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  • The goal of ISO/TS 16949 is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. Application: This standard applies to the design/development, production and, when relevant, installation and servicing of automotive-related products. Remote locations such as design centers, corporate headquarters and distribution centers cannot obtain stand-alone certification to ISO/TS 16949. While ISO 9001:2000 permitted exclusions from section 7, the only permitted exclusions from ISO/TS 16949 relate to clause 7.3 covering product and process design and development. However process design and development cannot be excluded. The requirements are intended to be applied throughout the supply chain and for the first time vehicle assembly plants will beencouraged to seek ISO/TS 16949 certification.
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  • Relaxations The requirement for a business plan has been deleted because it presented problems during auditing. The requirements for 100% on time delivery from suppliers and to customer has been replaced with a requirement to monitor delivery schedule performance Benchmarking has been reduced to a note probably because most organizations do this anyway and the because in general the intentwas to remove "how to" type statements and focus on "what to" type requirements. The requirements for goals to be defined has been removed because the ISO 9001 requirement for quality objectives to be defined by top management meets the intent of the former requirement. There is a change in focus from process to manufacturing process primarily because this is where the vehicle manufacturers believe there remains a problem. It does not reduce the ISO 9001. requirements.
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  • Automotive specific requirements Acceptance criteria Analysis and use of data Appearance items Calibration Records Cleanliness of premises Confidentiality Contingency plans Control of reworked product Control plan Corrective action impact Customer communication Customer designated special characteristics Customer information Customer owned tooling Customer representative Customer waiver Customer-approved sources Employee motivation and empowerment Error-proofing Feedback of information from service Identification of statistical tools Incoming product quality Internal audit plans Internal auditor qualification Knowledge of basic statistical concepts Laboratory requirements Layout inspection and functional testing Manufacturing process audit Manufacturing process design input Manufacturing process design output Manufacturing process improvement Measurement system analysis Measurements at specified stages of design and development Monitoring and measurement of manufacturing processes Multidisciplinary approach On the job training Organization manufacturing feasibility Personnel safety Plant, facility and equipment planning Preventive and predictive maintenance Problem solving Product approval process Product audit Product design outputs Product design skills Production scheduling Prototype program Quality objectives Quality management system audit Quality management system performance monitoring Quality responsibilities Regulatory compliance Rejected product test/analysis Servicing agreement with customer Storage and inventory Supplier monitoring Supplier quality management system development Tooling management Verification of job set-ups Work instructions
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  • Iso16949 new

    1. 1. To an Introduction to ISO/TS/16949©Robere & Associates (Thailand) Ltd. 2002 1
    2. 2. Agenda • Company approach • The Specification • Administrative issues©Robere & Associates (Thailand) Ltd. 2002 2
    3. 3. How to Create, Implement and Maintain an ISO/TS16949 System that adds “value” to your company..©Robere & Associates (Thailand) Ltd. 2002 3
    4. 4. Management vs Assurance • QS9000 with it’s foundation in ISO9001:1994 is a Quality Assurance Customer requirement. • ISO/TS 16949 with it’s foundation in ISO9001:2000 is a Quality Management System • This difference identifies the focus of our activities.©Robere & Associates (Thailand) Ltd. 2002 4
    5. 5. Steps to transition..QS – TS - The Seven “R’s” - 1. Review your existing system against the new requirements 2. Reformat the structure and the approach 3. Regulate the implementation activities 4. Renew your skills for the new system 5. Rejoice in the improvements 6. Report on the Audit activities and 7. Redo the process©Robere & Associates (Thailand) Ltd. 2002 5
    6. 6. Review your existing system against the new requirements • The second edition of the standard is being finalized • Look at the QS9000 requirements against ISO/TS16949 as well as ISO9001:2000. • Determine the “gap”. • There have been some “relaxations in the revised requirement©Robere & Associates (Thailand) Ltd. 2002 6
    7. 7. Reformat the structure and the approach • Existing document structure will work QUALITY SYSTEM DOCUMENTATION PROGRESSION • Identify new International Standards ISO 9001/ISO9002  Sector Requirements Defines international quality system requirements International automotive quality references ISO/TS 16949 system requirements Part and Process Approval Procedures Customer-supporting reference manuals on: Level 1  (see bibliography) RS Defines IE Quality Approach & Advanced • ISO/TS 16949 more Quality Planning PL Responsibility S UP Manual Level 2  Control Plan L Defines Who UA Procedures What, When Tools and techniques ID DIV Level 3 prescriptive than Job Instructions Answers IN How Level 4 Prompts recording of Other Documentation information such as forms, tags, labels ISO9001:2000©Robere & Associates (Thailand) Ltd. 2002 7
    8. 8. QUALITY SYSTEM DOCUMENTATION PROGRESSION Defines International Standards ISO 9001/ISO9002 international quality system requirements  International Sector Requirements automotive quality ISO/TS 16949 system requirements Part and Process Approval Procedures Customer-supporting reference manuals on: Level 1  (see bibliography) ERS Defines Approach & Advanced P LI Quality Responsibility Quality Planning SU P Manual Level 2  Control Plan U AL Procedures Defines Who What, When Tools and techniques V ID DI Level 3 Job Instructions Answers IN How Level 4 Prompts recording of Other Documentation information such as forms, tags, labels©Robere & Associates (Thailand) Ltd. 2002 8
    9. 9. QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT R S C e Management aC q responsibility t u su u is i r 5 s t o e ft m Resource Measurement, a mo e management 6 8 analysis improvement c e n t rm t o se nr Input Product Output (and/or service) 7 Realization Product/ Service Quality Management Process Model©Robere & Associates (Thailand) Ltd. 2002 9
    10. 10. Regulate the implementation activities • Establish the QMR and the team • Establish the plan • Follow the plan • Management must “lead” the activities through example©Robere & Associates (Thailand) Ltd. 2002 10
    11. 11. Renew your skills for the new • system Ensure that all staff responsible for the system are trained in: – Customer focused activities Eight Quality Management Principles – Leadership 1. Customer-Focused Organization. Customer- – How to involve their staff in the day 2. Leadership. 3. Involvement of People. to day activities 4. Process Approach. – The philosophy of a process and 5. System Approach to Management. 6. Continual Improvement. system approach to management 7. Factual approach to decision making. 8. Mutually beneficial supplier relationships. – Continuous improvement tools – The methods of a factual approach to decision making – The steps to develop supplier relationships©Robere & Associates (Thailand) Ltd. 2002 11
