ISPE Guide:
Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
Page 5
Table of Contents
1
2
3
4
5
5.1
5.2
5.3
5.4
5.5
5.6
5.7
6
Continual Improvement..................................................................................................... 51
7
Introduction.......................................................................................................................... 9
1.1
1.2
1.3
1.4
1.5
Background................................................................................................................................................... 9
Purpose and Objectives.............................................................................................................................. 10
Scope.......................................................................................................................................................... 10
Benefits....................................................................................................................................................... 11
Key Concepts............................................................................................................................................. 11
Overview of the Life Cycle................................................................................................ 15
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
Science-Based Approach........................................................................................................................... 15
Quality Risk Management in the Life Cycle................................................................................................ 16
Quality by Design........................................................................................................................................ 17
Specification and Verification...................................................................................................................... 17
Good Engineering Practice......................................................................................................................... 18
Continual Improvement............................................................................................................................... 18
Change Management................................................................................................................................. 19
Roles and Responsibilities.......................................................................................................................... 19
Requirements..................................................................................................................... 23
3.1 Introduction................................................................................................................................................. 23
3.2 Requirements Definition............................................................................................................................. 23
3.3 Requirements Development....................................................................................................................... 23
Specification and Design.................................................................................................. 27
4.1
4.2
4.3
4.4
4.5
4.6
Basis of Design........................................................................................................................................... 27
The Design Process................................................................................................................................... 27
Design and Delivery Processes.................................................................................................................. 30
Procurement............................................................................................................................................... 31
Fabrication and Installation......................................................................................................................... 32
Engineering Information Management........................................................................................................ 32
Verification, Acceptance, and Release............................................................................ 35
Introduction................................................................................................................................................. 35
Scope and Objectives................................................................................................................................. 35
The Risk-Based Verification Process.......................................................................................................... 37
Verification Execution................................................................................................................................. 42
Change Management during Verification.................................................................................................... 48
Acceptance and Release............................................................................................................................ 48
Automation.................................................................................................................................................. 48
Quality Risk Management................................................................................................. 53
7.1 Principles.................................................................................................................................................... 53
7.2 Quality Risk Management in the Life Cycle................................................................................................ 54
7.3 The Quality Risk Management Process..................................................................................................... 54
ISPE Guide: FSE – TOC
©2011 ISPE. All rights reserved.
www.ISPE.org
Page 6
ISPE Guide:
Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
8
9
10 Change Management......................................................................................................... 79
11 Appendix 1 – Risk Assessments...................................................................................... 83
Good Engineering Practice............................................................................................... 63
8.1
8.2
8.3
8.4
8.5
Background and Core Concepts................................................................................................................. 63
The Role of GEP within the Science and Risk-Based Approach................................................................ 63
Application of GEP across the Life Cycle................................................................................................... 64
Key Concepts for Applying GEP to Project Engineering............................................................................. 66
Common GEP Practices............................................................................................................................. 68
Design Review................................................................................................................... 73
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10
10.1
10.2
10.3
10.4
10.5
10.6
10.7
10.8
10.9
11.1
11.2
11.3
11.4
Introduction................................................................................................................................................. 73
Design Review Life Cycle........................................................................................................................... 74
Initiation....................................................................................................................................................... 74
Planning for Design Review........................................................................................................................ 74
Strategy for Design Review........................................................................................................................ 75
Process....................................................................................................................................................... 75
Design Acceptance..................................................................................................................................... 75
Risk Reduction versus Design Decisions................................................................................................... 76
Methods...................................................................................................................................................... 77
Deliverables................................................................................................................................................ 77
What Is a Change?..................................................................................................................................... 79
What Is Change Management?.................................................................................................................. 79
Why Do We Need Change Management?.................................................................................................. 79
Change Management before Acceptance and Release............................................................................. 79
Change Management after Acceptance and Release................................................................................ 80
Initiation of a Change.................................................................................................................................. 80
Implementation of a Change....................................................................................................................... 80
Test/Verification of a Change...................................................................................................................... 81
Close Out of a Change............................................................................................................................... 81
Introduction................................................................................................................................................. 84
Risk Assessment Methodologies................................................................................................................ 84
Rating Systems........................................................................................................................................... 88
Summary of Results.................................................................................................................................... 89
12 Appendix 2 –Impact Assessments Reflecting Risks to
Product Quality and Patient Safety.......................................................... 91
12.1 Definitions................................................................................................................................................... 92
12.2 Collect Product and Process Knowledge.................................................................................................... 93
12.3 Determine System and Component/Function Impact................................................................................. 94
13 Appendix 3 – Commissioning.......................................................................................... 95
14 Appendix 4 – Qualification Approaches.......................................................................... 99
14.1 Design Qualification.................................................................................................................................. 100
14.2 Installation and Operation Qualification.................................................................................................... 100
ISPE Guide: FSE – TOC
©2011 ISPE. All rights reserved.
www.ISPE.org
ISPE Guide:
Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
Page 7
15 Appendix 5 – Regulatory Basis and Background......................................................... 101
16 Appendix 6 – References................................................................................................ 105
17 Appendix 7 – Glossary.................................................................................................... 109
15.1
15.2
15.3
15.4
15.5
Introduction............................................................................................................................................... 102
Background............................................................................................................................................... 102
Terminology............................................................................................................................................... 103
Qualification.............................................................................................................................................. 104
Commissioning......................................................................................................................................... 104
17.1 Acronyms.................................................................................................................................................. 110
17.2 Definitions..................................................................................................................................................111
ISPE Guide: FSE – TOC
©2011 ISPE. All rights reserved.
www.ISPE.org