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Implementing ISO/TS 16949:2002 - Strategic Choices San Jose, California Chad Kymal
Agenda Basic Facts About ISO/TS 16949:2002 Transitioning from QS-9000 – Key Differences Importance of the Customer and Customer Specific Requirements Important Deadlines Getting Value from ISO/TS 16949:2002 Implementations Strategic Choices
ISO/TS 16949:2002 Basic Facts
ISO/TS 16949:2002 Basics – What is ISO/TS 16949:2002? Incorporates ISO 9001:2000 Replaces US, and European Standards QS-9000, VDA, etc. Document reflecting worldwide automotive requirements – US, Europe, and Asia Customized for Semiconductor Industry with ISO/TS 16949:2002 Semiconductor Supplement
ISO/TS 16949:2002 Basics  – Documents Auditors and Implementers need to Know ISO/TS 16949:2002 Technical Standard ISO/TS 16949:2002 Guidance Document Rules for Automotive Certification Scheme Quality System Checklist Customer Specific Requirements ISO/TS 16949:2002 Semiconductor Supplement
ISO/TS 16949:2002 Semiconductor Supplement Adds requirements to the ISO/TS 16949:2002 Required to be included in documented system Needs to be audited in QMS by internal auditors Needs to be audited by registrar Included in Scope of audit
ISO/TS 16949:2002 Third Party Registration Scheme
IATF View on ISO/TS 16949:2002 Automotive Industry – Value added requirements Global Quality System Content Global Recognition Certificate Common Registration Requirement and Oversight Body for registrars Reduced number of registrars- one contract and certification committee centralized in one office Common Auditor Qualification Process Approach to auditing is key to the transition from QS-9000 to ISO/TS 16949:2002!
Comparison of ISO/TS 16949 and QS-9000 QS-9000 Released in 1994 22,500 Certifications 174 Registrars with multiple offices 22 Accreditation Bodies ISO/TS 16949 First edition released in 1999 1724 Certifications 48 Registrars 5 Regional Offices for Accreditation
Transitioning from QS-9000 to ISO/TS 16949:2002 Key Differences
Key Transition Challenges Process Approach – COPs, MOPs, and SOPs Customer Focus Objectives Deployment Management (Business) Review Human Resources and Competency
Customer Oriented Processes
Process Characteristics A process can be identified by a series of unique, but consistent, characteristics. There are six characteristics of a process that are   mandatory  for effective quality management. A process owner exists The process is defined The process is documented The linkages of the process are established The process is monitored and improved Records are maintained
OMNEX’s View of the Processes OMNEX believes there are four types of processes. Customer Oriented Processes (COPs) Management Oriented Processes (MOPs) Support Processes (SOPs) ISO/TS 16949:2002 Related Processes
Process Approach – Omnex’s View Process Map Process List (linkage from Process Map (processes) to Documentation) BMS Control Plan Alignment Chart
Customer Focus -  Align Expectations, Objectives and and Processes Customer Expectations Customer Requirements Quality/Business Objectives Quality/Business Planning Processes
BMS ALIGNMENT
Key Transition Challenges (cont’d) Design and Development for Manufacturing Processes Purchasing Customer Satisfaction Supplemental Requirements Process Approach to Auditing
Auditing ISO/TS 16949:2002 – Key Approach Differences as Viewed by IATF Process Approach to Audit Customer Oriented Process- These processes start with customer requirements and then end with output. The input and output need to be checked against each other to see if the output satisfies the input. They want all the COPs identified in the organization. They want to the process to have a clear line of sight from the customer to the organization The Audit Plan should have key processes instead of elements Needs to identify the key processes and COPS from Readiness Review Performance Linked to common metrics for organization and supplier Oversight – Adherence to the “rules” and Common Global Process Throw away the checklist and use the organization’s procedure to do the audit Use the checklist to make sure you are through, but not as the list of questions.
