

    Draw a Block Diagram of the System , Subsystem orComponent being analysed

    A Block Diagram indicates

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    g

    the flow of inputs into the Block , the functionperformed in the Block and the outputs from the Block

    the Primary relationship between the items covered inthe analysis

    establishes a logical order to the analysis

    The Second Step

    Describe the function of each component/step in theprocess

    Determine the failure modes of each component oroperation . Failure Modes refer to the ways in which the/ f il f i i d d

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    component/process fails to perform its intendedfunction

    Identify the failure mechanisms for each failure . Failure

    Mechanisms refer to the root causes of failure or thesequence of events that lead to the failure

    Identify the current controls which address/detectthese causes . Controls must be established to pre-

    empt causes

    The Second Step * Controls are of two types :

    Design Controls these are features of the product

    itself that prevent or pre-empt the failure

    Process Controls these are various checks/indicatorsbuilt into the process steps that prevent the failure

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    Determine the severity of the failure ( refer guidelines here

    )

    Determine the occurrence of the failure ( refer guidelines

    here ) Determine extent to which the prevention/detection

    methods are effective ( refer guidelines here )

    Calculate the Risk Priority Number ( RPN ) accordingly

    Determine Corrective Action to be taken

    The Third Step

    Carry out the Corrective / Preventive Action

    Determine the new Risk Priority Number ( RPN )

    Document your findings in a systematic manner (

    refer suggested format )

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    refer suggested format )

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    Critical Safety

    hazard Causes or can cause injury or death.

    MajorRequires immediate attention. System is

    non-operational

    MinorRequires attention in the near future or assoon as possible. System performance is

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    p y p

    degraded but operation can continue

    InsignificantNo immediate effect on system

    performance

    1 None Effect will be undetected by customer or regarded as insignificant.

    2 Very minor A few customers may notice effect and may be annoyed.

    3 Minor Average customer will notice effect.

    4 Very low Effect recognized by most customers.

    5 Low

    Product is operable, however performance of comfort or convenience

    items is reduced.

    6 ModerateProducts operable, however comfort or convenience items are

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    6 Moderateinoperable.

    7 HighProduct is operable at reduced level of performance. High degree ofcustomer dissatisfaction.

    8 Very highLoss of primary function renders product inoperable. Intolerable effects

    apparent to customer. May violate non-safety related governmental

    regulations. Repairs lengthy and costly.

    9Hazardouswith warning

    Unsafe operation with warning before failure or non-conformance withgovernment regulations. Risk of injury or fatality.

    10Hazardous

    without

    warning

    Unsafe operation without warning before failure or non conformance withgovernment regulations. Risk of injury or fatality.

    1 Unlikely 1 in 1.5 million (= .0001%)2

    Low1 in 150, 000 (= .001%)

    3 1 in 15, 000 (= .01%)

    4

    Moderate

    1 in 2,000 (0.05%)

    5 1 in 400 (0 25%)

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    Moderate5 1 in 400 (0.25%)

    6 1 in 80 (1.25%)

    7High

    1 in 20 (5%)

    8 1 in 8 (12.5%)

    9

    Very high

    1 in 3 (33%)

    10 1 in 2 (50%)

    1 Excellent Control Mechanisms are Errorproofed2 Very High Controls Effective under all conditions

    3 High

    Controls Effective under most conditions4 Moderately High

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    5 Moderate Controls Effective under only certainconditions6 Low

    7 Very Low Controls Ineffective but causes might bedetected8 Poor

    9 Very Poor Controls Ineffective and causes might berarely detected10 Ineffective

    Mistake proofing

    Mistake proofing is a scientific technique for improvement ofoperating systems including materials, machines and methods

    with an aim of preventing problems due to human error.

    The term error means a sporadic deviation from standard

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    The term error means a sporadic deviation from standard

    procedures resulting from loss of memory, perception ormotion.

    Defect Vs errors

    It is important to understand that defects anderrors are not the same thing.

    A defect is the result of an error, or an error isthe cause of defects as explained below.