    12. 12. Eight Quality Management Principles 1. Customer-Focused Organization. 2. Leadership. 3. Involvement of People. 4. Process Approach. 5. System Approach to Management. 6. Continual Improvement. 7. Factual approach to decision making. 8. Mutually beneficial supplier relationships.©Robere & Associates (Thailand) Ltd. 2002 12
    13. 13. Renew your skills for the additional requirements • All clauses of ISO9001:2000 • Many requirements were carried over from the 1st edition • Helps to strengthen the automotive QMS Requirements©Robere & Associates (Thailand) Ltd. 2002 13
    14. 14. Rejoice in the improvements • Recognize those who have contributed to the system improvements • Plan other activities that would involve more staff • “Post” all the improvement activities for everyone to see.©Robere & Associates (Thailand) Ltd. 2002 14
    15. 15. Report on the Audit activities • Audits are for improvement and for the prevention of non-conformances. • Use the internal audits for continuous improvements©Robere & Associates (Thailand) Ltd. 2002 15
    16. 16. Redo the process • Even though you’ve been certified, constantly review existing process for improvement. • Document your activities..they become part of your overall quality improvement program©Robere & Associates (Thailand) Ltd. 2002 16
    17. 17. Part 1: Conclusion.. • The new requirement brings greater benefits • Upgrade your system for improvement, using the “Quality Management Tools • Focus on the long- term improvement©Robere & Associates (Thailand) Ltd. 2002 17
    18. 18. THE GLOBAL QUALITY SYSTEM SPECIFICATION FOR THE AUTOMOTIVE INDUSTRY©Robere & Associates (Thailand) Ltd. 2002 18
    19. 19. Evolution of ISO/TS16949 International Automotive Task Force (IATF) •France (EAQF-94) Peugeot / Citroen, Renault Automobiles •Germany (VDA 6.1) BMW, AUDI, Bosch, GME/Opel, Mercedes Benz, Volkswagen •Italy (AVSQ) Fiat, Magneti Marelli •USA (QS-9000) Daimler Chrysler, Ford, General Motors, VW of America©Robere & Associates (Thailand) Ltd. 2002 19
    20. 20. Evolution of ISO/TS16949 Trade Associations supporting the IATF •ANFIA, Italy •AIAG, USA •CCFA, France •FIEV, France •SMMT Ltd., UK •VDA, Germany©Robere & Associates (Thailand) Ltd. 2002 20
    21. 21. Goal of ISO/TS 16949 “The goal of this Technical Specification is the development of a quality management system that provide for continuous improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain”.©Robere & Associates (Thailand) Ltd. 2002 21
    22. 22. Scope of ISO/TS16949 The Technical Specification is applicable to production and service part supplier and subcontractor “sites” providing: •Parts or Materials, or •Heat Treating, painting, plating, or other finishing services, or other customer-specified products. •“Remote Locations” need to be covered too. •“Remote Locations” cannot obtain standalone certification •The Technical Specification can be applied throughout the automotive supply chain.©Robere & Associates (Thailand) Ltd. 2002 22
    23. 23. How does ISO/TS16949 align with the existing Sector Specific Standards? • The elements of the ISO/TS/are closely aligned with the elements of the four automotive standards •Most of the elements of ISO/TS/can be traced to a minimum of one of the four automotive standards. •Many of the elements can be traced to all four standards©Robere & Associates (Thailand) Ltd. 2002 23
    24. 24. Quality Related Requirements Part More Specific Commodity Division Company ISO/TS /TS16949 Sector Fundamental More ISO/TS 9001:2000 Generic©Robere & Associates (Thailand) Ltd. 2002 24
    25. 25. Expected Benefits of ISO/TS/16949 • Improved product and process quality •Provide additional confidence for global sourcing •Freeing up supplier resources for other quality activities •Common quality system approach in the supply chain for supplier/subcontractor development and consistency. •Reduction of variation and increased efficiency©Robere & Associates (Thailand) Ltd. 2002 25
    26. 26. Benefits of ISO/TS/16949 • Reduction in 2nd party system audits •Reduction in multiple 3rd party registrations •Common language to improve understanding of quality requirements©Robere & Associates (Thailand) Ltd. 2002 26
    27. 27. Foreword to the ISO/TS/16949 •Based on ISO9000 - ISO 9001:2000 Text is Boxed •Sector specific requirements are outside the boxes •“Shall” is a mandatory requirement •“Notes” are for guidance in understanding •“Should” in a note is for guidance purposes only •The term “such as” is used only for guidance©Robere & Associates (Thailand) Ltd. 2002 27
    28. 28. More Requirements for management!!  To list the goals, objectives, and measurements used to support the quality policy  To put in place a method of determining customer satisfaction  To develop a method of continuous improvement  To assign a customer representative (different from management representative)  To inform management of noncompliant goods and take corrective action  To assign quality responsible people on all shifts©Robere & Associates (Thailand) Ltd. 2002 28
    29. 29. More Requirements for management!!  To use of project management  To use of advanced product quality planning (APQP)  To establish cost of quality as part of management  To review a detailed business plan for the company  To analyze the company data on effectiveness, efficiency, quality, etc.  To use of benchmarking system of motivating employees towards continuous improvement  To analyze product safety  To account for applicable regulations, including health, safety, and the environment.©Robere & Associates (Thailand) Ltd. 2002 29
    30. 30. Foundation & Familiarization ISO/TS 16949 Conformance and Guidance Standards©Robere & Associates (Thailand) Ltd. 2002 30
    31. 31. Foundation & Familiarization The ISO/TS 16949 Conformance standard: – Contains five primary clauses (4-8) and 23 sub-clauses – 116 sub-sub clauses, 91 of which are directly related to automotive requirements.©Robere & Associates (Thailand) Ltd. 2002 31
    32. 32. ISO/TS16949:2000 Clause - 0 Introduction • Describes the standard to address customer satisfaction and regulatory requirements to compliment product technical requirements • Defines the “process approach” as the systematic identification and management of processes and their interaction • The clause structure of ISO/TS16949:2000 follows this “process approach”©Robere & Associates (Thailand) Ltd. 2002 32
    33. 33. ISO/TS16949:2000 – Clause 1 Scope (1.1) • Establishes the “intent” of the standard – To provide a product that meets specification – To address customer satisfaction – To ensure continual improvement – To prevent nonconformity – Additional focus on Automotive requirements – Applicable to production and service part organization sites where customer specified products are manufactured. – Remote locations such as design centers, corp headquarters, but cannot obtain a “stand-alone” certification – Can be applied throughout the automotive supply chain.©Robere & Associates (Thailand) Ltd. 2002 33
    34. 34. ISO/TS16949:2000 – Clause 1.2 Application (Exclusions) • States the rules for permitting exclusion of requirements of clause 7, where they do not apply because of the nature of the organization: – For ISO/TS16949 only 7.3 (Design) can be excluded – Cannot exclude “manufacturing process” design©Robere & Associates (Thailand) Ltd. 2002 34
    35. 35. ISO/TS16949:2000 – Clause 2 Normative reference • Identifies ISO 9000:2000 Quality Management Systems – Fundamentals and Vocabulary as a standard whose content also applies in meeting ISO/TS16949 requirements.©Robere & Associates (Thailand) Ltd. 2002 35
