{ "schemaVersion": "1.0", "item": { "slug": "quality-manager-qmr", "name": "Quality Manager Qmr", "source": "tencent", "type": "skill", "category": "安全合规", "sourceUrl": "https://clawhub.ai/alirezarezvani/quality-manager-qmr", "canonicalUrl": "https://clawhub.ai/alirezarezvani/quality-manager-qmr", "targetPlatform": "OpenClaw" }, "install": { "downloadMode": "redirect", "downloadUrl": "/downloads/quality-manager-qmr", "sourceDownloadUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=quality-manager-qmr", "sourcePlatform": "tencent", "targetPlatform": "OpenClaw", "installMethod": "Manual import", "extraction": "Extract archive", "prerequisites": [ "OpenClaw" ], "packageFormat": "ZIP package", "includedAssets": [ "SKILL.md", "references/management-review-guide.md", "references/quality-kpi-framework.md", "scripts/management_review_tracker.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. 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." } ] }, "sourceHealth": { "source": "tencent", "status": "healthy", "reason": "direct_download_ok", "recommendedAction": "download", "checkedAt": "2026-04-23T16:43:11.935Z", "expiresAt": "2026-04-30T16:43:11.935Z", "httpStatus": 200, "finalUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=4claw-imageboard", "contentType": "application/zip", "probeMethod": "head", "details": { "probeUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=4claw-imageboard", "contentDisposition": "attachment; filename=\"4claw-imageboard-1.0.1.zip\"", "redirectLocation": null, "bodySnippet": null }, "scope": "source", "summary": "Source download looks usable.", "detail": "Yavira can redirect you to the upstream package for this source.", "primaryActionLabel": "Download for OpenClaw", "primaryActionHref": "/downloads/quality-manager-qmr" }, "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." ] }, "downloadPageUrl": "https://openagent3.xyz/downloads/quality-manager-qmr", "agentPageUrl": "https://openagent3.xyz/skills/quality-manager-qmr/agent", "manifestUrl": "https://openagent3.xyz/skills/quality-manager-qmr/agent.json", "briefUrl": "https://openagent3.xyz/skills/quality-manager-qmr/agent.md" }, "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. 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": "Senior Quality Manager Responsible Person (QMR)", "body": "Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements." }, { "title": "Table of Contents", "body": "QMR Responsibilities\nManagement Review Workflow\nQuality KPI Management Workflow\nQuality Objectives Workflow\nQuality Culture Assessment Workflow\nRegulatory Compliance Oversight\nDecision Frameworks\nTools and References" }, { "title": "ISO 13485 Clause 5.5.2 Requirements", "body": "ResponsibilityScopeEvidenceQMS effectivenessMonitor system performance and suitabilityManagement review recordsReporting to managementCommunicate QMS performance to top managementQuality reports, dashboardsQuality awarenessPromote regulatory and quality requirementsTraining records, communicationsLiaison with external partiesInterface with regulators, Notified BodiesMeeting records, correspondence" }, { "title": "QMR Accountability Matrix", "body": "DomainAccountable ForReports ToFrequencyQuality PolicyPolicy adequacy and communicationCEO/BoardAnnual reviewQuality ObjectivesObjective achievement and relevanceExecutive TeamQuarterlyQMS PerformanceSystem effectiveness metricsManagementMonthlyRegulatory ComplianceCompliance status across jurisdictionsCEOQuarterlyAudit ProgramAudit schedule completion, findings closureManagementPer auditCAPA OversightCAPA effectiveness and timelinessExecutive TeamMonthly" }, { "title": "Authority Boundaries", "body": "Decision TypeQMR AuthorityEscalation RequiredProcess changes within QMSApprove with ownerMajor process redesignDocument approvalFinal QA approvalPolicy-level changesNonconformity dispositionAccept/reject with MRBProduct release decisionsSupplier quality actionsQuality holds, auditsSupplier terminationAudit schedulingAdjust