{ "schemaVersion": "1.0", "item": { "slug": "risk-management-specialist", "name": "Risk Management Specialist", "source": "tencent", "type": "skill", "category": "安全合规", "sourceUrl": "https://clawhub.ai/alirezarezvani/risk-management-specialist", "canonicalUrl": "https://clawhub.ai/alirezarezvani/risk-management-specialist", "targetPlatform": "OpenClaw" }, "install": { "downloadMode": "redirect", "downloadUrl": "/downloads/risk-management-specialist", "sourceDownloadUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=risk-management-specialist", "sourcePlatform": "tencent", "targetPlatform": "OpenClaw", "installMethod": "Manual import", "extraction": "Extract archive", "prerequisites": [ "OpenClaw" ], "packageFormat": "ZIP package", "includedAssets": [ "SKILL.md", "references/iso14971-implementation-guide.md", "references/risk-analysis-methods.md", "references/risk-assessment-templates.md", "scripts/risk_matrix_calculator.py" ], "primaryDoc": "SKILL.md", "quickSetup": [ "Download the package from Yavira.", "Extract the archive and review SKILL.md first.", "Import or place the package into your OpenClaw setup." ], "agentAssist": { "summary": "Hand the extracted package to your coding agent with a concrete install brief instead of figuring it out manually.", "steps": [ "Download the package from Yavira.", "Extract it into a folder your agent can access.", "Paste one of the prompts below and point your agent at the extracted folder." ], "prompts": [ { "label": "New install", "body": "I downloaded a skill package from Yavira. 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Read SKILL.md from the extracted folder and install it by following the included instructions. Tell me what you changed and call out any manual steps you could not complete." }, { "label": "Upgrade existing", "body": "I downloaded an updated skill package from Yavira. Read SKILL.md from the extracted folder, compare it with my current installation, and upgrade it while preserving any custom configuration unless the package docs explicitly say otherwise. Summarize what changed and any follow-up checks I should run." } ] }, "documentation": { "source": "clawhub", "primaryDoc": "SKILL.md", "sections": [ { "title": "Risk Management Specialist", "body": "ISO 14971:2019 risk management implementation throughout the medical device lifecycle." }, { "title": "Table of Contents", "body": "Risk Management Planning Workflow\nRisk Analysis Workflow\nRisk Evaluation Workflow\nRisk Control Workflow\nPost-Production Risk Management\nRisk Assessment Templates\nDecision Frameworks\nTools and References" }, { "title": "Risk Management Planning Workflow", "body": "Establish risk management process per ISO 14971." }, { "title": "Workflow: Create Risk Management Plan", "body": "Define scope of risk management activities:\n\nMedical device identification\nLifecycle stages covered\nApplicable standards and regulations\n\n\nEstablish risk acceptability criteria:\n\nDefine probability categories (P1-P5)\nDefine severity categories (S1-S5)\nCreate risk matrix with acceptance thresholds\n\n\nAssign responsibilities:\n\nRisk management lead\nSubject matter experts\nApproval authorities\n\n\nDefine verification activities:\n\nMethods for control verification\nAcceptance criteria\n\n\nPlan production and post-production activities:\n\nInformation sources\nReview triggers\nUpdate procedures\n\n\nObtain plan approval\nEstablish risk management file\nValidation: Plan approved; acceptability criteria defined; responsibilities assigned; file established" }, { "title": "Risk Management Plan Content", "body": "SectionContentEvidenceScopeDevice and lifecycle coverageScope statementCriteriaRisk acceptability matrixRisk matrix documentResponsibilitiesRoles and authoritiesRACI chartVerificationMethods and acceptanceVerification planProduction/Post-ProductionMonitoring