Reducing timeincreasingvalue0503


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Reducing timeincreasingvalue0503

  1. 1. ISO 9001:2000 Implementation – Increasing Value and Reducing Lead Time - Removing Implementation Roadblocks Chad Kymal, CEO Omnex © Omnex All rights reserved
  2. 2. Speaker Biography <ul><li>Chad Kymal is a widely sought international trainer and consultant whose broad experience includes TQM, setup reduction, technology assessment and inventory analysis, statistical process control, and quality function deployment. He has co-authored or championed most of Omnex's quality training courses. He is on the Malcolm Baldrige Board of Examiners and is an RAB certified Lead Auditor. </li></ul><ul><li>He has a Bachelor’s degree Mechanical Engineering from General Motors Institute, a Master's degree in Industrial and Operations Engineering from the University of Michigan, and an MBA from the University of Michigan. </li></ul><ul><li>Kymal founded Omnex, Inc., a business/quality management solution provider that offers training to semi-conductor, automotive, manufacturing, and service industries. Omnex has worked with Ford Motor Company, Lucent Technologies, Philips Semiconductor, Magna, and most of the Fortune 500 companies worldwide. Omnex provides over 50 training courses in subject areas ranging from APQP to Six Sigma and has 15 offices worldwide. </li></ul><ul><li>Chad is also the founder of AQSR, one of the top five rated Quality System registrars in the US as rated by Quality Digest. Chad and AQSR specialize in providing auditing services in ISO 9000, QS-9000, TE Supplement, TS 16949, VDA 6*, AS-9000 and the ISO 14001 series of international standards. </li></ul><ul><li>He also founded Omnex Systems, which provides Omnex's industry-leading Advance Product Quality Planning Software, AQuA®, which is being used by several leading companies in the industry. Currently, Omnex Systems is offering the Enterprise-wide Quality Management System (EwQMS™) Suite, which features AQuA, Audit Pro, Boss, Document Pro, MSA Pro, HR Pro, Process Analyzer, Process Pro, and TPM Pro. </li></ul><ul><li>Chad has recently published a book on ISO 9001:2000 auditing for Paton Press, and is working on a book for ISO/TS 16949:2002 auditing. Chad led the Omnex team that helped Ford Motor Company rewrite the QOS methodology. He helped write the QS-9000 requirements and did the first worldwide witness audit for the same. </li></ul><ul><li>Chad Kymal worked closely with the Automotive Electronic Council (AEC) to develop the Semiconductor Supplement. He has also helped Visteon and Delphi in developing their customer specific requirement. </li></ul><ul><li>Chad was named Executive Director of SAC. He is currently leading SAC to develop a second party/third party auditing process for the semiconductor supply chain. He is also helping SAC remove waste and redundancy in quality system requirements auditing in the semiconductor supply chain. </li></ul>
  3. 3. Agenda <ul><li>ISO 9001:2000 Requirements and Deadlines </li></ul><ul><li>ISO 9001:2000 Roadblocks and Preventing them </li></ul><ul><li>Transitioning from ISO 9001:1994 – Key Differences </li></ul><ul><li>Creating Value from ISO 9001:2000 Implementation </li></ul><ul><li>Creating the culture change and the savings quickly </li></ul>
  4. 4. About Omnex <ul><li>Consulting </li></ul><ul><ul><li>Omnex provides leading Quality Management and Performance Enhancement consulting and training to an extensive array of both service and manufacturing sectors. </li></ul></ul><ul><li>Training </li></ul><ul><ul><li>Omnex is the leading provider of quality-focused training to the manufacturing and service industries. </li></ul></ul><ul><li>Software </li></ul><ul><ul><li>Omnex Systems LLC specializes in developing management improvement software to cater to the needs of a variety of quality management systems. </li></ul></ul>
  5. 5. About Omnex <ul><li>Offices Worldwide </li></ul><ul><ul><li>Brazil </li></ul></ul><ul><ul><li>Canada </li></ul></ul><ul><ul><li>China </li></ul></ul><ul><ul><li>India </li></ul></ul><ul><ul><li>Korea </li></ul></ul><ul><ul><li>Mexico </li></ul></ul><ul><ul><li>Taiwan </li></ul></ul><ul><ul><li>Saudi Arabia </li></ul></ul><ul><ul><li>Germany </li></ul></ul><ul><ul><li>Thailand </li></ul></ul><ul><ul><li>UK </li></ul></ul><ul><ul><li>Venezuela </li></ul></ul>
  6. 6. Omnex Systems EwQMS Suite of Integrated Modules
  7. 7. Agenda <ul><li>ISO 9001:2000 Requirements and Deadlines </li></ul><ul><li>ISO 9001:2000 Roadblocks and Prevention </li></ul><ul><li>Transitioning from ISO 9001:1994 – Key Differences </li></ul><ul><li>Creating Value from ISO 9001:2000 Implementations </li></ul><ul><li>Creating the culture change and the savings quickly </li></ul>
  8. 8. ISO 9001:2000 Requirements and Deadlines
  9. 9. ISO 9001:2000 Process Model
