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El. knyga: Reliable Design of Medical Devices

(ISORel, Inc., Fitchburg, Wisconsin, USA)
  • Formatas: 501 pages
  • Išleidimo metai: 19-Apr-2016
  • Leidėjas: CRC Press Inc
  • Kalba: eng
  • ISBN-13: 9781439894941
Kitos knygos pagal šią temą:
Reliable Design of Medical DevicesDidesnis paveikslėlis
  • Formatas: 501 pages
  • Išleidimo metai: 19-Apr-2016
  • Leidėjas: CRC Press Inc
  • Kalba: eng
  • ISBN-13: 9781439894941
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Following in the footsteps of the bestselling second edition, this book shows you how to improve reliability in the design of advanced medical devices. The organization of the book now mirrors the typical product development process, from the concept, feasibility, and design phases through to verification and validation, design transfer and manufacturing, and field activity. Updated throughout, it reflects recent changes in the medical device field, including in software development and hardware test procedures. This practical, hands-on book guides you in preparing, designing, and testing medical devices more effectively.



As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices.

Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT).

What’s New in This Edition

  • Updates throughout, reflecting changes in the field
  • An updated software development process
  • Updated hardware test procedures
  • A new layout that follows the product development process
  • A list of deliverables needed at the end of each development phase

Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

Recenzijos

"This book focuses on an important topic ... that engineers need to understand in all of its aspectsphilosophy, design, and testing and evaluation. They also need to know how they fit in to the larger picture (manufacturing, packaging, etc). This book provides both an overview of those facets, along with details to implement them. It is thus a valuable resource for students, researchers, and industry [ professionals] who wish to develop a product." Jon Sensinger, Rehabilitation Institute of Chicago, Illinois, USA

" my interest is piqued. I think it can be a very interesting and useful resource for engineers and other stakeholders involved in the medical device design and production process." Carl Nelson, University of Nebraska-Lincoln, USA

"Dont let the name fool you this book is about much more than reliability engineering. While this book opens with a discussion of reliability and failure, it quickly transitions to discussing the entire product development process, from concept through verification, and even includes design transfer and post-market field actions. There is a lot of wisdom in this book. You can tell that the author has seen a lot of projects and wants the reader to avoid the mistakes that he has encountered." Reading Room, Biomedical Instrumentation and Technology, September/October 2013 "This book focuses on an important topic ... that engineers need to understand in all of its aspectsphilosophy, design, and testing and evaluation. They also need to know how they fit in to the larger picture (manufacturing, packaging, etc). This book provides both an overview of those facets, along with details to implement them. It is thus a valuable resource for students, researchers, and industry [ professionals] who wish to develop a product."Jon Sensinger, Rehabilitation Institute of Chicago, Illinois, USA





" my interest is piqued. I think it can be a very interesting and useful resource for engineers and other stakeholders involved in the medical device design and production process."Carl Nelson, University of Nebraska-Lincoln, USA

"Dont let the name fool you this book is about much more than reliability engineering. While this book opens with a discussion of reliability and failure, it quickly transitions to discussing the entire product development process, from concept through verification, and even includes design transfer and post-market field actions. There is a lot of wisdom in this book. You can tell that the author has seen a lot of projects and wants the reader to avoid the mistakes that he has encountered."Reading Room, Biomedical Instrumentation and Technology, September/October 2013

Preface xxvii
PART I The Basics of Reliability
Chapter 1 Reliability
3(12)
1.1 History of Reliability
3(1)
1.2 Definition of Reliability
4(1)
1.3 Quality versus Reliability
5(1)
1.4 Reliability versus Unreliability
5(1)
1.5 Reliability Assurance
6(1)
1.6 Types of Reliability
6(6)
1.6.1 Electronic Reliability
7(1)
1.6.1.1 Infant Mortality
7(1)
1.6.1.2 Useful Life
7(1)
1.6.1.3 Wear-Out
8(1)
1.6.2 Mechanical Reliability
8(1)
1.6.3 Software Reliability
9(2)
1.6.4 System Reliability
11(1)
1.7 Optimizing Reliability
12(1)
1.8 Reliability's Effect on Medical Devices
12(1)
1.9 Reliability and Regulation
12(3)
Bibliography
13(2)
Chapter 2 The Concept of Failure
15(8)
2.1 Failure
15(1)
2.2 Practical Aspects of Failure
16(1)
2.3 Failure Rate
17(1)
2.4 Causes of Failures
17(5)
2.4.1 Systematic Failures
18(1)
2.4.2 Random Failures
18(1)
2.4.3 Hardware Failures
18(1)
2.4.3.1 Early Failures
18(1)
2.4.3.2 Chance Failures
19(1)
2.4.3.3 Wear-Out Failures
19(1)
2.4.4 Software Failures
19(1)
2.4.4.1 Specification Errors
20(1)
2.4.4.2 Design Errors
20(1)
2.4.4.3 Coding Errors
20(1)
2.4.4.4 Resource Errors
20(1)
2.4.4.5 Time-Critical Errors
20(1)
2.4.5 Failures due to Human Error
21(1)
2.5 Failures from the Customer's Point of View
22(1)
Bibliography
22(1)
Chapter 3 The Product Design and Development Process
23(6)
3.1 Concept Phase
23(1)
3.2 Feasibility Phase
24(1)
3.3 Design Phase
24(1)
3.4 Verification and Validation
24(1)
3.5 Design Transfer and Manufacturing
25(1)
3.6 Field Activity
25(4)
Bibliography
25(4)
PART II The Concept Phase
Chapter 4 Defining the Device
29(16)
4.1 Product Definition Process
29(3)
4.1.1 Surveying the Customer
30(1)
4.1.2 Defining the Company's Needs
31(1)