activitiesSurveillance plan" }, { "title": "Risk Acceptability Matrix (5x5)", "body": "Probability \\ SeverityNegligibleMinorSeriousCriticalCatastrophicFrequent (P5)MediumHighHighUnacceptableUnacceptableProbable (P4)MediumMediumHighHighUnacceptableOccasional (P3)LowMediumMediumHighHighRemote (P2)LowLowMediumMediumHighImprobable (P1)LowLowLowMediumMedium" }, { "title": "Risk Level Actions", "body": "LevelAcceptableAction RequiredLowYesDocument and acceptMediumALARPReduce if practicable; document rationaleHighALARPReduction required; demonstrate ALARPUnacceptableNoDesign change mandatory" }, { "title": "Risk Analysis Workflow", "body": "Identify hazards and estimate risks systematically." }, { "title": "Workflow: Conduct Risk Analysis", "body": "Define intended use and reasonably foreseeable misuse:\n\nMedical indication\nPatient population\nUser population\nUse environment\n\n\nSelect analysis method(s):\n\nFMEA for component/function analysis\nFTA for system-level analysis\nHAZOP for process deviations\nUse Error Analysis for user interaction\n\n\nIdentify hazards by category:\n\nEnergy hazards (electrical, mechanical, thermal)\nBiological hazards (bioburden, biocompatibility)\nChemical hazards (residues, leachables)\nOperational hazards (software, use errors)\n\n\nDetermine hazardous situations:\n\nSequence of events\nForeseeable misuse scenarios\nSingle fault conditions\n\n\nEstimate probability of harm (P1-P5)\nEstimate severity of harm (S1-S5)\nDocument in hazard analysis worksheet\nValidation: All hazard categories addressed; all hazards documented; probability and severity assigned" }, { "title": "Hazard Categories Checklist", "body": "CategoryExamplesAnalyzedElectricalShock, burns, interference☐MechanicalCrushing, cutting, entrapment☐ThermalBurns, tissue damage☐RadiationIonizing, non-ionizing☐BiologicalInfection, biocompatibility☐ChemicalToxicity, irritation☐SoftwareIncorrect output, timing☐Use ErrorMisuse, perception, cognition☐EnvironmentEMC, mechanical stress☐" }, { "title": "Analysis Method Selection", "body": "SituationRecommended MethodComponent failuresFMEASystem-level failureFTAProcess deviationsHAZOPUser interactionUse Error AnalysisSoftware behaviorSoftware FMEAEarly design phasePHA" }, { "title": "Probability Criteria", "body": "LevelNameDescriptionFrequencyP5FrequentExpected to occur>10⁻³P4ProbableLikely to occur10⁻³ to 10⁻⁴P3OccasionalMay occur10⁻⁴ to 10⁻⁵P2RemoteUnlikely10⁻⁵ to 10⁻⁶P1ImprobableVery unlikely<10⁻⁶" }, { "title": "Severity Criteria", "body": "LevelNameDescriptionHarmS5CatastrophicDeathDeathS4CriticalPermanent impairmentIrreversible injuryS3SeriousInjury requiring interventionReversible injuryS2MinorTemporary discomfortNo treatment neededS1NegligibleInconvenienceNo injury\n\nSee: references/risk-analysis-methods.md" }, { "title": "Risk Evaluation Workflow", "body": "Evaluate risks against acceptability criteria." }, { "title": "Workflow: Evaluate Identified Risks", "body": "Calculate initial risk level from probability × severity\nCompare to risk acceptability criteria\nFor each risk, determine:\n\nAcceptable: Document and accept\nALARP: Proceed to risk control\nUnacceptable: Mandatory risk control\n\n\nDocument evaluation rationale\nIdentify risks requiring benefit-risk analysis\nComplete benefit-risk analysis if applicable\nCompile risk evaluation summary\nValidation: All risks evaluated; acceptability determined; rationale documented" }, { "title": "Risk Evaluation Decision Tree", "body": "Risk Estimated\n │\n ▼\nApply Acceptability Criteria\n │\n ├── Low Risk ──────────► Accept and document\n │\n ├── Medium Risk ───────► Consider risk reduction\n │ │ Document ALARP if not reduced\n │ ▼\n │ Practicable to reduce?