QUALITY MANAGEMENT FUNDAMENTALS

1
QUALITY MANAGEMENT FUNDAMENTALS

• The Quality System
• Probability And Statistics Review

2
THE QUALITY SYSTEM

• What is Quality?
• Quality Management a Brief History
• ISO 9000 MBNQA
• Six Sigma

3
DEFINING QUALITY DESIGN VERSUS CONFORMANCE

• What is product (or service) "quality"?
• What factors influence customer satisfaction?
• Design quality -- is the product designed to
  satisfy customer needs? Is the product
  "manufacturable"?
• Conformance quality -- is the product
  manufactured to design specs?

4
DEFINING QUALITY QA, QC, QI, AND QM

• Quality Control
• Keep quality from getting worse
• Quality Assurance
• Procedures/documentation used to prove standards
  have been met
• Quality Improvement
• Make quality better
• Quality Management
• Managing all of the above

5
QUALITY MANAGEMENT

• Quality System Design set of policies and
  procedures needed to produce a quality product
• Process Improvement Control maintain and
  improve quality of products
• Manufacturing
• Purchasing
• Industrial Experimentation - process improvement
  and control taken to the next level

6
QM IS DATA-DRIVEN

• To manage quality, we must measure it
• Quality characteristics are what we measure
• Dimensions
• Other chemical, physical properties
• Defects per unit

7
THE COSTS OF QUALITY

• Is QM expensive? What's the alternative?
• Consider all the quality costs at a facility
•  
• Costs of not doing QM
• Costs of internal failure (scrap)
• Costs of external failure (warranties, returns)
• Costs of doing QM wrong
• Costs of inspection
• Costs of doing QM right
• Costs of prevention (QM system)

8
QUALITY MANAGEMENT A BRIEF HISTORY I

• Walter Shewhart (1891-1967)
• Developed control charts, PDCA cycle at Bell Labs
• Economic Control of Quality of a Manufactured
  Product, 1931
• W. Edwards Ed Deming (1900-1993)
• Yale class of 1928
• Worked for the U.S. Census bureau
• Went to Japan to administer a census (1950),
  gives lectures on quality control
• Invited back to Japan by J.U.S.E.
• Developed the 14 points

9
PLAN/DO/CHECK/ACT CYCLE

• Four basic steps of quality improvement
• Plan
•  How can quality be improved?
• Do
• Implement the plan on a trial basis
• Check
• Did the trial work?
• Act
• Adopt or reject the plan

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QUALITY MANAGEMENT A BRIEF HISTORY II

• Armand Vallin Feigenbaum (1922- )
• Top quality guru for G.E. By 1944
• Total Quality Control, 1951, published while
  attending graduate school (MIT)
• "Total Quality Management" (1980s)
•  Quality throughout the organization
•  Malcolm Baldridge Award (1987)
•  Focus customer satisfaction

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QUALITY MANAGEMENT A BRIEF HISTORY III

• ISO 9000/ANSI Q9000 standards (1987)
• Focus quality systems and procedures
• Six Sigma (1990s)
• Focus process improvement through advanced
  statistical techniques

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THE QUALITY SYSTEM

• The documented set of procedures used to run QA,
  QC, QI, etc. on a daily basis
• How do we select suppliers?
• Who reviews new product designs?
• What do we do when we produce defects?
• How often is our testing equipment calibrated?
• The Quality Manual is the apex of the quality
  system documentation pyramid

13
THE PYRAMID
14
ISO 9000 AND BALDRIDGE

• ISO 9000 emphasizes
• Documentation
• Basic procedures for TQC
• But latest version (ISO 90002000) has more
  customer focus
• Malcolm Baldridge emphasizes
• Customer satisfaction
• Quality results
• Business results
• Baldridge focuses on the what, ISO 9000 on the
  how
• Baldridge awards world-class, ISO certifies
  base-line

15
ISO

• A non-governmental organization set up in 1947
• Comprised of reps from 100 countries
• Comprised of 214 Technical Committees
• Many TCs cover an industry/product
• TC 1 screw threads, TC 214 elevating work
  platforms
• Dedicated to standardization of systems product
  testing
• TC 176 created ISO 9000

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THE ISO 9000 QUALITY SYSTEM

• ISO -- International Organization for
  Standardization iso is Greek for same as
• ISO 9000 adopted -- without change -- as
  "official" (but voluntary) national standards in
  120 countries
•  The European Union (EU)
•  Japan
•  USA (ANSI/ASQC Q9000)
• Emphasis has been on procedure and documentation
• Assumes quality results follow from using the
  correct baseline system