    36. 36. ISO/TS16949:2000 Clause 3:Terms and definitions  Describes the change in terms:  Supplier (old) = organization (new)  Sub-contractor (old) = supplier (new)  Notes that “product” can apply to hardware, software, services and processed materials.  Product can therefore be a “product” or “service”.©Robere & Associates (Thailand) Ltd. 2002 36
    37. 37. Additional ISO/TS 16949 3.1 Terms and Definitions for the automotive Industry • Continual Improvement • Control Plan • Design Responsible Organization • Error Proofing • Laboratory Scope • Manufacturing • Outsourcing • Predictive Maintenance • Premium freight©Robere & Associates (Thailand) Ltd. 2002 37
    38. 38. 4.1 General Requirements • Shall – Establish – Document – Implement – Maintain – Continually improve the Quality Management System (QMS)©Robere & Associates (Thailand) Ltd. 2002 38
    39. 39. 4.1 General Requirements • Shall implement by; a. Identify processes required for the QMS b. Determine sequence & interaction of process c. Determine criteria and methods required for effective operation and control d. Ensure availability of resources/information to support operations and monitoring e. Measure, monitor & analyse f. Implement actions necessary to achieve planned results & continual improvement Note: When an organization outsources, they cannot delegate the technical responsibility©Robere & Associates (Thailand) Ltd. 2002 39
    40. 40. 4.2 General - Documentation requirements • The QMS documentation shall include; a. Documented statements of a quality policy and quality objectives b. A Quality Manual c. Documented procedures as required by ISO/TS 9001:2000 d. Documents required by an organisation to ensure; • Effective planning/operation • Control of its processes a. Quality records required by ISO/TS 9001:2000©Robere & Associates (Thailand) Ltd. 2002 40
    41. 41. 4.2 General Documentation requirements • Note: • The scope of the QMS shall be dependant upon a. Size and type of the organisation b. Complexity and interaction of the processes c. Competence of personnel©Robere & Associates (Thailand) Ltd. 2002 41
    42. 42. 4.2.2 Quality Manual • A quality manual shall be established and maintained which includes; a. The scope of the QMS • Including details and justification of any exclusions a. Documented procedures or reference to these b. Description of sequence & interaction of processes included in the QMS.©Robere & Associates (Thailand) Ltd. 2002 42
    43. 43. 4.2.3 Control of documents • Documents required for the QMS shall be controlled. Documents defined as quality records shall be controlled as per 4.2.4 • A documented procedure shall be established to; a. approve documents for adequacy prior to use b. review, update as necessary and re-approve documents c. To assure that changes and the current revision status of documents are identified d. Ensure that relevant versions of applicable documents are available at points of use e. Ensure that documents remain legible and readily identifiable f. Ensure documents of external origin are identified and their distribution controlled g. Prevent unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any other purpose©Robere & Associates (Thailand) Ltd. 2002 43
    44. 44. 4.2.3 Control of documents 4.2.3.1 – Engineering Specifications •Shall have a process to assure a timely (not more than two weeks) review, distribution and implementation of all customer engineering standards/specifications and changes. •Must keep records of the change©Robere & Associates (Thailand) Ltd. 2002 44
    45. 45. 4.2.4 Control of Quality Records• Quality records shall be established and maintained as objective evidence• Quality records shall be – Legible – Readily identifiable – Retrievable• A documented procedure shall define; ISO I SO / TS 169 49 / TS – Identification 900 1 – Legibility ISO ISO / TS 900 4 / TS – Storage 100 11 – Protection – Retrieval – Retention period – Disposition of quality records • 4.2.4.1: The organization shall define retention periods for QMS related documents and records to satisfy retulatory and customer requirements©Robere & Associates (Thailand) Ltd. 2002 45
    46. 46. TEAM EXERCISE: 15 Minutes Summarize in your team the preceding element of ISO/TS16949:2001. Explain in a short statement what the intent of the element is and it’s affect on your management approach.©Robere & Associates (Thailand) Ltd. 2002 46
    47. 47. 5.1 Management Commitment • Top management shall provide evidence of commitment to the development and improvement of the QMS by; a. Communicating the importance of meeting – Customer – Statutory – Regulatory a. Establishing the quality policy b. Ensuring quality objectives are established c. Conducting management reviews d. Ensuring the availability of resources©Robere & Associates (Thailand) Ltd. 2002 47
    48. 48. 5.1.1 Process efficiency • Top management shall monitor the product realization processes and the support processes to assure their effectiveness and efficiency©Robere & Associates (Thailand) Ltd. 2002 48
    49. 49. 5.2 Customer Focus • Top management shall ensure – Customer requirements are determined, then – Fulfilled, thereby, – enhancing customer satisfaction©Robere & Associates (Thailand) Ltd. 2002 49
    50. 50. 5.3 Quality Policy • Top management shall ensure that the quality policy; a. is appropriate to the purpose of the organisation b. Includes a commitment to comply with requirements and continual improve the effectiveness of the QMS c. Provides a framework for establishing and reviewing quality objectives d. Is communicated and understood within the organisation e. Is reviewed for continuing suitability©Robere & Associates (Thailand) Ltd. 2002 50
    51. 51. Planning: 5.4.1 Quality Objectives • Top Management shall ensure objectives, including product related objectives, are established at relevant functions and levels of the organisation. • These objectives shall be; – Measurable – Consistent with the Quality Policy • 5.4.1.1: The objectives shall be included in the business plan and used to deploy the quality policy©Robere & Associates (Thailand) Ltd. 2002 51
    52. 52. 5.4.2 Quality Management System Planning • Top management shall ensure that a. The planning of the QMS is carried out such that in meets the requirements of • “General Requirements” (4.1) • The stated Quality Objectives a. The integrity of the QMS is maintained when changes to the QMS are planned and implemented©Robere & Associates (Thailand) Ltd. 2002 52
    53. 53. 5.5.1 Responsibility, Authority and Communication • Top management shall ensure that the – Responsibilities and the – Authorities are defined and communicated within the organization • 5.5.1.1: – Management responsible for corrective action shall be promptly informed of non-conforming products or processes – Personnel responsible for quality shall have the authority to stop production to correct problems. – All shifts shall have someone responsible for quality©Robere & Associates (Thailand) Ltd. 2002 53
    54. 54. 5.5.2 Management Representative  Top Management shall appoint a member(s) from within its management team who is responsible for;  Ensuring the processes of the QMS are established, implemented and maintained  Reporting to top management on the performance of the QMS, including needs for improvement  Promoting awareness of customer requirements throughout the organization 5.5.2.1: Customer representative: Top management shall designate someone to represent the needs of the customer in all areas.©Robere & Associates (Thailand) Ltd. 2002 54
    55. 55. 5.5.3 Internal Communication • Top management shall; – Ensure appropriate communication processes are established – Ensure communication takes place regarding the effectiveness of the QMS©Robere & Associates (Thailand) Ltd. 2002 55