\n │ │\n │ Yes──► Implement control\n │ No───► Document ALARP rationale\n │\n ├── High Risk ─────────► Risk reduction required\n │ │ Must demonstrate ALARP\n │ ▼\n │ Implement control\n │ Verify residual risk\n │\n └── Unacceptable ──────► Design change mandatory\n Cannot proceed without control" }, { "title": "ALARP Demonstration Requirements", "body": "CriterionEvidence RequiredTechnical feasibilityAnalysis of alternative controlsProportionalityCost-benefit of further reductionState of the artComparison to similar devicesStakeholder inputClinical/user perspectives" }, { "title": "Benefit-Risk Analysis Triggers", "body": "SituationBenefit-Risk RequiredResidual risk remains highYesNo feasible risk reductionYesNovel deviceYesUnacceptable risk with clinical benefitYesAll risks lowNo" }, { "title": "Risk Control Workflow", "body": "Implement and verify risk control measures." }, { "title": "Workflow: Implement Risk Controls", "body": "Identify risk control options:\n\nInherent safety by design (Priority 1)\nProtective measures in device (Priority 2)\nInformation for safety (Priority 3)\n\n\nSelect optimal control following hierarchy\nAnalyze control for new hazards introduced\nDocument control in design requirements\nImplement control in design\nDevelop verification protocol\nExecute verification and document results\nEvaluate residual risk with control in place\nValidation: Control implemented; verification passed; residual risk acceptable; no unaddressed new hazards" }, { "title": "Risk Control Hierarchy", "body": "PriorityControl TypeExamplesEffectiveness1Inherent SafetyEliminate hazard, fail-safe designHighest2Protective MeasuresGuards, alarms, automatic shutdownHigh3InformationWarnings, training, IFULower" }, { "title": "Risk Control Option Analysis Template", "body": "RISK CONTROL OPTION ANALYSIS\n\nHazard ID: H-[XXX]\nHazard: [Description]\nInitial Risk: P[X] × S[X] = [Level]\n\nOPTIONS CONSIDERED:\n| Option | Control Type | New Hazards | Feasibility | Selected |\n|--------|--------------|-------------|-------------|----------|\n| 1 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] |\n| 2 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] |\n\nSELECTED CONTROL: Option [X]\nRationale: [Justification for selection]\n\nIMPLEMENTATION:\n- Requirement: [REQ-XXX]\n- Design Document: [Reference]\n\nVERIFICATION:\n- Method: [Test/Analysis/Review]\n- Protocol: [Reference]\n- Acceptance Criteria: [Criteria]" }, { "title": "Risk Control Verification Methods", "body": "MethodWhen to UseEvidenceTestQuantifiable performanceTest reportInspectionPhysical presenceInspection recordAnalysisDesign calculationAnalysis reportReviewDocumentation checkReview record" }, { "title": "Residual Risk Evaluation", "body": "After ControlActionAcceptableDocument, proceedALARP achievedDocument rationale, proceedStill unacceptableAdditional control or design changeNew hazard introducedAnalyze and control new hazard" }, { "title": "Post-Production Risk Management", "body": "Monitor and update risk management throughout product lifecycle." }, { "title": "Workflow: Post-Production Risk Monitoring", "body": "Identify information sources:\n\nCustomer complaints\nService reports\nVigilance/adverse events\nLiterature monitoring\nClinical studies\n\n\nEstablish collection procedures\nDefine review triggers:\n\nNew hazard identified\nIncreased frequency of known hazard\nSerious incident\nRegulatory feedback\n\n\nAnalyze incoming information for risk relevance\nUpdate risk management file as needed\nCommunicate significant findings\nConduct periodic risk management review\nValidation: Information sources monitored; file current; reviews completed per schedule" }, { "title": "Information Sources", "body": "SourceInformation TypeReview FrequencyComplaintsUse issues, failuresContinuousServiceField failures, repairsMonthlyVigilanceSerious incidentsImmediateLiteratureSimilar device issuesQuarterlyRegulatoryAuthority feedbackAs