4.1.3 What Are the Company's Competencies?
31(1)
4.1.4 What Are the Competition's Competencies?
31(1)
4.1.5 Completing the Product Definition
31(1)
4.2 Overview of Quality Function Deployment
32(7)
4.2.1 QFD Process
32(1)
4.2.1.1 Voice of the Customer
33(1)
4.2.1.2 Technical Portion of the Matrix
33(1)
4.2.1.3 QFD Activity
34(5)
4.2.1.4 Summary of QFD
39(1)
4.3 Business Proposal
39(6)
4.3.1 Project Overview, Objectives, Major Milestones, and Schedule
41(1)
4.3.2 Market Need and Market Potential
41(1)
4.3.3 Product Proposal
42(1)
4.3.4 Strategic Fit
42(1)
4.3.5 Risk Analysis and Research Plan
42(2)
4.3.6 Economic Analysis
44(1)
Bibliography
44(1)
Chapter 5 Safety and Risk Management
45(18)
5.1 Risk
45(2)
5.2 Deciding on Acceptable Risk
47(1)
5.3 Factors Important to Medical Device Risk Assessment
47(2)
5.3.1 Device Design and Manufacture
48(1)
5.3.2 Materials
48(1)
5.3.3 Device Users
48(1)
5.3.4 Human Factors
49(1)
5.3.5 Medical Device Systems
49(1)
5.4 Risk Management
49(1)
5.5 The Risk Management Process
49(4)
5.5.1 Identifying the Risk Factors
50(1)
5.5.2 Assessing Risk Probabilities and Risks on the Project
50(2)
5.5.3 Developing Strategies to Mitigate Identified Risks
52(1)
5.5.4 Monitoring Risk Factors
52(1)
5.5.5 Invoking a Contingency Plan
53(1)
5.5.6 Managing the Crisis
53(1)
5.5.7 Recovering from the Crisis
53(1)
5.6 Tools for Risk Estimation
53(10)
5.6.1 Hazard/Risk Analysis
53(2)
5.6.2 FMEA Process
55(3)
5.6.3 FTA
58(1)
5.6.3.1 FTA Process
58(1)
5.6.3.2 Example of an FTA
59(3)
Bibliography
62(1)
Chapter 6 Documents and Deliverables
63(8)
6.1 Establishing Preliminary System Reliability Requirements
63(1)
6.2 Developing a Device Profile at the System Level
64(1)
6.2.1 Power Requirements
64(1)
6.2.2 Environmental Requirements
64(1)
6.2.3 Customer Usage
65(1)
6.2.4 Transportation
65(1)
6.2.5 Esthetics
65(1)
6.3 Reviewing Field Failure Information
65(1)
6.4 Participating in Design and Phase Reviews
66(1)
6.5 Customer Needs
66(1)
6.6 Marketing Requirements
66(1)
6.7 Preliminary Risk Analysis
66(1)
6.8 Minutes of Design Reviews
66(1)
6.9 Results of the Phase Review
66(5)
Bibliography
66(5)
PART III The Feasibility Phase
Chapter 7 The FDA
71(22)
7.1 Device Classification
71(3)
7.1.1 Class I Devices
72(1)
7.1.2 Class II Devices
72(1)
7.1.3 Class III Devices
73(1)
7.2 Registration and Listing
74(1)
7.3 The 510(k) Process
74(8)
7.3.1 Determining Substantial Equivalency
74(1)
7.3.2 Types of 510(k)s
75(2)
7.3.3 The 510(k) Format
77(1)
7.3.4 The Special 510(k)
78(3)
7.3.4.1 The Special 510(k) Content
81(1)
7.3.5 The Abbreviated 510(k)
81(1)
7.3.5.1 The Abbreviated 510(k) Content
82(1)
7.4 Declaration of Conformance to a Recognized Standard
82(1)
7.5 The PMA Application
83(1)
7.5.1 The PMAA Process
83(1)
7.5.2 Contents of a PMAA
83(1)
7.6 IDEs
84(2)
7.6.1 Institutional Review Boards (IRB)
84(1)
7.6.2 IDE Format
85(1)
7.7 Good Laboratory Practices (GLPs)
86(1)
7.8 Good Manufacturing Practices (GMPs)
86(1)
7.9 Human Factors
86(1)
7.10 Design Control
87(1)
7.11 The FDA and Software
88(1)
7.11.1 Software Classification
89(1)
7.12 The FDA Inspection
89(1)
7.13 Advice on Dealing with the FDA
90(3)
Bibliography
91(2)
Chapter 8 The Medical Devices Directive
93(22)
8.1 Definition of a Medical Device
93(1)
8.2 The MDD Process
94(1)
8.3 Choosing the Appropriate Directive
94(1)
8.3.1 AIMDD
94(1)
8.3.2 MDD
95(1)
