Summarize risk management activities demonstrating successful hazard control and regulatory compliance achievement.
Criteria | Data |
---|---|
Number of Risks | 15 |
Risk types identified | Data Security, Calculation Error, Connectivity, User Error |
Number of Acceptable Risks | 8 |
Number of Unacceptable Risks Prior to Risk Controls | 7 |
Number of Unacceptable Risks After Risk Controls | 1 |
Criteria | Data |
---|---|
Number of Inherent Safety Controls | 3 |
Number of Protective Measures | 2 |
Number of Information for Safety Controls | 2 |
Total Risk Controls Implemented | 7 |
How can I improve my risk assessment?
What should I do if a new risk is identified during vigilance database review?
How deep should my risk assessment documentation be?
What is the recommendation for categorizing software risk components?
How should I handle risks that remain unacceptable after risk controls?