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The Quality Management of New Product Design and Development

By H. M. Wang


The quality management of a modern complex product from design to production is very complicated matter which involves the whole company as well as external bodies (customer and supplier etc). In this thesis, based on customer-oriented principles, major management techniques, creating a time phased quality management programme to approach the quality related design processes, combines with the development of a quantitative method to measure the quality achievement of each design activity, including each phase and the overall design stage, for their correctness and efficiency in terms of time, cost and performance. A practical example is given for demonstrating the validation of the quantification. Through proper tailoring, the time phased quality management programme can be applied to different types of product, simple and complex, and to hardware and software, as well as to totally new design or partial design improvement. A quality information system is also developed to enhance the efficiency and effectiveness of the design and development process and to obtain improved product performance. Through a systematic analysis of the design process, it is shown that the majority of the steps taken are amenable to discipline and control and, therefore, design can realistically be included in a formal quality management system

Publisher: Cranfield University
Year: 1993
OAI identifier:
Provided by: Cranfield CERES

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  1. 4.16 Are all records legible and identifiable to the product involved?
  2. 4.16 Are quality records stored and maintained in a way that enhances ready retrieval?
  3. 4.16 Do the records demonstrate achievement of the required quality?
  4. 4.4.1 Has a system been established, documented and authorised to provide for design and development control?
  5. 4.4.2 Are the accountabilities, responsibilities and authorities for design and development activities defined and documented?
  6. Are design, development and verification activities planned and assigned to competent and adequately equipped staff?
  7. Are the technical interfaces between groups involved in , design, development and verification defined and documented?
  8. 4.4.3 Are design and development input requirements identified änd documented and their selection reviewed for adequacy?
  9. 4.4.4 Does the design and development output clearly identify characteristics of safety as well as critical major or minor features?
  10. 4.4.4 Is the design and development input controlled to ensure that regulatory or statutory requirements have been stated and complied with?
  11. 4.4.4 Is the design output documented and expressed in terms of drawings, specifications, calculations and analysis?
  12. 4.4.4 Is the development output controlled to ensure that it meets the design input requirements and that acceptance criteria are referenced?
  13. 4.4.5 Are design reviews, qualification tests, comparisons to similar designs, demonstrations and alternative calculations identified, performed, recorded and verified?
  14. 4.4.5 Is the design verification process established, documented and authorised?
  15. 4.4.6 Has a system been established, documented and authorised to provide for the identification, review and authorisation of changes and modifications?
  16. 4.5.1 Are documents reviewed and approved by authorised staff?
  17. 4.5.1 Are the pertinent issues of appropriated documentation available at all locations where operations are performed?
  18. 4.5.1 Does the system ensure prompt removal of obsolete documents?
  19. 4.5.2 Are changes to documents reviewed and approved by the same functions/organisations that performed the original review and approval?
  20. 4.5.2 Does the designated authorisation organisation have access to pertinent background information upon which to base their review and approval?
  21. 4.5.2 Hasa procedure for a master list (or equivalent document such as an MRI) been established to identify document status? 11-6
  22. 4.5.2 Is the nature of the change identified on the document or appropriate attachments?
  23. Are all documents that need controlling identified?
  24. Are periodic managerial reports compiled and action initiated?
  25. BIT requirements/constraints are not integrated into detailed design effort. ii. Integration of BIT with production test needs is considered at the start of the production phase (too late! ). iii. Trade-offs are not done for total test requirements.
  26. Configuration Control: i. Requirements are not tailored. ii. Sub-contractors are left alone. iii. Configuration control is ended with delivery. iv. Improvement changes are expedited.
  27. Design release points are pre-established. ii. Pre-release drawings are used. iii. Releases are not compatible with purchasing and manufacturing requirements. iv. Drawings are approved for release only by design engineering.
  28. Does the system provide for immediate withdrawal and rectification of non-conforming design output or products?
  29. (1985). DON CLAUSING Systematic Design Method : Application
  30. Has this system been implemented and maintained? doi
  31. Is the development output documented and expressed in terms of drawings, specifications, calculations and analysis?
  32. Is this system implemented and maintained?
  33. Materials selection: i. Lack of standardisation is indicated by design reviews. ii. Engineers use their own derating criteria. iii. Thermal design is verified by early performance tests. (Numerous design deficiencies are revealed during testing.

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