  10. 10. ISO 9000 Series of Standards Terms and Definitions Guidance QMS Requirements ISO 9000:2000 ISO 9001:2000 ISO 9004:2000
  11. 11. ISO 9001:2000 Registration Process <ul><li>Documentation Review </li></ul><ul><li>Onsite Audit </li></ul><ul><li>Corrective Action </li></ul><ul><li>Certificate Issuance </li></ul><ul><li>Surveillance </li></ul>
  12. 12. Steps to ISO 9001:2000 Implementation
  13. 13. ISO 9001:2000 Deadlines <ul><li>Organizations need to get registered by Dec.31, 2003 to retain their ISO Certification </li></ul><ul><li>Organizations not upgraded to ISO 9001:2000 will lose their ISO certification </li></ul><ul><li>ANSI/RAB and registrars will not continue to support ISO 9001:1994 past the deadline </li></ul>
  14. 14. ISO 9001:2000 Roadblocks and Prevention
  15. 15. Roadblocks and Problems <ul><li>Top Management commitment and involvement </li></ul><ul><li>ISO 9001:2000 Implementation seen as a Quality Department effort </li></ul><ul><li>Goal of Implementation is passing the audit </li></ul><ul><li>No Plan or leadership for the implementation. </li></ul><ul><li>Providing Customer Focus/Measuring Customer Satisfaction </li></ul><ul><li>Over documentation </li></ul><ul><li>Understanding steps for Process Focus </li></ul><ul><li>Implementing a process for continual improvement </li></ul><ul><li>Objectives deployment and Business Review </li></ul><ul><li>Poor internal audits </li></ul>
  16. 16. Transitioning from ISO 9001:1994 - Key Differences
  17. 17. Transitioning from ISO 9001:1994 - Key Differences <ul><li>Process Focus and business process measurement </li></ul><ul><li>Documentation of Procedures </li></ul><ul><li>Customer Focus </li></ul><ul><li>Objectives Deployment </li></ul><ul><li>Management Review </li></ul>
  18. 18. Transitioning from ISO 9001:1994 - Key Differences (cont’d) <ul><li>Resources Planning and including Competency </li></ul><ul><li>Customer Satisfaction </li></ul><ul><li>Analysis of Data </li></ul><ul><li>Continual Improvement </li></ul>
  19. 19. Providing Value In ISO 9001:2000 Implementations
  20. 20. Getting Value from Your Implementation <ul><li>Set Objectives for your ISO/TS 16949:2002 Implementations </li></ul><ul><ul><li>Find crucial senior management problems to work on </li></ul></ul><ul><ul><li>SAVE Money with the implementation </li></ul></ul><ul><ul><ul><li>For example: </li></ul></ul></ul><ul><ul><ul><ul><li>Setting business objectives and a management process </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Implement Six Sigma or Lean as a part of the continual improvement process – Save Money </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Process and documentation Commonization </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Improved Problem solving with lead time and cost savings target </li></ul></ul></ul></ul><ul><li>Become Process focused –process map, process list, BMS control plans, and alignment charts </li></ul>
  21. 21. Getting Value from Your Implementation (cont’d) <ul><li>Use the alignment methodology to become customer focused </li></ul><ul><li>Train your implementation team and Auditors </li></ul><ul><ul><li>Use the idea of a BMS and not a QMS </li></ul></ul><ul><li>Use software which has prescribed Best In Class Methods. Use it to optimize the implementation and make it easy. Use web based software </li></ul><ul><ul><li>Documentation </li></ul></ul><ul><ul><li>Customer Focus and Continual Improvement </li></ul></ul><ul><ul><li>New Product Development (FMEAs?) </li></ul></ul><ul><ul><li>Process Mapping and Process Flows </li></ul></ul><ul><li>Get your top management involved in the implementation </li></ul>
  22. 22. Creating the culture change and the savings quickly
  23. 23. ISO 9001:2000 Implementation Plan <ul><li>Form Overall Objectives and Strategy </li></ul><ul><li>Form Team and Train Team </li></ul><ul><li>Form ISO and Software Implementation Plan </li></ul><ul><li>Develop Documentation </li></ul><ul><li>Implement Software Modules – Documentation, Process Focus, Customer Focus </li></ul><ul><li>Train Auditors and Conduct Audit –implement Audit Pro </li></ul>
  24. 24. ISO 9001:2000 Implementation Plan <ul><li>Form Overall Objectives and Strategy – Month 1 </li></ul><ul><li>Form Team and Train Team – Month 1 </li></ul><ul><li>Form ISO and Software Implementation Plan – Month 1 </li></ul><ul><li>Develop Documentation – Month 2 </li></ul><ul><li>Implement Software Modules – Documentation, Process Focus, Customer Focus – Month 2 to 4 </li></ul><ul><li>Train Auditors and Conduct Audit –implement Audit Pro – Month 5 </li></ul>
  25. 25. Month 1 <ul><li>Conduct Discovery Analysis and formulate overall objectives and strategy for ISO 9001:2000 </li></ul><ul><li>Form ISO and Software Implementation Plan </li></ul><ul><li>Conduct Executive Overview for Senior Management </li></ul><ul><li>Form Team and Train Team </li></ul>
