rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Mission-critical and safety-critical systems handbook
    sub title: design and development for embedded applications
  name:
    name part: Fowler, Kim R.
    name part: 1956-
  name:
    name part: ScienceDirect (Online service)
  type of resource: text
  genre: bibliography
  genre: Electronic books.
  genre: Handbook
  genre: handbooks.
  genre: Handbooks and manuals
  genre: Handbooks and manuals.
  genre: Guides et manuels.
  origin info:
    place:
      place term: ne
    place:
      place term: Amsterdam
    place:
      place term: Boston
    publisher: Elsevier/Newnes
    date issued: ©2010
    date issued: 2010
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource (xiv, 578 pages) : illustrations
  abstract: 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: 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.
  table of contents: 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,
  table of contents: 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
  table of contents: 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
  table of contents: 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.
  table of contents: 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
  table of contents: 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,
  table of contents: 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
  table of contents: ; ; 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
  table of contents: ; ; 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
  note: edited by Kim Fowler ; technical consultant, Sharfus Draid, Inc.
  note: Includes bibliographical references and index.
  note: English.
  subject:
    topic: Reliability (Engineering)
  subject:
    topic: Fault tolerance (Engineering)
  subject:
    topic: Embedded computer systems
    topic: Design and construction
  subject:
    topic: Safety factor in engineering
  subject:
    topic: Fiabilité
  subject:
    topic: Tolérance aux fautes (Ingénierie)
  subject:
    topic: Coefficient de sécurité en ingénierie
  subject:
    topic: TECHNOLOGY & ENGINEERING
    topic: Quality Control
  subject:
    topic: Embedded computer systems
    topic: Design and construction
  subject:
    topic: Fault tolerance (Engineering)
  subject:
    topic: Reliability (Engineering)
  subject:
    topic: Safety factor in engineering
  classification: TA169 .M574 2010eb
  classification: 620/.00452
  related item:
    title info:
      title: Mission-critical and safety-critical systems handbook
    origin info:
      publisher: Amsterdam ; Boston : Elsevier/Newnes, ©2010
    identifier: (DLC) 2009038373
    identifier: (OCoLC)454361096
  identifier: 9780080942551
  identifier: 0080942555
  identifier: 9780750685672
  identifier: 0750685670
  identifier: 1282618520
  identifier: 9781282618527
  identifier: 9786612618529
  identifier: 6612618523
  identifier: Knovel Corporation
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: KNOVL
    record creation date: 100316
    record change date: 20260326171603.5
    record identifier: in00005739573
    language of cataloging:
      language term: eng