Engineering Documentation Control / Configuration Management Standards Manual [Hardcover]

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.

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&ll: