# Send Risk Management Specialist to your agent Hand the extracted package to your coding agent with a concrete install brief instead of figuring it out manually. ## Fast path - 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. ## Suggested prompts ### New install ```text I downloaded a skill package from Yavira. 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. ``` ### Upgrade existing ```text 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. ``` ## Machine-readable fields ```json { "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": { "downloadUrl": "/downloads/risk-management-specialist", "sourceDownloadUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=risk-management-specialist", "sourcePlatform": "tencent", "targetPlatform": "OpenClaw", "packageFormat": "ZIP package", "primaryDoc": "SKILL.md", "includedAssets": [ "SKILL.md", "references/iso14971-implementation-guide.md", "references/risk-analysis-methods.md", "references/risk-assessment-templates.md", "scripts/risk_matrix_calculator.py" ], "downloadMode": "redirect", "sourceHealth": { "source": "tencent", "slug": "risk-management-specialist", "status": "healthy", "reason": "direct_download_ok", "recommendedAction": "download", "checkedAt": "2026-04-29T12:25:53.617Z", "expiresAt": "2026-05-06T12:25:53.617Z", "httpStatus": 200, "finalUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=risk-management-specialist", "contentType": "application/zip", "probeMethod": "head", "details": { "probeUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=risk-management-specialist", "contentDisposition": "attachment; filename=\"risk-management-specialist-2.1.1.zip\"", "redirectLocation": null, "bodySnippet": null, "slug": "risk-management-specialist" }, "scope": "item", "summary": "Item download looks usable.", "detail": "Yavira can redirect you to the upstream package for this item.", "primaryActionLabel": "Download for OpenClaw", "primaryActionHref": "/downloads/risk-management-specialist" }, "validation": { "installChecklist": [ "Use the Yavira download entry.", "Review SKILL.md after the package is downloaded.", "Confirm the extracted package contains the expected setup assets." ], "postInstallChecks": [ "Confirm the extracted package includes the expected docs or setup files.", "Validate the skill or prompts are available in your target agent workspace.", "Capture any manual follow-up steps the agent could not complete." ] } }, "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" } } ``` ## Documentation ### Risk Management Specialist ISO 14971:2019 risk management implementation throughout the medical device lifecycle. ### Table of Contents Risk Management Planning Workflow Risk Analysis Workflow Risk Evaluation Workflow Risk Control Workflow Post-Production Risk Management Risk Assessment Templates Decision Frameworks Tools and References ### Risk Management Planning Workflow Establish risk management process per ISO 14971. ### Workflow: Create Risk Management Plan Define scope of risk management activities: Medical device identification Lifecycle stages covered Applicable standards and regulations Establish risk acceptability criteria: Define probability categories (P1-P5) Define severity categories (S1-S5) Create risk matrix with acceptance thresholds Assign responsibilities: Risk management lead Subject matter experts Approval authorities Define verification activities: Methods for control verification Acceptance criteria Plan production and post-production activities: Information sources Review triggers Update procedures Obtain plan approval Establish risk management file Validation: Plan approved; acceptability criteria defined; responsibilities assigned; file established ### Risk Management Plan Content SectionContentEvidenceScopeDevice and lifecycle coverageScope statementCriteriaRisk acceptability matrixRisk matrix documentResponsibilitiesRoles and authoritiesRACI chartVerificationMethods and acceptanceVerification planProduction/Post-ProductionMonitoring activitiesSurveillance plan ### Risk Acceptability Matrix (5x5) Probability \\ SeverityNegligibleMinorSeriousCriticalCatastrophicFrequent (P5)MediumHighHighUnacceptableUnacceptableProbable (P4)MediumMediumHighHighUnacceptableOccasional (P3)LowMediumMediumHighHighRemote (P2)LowLowMediumMediumHighImprobable (P1)LowLowLowMediumMedium ### Risk Level Actions LevelAcceptableAction RequiredLowYesDocument and acceptMediumALARPReduce if practicable; document rationaleHighALARPReduction required; demonstrate ALARPUnacceptableNoDesign change mandatory ### Risk Analysis Workflow Identify hazards and estimate risks systematically. ### Workflow: Conduct Risk Analysis Define intended use and reasonably foreseeable misuse: Medical indication Patient population User population Use environment Select analysis method(s): FMEA for component/function analysis FTA for system-level analysis HAZOP for process deviations Use Error Analysis for user interaction Identify hazards by category: Energy hazards (electrical, mechanical, thermal) Biological hazards (bioburden, biocompatibility) Chemical hazards (residues, leachables) Operational hazards (software, use errors) Determine hazardous situations: Sequence of events Foreseeable misuse scenarios Single fault conditions Estimate probability of harm (P1-P5) Estimate severity of harm (S1-S5) Document in hazard analysis worksheet Validation: All hazard categories addressed; all hazards documented; probability and severity assigned ### Hazard Categories Checklist 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☐ ### Analysis Method Selection SituationRecommended MethodComponent failuresFMEASystem-level failureFTAProcess deviationsHAZOPUser interactionUse Error AnalysisSoftware behaviorSoftware FMEAEarly design phasePHA ### Probability Criteria LevelNameDescriptionFrequencyP5FrequentExpected to occur>10⁻³P4ProbableLikely to occur10⁻³ to 10⁻⁴P3OccasionalMay occur10⁻⁴ to 10⁻⁵P2RemoteUnlikely10⁻⁵ to 10⁻⁶P1ImprobableVery unlikely<10⁻⁶ ### Severity Criteria LevelNameDescriptionHarmS5CatastrophicDeathDeathS4CriticalPermanent impairmentIrreversible injuryS3SeriousInjury requiring interventionReversible injuryS2MinorTemporary discomfortNo treatment neededS1NegligibleInconvenienceNo injury See: references/risk-analysis-methods.md ### Risk Evaluation Workflow Evaluate risks against acceptability criteria. ### Workflow: Evaluate Identified Risks Calculate initial risk level from probability × severity Compare to risk acceptability criteria For each risk, determine: Acceptable: Document and accept ALARP: Proceed to risk control Unacceptable: Mandatory risk control Document evaluation rationale Identify risks requiring benefit-risk analysis Complete benefit-risk analysis if applicable Compile risk evaluation summary Validation: All risks evaluated; acceptability determined; rationale documented ### Risk Evaluation Decision Tree Risk Estimated │ ▼ Apply Acceptability Criteria │ ├── Low Risk ──────────► Accept and document │ ├── Medium Risk ───────► Consider risk reduction │ │ Document ALARP if not reduced │ ▼ │ Practicable to reduce? │ │ │ Yes──► Implement control │ No───► Document ALARP rationale │ ├── High Risk ─────────► Risk reduction required │ │ Must demonstrate ALARP │ ▼ │ Implement control │ Verify residual risk │ └── Unacceptable ──────► Design change mandatory Cannot proceed without control ### ALARP Demonstration Requirements CriterionEvidence RequiredTechnical feasibilityAnalysis of alternative controlsProportionalityCost-benefit of further reductionState of the artComparison to similar devicesStakeholder inputClinical/user perspectives ### Benefit-Risk Analysis Triggers SituationBenefit-Risk RequiredResidual risk remains highYesNo feasible risk reductionYesNovel deviceYesUnacceptable risk with clinical benefitYesAll risks lowNo ### Risk Control Workflow Implement and verify risk control measures. ### Workflow: Implement Risk Controls Identify risk control options: Inherent safety by design (Priority 1) Protective measures in device (Priority 2) Information for safety (Priority 3) Select optimal control following hierarchy Analyze control for new hazards introduced Document control in design requirements Implement control in design Develop verification protocol Execute verification and document results Evaluate residual risk with control in place Validation: Control implemented; verification passed; residual risk acceptable; no unaddressed new hazards ### Risk Control Hierarchy PriorityControl TypeExamplesEffectiveness1Inherent SafetyEliminate hazard, fail-safe designHighest2Protective MeasuresGuards, alarms, automatic shutdownHigh3InformationWarnings, training, IFULower ### Risk Control Option Analysis Template RISK CONTROL OPTION ANALYSIS Hazard ID: H-[XXX] Hazard: [Description] Initial Risk: P[X] × S[X] = [Level] OPTIONS CONSIDERED: | Option | Control Type | New Hazards | Feasibility | Selected | |--------|--------------|-------------|-------------|----------| | 1 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] | | 2 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] | SELECTED CONTROL: Option [X] Rationale: [Justification for selection] IMPLEMENTATION: - Requirement: [REQ-XXX] - Design Document: [Reference] VERIFICATION: - Method: [Test/Analysis/Review] - Protocol: [Reference] - Acceptance Criteria: [Criteria] ### Risk Control Verification Methods MethodWhen to UseEvidenceTestQuantifiable performanceTest reportInspectionPhysical presenceInspection recordAnalysisDesign calculationAnalysis reportReviewDocumentation checkReview record ### Residual Risk Evaluation After ControlActionAcceptableDocument, proceedALARP achievedDocument rationale, proceedStill unacceptableAdditional control or design changeNew hazard introducedAnalyze and control new hazard ### Post-Production Risk Management Monitor and update risk management throughout product lifecycle. ### Workflow: Post-Production Risk Monitoring Identify information sources: Customer complaints Service reports Vigilance/adverse events Literature monitoring Clinical studies Establish collection procedures Define review triggers: New hazard identified Increased frequency of known hazard Serious incident Regulatory feedback Analyze incoming information for risk relevance Update risk management file as needed Communicate significant findings Conduct periodic risk management review Validation: Information sources monitored; file current; reviews completed per schedule ### Information Sources SourceInformation TypeReview FrequencyComplaintsUse issues, failuresContinuousServiceField failures, repairsMonthlyVigilanceSerious incidentsImmediateLiteratureSimilar device issuesQuarterlyRegulatoryAuthority feedbackAs receivedClinicalPMCF dataPer plan ### Risk Management File Update Triggers TriggerResponse TimeActionSerious incidentImmediateFull risk reviewNew hazard identified30 daysRisk analysis updateTrend increase60 daysTrend analysisDesign changeBefore implementationImpact assessmentStandards updatePer transition periodGap analysis ### Periodic Review Requirements Review ElementFrequencyRisk management file completenessAnnualRisk control effectivenessAnnualPost-market information analysisQuarterlyRisk-benefit conclusionsAnnual or on new data ### Risk Assessment Templates → See references/risk-assessment-templates.md for details ### Risk Control Selection What is the risk level? │ ├── Unacceptable ──► Can hazard be eliminated? │ │ │ Yes─┴─No │ │ │ │ ▼ ▼ │ Eliminate Can protective │ hazard measure reduce? │ │ │ Yes─┴─No │ │ │ │ ▼ ▼ │ Add Add warning │ protection + training │ └── High/Medium ──► Apply hierarchy starting at Level 1 ### New Hazard Analysis 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 ### Risk Acceptability Decision ConditionDecisionAll risks LowAcceptableMedium risks with ALARPAcceptableHigh risks with ALARP documentedAcceptable if benefits outweighAny Unacceptable residualNot acceptable - redesign ### Scripts ToolPurposeUsagerisk_matrix_calculator.pyCalculate risk levels and FMEA RPNpython risk_matrix_calculator.py --help Risk Matrix Calculator Features: ISO 14971 5x5 risk matrix calculation FMEA RPN (Risk Priority Number) calculation Interactive mode for guided assessment Display risk criteria definitions JSON output for integration ### References DocumentContentiso14971-implementation-guide.mdComplete ISO 14971:2019 implementation with templatesrisk-analysis-methods.mdFMEA, FTA, HAZOP, Use Error Analysis methods ### Quick Reference: ISO 14971 Process 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 ### Related Skills SkillIntegration Pointquality-manager-qms-iso13485QMS integrationcapa-officerRisk-based CAPAregulatory-affairs-headRegulatory submissionsquality-documentation-managerRisk file management ## Trust - Source: tencent - Verification: Indexed source record - Publisher: alirezarezvani - Version: 2.1.1 ## Source health - Status: healthy - Item download looks usable. - Yavira can redirect you to the upstream package for this item. - Health scope: item - Reason: direct_download_ok - Checked at: 2026-04-29T12:25:53.617Z - Expires at: 2026-05-06T12:25:53.617Z - Recommended action: Download for OpenClaw ## Links - [Detail page](https://openagent3.xyz/skills/risk-management-specialist) - [Send to Agent page](https://openagent3.xyz/skills/risk-management-specialist/agent) - [JSON manifest](https://openagent3.xyz/skills/risk-management-specialist/agent.json) - [Markdown brief](https://openagent3.xyz/skills/risk-management-specialist/agent.md) - [Download page](https://openagent3.xyz/downloads/risk-management-specialist)