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Engineering Documentation Control / Configuration Management Standards Manual

Engineering Documentation Control / Configuration Management Standards Manual

Frank B. Watts

ISBN: 978-1-119-47933-8

Apr 2018

192 pages

$156.99

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.

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Introduction ix

Questions and Answers xiii

Part I Company EDC/CM Policy 1

1 Policy Statement 3

EDC/CM Manager Job Description 7

Part II Basic Standards 9

2 Writing CM Standards 11

3 CM Requirements for Drafting Standards 15

4 Technical Document Groups 17

5 Teams for All CM Processes 21

6 Cognizant Engineers 25

7 Part Numbers 27

8 Quantity and Units of Measure 33

9 Bills of Material 35

10 Approved Manufacturers List (AML) 37

11 Deviations 39

12 Spares List 43

13 Prints/Point of Use/Paperless 45

14 Signatures 47

15 Class Coding/Naming Conventions/Group Technology 49

16 Tabulated Documents 53

17 Nameplate and Serial Number 55

Part III Product and Document Release Process 57

18 Release Policy 59

19 Team in Release 63

20 Phase Release 65

Part IV Change Request Process 69

21 Change Request Policy 71

22 Team in Request 75

23 Request Form 77

Part V Change Control Process 81

24 Change Control Policy 83

25 Team in Change 89

26 Change Form 91

27 Interchangeability 99

28 Part Number & Revision Level Changes 101

29 Change Classification 103

30 Mark Up of Design Documents 105

31 Effectivity 109

32 Effectivity Management 111

33 Disposition of Old Design Parts 115

34 Impacted/Affected by a Change 117

35 Product Improvements 119

36 Change Design Complete 121

37 Actual Effectivity Tracking 125

38 Line-Down Change 129

39 Closing a Change 131

40 Tracing Changes 133

Part VI Changing Product shipped - Field Changes 135

41 Change of Field Units 137

42 Field Change Policy 139

43 Field Change Order Form 141

Part VII Odds and Ends 143

44 Costing Design Changes 145

45 Data Dictionary 151

46 System Measurements 153

47 Users Guide/CM Plan 157

48 Acronyms and Definitions 163

Author Biogaphy 173