8.3.3 IVDMDD
95(1)
8.4 Identifying the Applicable Essential Requirements
95(2)
8.5 Identification of Corresponding Harmonized Standards
97(1)
8.5.1 Horizontal Standards
97(1)
8.5.2 Semihorizontal Standards
98(1)
8.5.3 Vertical Standards
98(1)
8.6 Assurance That the Device Meets the Essential Requirements and Harmonized Standards, and Documentation of the Evidence
98(5)
8.6.1 Essential Requirement 1
99(1)
8.6.1.1 Hazard Analysis
99(1)
8.6.1.2 Safety Review
100(1)
8.6.2 Essential Requirement 2
101(1)
8.6.2.1 Peer Review
101(1)
8.6.2.2 Safety Review
101(1)
8.6.3 Essential Requirement 3
101(1)
8.6.3.1 Specification Reviews
101(1)
8.6.3.2 Validation Testing
101(1)
8.6.4 Essential Requirement 4
101(1)
8.6.4.1 Environmental Testing
101(1)
8.6.4.2 ESS
102(1)
8.6.4.3 Use/Misuse Evaluation
102(1)
8.7 Classification of the Device
103(2)
8.8 Decision on the Appropriate Conformity Assessment Procedure
105(2)
8.8.1 Medical Devices Directive
105(1)
8.8.1.1 Annex II
105(1)
8.8.1.2 Annex III
105(1)
8.8.1.3 Annex IV
105(1)
8.8.1.4 Annex V
105(1)
8.8.1.5 Annex VI
105(1)
8.8.1.6 Annex VII
106(1)
8.8.1.7 Class I
106(1)
8.8.1.8 Class IIa
106(1)
8.8.1.9 Class IIb
106(1)
8.8.1.10 Class III
106(1)
8.8.2 Active Implantable Medical Devices Directive
106(1)
8.8.2.1 Alternative 1
106(1)
8.8.2.2 Alternative 2
107(1)
8.8.3 IVDMDD
107(1)
8.9 Type Testing
107(1)
8.10 Identification and Choice of a Notified Body
108(3)
8.11 Establishing a Declaration of Conformity
111(1)
8.12 Application of the CE Mark
111(1)
8.13 Conclusion
112(3)
Bibliography
113(2)
Chapter 9 Important Medical Device Standards
115(6)
9.1 ISO 13485
115(1)
9.2 ISO 14971
116(1)
9.3 IEC 60601-1
117(2)
9.3.1 Collateral Standards
118(1)
9.3.2 Particular Standards
118(1)
9.3.3 Performance Standards
118(1)
9.4 IEC 62304
119(2)
Bibliography
120(1)
Chapter 10 Human Factors
121(28)
10.1 What Are Human Factors?
121(1)
10.2 Human Element in Human Factors
122(2)
10.3 Hardware Element in Human Factors
124(1)
10.4 Software Element in Human Factors
124(1)
10.5 Human Factors Process
124(10)
10.5.1 Planning
128(1)
10.5.2 Analysis
128(1)
10.5.3 Conduct User Studies
128(1)
10.5.3.1 Observations
128(1)
10.5.3.2 Interviews
129(1)
10.5.3.3 Focus Groups
129(1)
10.5.3.4 Task Analysis
130(1)
10.5.3.5 Benchmark Usability Test
130(1)
10.5.3.6 Write the User Profile
130(1)
10.5.4 Set Up an Advisory Panel
130(1)
10.5.5 Set Usability Goals
130(1)
10.5.6 Design User Interface Concepts
131(1)
10.5.6.1 Develop a Conceptual Model
131(1)
10.5.6.2 Develop a User Interface Structure
131(1)
10.5.6.3 Define Interaction Styles
132(1)
10.5.6.4 Develop Screen Templates
132(1)
10.5.6.5 Develop a Hardware Layout
132(1)
10.5.6.6 Develop a Screenplay
132(1)
10.5.6.7 Develop a Refined Design
132(1)
10.5.6.8 Develop a Final Design
132(1)
10.5.7 Model the User Interface
132(1)
10.5.8 Test the User Interface
133(1)
10.5.9 Specify the User Interface
133(1)
10.5.9.1 Style Guide
133(1)
10.5.9.2 Screen Hierarchy Map
134(1)
10.5.9.3 Screenplay
134(1)
10.5.9.4 Specification Prototype
134(1)
10.5.9.5 Hardware Layout
134(1)
10.6 Additional Human Factors Considerations
134(2)
10.6.1 Consistency and Simplicity
134(1)
10.6.2 Safety
135(1)
10.6.3 Environmental Considerations
135(1)
10.6.4 Documentation
136(1)
10.7 Anthropometry
136(13)
10.7.1 Functional Dimensions
137(1)
10.7.2 Psychological Elements
137(1)
10.7.3 Workstation Design Considerations