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    Error Defect

    Cause Result

    Prevention of defects

    Cause Intermediate result End result

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    Machine

    or

    human error

    Detect error

    Take

    corrective

    action

    zero

    defect

    Analyse for

    preventive

    action

    Modify work

    procedure to

    prevent such

    errors

    Work

    Procedure

    Error in memory of PLAN : Error of forgetting the contents operationsrequired or restricted in standard procedures.

    Error in memory of EXECUTION : Errors of forgetting the sequence of

    operations having been finished.

    Error in perception of TYPE : Error of selecting the wrong object in

    Types of Error

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    Error in perception of TYPE : Error of selecting the wrong object intype or quantity.

    Error in perception of MOVEMENT : Error ofmisunderstanding/misjudging the position, direction or othercharacteristics of the objects.

    Error in motion of HOLDING : Error in gripping the object

    Error in motion of CHANGING : Errors of failing to change the position

    , direction , or other characteristics of object .

    Human error provoking situations

    Complex design Too many parts

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    Too many steps

    Too many adjustments

    Repetitions

    Examples of mistakeproofing

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    Finger print ID lock is an excellent example of

    mistake proofing. There's no need to fumble for yourkeys in the dark any more. The Fingerprint ID DoorLock is a cylindrical lock combined with a securitybolt that will let you into the house using just your

    finger. It reads your unique fingerprint and onlyallows entry to prints it recognises.

    Examples of mistake proofing

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    Gas pumps are equipped with hose couplingsthat break away and quickly shutoff the flow of

    petrol.

    Examples of mistake proofing

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    Automobiles controls have a mistake proofing device toensure that the key in the on position before allowingthe driver to shift out of park ( for automatic gears ).Thekeys can not be removed until the car is in park.

    Examples of mistake proofing

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    3.5 inch diskette can not be inserted unless disketteis oriented correctly.This is as far as diskette can

    be inserted upside-down.

    The beveled corner of the diskette pushes a stop inthe disk drive out of the way allowing diskette to beinserted.This feature,along with the fact that the

    diskette is not square,prohibit incorrect orientation.

    Examples of mistake proofing

    Electronic car locks can have threemistake proofing devices:

    E h d i l f

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    Ensures that no door is leftunlocked.

    Door automatically locks when carexceeds a predetermined speed

    Lock wont operate when door is

    open and engine is running.

    Examples of mistake proofing

    New lawn mowers are required to

    have a safety bar on the handle thatmust be pulled back in order to startthe engine If you let go of the safety

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    the engine.If you let go of the safetybar,the mowers blade stops in 3

    seconds or less.This is an adaptationof thedead man switch fromrailroad locomotives.

    Examples of mistake proofing

    Retail stores use electronic

    article surveillance to ensurethat no one walks away

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    without making payment.

    Evolution of Quality Standards

    1942 1945 : MIL STDs

    1959 : MIL Q 9858

    1963 : MIL Q 9858 A

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    1968 : AQAP 1 / 4 / 9

    1970 : DEF / STD 05 8

    1979 : BS 5750

    1987 : ISO 9000 series

    ISO 9000 : 1987

    ISO 9001 : 1987ISO 9002 : 1987

    ISO 9003 : 1987

    Revised to ISO 9000 : 1994

    ISO 9001 : 1994ISO 9002 : 1994

    ISO 9003 : 1994

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    ISO 9003 : 1994

    QS 9000 : 1995 ISO 9001 : 1994 + additional requirements

    QS 9000 : 1998 ISO 9001 : 1994 + additional requirements (second revision )

    ISO / TS 16949 : 1999 = QS 9000 adopted by the ISO based on

    ISO 9001 : 1994

    ISO / TS 16949 : 2002 = QS 9000 reworded by the ISO based onISO 9001 : 2000

    Plan

    What do we do?How do we do

    it?

    Do

    Do what wasplanned

    Check(Study)Did thingshappen

    according to

    plan?

