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Mission-Critical and Safety-Critical Systems Handbook

Name: Mission-Critical and Safety-Critical Systems Handbook
Author: Kim Fowler
ISBN: 9780080942551

by Kim Fowler

November 2009

Intermediate to advanced

592 pages

17h 16m

English

Newnes

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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 Book1.1 Systems Engineering1.2 Important Issues1.3 Material Covered2 Best Practices2.1 What and Why?2.2 Rationale2.3 Standards and Guidelines for a QMS3 Project Management and Systems Engineering3.1 Project Management3.2 Systems Engineering3.3 Mission Assurance4 Process Flows for Developing Products4.1 Plan, Execute, Review, Report, and Update (PERRU)4.2 Development Processes4.3 Processes vs. Procedures4.4 General Process Models4.5 An Example of Phases, Processes, and Procedures5 Standards5.1 General Standards Organizations5.2 Industry-Based Standards Organizations5.3 Military Standards Organizations5.4 Aviation and Aerospace Standards Organizations6 Potential Procedures, Checklists, and Documents7 Review of Procedures and Processes7.1 Difference between Procedures and Processes7.2 Why Review Procedures and Processes?7.3 Types of Review7.4 Frequency of Review7.5 Review Content7.6 Course of Action, Changes, and Updates Following Review7.7 Review Responsibilities8 Configuration Management8.1 Rationale for Configuration Management8.2 Configuration Management Coverage8.3 Records Responsibility8.4 System and Location8.5 Version Control8.6 Design Repository8.7 File Structure8.8 Obsolete Documents8.9 Training for Use of the System9 Documentation9.1 Rationale for Documentation9.2 Coverage and Responsibility for Documentation9.3 Types of Documentation9.4 Best Practices for DocumentationAppendix A: Example Document OutlinesWork Order (WO)MinutesProblem Report/Corrective Action (PRCA)Engineering Change Request (ECR)Engineering Change Notice (ECN)Project Management Plan (PMP)Interface Control Documents (ICDs)Development PlansRequirementsRisk Management PlanConfiguration Management PlanDocumentation PlanAnalysis ReportsDesign DescriptionTest PlanOperation PlanMetrology Concerns and ProceduresAppendix B: Program Management Documents for Project DevelopmentAppendix C: Technical Project Documents for Project Development
Chapter 2 Failsafe Software Design: Embedded Programming in a Fail-Certain World
1 Software Matters2 The Essence of Process3 Three Principles for Design and Coding3.1 What Does It Mean to Be Failsafe?3.2 Safety (and Mission) First3.3 Verification and Redundancy in the Implementation Process4 The User Interface5 Rolling Your Own6 Hardware as Software: A Thought Exercise in Crossover Thinking7 Conclusions
Chapter 3 Compliance Concerns for Medical Equipment
1 Introduction2 National and International Requirements2.1 U.S. Requirements2.2 European Requirements2.3 Other Countries3 Medical Device Certification4 Philosophy of the Standards5 Evaluation Process5.1 Preliminary Evaluation5.2 Testing5.3 Compliance Reports5.4 Common Noncompliances6 Conclusion
Chapter 4 Software for Medical Systems
1 Introduction1.1 Verification and Validation1.2 Life Cycle Model2 The Medical Regulatory Environment2.1 Worldwide Quality System Requirements2.2 Subpart A: General Provisions2.3 Subpart B: Quality System Requirements2.4 Subpart C—Design Controls2.5 Subpart D—Document Controls2.6 Subpart E—Purchasing Controls2.7 Subpart F—Identification and Traceability2.8 Subpart G—Production and Process Controls2.9 Subpart H—Acceptance Activities, and Subpart I—Nonconforming Product2.10 Subpart J—Corrective and Preventive Action2.11 Subpart K—Labeling and Packaging Control2.12 Subpart L—Handling, Storage, Distribution, and Installation2.13 Subpart M—Records2.14 Subpart N—Servicing and Subpart O Statistical Techniques2.15 Post-Market Activities3 Design Control Explained3.1 Purpose of Design Control3.2 Project Planning3.3 Design Input3.4 Design Output3.5 Design Review3.6 Design Verification and Validation3.7 Design Changes3.8 Design History File3.9 Change Control3.10 Software Change Control in the Medical Environment3.11 Software Configuration Management Methods3.12 Software Problem Resolution3.13 Problem Evaluation3.14 Outcomes of the Evaluation Phase3.15 Corrective Action Process3.16 Outcomes of the System Test Phase3.17 Reports3.18 Software Observation Reporting and Version Control4 Risk Management5 Software Verification and Validation in the Context of Design Control5.1 Software Verification Methods5.2 Software System Testing

5.3 System Validation (Acceptance Tests)
5.4 Traceability5.5 Metrics5.6 FDA Regulatory Approval Process5.7 Device Risk Classes5.8 Software Level of Concern5.9 Software Documentation Requirements for Premarket Submissions5.10 The Review Process and What to Expect from the FDA6 Special Topics6.1 Software of Unknown Provenance6.2 Security and Privacy—HIPAA7 Summary8 FAQS
Chapter 5 Best Practices in Spacecraft Development
1 Regulations and Standard Practices1.1 Government Regulations1.2 Industry Standards1.3 Commercial Off-the-Shelf2 Company Processes2.1 Project Management
2.2 Systems Engineering
2.3 Fault Protection2.4 Mission Assurance and Safety2.5 Integration and Test2.6 Mission Operations3 Documentation3.1 Project Documentation3.2 Corporate Documentation3.3 Documentation Tools4 Case Study—New Horizons4.1 Pluto-Kuiper Belt Announcement of Opportunity4.2 Mission Concept Overview4.3 Project Management4.4 Systems Engineering4.5 Fault Protection4.6 Mission Assurance and Safety4.7 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 Operations5 Future Directions6 Summary of Good PracticesAcknowledgmentsAppendix A Example of a Systems Engineering PlanAppendix B Example of a Small Requirements Document for a SubsystemAppendix C Example of a Small Test Plan
Chapter 6 Systems Engineering in Military Projects
1 Introduction2 Historical Background2.1 JCIDS2.2 Defense Acquisition2.3 Where Is JCIDS Now?2.4 Recent History of Systems Engineering2.5 Evolution of Standards for Systems Engineering3 Processes, Procedures, and Tasks3.1 MIL-STD-499B: Systems Engineering Planning and Implementation3.2 Systems Engineering Input Information3.3 Technical Objectives3.4 Systems Engineering Process Requirements3.5 Requirements Analysis3.6 Functional Analysis and Functional Allocation3.7 Design3.8 Systems Analysis and Control3.9 Tradeoff Studies3.10 System/Cost-Effectiveness Analysis3.11 Configuration Management3.12 Interface Management3.13 Data Management3.14 Integrated Master Plan3.15 Technical Performance Measurement3.16 Technical Reviews3.17 Response to Change4 U.S Department of Defense Resources5 Military Standards and Handbooks6 Other Military Standards and Specifications6.1 Specifications6.2 Standards6.3 Handbooks6.4 Current Guidance7 Avionics Standards: DO-178 and DO-2547.1 DO-178B/C7.2 DO-2548 Test and Evaluation8.1 Inspection8.2 Peer Review8.3 Subsystem Tests8.4 Integration8.5 Environmental8.6 EMC8.7 Field Tests, Final Acceptance Tests, Builder’s Trials, and Commissioning8.8 Manufacturing8.9 BIT, BITE, and ATE
9 Obsolescence and Legacy Systems
10 Case Studies
Index

Overview

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

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