137(2)
10.7.4 Alarms and Signals
139(3)
10.7.5 Labeling
142(1)
10.7.6 Software
143(1)
10.7.7 Data Entry
143(1)
10.7.8 Displays
144(1)
10.7.9 Interactive Controls
145(1)
10.7.10 Feedback
146(1)
10.7.11 Prompts
147(1)
10.7.12 Defaults
147(1)
10.7.13 Error Management and Data Protection
147(1)
Bibliography
147(2)
Chapter 11 Requirements Engineering
149(14)
11.1 Requirements, Design, Verification, and Validation
149(3)
11.1.1 Refinement of Requirements
150(1)
11.1.2 Assimilation of Requirements
150(1)
11.1.3 Requirements versus Design
151(1)
11.2 Product Specification
152(1)
11.3 Specification Review
153(2)
11.4 Design Specification
155(1)
11.5 Software Quality Assurance Plan (SQAP)
156(2)
11.5.1 Purpose
156(1)
11.5.2 Reference Documents
156(1)
11.5.3 Management
156(1)
11.5.4 Documentation
157(1)
11.5.5 Standards, Practices, Metrics, and Conventions
157(1)
11.5.6 Review and Audits
157(1)
11.5.7 Test
157(1)
11.5.8 Problem Reporting and Corrective Action
157(1)
11.5.9 Tools, Techniques, and Methodologies
157(1)
11.5.10 Code Control
157(1)
11.5.11 Media Control
157(1)
11.5.12 Supplier Control
158(1)
11.5.13 Records Collection, Maintenance, and Retention
158(1)
11.5.14 Training
158(1)
11.5.15 Risk Management
158(1)
11.5.16 Additional Sections as Required
158(1)
11.6 Software Requirements Specification (SRS)
158(2)
11.6.1 Purpose
159(1)
11.6.2 Scope
159(1)
11.6.3 Definitions, Abbreviations, and Acronyms
159(1)
11.6.4 References
159(1)
11.6.5 Overview
159(1)
11.6.6 Product Perspective
159(1)
11.6.7 Product Functions
159(1)
11.6.8 User Characteristics
159(1)
11.6.9 General Constraints
160(1)
11.6.10 Assumptions and Dependencies
160(1)
11.6.11 Specific Requirements
160(1)
11.7 Software Design Description (SDD)
160(3)
11.7.1 Decomposition Description
161(1)
11.7.2 Dependency Description
161(1)
11.7.3 Interface Description
161(1)
11.7.4 Detailed Design Description
162(1)
Bibliography
162(1)
Chapter 12 Liability
163(8)
12.1 Negligence
163(1)
12.2 Strict Liability
164(1)
12.3 Breach of Warranty
165(1)
12.3.1 Implied Warranties
165(1)
12.3.2 Exclusion of Warranties
165(1)
12.4 Defects
166(1)
12.5 Failure to Warn of Dangers
167(1)
12.6 Plaintiff's Conduct
168(1)
12.7 Defendant's Conduct
168(1)
12.8 Defendant-Related Issues
168(1)
12.9 Manufacturer's and Physician's Responsibilities
168(1)
12.10 Conclusion
169(2)
Bibliography
170(1)
Chapter 13 Intellectual Property
171(18)
13.1 Patents
171(6)
13.1.1 What Qualifies as a Patent?
171(1)
13.1.1.1 Patentable Subject Matter
172(1)
13.1.1.2 Usefulness
172(1)
13.1.1.3 Novelty
172(1)
13.1.1.4 Nonobviousness
172(1)
13.1.1.5 Improvement of an Existing Invention
173(1)
13.1.1.6 Design
173(1)
13.1.2 Patent Process
173(1)
13.1.3 Patent Claims
174(1)
13.1.4 Protecting Your Rights as an Inventor
175(1)
13.1.5 Patent Infringements
176(1)
13.2 Copyrights
177(3)
13.2.1 What Can Be Copyrighted?
177(2)
13.2.2 Copyright Process
179(1)
13.2.2.1 Copyright Notice
179(1)
13.2.2.2 Copyright Registration
179(1)
13.2.2.3 Copyright Duration
179(1)
13.2.2.4 Protecting Your Copyright Rights
180(1)
13.2.2.5 Copyright Infringement
180(1)
13.3 Trademarks
180(4)
13.3.1 Selecting a Trademark
181(1)
13.3.1.1 What Is a Distinctive Trademark?
181(1)
13.3.2 Trademark Process
182(1)
13.3.3 Intent to Use Registration
183(1)
13.3.4 Protecting Your Trademark Rights
183(1)
13.4 Trade Secrets
184(5)
