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 |  موضوع: كتاب Developing and Managing Engineering Procedures - Concepts and Applications الجمعة 14 سبتمبر 2012, 1:15 pm | |
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Developing and Managing Engineering Procedures - Concepts and Applications
By
Phillip A. Cloud
Geneva Pharmaceutical, Inc.
Broomfield, Colorado
و المحتوى كما يلي :
vii
Contents
1 Introduction 1
1.1.0 ENGINEERING PROCEDURES CASE STUDY 4
1.2.0 ENGINEERING PROCEDURES MANAGEMENT 5
1.3.0 DOCUMENT CONTROL SYSTEM . 6
1.4.0 DOCUMENT CONTROL COMPONENTS . 6
1.5.0 WHAT EXACTLY DO YOU NEED TO DOCUMENT? 7
1.6.0 ENGINEERING PROCEDURE WRITING 8
1.7.0 HOW TO USE THIS BOOK . 9
2 Engineering Procedure Writing Group . 10
2.1.0 HOW TO ESTABLISH AN ENGINEERING
PROCEDURE WRITING GROUP . 11
2.1.1 Kick-off Meeting Memo 13
2.1.2 Agenda for the Kick-off Meeting 13
2.2.0 BASIC WRITING GROUP FUNCTIONS 14
2.2.1 Which Documents are Necessary? . 14
2.2.2 Establish Document Format and Contents 15
2.3.0 BEFORE YOU START WRITING . 16
2.3.1 Interviewing . 16
2.3.2 Questions to ask for a New Procedure . 16
2.3.3 Questions to ask for a New Form . 17viii Contents
2.4.0 POLICY WRITING TIPS . 17
2.4.1 How Many Policies are Really Needed? . 18
2.5.0 DEPARTMENTAL INSTRUCTION WRITING TIPS 20
2.5.1 How Many Departmental Instructions are Really
Needed? . 20
2.6.0 ENGINEERING PROCEDURE WRITING TIPS 20
2.6.1 Definitions 21
3 Document Format and Contents . 23
3.1.0 POLICY FORMAT 23
3.2.0 POLICY CONTENT 27
3.3.0 EXAMPLE POLICY 27
3.4.0 DEPARTMENTAL INSTRUCTION FORMAT 30
3.5.0 DEPARTMENTAL INSTRUCTION CONTENTS 34
3.6.0 EXAMPLE DEPARTMENTAL INSTRUCTION 34
3.7.0 ENGINEERING PROCEDURE FORMAT 41
3.8.0 ENGINEERING PROCEDURE CONTENTS 45
3.9.0 EXAMPLE ENGINEERING PROCEDURE 46
3.10.0 FORMS 54
3.11.0 FORM FORMAT 55
3.12.0 EXAMPLE FORM 55
4 Engineering Procedure Manuals 59
4.1.0 MANUAL COMPONENTS 60
4.1.1 Cover Page 61
4.1.2 Spine 62
4.1.3 Binders . 63
4.1.4 Dividers 63
4.2.0 ENGINEERING PROCEDURE MANUAL PAGE . 64
4.2.1 Manual Introduction and Maintenance Page . 66
4.2.2 Table of Contents with Revision History Page . 68
4.3.0 ENGINEERING PROCEDURE MANUAL
DISTRIBUTION . 71
4.3.1 Distribution of Manuals to Individuals . 72
4.3.2 Distribution of Manuals to Departments . 72
4.3.3 Document Agreement Form 72
4.3.4 Engineering Procedure Manual Distribution List . 76
4.3.5 Example—Engineering Procedure Manual
Distribution List 78
4.4.0 MANUAL REVISIONS 79Contents ix
5 Change Control . 80
5.1.0 DOCUMENT REVIEW AND APPROVAL 81
5.1.1 Engineering Department Review . 82
5.1.2 Outside Department Review and Approval 82
5.1.3 Document Review Form . 83
5.1.4 Example Document Review Form 86
5.2.0 CHANGE CONTROL METHODS . 87
5.2.1 Document Change Request Form . 88
5.2.2 Example—Document Change Request Form . 91
5.3.0 DOCUMENT REVIEW BOARD 92
5.4.0 REVISION HISTORY SHEET 93
5.5.0 REVISION HISTORY LIST 96
5.5.1 Example—Revision History List . 99
6 Engineering Document Control . 101
6.1.0 BLOCK NUMBERING SYSTEM . 101
6.2.0 POLICY NUMBERS . 103
6.2.1 Example—Policy Numbers and Interpretation 104
6.3.0 POLICY NUMBER ASSIGNMENT . 104
6.3.1 Policy Number Assignment Log 104
6.3.2 Example—Policy Number Assignment Log . 106
6.4.0 POLICY TITLES 106
6.5.0 DEPARTMENTAL INSTRUCTION NUMBERS . 108
6.5.1 Example—Departmental Instruction Numbers
and Interpretation . 109
6.6.0 DEPARTMENTAL INSTRUCTIONS NUMBER
ASSIGNMENT 109
6.6.1 Departmental Instruction Number
Assignment Log . 109
6.6.2 Example—Departmental Instruction Number
Assignment Log . 111
6.7.0 DEPARTMENTAL INSTRUCTION TITLES . 111
6.8.0 ENGINEERING PROCEDURE NUMBERS 113
6.8.1 Example—Engineering Procedure Numbers
and Interpretation 114
6.9.0 ENGINEERING PROCEDURE NUMBER
ASSIGNMENT 114
6.9.1 Engineering Procedure Number Assignment Log 114x Contents
6.9.2 Example—Engineering Procedure Number
Assignment Log . 116
6.10.0 ENGINEERING PROCEDURE TITLES 116
