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Book Description

Get to know a key ingredient to world-class product manufacturing

With this manual, you have the best of the best management practices for the configuration management processes. It goes a long way toward satisfying Total Quality Management, FDA, GMP, Lean CM and ISO/QS/AS 9XXX process documentation requirements. The one requirement common to all those standards is to document the processes and to do what you document.

Table of Contents

  1. Cover
  2. Title page
  3. Copyright page
  4. Introduction
  5. Questions and Answers
  6. Part I Company EDC/CM Policy
    1. Chapter 1 Policy Statement
    2. EDC/CM Manager Job Description
  7. Part II Basic Standards
    1. Chapter 2 Writing CM Standards
    2. Chapter 3 CM Requirements for Drafting Standards
    3. Chapter 4 Technical Document Groups
    4. Chapter 5 Teams for All CM Processes
    5. Chapter 6 Cognizant Engineers
    6. Chapter 7 Part Numbers
    7. Chapter 8 Quantity and Units of Measure
    8. Chapter 9 Bills of Material
    9. Chapter 10 Approved Manufacturers List (AML)
    10. Chapter 11 Deviations
    11. Chapter 12 Spares List
    12. Chapter 13 Prints/Point of Use/Paperless
    13. Chapter 14 Signatures
    14. Chapter 15 Class Coding/Naming Conventions/Group Technology
    15. Chapter 16 Tabulated Documents
    16. Chapter 17 Nameplate and Serial Number
  8. Part III Product and Document Release Process
    1. Chapter 18 Release Policy
    2. Chapter 19 Team in Release
    3. Chapter 20 Phase Release
  9. Part IV Change Request Process
    1. Chapter 21 Change Request Policy
    2. Chapter 22 Team in Request
    3. Chapter 23 Request Form
  10. Part V Change Control Process
    1. Chapter 24 Change Control Policy
    2. Chapter 25 Team in Change
    3. Chapter 26 Change Form
    4. Chapter 27 Interchangeability
    5. Chapter 28 Part Number & Revision Level Changes
    6. Chapter 29 Change Classification
    7. Chapter 30 Mark Up of Design Documents
    8. Chapter 31 Effectivity
    9. Chapter 32 Effectivity Management
    10. Chapter 33 Disposition of Old Design Parts
    11. Chapter 34 Impacted/Affected by a Change
    12. Chapter 35 Product Improvements
    13. Chapter 36 Change Design Complete
    14. Chapter 37 Actual Effectivity Tracking
    15. Chapter 38 Line-Down Change
    16. Chapter 39 Closing a Change
    17. Chapter 40 Tracing Changes
  11. Part VI Changing Product shipped - Field Changes
    1. Chapter 41 Change of Field Units
    2. Chapter 42 Field Change Policy
    3. Chapter 43 Field Change Order Form
  12. Part VII Odds and Ends
    1. Chapter 44 Costing Design Changes
    2. Chapter 45 Data Dictionary
    3. Chapter 46 System Measurements
    4. Chapter 47 Users Guide/CM Plan
    5. Chapter 48 Acronyms and Definitions
  13. Author Biogaphy
  14. End User License Agreement