Mission-Critical and Safety-Critical Systems Handbook: Design and Development for Embedded Applications

by Kim Fowler

Overview

This handbook provides a consolidated, comprehensive information resource for engineers working with mission and safety critical systems. Principles, regulations, and processes common to all critical design projects are introduced in the opening chapters. Expert contributors then offer development models, process templates, and documentation guidelines from their own core critical applications fields: medical, aerospace, and military. Readers will gain in-depth knowledge of how to avoid common pitfalls and meet even the strictest certification standards. Particular emphasis is placed on best practices, design tradeoffs, and testing procedures. - Comprehensive coverage of all key concerns for designers of critical systems including standards compliance, verification and validation, and design tradeoffs - Real-world case studies contained within these pages provide insight from experience

Product Details

ISBN-13:	9780080942551
Publisher:	Butterworth-Heinemann
Publication date:	11/19/2009
Sold by:	Barnes & Noble
Format:	eBook
Pages:	592
File size:	6 MB

About the Author

Kim Fowler has spent over 30 years in the design, development, and project management of medical, military, and satellite equipment. His interest is the rigorous development of diverse, mission-critical, embedded systems. Kim co-founded Stimsoft, a medical products company, in 1998 and sold it in 2003. He has also worked for JHU/APL designing embedded systems, for a company now part of Curtiss-Wright Embedded Computing that built digital signal processing boards, and consulted for both commercial companies and government agencies. Kim is a Fellow of the IEEE and lectures internationally on systems engineering and developing real-time embedded products. He has been President of the IEEE Instrumentation & Measurement society and an adjunct professor for the Johns Hopkins University Engineering Professional Program. He has published widely and has written three textbooks - this book is his fourth. He has 18 patents - granted, pending, or disclosed. Kim currently is a graduate student in Electrical and Computer Engineering at Kansas State University to finally get his PhD to teach and research.

Table of Contents

About the EditorAbout the ContributorsChapter 1 Best Practices in Mission-Assured, Mission-Critical, and Safety-Critical Systems 1 Roadmap to This Book 1.1 Systems Engineering 1.2 Important Issues 1.3 Material Covered 2 Best Practices 2.1 What and Why? 2.2 Rationale 2.3 Standards and Guidelines for a QMS 3 Project Management and Systems Engineering 3.1 Project Management 3.2 Systems Engineering 3.3 Mission Assurance 4 Process Flows for Developing Products 4.1 Plan, Execute, Review, Report, and Update (PERRU) 4.2 Development Processes 4.3 Processes vs. Procedures 4.4 General Process Models 4.5 An Example of Phases, Processes, and Procedures 5 Standards 5.1 General Standards Organizations 5.2 Industry-Based Standards Organizations 5.3 Military Standards Organizations 5.4 Aviation and Aerospace Standards Organizations 6 Potential Procedures, Checklists, and Documents 7 Review of Procedures and Processes 7.1 Difference between Procedures and Processes 7.2 Why Review Procedures and Processes? 7.3 Types of Review 7.4 Frequency of Review 7.5 Review Content 7.6 Course of Action, Changes, and Updates Following Review 7.7 Review Responsibilities 8 Configuration Management 8.1 Rationale for Configuration Management 8.2 Configuration Management Coverage 8.3 Records Responsibility 8.4 System and Location 8.5 Version Control 8.6 Design Repository 8.7 File Structure 8.8 Obsolete Documents 8.9 Training for Use of the System 9 Documentation 9.1 Rationale for Documentation 9.2 Coverage and Responsibility for Documentation 9.3 Types of Documentation 9.4 Best Practices for DocumentationAppendix A: Example Document Outlines Work Order (WO) Minutes Problem Report/Corrective Action (PRCA) Engineering Change Request (ECR) Engineering Change Notice (ECN) Project Management Plan (PMP) Interface Control Documents (ICDs) Development Plans Requirements Risk Management Plan Configuration Management Plan Documentation Plan Analysis Reports Design Description Test Plan Operation Plan Metrology Concerns and Procedures Appendix B: Program Management Documents for Project Development Appendix C: Technical Project Documents for Project DevelopmentChapter 2 Failsafe Software Design: Embedded Programming in a Fail-Certain World 1 Software Matters 2 The Essence of Process 3 Three Principles for Design and Coding 3.1 What Does It Mean to Be Failsafe? 3.2 Safety (and Mission) First 3.3 Verification and Redundancy in the Implementation Process 4 The User Interface 5 Rolling Your Own 6 Hardware as Software: A Thought Exercise in Crossover Thinking 7 ConclusionsChapter 3 Compliance Concerns for Medical Equipment 1 Introduction 2 National and International Requirements 2.1 U.S. Requirements 2.2 European Requirements 2.3 Other Countries 3 Medical Device Certification 4 Philosophy of the Standards 5 Evaluation Process 5.1 Preliminary Evaluation 5.2 Testing 5.3 Compliance Reports 5.4 Common Noncompliances 6 Conclusion Chapter 4 Software for Medical Systems 1 Introduction 1.1 Verification and Validation 1.2 Life Cycle Model 2 The Medical Regulatory Environment 2.1 Worldwide Quality System Requirements 2.2 Subpart A: General Provisions 2.3 Subpart B: Quality System Requirements 2.4 Subpart C—Design Controls 2.5 Subpart D—Document Controls 2.6 Subpart E—Purchasing Controls 2.

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