receivedClinicalPMCF dataPer plan" }, { "title": "Risk Management File Update Triggers", "body": "TriggerResponse TimeActionSerious incidentImmediateFull risk reviewNew hazard identified30 daysRisk analysis updateTrend increase60 daysTrend analysisDesign changeBefore implementationImpact assessmentStandards updatePer transition periodGap analysis" }, { "title": "Periodic Review Requirements", "body": "Review ElementFrequencyRisk management file completenessAnnualRisk control effectivenessAnnualPost-market information analysisQuarterlyRisk-benefit conclusionsAnnual or on new data" }, { "title": "Risk Assessment Templates", "body": "→ See references/risk-assessment-templates.md for details" }, { "title": "Risk Control Selection", "body": "What is the risk level?\n │\n ├── Unacceptable ──► Can hazard be eliminated?\n │ │\n │ Yes─┴─No\n │ │ │\n │ ▼ ▼\n │ Eliminate Can protective\n │ hazard measure reduce?\n │ │\n │ Yes─┴─No\n │ │ │\n │ ▼ ▼\n │ Add Add warning\n │ protection + training\n │\n └── High/Medium ──► Apply hierarchy\n starting at Level 1" }, { "title": "New Hazard Analysis", "body": "QuestionIf YesIf NoDoes control introduce new hazard?Analyze new hazardProceedIs new risk higher than original?Reject control optionAcceptable trade-offCan new hazard be controlled?Add controlReject control option" }, { "title": "Risk Acceptability Decision", "body": "ConditionDecisionAll risks LowAcceptableMedium risks with ALARPAcceptableHigh risks with ALARP documentedAcceptable if benefits outweighAny Unacceptable residualNot acceptable - redesign" }, { "title": "Scripts", "body": "ToolPurposeUsagerisk_matrix_calculator.pyCalculate risk levels and FMEA RPNpython risk_matrix_calculator.py --help\n\nRisk Matrix Calculator Features:\n\nISO 14971 5x5 risk matrix calculation\nFMEA RPN (Risk Priority Number) calculation\nInteractive mode for guided assessment\nDisplay risk criteria definitions\nJSON output for integration" }, { "title": "References", "body": "DocumentContentiso14971-implementation-guide.mdComplete ISO 14971:2019 implementation with templatesrisk-analysis-methods.mdFMEA, FTA, HAZOP, Use Error Analysis methods" }, { "title": "Quick Reference: ISO 14971 Process", "body": "StageKey ActivitiesOutputPlanningDefine scope, criteria, responsibilitiesRisk Management PlanAnalysisIdentify hazards, estimate riskHazard AnalysisEvaluationCompare to criteria, ALARP assessmentRisk EvaluationControlImplement hierarchy, verifyRisk Control RecordsResidualOverall assessment, benefit-riskRisk Management ReportProductionMonitor, review, updateUpdated RM File" }, { "title": "Related Skills", "body": "SkillIntegration Pointquality-manager-qms-iso13485QMS integrationcapa-officerRisk-based CAPAregulatory-affairs-headRegulatory submissionsquality-documentation-managerRisk file management" } ], "body": "Risk Management Specialist\n\nISO 14971:2019 risk management implementation throughout the medical device lifecycle.\n\nTable of Contents\nRisk Management Planning Workflow\nRisk Analysis Workflow\nRisk Evaluation Workflow\nRisk Control Workflow\nPost-Production Risk Management\nRisk Assessment Templates\nDecision Frameworks\nTools and References\nRisk Management Planning Workflow\n\nEstablish risk management process per ISO 14971.\n\nWorkflow: Create Risk Management Plan\nDefine scope of risk management activities:\nMedical device identification\nLifecycle stages covered\nApplicable standards and regulations\nEstablish risk acceptability criteria:\nDefine probability categories (P1-P5)\nDefine severity categories (S1-S5)\nCreate risk matrix with acceptance thresholds\nAssign responsibilities:\nRisk management lead\nSubject matter experts\nApproval authorities\nDefine verification activities:\nMethods for control verification\nAcceptance criteria\nPlan production and post-production activities:\nInformation sources\nReview