    Act

    How do weimprove next

    time? PLAN

    establ ish the ob ject ives and p rocesses

    necessary to deliver results in

    accordance w ith customer

    requirements and the organisation 's

    pol ic ies

    DO imp lement the processes

    CHECKmon itor and measure p rocesses and

    product against pol ic ies object ives

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    The Methodology known as Plan Do Check ( Study ) Act

    [ PDC(S)A ] can be applied to all processes . PDC(S)A is briefly described as above

    CHECK(STUDY)

    product against pol ic ies, object ives

    and requirements for th e product and

    report the results

    ACTtake act ions to cont in ual ly improve

    process performance

    Customer Focus

    Leadership Involvement Of People

    Process Approach

    Quality Management Principles

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    Process Approach

    System Approach To Management

    Continual Improvement

    Factual Approach To Decision Making Mutually Beneficial Supplier Relationships

    CUSTOMER

    FOCUSLEADERSHIP

    MUTUALLYBENEFICIAL

    SYSTEMAPPR

    OACH TO

    MANAGEMENT

    PROCESSAPPROACH

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    CONTINUALIMPROVEMENT

    LEADERSHIP

    INVOLVEMENTOF PEOPLE

    FACTUALAPPROACH TO

    DECISION

    MAKING

    SUPPLIER

    RELATIONSHIPS

    ManagementResponsibility

    ResourceManagement

    Me asurement , Analysis andImprovement

    Satisfac

    tion

    Continual Improvement of the QualityManagement System

    CustomerR

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    Management

    Product and /

    or Service

    realisation

    Improvement

    Productand / or

    Service

    Cust

    omerS

    Requirements

    InputOutput

    Quality Management System

    Model of a Process Based QualityManagement System

    Value Adding Activities

    Information Flow

    Quality Management Principles

    A quality management principle is a comprehensive

    and fundamental rule or belief, for leading andoperating an organisation, aimed at continuallyimproving performance over the long term by

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    improving performance over the long term byfocusing on customers while addressing the needs of

    all other stakeholders.

    Principle 1 Customer-Focused Organisation

    Organisations depend on their customers andtherefore should understand current and future

    customer needs, meet customer requirementsand strive to exceed customer expectations.

    A f t d fi d t i t

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    Assure conformance to defined customer requirements.

    Understand current and future customers needs and

    expectations.

    Measure customer satisfaction and act on it.

    Principle 2 Leadership

    Leaders establish unity of purpose and direction ofthe organisation. They should create and maintain

    the internal environment in which people canbecome fully involved in achieving theorganisation's objectives.

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    Set policy and verifiable objectives, deploy policy, provide

    resources and establish an environment for Quality.

    Establish vision, direction and shared values. Setchallenging targets and goals and implement strategies to

    achieve them. Coach, facilitate, and empower people.

    Principle 3 Invo lvement of People

    People at all levels are the essence of anorganisation and their full involvement enablestheir abilities to be used for the organisation's

    benefit.

    Establish competency levels, train & qualify personnel.Provide clear authority and responsibility

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    Provide clear authority and responsibility.

    Create personal ownership of an organisations targets

    and goals, by using its peoples knowledge andexperience, and through training achieve involvement in

    operational decisions and process improvement.

    Principle 4 Process Approach

    A desired result is achieved more efficiently whenrelated resources and activities are managed as a

    process.Establish, control and maintain documented processes.

    Explicitly identify internal/external customers and suppliers

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    Explicitly identify internal/external customers and suppliersof processes. Focus on the use of resources in process

    activities, leading to effective use of people, equipment,

    methods and materials.

    Principle 5 System Approach to Management

    Identifying, understanding and managing interrelatedprocesses as a system contributes to the

    organisation's effectiveness and efficiency inachieving its objectives .

    Establish and maintain a suitable and effective documented

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    Quality System.

    Identify a set of processes in a system. Understand theirinterdependencies. Align the processes with theorganisations goals and targets. Measure results against key

    objectives.

    Principle 6 Continual Improvement

    Continual improvement of the organisation's overallperformance should be a permanent objective of the

    organisation .

    Through management review, internal/external audits and

    corrective/preventive actions, continually improve theeffectiveness of the Quality System.

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    effectiveness of the Quality System.

    Set realistic and challenging improvement goals, provide

    resources and give people the tools, opportunities andencouragement to contribute to the continual improvement

    of the processes.

    Principle 7 Factual approach to decision making

    Effective decisions are based on the analysis of dataand information.

