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QS-9000 Topics We Will Cover

QS-9000 Topics We Will Cover. . Overview of QS-9000 The 20 Elements The Referenced Documents The Registration Process. QS-9000. Quality System Requirements. Section II Customer-Specific Requirements. Section I ISO 9000-Based Requirements. QS-9000 1. Management Responsibility.

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QS-9000 Topics We Will Cover

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  1. QS-9000Topics We Will Cover  Overview of QS-9000 The 20 Elements The Referenced Documents The Registration Process

  2. QS-9000 Quality System Requirements Section II Customer-Specific Requirements Section I ISO 9000-Based Requirements

  3. QS-90001. Management Responsibility • Quality policy • Organization • Responsibility and authority • Represent needs of the customer • Resources • Management representative • Organizational interfaces (APQP) • Information to Management (cont’d)

  4. QS-90001. Management Responsibility (cont’d) • Management review • All elements • Business plan (long and short term) • Analysis and use of company-level data • Customer satisfaction • Certification Body/Registrar Notification

  5. QS-90002. Quality System • Documented quality system • Effective implementation • Quality planning • APQP • Special characteristics • Feasibility Reviews • Product Safety • FMEA’s (cont’d)

  6. QS-90002. Quality System (cont’d) • Mistake Proofing • Control plan • Prototype • Pre-launch • Production • APQP / PPAP • Product Approval Process • PPAP (cont’d)

  7. QS-90002. Quality System (cont’d) • Subcontractor Requirements • Engineering Change Validation • Continuous Improvement • Quality, service and Price • Identify OFI’s • Demonstrate Knowledge of Techniques (cont’d)

  8. QS-90002. Quality System (cont’d) • Facilities and Tooling Management • Multi-disciplinary approach • Minimize travel and handling • Evaluate effectiveness • Tooling Management • Maintenance, storage, setup, etc • Resources for design and inspection

  9. QS-90003. Contract Review • Requirements defined • Resolution of differences from quote • Amendment to contract • Capability • All customer requirements • (QS-9000 Section II) • Contract reviews recorded

  10. QS-90004. Design Control • General • Use of previous design data • Design and development planning • Required skills • Organizational and technical interfaces • Design input • CAD/CAE (cont’d)

  11. QS-9000 4. Design Control (cont’d) • Design output • Specific process requirements • Design Review • Design verification • Design validation • Customer program timing • Design failures documented (cont’d)

  12. QS-9000 4. Design Control (cont’d) • Design changes • Written customer approval or waiver • PPAP • Proprietary designs • Consider effect on system • Customer prototype support • Confidentiality

  13. QS-9000 5. Document and Data Control • Document approval and issue • Reviewed and approved • Available • Appropriate Documents • Dwgs, stds, CAD data, WI’s, insp/test, Q man, specs, etc • Obsolete documents • Master list (cont’d)

  14. QS-9000 5. Document and Data Control (cont’d) • Engineering specifications • Timely review • Document changes • Reviewed and approved • Access to background info • Identify nature of change

  15. QS-90006. Purchasing • General • Approved materials for ongoing production • Government, safety and environmental regulations • Evaluation of subcontractors • Selection and control • Maintain records (cont’d)

  16. QS-90006. Purchasing • Subcontractor development - goal of compliance to QS-9000, Section 1 • Supplier still responsible for customer-designated subcontractors • Scheduling subcontractors - 100% on-time delivery (cont’d)

  17. QS-90006. Purchasing (cont’d) • Purchasing Data • Type • Specifications • Standards • Review and approve (cont’d)

  18. QS-90006. Purchasing (cont’d) • Verification of purchased product • By supplier • By customer

  19. QS-9000 7. Customer-Supplied Product • Returnable packaging included • Customer-owned tooling • affixed tag is preferred

  20. QS-90008. Product Identification and Traceability • Where appropriate...from receipt, through production, delivery, and installation • Suitable means, e.g. lot/part traveler or other identification • “Where appropriate” is not applicable

  21. Over 4,000 parts per car 70,000 combinations Biggest Problem = Stacked Tolerances

  22. QS-9000 9. Process Control • Documented procedures • Suitable equipment and environment • Cleanliness of premises • Contingency plans • Compliance with standards, codes, quality plans, procedures, etc. (cont’d)

  23. Process parameters and product characteristics Special characteristics Approval of processes and equipment Maintenance Preventive Maintenance procedure scheduled Predictive Improving Objectives QS-90009. Process Control (cont’d) (cont’d)

  24. QS-9000 9. Process Control (cont’d) • Special Processes • Records for processes, equipment and personnel • Process monitoring and operator instructions • Accessible at the work station (without job disruption) • Derived from APQP • Can be process sheets, travelers, instructions, procedures, standard operation sheets, etc. • Shall include 13 items as appropriate (cont’d)

  25. QS-9000 9. Process Control (cont’d) • Maintaining process control • Meet or exceed capability per PPAP • Reaction plans • Modified Process Control Requirements • Verification of Job Setups

  26. QS-9000 9. Process Control (cont’d) • Process Changes • Maintain records of effective dates • Changes for CI are encouraged • Appearance Items • Lighting, masters, qualified personnel