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ISO 90002000 QUALITY SYSTEM

• ISO 9000 Quality Management Systems
  Fundamentals and Vocabulary
• An overview of quality management
• ISO 9001 Quality Management Systems
  Requirements
• Outlines the requirements of the standard for all
  manufacturers
• If some requirements dont apply, you ask for an
  exclusion
• ISO 9004 Quality Management Systems
  Guidelines for Performance Improvement
• Discusses 9001 elements in details

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ISO 90002000 ELEMENTS

• The Quality Management System is a system in
  place, and is it documented?
• Management Responsibility company policy,
  commitment to quality, management involvement
• Resource Management is the money and training
  there?
• Product Realization --customer, process, and
  vendor management
• Measurement, Analysis Improvement proper
  collection and use of data

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ISO 90002000 ELEMENTS4. The Quality Management
System

• 4.1 General Requirements
• The organization shall establish, document,
  implement, and maintain a quality management
  system and continually improve its effectiveness
  . . .
• 4.2 Documentation Requirements
• The organization shall establish and maintain a
  quality manual . . .
• Documents required by the quality management
  system shall be controlled . . .
• Records shall be established and maintained to
  provide evidence of conformity to requirements .
  . .

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ISO 90002000 ELEMENTS 6. Resource Management

• 6.1 Provision of Resources
• The organization shall determine and provide the
  resources needed to implement and maintain the
  quality management system . . .
• 6.2 Human Resources
• Personnel performing work affecting product
  quality shall be competent . . .
• 6.3 Infrastructure
• The organization shall determine, provide and
  maintain the . . . buildings . . . process
  equipment . . . Supporting services

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ISO 90002000 ELEMENTS 7. Product Realization

• 7.4 Purchasing
• The organization shall ensure that purchased
  product conforms to specified purchase
  requirements . . .
• 7.5 Production and Service Provision
• The organization shall plan and carry out
  production . . . under controlled conditions . .
  .
• Controlled conditions shall include . . . the
  availability of work instructions . . the
  implementation of monitoring and measurement . .
  .
• 7.6 Control of Monitoring and Measuring Devices
• Measuring equipment shall be calibrated or
  verified at specified intervals . . .

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ISO 90002000 ELEMENTS 8. Measurement, Analysis
Improvement

• 8.3 Control of Nonconforming Product
• The organization shall ensure that product which
  does not conform to product requirements is
  identified and controlled . . .
• 8.4 Analysis of Data
• The analysis of data shall provide information
  relating to customer satisfaction . .. conformity
  to product requirements . . . processes . .
  suppliers
• 8.5 Improvement
• A documented procedure shall be established to
  define requirements for . . . determining the
  causes of nonconformities . . .

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THIRD PARTY CERTIFICATION

• How does a company become certified? Calling in
  a registrar to audit the company's quality system
• Registrar is third-party, as opposed to first
  party (auditee) or second party (auditees
  customer)
•  Approximate cost of registration
  10,000-20,000
• Each country has its own organization for
  accrediting registrars and their employees
  (auditors)
• In US, Registrar Accreditation Board (RAB)
• Not all countries recognize each other's systems
  for accreditation

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THIRD PARTY CERTIFICATION
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EXAMPLE CERTIFICATION PROCESS I

• Firm submits application
• Quality manual of firm is audited
• Preliminary evaluation (one-day quickie) or
  preliminary assessment (full-blown mock audit)
• Full audit
• Auditors' report to its registration board

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EXAMPLE CERTIFICATION PROCESS II

• Registration board's decision
• Semi-annual follow-up audits
• Triannual full audits

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THE REGISTRAR ACCREDITATION BOARD

• A non-governmental organization
• Intended to certify registrars/auditors for ISO
  9000
• May certify registrars which may not be
  recognized by other member countries of ISO

28
THE AMERICAN SOCIETY FOR QUALITY

• A non-governmental organization
• Dedicated to improving quality in the U.S.
• Creator of the Registrar Accreditation Board
  (RAB) for certifying ISO 9000 registrars in the
  U.S.
• Runs U.S. Technical Advisory Group (TAG) which
  presents its views to ISO TC 176