internal audit scheduleExternal audit timingTraining requirementsDefine quality training needsOrganization-wide training budget" }, { "title": "Management Review Workflow", "body": "Conduct management reviews per ISO 13485 Clause 5.6 requirements." }, { "title": "Workflow: Prepare and Execute Management Review", "body": "Schedule management review (minimum annually, typically quarterly or semi-annually)\nNotify all required attendees minimum 2 weeks prior\nCollect required inputs from process owners:\n\nAudit results (internal and external)\nCustomer feedback (complaints, satisfaction, returns)\nProcess performance and product conformity\nCAPA status and effectiveness\nPrevious review action items\nChanges affecting QMS (regulatory, organizational)\nRecommendations for improvement\n\n\nCompile input summary report with trend analysis\nPrepare presentation materials with supporting data\nDistribute agenda and input package 1 week prior\nConduct review meeting per agenda\nValidation: All required inputs reviewed; decisions documented with owners and due dates" }, { "title": "Required Attendees", "body": "RoleRequirementInput ResponsibilityCEO/General ManagerRequiredStrategic decisionsQMRChairOverall QMS statusDepartment HeadsRequiredProcess performanceRA ManagerRequiredRegulatory changesProduction ManagerRequiredProduct conformityCustomer QualityRequiredComplaint data" }, { "title": "Management Review Input Template", "body": "MANAGEMENT REVIEW INPUT SUMMARY\n\nReview Period: [Start Date] to [End Date]\nReview Date: [Scheduled Date]\nPrepared By: [QMR Name]\n\n1. AUDIT RESULTS\n Internal audits completed: [X] of [X] planned\n External audits completed: [X]\n Total findings: [X] major / [X] minor\n Open findings: [X]\n Finding trends: [Analysis]\n\n2. CUSTOMER FEEDBACK\n Complaints received: [X]\n Complaint rate: [X per 1000 units]\n Customer satisfaction score: [X.X/5.0]\n Returns: [X] units ([X]%)\n Top issues: [Categories]\n\n3. PROCESS PERFORMANCE\n [Process 1]: [Metric] vs [Target] - [Status]\n [Process 2]: [Metric] vs [Target] - [Status]\n Out-of-spec processes: [List]\n\n4. PRODUCT CONFORMITY\n First pass yield: [X]%\n Nonconformance rate: [X]%\n Scrap cost: $[X]\n Top defect categories: [List]\n\n5. CAPA STATUS\n Open CAPAs: [X]\n Overdue: [X]\n Effectiveness rate: [X]%\n Average age: [X] days\n\n6. PREVIOUS ACTIONS\n Total from last review: [X]\n Completed: [X] | In progress: [X] | Overdue: [X]\n\n7. CHANGES AFFECTING QMS\n Regulatory: [List changes]\n Organizational: [List changes]\n Process: [List changes]\n\n8. RECOMMENDATIONS\n [Collected improvement opportunities]" }, { "title": "Management Review Output Requirements", "body": "OutputDocumentationOwnerQMS improvement decisionsAction items with due datesAssigned per itemResource needsResource plan updatesDepartment headsQuality objectives changesUpdated objectives documentQMRProcess improvement needsImprovement project chartersProcess owners\n\nSee: references/management-review-guide.md" }, { "title": "Quality KPI Management Workflow", "body": "Establish, monitor, and report quality performance indicators." }, { "title": "Workflow: Establish Quality KPI Framework", "body": "Identify quality objectives requiring measurement\nSelect KPIs per objective using SMART criteria:\n\nSpecific: Clear definition and calculation\nMeasurable: Quantifiable with available data\nActionable: Team can influence results\nRelevant: Aligned to quality objectives\nTime-bound: Defined measurement frequency\n\n\nDefine target values based on baseline data and benchmarks\nAssign data source and collection responsibility\nEstablish reporting frequency per KPI category\nConfigure dashboard displays and trend analysis\nDefine escalation thresholds and alert triggers\nValidation: Each KPI has owner, target, data source, and escalation criteria" }, { "title": "Core Quality KPIs", "body": "CategoryKPITargetCalculationProcessFirst Pass Yield>95%(Units passed first time / Total units) × 100ProcessNonconformance Rate<1%(NC count / Total units) × 100CAPACAPA Closure Rate>90%(On-time closures / Due closures) × 100CAPACAPA Effectiveness>85%(Effective CAPAs / Verified CAPAs) × 100AuditFinding Closure Rate>90%(On-time closures / Due closures) × 100AuditRepeat Finding Rate<10%(Repeat findings / Total findings) × 100CustomerComplaint Rate<0.1%(Complaints / Units sold) × 100CustomerSatisfaction Score>4.0/5.0Average of survey scores" }, { "title": "KPI Review Frequency", "body": "KPI TypeReview FrequencyTrend PeriodAudienceSafety/ComplianceDaily monitoringWeeklyOperationsProduction QualityWeeklyMonthlyDepartment headsCustomer QualityMonthlyQuarterlyExecutive teamStrategic QualityQuarterlyAnnualBoard/C-suite" }, { "title": "Performance Response Matrix", "body": "Performance LevelStatusAction Required>110% of targetExceedingConsider raising target100-110% of targetMeetingMaintain current approach90-100% of targetApproachingMonitor closely80-90% of targetBelowImprovement plan required<80% of targetCriticalImmediate intervention\n\nSee: references/quality-kpi-framework.md" }, { "title": "Quality Objectives Workflow", "body": "Establish and maintain measurable quality objectives per ISO 13485 Clause 5.4.1." }, { "title": "Workflow: Annual Quality Objectives Setting", "body": "Review prior year objective achievement\nAnalyze quality performance trends and gaps\nAlign with organizational strategic plan\nDraft objectives with measurable targets\nValidate resource availability for achievement\nObtain executive approval\nCommunicate objectives organization-wide\nValidation: Each objective is measurable, has owner, target, and timeline" }, { "title": "Quality Objective Structure", "body": "QUALITY OBJECTIVE [Number]\n\nObjective Statement: [Clear, measurable statement]\nAligned to Policy Element: [Quality policy section]\nTarget: [Specific measurable target]\nBaseline: [Current performance]\nOwner: [Name and title]\nDue Date: [Target achievement date]\n\nSuccess Criteria:\n- [Criterion 1]\n- [Criterion 2]\n\nMeasurement Method: [How progress is tracked]\nReporting Frequency: [Monthly/Quarterly]\n\nSupporting Initiatives:\n- [Initiative 1]\n- [Initiative 2]\n\nResource Requirements:\n- [Resource 1]\n- [Resource 2]" }, { "title": "Objective Categories", "body": "CategoryExample ObjectivesTypical TargetsCustomer QualityReduce complaint rate<0.1% of units soldProcess QualityImprove first pass yield>96%ComplianceMaintain certificationZero major NCsEfficiencyReduce quality costs<4% of revenueCultureIncrease training completion>98% on-time" }, { "title": "Quarterly Objective Review", "body": "Review ElementAssessmentActionProgress vs. targetOn track / Behind / AheadAdjust resources if behindRelevanceStill valid / Needs updateModify if conditions changedResourcesAdequate / InsufficientRequest additional if neededBarriersIdentified obstaclesEscalate for resolution" }, { "title": "Quality Culture Assessment Workflow", "body": "Assess and improve organizational quality culture." }, { "title": "Workflow: Annual Quality Culture Assessment", "body": "Design or select quality culture survey instrument\nDefine survey population (all employees or sample)\nCommunicate survey purpose and confidentiality\nAdminister survey with 2-week response window\nAnalyze results by department, role, and tenure\nIdentify strengths and improvement areas\nDevelop action plan for culture gaps\nValidation: Response rate >60%; action plan addresses bottom 3 scores" }, { "title": "Quality Culture Dimensions", "body": "DimensionIndicatorsAssessment MethodLeadership commitmentManagement visible support for qualitySurvey, observationQuality ownershipEmployees feel responsible for qualitySurveyCommunicationQuality information flows effectivelySurvey, auditContinuous improvementSuggestions submitted and implementedMetricsTraining and competenceEmployees feel adequately trainedSurvey, recordsProblem solvingIssues addressed at root causeCAPA analysis" }, { "title": "Culture Survey Categories", "body": "CategorySample