  26. 26. Month 2 – Develop Documentation <ul><li>Required Procedures – Most can be reused from ISO 9001:1994 system </li></ul><ul><ul><li>Document Control </li></ul></ul><ul><ul><li>Records Control </li></ul></ul><ul><ul><li>Internal Audit </li></ul></ul><ul><ul><li>Non Conforming Product </li></ul></ul><ul><ul><li>Corrective Action </li></ul></ul><ul><ul><li>Preventive Action </li></ul></ul><ul><li>Review documentation from current system and decide which to keep </li></ul><ul><li>Identify additional value added documentation </li></ul>Keep documentation to a minimum. Use software To implement and provide evidence of a process
  27. 27. Month 2 to 4 – Implement Software Modules 4.1, 4.2 building the process model, review of process metrics and managing process variation. 4.2 document management. 5.1 - 5.4, 6.1 managing customer expectations, customer satisfaction, continual improvement, and data analysis. 5.5 6.2, 6.4 human performance management functions, competency, training management and satisfaction surveys 6.3 preventive and reactive maintenance. 7.1 project management. 7.1, 7.3 APQP, PPAP processes 7.4, 7.5 document management. 7.5 preventive and reactive maintenance. 7.4, 8.2.2 internal and external audit function with a focus on process improvement. 7.6, 8.4 calibration and measurement systems analyses. 8.2.1 human performance management functions, competency, training management and satisfaction surveys 8.2.3, 8.4, 8.5 managing customer expectations, customer satisfaction, continual improvement, and data analysis. 8.5.2, 8.5.3 document management. Process Pro Document Pro BOSS HR Pro TPM Pro Project Planner AQuA Pr Document Pro TPM Pro Audit Pro MSA Pro HR Pro BOSS Document Pro
  28. 28. Process Focus - Process Pro
  29. 29. The process flow shows the linkages between each step within the process. You can then click to see the process flow definition.
  30. 31. Business Management System Control Plan – Example A
  31. 32. Customer Focus and Continual Improvement - BOSS
  32. 33. It all starts with the customer
  33. 34. Quality is what the customer says it is! Multiple customers and multiple expectations categories.
  34. 35. You can then align customer quality expectations with company driven process improvement activities. EwQMS helps you measure key processes.
  35. 36. OFI’s can trigger improvement proposals so the team can make adjustments to the process.
  36. 37. If results indicate further analysis, team meetings can be held to determine OFI’s.
  37. 38. Data for process measurables is kept within the EwQMS system for analysis and continuous improvement activities.
  38. 39. Excel data can also be imported using Data Exchanger, an EwQMS tool giving you total flexibility in data collection.
  39. 40. You can then use the EwQMS report generator to report detailed information on a variety of process metrics.
  40. 41. EwQMS drill down functionality allows management to quickly find the root cause of process variation.
  41. 42. Again, EwQMS visual management tools allow easy interpretation of metrics data.
  42. 43. Improvement proposals can be documented and tracked against results.
  43. 44. Documentation – Document Pro
  44. 46. The Document Management Process <ul><li>Spans multiple sites, groups and levels. </li></ul><ul><li>No limited file types; graphics, audio, video </li></ul><ul><li>Action items with email support </li></ul><ul><li>Automated routing and escalation </li></ul><ul><li>Records management </li></ul><ul><li>Document draft functionality </li></ul><ul><li>User defined login default </li></ul><ul><li>On line revision history and reference documents </li></ul><ul><li>EwQMS module hot links </li></ul><ul><li>Customer complaint and concern management </li></ul>
  45. 47. Month 5 – Train Auditors and Conduct Audit <ul><li>Train Internal Auditors </li></ul><ul><li>Conduct Internal Audit using Audit Pro </li></ul><ul><li>Use Audit Pro to follow up on Corrective Actions </li></ul>
  46. 48. Audit Pro
  47. 49. The Auditing Process <ul><li>Scheduling of Audits </li></ul><ul><ul><li>Auditor selection criteria ( i.e. qualifications) </li></ul></ul><ul><ul><li>Auditor calendar and date verification </li></ul></ul><ul><li>Managing Audits </li></ul><ul><ul><li>Visual audit status </li></ul></ul><ul><ul><li>Audit query and report capability </li></ul></ul><ul><ul><li>Visual CAR status </li></ul></ul><ul><ul><li>Reminders and escalation functionality </li></ul></ul><ul><ul><li>Custom email messages </li></ul></ul><ul><li>Sharing across the Enterprise </li></ul><ul><ul><li>Audit information </li></ul></ul><ul><ul><li>Auditee information </li></ul></ul><ul><ul><li>Auditors </li></ul></ul>
  48. 52. Conduct Registration Audit <ul><li>Conduct Registration Audit </li></ul><ul><li>Track and record – overall objectives accomplished </li></ul><ul><li>Provide Senior Management Presentation </li></ul>