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THE AMERICAN NATIONAL STANDARDS INSTITUTE

• A non-governmental organization
• Facilitates consensus on standards within U.S.
• ANSI does not write standards
• U.S. rep to ISO and other international standards
  bodies
• ANSI "signs off" on new standards for the US

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ADDITIONAL QUALITY SYSTEMS

• QS-9000
• Augmented version of ISO-9000 developed by the
  Big 3 for the automobile industry and its
  suppliers
• Mandates use of specific tools appropriate to the
  automobile industry
• GMPs
• Good Manufacturing Practices
• Industry-specific QA systems for regulated
  industries (drugs, medical devices, food)

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THE MALCOLM BALDRIDGE NATIONAL QUALITY AWARD

• 1983 -- White House conference on productivity
•  
• 1984 -- Conference report calls for national
  quality award
•  
• 1986 -- Bill introduced to Congress to establish
  award
•  
• 1987 -- Bill passes Congress
•  
• 1988 -- Reagan signs bill into law

32
THE MALCOLM BALDRIDGE NATIONAL QUALITY AWARD

• U.S. response to the Japanese Deming Prize"
•  
• Run by the National Institute of Standards and
  Technology (NIST) with the help of ASQ
•  NIST is an agency of the Commerce Department
•  ASQ performs day-to-day operations
•  
• Board of examiners (200 members) review all
  applications
•  Separate awards for manufacturing, service,
  small business, health care, and education

33
THE MBNQA AWARD CRITERIA

• Examination consists of seven broad categories
•  
• 1) Leadership (12)
• 2) Strategic planning (8.5)
• 3) Customer and market focus (8.5)
• 4) Measurement, Analysis, Knowledge Mgmt (9)
• 5) Human resource focus (8.5)
• 6) Process management (8.5)
• 7) Business results (45)
• The seven categories cover 20 examination items

34
MBNQA CUSTOMER AND MARKET FOCUS (8.5)

• 3.1 Customer and market knowledge (4)
• Describe how your organization determines
  requirements, expectations, and preferences of
  customers . . .
•  
•  
• 3.2 Customer satisfaction and relationships
  (4.5)
• Describe how your organization builds
  relationships to acquire and satisfy customers .
  . .

35
MBNQA BUSINESS RESULTS (45)

• 7.1 Customer focused results (7.5)
• Summarize your organizations key
  customer-focused results
•  
• 7.2 Product Service results (7.5)
• Summarize your organizations key product
  service performance results.
•  
• 7.3 Financial performance results (7.5)
• Summarize your organizations key financial and
  marketplace results.
•  
• 7.4 Human resource results (7.5)
• Summarize your organizations key human resource
  results.

36
OTHER QUALITY AWARDS

• Deming Prize
• Managed by Japanese Union of Scientists and
  Engineers (JUSE)
• Established in 1951
• Greater focus on statistical techniques
• European Quality Award
• Similar criteria to Baldridge
• Pass/Fail award no maximum number of winners

37
SIX SIGMA

• A structured collection of existing tools for
  quality control and improvement
• Developed by Motorola in the 1980s
• Tools range from simple to complex
• Managers become black belts through
  well-organized accelerated training program
• Refers to the robust process and product design
  which is the target of the tools
• Six sigma is the number of standard deviations
  from the spec limit to the mean of the quality
  characteristic
• Implies less than ppb defects when the process is
  working
• Implies 3.4 ppm defects when the process shifts
  by 1.5 standard deviations

38
ORGANIZING FOR SIX SIGMA

• Starting a six sigma campaign requires the
  identification of key personnel
• Champions senior managers that will steer and
  support six sigma teams
• Black Belts managers/engineers that lead the
  six sigma teams
• Each team is focused on solving a major quality
  problem
• Black Belts are dedicated to the the team
• Green Belts managers/engineers that help out
  the Black Belts on a part-time basis

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BLACK BELT TRAINING I

• Follows the DMAIC model
• Typically completed in four to six weeks
• Lots of hands-on problem solving
• Define outline scope and goals of team project
• Includes important step of identifying metrics
• Measure review tools needed to collect and
  analyze quality data
• Process flow analysis tools
• Probability and statistics review
• Measurement systems and technology
• Process capability studies

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BLACK BELT TRAINING II

• Analyze search for root causes of quality
  problem(s)
• Exploratory data analysis
• Formal hypothesis testing
• Improve determine critical root causes and how
  to use them to solve the quality problem
• Design of Experiments
• Control keep the newly-improved process on
  track
• Statistical process control
• Mistake-proofing