Auditing Approach (cont’d) They stressed the definition of remote location (not being able to get certificates) and that the site being production and manufacturing.  Sites should supply Automotive to get ISO/TS 16949:2002 certificates Each of the OEMs will have links to their websites where the customer specific documents can be gotten.
How Much Training for Auditors? Omnex View If they have already attended RAB-certified internal or lead auditor training, then take the transition training with one day readiness and customer specific training If they are new auditors, then the RAB certified internal auditor training for ISO/TS with one day readiness and customer specific training If they are lead auditors for the system audit or the lead implementers, then the RAB certified lead auditor training for ISO/TS
Importance of Customer and Customer Specific Requirements
Importance of Customer Specific Requirements Understanding and Implementing Customer Specific Requirements is key to ISO/TS 16949:2002 Customer names will be included in the Scope of the Certificate
Customer Specific Requirements Customer specific requirements will fundamentally change the following: Documentation requirements Auditor requirements Many other requirements For Example Ford Additional Requirements adds the following: ISO 14001 mandatory requirements Manufacturing Plant Requirements – 10 requirements – affecting everything from FMEA to PPAP Phased PPAP requirements APQP requirements MMOG Requirements
Customer Specific Requirements – Visteon and Delphi Currently being worked on Adds many new requirements to ISO/TS 16949:2002 Needs to be included in documented system Needs to be audited in internal audit by trained auditors
Customer Requirements for Internal Auditors Curriculum requirements Pretest requirements Training and testing requirements Practice session equivalent to one day Trainer requirements equivalent to Registrar Auditor Certification Requirements (with some latitude)
Important Deadlines
Facts About ISO/TS 16949:2002 QS-9000 goes away 2006, Dec. 15 Note: DCX deadline is July, 2004 Past Dec. 15, 2003 the organization needs to get QS-9000 audits and ISO 9001:2000 audits to maintain ISO standing Chad’s note: If you are going to implement QS with ISO 9001:2000, why then not go directly to ISO/TS 16949:2002. Imagine the conflicts between the ISO 1994 version and the ISO 2000 version. Includes Vehicle Assembly Centers For all practical purposes, ISO/TS 16949:2002 deadline is Dec. 15, 2003.
What happens after Dec. 15, 2003? ISO 9001:1994 will no longer be a certifiable standard QS-9000 will become a stand alone certificate Note if you seek ISO 9001:2000 registration you must get a separate certification ISO/TS 16949:1999 will end in 2004 Visteon and Delphi will announce their own deadlines
Getting Value from Implementations
Getting Value from Your Implementation Set Objectives for your ISO/TS 16949:2002 Implementations Find crucial senior management problems to work on  SAVE Money with the implementation For example: Setting business objectives and a management process Implement Six Sigma or Lean as a part of the continual improvement process – Save Money Process  and documentation Commonization Improved Problem solving with lead time and cost savings target Become Process focused – Follow the Omnex approach
Getting Value from Your Implementation (cont’d) Use the alignment methodology to become customer focused Train your implementation team and Auditors Use the idea of a BMS and not a QMS Use software which has prescribed Best In Class Methods – Use to optimize the implementation and make it easy. Use web based software Documentation Customer Focus and Continual Improvement APQP and PPAP Process Mapping and Process Flows Get your top management involved in the implementation
Getting Value from ISO/TS 16949:2002 Disciplined product development and product approval process Disciplined problem solving approach Common customer satisfaction metrics Common Process Approach – COPS, MOPS etc. Higher quality registrar audit worldwide FMEA/Control Plans/Work Instructions Emphasis on Statistical methods and process improvement Emphasis on Measurement Systems Analysis
Strategic Choices
Strategic Choices How to implement ISO/TS 16949:2002 Site vs. remote location Implement everywhere or just implement in automotive plants/design groups Setting overall objectives for success Choose your registrar for worldwide registration Commonization of processes and documentation Documentation decisions for customization How to integrate customer specific requirements? What to do with the supply base? Planning the involvement of top management

