1 It Has to Be Safe 3 1.1 What Is Safety? 4 1.2 The Limits of Safety 6 1.3 Quantifying Safety 7 2 Independence 13 2.1 Defining Independence 14 2.2 Types of Independence 15 2.3 Visualizing Independence (Orthogonal Views) 24 2.4 Applying Independence 26 2.
5 Too much Independence 27 2.6 Balancing Independence and Integration 32 3 Engineering Change Control (ECC) 35 3.1 What is Engineering Change Control? 36 3.2 How to Implement Effective ECC 39 3.3 Why ECC Matters in Safety-Critical Systems 44 3.4 ECC in Project Management 46 3.5 Templates for ECC Documentation 48 3.6 Managing Emergency Changes 49 3.
7 Integrating ECC with Configuration Management 51 4 Building a Safety-Critical System 53 4.1 System Context 55 4.2 General Design Considerations 56 4.3 Generic Process Steps 59 4.4 The Engineering Design Process 61 4.5 Engineering Techniques 62 4.6 Safety Architectures 65 4.7 Safety Lifecycle Management 67 5 Verification & Validation 71 5.
1 The "Checking" Process 71 5.2 Key Principles of the "Checking" Process 74 5.3 Impact of Neglecting Early Iterative Planning 75 5.4 The V&V Lifecycle 78 5.5 Reducing Risk Through Effective V&V 80 5.6 Implications of Improper V&V Execution 82 5.7 V&V Documentation and Deliverables 84 6 Analytical Methods 87 6.1 Deterministic Analysis 87 6.
2 Probabilistic Analysis 92 6.3 Orthogonal Views 96 6.4 Applying Analytical Methods 101 6.5 Advanced Analytical Techniques 104 7 Common Fallacies 107 7.1 Independence of Events 107 7.2 Complexity Versus Probability 111 7.3 Safer Than Safe 112 7.4 Safety Through Testing 114 7.
5 Independence in the Design Process 116 7.6 Excessive Maintenance Is Not a Safety Issue 117 7.7 Complexity Is Not a Safety Issue 119 7.8 Latent Failures 120 7.9 Impossible but Conceivable Failure Mode 122 7.10 Personnel Are Infallible 124 7.11 Normalization of Deviance 125 7.12 System Safety is Just Component Safety 127 8 Dirty Little Secrets 131 8.
1 Bug-Free Software 131 8.2 Quantification of Safety 134 8.3 Documentation Equals Safety 137 8.4 Process Can Be "Backfilled" 139 8.5 Safety Teams 141 8.6 Customers 142 8.7 Most Work Equals Least Results 143 8.8 The Better Idiot 145 9 Managing Projects 149 9.
1 Introduction to Safety-Critical Project Management 149 9.2 Risk Management 151 9.3 Schedule Management 153 9.4 Temptations to Avoid 155 9.5 Viable Efficiency Strategies 157 9.6 Team Management in Safety-Critical Projects 160 9.7 Regulatory Compliance Management 162 10 Managing People 167 10.1 Understanding the Adversarial Dynamic 168 10.
2 Organizational Structure Considerations 169 10.3 Strategies for Managing the Dynamic 172 10.4 Human Factors in Team Dynamics 177 10.5 Leadership Approaches 178 10.6 Case Example: Automated Medical Device 180 10.7 Measuring Team Effectiveness 181 11 Supporting New Systems 185 11.1 Why Monitor? 186 11.2 What to Monitor? 187 11.
3 How to Monitor? 192 11.4 Data Analysis and Interpretation 195 11.5 Handling Corrections 196 11.6 Establishing a Comprehensive Support System 198 11.7 Templates for Monitoring 199 11.8 Regulatory Considerations in Operational Support 201 12 New Technologies 205 12.1 Key Terms and Applicable Standards 206 12.2 Self-Driving Cars and Neural Networks: Defining the Limits of "Safety" 207 12.
3 Using Large Language Models in Safety-Critical Systems Engineering 213 12.4 Challenges and Considerations in Using LLMs 218 12.5 Case-Specific Considerations 221 12.6 Emerging Standards and Best Practices 223 12.7 Concluding Reflections 223 13 Final Considerations 227 13.1 Key Takeaways Revisited 228 13.2 Exploring Further: Practical Steps and Recommendations 232 13.3 Exploring New Domains and Cross-Disciplinary Applications 238 13.
4 Looking to the Future: Your Role as a Safety Leader 239.