6.11.0 FORM NUMBERS . 118
6.11.1 Example—Form Numbers and Interpretation . 118
6.12.0 FORM NUMBER ASSIGNMENT 119
6.12.1 Example—Form Number Assignment Log . 119
6.13.0 MANUAL NUMBERS 122
6.13.1 Manual Numbers and Interpretation 123
6.14.0 MANUAL NUMBER ASSIGNMENT 123
6.14.1 Example—Manual Number Assignment Log . 123
6.15.0 DOCUMENT REVIEW FORM NUMBERS 126
6.15.1 Example—Document Review Form Numbers
and Interpretation . 127
6.16.0 DOCUMENT REVIEW FORM NUMBER
ASSIGNMENT 127
6.16.1 Document Review Form Number
Assignment Log . 128
6.17.0 DOCUMENT CHANGE REQUEST FORM NUMBERS 131
6.17.1 Example—Document Change Request Form
Numbers and Interpretation . 132
6.18.0 DOCUMENT CHANGE REQUEST FORM
NUMBER ASSIGNMENT . 132
6.18.1 Document Change Request Form Number
Assignment Log . 132
6.18.2 Example—Change Request Form Number
Assignment Log . 134
6.19.0 DOCUMENT MASTER LIST . 134
6.19.1 Example—Document Master List . 136
7 Electronic Database 139
7.1.0 DOCUMENT NUMBER STRUCTURE . 139
7.1.1 Prefix . 140
7.1.2 Suffix 140
7.1.3 Identification Numbers and Interpretation . 140
7.2.0 DOCUMENT DATABASE . 141
7.2.1 Example—Document Database 142Contents xi
Appendix A: Policy Example . 145
Appendix B: Departmental Instructions Example . 148
Appendix C: Engineering Procedure Example . 156
Appendix D: Forms, Lists, and Logs 163
Controlled Document Agreement . 164
Engineering Procedure Manual Distribution List 165
Document Review Form . 166
Document Change Request Form . 166
Policy Number Assignment Log . 168
Departmental Instruction Number Assignment Log . 169
Engineering Procedure Number Assignment Log 170
Form Number Assignment Log 171
Manual Number Assignment Log . 172
Document Review Form Number Assignment Log . 173
Document Change Request Form No. Assignment Log 174
Document Master List 175
Document Database . 176
Appendix E: Further Reading . 177
WORLD WIDE WEB REFERENCES . 178
Index . 179
179
Index
Administrative
costs 3
procedures 20
Approved vendor list
example form 55
Assigned number form
examples 118
Assigning document numbers
electronic method 139
Assignment log 163
example 126
policy number 105, 163
policy number example 106
Back cover 63
Binders 63
Block number system 101
Blocks of numbers 101
Centralized procedure writing group
functions 8
Change control 92
process 87
Change request
reject or accept 87
Changes incorporated 83
Collecting information 16
Complete engineering procedure 41
Controlled document agreement
form 72, 163
Cover page 61
example 71
Database 141
example page 141
structure 139
Departmental instruction number
assignment 109
assignment log 163
assignment log example 111
Departmental instructions 20,
108, 148
develop a database 141
example pages 30, 32, 34
how many needed 20
how to identify 109
logbook 101
questions 30
required sections 34
revision history list 96
revision history sheet 93180 Developing and Managing Engineering Procedures
template 148
title 111
Distribution copy 82
Distribution to departments
memo example 72
Distribution to individuals
memo example 72
Dividers 63
Document change request
form 87, 88, 163
example 90
how to identify 132
identification numbers 131
number assignment log 163
number assignment log
example 134
number logbook 132
questions 88
Document control 2
requirements 7
system 6
Document database 140, 163
example page 142
Document format standard 15
Document master list 101, 134, 163
example page 136
Document number 139
prefix 140
suffix 140
Document number assignment
log 132
example page 104, 109,
114, 123
questions 128
Document review and approval
method used 81
Document review board 10, 81,
82, 92
meeting 83
memo 93
review and approval 92
Document review flow 81
Document review
form 82, 126, 163
example pages 85, 128
identification number 127
logbooks 101
number logbook 127
questions 83
Document review form number
assignment log 163
Document titles 101
Document-numbering systems 101
Documentation
approval 81
components list 6
