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
- 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
Product information
- Title: Mission-Critical and Safety-Critical Systems Handbook
- Author(s):
- Release date: November 2009
- Publisher(s): Newnes
- ISBN: 9780080942551
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