http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Mission-critical and safety-critical systems handbook
design and development for embedded applications
1 online resource (xiv, 578 pages) : illustrations
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.
About the Editor; ; About the Contributors; ; Chapter 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 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; ; 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 Conclusions; ; Chapter 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 Ho
edited by Kim Fowler ; technical consultant, Sharfus Draid, Inc.
Includes bibliographical references and index.
Amsterdam ; Boston : Elsevier/Newnes, ©2010