    56. 56. 5.6.1 Management Review: General • Top Management shall review the organisations QMS at planned intervals to ensure continuing; – Suitability – Adequacy – Effectiveness • The review shall include – Assessing opportunities for improvement – Need for changes to the QMS – Review of quality policy – Review of quality objectives • Records of management reviews shall be maintained • 5.6.1.1: The review shall cover – all elements of the QMS and performance trends. – Cost of poor quality – The achievement of objectives in the Quality Policy, the business plan and the level of customer satisfaction with supplied product©Robere & Associates (Thailand) Ltd. 2002 56
    57. 57. 5.6.2 Review Input  The input to management review shall include information on; • Results of audits • Customer feedback • Process performance and product conformity • Status of preventive and corrective action • Follow up actions from previous management reviews • Planned changes that could effect the QMS • Recommendations for improvement • 5.6.2.1: Input shall include an analysis of actual and potential field-failures and their impact on quality, safety, or the environment©Robere & Associates (Thailand) Ltd. 2002 57
    58. 58. 5.6.3 Review Output • The output from the management review shall include any decisions and actions related to; – Improvement of the effectiveness of the QMS and its processes – Improvement of product, related to customer requirements – Resource needs©Robere & Associates (Thailand) Ltd. 2002 58
    59. 59. TEAM EXERCISE: 15 Minutes Summarize in your team the preceding element of ISO/TS16949:2001. Explain in a short statement what the intent of the element is and it’s affect on your management approach.©Robere & Associates (Thailand) Ltd. 2002 59
    60. 60. Resource Management: 6.1 Provision of resources • The organisation shall determine and provide the resources needed to; a. To implement and maintain the QMS and continually improve its effectiveness b. To enhance customer satisfaction©Robere & Associates (Thailand) Ltd. 2002 60
    61. 61. Human Resources: 6.2.1 General • Personnel performing work affecting quality shall be competent on the basis of; – Appropriate education – Training – Skills – Experience©Robere & Associates (Thailand) Ltd. 2002 61
    62. 62. 6.2.2 Competence, awareness and training • The organisation shall; a. Determine the necessary competence for personnel performing work affecting quality b. Provide training or take other actions to satisfy these needs c. Evaluate the effectiveness of the actions taken d. Ensure that its personnel are aware of their own impact on quality e. Maintain appropriate records of education/training, skills and experience©Robere & Associates (Thailand) Ltd. 2002 62
    63. 63. Additional Automotive Requirements for training • 6.2.2.1: Product design skills: Individuals responsible for product design must be trained in tools and techniques • 6.2.2.2: Training: Must have a documented procedure to identify needs and achieving competence. Applies to everyone in the organization.©Robere & Associates (Thailand) Ltd. 2002 63
    64. 64. Additional Automotive Requirements for training • 6.2.2.3: Training on the job:Must have training in any new or modified job affecting product quality (includes contract or agency personnel) • 6.2.2.4: Employee Motivation and Empowerment: shall have a process to motivate and measure the extent the employees : – achieve quality objectives, – make continual improvements and – Create an environment to promote innovation – Shall include the promotion of quality and technological awareness throughout the whole organization.©Robere & Associates (Thailand) Ltd. 2002 64
    65. 65. • 6.3 Infrastructure The organisation shall: The organisation shall: – Determine – Provide – Maintain The infrastructure needed to achieve conformity to product requirements. As an example, infrastructure might be; a. Buildings, workspace and associated utilities b. Process equipment, both hardware & software c. Supporting services such as transport or communication©Robere & Associates (Thailand) Ltd. 2002 65
    66. 66. Additional Automotive Requirements • 6.3.1 Plant, Facility and equipment planning: – Use a multidisciplinary approach – Shall optimize material travel, handling and value- added use of floor space – Shall facilitate synchronous material flow – Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations. • 6.3.2 Contingency Plans: – Shall prepare contingency plans to satisfy customer requirements in case of emergency©Robere & Associates (Thailand) Ltd. 2002 66
    67. 67. 6.4 Work Environment • The organisation shall – Determine and manage the conditions of the work environment needed to achieve conformity to product requirements • 6.4.1 Personnel safety: – The quality policy and practices shall address activities to minimize potential risks • 6.4.2 Cleanliness of premises – Shall maintain the premises in a state of order, cleanliness and repair.©Robere & Associates (Thailand) Ltd. 2002 67
    68. 68. TEAM EXERCISE: 15 Minutes Summarize in your team the preceding element of ISO/TS16949:2001. Explain in a short statement what the intent of the element is and it’s affect on your management approach.©Robere & Associates (Thailand) Ltd. 2002 68
    69. 69. Product realization: 7.1 Planning and product realization  The organisation shall plan and develop the processes needed for product realization.  Planning of product realization shall be consistent with the QMS  In planning product realization, the organisation shall determine the following as appropriate  Quality objectives & requirements for the product  The need to establish processes, documents, and provide product specific resources  Continued next slide©Robere & Associates (Thailand) Ltd. 2002 69
    70. 70. 7.1 Planning and product realization ….cont… • In planning product realization, the organisation shall determine the following as appropriate….. c. Required • Verification, • Validation, • Monitoring, • Inspection and test activities specific to the product and the criteria for product acceptance d. Records needed to provide evidence that the realization processes and resulting product fulfill requirements • The output of this planning shall be in a form suitable for the organisations method of operations©Robere & Associates (Thailand) Ltd. 2002 70
    71. 71. Additional Automotive Requirements • 7.1.1 Planning of product realization: Customer requirements and tech specs shall be included in the planning • 7.1.2 Acceptance criteria: shall be defined by the organization and, where required, by the customer. For attribute data sampling, zero defects is required©Robere & Associates (Thailand) Ltd. 2002 71
    72. 72. Additional Automotive Requirements • 7.1.3 Confidentiality: Organization shall ensure the confidentiality of customer-contracted products and projects • 7.1.4 Change Control: – Organization must have a process to control and react to changes that impact product realization (including the supplier). – All proprietary designs, impact on form, fit and function shall be reviewed with the customer – If customer has additional verification/identification requirements, they shall be met©Robere & Associates (Thailand) Ltd. 2002 72
    73. 73. Customer Related Processes: 7.2.1 Determination of requirements related to the product • The organisation shall determine; a. Requirements specified by customer including • Requirements for delivery and post-delivery activities* a. Requirements not stated by the customer but necessary for specified use or known intended use b. Statutory and regulatory requirements related to the product c. Any additional requirements determined by the organisation * Post-delivery includes any after sales servicing©Robere & Associates (Thailand) Ltd. 2002 73
