Quality Systems in United States

1. 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

2. Evolution of Manufacturing

3. Principles Remain Unchanged:Build and Sustain Total Quality Systems/Organizations

4. Customers are the focus of any organization Customers Satisfaction

5. Leadership provides organizational foundation for success Leadership Customers Customers Satisfaction

6. Total Quality System: Put it Altogether Employee Motivation Leadership Customers Customers Satisfaction Partnership Continuous Improvement Performance Measure

7. ISO 9000 StandardsQuality Management Systems • ISO 9000:2000--fundamentals and vocabulary • ISO 9001:2000--requirements • ISO 9004: 2000—guidelines for performance improvement

8. ISO 14000:Environmental Management System • Organizational Evaluation Standards • Product Evaluation Standards

9. 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)

10. 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)

11. 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)

12. Automotive IndustryFrom 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.

13. 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

14. 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

15. 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

16. New and Different (Cont.) • Greater emphasis upon the role of top management • Measurable quality objectives • Reduced emphasis on documented procedures

17. 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.

18. The Process Approach Purpose Objectives Risks Inputs Outputs Process • Stakeholder Wants & Needs • Specifications • Schedule/Timing • Market Data • Industry Trends • Economic Conditions • Products • Information Results

19. Contrast between QS-9000 & TS-16949:2002 TS-16949:2002 (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