Systematically identify analyze and evaluate device hazards establishing foundation for targeted risk control measures.
Risk ID | Risk Type | Hazard | P1 | Hazardous Situation | P2 | Harm | Severity | Overall Prob | Risk Level |
---|---|---|---|---|---|---|---|---|---|
R001 | Hardware | Sensor malfunction | P3 | Inaccurate physiological readings | P3 | Incorrect stress level information leading to inappropriate actions | S2 | P3 | Reduce AFAP |
R002 | Software | Algorithm error | P2 | Stress level calculation error | P3 | User misinterprets stress state, ignoring symptoms | S2 | P2 | Acceptable |
R003 | Usability | Confusing user interface | P4 | User misunderstands stress display | P2 | Inappropriate action based on misunderstanding | S2 | P3 | Reduce AFAP |
R004 | Cybersecurity | Data breach | P2 | Unauthorized access to health data | P4 | Privacy violation and potential discrimination | S3 | P3 | Reduce AFAP |
R005 | Hardware | Battery overheating | P1 | Device becomes hot during charging | P2 | Skin burn from prolonged contact | S3 | P1 | Acceptable |
R006 | Biological | Allergic reaction | P2 | Skin contact with device materials | P3 | Contact dermatitis or allergic reaction | S2 | P2 | Acceptable |
R007 | Software | App crash during critical reading | P3 | Loss of stress monitoring during high-stress period | P2 | User unaware of stress level when intervention needed | S2 | P2 | Acceptable |
R008 | Environmental | Water damage | P2 | Device exposed to water beyond IP rating | P4 | Device malfunction leading to no stress monitoring | S1 | P3 | Acceptable |
R009 | Use Error | Incorrect device placement | P4 | Device worn incorrectly affecting readings | P3 | Inaccurate stress measurements, poor management | S2 | P4 | Reduce AFAP |
R010 | Cybersecurity | Malware infection | P1 | Malicious software affects device operation | P2 | Device provides false readings or stops functioning | S3 | P1 | Acceptable |
Risk ID | Risk Control Type | Control Description | Implementation | Verification Method |
---|---|---|---|---|
R001 | Inherent Safety | Implement sensor redundancy and cross-validation algorithms | Software Requirements Document | System testing with sensor failure simulation |
R001 | Information for Safety | User training on recognizing device malfunction indicators | Instructions for Use | Usability testing validation |
R003 | Inherent Safety | Redesign user interface with clear stress level indicators and explanatory text | Software Requirements Document | Usability testing with target users |
R003 | Information for Safety | Provide user guide with interpretation examples | Instructions for Use | Usability testing validation |
R004 | Protective Measures | Implement end-to-end encryption and secure authentication | Software Requirements Document | Cybersecurity penetration testing |
R004 | Protective Measures | Regular security updates and vulnerability monitoring | Software Maintenance Plan | Post-market security monitoring |
R009 | Information for Safety | Clear placement instructions with visual guides | Instructions for Use | Usability testing validation |
R009 | Protective Measures | Device placement detection algorithm with user feedback | Software Requirements Document | System testing with placement variations |
How do I ensure my hazard identification is comprehensive enough?
How do I estimate probabilities when I don't have quantitative data?
What level of detail should I include in my risk analysis documentation?
How do I handle risks that span multiple device components or systems?
When should I update my risk assessment during development?
How do I demonstrate that my risk assessment is adequate for regulatory review?