    74. 74. Additional Automotive Requirements • 7.2.1.1 Customer-designated special characteristics: The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.©Robere & Associates (Thailand) Ltd. 2002 74
    75. 75. 7.2.2 Review of requirements related to the product • The organisation shall – Review the requirements related to the product – Conduct this review prior a commitment to supply • The review shall ensure – Product requirements are defined – Contract or order requirements differing from those previously expressed are resolved – The organisation has the ability to meet the defined requirements • Records of the results of the review and actions arising from the review shall be maintained. Continued next slide…..©Robere & Associates (Thailand) Ltd. 2002 75
    76. 76. 7.2.2 Review of requirements related to the product…(cont) • Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organisation before acceptance • Where product requirements are changed, the organisation shall ensure – that relevant documents are amended – Relevant personnel are made aware of the changes©Robere & Associates (Thailand) Ltd. 2002 76
    77. 77. Additional Automotive Requirements • 7.2.2.1 Organization manufacturing feasibility: – The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process including risk analysis.©Robere & Associates (Thailand) Ltd. 2002 77
    78. 78. 7.2.3 Customer Communication  The organisation shall determine and implement effective arrangements for customer communication in relation to;  Product information  Enquiries, contracts or order handling, including amendments  Customer feedback, including customer complaints©Robere & Associates (Thailand) Ltd. 2002 78
    79. 79. Additional Automotive Requirements • 7.2.3.1 Customer communication – Supplemental – The organization shall have the ability to communicate necessary information, including data, in a customer-specified language and format (e.g. computer-aided design data, electronic data exchange).©Robere & Associates (Thailand) Ltd. 2002 79
    80. 80. Design and Development: 7.3.1 Design & Development planning • The organisationthe product.and control the design and development of shall plan • During design and development staged determine; The this stage the organisation shall  The review, verification and validation that are appropriate to each design and development stage  The responsibilities and authorities for design and development • The organisation shall manage all interfaces involved in design and development to ensure effective communication and clear assignment of responsibility • Planning output shall be updated, as appropriate, as the design and development progresses.©Robere & Associates (Thailand) Ltd. 2002 80
    81. 81. Additional Automotive Requirements • 7.3.1.1 Multidisciplinary approach: – The organization shall use a multidisciplinary approach to prepare for product realization, including: • Development/finalization and monitoring of special characteristics, • Development and review of FMEAs including actions to reduce potential risks, and • Development and review of control plans©Robere & Associates (Thailand) Ltd. 2002 81
    82. 82. 7.3.2 Design & Development Inputs • Inputs relating to product requirements shall be determined and records maintained. The shall include; – Functional and performance requirements – Applicable statutory and regulatory requirements – Where applicable, information derived from previous similar designs – Other requirements essential for design and development • These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.©Robere & Associates (Thailand) Ltd. 2002 82
    83. 83. Additional Automotive Requirements • 7.3.2.1 Product design input: – Shall identify, document and review the product design inputs including: • Customer requirements • Use of information • 7.3.2.2 Manufacturing process design input: – Shall identify, document and review the manufacturing design inputs including: • Product design output data • Targets for productivity • Customer requirements • Experience from previous developments©Robere & Associates (Thailand) Ltd. 2002 83
    84. 84. Additional Automotive Requirements • 7.3.2.3 Special Characteristics: – The organization shall identify special characteristics and • Include all special characteristics in the control plan • Comply with customer specified definitions and symbols and • Identify process control documents including: – Drawings, FMEAs, control plans, and operator instructions with customer’s special characteristic symbol.©Robere & Associates (Thailand) Ltd. 2002 84
    85. 85. 7.3.3 Design & Development Outputs • The outputs of design and development shall be provided in a form that enable verification against the design and development input and shall be approved prior to release. Design and development outputs shall; a. Meet the input requirements for design and development b. Provide appropriate information for purchasing, production and for service provision c. Contain or reference product acceptance criteria d. Specify the characteristics of the product that are essential for its safe and proper use©Robere & Associates (Thailand) Ltd. 2002 85
    86. 86. Additional Automotive Requirements • 7.3.3.1 Product design outputs – Supplemental: – Product design output shall be expressed in terms that can be verified and validated against product design input requirements – Shall include: • Design FMEA, reliability results, • Product special characteristics, specifications, • Product error-proofing, as appropriate, • Product definition including drawings or mathematically based data, • Product design reviews results, and • Diagnostic guidelines where applicable.©Robere & Associates (Thailand) Ltd. 2002 86
    87. 87. Additional Automotive Requirements • 7.3.3.2 Manufacturing process design output: – The output shall be expressed in terms that can be verified. They shall include: • Specifications and drawings, • Manufacturing process flow chart/layout, • Manufacturing process FMEAs • Control plan • Work instructions, • Process approval acceptance criteria, • Data for quality, reliability, maintainability and measurability, • Results of error-proofing activities as appropriate • Methods of rapid detection and feedback of product/manufacturing nonconformities©Robere & Associates (Thailand) Ltd. 2002 87
    88. 88. 7.3.4 Design & Development review • At suitable stages, systematic reviews of design and development shall be conducted; a. To evaluate the ability of the results of design and development to fulfill requirements b. To identify any problems and propose necessary actions • Participants in such reviews shall include representatives of functions concerned I the design and development area. Records of both the results of the reviews and actions shall be maintained©Robere & Associates (Thailand) Ltd. 2002 88
    89. 89. Additional Automotive Requirements • 7.3.4.1 Monitoring – Measurements at specified stages of design and development shall be defined, analyzed and reported with summary results as an input to management review.©Robere & Associates (Thailand) Ltd. 2002 89
    90. 90. 7.3.5 Design & Development Verification • Verification shall be performed to ensure; – Design & development outputs have satisfied the design and development inputs. • Records of the results of the verification and any action shall be maintained©Robere & Associates (Thailand) Ltd. 2002 90
