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1、9/8/2024Risk Management for Medical DevicesSafe and Effective ProductsPaul McDanielASQ CQM/OEExecutive VP Operations and QASicel Technologies9/8/2024OverviewProduct Life Cycle Model RoleProcess HintsIn-depth discussion of a Risk Management Analytical Tool: FMEA9/8/2024Risk Management Defined(a pract
2、itioners definition)Risk: probability of harm occurring AND the severity of harmRisk Management: Use of relevant information to identify possible harmful events, to assess the events acceptability in the eyes of the at risk population (probability*severity), and exert effective controls of the risk9
3、/8/2024Risk Analysis-Intended use andId of Char related to safetyof the device-Id hazards-Est risk for eachhazardous situationRisk evaluationRisk Control-Option analysis-Implement controls-Residual risk evaluation-Risk/benefit analysis-Risks arising from controlmeasures-Completeness of risk controlR
4、isk AssessmentEvaluation of overallresidual riskacceptabilityRisk ManagementReportProduction andpost-productioninformationRisk ManagementAdapted from ISO 14971:2007 Figure 19/8/2024Product Life Cycle Model RoleUnderstand the Regulatory ModelA product life cycle has many phasesInformation/Products/De
5、sign at the start of a phase is input; possibly input requirementsInformation/Products/Design at the end of each phase is outputOutputs must be verified against inputsThe model assumes verification at each phase end9/8/2024Product Life Cycle Model RoleThe Current State of the Risk Management Standar
6、d Assumes the Regulatory modelYou may follow the described process and be confused unless you recognize the phase boundariesHow can I determine the answer to “is risk acceptable if Im just defining design inputsThe planned mitigation is acceptable, detail design may introduce new information, stay a
7、lert in the next phase!9/8/2024Risk Management by PhaseDesign Input (Hazard Analysis/Fault Tree)Focus on generating product “shall not do or “shall comply with standard. type of specification requirementsDetailed Design (Fault Tree/FMEA)Look to your product architecture and add architecture interfac
8、e risks to your analysesFurther on, examine higher risk areas and product failure risks in detail9/8/2024Risk Management by PhaseDesign Verification/ValidationWatch for occurrence of anticipated but “intended to be mitigated risksRisk Control failureAssess impact of V&V findings for new risks needin
9、g analysesWe didnt imagine that would happen: Risk?Listen to any customer feedback for risk acceptability“Those safety lock outs are too confusing to work with, can we disable them?9/8/2024Risk Management by PhaseCommercial Distribution/DisposalVigilance Reporting is a Risk Analysis Update Opportuni
10、tyNEW for 2007!Production feedback into the Risk AnalysisAm I seeing higher rates of occurrence?Are new failure modes presenting themselves that we havent analyzed?Are we having control failures or excessive cause failures9/8/2024Risk Analysis in ProductionNon-conforming material and Material Review
11、 Board Processes?Can they effectively consider risks on each occurrence?Control charts, acceptance dataAre risk controls part of acceptance testing?Frequency of occurrence suggesting anything“Risk of failure was ranked as remote yet weve had three catastrophic hot-pot test failures this month!9/8/20
12、24Risk Analysis in ProductionComment period9/8/2024Process ConsiderationsDefine the scope of your analysisWhat systems, what interfaces, who as user.The records produced will be subject to second guessing if harm occurs: dont allow hindsight to change the rulesDocument your information sources!When
13、you made your risk acceptability decision, what information was available and used?We can only be diligent, not psychic9/8/2024Analysis ScopeIntended Use: Use for which the product, process or service is intended according to the specifications, instructions, and information supplied by the manufact
14、urerEssential Performance: Performance necessary to achieve freedom from unacceptable riskNote: is most easily understood by considering whether its absence or degradation would result in an unacceptable riskYou must have these two clearly in front of the analysis team.9/8/2024Process Considerations