  27. QS-9000 10. Inspection and Testing • General • Acceptance criteria for attributes • Receiving inspection and testing • Specific methods • In-process inspection and testing • Direct activities to prevention vs detection (cont’d)

  28. QS-900010. Inspection and Testing (cont’d) • Final inspection and testing • Layout inspection and functional testing • Final product audit • Inspection and test records • Inspection authority (cont’d)

  29. QS-900010. Inspection and Testing (cont’d) • Supplier Laboratory Requirements • Laboratory quality systems - many similar requirements to ISO Guide 25/ISO 17025 • Laboratory personnel • Laboratory product ID and testing • Laboratory process control • Laboratory testing and calibration methods • Laboratory statistical methods (cont’d)

  30. QS-900010. Inspection and Testing (cont’d) • Accredited Laboratories • ISO Guide 25/ISO17025 • Cannot be QS-9000 registered

  31. QS-900011. Inspection, Measuring, & Test Equip. • Procedures • Conformance demonstration • ISO 10012-1:1992 • Capable of accuracy & precision • Id & calibrate at prescribed intervals • Calibration services • Qualified in-house • Accredited commercial/independent • Customer recognized government agency • Calibration status • Validity of previous results • Hardware and software safeguards • Specific records • Measurement system analysis (cont’d)

  32. QS-900011. Inspection, Measuring, & Test Equip. (cont’d) • Define process • Id, location, frequency, method, criteria, etc • Indicator of calibration status • Records • Validity of previous results • Environmental conditions • Handling, preservation & storage • Safeguard from adjustments (cont’d)

  33. QS-900011. Inspection, Measuring, & Test Equip. (cont’d) • Inspection, measuring and test equipment records • Revisions following engineering changes • As found readings • As left readings • Notification of suspect product • Measurement System Analysis

  34. QS-900012. Inspection and Test Status • Inspection stamps/tags/records • Authorized concessions • Product location • Supplemental verification

  35. QS-9000 13. Control of Nonconforming Product • Prevention from unintended use • Id, document, evaluate, segregate, dispose, notify • Suspect product • Visual identification • Nonconformity review and disposition • Re-inspection • Prioritized reduction plan with tracking (cont’d)

  36. QS-9000 13. Control of Nonconforming Product (cont’d) • Control of re-worked product • Rework instructions accessible and utilized • No visible rework for service parts • Engineering-approved product authorization • When product or process differs from PPAP • Identified on each shipping container

  37. QS-9000 14. Corrective and Preventive Action • Eliminate causes of actual or potential NC’s • Consider magnitude and risk • Disciplined problem solving methods • Mistake proofing • Corrective action • Customer complaints and product NC’s • Investigate, record, eliminate cause, ensure effectiveness (cont’d)

  38. QS-9000 14. Corrective and Preventive Action (cont’d) • Returned product test/analyze • Corrective action impact • Other processes • Other products • Preventive action • Sources of information • Determine, initiate, ensure effectiveness • Management review

  39. QS-9000 15. Handling, Storage, Packaging, Preservation, and Delivery • Handling • Storage • Inventory turns optimized • Packaging • Customer packaging standards and labeling (cont’d)

  40. QS-900015. Handling, Storage, Packaging, Preservation, and Delivery (cont’d) • Preservation • Delivery • 100% on-time shipments • Records of premium freight • Order-driven production scheduling • Send and receive on-line (plans, sched’s, ASN’s)

  41. QS-900016. Quality Records • Identify, collect, index, access, file, store, maintain, and dispose • Subcontractor records • Retention period • Availability to customer (cont’d)

  42. QS-900016. Quality Records (cont’d) • Record retention • Production records - active plus one calendar year • Quality records - one calendar year after year created • Internal audits and Mgt Review - three years • Longer periods may be specified • Must eventually dispose of records • Does not supersede government requirements

  43. QS-9000 17. Internal Quality Audits • Audits planned and recorded (no specified checklist) • Procedures documented • Corrective action taken • Verify and record implementation and effectiveness • All shifts / annual schedule

  44. QS-9000 18. Training • Identify training needs • Training for personnel affecting quality • Maintain records • Periodically review effectiveness • Pre/post testing, audits, etc

  45. QS-900019. Servicing • Procedures established and maintained • Specified requirements met • Applies to after-sales product servicing on OEM contract or P.O. • Feedback of information from service • To ensure supplier is aware of external NC’s

  46. QS-9000 20. Statistical Techniques • Needs identification • Process capability established, controlled, and verified • Procedures documented for use • Techniques selected during advanced quality planning and included in the control plan • Basic concepts known (variation, overadjustment, etc) • Statistical process control manual

  47. QS-9000 Topics We Will Cover  Overview of QS-9000 The 20 Elements The Referenced Documents The Registration Process 

  48. QS-9000 Framework Quality Manual Procedures Work Instructions Forms and Records Supplier Documentation QSA ISO QS What The Auto Industry Requires From Their Suppliers Customer Requirements PPAP Other Customer Requirements FMEA SPC Reference Documents “Mandatory” Guidelines To Suppliers On How To Meet The Auto Industry Requirements APQP MSA Continuous Improvement References Customer Approvals

  49. The Referenced Documents QSA PPAP APQP FMEA SPC MSA

  50. QS-9000For each document we will tell you: • What it is • When it is used • A quick overview of how it is used

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