Mission-Critical and Safety-Critical Systems Handbook. Design and Development for Embedded Applications

Copyright
......Page 1
About the Editor......Page 2
About the Contributors......Page 3
Systems Engineering......Page 5
Important Issues......Page 7
Material Covered......Page 9
Rationale......Page 11
QMS Components......Page 12
Resource Management within QMS......Page 13
ISO 9001......Page 14
AS9100......Page 15
CMMI......Page 16
Comparison of ISO 9001 versus CMMI......Page 18
Measurement, Analysis, and Improvement within QMS......Page 19
Definitions......Page 21
Operations......Page 22
Best Practices-Scheduling......Page 23
Definitions......Page 24
Best Practices-Requirements......Page 25
Best Practices-Efficient Development of Requirements......Page 26
Mission Assurance......Page 28
Plan, Execute, Review, Report, and Update PERRU......Page 30
General Process Models......Page 31
An Example of Phases, Processes, and Procedures......Page 32
Mechanical and Systems......Page 37
Potential Procedures, Checklists, and Documents......Page 38
Types of Review......Page 43
Frequency of Review......Page 44
Review Responsibilities......Page 45
Version Control......Page 46
Design Repository......Page 47
References......Page 53
Problem Report/Corrective Action PRCA......Page 55
Engineering Change Notice ECN......Page 56
Interface Control Documents ICDs......Page 60
Operational Requirements......Page 62
Documentation Plan......Page 65
Software Matters......Page 87
The Essence of Process......Page 89
What Does It Mean to Be Failsafe?......Page 93
Safety and Mission First......Page 103
Verification and Redundancy in the Implementation Process......Page 107
The User Interface......Page 109
Rolling Your Own......Page 114
Hardware as Software: A Thought Exercise in Crossover Thinking......Page 120
Conclusions......Page 136
U.S. Requirements......Page 138
European Requirements......Page 139
Medical Device Certification......Page 140
Philosophy of the Standards......Page 141
Preliminary Evaluation......Page 144
Compliance Reports......Page 146
Common Noncompliances......Page 147
Bibliography......Page 148
Introduction......Page 149
Verification and Validation......Page 151
Life Cycle Model......Page 153
The Medical Regulatory Environment......Page 156
Worldwide Quality System Requirements......Page 159
Subpart B: Quality System Requirements......Page 160
Subpart D-Document Controls......Page 161
The Interface of Software to Document Control......Page 162
Subpart E-Purchasing Controls......Page 163
Subpart H-Acceptance Activities, and Subpart I-Nonconforming Product......Page 164
Subpart J-Corrective and Preventive Action......Page 165
Subpart L-Handling, Storage, Distribution, and Installation......Page 166
Subpart M-Records......Page 167
Subpart N-Servicing and Subpart O Statistical Techniques......Page 168
Audits......Page 169
Purpose of Design Control......Page 170
Project Planning......Page 172
Design Input......Page 174
Design Output......Page 178
Design Review......Page 179
Design Verification and Validation......Page 180
Design History File......Page 182
Change Control......Page 184
Software Change Control in the Medical Environment......Page 185
Software Configuration Management Methods......Page 186
Software Problem Resolution......Page 189
Evaluation Phase......Page 190
Drop......Page 192
Requirements Analysis Phase......Page 193
Fixed......Page 194
Risk Management......Page 195
Software Verification and Validation in the Context of Design Control......Page 208
Example Review Process......Page 214
Unit Testing......Page 218
Unit Testing with Test Harnesses......Page 219
Static Tests......Page 226
Integration Tests......Page 228
References......Page 268
Bibliography......Page 270
Government Regulations......Page 271
Project Management......Page 272
Systems Engineering......Page 274
Mission Assurance and Safety......Page 277
Integration and Test......Page 318
Mission Operations......Page 319
Industry Standards......Page 320
Mission Assurance and Safety......Page 326
Miscellaneous Industrial and Commercial Standards......Page 327
Commercial Off-the-Shelf......Page 328
Project Management......Page 330
Communication and Teamwork......Page 331
Work Breakdown Structure......Page 335
Project Phases......Page 337
Review Process......Page 339
Risk Management......Page 348
Requirements Engineering......Page 352
Resource Management......Page 354
Lessons Learned......Page 355
Fault Protection Requirements......Page 358
Fault Protection Design......Page 362
Fault Protection Implementation......Page 363
Fault Protection Verification......Page 364
Mission Assurance and Safety......Page 365
Custom or Unique Design......Page 367
Software......Page 368
Electrical, Electronic, and Electromechanical Part Procurement......Page 369
Materials and Process Control......Page 370
Data Management......Page 372
Nonconformance Processes......Page 373
System Safety......Page 375
Personnel Safety......Page 376
National Environmental Protection Act Approval Process......Page 377
Integration and Test......Page 378
Requirements and Test......Page 379
Independent Data Review......Page 380
Elements of a Successful Integration-and-Test Program......Page 381
Component-Level Tests......Page 382
Spacecraft-Level Tests......Page 383
References......Page 424
Historical Background......Page 463
JCIDS......Page 464
Defense Acquisition......Page 466
Where Is JCIDS Now?......Page 468
Recent History of Systems Engineering......Page 469
Evolution of Standards for Systems Engineering......Page 470
Processes, Procedures, and Tasks......Page 474
MIL-STD-499B: Systems Engineering Planning and Implementation......Page 476
Systems Engineering Input Information......Page 478
Technical Objectives......Page 479
Life Cycle Support Data......Page 480
Systems Engineering Output......Page 481
Requirements Analysis......Page 482
Requirements Validation......Page 483
Functional Verification Process......Page 486
Functional Analysis......Page 488
Synthesis......Page 490
Design......Page 491
Design Verification Process......Page 493
System Analysis and Control Processes......Page 495
Tradeoff Studies......Page 496
Functional Analysis and Allocation......Page 498
Configuration Management......Page 500
Data Management......Page 501
TPM on Requirements......Page 502
Response to Change......Page 503
Department of Defense Resources......Page 504
Military Standards and Handbooks......Page 506
Specifications......Page 520
Standards......Page 522
Handbooks......Page 523
Avionics Standards: DO-178 and DO-254......Page 524
DO-178B/C......Page 525
DO-254......Page 527
Subsystem Tests......Page 529
Integration......Page 531
Environmental......Page 532
EMC......Page 533
Field Tests, Final Acceptance Tests, Builder's Trials, and Commissioning......Page 534
References......Page 571
D......Page 573
H......Page 574
M......Page 575
Q......Page 577
S......Page 578
W......Page 580