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
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
