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Mission-Critical and Safety-Critical Systems Handbook

Book Description

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

Table of Contents

  1. Cover
  2. Title
  3. Copyright
  4. Contents
  5. About the Editor
  6. About the Contributors
  7. Chapter 1 Best Practices in Mission-Assured, Mission-Critical, and Safety-Critical Systems
    1. 1 Roadmap to This Book
      1. 1.1 Systems Engineering
      2. 1.2 Important Issues
      3. 1.3 Material Covered
    2. 2 Best Practices
      1. 2.1 What and Why?
      2. 2.2 Rationale
      3. 2.3 Standards and Guidelines for a QMS
    3. 3 Project Management and Systems Engineering
      1. 3.1 Project Management
      2. 3.2 Systems Engineering
      3. 3.3 Mission Assurance
    4. 4 Process Flows for Developing Products
      1. 4.1 Plan, Execute, Review, Report, and Update (PERRU)
      2. 4.2 Development Processes
      3. 4.3 Processes vs. Procedures
      4. 4.4 General Process Models
      5. 4.5 An Example of Phases, Processes, and Procedures
    5. 5 Standards
      1. 5.1 General Standards Organizations
      2. 5.2 Industry-Based Standards Organizations
      3. 5.3 Military Standards Organizations
      4. 5.4 Aviation and Aerospace Standards Organizations
    6. 6 Potential Procedures, Checklists, and Documents
    7. 7 Review of Procedures and Processes
      1. 7.1 Difference between Procedures and Processes
      2. 7.2 Why Review Procedures and Processes?
      3. 7.3 Types of Review
      4. 7.4 Frequency of Review
      5. 7.5 Review Content
      6. 7.6 Course of Action, Changes, and Updates Following Review
      7. 7.7 Review Responsibilities
    8. 8 Configuration Management
      1. 8.1 Rationale for Configuration Management
      2. 8.2 Configuration Management Coverage
      3. 8.3 Records Responsibility
      4. 8.4 System and Location
      5. 8.5 Version Control
      6. 8.6 Design Repository
      7. 8.7 File Structure
      8. 8.8 Obsolete Documents
      9. 8.9 Training for Use of the System
    9. 9 Documentation
      1. 9.1 Rationale for Documentation
      2. 9.2 Coverage and Responsibility for Documentation
      3. 9.3 Types of Documentation
      4. 9.4 Best Practices for Documentation
    10. Appendix A: Example Document Outlines
      1. Work Order (WO)
      2. Minutes
      3. Problem Report/Corrective Action (PRCA)
      4. Engineering Change Request (ECR)
      5. Engineering Change Notice (ECN)
      6. Project Management Plan (PMP)
      7. Interface Control Documents (ICDs)
      8. Development Plans
      9. Requirements
      10. Risk Management Plan
      11. Configuration Management Plan
      12. Documentation Plan
      13. Analysis Reports
      14. Design Description
      15. Test Plan
      16. Operation Plan
      17. Metrology Concerns and Procedures
    11. Appendix B: Program Management Documents for Project Development
    12. Appendix C: Technical Project Documents for Project Development
  8. Chapter 2 Failsafe Software Design: Embedded Programming in a Fail-Certain World
    1. 1 Software Matters
    2. 2 The Essence of Process
    3. 3 Three Principles for Design and Coding
      1. 3.1 What Does It Mean to Be Failsafe?
      2. 3.2 Safety (and Mission) First
      3. 3.3 Verification and Redundancy in the Implementation Process
    4. 4 The User Interface
    5. 5 Rolling Your Own
    6. 6 Hardware as Software: A Thought Exercise in Crossover Thinking
    7. 7 Conclusions
  9. Chapter 3 Compliance Concerns for Medical Equipment
    1. 1 Introduction
    2. 2 National and International Requirements
      1. 2.1 U.S. Requirements
      2. 2.2 European Requirements
      3. 2.3 Other Countries
    3. 3 Medical Device Certification
    4. 4 Philosophy of the Standards
    5. 5 Evaluation Process
      1. 5.1 Preliminary Evaluation
      2. 5.2 Testing
      3. 5.3 Compliance Reports
      4. 5.4 Common Noncompliances
    6. 6 Conclusion
  10. Chapter 4 Software for Medical Systems
    1. 1 Introduction
      1. 1.1 Verification and Validation
      2. 1.2 Life Cycle Model
    2. 2 The Medical Regulatory Environment
      1. 2.1 Worldwide Quality System Requirements
      2. 2.2 Subpart A: General Provisions
      3. 2.3 Subpart B: Quality System Requirements
      4. 2.4 Subpart C—Design Controls
      5. 2.5 Subpart D—Document Controls
      6. 2.6 Subpart E—Purchasing Controls
      7. 2.7 Subpart F—Identification and Traceability
      8. 2.8 Subpart G—Production and Process Controls
      9. 2.9 Subpart H—Acceptance Activities, and Subpart I—Nonconforming Product
      10. 2.10 Subpart J—Corrective and Preventive Action
      11. 2.11 Subpart K—Labeling and Packaging Control
