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.
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 2.7 Subpart F—Identification and Traceability 2.8 Subpart G—Production and Process Controls 2.9 Subpart H—Acceptance Activities, and Subpart I—Nonconforming Product 2.10 Subpart J—Corrective and Preventive Action 2.11 Subpart K—Labeling and Packaging Control 2.12 Subpart L—Handling, Storage, Distribution, and Installation 2.13 Subpart M—Records 2.14 Subpart N—Servicing and Subpart O Statistical Techniques 2.15 Post-Market Activities 3 Design Control Explained 3.1 Purpose of Design Control 3.2 Project Planning 3.3 Design Input 3.4 Design Output 3.5 Design Review 3.6 Design Verification and Validation 3.7 Design Changes 3.8 Design History File 3.9 Change Control 3.10 Software Change Control in the Medical Environment 3.11 Software Configuration Management Methods 3.12 Software Problem Resolution 3.13 Problem Evaluation 3.14 Outcomes of the Evaluation Phase 3.15 Corrective Action Process 3.16 Outcomes of the System Test Phase 3.17 Reports 3.18 Software Observation Reporting and Version Control 4 Risk Management 5 Software Verification and Validation in the Context of Design Control 5.1 Software Verification Methods 5.2 Software System Testing 5.3 System Validation (Acceptance Tests) 5.4 Traceability 5.5 Metrics 5.6 FDA Regulatory Approval Process 5.7 Device Risk Classes 5.8 Software Level of Concern 5.9 Software Documentation Requirements for Premarket Submissions 5.10 The Review Process and What to Expect from the FDA 6 Special Topics 6.1 Software of Unknown Provenance 6.2 Security and Privacy—HIPAA 7 Summary 8 FAQS Chapter 5 Best Practices in Spacecraft Development 1 Regulations and Standard Practices 1.1 Government Regulations 1.2 Industry Standards 1.3 Commercial Off-the-Shelf 2 Company Processes 2.1 Project Management 2.2 Systems Engineering 2.3 Fault Protection 2.4 Mission Assurance and Safety 2.5 Integration and Test 2.6 Mission Operations 3 Documentation 3.1 Project Documentation 3.2 Corporate Documentation 3.3 Documentation Tools 4 Case Study—New Horizons 4.1 Pluto-Kuiper Belt Announcement of Opportunity 4.2 Mission Concept Overview 4.3 Project Management 4.4 Systems Engineering 4.5 Fault Protection 4.6 Mission Assurance and Safety 4.7 Assembly, Integration, and Test—Fabrication and Assembly of Circuit Boards 4.8 Subsystem Tests and Testing—Notable Anomalies and Lessons Learned 4.9 Launch and Mission Operations 5 Future Directions 6 Summary of Good Practices Acknowledgments Appendix A Example of a Systems Engineering Plan Appendix B Example of a Small Requirements Document for a SubsystemAppendix C Example of a Small Test Plan Chapter 6 Systems Engineering in Military Projects 1 Introduction 2 Historical Background 2.1 JCIDS 2.2 Defense Acquisition 2.3 Where Is JCIDS Now? 2.4 Recent History of Systems Engineering 2.5 Evolution of Standards for Systems Engineering 3 Processes, Procedures, and Tasks 3.1 MIL-STD-499B: Systems Engineering Planning and Implementation 3.2 Systems Engineering Input Information 3.3 Technical Objectives 3.4 Systems Engineering Process Requirements 3.5 Requirements Analysis 3.6 Functional Analysis and Functional Allocation 3.7 Design 3.8 Systems Analysis and Control 3.9 Tradeoff Studies 3.10 System/Cost-Effectiveness Analysis 3.11 Configuration Management 498 3.12 Interface Management 3.13 Data Management 3.14 Integrated Master Plan 3.15 Technical Performance Measurement 3.16 Technical Reviews 3.17 Response to Change 4 U.S Department of Defense Resources 5 Military Standards and Handbooks 6 Other Military Standards and Specifications 6.1 Specifications 6.2 Standards 6.3 Handbooks 6.4 Current Guidance 7 Avionics Standards: DO-178 and DO-254 7.1 DO-178B/C 7.2 DO-254 8 Test and Evaluation 8.1 Inspection 8.2 Peer Review 8.3 Subsystem Tests 8.4 Integration 8.5 Environmental 8.6 EMC 8.7 Field Tests, Final Acceptance Tests, Builder’s Trials, and Commissioning 8.8 Manufacturing 8.9 BIT, BITE, and ATE 9 Obsolescence and Legacy Systems 10 Case StudiesIndex
Kim has spent over 30 years in the design, development, and project management of medical, military, and satellite equipment. He co-founded Stimsoft, a medical products company, in 1998 (sold in 2003). He has worked for JHU/APL and Ixthos, a company now part of Curtiss-Wright Embedded Computing. He is a past President of the IEEE I&M society and has been an adjunct professor for the Johns Hopkins University Engineering Professional Program. He lectures internationally on systems engineering and developing real-time embedded products. He has written seven textbooks and is working on an eighth. He has 18 patents - granted, pending, or disclosed. He has returned to graduate school for his PhD at Kansas State University.
