Omnex sac may01


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Omnex sac may01

  1. 1. ISO/TS 16949 - Second Edition Chad Kymal - Omnex QS-9000 Killer? OMNEX
  2. 2. 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
  3. 3. What is ISO/TS 16949, Second Edition? <ul><li>Eagerly awaited ISO 9001:2000 based QS-9000 update </li></ul><ul><li>Harmonized U.S., European and Asia - Pacific OEM standard </li></ul><ul><li>Accepted in lieu of QS-9000, Third Edition </li></ul><ul><li>Technical specification accepted by ISO/TC-176 </li></ul>
  4. 4. Implication of ISO/TS16949, Second Edition <ul><li>Based on the following facts: </li></ul><ul><ul><li>ISO 9001:2000 registered organizations have 3 years to upgrade (until December 2003). </li></ul></ul><ul><ul><li>QS-9000 will not be upgraded. </li></ul></ul><ul><ul><ul><li>Note: It is based on ISO 9001:1994. </li></ul></ul></ul><ul><ul><li>Only ISO/TS 16949 is getting upgraded to ISO 9001:2000 </li></ul></ul>
  5. 5. ISO/TS 16949 Facts <ul><li>Only 33 Registrars worldwide can audit this standard. </li></ul><ul><li>Has 90% to 95% QS-9000 content (First edition) </li></ul><ul><li>Accepted instead of QS-9000, AVSQ, VDA or EAQF </li></ul>
  6. 6. ISO/TS 16949, Second Edition Standard Structure <ul><li>Note: The standard incorporates the structure of ISO 9001:2000 </li></ul>Example: <ul><li>Scope </li></ul><ul><ul><li>1.1 General </li></ul></ul><ul><ul><li>1.2 Applicability </li></ul></ul><ul><li>Normative References </li></ul><ul><li>Terms and Definitions </li></ul><ul><li>Quality Management System </li></ul><ul><ul><li>4.1 General Requirements </li></ul></ul><ul><ul><li>4.2 Documentation Requirements </li></ul></ul><ul><ul><ul><li>4.2.1 General </li></ul></ul></ul><ul><ul><ul><li>4.2.2 Quality manual </li></ul></ul></ul><ul><ul><ul><li>4.2.3 Control of Documents </li></ul></ul></ul><ul><ul><ul><ul><li> Engineering Specifications </li></ul></ul></ul></ul><ul><ul><ul><li>4.2.4 Control of Records </li></ul></ul></ul><ul><ul><ul><ul><li> Records Retention </li></ul></ul></ul></ul>
  7. 7. ISO/TS 16949, First Edition Additions <ul><li>25 additions at sub-element level </li></ul><ul><ul><li>For example, 4.1.4 </li></ul></ul><ul><li>74 additions lower than sub-element level </li></ul><ul><ul><li>For example, Objectives or Process Design Inputs </li></ul></ul>
  8. 8. Summary of Changes <ul><li>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. </li></ul><ul><li>Just 2 additions from 1st edition to 2nd edition - 6.5 Sourcing, 7.1.2 Change Control </li></ul><ul><li>Changes have not been made in 17 areas </li></ul><ul><li>A change is made to the language of almost every requirement, whether a change to the wording or removal of a term </li></ul>
  9. 9. Any Surprises? <ul><li>ISO 17025 is not required for internal laboratories. </li></ul><ul><li>External laboratories could have customer or second party concurrence or assessment </li></ul><ul><li>7.3 Design and development includes Product and Manufacturing Design </li></ul><ul><li>Addition of requirements to 7.4 Purchasing that at a minimum, “the supplier shall be compliant to ISO 9001:2000” </li></ul><ul><li>Undecided about direction on documentation “parking lot issue” </li></ul>
  10. 10. Any Surprises? Continued... <ul><li>Sanctioned Interpretations , added as notes to First Edition, is virtually missing in Second Edition. </li></ul><ul><li>Many small edits including: </li></ul><ul><ul><li>No requirement for 100% on-time delivery ( 4.15.6 Delivery ) </li></ul></ul><ul><ul><li>No mention of linearity, bias and discrimination (4.11.4) </li></ul></ul>
  11. 11. What ISO/TS 16949 First Edition Additions Were Removed? <ul><li>4.1.4 Business Plan </li></ul><ul><li>4.1.6 Employee Satisfaction (please note change) </li></ul><ul><li> Product Safety - Significantly reduced </li></ul><ul><li> Regulations - Added as note </li></ul><ul><li> Review Cycle - incorporated into 7.3.4 Design and development review </li></ul><ul><li> Management of Process Design - General </li></ul><ul><li> Review - Supplemental </li></ul>
  12. 12. What ISO/TS 16949 First Edition Additions Were Removed? <ul><li> Document and Data Approval and Issue - Note </li></ul><ul><li> General - Note </li></ul><ul><li> General - Note </li></ul><ul><li> Customer Packaging Standards </li></ul><ul><li> Labeling </li></ul><ul><li> Electronic Communication </li></ul><ul><li> Shipment Notification </li></ul><ul><li>4.19.1 Servicing - Note </li></ul>
  13. 13. Be Cautious on Changes!! <ul><li>Many requirements not present in the second edition may very well become customer specific requirements </li></ul>
  14. 14. What Was Added? <ul><li>6.5 Sourcing </li></ul><ul><li>7.1.2 Change Control (note change) </li></ul>
  15. 15. Impact on QS-9000 Implementation <ul><li>Process Approach </li></ul><ul><ul><li>Process versus elements </li></ul></ul><ul><ul><li>Impact on documentation </li></ul></ul><ul><li>Customer Focus </li></ul>
  16. 16. The Hierarchical Organization vs. The Process Focus <ul><li>How do you document your system? </li></ul>
  17. 17. Process Mapping
  18. 18. Process Documentation
  19. 19. 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)
  20. 20. What to Do Now? <ul><li>The impact on QS-9000 is really ISO 9001:2000. </li></ul><ul><ul><li>Upgrade your QS-9000. </li></ul></ul><ul><ul><li>Implement ISO/TS 16949, Second Edition. </li></ul></ul>
  21. 21. 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