QuestionsLeadership\"Management demonstrates commitment to quality\"Resources\"I have the tools and training to do quality work\"Communication\"Quality expectations are clearly communicated\"Empowerment\"I am encouraged to report quality issues\"Recognition\"Quality achievements are recognized\"" }, { "title": "Culture Improvement Actions", "body": "Gap IdentifiedPotential ActionsLow leadership visibilityQuality gemba walks, all-hands quality updatesInadequate trainingCompetency-based training programPoor communicationQuality newsletters, department huddlesLow reportingAnonymous reporting system, no-blame cultureLack of recognitionQuality award program, team celebrations" }, { "title": "Regulatory Compliance Oversight", "body": "Monitor and maintain regulatory compliance across jurisdictions." }, { "title": "Multi-Jurisdictional Compliance Matrix", "body": "JurisdictionRegulationRequirementStatus TrackingEUMDR 2017/745CE marking, Notified BodyTechnical file, annual reviewUSA21 CFR 820FDA registration, QSR complianceAnnual registration, inspectionsInternationalISO 13485QMS certificationSurveillance auditsGermanyMPG/MPDGNational implementationCompetent authority filings" }, { "title": "Compliance Monitoring Workflow", "body": "Maintain regulatory requirement register\nSubscribe to regulatory update services\nAssess impact of regulatory changes monthly\nUpdate affected processes within 90 days of effective date\nVerify training completion for regulatory changes\nDocument compliance status in management review\nMaintain inspection readiness checklist\nValidation: All applicable requirements mapped; no expired registrations" }, { "title": "Regulatory Authority Interface", "body": "ActivityQMR RolePreparation RequiredNotified Body auditPrimary contactAudit package, personnel schedulesFDA inspectionHost, escort coordinatorInspection readiness reviewCompetent Authority inquiryResponse coordinatorTechnical file accessRegulatory meetingAttendee or delegateBriefing materials" }, { "title": "Inspection Readiness Checklist", "body": "AreaReadyAction NeededDocument control system current☐Training records complete☐CAPA system current, no overdue items☐Complaint files complete☐Equipment calibration current☐Supplier qualification files complete☐Management review records available☐Internal audit program current☐" }, { "title": "Escalation Decision Tree", "body": "Issue Identified\n │\n ▼\nIs it a regulatory violation?\n │\n Yes─┴─No\n │ │\n ▼ ▼\nEscalate to Is it a safety issue?\nExecutive │\nimmediately Yes─┴─No\n │ │\n ▼ ▼\n Escalate to Does it affect\n Safety Team multiple departments?\n │\n Yes─┴─No\n │ │\n ▼ ▼\n Escalate to Handle at\n Executive department level" }, { "title": "Quality Investment Prioritization", "body": "CriteriaWeightScore MethodRegulatory requirement30%Required=10, Recommended=5, Optional=2Customer impact25%Direct=10, Indirect=5, None=0Cost savings potential20%>$100K=10, $50-100K=7, <$50K=3Implementation complexity15%Simple=10, Moderate=5, Complex=2Strategic alignment10%Core=10, Supporting=5, Peripheral=2" }, { "title": "Resource Allocation Matrix", "body": "Resource TypeAllocation AuthorityEscalation ThresholdQuality personnelQMR>1 FTE additionQuality equipmentQMR>$25KExternal consultantsQMR>$50K or >30 daysQuality systemsExecutive approval>$100K" }, { "title": "Scripts", "body": "ToolPurposeUsagemanagement_review_tracker.pyTrack review inputs, actions, metricspython management_review_tracker.py --help\n\nManagement Review Tracker Features:\n\nTrack input collection status from process owners\nMonitor action item completion and aging\nGenerate metrics summary for review\nProduce recommendations for review focus areas" }, { "title": "References", "body": "DocumentContentmanagement-review-guide.mdISO 13485 Clause 5.6 requirements, input/output templates, action trackingquality-kpi-framework.mdKPI categories, targets, calculations, dashboard templates" }, { "title": "Quick Reference: Management Review Inputs (ISO 13485 Clause 5.6.2)", "body": "InputSourceRequiredFeedbackCustomer complaints, surveysYesAudit resultsInternal and external auditsYesProcess performanceProcess metricsYesProduct conformityInspection, NC dataYesCAPA statusCAPA systemYesPrevious actionsPrior review recordsYesChangesRegulatory, organizationalYesRecommendationsAll sourcesYes" }, { "title": "Quick Reference: Management Review Outputs (ISO 13485 Clause 5.6.3)", "body": "OutputDocumentation RequiredImprovement to QMS and processesAction items with ownersImprovement to productProject initiation if neededResource needsResource plan updates" }, { "title": "Related Skills", "body": "SkillIntegration Pointquality-manager-qms-iso13485QMS process managementcapa-officerCAPA system oversightqms-audit-expertInternal audit programquality-documentation-managerDocument control oversight" } ], "body": "Senior Quality Manager Responsible Person (QMR)\n\nQuality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.\n\nTable of Contents\nQMR Responsibilities\nManagement Review Workflow\nQuality KPI Management Workflow\nQuality Objectives Workflow\nQuality Culture Assessment Workflow\nRegulatory Compliance Oversight\nDecision Frameworks\nTools and References\nQMR Responsibilities\nISO 13485 Clause 5.5.2 Requirements\nResponsibility\tScope\tEvidence\nQMS effectiveness\tMonitor system performance and suitability\tManagement review records\nReporting to management\tCommunicate QMS performance to top management\tQuality reports, dashboards\nQuality awareness\tPromote regulatory and quality requirements\tTraining records, communications\nLiaison with external parties\tInterface with regulators, Notified Bodies\tMeeting records, correspondence\nQMR Accountability Matrix\nDomain\tAccountable For\tReports To\tFrequency\nQuality Policy\tPolicy adequacy and communication\tCEO/Board\tAnnual review\nQuality Objectives\tObjective achievement and relevance\tExecutive Team\tQuarterly\nQMS Performance\tSystem effectiveness metrics\tManagement\tMonthly\nRegulatory Compliance\tCompliance status across jurisdictions\tCEO\tQuarterly\nAudit Program\tAudit schedule completion, findings closure\tManagement\tPer audit\nCAPA Oversight\tCAPA effectiveness and timeliness\tExecutive Team\tMonthly\nAuthority Boundaries\nDecision Type\tQMR Authority\tEscalation Required\nProcess changes within QMS\tApprove with owner\tMajor process redesign\nDocument approval\tFinal QA approval\tPolicy-level changes\nNonconformity disposition\tAccept/reject with MRB\tProduct release decisions\nSupplier quality actions\tQuality holds, audits\tSupplier termination\nAudit scheduling\tAdjust internal audit schedule\tExternal audit timing\nTraining requirements\tDefine quality training needs\tOrganization-wide training budget\nManagement Review Workflow\n\nConduct management reviews per ISO 13485 Clause 5.6 requirements.\n\nWorkflow: Prepare and Execute Management Review\nSchedule management review (minimum annually, typically quarterly or semi-annually)\nNotify all required attendees minimum 2 weeks prior\nCollect required inputs from process owners:\nAudit results (internal and external)\nCustomer feedback (complaints, satisfaction, returns)\nProcess performance and product conformity\nCAPA status and effectiveness\nPrevious review action items\nChanges affecting QMS (regulatory, organizational)\nRecommendations for improvement\nCompile input summary report with trend analysis\nPrepare presentation materials with supporting data\nDistribute agenda and input package 1 week prior\nConduct review meeting per agenda\nValidation: All required inputs reviewed; decisions documented with owners and due dates\nRequired Attendees\nRole\tRequirement\tInput Responsibility\nCEO/General Manager\tRequired\tStrategic decisions\nQMR\tChair\tOverall QMS status\nDepartment Heads\tRequired\tProcess performance\nRA Manager\tRequired\tRegulatory changes\nProduction Manager\tRequired\tProduct conformity\nCustomer Quality\tRequired\tComplaint data\nManagement Review Input Template\nMANAGEMENT REVIEW INPUT SUMMARY\n\nReview Period: [Start Date] to [End Date]\nReview Date: [Scheduled Date]\nPrepared By: [QMR Name]\n\n1. AUDIT RESULTS\n Internal audits completed: [X] of [X] planned\n External audits completed: [X]\n Total findings: [X] major / [X] minor\n Open findings: [X]\n Finding trends: [Analysis]\n\n2. CUSTOMER FEEDBACK\n Complaints received: [X]\n Complaint rate: [X per 1000 units]\n Customer satisfaction score: [X.X/5.0]\n Returns: [X] units ([X]%)\n Top issues: [Categories]\n\n3. PROCESS PERFORMANCE\n [Process 1]: [Metric] vs [Target] - [Status]\n [Process 2]: [Metric] vs [Target] - [Status]\n Out-of-spec processes: [List]\n\n4. PRODUCT CONFORMITY\n First pass yield: [X]%\n Nonconformance rate: [X]%\n Scrap cost: $[X]\n Top defect categories: [List]\n\n5. CAPA STATUS\n Open CAPAs: [X]\n Overdue: [X]\n Effectiveness rate: [X]%\n Average age: [X] days\n\n6. PREVIOUS ACTIONS\n Total from last review: [X]\n Completed: [X] | In progress: [X] | Overdue: [X]\n\n7. CHANGES AFFECTING QMS\n Regulatory: [List changes]\n Organizational: [List changes]\n Process: [List changes]\n\n8. RECOMMENDATIONS\n [Collected improvement opportunities]\n\nManagement Review Output Requirements\nOutput\tDocumentation\tOwner\nQMS improvement decisions\tAction items with due dates\tAssigned per item\nResource needs\tResource plan updates\tDepartment heads\nQuality objectives changes\tUpdated objectives document\tQMR\nProcess improvement needs\tImprovement project charters\tProcess owners\n\nSee: references/management-review-guide.md\n\nQuality KPI Management Workflow\n\nEstablish, monitor, and report quality performance indicators.\n\nWorkflow: Establish Quality KPI Framework\nIdentify quality objectives requiring measurement\nSelect KPIs per objective using SMART criteria:\nSpecific: Clear definition and calculation\nMeasurable: Quantifiable with available data\nActionable: Team can influence results\nRelevant: Aligned to quality objectives\nTime-bound: Defined measurement frequency\nDefine target values based on baseline data and benchmarks\nAssign data source and collection responsibility\nEstablish reporting frequency per KPI category\nConfigure dashboard displays and trend analysis\nDefine escalation thresholds and alert triggers\nValidation: Each KPI has owner, target, data source, and escalation criteria\nCore Quality KPIs\nCategory\tKPI\tTarget\tCalculation\nProcess\tFirst Pass Yield\t>95%\t(Units passed first time / Total units) × 100\nProcess\tNonconformance Rate\t<1%\t(NC count / Total units) × 100\nCAPA\tCAPA Closure Rate\t>90%\t(On-time closures / Due closures) × 100\nCAPA\tCAPA Effectiveness\t>85%\t(Effective CAPAs / Verified CAPAs) × 100\nAudit\tFinding Closure Rate\t>90%\t(On-time closures / Due closures) × 100\nAudit\tRepeat Finding Rate\t<10%\t(Repeat findings / Total findings) × 100\nCustomer\tComplaint Rate\t<0.1%\t(Complaints / Units sold) × 100\nCustomer\tSatisfaction Score\t>4.0/5.0\tAverage of survey scores\nKPI Review Frequency\nKPI Type\tReview Frequency\tTrend Period\tAudience\nSafety/Compliance\tDaily monitoring\tWeekly\tOperations\nProduction Quality\tWeekly\tMonthly\tDepartment heads\nCustomer Quality\tMonthly\tQuarterly\tExecutive team\nStrategic Quality\tQuarterly\tAnnual\tBoard/C-suite\nPerformance Response Matrix\nPerformance Level\tStatus\tAction Required\n>110% of target\tExceeding\tConsider raising target\n100-110% of target\tMeeting\tMaintain current approach\n90-100% of target\tApproaching\tMonitor closely\n80-90% of target\tBelow\tImprovement plan required\n<80% of target\tCritical\tImmediate intervention\n\nSee: references/quality-kpi-framework.md\n\nQuality Objectives Workflow\n\nEstablish and maintain measurable quality objectives per ISO 13485 Clause 5.4.1.\n\nWorkflow: Annual Quality Objectives Setting\nReview prior year objective achievement\nAnalyze quality performance trends and gaps\nAlign with organizational strategic plan\nDraft objectives with measurable targets\nValidate resource availability for achievement\nObtain executive approval\nCommunicate objectives organization-wide\nValidation: Each objective is measurable, has owner, target, and timeline\nQuality Objective Structure\nQUALITY OBJECTIVE [Number]\n\nObjective Statement: [Clear, measurable statement]\nAligned to Policy Element: [Quality policy section]\nTarget: [Specific measurable target]\nBaseline: [Current performance]\nOwner: [Name and title]\nDue Date: [Target achievement date]\n\nSuccess Criteria:\n- [Criterion 1]\n- [Criterion 2]\n\nMeasurement Method: [How progress is tracked]\nReporting Frequency: [Monthly/Quarterly]\n\nSupporting Initiatives:\n- [Initiative 1]\n- [Initiative 2]\n\nResource Requirements:\n- [Resource 1]\n- [Resource 2]\n\nObjective Categories\nCategory\tExample Objectives\tTypical Targets\nCustomer Quality\tReduce complaint rate\t<0.1% of units sold\nProcess Quality\tImprove first pass yield\t>96%\nCompliance\tMaintain certification\tZero major NCs\nEfficiency\tReduce quality costs\t<4% of revenue\nCulture\tIncrease training completion\t>98% on-time\nQuarterly Objective Review\nReview Element\tAssessment\tAction\nProgress vs. target\tOn track / Behind / Ahead\tAdjust resources if behind\nRelevance\tStill valid / Needs update\tModify if conditions changed\nResources\tAdequate / Insufficient\tRequest additional if needed\nBarriers\tIdentified obstacles\tEscalate for resolution\nQuality Culture Assessment Workflow\n\nAssess and improve organizational quality culture.\n\nWorkflow: Annual Quality Culture Assessment\nDesign or select quality culture survey instrument\nDefine survey population (all employees or sample)\nCommunicate survey purpose and confidentiality\nAdminister survey with 2-week response window\nAnalyze results by department, role, and tenure\nIdentify strengths and improvement areas\nDevelop action plan for culture gaps\nValidation: Response rate >60%; action plan addresses bottom 3 scores\nQuality Culture Dimensions\nDimension\tIndicators\tAssessment Method\nLeadership commitment\tManagement visible support for quality\tSurvey, observation\nQuality ownership\tEmployees feel responsible for quality\tSurvey\nCommunication\tQuality information flows effectively\tSurvey, audit\nContinuous improvement\tSuggestions submitted and implemented\tMetrics\nTraining and competence\tEmployees feel adequately trained\tSurvey, records\nProblem solving\tIssues addressed at root cause\tCAPA analysis\nCulture Survey Categories\nCategory\tSample Questions\nLeadership\t\"Management demonstrates commitment to quality\"\nResources\t\"I have the tools and training to do quality work\"\nCommunication\t\"Quality expectations are clearly communicated\"\nEmpowerment\t\"I am encouraged to report quality issues\"\nRecognition\t\"Quality achievements are recognized\"\nCulture Improvement Actions\nGap Identified\tPotential Actions\nLow leadership visibility\tQuality gemba walks, all-hands quality updates\nInadequate training\tCompetency-based training program\nPoor communication\tQuality newsletters, department huddles\nLow reporting\tAnonymous reporting system, no-blame culture\nLack of recognition\tQuality award program, team celebrations\nRegulatory Compliance Oversight\n\nMonitor and maintain regulatory compliance across jurisdictions.\n\nMulti-Jurisdictional Compliance Matrix\nJurisdiction\tRegulation\tRequirement\tStatus Tracking\nEU\tMDR 2017/745\tCE marking, Notified Body\tTechnical file, annual review\nUSA\t21 CFR 820\tFDA registration, QSR compliance\tAnnual registration, inspections\nInternational\tISO 13485\tQMS certification\tSurveillance audits\nGermany\tMPG/MPDG\tNational implementation\tCompetent authority filings\nCompliance Monitoring Workflow\nMaintain regulatory requirement register\nSubscribe to regulatory update services\nAssess impact of regulatory changes monthly\nUpdate affected processes within 90 days of effective date\nVerify training completion for regulatory changes\nDocument compliance status in management review\nMaintain inspection readiness checklist\nValidation: All applicable requirements mapped; no expired registrations\nRegulatory Authority Interface\nActivity\tQMR Role\tPreparation Required\nNotified Body audit\tPrimary contact\tAudit package, personnel schedules\nFDA inspection\tHost, escort coordinator\tInspection readiness review\nCompetent Authority inquiry\tResponse coordinator\tTechnical file access\nRegulatory meeting\tAttendee or delegate\tBriefing materials\nInspection Readiness Checklist\nArea\tReady\tAction Needed\nDocument control system current\t☐\t\nTraining records complete\t☐\t\nCAPA system current, no overdue items\t☐\t\nComplaint files complete\t☐\t\nEquipment calibration current\t☐\t\nSupplier qualification files complete\t☐\t\nManagement review records available\t☐\t\nInternal audit program current\t☐\t\nDecision Frameworks\nEscalation Decision Tree\nIssue Identified\n │\n ▼\nIs it a regulatory violation?\n │\n Yes─┴─No\n │ │\n ▼ ▼\nEscalate to Is it a safety issue?\nExecutive │\nimmediately Yes─┴─No\n │ │\n ▼ ▼\n Escalate to Does it affect\n Safety Team multiple departments?\n │\n Yes─┴─No\n │ │\n ▼ ▼\n Escalate to Handle at\n Executive department level\n\nQuality Investment Prioritization\nCriteria\tWeight\tScore Method\nRegulatory requirement\t30%\tRequired=10, Recommended=5, Optional=2\nCustomer impact\t25%\tDirect=10, Indirect=5, None=0\nCost savings potential\t20%\t>$100K=10, $50-100K=7, <$50K=3\nImplementation complexity\t15%\tSimple=10, Moderate=5, Complex=2\nStrategic alignment\t10%\tCore=10, Supporting=5, Peripheral=2\nResource Allocation Matrix\nResource Type\tAllocation Authority\tEscalation Threshold\nQuality personnel\tQMR\t>1 FTE addition\nQuality equipment\tQMR\t>$25K\nExternal consultants\tQMR\t>$50K or >30 days\nQuality systems\tExecutive approval\t>$100K\nTools and References\nScripts\nTool\tPurpose\tUsage\nmanagement_review_tracker.py\tTrack review inputs, actions, metrics\tpython management_review_tracker.py --help\n\nManagement Review Tracker Features:\n\nTrack input collection status from process owners\nMonitor action item completion and aging\nGenerate metrics summary for review\nProduce recommendations for review focus areas\nReferences\nDocument\tContent\nmanagement-review-guide.md\tISO 13485 Clause 5.6 requirements, input/output templates, action tracking\nquality-kpi-framework.md\tKPI categories, targets, calculations, dashboard templates\nQuick Reference: Management Review Inputs (ISO 13485 Clause 5.6.2)\nInput\tSource\tRequired\nFeedback\tCustomer complaints, surveys\tYes\nAudit results\tInternal and external audits\tYes\nProcess performance\tProcess metrics\tYes\nProduct conformity\tInspection, NC data\tYes\nCAPA status\tCAPA system\tYes\nPrevious actions\tPrior review records\tYes\nChanges\tRegulatory, organizational\tYes\nRecommendations\tAll sources\tYes\nQuick Reference: Management Review Outputs (ISO 13485 Clause 5.6.3)\nOutput\tDocumentation Required\nImprovement to QMS and processes\tAction items with owners\nImprovement to product\tProject initiation if needed\nResource needs\tResource plan updates\nRelated Skills\nSkill\tIntegration Point\nquality-manager-qms-iso13485\tQMS process management\ncapa-officer\tCAPA system oversight\nqms-audit-expert\tInternal audit program\nquality-documentation-manager\tDocument control oversight" }, "trust": { "sourceLabel": "tencent", "provenanceUrl": "https://clawhub.ai/alirezarezvani/quality-manager-qmr", "publisherUrl": "https://clawhub.ai/alirezarezvani/quality-manager-qmr", "owner": "alirezarezvani", "version": "2.1.1", "license": null, "verificationStatus": "Indexed source record" }, "links": { "detailUrl": "https://openagent3.xyz/skills/quality-manager-qmr", "downloadUrl": "https://openagent3.xyz/downloads/quality-manager-qmr", "agentUrl": "https://openagent3.xyz/skills/quality-manager-qmr/agent", "manifestUrl": "https://openagent3.xyz/skills/quality-manager-qmr/agent.json", "briefUrl": "https://openagent3.xyz/skills/quality-manager-qmr/agent.md" } }