    91. 91. 7.3.6 Design & Development validation • Design and Development validation shall be performed in accordance with planned arrangements to ensure – The product is capable of fulfilling the requirements for the specified or known intended use or application. • Wherever, practical, validation shall be completed prior to delivery or implementation of the product. • Records of the results of validation and any necessary actions shall be maintained.©Robere & Associates (Thailand) Ltd. 2002 91
    92. 92. Additional Automotive Requirements • 7.3.6.1 Design and development validation – Supplemental: – Design and development shall be performed in accordance with customer requirements including timing • 7.3.6.2 Prototype program: – When required, the organization shall have a prototype program and control plan. – All testing activities shall be monitored – Must be responsible for all outsourced services©Robere & Associates (Thailand) Ltd. 2002 92
    93. 93. Additional Automotive Requirements • 7.3.6.3 Product approval process: – The organization shall conform to a product and process approval procedure recognized by the customer.©Robere & Associates (Thailand) Ltd. 2002 93
    94. 94. 7.3.7 Control of design and development stages • Design and development changes shall be implemented and records maintained. • The changes shall be reviewed, verified and validated, as appropriate, and approved prior to implementation. • The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and delivered product. • Records of the result of the review of changes and any necessary actions shall be maintained©Robere & Associates (Thailand) Ltd. 2002 94
    95. 95. Purchasing: 7.4.1 Purchasing process • The organisation shall ensure that purchased product conforms to specified purchase requirements. • The type and extent of control applied to the supplier and the purchased product is dependant upon the effect of the purchased product on subsequent product realization or the final product. • The organisation shall evaluate and select suppliers based on their ability to supply product in accordance with the organisations requirements. • Criteria for selection, evaluation and re-evaluation shall be established. • Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.©Robere & Associates (Thailand) Ltd. 2002 95
    96. 96. Additional Automotive Requirements • 7.4.1.1 Regulatory compliance: all products or materials shall satisfy applicable regulatory requirements. • 7.4.1.2 Supplier quality management system development: suppliers to the organization shall be third- party registered to ISO9001:2000 by an accredited third party certification body • 7.4.1.3 customer-approved sources: where specified by the contract (e.g. customer engineering drawing specification) the organization shall purchase products, materials or services from approved sources©Robere & Associates (Thailand) Ltd. 2002 96
    97. 97. 7.4.2 Purchasing Information • Purchasing information shall describe the product to be purchased, including where appropriate; a. Requirements for approval of product, procedures, processes and equipment b. Requirements for qualification of personnel c. QMS requirements • The organisation shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier©Robere & Associates (Thailand) Ltd. 2002 97
    98. 98. 7.4.3 Verification of purchased product • The organisation shall establish and implement the inspection or other activities necessary for ensuring that purchased product conforms to specified requirements. • Where the organisation or the customer intends to perform verification at the suppliers premises, the organisation shall state the intended verification arrangements and method of product release in the purchasing information.©Robere & Associates (Thailand) Ltd. 2002 98
    99. 99. Additional Automotive Requirements • 7.4.3.1 Incoming product quality: – The organization shall have a proces to assure the quality of purchased products: • Receipt of and evaluation of statistical data by the organization • Receiving inspection and/or testing • Second or third party assessments or audits • Part evaluation by a designated laboratory • Another method agreed with the customer©Robere & Associates (Thailand) Ltd. 2002 99
    100. 100. Additional Automotive Requirements • 7.4.3.2 Supplier monitoring: – Supplier monitoring shall be monitored through: • Delivered part quality performance • Customer disruptions including field returns • Delivery schedule performance • Special status customer notifications related to quality or delivery issues©Robere & Associates (Thailand) Ltd. 2002 100
    101. 101. Production and service Provision: 7.5.1 Control of production & service provision • The organisation shall plan and carry out production and service provision under controlled conditions that shall include, as applicable; a. The availability of information that describes the characteristics of the product b. The availability of work instructions c. The use of suitable equipment d. The availability and use of monitoring and measuring devices e. The implementation of monitoring and measurement f. The implementation of release, delivery and post delivery activities©Robere & Associates (Thailand) Ltd. 2002 101
    102. 102. Additional Automotive Requirements • 7.5.1.1 Control Plan – Organization shall: • Develop control plans • Have a control plan for pre-launch and production – The control plan shall: • List the controls used for the manufacturing process • Include methods for monitoring special characteristics • Include customer required information • Initiate the specified reaction plan when the process is unstable.©Robere & Associates (Thailand) Ltd. 2002 102
    103. 103. Additional Automotive Requirements • 7.5.1.2 Work Instructions: The organization shall prepare documented work instructions for all employees having responsibilities for the operation of the processes. • 7.5.1.2 Verification of Job set-ups – Shall be verified whenever performed – Work instructions shall be available for set-up personnel©Robere & Associates (Thailand) Ltd. 2002 103
    104. 104. Additional Automotive Requirements • 7.5.1.4 Prevention and predictive maintenance: – The organization shall identify key process equipment and provide a planned preventive maintenance system: • Planned maintenance activities • Packaging and preservation of equipment, tooling • Availability of replacement parts for key manufacturing equipment • Documenting, evaluating and improving maintenance objectives.©Robere & Associates (Thailand) Ltd. 2002 104
    105. 105. Additional Automotive Requirements • 7.5.1.5 Management of production tooling: – Shall provide resources for tool and guage design, fabrication and verification – Shall establish a system for production tooling management: • Maintenance and repair facilities and personnel • Storage and recovery • Set-up • Tool-change programs for perishable tools • Tool design modification documentation • Tool modification and revision to documentation • Tool identification, defining the status, production repair or disposal – Shall implement a system to monitor these activities if any work is outsourced©Robere & Associates (Thailand) Ltd. 2002 105
    106. 106. Additional Automotive Requirements • 7.5.1.6 Production scheduling: shall be scheduled to meet customer requirements • 7.5.1.7 Feedback of Information from service: a process for communication of information shall be established and maintained • 7.5.1.8 Servicing agreement with customer: if there is a servicing agreement with the customer the organization shall verify the effectiveness of: – Organization service centers, – Any special purpose tools or measurement equipment – The training of servicing personnel©Robere & Associates (Thailand) Ltd. 2002 106
