{
  "schemaVersion": "1.0",
  "item": {
    "slug": "capa-officer",
    "name": "Capa Officer",
    "source": "tencent",
    "type": "skill",
    "category": "效率提升",
    "sourceUrl": "https://clawhub.ai/alirezarezvani/capa-officer",
    "canonicalUrl": "https://clawhub.ai/alirezarezvani/capa-officer",
    "targetPlatform": "OpenClaw"
  },
  "install": {
    "downloadMode": "redirect",
    "downloadUrl": "/downloads/capa-officer",
    "sourceDownloadUrl": "https://wry-manatee-359.convex.site/api/v1/download?slug=capa-officer",
    "sourcePlatform": "tencent",
    "targetPlatform": "OpenClaw",
    "installMethod": "Manual import",
    "extraction": "Extract archive",
    "prerequisites": [
      "OpenClaw"
    ],
    "packageFormat": "ZIP package",
    "includedAssets": [
      "SKILL.md",
      "references/effectiveness-verification-guide.md",
      "references/rca-methodologies.md",
      "scripts/capa_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/capa-officer"
    },
    "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/capa-officer",
    "agentPageUrl": "https://openagent3.xyz/skills/capa-officer/agent",
    "manifestUrl": "https://openagent3.xyz/skills/capa-officer/agent.json",
    "briefUrl": "https://openagent3.xyz/skills/capa-officer/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": "CAPA Officer",
        "body": "Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification."
      },
      {
        "title": "Table of Contents",
        "body": "CAPA Investigation Workflow\nRoot Cause Analysis\nCorrective Action Planning\nEffectiveness Verification\nCAPA Metrics and Reporting\nReference Documentation\nTools"
      },
      {
        "title": "CAPA Investigation Workflow",
        "body": "Conduct systematic CAPA investigation from initiation through closure:\n\nDocument trigger event with objective evidence\nAssess significance and determine CAPA necessity\nForm investigation team with relevant expertise\nCollect data and evidence systematically\nSelect and apply appropriate RCA methodology\nIdentify root cause(s) with supporting evidence\nDevelop corrective and preventive actions\nValidation: Root cause explains all symptoms; if eliminated, problem would not recur"
      },
      {
        "title": "CAPA Necessity Determination",
        "body": "Trigger TypeCAPA RequiredCriteriaCustomer complaint (safety)YesAny complaint involving patient/user safetyCustomer complaint (quality)EvaluateBased on severity and frequencyInternal audit finding (Major)YesSystematic failure or absence of elementInternal audit finding (Minor)RecommendedIsolated lapse or partial implementationNonconformance (recurring)YesSame NC type occurring 3+ timesNonconformance (isolated)EvaluateBased on severity and riskExternal audit findingYesAll Major and Minor findingsTrend analysisEvaluateBased on trend significance"
      },
      {
        "title": "Investigation Team Composition",
        "body": "CAPA SeverityRequired Team MembersCriticalCAPA Officer, Process Owner, QA Manager, Subject Matter Expert, Management RepMajorCAPA Officer, Process Owner, Subject Matter ExpertMinorCAPA Officer, Process Owner"
      },
      {
        "title": "Evidence Collection Checklist",
        "body": "Problem description with specific details (what, where, when, who, how much)\n Timeline of events leading to issue\n Relevant records and documentation\n Interview notes from involved personnel\n Photos or physical evidence (if applicable)\n Related complaints, NCs, or previous CAPAs\n Process parameters and specifications"
      },
      {
        "title": "Root Cause Analysis",
        "body": "Select and apply appropriate RCA methodology based on problem characteristics."
      },
      {
        "title": "RCA Method Selection Decision Tree",
        "body": "Is the issue safety-critical or involves system reliability?\n├── Yes → Use FAULT TREE ANALYSIS\n└── No → Is human error the suspected primary cause?\n    ├── Yes → Use HUMAN FACTORS ANALYSIS\n    └── No → How many potential contributing factors?\n        ├── 1-2 factors (linear causation) → Use 5 WHY ANALYSIS\n        ├── 3-6 factors (complex, systemic) → Use FISHBONE DIAGRAM\n        └── Unknown/proactive assessment → Use FMEA"
      },
      {
        "title": "5 Why Analysis",
        "body": "Use when: Single-cause issues with linear causation, process deviations with clear failure point.\n\nTemplate:\n\nPROBLEM: [Clear, specific statement]\n\nWHY 1: Why did [problem] occur?\nBECAUSE: [First-level cause]\nEVIDENCE: [Supporting data]\n\nWHY 2: Why did [first-level cause] occur?\nBECAUSE: [Second-level cause]\nEVIDENCE: [Supporting data]\n\nWHY 3: Why did [second-level cause] occur?\nBECAUSE: [Third-level cause]\nEVIDENCE: [Supporting data]\n\nWHY 4: Why did [third-level cause] occur?\nBECAUSE: [Fourth-level cause]\nEVIDENCE: [Supporting data]\n\nWHY 5: Why did [fourth-level cause] occur?\nBECAUSE: [Root cause]\nEVIDENCE: [Supporting data]\n\nExample - Calibration Overdue:\n\nPROBLEM: pH meter (EQ-042) found 2 months overdue for calibration\n\nWHY 1: Why was calibration overdue?\nBECAUSE: Equipment was not on calibration schedule\nEVIDENCE: Calibration schedule reviewed, EQ-042 not listed\n\nWHY 2: Why was it not on the schedule?\nBECAUSE: Schedule not updated when equipment was purchased\nEVIDENCE: Purchase date 2023-06-15, schedule dated 2023-01-01\n\nWHY 3: Why was the schedule not updated?\nBECAUSE: No process requires schedule update at equipment purchase\nEVIDENCE: SOP-EQ-001 reviewed, no such requirement\n\nWHY 4: Why is there no such requirement?\nBECAUSE: Procedure written before equipment tracking was centralized\nEVIDENCE: SOP last revised 2019, equipment system implemented 2021\n\nWHY 5: Why has procedure not been updated?\nBECAUSE: Periodic review did not assess compatibility with new systems\nEVIDENCE: No review against new equipment system documented\n\nROOT CAUSE: Procedure review process does not assess compatibility\nwith organizational systems implemented after original procedure creation."
      },
      {
        "title": "Fishbone Diagram Categories (6M)",
        "body": "CategoryFocus AreasTypical CausesMan (People)Training, competency, workloadSkill gaps, fatigue, communicationMachine (Equipment)Calibration, maintenance, ageWear, malfunction, inadequate capacityMethod (Process)Procedures, work instructionsUnclear steps, missing controlsMaterialSpecifications, suppliers, storageOut-of-spec, degradation, contaminationMeasurementCalibration, methods, interpretationInstrument error, wrong methodMother NatureTemperature, humidity, cleanlinessEnvironmental excursions\n\nSee references/rca-methodologies.md for complete method details and templates."
      },
      {
        "title": "Root Cause Validation",
        "body": "Before proceeding to action planning, validate root cause:\n\nRoot cause can be verified with objective evidence\n If root cause is eliminated, problem would not recur\n Root cause is within organizational control\n Root cause explains all observed symptoms\n No other significant causes remain unaddressed"
      },
      {
        "title": "Corrective Action Planning",
        "body": "Develop effective actions addressing identified root causes:\n\nDefine immediate containment actions\nDevelop corrective actions targeting root cause\nIdentify preventive actions for similar processes\nAssign responsibilities and resources\nEstablish timeline with milestones\nDefine success criteria and verification method\nDocument in CAPA action plan\nValidation: Actions directly address root cause; success criteria are measurable"
      },
      {
        "title": "Action Types",
        "body": "TypePurposeTimelineExampleContainmentStop immediate impact24-72 hoursQuarantine affected productCorrectionFix the specific occurrence1-2 weeksRework or replace affected itemsCorrectiveEliminate root cause30-90 daysRevise procedure, add controlsPreventivePrevent in other areas60-120 daysExtend solution to similar processes"
      },
      {
        "title": "Action Plan Components",