13.4.1 What Qualifies as a Trade Secret?
184(1)
13.4.2 Trade Secrecy Authorship
185(1)
13.4.3 How Trade Secrets Are Lost
185(1)
13.4.4 Duration of a Trade Secret
185(1)
13.4.5 Protecting Your Trade Secrecy Rights
185(1)
13.4.6 Trade Secrecy Program
186(1)
13.4.7 Use of Trade Secrecy with Copyrights and Patents
186(1)
13.4.7.1 Trade Secrets and Patents
186(1)
13.4.7.2 Trade Secrets and Copyrights
186(1)
Bibliography
187(2)
Chapter 14 The Project Team
189(4)
14.1 Project Team Essentials
189(2)
14.1.1 Team Composition and Roles
190(1)
14.1.2 Team Goals and Expectations
190(1)
14.1.3 Team Resources
191(1)
14.1.4 Team Sponsorship
191(1)
14.1.5 Team Rewards and Recognition
191(1)
14.2 Project Team Personnel
191(1)
14.3 Process And Product Metrics
192(1)
Bibliography
192(1)
Chapter 15 The Reliability Goal and Plan
193(4)
15.1 Reliability Goal
193(1)
15.2 Reliability Plan
194(3)
15.2.1 Purpose
195(1)
15.2.2 Scope
195(1)
15.2.3 General Strategy
195(1)
15.2.4 List of Activities
195(1)
15.2.5 References
196(1)
Bibliography
196(1)
Chapter 16 Documents and Deliverables
197(4)
16.1 Deliverables Checklist
197(1)
16.2 Minutes of Design Reviews
198(1)
16.3 Results of the Phase Review
198(3)
PART IV The Design Phase
Chapter 17 Hardware Design
201(24)
17.1 Block Diagram
201(1)
17.2 Redundancy
201(3)
17.2.1 Active Redundancy
201(2)
17.2.2 Standby Redundancy
203(1)
17.3 Component Selection
204(3)
17.3.1 Component Fitness for Use
205(1)
17.3.2 Component Reliability
205(1)
17.3.3 Component History
206(1)
17.3.4 Component Safety
207(1)
17.4 Component Derating
207(1)
17.5 Safety Margin
208(1)
17.6 Load Protection
209(1)
17.7 Environmental Protection
209(1)
17.8 Product Misuse
209(1)
17.9 Reliability Prediction
210(6)
17.9.1 Parts Count Prediction
211(1)
17.9.2 Parts Count Example
212(4)
17.9.3 Summary of Reliability Prediction
216(1)
17.10 Design for Variation
216(1)
17.11 Design of Experiments
217(1)
17.11.1 Taguchi Method
217(1)
17.12 Design Changes
217(1)
17.13 Design for Manufacturability (DFM)
218(1)
17.13.1 DFM Process
219(1)
17.14 Design For Assembly (DFA)
219(2)
17.14.1 Overall Design Concept
219(1)
17.14.2 Component Mounting
220(1)
17.14.3 Test Points
220(1)
17.14.4 Stress Levels and Tolerances
220(1)
17.14.5 PCBs
220(1)
17.14.6 Miscellaneous
220(1)
17.14.7 DFA Process
221(1)
17.15 Design Reviews
221(4)
Bibliography
223(2)
Chapter 18 Hardware Risk Analysis
225(18)
18.1 Risk
225(1)
18.2 Deciding on Acceptable Risk
226(1)
18.3 Factors Important to Medical Device Risk Assessment
227(2)
18.3.1 Device Design and Manufacture
227(1)
18.3.2 Materials
228(1)
18.3.3 Device Users
228(1)
18.3.4 Human Factors
228(1)
18.3.5 Medical Device Systems
229(1)
18.4 Risk Management
229(1)
18.5 Risk Management Process
229(4)
18.5.1 Identifying the Risk Factors
230(1)
18.5.2 Assessing Risk Probabilities and Effects on the Project
230(1)
18.5.3 Developing Strategies to Mitigate Identified Risks
230(2)
18.5.4 Monitoring Risk Factors
232(1)
18.5.5 Invoking a Contingency Plan
232(1)
18.5.6 Managing the Crisis
233(1)
18.5.7 Recovering from the Crisis
233(1)
18.6 Tools for Risk Estimation
233(10)
18.6.1 Hazard/Risk Analysis
233(2)
18.6.2 FMEA
235(2)
18.6.2.1 FMEA Process
237(1)
18.6.3 FTA
238(1)
18.6.3.1 FTA Process
239(1)
18.6.3.2 Example of an FTA
239(3)
Bibliography
242(1)
Chapter 19 Design and Project Metrics
243(6)
19.1 Metric Selection Process
244(1)
19.2 Characteristics of Metrics
244(1)
19.3 Design Metrics
245(1)
19.3.1 Number of Components
245(1)
19.3.2 Component Arrangement and Mounting
245(1)
19.3.3 Tools for Assembly
245(1)
19.3.4 Test Points
245(1)
19.3.5 Stress Levels
246(1)
19.3.6 Tolerances
246(1)
19.3.7 Component Clearances on PCBs
246(1)
19.3.8 Filtering of Air Intakes
246(1)
19.3.9 Number of Operations
246(1)
19.3.10 Assembly Time
246(1)
19.3.11 Time for Service
246(1)
19.3.12 Capability Index
246(1)
19.4 Project Metrics
246(3)
19.4.1 KPIs
246(1)
19.4.2 Dashboards
247(1)
Bibliography
247(2)
Chapter 20 Design for Six Sigma
249(20)
20.1 Design for Six Sigma (DFSS)
249(1)
20.2 Methodologies
250(1)
20.3 Structure
251(1)
20.4 DFSS Tools
252(17)
20.4.1 Robust Design
252(1)