triggers\nUpdate procedures\nObtain plan approval\nEstablish risk management file\nValidation: Plan approved; acceptability criteria defined; responsibilities assigned; file established\nRisk Management Plan Content\nSection\tContent\tEvidence\nScope\tDevice and lifecycle coverage\tScope statement\nCriteria\tRisk acceptability matrix\tRisk matrix document\nResponsibilities\tRoles and authorities\tRACI chart\nVerification\tMethods and acceptance\tVerification plan\nProduction/Post-Production\tMonitoring activities\tSurveillance plan\nRisk Acceptability Matrix (5x5)\nProbability \\ Severity\tNegligible\tMinor\tSerious\tCritical\tCatastrophic\nFrequent (P5)\tMedium\tHigh\tHigh\tUnacceptable\tUnacceptable\nProbable (P4)\tMedium\tMedium\tHigh\tHigh\tUnacceptable\nOccasional (P3)\tLow\tMedium\tMedium\tHigh\tHigh\nRemote (P2)\tLow\tLow\tMedium\tMedium\tHigh\nImprobable (P1)\tLow\tLow\tLow\tMedium\tMedium\nRisk Level Actions\nLevel\tAcceptable\tAction Required\nLow\tYes\tDocument and accept\nMedium\tALARP\tReduce if practicable; document rationale\nHigh\tALARP\tReduction required; demonstrate ALARP\nUnacceptable\tNo\tDesign change mandatory\nRisk Analysis Workflow\n\nIdentify hazards and estimate risks systematically.\n\nWorkflow: Conduct Risk Analysis\nDefine intended use and reasonably foreseeable misuse:\nMedical indication\nPatient population\nUser population\nUse environment\nSelect analysis method(s):\nFMEA for component/function analysis\nFTA for system-level analysis\nHAZOP for process deviations\nUse Error Analysis for user interaction\nIdentify hazards by category:\nEnergy hazards (electrical, mechanical, thermal)\nBiological hazards (bioburden, biocompatibility)\nChemical hazards (residues, leachables)\nOperational hazards (software, use errors)\nDetermine hazardous situations:\nSequence of events\nForeseeable misuse scenarios\nSingle fault conditions\nEstimate probability of harm (P1-P5)\nEstimate severity of harm (S1-S5)\nDocument in hazard analysis worksheet\nValidation: All hazard categories addressed; all hazards documented; probability and severity assigned\nHazard Categories Checklist\nCategory\tExamples\tAnalyzed\nElectrical\tShock, burns, interference\t☐\nMechanical\tCrushing, cutting, entrapment\t☐\nThermal\tBurns, tissue damage\t☐\nRadiation\tIonizing, non-ionizing\t☐\nBiological\tInfection, biocompatibility\t☐\nChemical\tToxicity, irritation\t☐\nSoftware\tIncorrect output, timing\t☐\nUse Error\tMisuse, perception, cognition\t☐\nEnvironment\tEMC, mechanical stress\t☐\nAnalysis Method Selection\nSituation\tRecommended Method\nComponent failures\tFMEA\nSystem-level failure\tFTA\nProcess deviations\tHAZOP\nUser interaction\tUse Error Analysis\nSoftware behavior\tSoftware FMEA\nEarly design phase\tPHA\nProbability Criteria\nLevel\tName\tDescription\tFrequency\nP5\tFrequent\tExpected to occur\t>10⁻³\nP4\tProbable\tLikely to occur\t10⁻³ to 10⁻⁴\nP3\tOccasional\tMay occur\t10⁻⁴ to 10⁻⁵\nP2\tRemote\tUnlikely\t10⁻⁵ to 10⁻⁶\nP1\tImprobable\tVery unlikely\t<10⁻⁶\nSeverity Criteria\nLevel\tName\tDescription\tHarm\nS5\tCatastrophic\tDeath\tDeath\nS4\tCritical\tPermanent impairment\tIrreversible injury\nS3\tSerious\tInjury requiring intervention\tReversible injury\nS2\tMinor\tTemporary discomfort\tNo treatment needed\nS1\tNegligible\tInconvenience\tNo injury\n\nSee: references/risk-analysis-methods.md\n\nRisk Evaluation Workflow\n\nEvaluate risks against acceptability criteria.\n\nWorkflow: Evaluate Identified Risks\nCalculate initial risk level from probability × severity\nCompare to risk acceptability criteria\nFor each risk, determine:\nAcceptable: Document and accept\nALARP: Proceed to risk control\nUnacceptable: Mandatory risk control\nDocument evaluation rationale\nIdentify risks requiring benefit-risk analysis\nComplete benefit-risk analysis if applicable\nCompile risk evaluation summary\nValidation: All risks evaluated; acceptability determined; rationale documented\nRisk Evaluation Decision Tree\nRisk Estimated\n │\n ▼\nApply Acceptability Criteria\n │\n ├── Low Risk ──────────► Accept and document\n │\n ├── Medium Risk ───────► Consider risk reduction\n │ │ Document ALARP if not reduced\n │ ▼\n │ Practicable to reduce?