    Management decisions and actions on the Quality System

    are based on the analysis of the factual data and information

    gained from reports on audits, corrective action,nonconforming product, customer complaints and other

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    g p , p

    sources.

    Decisions and actions are based on the analyses of dataand information to maximise productivity and to minimise

    waste and rework. Effort is placed on minimising cost,

    improving performance and market share through the use ofsuitable management tools and technology.

    Principle 8 Mutually beneficial supp lierrelationships

    An organisation and its suppliers are interdependent,and a mutually beneficial relationship enhances the

    ability of both to create value

    Adequately define and document requirements to be met by sub-

    contractors. Review and evaluate their performance to control

    the supply of quality products and services.

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    pp y q y p

    Establish strategic alliances or partnerships, ensuring early

    involvement and participation defining requirements for joint

    development and improvement of products, processes and

    systems. Develop mutual trust, respect and commitment to

    customer satisfaction and continual improvement.

    ManagementResponsibility

    ResourceManagement

    Me asurement , Analysis andImprovement

    erSatisfaction

    Continual Improvement of the Quality

    Management System

    CustomerRe

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    Product and /

    or Service

    realisation

    Productand / or

    Service

    Custome

    equirements

    Input Output

    Quality Management System

    Model of a Process Based QualityManagement System

    Value Adding Activities

    Information Flow

    Organise around outcomes, not tasks. This principle suggests that a

    single person perform all the steps in a process and that person's jobbe designed around the outcome or objective rather than a single

    task.

    Have those who use the output of the process oversee the process.

    Include information-processing work into the real work that produces

    the information.

    Capture information once and at the source.

    Put the decision point where the work is performed, and build control

    into the process.

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    Link parallel activities instead of integrating their results. This

    principle means to forge links between parallel functions and to

    coordinate them while their activities are in process rather than afterthey are completed.

    Treat geographically dispersed resources as though they were

    centralised.

    "Reengineering Work: Don't Automate, Obliterate"

    by Michael Hammer Harvard Business Review, July-August 1990,pp104-112.

    Business Process Reengineering

    Can several jobs be combined into one?

    Can workers make decisions that were previously

    reserved for managers? Can the steps in the process be performed in a more

    natural order?

    C b d i d t b fl ibl d

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    Can processes be designed to be more flexible, and

    thus to handle more contingencies? Can work be performed where it makes the most

    sense?

    Business Process Reengineering is the fundamental rethinking

    and radical redesign of Business Processes to achievedramatic improvements in critical contemporary measures of

    performance such as cost , Quality , service and speed...

    Michael Hammer and James Champy

    1993

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    Fundamental = Basic

    Radical Redesign = Roots Up

    Processes = Set of tasks that add value

    Dramatic = Quantum Leap

    Improvement Innovation

    Level of Change Incremental Radical

    Starting Point Existing Process Clean Slate

    Frequency of Change One-time / Continuous One-time

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    Time Required Short Long

    Risk Moderate High

    Primary Enabler Statistical Control Information Technology

    What is Value ?

    Value is not just offering a Product or a Service

    Value is providing a solution to Customers problems

    Its the organisations processes that create value for

    its customers

    Business success comes from superior process

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    performance

    Superior process performance is achieved by

    Superior process design

    The right people

    The right environment

    Every Process has three types of tasks

    Value Added tasks

    Non Value added tasksWastes

    Wastes have to be eliminated

    Value added tasks are not eliminated only improved

    Non Value added tasks are the binding glue for the different value

    added tasks

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    Non Value added tasks often cause :Errors

    Delays

    Rigidity

    Reengineering involves reorganising value added tasks in such away that non value tasks are automatically weeded out

    Peter Drucker once said :

    It is the age of the Knowledge Workeri.e. Manager..

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    .we see now that this definition of theManager is limited and ineffective

    Solves problems him / herselfRefers to her / is Boss in

    f bl

    Learns whatever it takes to get thejob done

    Is trained to perform anactivity

    Has a CareerHas a Job

    PROFESSIONALWORKER

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    Reflects on her / is own workWork is Supervised

    In th