15、Use a Risk Source List as a ReminderISO 14971 has such listsAdd your Industrys ExperienceIf a harmful event has been reported, it has higher mitigation priority than hypothetical risksflag real occurrences in your analysesRely on accepted standardsIf there is a “test standard, understand the underly
16、ing reason for the tests9/8/2024Process ConsiderationsSources of harm should suggest actionelectricity is not harmful, electrocution isA hazard existsA sequence of events leads to a hazardous situation (normal or fault conditions)The hazardous situation has a probability (P1)Harm occurs from the sit
17、uationA probability of harm exists (P2)A severity of outcome can be assigned (S)Risk = S, P1 x P29/8/2024Process ConsiderationsWhile defining the system inputs, what harmful things can occur:Very early on, a “Preliminary Hazard Analysis can screen out higher risk approachesWhat are the harmful thing
18、s that the system can do considering:user, patient, environment or property (a subject)9/8/2024Process ConsiderationsTypically, the Device Design Requirements Are Broken Down Into Smaller Pieces During Detailed Designfocus on interfaces, signal and data path integritytrace system requirements to sub
19、-systemUse Fault Tree Analysis (top down)Consider Using Failure Modes and Effects Analysis (bottoms up)9/8/2024Process ConsiderationsObserve Verification/Validation findings for unanticipated device behaviorthe best design analysts miss thingsInitiate a process for V&V findings classificationdid har
20、m occur?, or if the behavior re-occurs, could harm occur?if I cant recreate the behavior, I still may have to mitigate it9/8/2024Risk Management Process Tools9/8/2024System Hazard Analysis(design input)Draw boundaries between the system and the at risk subject and define harmful eventsEnergy sent ac
21、ross a boundaryLook for potential to kinetic energy transitiondid you control the transitionChanges in state may be potentially harmfulYour seed list may leave you with many “deferred answers9/8/2024Probability and Severity EstimatesRisk management relies on expert judgment so dont let novices work
22、alone!Focus on one device, one device lifetimeSet Quantitative or Qualitative criteriahigh probability is.several times in a device lifetime?, 1 per million usesmoderate injury is.medical attention to return to pre-risk exposure state9/8/2024Probability and Severity(use graphical techniques)Increasi
23、ng SeverityIncreasing probabilityunacceptableokayIncreasing SeverityIncreasing probabilityno risk or too great a risk is easy, what about moderate risks?Split up the quadrants to refinethe estimates in stages of analysis9/8/2024Detailed Risk AnalysesOne of the more popular design evaluation tools is
24、 the Failure Modes and Effects Analysis (FMEA)IEC 60812, Analysis techniques for system reliability - Procedure for failure modes and effects analysisFMEA is used more for design evaluation than for design developmentWorks for manufacturing processes too!9/8/2024Detailed Risk AnalysesDefinitions:FME
25、A: a structured analytical technique which determines relationships between basic element failure characteristics and the system failuresFailure mode is how a failure manifests itself (system shuts down)Failure mechanism is why a failure occurs (defect in the transistor silicon)9/8/2024Process Needs
26、 for a FMEAPrior risk analysis work to build on if availableSystem level harmful events will be analyzed to see how component/assemblies may contribute to the harm causeSystem failure and degraded modes definitionsfunctional block diagrams may be needed for each operating/failure mode9/8/2024FMEA Pr
27、ocess Needsa design solution, down to the component level, has been identifiedfailure modes of components are definedresistors fail open circuit, shorted, does the analysis include increasing or decreasing resistance?Component vendors may provide failure modesopen 30%, shorted 70%a complete understa
28、nding of the design solution9/8/2024FMEA Form9/8/2024FMEA ProcessAt the appropriate level of system detail consider the first itemHow can the item fail (failure modes) and whymay be more than one cause for each failure modefor each mode of failure, what happens at the system levelEstimate Probabilit
29、y, Severity, DetectabilityIf necessary, implement corrective measures9/8/2024Q & A?9/8/2024ConclusionsRegulatory Agencies are requiring Risk Management processesInternational standards are being utilized to meet the requirements and standardize processesThe analytical tools necessary to support a device risk management process exist today
