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