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Implementing ts strategic-choices_5_2003

  • 1. Implementing ISO/TS 16949:2002 - Strategic Choices San Jose, California Chad Kymal
  • 2. Agenda Basic Facts About ISO/TS 16949:2002 Transitioning from QS-9000 – Key Differences Importance of the Customer and Customer Specific Requirements Important Deadlines Getting Value from ISO/TS 16949:2002 Implementations Strategic Choices
  • 4. ISO/TS 16949:2002 Basics – What is ISO/TS 16949:2002? Incorporates ISO 9001:2000 Replaces US, and European Standards QS-9000, VDA, etc. Document reflecting worldwide automotive requirements – US, Europe, and Asia Customized for Semiconductor Industry with ISO/TS 16949:2002 Semiconductor Supplement
  • 5. ISO/TS 16949:2002 Basics – Documents Auditors and Implementers need to Know ISO/TS 16949:2002 Technical Standard ISO/TS 16949:2002 Guidance Document Rules for Automotive Certification Scheme Quality System Checklist Customer Specific Requirements ISO/TS 16949:2002 Semiconductor Supplement
  • 6. ISO/TS 16949:2002 Semiconductor Supplement Adds requirements to the ISO/TS 16949:2002 Required to be included in documented system Needs to be audited in QMS by internal auditors Needs to be audited by registrar Included in Scope of audit
  • 7. ISO/TS 16949:2002 Third Party Registration Scheme
  • 8. IATF View on ISO/TS 16949:2002 Automotive Industry – Value added requirements Global Quality System Content Global Recognition Certificate Common Registration Requirement and Oversight Body for registrars Reduced number of registrars- one contract and certification committee centralized in one office Common Auditor Qualification Process Approach to auditing is key to the transition from QS-9000 to ISO/TS 16949:2002!
  • 9. Comparison of ISO/TS 16949 and QS-9000 QS-9000 Released in 1994 22,500 Certifications 174 Registrars with multiple offices 22 Accreditation Bodies ISO/TS 16949 First edition released in 1999 1724 Certifications 48 Registrars 5 Regional Offices for Accreditation
  • 10. Transitioning from QS-9000 to ISO/TS 16949:2002 Key Differences
  • 11. Key Transition Challenges Process Approach – COPs, MOPs, and SOPs Customer Focus Objectives Deployment Management (Business) Review Human Resources and Competency
  • 13. Process Characteristics A process can be identified by a series of unique, but consistent, characteristics. There are six characteristics of a process that are mandatory for effective quality management. A process owner exists The process is defined The process is documented The linkages of the process are established The process is monitored and improved Records are maintained
  • 14. OMNEX’s View of the Processes OMNEX believes there are four types of processes. Customer Oriented Processes (COPs) Management Oriented Processes (MOPs) Support Processes (SOPs) ISO/TS 16949:2002 Related Processes
  • 15. Process Approach – Omnex’s View Process Map Process List (linkage from Process Map (processes) to Documentation) BMS Control Plan Alignment Chart
  • 16. Customer Focus - Align Expectations, Objectives and and Processes Customer Expectations Customer Requirements Quality/Business Objectives Quality/Business Planning Processes
  • 18. Key Transition Challenges (cont’d) Design and Development for Manufacturing Processes Purchasing Customer Satisfaction Supplemental Requirements Process Approach to Auditing
  • 19. Auditing ISO/TS 16949:2002 – Key Approach Differences as Viewed by IATF Process Approach to Audit Customer Oriented Process- These processes start with customer requirements and then end with output. The input and output need to be checked against each other to see if the output satisfies the input. They want all the COPs identified in the organization. They want to the process to have a clear line of sight from the customer to the organization The Audit Plan should have key processes instead of elements Needs to identify the key processes and COPS from Readiness Review Performance Linked to common metrics for organization and supplier Oversight – Adherence to the “rules” and Common Global Process Throw away the checklist and use the organization’s procedure to do the audit Use the checklist to make sure you are through, but not as the list of questions.