    107. 107. 7.5.2 Validation of processes for product and service provision • The organisation shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. • This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. • Validation shall demonstrate the ability of these processes to achieve planned results Continued next slide©Robere & Associates (Thailand) Ltd. 2002 107
    108. 108. 7.5.2 Validation of processes for product and service provision..cont • The organisation shall establish arrangements for these processes including, as applicable;  Defined criteria for review and approval of processes  Approval of equipment and qualification of personnel  Use of specific methods and procedures  Requirements for records  Re-validation©Robere & Associates (Thailand) Ltd. 2002 108
    109. 109. 7.5.3 Identification & Traceability • The organisation shall identify, where appropriate*, the product by suitable means through product realization • The organisation shall identify the product status with respect to monitoring and measuring requirements • Where traceability is a specified requirement, the organisation shall control and record the unique identification of the product. 7.5.3.1: the words “where appropriate” do not apply©Robere & Associates (Thailand) Ltd. 2002 109
    110. 110. 7.5.4 Customer property• The organisation shall exercise care with customer property while it is under the organisations control.• The organisation shall; – Identify – Verify – Protect – Safeguard customer property• If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained 7.5.4.1 Customer-owned production tooling: shall be permanently marked so that the ownership is visible and can be determined.©Robere & Associates (Thailand) Ltd. 2002 110
    111. 111. 7.5.5 Preservation of product• The organisation shall preserve the conformity of product during internal processing and delivery to the intended destination.• This preservation shall include; – Identification – Handling – Packaging – Storage – Protection• Preservation shall also apply to the constituent parts of a product 7.5.5.1 Storage and Inventory: stock shall be assessed at appropriate intervals. Organization shall use a stock rotation system like “FIFO”. Obsolete material shall be controlled.©Robere & Associates (Thailand) Ltd. 2002 111
    112. 112. 7.6 Control of Monitoring andmeasuring devices • The organisation shall determine the monitoring and measurement to be taken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements • The organisation shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements Continued next slide©Robere & Associates (Thailand) Ltd. 2002 112
    113. 113. 7.6 Control of Monitoring andmeasuring devices….cont… • Where necessary to ensure valid results, measuring equipment shall; a. Be calibrated or verified at specified intervals or prior to use, against national or international standards • Where no such standards exist, the basis used for calibration or verification shall be recorded a. Be adjusted or re-adjusted as necessary b. Be identified to enable calibration status to be determined c. Be safeguarded from adjustments that would invalidate the measurement result d. Be protected from damage and deterioration during handling, maintenance and storage Continued next slide…©Robere & Associates (Thailand) Ltd. 2002 113
    114. 114. 7.6 Control of Monitoring and measuring devices….cont…  Additionally, that organisation shall assess and record the validity of previous measuring results when equipment is found not to conform to specified requirements.  The organisation shall take appropriate action on the equipment and any product affected.  Records of the results of calibration and verification shall be maintained.  When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary©Robere & Associates (Thailand) Ltd. 2002 114
    115. 115. Additional Automotive Requirements • 7.6.1 Measurement system analysis: – statistical studies shall be conducted to analyze the variation in each type of measuring and test equipment – Shall apply to measurement systems referenced in the control plan – Shall conform to those in customer reference manuals©Robere & Associates (Thailand) Ltd. 2002 115
    116. 116. Additional Automotive Requirements • 7.6.2 Calibration records: – Records of the calibration shall include: • Equipment identification • Revisions from engineering changes • Any out-of-specification readings • An assessment of the impact of the out-of- specification • Statements of conformance to spec • Notification to the customer is suspect product has been shipped.©Robere & Associates (Thailand) Ltd. 2002 116
    117. 117. Additional Automotive Requirements – 7.6.3 Laboratory Requirements • 7.6.3.1 Internal Laboratory: – Shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. – Scope shall be included in the QMS documentation – Shall comply with: • Adequacy of laboratory procedures • Qualifications of the laboratory personnel conducting tests • Testing of the commodities • Capability to performs tests correctly traceable to standard • Review of related quality records©Robere & Associates (Thailand) Ltd. 2002 117
    118. 118. Additional Automotive Requirements – 7.6.3 Laboratory Requirements • 7.6.3.2 External Laboratory: – Shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. • Shall be accredited to ISO/IEC 17025 or equivalent or • Shall be evidence that the lab is acceptable to the customer©Robere & Associates (Thailand) Ltd. 2002 118
    119. 119. TEAM EXERCISE: 15 Minutes Summarize in your team the preceding element of ISO/TS9000:2000. Explain in a short statement what the intent of the element is and it’s affect on your management approach.©Robere & Associates (Thailand) Ltd. 2002 119
    120. 120. Measurement, Analysis and Improvement: 8.1 General 1. The organisation shall plan and implement the monitoring, measurement, analysis and improvement processes needed; a. To demonstrate conformity of the product b. To ensure conformity of the QMS c. To continually improve the effectiveness of the QMS 2. This shall include determination of applicable methods, including statistical techniques and the extent of their use.©Robere & Associates (Thailand) Ltd. 2002 120
    121. 121. Additional Automotive Requirements • 8.1.1 Identification of statistical tools: appropriate tools for each process shall be determined during advanced quality planning and included in the control plan • 8.1.2 Knowledge of basic statistical concepts: shall be understood and utilized throughout the organization©Robere & Associates (Thailand) Ltd. 2002 121
    122. 122. Monitoring and measurement: 8.2.1 Customer satisfaction • The organisation shall monitor information relating to customer perception as to whether the organisation has fulfilled customer requirements. • The methods for obtaining and using this information shall be determined©Robere & Associates (Thailand) Ltd. 2002 122
    123. 123. Additional Automotive Requirements • Customer satisfaction – Supplemental: shall be continually evaluated. Performance indicators include – Delivered part quality performance – Customer disruptions including field returns – Delivery schedule performance – Customer notification related to quality or delivery issues©Robere & Associates (Thailand) Ltd. 2002 123
    124. 124. 8.2.2 Internal Audit • The organisation shall conduct internal audits at planned intervals to determine whether the QMS; a. Conforms to planned arrangements, to the requirements of this international standard and to the QMS requirements established by the organisation b. Is effectively implemented and maintained Continued next slide…©Robere & Associates (Thailand) Ltd. 2002 124
