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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 Unchanged: Build and Sustain Total Quality Systems/Organizations
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Customers Satisfaction Customers are the focus of any organization
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Customers Satisfaction Leadership Leadership provides organizational foundation for success
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Customers Satisfaction Leadership Employee Motivation Partnership Continuous Improvement Performance Measure Total Quality System: Put it Altogether
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ISO 9000 Standards Quality Management Systems ISO 9000:2000--fundamentals and vocabulary ISO 9001:2000--requirements ISO 9004: 2000—guidelines for performance improvement
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ISO 14000:Environmental Management System Organizational Evaluation Standards Product Evaluation Standards
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Sector-Specific Standards: AS 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 Standards: TL 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 Standards: Medical 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 Industry From QS9000 to ISO/TS 16949 QS-9000 has been extended by 3 years, and will expire on December 14, 2006 The ISO 9000:1994 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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Management Responsibility Resource Management Product Realization Measurement, Analysis & Improvement Inputs Product CUSTOMERCUSTOMER Outputs REQUIREMENTSREQUIREMENTS CUSTOMERCUSTOMER SATISFACTIONSATISFACTION C.I. Continual Improvement Cycle
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What’s New (and Different) Based on ISO 9001:2000 not ISO 9001:1994 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 Inputs Outputs Process Objectives Results Risks Purpose Stakeholder Wants & Needs Specifications Schedule/Timing Market Data Industry Trends Economic Conditions Products Information
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Contrast between QS-9000 & TS-16949:2002 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 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 QS-9000 (Procedure Based) TS-16949:2002 (Process Based)
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