        "body": "ACTION PLAN TEMPLATE\n\nCAPA Number: [CAPA-XXXX]\nRoot Cause: [Identified root cause]\n\nACTION 1: [Specific action description]\n- Type: [ ] Containment [ ] Correction [ ] Corrective [ ] Preventive\n- Responsible: [Name, Title]\n- Due Date: [YYYY-MM-DD]\n- Resources: [Required resources]\n- Success Criteria: [Measurable outcome]\n- Verification Method: [How success will be verified]\n\nACTION 2: [Specific action description]\n...\n\nIMPLEMENTATION TIMELINE:\nWeek 1: [Milestone]\nWeek 2: [Milestone]\nWeek 4: [Milestone]\nWeek 8: [Milestone]\n\nAPPROVAL:\nCAPA Owner: _____________ Date: _______\nProcess Owner: _____________ Date: _______\nQA Manager: _____________ Date: _______"
      },
      {
        "title": "Action Effectiveness Indicators",
        "body": "IndicatorTargetRed FlagAction scopeAddresses root cause completelyTreats only symptomsSpecificityMeasurable deliverablesVague commitmentsTimelineAggressive but achievableNo due dates or unrealisticResourcesIdentified and allocatedNot specifiedSustainabilityPermanent solutionTemporary fix"
      },
      {
        "title": "Effectiveness Verification",
        "body": "Verify corrective actions achieved intended results:\n\nAllow adequate implementation period (minimum 30-90 days)\nCollect post-implementation data\nCompare to pre-implementation baseline\nEvaluate against success criteria\nVerify no recurrence during verification period\nDocument verification evidence\nDetermine CAPA effectiveness\nValidation: All criteria met with objective evidence; no recurrence observed"
      },
      {
        "title": "Verification Timeline Guidelines",
        "body": "CAPA SeverityWait PeriodVerification WindowCritical30 days30-90 days post-implementationMajor60 days60-180 days post-implementationMinor90 days90-365 days post-implementation"
      },
      {
        "title": "Verification Methods",
        "body": "MethodUse WhenEvidence RequiredData trend analysisQuantifiable issuesPre/post comparison, trend chartsProcess auditProcedure compliance issuesAudit checklist, interview notesRecord reviewDocumentation issuesSample records, compliance rateTesting/inspectionProduct quality issuesTest results, pass/fail dataInterview/observationTraining issuesInterview notes, observation records"
      },
      {
        "title": "Effectiveness Determination",
        "body": "Did recurrence occur during verification period?\n├── Yes → CAPA INEFFECTIVE (re-investigate root cause)\n└── No → Were all effectiveness criteria met?\n    ├── Yes → CAPA EFFECTIVE (proceed to closure)\n    └── No → Extent of gap?\n        ├── Minor gap → Extend verification or accept with justification\n        └── Significant gap → CAPA INEFFECTIVE (revise actions)\n\nSee references/effectiveness-verification-guide.md for detailed procedures."
      },
      {
        "title": "CAPA Metrics and Reporting",
        "body": "Monitor CAPA program performance through key indicators."
      },
      {
        "title": "Key Performance Indicators",
        "body": "MetricTargetCalculationCAPA cycle time<60 days average(Close Date - Open Date) / Number of CAPAsOverdue rate<10%Overdue CAPAs / Total Open CAPAsFirst-time effectiveness>90%Effective on first verification / Total verifiedRecurrence rate<5%Recurred issues / Total closed CAPAsInvestigation quality100% root cause validatedRoot causes validated / Total CAPAs"
      },
      {
        "title": "Aging Analysis Categories",
        "body": "Age BucketStatusAction Required0-30 daysOn trackMonitor progress31-60 daysMonitorReview for delays61-90 daysWarningEscalate to management>90 daysCriticalManagement intervention required"
      },
      {
        "title": "Management Review Inputs",
        "body": "Monthly CAPA status report includes:\n\nOpen CAPA count by severity and status\nOverdue CAPA list with owners\nCycle time trends\nEffectiveness rate trends\nSource analysis (complaints, audits, NCs)\nRecommendations for improvement"
      },
      {
        "title": "Root Cause Analysis Methodologies",
        "body": "references/rca-methodologies.md contains:\n\nMethod selection decision tree\n5 Why analysis template and example\nFishbone diagram categories and template\nFault Tree Analysis for safety-critical issues\nHuman Factors Analysis for people-related causes\nFMEA for proactive risk assessment\nHybrid approach guidance"
      },
      {
        "title": "Effectiveness Verification Guide",