review 81
system 3, 6
Draft 82
Effective engineering program 59
Electronic based documentation
system 126, 139
Electronic database 3, 139
Engineering department
review and approval 82
Engineering document
control 10, 83, 141
identification number 118
Engineering documentation
system 3
Engineering operation
documentation 3
Engineering policies 18
Engineering procedure 1, 21, 30,
54, 59
associated documentation 4
case study 4
contents 45
develop a database 141
develop and manage 4
developement 9
example pages 41, 43, 46, 156
format 41
format and contents 20
identification number
example 113Index 181
ISO 9000 regulations 80
logbooks 101
management 9
manual distribution 71
revision history list 96
revision history sheet 93
template 156
Engineering procedure documentation
organizing 8
training or retraining 9
Engineering procedure manuals
approving, publishing and
distributing 59
distribution list 163
identification numbers 122
numbering system 122
Engineering procedure number 113
assignment log 163
example 116
logbook 114
Engineering procedure writing
group 10
reason for creating 11
Engineering systems
policies 18
Find number 139
Form format 55
questions 55
Form number
logbook 119
Form number assignment log 163
example page 119
Format and contents
established 16
Forms
documented evidence 54
logbooks 101
record 54
unique identification number 118
Front cover 63
GMP. See Good manufacturing
practices
Good manufacturing practices 3
House style 15
Identification number
departmental instructions 108
Identifying number 72
Instructions
step-by-step 21
Interviewing for information 16
ISO 9000 3, 20
guidelines 3, 27, 34
requirements 6
Key database 141
Key documents 7
Logbook 114
Manual copies
control of 72
Manual distribution list 71, 76–78
Manual introduction and maintenance
page 66
Manual number
logbook 123
Manual pages
engineering procedure
example 64
Manual paper-based documentation
system 108, 123, 126, 132, 139
numbering system 109
Manual revisions 79182 Developing and Managing Engineering Procedures
Manuals
changes 59
components 60
distribution to departments 72
distribution to individuals 72
identification numbers 59
logbooks 101
reviewed 59
three-ring binders 63
Marketing
improvements 3
Master list 2
Memo example 79
Numbering system 104
Operating procedures
write, change, and control 8
Operational efficiency 3
Paper-based system 3
Performing routine tasks
goal 20
Plastic jackets 63
Policies 18
develop a database 141
example pages 145
general record 17
how many needed 18
identification numbers 103
Policy
example pages 24, 27
format 23
identify 104
logbooks 101
questions 24
required sections 27
revision history 93, 96
template example 145
title examples 106
Policy numbers 103
assigning new numbers 104
example 139
Prefix 140
Prioritize documents 14
Procedural information 59
Procedure manuals 5
Procedure writing group
list of questions 14
Profitability 3
Quality documentation standard 20
Research and Development
policy 19
Review board 92
Revision history list 96, 98
example 100
Revision history sheet 93
questions 93
Revision level 79
Sales activity
improvement 3
Spine 62, 63
Suffix 140
Traditional documentation system 7
Write a policy 17
Writing group
functions 14
This book explains:
• How to develop a procedure writing group
• How to determine which documents need to be written
• How to write policies, departmental instructions, and engineering procedures.
• How to develop document formats and contents
• How to develop a document numbering system
• How to assign identification numbers
• How to establish a Document Review Board
• How to establish a change control system
• How to establish a document control system
• How to develop document number assignment logs
• How to publish engineering procedure manuals
• How to distribute manuals
• How documents relate to each other and to an overall documentation system.
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