      12. 2.12 Subpart L—Handling, Storage, Distribution, and Installation
      13. 2.13 Subpart M—Records
      14. 2.14 Subpart N—Servicing and Subpart O Statistical Techniques
      15. 2.15 Post-Market Activities
    3. 3 Design Control Explained
      1. 3.1 Purpose of Design Control
      2. 3.2 Project Planning
      3. 3.3 Design Input
      4. 3.4 Design Output
      5. 3.5 Design Review
      6. 3.6 Design Verification and Validation
      7. 3.7 Design Changes
      8. 3.8 Design History File
      9. 3.9 Change Control
      10. 3.10 Software Change Control in the Medical Environment
      11. 3.11 Software Configuration Management Methods
      12. 3.12 Software Problem Resolution
      13. 3.13 Problem Evaluation
      14. 3.14 Outcomes of the Evaluation Phase
      15. 3.15 Corrective Action Process
      16. 3.16 Outcomes of the System Test Phase
      17. 3.17 Reports
      18. 3.18 Software Observation Reporting and Version Control
    4. 4 Risk Management
    5. 5 Software Verification and Validation in the Context of Design Control
      1. 5.1 Software Verification Methods
      2. 5.2 Software System Testing
      3. 5.3 System Validation (Acceptance Tests)
      4. 5.4 Traceability
      5. 5.5 Metrics
      6. 5.6 FDA Regulatory Approval Process
      7. 5.7 Device Risk Classes
      8. 5.8 Software Level of Concern
      9. 5.9 Software Documentation Requirements for Premarket Submissions
      10. 5.10 The Review Process and What to Expect from the FDA
    6. 6 Special Topics
      1. 6.1 Software of Unknown Provenance
      2. 6.2 Security and Privacy—HIPAA
    7. 7 Summary
    8. 8 FAQS
  11. Chapter 5 Best Practices in Spacecraft Development
    1. 1 Regulations and Standard Practices
      1. 1.1 Government Regulations
      2. 1.2 Industry Standards
      3. 1.3 Commercial Off-the-Shelf
    2. 2 Company Processes
      1. 2.1 Project Management
      2. 2.2 Systems Engineering
      3. 2.3 Fault Protection
      4. 2.4 Mission Assurance and Safety
      5. 2.5 Integration and Test
      6. 2.6 Mission Operations
    3. 3 Documentation
      1. 3.1 Project Documentation
      2. 3.2 Corporate Documentation
      3. 3.3 Documentation Tools
    4. 4 Case Study—New Horizons
      1. 4.1 Pluto-Kuiper Belt Announcement of Opportunity
      2. 4.2 Mission Concept Overview
      3. 4.3 Project Management
      4. 4.4 Systems Engineering
      5. 4.5 Fault Protection
      6. 4.6 Mission Assurance and Safety
      7. 4.7 Assembly, Integration, and Test—Fabrication and Assembly of Circuit Boards
      8. 4.8 Subsystem Tests and Testing—Notable Anomalies and Lessons Learned
      9. 4.9 Launch and Mission Operations
    5. 5 Future Directions
    6. 6 Summary of Good Practices
    7. Acknowledgments
    8. Appendix A Example of a Systems Engineering Plan
    9. Appendix B Example of a Small Requirements Document for a Subsystem
    10. Appendix C Example of a Small Test Plan
  12. Chapter 6 Systems Engineering in Military Projects
    1. 1 Introduction
    2. 2 Historical Background
    3. 2.1 JCIDS
      1. 2.2 Defense Acquisition
      2. 2.3 Where Is JCIDS Now?
      3. 2.4 Recent History of Systems Engineering
      4. 2.5 Evolution of Standards for Systems Engineering
    4. 3 Processes, Procedures, and Tasks
      1. 3.1 MIL-STD-499B: Systems Engineering Planning and Implementation
      2. 3.2 Systems Engineering Input Information
      3. 3.3 Technical Objectives
      4. 3.4 Systems Engineering Process Requirements
      5. 3.5 Requirements Analysis
      6. 3.6 Functional Analysis and Functional Allocation
      7. 3.7 Design
      8. 3.8 Systems Analysis and Control
      9. 3.9 Tradeoff Studies
      10. 3.10 System/Cost-Effectiveness Analysis
      11. 3.11 Configuration Management
      12. 3.12 Interface Management
      13. 3.13 Data Management
      14. 3.14 Integrated Master Plan
      15. 3.15 Technical Performance Measurement
      16. 3.16 Technical Reviews
      17. 3.17 Response to Change
    5. 4 U.S Department of Defense Resources
    6. 5 Military Standards and Handbooks
    7. 6 Other Military Standards and Specifications
      1. 6.1 Specifications
      2. 6.2 Standards
      3. 6.3 Handbooks
      4. 6.4 Current Guidance
    8. 7 Avionics Standards: DO-178 and DO-254
      1. 7.1 DO-178B/C
      2. 7.2 DO-254
    9. 8 Test and Evaluation
      1. 8.1 Inspection
      2. 8.2 Peer Review
      3. 8.3 Subsystem Tests
      4. 8.4 Integration
      5. 8.5 Environmental
      6. 8.6 EMC
      7. 8.7 Field Tests, Final Acceptance Tests, Builder’s Trials, and Commissioning
      8. 8.8 Manufacturing
      9. 8.9 BIT, BITE, and ATE
    10. 9 Obsolescence and Legacy Systems
    11. 10 Case Studies
  13. Index