        "body": "references/effectiveness-verification-guide.md contains:\n\nVerification planning requirements\nVerification method selection\nEffectiveness criteria definition (SMART)\nClosure requirements by severity\nIneffective CAPA process\nDocumentation templates"
      },
      {
        "title": "CAPA Tracker",
        "body": "# Generate CAPA status report\npython scripts/capa_tracker.py --capas capas.json\n\n# Interactive mode for manual entry\npython scripts/capa_tracker.py --interactive\n\n# JSON output for integration\npython scripts/capa_tracker.py --capas capas.json --output json\n\n# Generate sample data file\npython scripts/capa_tracker.py --sample > sample_capas.json\n\nCalculates and reports:\n\nSummary metrics (open, closed, overdue, cycle time, effectiveness)\nStatus distribution\nSeverity and source analysis\nAging report by time bucket\nOverdue CAPA list\nActionable recommendations"
      },
      {
        "title": "Sample CAPA Input",
        "body": "{\n  \"capas\": [\n    {\n      \"capa_number\": \"CAPA-2024-001\",\n      \"title\": \"Calibration overdue for pH meter\",\n      \"description\": \"pH meter EQ-042 found 2 months overdue\",\n      \"source\": \"AUDIT\",\n      \"severity\": \"MAJOR\",\n      \"status\": \"VERIFICATION\",\n      \"open_date\": \"2024-06-15\",\n      \"target_date\": \"2024-08-15\",\n      \"owner\": \"J. Smith\",\n      \"root_cause\": \"Procedure review gap\",\n      \"corrective_action\": \"Updated SOP-EQ-001\"\n    }\n  ]\n}"
      },
      {
        "title": "ISO 13485:2016 Clause 8.5",
        "body": "Sub-clauseRequirementKey Activities8.5.2 Corrective ActionEliminate cause of nonconformityNC review, cause determination, action evaluation, implementation, effectiveness review8.5.3 Preventive ActionEliminate potential nonconformityTrend analysis, cause determination, action evaluation, implementation, effectiveness review"
      },
      {
        "title": "FDA 21 CFR 820.100",
        "body": "Required CAPA elements:\n\nProcedures for implementing corrective and preventive action\nAnalyzing quality data sources (complaints, NCs, audits, service records)\nInvestigating cause of nonconformities\nIdentifying actions needed to correct and prevent recurrence\nVerifying actions are effective and do not adversely affect device\nSubmitting relevant information for management review"
      },
      {
        "title": "Common FDA 483 Observations",
        "body": "ObservationRoot Cause PatternCAPA not initiated for recurring issueTrend analysis not performedRoot cause analysis superficialInadequate investigation trainingEffectiveness not verifiedNo verification procedureActions do not address root causeSymptom treatment vs. cause elimination"
      }
    ],
    "body": "CAPA Officer\n\nCorrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.\n\nTable of Contents\nCAPA Investigation Workflow\nRoot Cause Analysis\nCorrective Action Planning\nEffectiveness Verification\nCAPA Metrics and Reporting\nReference Documentation\nTools\nCAPA Investigation Workflow\n\nConduct systematic CAPA investigation from initiation through closure:\n\nDocument trigger event with objective evidence\nAssess significance and determine CAPA necessity\nForm investigation team with relevant expertise\nCollect data and evidence systematically\nSelect and apply appropriate RCA methodology\nIdentify root cause(s) with supporting evidence\nDevelop corrective and preventive actions\nValidation: Root cause explains all symptoms; if eliminated, problem would not recur\nCAPA Necessity Determination\nTrigger Type\tCAPA Required\tCriteria\nCustomer complaint (safety)\tYes\tAny complaint involving patient/user safety\nCustomer complaint (quality)\tEvaluate\tBased on severity and frequency\nInternal audit finding (Major)\tYes\tSystematic failure or absence of element\nInternal audit finding (Minor)\tRecommended\tIsolated lapse or partial implementation\nNonconformance (recurring)\tYes\tSame NC type occurring 3+ times\nNonconformance (isolated)\tEvaluate\tBased on severity and risk\nExternal audit finding\tYes\tAll Major and Minor findings\nTrend analysis\tEvaluate\tBased on trend significance\nInvestigation Team Composition\nCAPA Severity\tRequired Team Members\nCritical\tCAPA Officer, Process Owner, QA Manager, Subject Matter Expert, Management Rep\nMajor\tCAPA Officer, Process Owner, Subject Matter Expert\nMinor\tCAPA Officer, Process Owner\nEvidence Collection Checklist\n Problem description with specific details (what, where, when, who, how much)\n Timeline of events leading to issue\n Relevant records and documentation\n Interview notes from involved personnel\n Photos or physical evidence (if applicable)\n Related complaints, NCs, or previous CAPAs\n Process parameters and specifications\nRoot Cause Analysis\n\nSelect and apply appropriate RCA methodology based on problem characteristics.