  • 20. Auditing Approach (cont’d) They stressed the definition of remote location (not being able to get certificates) and that the site being production and manufacturing. Sites should supply Automotive to get ISO/TS 16949:2002 certificates Each of the OEMs will have links to their websites where the customer specific documents can be gotten.
  • 21. How Much Training for Auditors? Omnex View If they have already attended RAB-certified internal or lead auditor training, then take the transition training with one day readiness and customer specific training If they are new auditors, then the RAB certified internal auditor training for ISO/TS with one day readiness and customer specific training If they are lead auditors for the system audit or the lead implementers, then the RAB certified lead auditor training for ISO/TS
  • 22. Importance of Customer and Customer Specific Requirements
  • 23. Importance of Customer Specific Requirements Understanding and Implementing Customer Specific Requirements is key to ISO/TS 16949:2002 Customer names will be included in the Scope of the Certificate
  • 24. Customer Specific Requirements Customer specific requirements will fundamentally change the following: Documentation requirements Auditor requirements Many other requirements For Example Ford Additional Requirements adds the following: ISO 14001 mandatory requirements Manufacturing Plant Requirements – 10 requirements – affecting everything from FMEA to PPAP Phased PPAP requirements APQP requirements MMOG Requirements
  • 25. Customer Specific Requirements – Visteon and Delphi Currently being worked on Adds many new requirements to ISO/TS 16949:2002 Needs to be included in documented system Needs to be audited in internal audit by trained auditors
  • 26. Customer Requirements for Internal Auditors Curriculum requirements Pretest requirements Training and testing requirements Practice session equivalent to one day Trainer requirements equivalent to Registrar Auditor Certification Requirements (with some latitude)
  • 28. Facts About ISO/TS 16949:2002 QS-9000 goes away 2006, Dec. 15 Note: DCX deadline is July, 2004 Past Dec. 15, 2003 the organization needs to get QS-9000 audits and ISO 9001:2000 audits to maintain ISO standing Chad’s note: If you are going to implement QS with ISO 9001:2000, why then not go directly to ISO/TS 16949:2002. Imagine the conflicts between the ISO 1994 version and the ISO 2000 version. Includes Vehicle Assembly Centers For all practical purposes, ISO/TS 16949:2002 deadline is Dec. 15, 2003.
  • 29. What happens after Dec. 15, 2003? ISO 9001:1994 will no longer be a certifiable standard QS-9000 will become a stand alone certificate Note if you seek ISO 9001:2000 registration you must get a separate certification ISO/TS 16949:1999 will end in 2004 Visteon and Delphi will announce their own deadlines
  • 30. Getting Value from Implementations
  • 31. Getting Value from Your Implementation Set Objectives for your ISO/TS 16949:2002 Implementations Find crucial senior management problems to work on SAVE Money with the implementation For example: Setting business objectives and a management process Implement Six Sigma or Lean as a part of the continual improvement process – Save Money Process and documentation Commonization Improved Problem solving with lead time and cost savings target Become Process focused – Follow the Omnex approach
  • 32. Getting Value from Your Implementation (cont’d) Use the alignment methodology to become customer focused Train your implementation team and Auditors Use the idea of a BMS and not a QMS Use software which has prescribed Best In Class Methods – Use to optimize the implementation and make it easy. Use web based software Documentation Customer Focus and Continual Improvement APQP and PPAP Process Mapping and Process Flows Get your top management involved in the implementation
  • 33. Getting Value from ISO/TS 16949:2002 Disciplined product development and product approval process Disciplined problem solving approach Common customer satisfaction metrics Common Process Approach – COPS, MOPS etc. Higher quality registrar audit worldwide FMEA/Control Plans/Work Instructions Emphasis on Statistical methods and process improvement Emphasis on Measurement Systems Analysis
  • 35. Strategic Choices How to implement ISO/TS 16949:2002 Site vs. remote location Implement everywhere or just implement in automotive plants/design groups Setting overall objectives for success Choose your registrar for worldwide registration Commonization of processes and documentation Documentation decisions for customization How to integrate customer specific requirements? What to do with the supply base? Planning the involvement of top management