20.4.1.1 Why Use the Robust Design Methodology?
252(1)
20.4.1.2 Typical Problems Addressed by Robust Design
253(1)
20.4.1.3 Robustness Strategy
253(3)
20.4.1.4 Quality Measurement
256(1)
20.4.1.5 Signal-to-Noise (S/N) Ratios
257(1)
20.4.2 Quality Function Deployment
258(1)
20.4.3 Robust Design Failure Mode and Effects Analysis
258(1)
20.4.3.1 Benefits of a Robust DFMEA
258(1)
20.4.3.2 Performing a Robust DFMEA
259(4)
20.4.3.3 Conclusion
263(1)
20.4.4 Axiomatic Design
264(1)
20.4.4.1 What Is Axiomatic Design?
264(1)
20.4.4.2 Mapping of Axiomatic Design
265(2)
Bibliography
267(2)
Chapter 21 Software Design
269(14)
21.1 Software Design Levels
269(1)
21.2 Design Alternatives and Trade-Offs
270(1)
21.3 Software Architecture
270(2)
21.4 Choosing a Methodology
272(1)
21.5 Structured Analysis
273(1)
21.6 Object-Oriented Design
274(1)
21.7 Choosing a Language
274(3)
21.8 Requirements Traceability Matrix (RTM)
277(1)
21.9 Design Techniques
278(1)
21.10 Performance Predictability and Design Simulation
278(1)
21.11 Module Specifications
278(1)
21.12 Coding and Software Design
279(1)
21.13 Design Support Tools
279(1)
21.14 Design as the Basis for Verification and Validation
280(1)
21.15 Summary
280(3)
Bibliography
281(2)
Chapter 22 Software Coding
283(12)
22.1 Structured Coding Techniques
283(1)
22.2 Single Entry, Single Exit Constructs
283(1)
22.3 Good Coding Practices
284(2)
22.3.1 Review Every Line of Code
284(1)
22.3.2 Require Coding Sign-Offs
285(1)
22.3.3 Route Good Code Examples for Review
285(1)
22.3.4 Emphasize That Code Listings Are Public Assets
285(1)
22.3.5 Reward Good Code
285(1)
22.3.6 One Easy Standard
286(1)
22.4 Coding Process
286(3)
22.4.1 Start with a Program Design Language (PDL)
286(1)
22.4.2 Writing the Routine Declaration
286(1)
22.4.3 Turning the PDL into High Level Comments
286(1)
22.4.4 Fill in the Code below Each Comment
286(2)
22.4.5 Check the Code Informally
288(1)
22.4.6 Clean Up the Leftovers
288(1)
22.4.7 Check the Code Formally
288(1)
22.5 Using Static Analysis to Check Code
289(2)
22.6 Implementation Checklist
291(1)
22.7 Software Reviews
291(4)
22.7.1 Inspections
292(1)
22.7.2 Code Walk-Throughs
293(1)
22.7.3 Code Reading
294(1)
22.7.4 Dog and Pony Shows
294(1)
Bibliography
294(1)
Chapter 23 Software Risk Analysis
295(2)
23.1 Software Hazard Analysis
295(1)
23.2 Fault Tree Analysis
295(1)
23.3 Real-Time Logic
296(1)
23.4 Software Failure Modes and Effects Analysis
296(1)
Bibliography
296(1)
Chapter 24 Software Metrics
297(18)
24.1 Software Complexity Metrics
299(1)
24.2 Objective and Algorithmic Measurement
299(1)
24.3 Metametrics
300(1)
24.4 Size Metrics
300(2)
24.4.1 Lines of Code (LOC)
300(1)
24.4.2 Token Count
301(1)
24.4.3 Function Count
302(1)
24.5 McCabe's Complexity
302(1)
24.6 Halstead Measures
303(2)
24.6.1 Vocabulary of the Software
304(1)
24.6.2 Length of the Program
304(1)
24.6.3 Volume of the Software
304(1)
24.6.4 Potential Volume
304(1)
24.6.5 Program Level
304(1)
24.6.6 Effort
305(1)
24.7 Other Metrics
305(1)
24.8 Computer-Aided Metrics
305(1)
24.9 Function Point Analysis
305(6)
24.9.1 Function Points
306(1)
24.9.2 Function Point Methodology
306(1)
24.9.2.1 Calculate the Number of Function Counts
307(1)
24.9.2.2 Assess the General Characteristics
307(2)
24.9.2.3 Calculate the Value Adjustment Factor (VAF)
309(1)
24.9.2.4 Calculate the Number of Function Points
310(1)
24.9.3 Benefits of Using Function Points
311(1)
24.10 Software Metrics Methodology
311(4)
Bibliography
312(3)
Chapter 25 Documents and Deliverables
315(4)
25.1 Deliverables Checklist
315(1)
25.2 Minutes of Design Reviews
316(1)
25.3 Results of the Phase Review
316(3)
PART V Verification and Validation
