- Cover
- Title
- Copyright
- Contents
- About the Editor
- About the Contributors
- Chapter 1 Best Practices in Mission-Assured, Mission-Critical, and Safety-Critical Systems
- 1 Roadmap to This Book
- 2 Best Practices
- 3 Project Management and Systems Engineering
- 4 Process Flows for Developing Products
- 5 Standards
- 6 Potential Procedures, Checklists, and Documents
- 7 Review of Procedures and Processes
- 8 Configuration Management
- 9 Documentation
- Appendix 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 Development
- Chapter 2 Failsafe Software Design: Embedded Programming in a Fail-Certain World
- Chapter 3 Compliance Concerns for Medical Equipment
- Chapter 4 Software for Medical Systems
- 1 Introduction
- 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
- 7 Summary
- 8 FAQS
- Chapter 5 Best Practices in Spacecraft Development
- 1 Regulations and Standard Practices
- 2 Company Processes
- 3 Documentation
- 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 Subsystem
- Appendix C Example of a Small Test Plan
- Chapter 6 Systems Engineering in Military Projects
- 1 Introduction
- 2 Historical Background
- 2.1 JCIDS
- 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
- 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
- 7 Avionics Standards: DO-178 and DO-254
- 8 Test and Evaluation
- 9 Obsolescence and Legacy Systems
- 10 Case Studies
- Index
Mission-Critical and Safety-Critical Systems Handbook
Design and Development for Embedded Applications
Edited by
Kim Fowler
Technical Consultant, Sharfus Draid, Inc.
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