Mission-critical and safety-critical systems handbook : design and development for embedded applications /: design and development for embedded applications. (©2010)

• Record Type: Book
• Further Information: Note: Edited by Kim Fowler ; technical consultant, Sharfus Draid, Inc.
• Other Names: Fowler, Kim R, 1956-
• 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; ; 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
• Publisher Details: Amsterdam Boston : Elsevier/Newnes
• Publication Date: 2010
• Copyright Date: 2010
• Extent: 1 online resource (xiv, 578 pages), illustrations
• Subjects: 620/.00452; Reliability (Engineering); Fault tolerance (Engineering); Embedded computer systems -- Design and construction; Safety factor in engineering; TECHNOLOGY & ENGINEERING -- Quality Control; Embedded computer systems -- Design and construction; Fault tolerance (Engineering); Reliability (Engineering); Safety factor in engineering; Electronic books
• Languages: English
• ISBNs: 9780080942551; 0080942555; 9780750685672; 0750685670
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.