\n │ │\n │ Yes──► Implement control\n │ No───► Document ALARP rationale\n │\n ├── High Risk ─────────► Risk reduction required\n │ │ Must demonstrate ALARP\n │ ▼\n │ Implement control\n │ Verify residual risk\n │\n └── Unacceptable ──────► Design change mandatory\n Cannot proceed without control\n\nALARP Demonstration Requirements\nCriterion\tEvidence Required\nTechnical feasibility\tAnalysis of alternative controls\nProportionality\tCost-benefit of further reduction\nState of the art\tComparison to similar devices\nStakeholder input\tClinical/user perspectives\nBenefit-Risk Analysis Triggers\nSituation\tBenefit-Risk Required\nResidual risk remains high\tYes\nNo feasible risk reduction\tYes\nNovel device\tYes\nUnacceptable risk with clinical benefit\tYes\nAll risks low\tNo\nRisk Control Workflow\n\nImplement and verify risk control measures.\n\nWorkflow: Implement Risk Controls\nIdentify risk control options:\nInherent safety by design (Priority 1)\nProtective measures in device (Priority 2)\nInformation for safety (Priority 3)\nSelect optimal control following hierarchy\nAnalyze control for new hazards introduced\nDocument control in design requirements\nImplement control in design\nDevelop verification protocol\nExecute verification and document results\nEvaluate residual risk with control in place\nValidation: Control implemented; verification passed; residual risk acceptable; no unaddressed new hazards\nRisk Control Hierarchy\nPriority\tControl Type\tExamples\tEffectiveness\n1\tInherent Safety\tEliminate hazard, fail-safe design\tHighest\n2\tProtective Measures\tGuards, alarms, automatic shutdown\tHigh\n3\tInformation\tWarnings, training, IFU\tLower\nRisk Control Option Analysis Template\nRISK CONTROL OPTION ANALYSIS\n\nHazard ID: H-[XXX]\nHazard: [Description]\nInitial Risk: P[X] × S[X] = [Level]\n\nOPTIONS CONSIDERED:\n| Option | Control Type | New Hazards | Feasibility | Selected |\n|--------|--------------|-------------|-------------|----------|\n| 1 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] |\n| 2 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] |\n\nSELECTED CONTROL: Option [X]\nRationale: [Justification for selection]\n\nIMPLEMENTATION:\n- Requirement: [REQ-XXX]\n- Design Document: [Reference]\n\nVERIFICATION:\n- Method: [Test/Analysis/Review]\n- Protocol: [Reference]\n- Acceptance Criteria: [Criteria]\n\nRisk Control Verification Methods\nMethod\tWhen to Use\tEvidence\nTest\tQuantifiable performance\tTest report\nInspection\tPhysical presence\tInspection record\nAnalysis\tDesign calculation\tAnalysis report\nReview\tDocumentation check\tReview record\nResidual Risk Evaluation\nAfter Control\tAction\nAcceptable\tDocument, proceed\nALARP achieved\tDocument rationale, proceed\nStill unacceptable\tAdditional control or design change\nNew hazard introduced\tAnalyze and control new hazard\nPost-Production Risk Management\n\nMonitor and update risk management throughout product lifecycle.