Quality Systems in United States

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Quality Systems in United States

• Peter Ping Liu, Ph D, PE, CQE, OCP and CSIT
• Professor and Coordinator of Graduate Programs
• School of Technology
• Eastern Illinois University
• Charleston, IL 61920

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Evolution of Manufacturing
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Principles Remain UnchangedBuild and Sustain
Total Quality Systems/Organizations
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Customers are the focus of any organization
Customers Satisfaction
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Leadership provides organizational foundation for
success
Leadership
Customers
Customers Satisfaction
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Total Quality System Put it Altogether
Employee Motivation
Leadership
Customers
Customers Satisfaction
Partnership
Continuous Improvement
Performance Measure
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ISO 9000 StandardsQuality Management Systems

• ISO 90002000--fundamentals and vocabulary
• ISO 90012000--requirements
• ISO 9004 2000guidelines for performance
  improvement

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ISO 14000Environmental Management System

• Organizational Evaluation Standards
• Product Evaluation Standards

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Sector-Specific StandardsAS 9100

• Developed by Society of Automotive Engineers
  (SAE) for aerospace industry (1997).
• Unified requirements of NASA, DOD and FAA.
• Endorsed by International Aerospace Quality Group
  (2001)

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Sector-Specific StandardsTL 9000

• Developed by Quality Excellence for Suppliers of
  Telecommunications Forum
• Book 1 Common TL 9000 Requirements (QSR)
• Book 2 Common TL 9000 Measurements (QSM)

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Sector-Specific StandardsMedical Devices

• ISO 13485 13488 Quality systems for medical
  device manufacturers under the medical device
  directives. Used in conjunction with the ISO
  9000.
• FDA Regulatory and quality standards (GMP)

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Automotive IndustryFrom QS9000 to ISO/TS 16949

• QS-9000 has been extended by 3 years, and will
  expire on December 14, 2006
• The ISO 90001994 standard embedded within
  QS-9000 expired December 15, 2003.

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TS 16949 Eight Principles

• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

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Continual Improvement Cycle
Management Responsibility


R E Q U I R E M E N T S
S A T I S F A C T I O N
C U S T O M E R
C U S T O M E R
Resource Management
Measurement, Analysis Improvement
C.I.
Product Realization
Inputs
Outputs
Product
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Whats New (and Different)

• Based on ISO 90012000 not ISO 90011994
• Greater focus on the customer and customer
  satisfaction
• New focus on the Process approach vs. the
  elemental approach
• Clarification of requirements for continual
  improvement

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New and Different (Cont.)

• Greater emphasis upon the role of top management
• Measurable quality objectives
• Reduced emphasis on documented procedures

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New and Diff. (Cont.)

• Modification in the purpose of internal audits
• Use the Deming Cycle of Plan, Do, Check, and
  Act as a basic methodology
• Process control and improvement is expanded from
  product to include all activities of the
  organization.

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The Process Approach
Purpose
Objectives
Risks
Inputs
Outputs
Process

• Stakeholder Wants Needs
• Specifications
• Schedule/Timing
• Market Data
• Industry Trends
• Economic Conditions

• Products
• Information

Results
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Contrast between QS-9000 TS-169492002
TS-169492002 (Process Based)
QS-9000 (Procedure Based)

• Processes Are
• Driven by desired output
• Managed
• May be completed by different departments
  with the same objectives
• Flow to conclusion
• Satisfy the stakeholders
• Transform inputs into outputs
• Dynamic

• Procedures Are
• Driven by task completion
• Issued
• May be completed by different departments
  with different objectives
• Are segmented
• Satisfy the standard
• Define the sequence of steps to perform a
  task
• Static