Chapter 26 The Basis and Types of Testing
319(16)
26.1 Testing Defined
319(1)
26.2 Parsing Test Requirements
320(1)
26.3 Test Protocol
321(1)
26.4 Test Methodology
322(1)
26.4.1 Time Testing
322(1)
26.4.2 Event Testing
322(1)
26.4.3 Stress Testing
322(1)
26.4.4 Environmental Testing
322(1)
26.4.5 Time Related
323(1)
26.4.6 Failure Related
323(1)
26.5 Purpose of the Test
323(1)
26.6 Failure Definition
324(1)
26.7 Determining Sample Size and Test Length
324(3)
26.7.1 Example 26.1
325(1)
26.7.2 Example 26.2
326(1)
26.8 Types of Testing
327(8)
26.8.1 Verification
327(1)
26.8.2 Validation
327(1)
26.8.3 Black Box
327(1)
26.8.4 White Box
327(1)
26.8.5 Hardware Testing
328(1)
26.8.6 Software Testing
328(1)
26.8.7 Functional Testing
328(1)
26.8.8 Robustness Testing
329(1)
26.8.9 Stress Testing
330(1)
26.8.10 Safety Testing
331(1)
26.8.11 Regression Testing
331(2)
Bibliography
333(2)
Chapter 27 Hardware Verification and Validation
335(24)
27.1 Standard Tests
335(1)
27.1.1 Cycle Testing
335(1)
27.1.2 Typical Use Testing
335(1)
27.1.3 10 x 10 Testing
336(1)
27.2 Environmental Testing
336(5)
27.2.1 Operating Temperature Testing
337(1)
27.2.2 Storage Temperature Testing
337(1)
27.2.3 Thermal Shock Testing
337(1)
27.2.4 Humidity Testing
337(1)
27.2.5 Mechanical Shock Testing
338(1)
27.2.6 Mechanical Vibration Testing
338(1)
27.2.7 Impact Testing
339(1)
27.2.8 Electrostatic Discharge
340(1)
27.2.9 EMC
340(1)
27.3 Highly Accelerated Stress Testing (HAST)
341(1)
27.4 Highly Accelerated Life Testing (HALT)
342(2)
27.5 Other Accelerated Testing
344(3)
27.5.1 Increased Sample Size
345(1)
27.5.2 Increased Test Severity
345(1)
27.5.2.1 Example 27.1
346(1)
27.5.2.2 Example 27.2
347(1)
27.5.3 Sudden Death Testing
347(1)
27.6 Weibull Testing and Plotting
347(6)
27.6.1 Example 27.3
348(1)
27.6.2 Confidence Limits
348(1)
27.6.3 Shape of the Weibull Plot
348(5)
27.7 Sudden Death Test
353(4)
27.7.1 Sudden Death Example
353(4)
27.8 Misuse Testing
357(2)
Bibliography
357(2)
Chapter 28 Hardware Data Analysis
359(12)
28.1 Failure Rate
359(1)
28.1.1 Example 28.1
359(1)
28.1.2 Example 28.2
360(1)
28.2 MTBF
360(3)
28.2.1 Time Terminated, Failed Parts Replaced
360(1)
28.2.1.1 Example 28.3
360(1)
28.2.2 Time Terminated, No Replacement
361(1)
28.2.3 Failure Terminated, Failed Parts Replaced
362(1)
28.2.3.1 Example 28.4
362(1)
28.2.4 Failure Terminated, No Replacement
362(1)
28.2.5 No Failures Observed
363(1)
28.2.5.1 Example 28.5
363(1)
28.3 Reliability
363(1)
28.3.1 Example 28.6
364(1)
28.3.2 Example 28.7
364(1)
28.4 Confidence Level
364(1)
28.4.1 Example 28.8
365(1)
28.5 Confidence Limits
365(1)
28.5.1 Time Terminated Confidence Limits
365(1)
28.5.1.1 Example 28.9
365(1)
28.5.2 Failure Terminated Confidence Limits
366(1)
28.6 Minimum Life
366(1)
28.7 Graphical Analysis
366(5)
28.7.1 Pareto Analysis
367(1)
28.7.2 Graphical Plotting
367(1)
28.7.2.1 Example 28.10
368(1)
28.7.3 Weibull Plotting
368(1)
Bibliography
368(3)
Chapter 29 Software Verification and Validation
371(10)
29.1 Allocation of Software Testing
372(1)
29.2 Verification and Validation Test Method Commonality
373(1)
29.3 Validation and Test Overview
374(3)
29.3.1 Techniques, Methods, and Test Approach
374(2)
29.3.2 Software Testing Requirements
376(1)
29.3.3 Verification and Validation Reporting
377(1)
29.4 Essentials of Software Testing
377(1)
29.4.1 Quality of the Test Process Determines the Success of the Test Effort
377(1)
29.4.2 Prevent Defect Migration by Using Early Life Cycle Testing Techniques
378(1)
29.4.3 The Time for Software Testing Tools Is Now
378(1)
29.5 A Real Person Must Take Responsibility for Improving the Test Process
378(3)
29.5.1 Testing Is a Professional Discipline Requiring Trained, Skilled People
