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Omnex sac may01 Omnex sac may01 Presentation Transcript

  • ISO/TS 16949 - Second Edition Chad Kymal - Omnex QS-9000 Killer? OMNEX
  • This publication is protected by Federal Copyright Law, with all rights reserved. No part of this publication may be reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in any form, or by any means manual, electronic, electro-magnetic, mechanical, chemical, optical, or otherwise, without prior explicit written permission from Omnex, Inc. OMNEX 3025 Broadway Suite #120 Ann Arbor, MI 48108 (734) 761-4940 Fax: (734) 761-4966  May 20, 2001
  • What is ISO/TS 16949, Second Edition?
    • Eagerly awaited ISO 9001:2000 based QS-9000 update
    • Harmonized U.S., European and Asia - Pacific OEM standard
    • Accepted in lieu of QS-9000, Third Edition
    • Technical specification accepted by ISO/TC-176
  • Implication of ISO/TS16949, Second Edition
    • Based on the following facts:
      • ISO 9001:2000 registered organizations have 3 years to upgrade (until December 2003).
      • QS-9000 will not be upgraded.
        • Note: It is based on ISO 9001:1994.
      • Only ISO/TS 16949 is getting upgraded to ISO 9001:2000
  • ISO/TS 16949 Facts
    • Only 33 Registrars worldwide can audit this standard.
    • Has 90% to 95% QS-9000 content (First edition)
    • Accepted instead of QS-9000, AVSQ, VDA or EAQF
  • ISO/TS 16949, Second Edition Standard Structure
    • Note: The standard incorporates the structure of ISO 9001:2000
    Example:
    • Scope
      • 1.1 General
      • 1.2 Applicability
    • Normative References
    • Terms and Definitions
    • Quality Management System
      • 4.1 General Requirements
      • 4.2 Documentation Requirements
        • 4.2.1 General
        • 4.2.2 Quality manual
        • 4.2.3 Control of Documents
          • 4.2.3.1 Engineering Specifications
        • 4.2.4 Control of Records
          • 4.2.4.1 Records Retention
  • ISO/TS 16949, First Edition Additions
    • 25 additions at sub-element level
      • For example, 4.1.4
    • 74 additions lower than sub-element level
      • For example, 4.1.1.2 Objectives or 4.2.4.9.2 Process Design Inputs
  • Summary of Changes
    • A majority of additions to First Edition migrate to 7.0 Product Realization, 8.0 Measurement, Analysis and Improvement and 6.0 Resources in Second Edition.
    • Just 2 additions from 1st edition to 2nd edition - 6.5 Sourcing, 7.1.2 Change Control
    • Changes have not been made in 17 areas
    • A change is made to the language of almost every requirement, whether a change to the wording or removal of a term
  • Any Surprises?
    • ISO 17025 is not required for internal laboratories.
    • External laboratories could have customer or second party concurrence or assessment
    • 7.3 Design and development includes Product and Manufacturing Design
    • Addition of requirements to 7.4 Purchasing that at a minimum, “the supplier shall be compliant to ISO 9001:2000”
    • Undecided about direction on documentation “parking lot issue”
  • Any Surprises? Continued...
    • Sanctioned Interpretations , added as notes to First Edition, is virtually missing in Second Edition.
    • Many small edits including:
      • No requirement for 100% on-time delivery ( 4.15.6 Delivery )
      • No mention of linearity, bias and discrimination (4.11.4)
  • What ISO/TS 16949 First Edition Additions Were Removed?
    • 4.1.4 Business Plan
    • 4.1.6 Employee Satisfaction (please note change)
    • 4.1.7.1 Product Safety - Significantly reduced
    • 4.1.7.2 Regulations - Added as note
    • 4.2.4.3 Review Cycle - incorporated into 7.3.4 Design and development review
    • 4.2.4.9 Management of Process Design - General
    • 4.3.2.2 Review - Supplemental
  • What ISO/TS 16949 First Edition Additions Were Removed?
    • 4.5.2.1 Document and Data Approval and Issue - Note
    • 4.6.1.1 General - Note
    • 4.10.1.1 General - Note
    • 4.15.4.2 Customer Packaging Standards
    • 4.15.4.3 Labeling
    • 4.15.6.4 Electronic Communication
    • 4.15.6.5 Shipment Notification
    • 4.19.1 Servicing - Note
  • Be Cautious on Changes!!
    • Many requirements not present in the second edition may very well become customer specific requirements
  • What Was Added?
    • 6.5 Sourcing
    • 7.1.2 Change Control (note change)
  • Impact on QS-9000 Implementation
    • Process Approach
      • Process versus elements
      • Impact on documentation
    • Customer Focus
  • The Hierarchical Organization vs. The Process Focus
    • How do you document your system?
  • Process Mapping
  • Process Documentation
  • Customer Focus Process Shipment Shipment Accuracy % Downtime Process Maintenance 100% On-Time Delivery Customer Need and Expectation (5.2) 100% of shipments received by customer on scheduled day Goal and Objectives (5.4) % On-Time (on day required) Result Measurable (5.4) Process Training Setup Jobs Filled Key Processes (4.1) Process Measurables (8.2.3)
  • What to Do Now?
    • The impact on QS-9000 is really ISO 9001:2000.
      • Upgrade your QS-9000.
      • Implement ISO/TS 16949, Second Edition.
  • Proposed SAC Quality System Standard SAC Quality System Standard = ISO 9001 + ISO 9004 + ISO/TS 16949 + QS-9000 Semiconductor Supplement + SAC Value added practices SAC Requirements ISO 9004:2000 + TS-16949 ISO 9001:2000