\n\nWorkflow: Post-Production Risk Monitoring\nIdentify information sources:\nCustomer complaints\nService reports\nVigilance/adverse events\nLiterature monitoring\nClinical studies\nEstablish collection procedures\nDefine review triggers:\nNew hazard identified\nIncreased frequency of known hazard\nSerious incident\nRegulatory feedback\nAnalyze incoming information for risk relevance\nUpdate risk management file as needed\nCommunicate significant findings\nConduct periodic risk management review\nValidation: Information sources monitored; file current; reviews completed per schedule\nInformation Sources\nSource\tInformation Type\tReview Frequency\nComplaints\tUse issues, failures\tContinuous\nService\tField failures, repairs\tMonthly\nVigilance\tSerious incidents\tImmediate\nLiterature\tSimilar device issues\tQuarterly\nRegulatory\tAuthority feedback\tAs received\nClinical\tPMCF data\tPer plan\nRisk Management File Update Triggers\nTrigger\tResponse Time\tAction\nSerious incident\tImmediate\tFull risk review\nNew hazard identified\t30 days\tRisk analysis update\nTrend increase\t60 days\tTrend analysis\nDesign change\tBefore implementation\tImpact assessment\nStandards update\tPer transition period\tGap analysis\nPeriodic Review Requirements\nReview Element\tFrequency\nRisk management file completeness\tAnnual\nRisk control effectiveness\tAnnual\nPost-market information analysis\tQuarterly\nRisk-benefit conclusions\tAnnual or on new data\nRisk Assessment Templates\n\n→ See references/risk-assessment-templates.md for details\n\nDecision Frameworks\nRisk Control Selection\nWhat is the risk level?\n │\n ├── Unacceptable ──► Can hazard be eliminated?\n │ │\n │ Yes─┴─No\n │ │ │\n │ ▼ ▼\n │ Eliminate Can protective\n │ hazard measure reduce?\n │ │\n │ Yes─┴─No\n │ │ │\n │ ▼ ▼\n │ Add Add warning\n │ protection + training\n │\n └── High/Medium ──► Apply hierarchy\n starting at Level 1\n\nNew Hazard Analysis\nQuestion\tIf Yes\tIf No\nDoes control introduce new hazard?\tAnalyze new hazard\tProceed\nIs new risk higher than original?\tReject control option\tAcceptable trade-off\nCan new hazard be controlled?\tAdd control\tReject control option\nRisk Acceptability Decision\nCondition\tDecision\nAll risks Low\tAcceptable\nMedium risks with ALARP\tAcceptable\nHigh risks with ALARP documented\tAcceptable if benefits outweigh\nAny Unacceptable residual\tNot acceptable - redesign\nTools and References\nScripts\nTool\tPurpose\tUsage\nrisk_matrix_calculator.py\tCalculate risk levels and FMEA RPN\tpython risk_matrix_calculator.py --help\n\nRisk Matrix Calculator Features:\n\nISO 14971 5x5 risk matrix calculation\nFMEA RPN (Risk Priority Number) calculation\nInteractive mode for guided assessment\nDisplay risk criteria definitions\nJSON output for integration\nReferences\nDocument\tContent\niso14971-implementation-guide.md\tComplete ISO 14971:2019 implementation with templates\nrisk-analysis-methods.md\tFMEA, FTA, HAZOP, Use Error Analysis methods\nQuick Reference: ISO 14971 Process\nStage\tKey Activities\tOutput\nPlanning\tDefine scope, criteria, responsibilities\tRisk Management Plan\nAnalysis\tIdentify hazards, estimate risk\tHazard Analysis\nEvaluation\tCompare to criteria, ALARP assessment\tRisk Evaluation\nControl\tImplement hierarchy, verify\tRisk Control Records\nResidual\tOverall assessment, benefit-risk\tRisk Management Report\nProduction\tMonitor, review, update\tUpdated RM File\nRelated Skills\nSkill\tIntegration Point\nquality-manager-qms-iso13485\tQMS integration\ncapa-officer\tRisk-based CAPA\nregulatory-affairs-head\tRegulatory submissions\nquality-documentation-manager\tRisk file management" }, "trust": { "sourceLabel": "tencent", "provenanceUrl": "https://clawhub.ai/alirezarezvani/risk-management-specialist", "publisherUrl": "https://clawhub.ai/alirezarezvani/risk-management-specialist", "owner": "alirezarezvani", "version": "2.1.1", "license": null, "verificationStatus": "Indexed source record" }, "links": { "detailUrl": "https://openagent3.xyz/skills/risk-management-specialist", "downloadUrl": "https://openagent3.xyz/downloads/risk-management-specialist", "agentUrl": "https://openagent3.xyz/skills/risk-management-specialist/agent", "manifestUrl": "https://openagent3.xyz/skills/risk-management-specialist/agent.json", "briefUrl": "https://openagent3.xyz/skills/risk-management-specialist/agent.md" } }