378(1)
29.5.2 Cultivate a Positive Team Attitude of Creative Destruction
379(1)
Bibliography
379(2)
Chapter 30 Software Data Analysis
381(10)
30.1 Software Reliability Models
381(2)
30.1.1 Static Models
381(1)
30.1.2 Dynamic Models
382(1)
30.2 Dynamic Modeling Process
383(1)
30.3 Rayleigh Model
383(2)
30.4 Software Reliability Modeling
385(1)
30.5 Other Software Reliability Models
385(3)
30.5.1 Jelinski-Moranda Model
386(1)
30.5.2 Nonhomogeneous Poisson Process Model
386(1)
30.5.3 Schneidewind Model
387(1)
30.5.4 Musa's Basic Execution Time Model
387(1)
30.5.5 Geometric Model
388(1)
30.6 Software Reliability Modeling and Acceptance Testing
388(3)
Bibliography
389(2)
Chapter 31 Documents and Deliverables
391(4)
31.1 Deliverables Checklist
391(1)
31.2 Minutes of Design Reviews
392(1)
31.3 Results of the Phase Review
392(3)
PART VI Design Transfer and Manufacturing
Chapter 32 Transfer to Manufacturing
395(6)
32.1 Objective of Design Transfer
395(1)
32.2 Number of Final Product Development Reviews
396(1)
32.3 Conducting Final Product Development Reviews
396(1)
32.4 Documenting Design Transfer
396(1)
32.5 Design Transfer Process
397(1)
32.6 Design Transfer Checklist
398(3)
Bibliography
399(2)
Chapter 33 Hardware Manufacturing
401(8)
33.1 Manufacturing Strategy
401(1)
33.2 Design for Manufacturability (DFM)
402(1)
33.2.1 DFM Process
402(1)
33.3 Design for Assembly (DFA)
403(2)
33.3.1 DFA Process
404(1)
33.4 Manufacturing Process
405(1)
33.4.1 Preproduction Activity
405(1)
33.4.2 Pilot Run Build
405(1)
33.4.3 Production Run
406(1)
33.4.4 Customer Delivery
406(1)
33.5 Highly Accelerated Stress Screening (HASS)
406(2)
33.6 Highly Accelerated Stress Audit (HASA)
408(1)
Bibliography
408(1)
Chapter 34 Software Manufacturing
409(2)
34.1 Archiving the Software
409(1)
34.2 Reproducing the Software
409(1)
34.3 Reliability of Manufactured Software
409(1)
34.4 Configuration Management
410(1)
Bibliography
410(1)
Chapter 35 Configuration Management
411(8)
35.1 Configuration Identification
412(2)
35.1.1 Functional Baseline
412(1)
35.1.2 Allocated Baseline
413(1)
35.1.3 Developmental Configuration
413(1)
35.1.4 Product Baseline
414(1)
35.2 Configuration Audits
414(1)
35.2.1 Functional Configuration Audits
414(1)
35.2.2 Physical Configuration Audits
415(1)
35.2.3 In-Process Audits
415(1)
35.3 Configuration Management Metrics
415(1)
35.4 FDA's View of Configuration Management
416(1)
35.5 Status Accounting
416(3)
Bibliography
417(2)
Chapter 36 Documents and Deliverables
419(4)
36.1 Deliverables Checklist
419(1)
36.2 Minutes of Manufacturing Reviews
419(1)
36.3 Results of the Phase Review
420(3)
PART VII Field Activity
Chapter 37 Analysis of Field Data
423(6)
37.1 Analysis of Field Service Reports
423(3)
37.1.1 Database
424(1)
37.1.2 Data Analysis
425(1)
37.2 Failure Analysis of Field Units
426(1)
37.3 Warranty Analysis
427(2)
Bibliography
427(2)
Chapter 38 Monitored Activity
429(2)
38.1 Monitored Activity Checklist
429(2)
Appendix 1 Chi-Square Table 431(2)
Appendix 2 Percent Rank Table 433(10)
Appendix 3 Common Failure Modes 443(10)
Appendix 4 Glossary 453(8)
Index 461
Richard Fries, PE, CSQE, CRE, is president of ISORel, Inc., a consulting firm located in Fitchburg, Wisconsin. He is a licensed professional engineer in the state of Wisconsin and is certified by the American Society for Quality as a Reliability Engineer and a Software Quality Engineer. Mr. Fries is a member of the IEEE Software Engineering Subcommittee. He was a member of the AAMI Medical Device Software Committee that developed IEC 62304. He was also a member of the AAMI Technical Committee that developed ISO 13485.
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