    125. 125. 8.2.2 Internal Audit …cont.. • An audit program shall be planned, taking into consideration;  The status of the importance of the activity being audited  Results of previous audits • The audit criteria, scope, frequency and methods shall be defined • The process of selection of auditors and auditors themselves shall ensure objectivity and impartiality of the audit process. • Auditors shall not audit their own work. • Continued next slide…©Robere & Associates (Thailand) Ltd. 2002 125
    126. 126. 8.2.2 Internal Audit …cont.. • The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure. • The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. • Follow up activities shall include the verification of the actions taken and the reporting of verification results.©Robere & Associates (Thailand) Ltd. 2002 126
    127. 127. Additional Automotive Requirements • 8.2.2.1 Quality management system audit: shall audit the QMS to verify compliance with this TS and additional QMS requirements • 8.2.2.2 Manufacturing process audit: shall audit each manufacturing process to determine effectiveness • 8.2.2.3 Product audit: shall audit products at appropriate stages of production and delivery to very conformance to all specified requirements (e.g.dimensions, functionality, packaging and labeling)©Robere & Associates (Thailand) Ltd. 2002 127
    128. 128. Additional Automotive Requirements • 8.2.2.4 Internal Audit plans: audits shall cover quality management related processes, activities and shifts, and shall be scheduled according to an annual plan • 8.2.2.5 Internal auditor qualification: auditors shall be qualified to audit the requirements of this technical specification©Robere & Associates (Thailand) Ltd. 2002 128
    129. 129. 8.2.3 Monitoring & Measurement of processes • The organisation shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. • These methods shall demonstrate the ability of the processes to achieve planned results • When planned results are not achieved, correction and preventive action shall be taken, as appropriate, to ensure conformity of product©Robere & Associates (Thailand) Ltd. 2002 129
    130. 130. Additional Automotive Requirements • 8.2.3.1 Monitoring and measurement of manufacturing processes: – Shall perform process studies on all new manufacturing – Shall maintain manufacturing process capability or performance as specified by the customer • Measurement techniques • Sampling plans • Acceptance criteria, and • Reaction plans when acceptance criteria are not met – Significant process events shall be noted on control charts – Shall initiate a reaction plan for unstable or non- capable characteristics©Robere & Associates (Thailand) Ltd. 2002 130
    131. 131. 8.2.4 Monitoring & measurement of product • The organisation shallproduct to verify that product characteristics of the monitor and measure the requirements are fulfilled. • This shall be carried out at appropriate stages of product realization in accordance with planned arrangements • Evidence of conformance with the acceptance criteria shall be maintained. Records shall indicate person(s) authorising release of product • Product release and service delivery shall not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer.©Robere & Associates (Thailand) Ltd. 2002 131
    132. 132. Additional Automotive Requirements • 8.2.4.1 Layout inspection and functional testing: a layout inspection and a functional verification shall be perform for all products • 8.2.4.2 Appearance items: for products that are “appearance items” the organization shall provide: – Appropriate resources including lighting – Masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (as appropriate – Maintenance of appearance masters – Verification that “qualified” personal are used©Robere & Associates (Thailand) Ltd. 2002 132
    133. 133. 8.3 Control of Nonconforming product • The organisation shall ensure that product that does not conform to product requirements is identified and controlled to prevent unintended use or delivery. • The controls are related to responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure Continued next slide©Robere & Associates (Thailand) Ltd. 2002 133
    134. 134. 8.3 Control of Nonconforming product….cont • The organisation shall deal with nonconforming product by one or more of the following methods; – By taking action to eliminate the detected nonconformity – By authorising its use, release or acceptance under concession by a relevant authority and where applicable by the customer – By taking action to preclude its original intended use or application Continued next slide©Robere & Associates (Thailand) Ltd. 2002 134
    135. 135. 8.3 Control of Nonconforming product….cont • Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained. • When nonconforming product is corrected, it shall be subject to re-verification to demonstrate conformity to the requirements • When nonconforming product is detected after delivery or use has started, the organisation shall take action appropriate to the effects, or potential effects, of the nonconformity©Robere & Associates (Thailand) Ltd. 2002 135
    136. 136. Additional Automotive Requirements • 8.3.1 Control of nonconforming product: product with unidentified or suspect status shall be classified as nonconforming • 8.3.2 Control of reworked product: Instruction for rework, including re- inspection requirements, shall be accessible to and utilized by the appropriate personnel©Robere & Associates (Thailand) Ltd. 2002 136
    137. 137. Additional Automotive Requirements • 8.3.3 Customer information: customers shall be informed promptly in the event that nonconforming product has been shipped. • 8.3.4 Customer waiver: – Shall obtain customer concession or deviation prior to processing the order – Shall maintain a record of the expiration date. – shall adhere to the original spec at expiration – Also applies to purchased product; the organization shall agree with any requests from suppliers before submission to customer©Robere & Associates (Thailand) Ltd. 2002 137
    138. 138. 8.4 Analysis of data • The organisation shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made. • This shall include data generated as a result of monitoring and measurement and from other relevant sources. • The analysis of data shall provide information relating to; a. Customer satisfaction b. Conformance to product requirements c. Characteristics and trends of processes and products including opportunities for preventive action d. suppliers©Robere & Associates (Thailand) Ltd. 2002 138
    139. 139. Additional Automotive Requirements • 8.4.1 analysis and use of data: – Trends in quality and operational performance shall be compared with progress toward objectives • Development of priorities for prompt solutions to customer- related problems • Determination of key customer-related trends and correlation to support status review, decision making and longer term planning • An information system for the timely reporting of product information arising from usage.©Robere & Associates (Thailand) Ltd. 2002 139
    140. 140. Improvement: 8.5.1 Continual Improvement • The organisation shall continually improve the effectiveness of the QMS through the use of the; – Quality Policy – Quality objectives – Audit results – Analysis of data – Corrective and preventive action – Management review©Robere & Associates (Thailand) Ltd. 2002 140
    141. 141. Additional Automotive Requirements • 8.5.1.1 Continual improvement of the organization: the organization shall define a process for continual improvement • 8.5.1.2 Manufacturing process improvement: Continual improvement shall focus on control and reduction of variation in product characteristics and manufacturing process parameters.©Robere & Associates (Thailand) Ltd. 2002 141

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