Contents
Chapter 1 Best Practices in Mission-Assured, Mission-Critical, and Safety-Critical Systems
2.3 Standards and Guidelines for a QMS
3 Project Management and Systems Engineering
4 Process Flows for Developing Products
4.1 Plan, Execute, Review, Report, and Update (PERRU)
4.5 An Example of Phases, Processes, and Procedures
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?
7.6 Course of Action, Changes, and Updates Following Review
8.1 Rationale for Configuration Management
8.2 Configuration Management Coverage
8.9 Training for Use of the System
9.1 Rationale for Documentation
9.2 Coverage and Responsibility for Documentation
9.4 Best Practices for Documentation
Appendix A: Example Document Outlines
Problem Report/Corrective Action (PRCA)
Engineering Change Request (ECR)
Engineering Change Notice (ECN)
Interface Control Documents (ICDs)
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
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
6 Hardware as Software: A Thought Exercise in Crossover Thinking
Chapter 3 Compliance Concerns for Medical Equipment
2 National and International Requirements
3 Medical Device Certification
Chapter 4 Software for Medical Systems
1.1 Verification and Validation
2 The Medical Regulatory Environment
2.1 Worldwide Quality System Requirements
2.2 Subpart A: General Provisions
2.3 Subpart B: Quality System Requirements
2.5 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
2.14 Subpart N—Servicing and Subpart O Statistical Techniques
3.6 Design Verification and Validation
3.10 Software Change Control in the Medical Environment
3.11 Software Configuration Management Methods
3.12 Software Problem Resolution
3.14 Outcomes of the Evaluation Phase
3.15 Corrective Action Process
3.16 Outcomes of the System Test Phase
3.18 Software Observation Reporting and Version Control
5 Software Verification and Validation in the Context of Design Control
5.1 Software Verification Methods
5.3 System Validation (Acceptance Tests)
5.6 FDA Regulatory Approval Process
5.9 Software Documentation Requirements for Premarket Submissions
5.10 The Review Process and What to Expect from the FDA
6.1 Software of Unknown Provenance
6.2 Security and Privacy—HIPAA
Chapter 5 Best Practices in Spacecraft Development
1 Regulations and Standard Practices
2.4 Mission Assurance and Safety
4.1 Pluto-Kuiper Belt Announcement of Opportunity
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
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
2.4 Recent History of Systems Engineering
2.5 Evolution of Standards for Systems Engineering
3 Processes, Procedures, and Tasks
3.1 MIL-STD-499B: Systems Engineering Planning and Implementation
3.2 Systems Engineering Input Information
3.4 Systems Engineering Process Requirements
3.6 Functional Analysis and Functional Allocation
3.8 Systems Analysis and Control
3.10 System/Cost-Effectiveness Analysis
3.15 Technical Performance Measurement
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
8.7 Field Tests, Final Acceptance Tests, Builder’s Trials, and Commissioning