Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALM
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The document outlines the integration of risk management within the IEC 62304 framework, emphasizing the interdependence of design and risk management in medical devices. It discusses various risk management elements, including hazard identification, risk evaluation, and control measures, alongside regulatory standards like ISO 14971 and ISO 13485. Additionally, it introduces aligned elements as tools for consistent documentation and risk analysis throughout the software lifecycle.
Applying IEC 62304 Risk Management in Aligned Elements - the medical device ALM
- 1. Risk Management and IEC 62304 Applying IEC 62304 Risk Management in Aligned Elements February 2015
- 2. Elements Medical Devices and Risk Management Workflows and functions drives Risk Management Risk Management drives Design Design and Risk Management are interdependent Traceability connects Design and Risk Management Workflows & Functions Hazardous Situation Risk Risk Control Design
- 3. Elements Risk Management and Regulations ISO 13485 QMS ISO 14971 Risk Management IEC 62304 Software Lifecycle IEC 60601-1 Security in Electromedical devices IEC 62366 Usability Refers to Refers to Refers to
- 4. Elements Risk Management and Regulations ISO 13485 QMS ISO 14971 Risk Management IEC 62304 Software Lifecycle Design & Maintenance of software in MD IEC 60601-1 Security in Electromedical devices IEC 62366 Usability Affects Affects Affects
- 5. Elements General Concepts of Risk Assessments Identify Hazards Evaluate Risks (likelihood & consequences) Perform Risk Reduction Evaluate residual Risks
- 6. Elements Risk Management in IEC 62304 Risk drives the level of documentation required Software Safety Classification of architectural artifacts Risk inheritance in architecture Systematic risks => 100% probability of occurrence Affects not only development, also affects maintenance Software System Class C Software Item Class C Software Unit Class C Software Unit Class B Software Item Class A Software Item Class A
- 7. Elements Documenting Medical Device Development Increasing number of regulations Development documentation is difficult, complex and resource intensive to manage Aligned Elements helps you “build” a consistent and complete documentation Free up valuable resources from cumbersome administrative tasks
- 8. Elements Aligned Elements – a medical device ALM Manages the DHF Design Control Items Version Control + Traceability + Documents Integrated Risk Management Real-time quality checks on content Ensures completeness and consistency
- 9. Elements FMEA Concerns Safety & “Business” Widely adopted technique Versatile usage Probability x Severity x Visibility Preliminary Hazard Analysis Concerns Safety / Harm only In the early design phase Full device implementation is not required Aligned with ISO 14971 Risk Assessments in Aligned Elements
- 10. Elements Preliminary Hazard Analysis (PHA) Overview Cause (with probability) Harm (with severity) Hazardous Situation Risk Control Measure Hazard
- 11. Elements Risk Analysis Element PHA in Aligned Elements Cause Harm (with severity) Hazardous Situation Risk Control Measure Reusable Elements Probability of Harm Potential Hazard
- 12. Elements PHA in Aligned Elements
- 13. Elements Aligned Elements PHA in Word
- 14. Elements Risk Analysis PHA and Traceability Cause 1 Measure 1 Cause 2 Cause 3 Measure 2 Measure 3 SW Use Case HW Function SW Item SW Requirement Instructions For Use HW Specification Potential Hazards
- 15. Elements Aligned Elements as Risk Management Tool Automatic calculation of RPN Automatic checks of RPN against thresholds Reuse of Harms, Causes and Measures Measures grouped and sorted according to Risk Reduction Type Highlighting of insufficiently controlled risks Highlighting of unimplemented Measures Risk elements integrated with Design trace landscape
- 16. Elements Risk Management in IEC 62304 Cause Hazardous Situation Risk Reduction Measure Hazard Software Item Software Requirement Verification IEC 62304 – 7.3.3 Document Traceability
- 17. Elements Risk Analysis IEC 62304 PHA in Aligned Elements Cause Measure Software Item (with classification) SW Requirement Verification Harm Does classification match Harms in the Risk Analysis? Hazardous Situation Are Risk Control Measures implemented and verified?
- 18. Elements Software Safety Classification (SSC) in Aligned Automatic Rule Checks: Is SSC consistent with severity of (implicitly) linked Harms? Is SSC consistent with classification of dependent Software Items? Specify Rules: SSC inheritance of Software Items Software Item must trace to Cause Connect Severity of Harm with SSC Severity of Harm Classification 5 or 4 C 3 or 2 B 1 A
- 19. Elements Risk Analysis SSC example in Aligned Elements Cause Software Item (Class B) SW Unit (Class C) Harm Severity: 5 Not OK! Not OK! Severity of Harm Classification 5 or 4 C 3 or 2 B 1 A
- 20. Elements IEC 62304 and Probability in Risk Management Software error probability is difficult to estimate Software errors are systematic IEC 62304 claims that Software Safety Classification shall not depend on probability, only on harm Assume Probability of software error = 100% (section 4.3. a) Can we reduce the probability with our Risk Control Measures?
- 21. Elements Use two probabilities: Probability of Hazardous Situation (P1) Probability of Harm (P2) Usage: P2 can be estimated by professional (e.g. a Medical Doctor) Adapt risk policy and thresholds Risk Control Measures affect P1 and P2 Using two probabilities Software Error Hazardous Situation Harm P1 P2
- 22. Elements Two probabilities in Aligned Elements
- 23. Elements Two probabilities in Aligned Elements
- 24. Elements Architecture vs. Functional Usage Architecture: Hierarchical decomposition of Software into Items and Units Software risk emanates from how we use the software i.e. in which functional context we use the software items Functional use cuts across the architecture Use Case 1 (high risk) Use Case 2 (mid risk) Use Case 3 (low risk) SW Item 1 SW Item 2 SW Item 4 SW Item 3 SW Unit 1 SW Unit 2 SW Unit 3
- 25. Elements The Matrix Model in IEC 62304
- 26. Elements Matrix Model in Aligned Elements Write Use Cases from SW Reqs Perform Risk Analysis on Use Cases Generate Causes from Use Cases where applicable Create Architecture Map Use Cases to Software Items by connecting Software Items to existing Causes If applicable, generate new Causes from Software Items and map back to User CasesRisk Analysis Causes Software Requirements Harm Hazardous Situation Software Items
- 27. Elements Software Problem Resolution Process Record Problem Report Identify Causes and perform risk analysis Evaluate Risk Create Change Request (if applicable) Verify Change Risk AnalysisCause Measure Problem Report Change Request Verification Harm Hazardous Situation
- 28. Elements Aligned Elements IEC 62304 Package Full template set for all IEC 62304 Artifacts Includes clear references to applicable sections in IEC 62304 Full usage of Aligned Elements automatic consistency checks Integrated Checklists and Review Generators Preconfigured Word reports Preconfigured Trace Tables Preconfigured Queries
- 29. Elements Maximal results, minimal effort
- 30. Thank You!Aligned AG Binzmühlstrasse 210 CH-8050 Zürich Switzerland t +41 (0)44 312 50 20 f +41 (0)44 312 50 20 m info@aligned.ch w www.aligned.ch