\n\nRCA Method Selection Decision Tree\nIs the issue safety-critical or involves system reliability?\n├── Yes → Use FAULT TREE ANALYSIS\n└── No → Is human error the suspected primary cause?\n    ├── Yes → Use HUMAN FACTORS ANALYSIS\n    └── No → How many potential contributing factors?\n        ├── 1-2 factors (linear causation) → Use 5 WHY ANALYSIS\n        ├── 3-6 factors (complex, systemic) → Use FISHBONE DIAGRAM\n        └── Unknown/proactive assessment → Use FMEA\n\n5 Why Analysis\n\nUse when: Single-cause issues with linear causation, process deviations with clear failure point.\n\nTemplate:\n\nPROBLEM: [Clear, specific statement]\n\nWHY 1: Why did [problem] occur?\nBECAUSE: [First-level cause]\nEVIDENCE: [Supporting data]\n\nWHY 2: Why did [first-level cause] occur?\nBECAUSE: [Second-level cause]\nEVIDENCE: [Supporting data]\n\nWHY 3: Why did [second-level cause] occur?\nBECAUSE: [Third-level cause]\nEVIDENCE: [Supporting data]\n\nWHY 4: Why did [third-level cause] occur?\nBECAUSE: [Fourth-level cause]\nEVIDENCE: [Supporting data]\n\nWHY 5: Why did [fourth-level cause] occur?\nBECAUSE: [Root cause]\nEVIDENCE: [Supporting data]\n\n\nExample - Calibration Overdue:\n\nPROBLEM: pH meter (EQ-042) found 2 months overdue for calibration\n\nWHY 1: Why was calibration overdue?\nBECAUSE: Equipment was not on calibration schedule\nEVIDENCE: Calibration schedule reviewed, EQ-042 not listed\n\nWHY 2: Why was it not on the schedule?\nBECAUSE: Schedule not updated when equipment was purchased\nEVIDENCE: Purchase date 2023-06-15, schedule dated 2023-01-01\n\nWHY 3: Why was the schedule not updated?\nBECAUSE: No process requires schedule update at equipment purchase\nEVIDENCE: SOP-EQ-001 reviewed, no such requirement\n\nWHY 4: Why is there no such requirement?\nBECAUSE: Procedure written before equipment tracking was centralized\nEVIDENCE: SOP last revised 2019, equipment system implemented 2021\n\nWHY 5: Why has procedure not been updated?\nBECAUSE: Periodic review did not assess compatibility with new systems\nEVIDENCE: No review against new equipment system documented\n\nROOT CAUSE: Procedure review process does not assess compatibility\nwith organizational systems implemented after original procedure creation.\n\nFishbone Diagram Categories (6M)\nCategory\tFocus Areas\tTypical Causes\nMan (People)\tTraining, competency, workload\tSkill gaps, fatigue, communication\nMachine (Equipment)\tCalibration, maintenance, age\tWear, malfunction, inadequate capacity\nMethod (Process)\tProcedures, work instructions\tUnclear steps, missing controls\nMaterial\tSpecifications, suppliers, storage\tOut-of-spec, degradation, contamination\nMeasurement\tCalibration, methods, interpretation\tInstrument error, wrong method\nMother Nature\tTemperature, humidity, cleanliness\tEnvironmental excursions\n\nSee references/rca-methodologies.md for complete method details and templates.\n\nRoot Cause Validation\n\nBefore proceeding to action planning, validate root cause:\n\n Root cause can be verified with objective evidence\n If root cause is eliminated, problem would not recur\n Root cause is within organizational control\n Root cause explains all observed symptoms\n No other significant causes remain unaddressed\nCorrective Action Planning\n\nDevelop effective actions addressing identified root causes:\n\nDefine immediate containment actions\nDevelop corrective actions targeting root cause\nIdentify preventive actions for similar processes\nAssign responsibilities and resources\nEstablish timeline with milestones\nDefine success criteria and verification method\nDocument in CAPA action plan\nValidation: Actions directly address root cause; success criteria are measurable\nAction Types\nType\tPurpose\tTimeline\tExample\nContainment\tStop immediate impact\t24-72 hours\tQuarantine affected product\nCorrection\tFix the specific occurrence\t1-2 weeks\tRework or replace affected items\nCorrective\tEliminate root cause\t30-90 days\tRevise procedure, add controls\nPreventive\tPrevent in other areas\t60-120 days\tExtend solution to similar processes\nAction Plan Components\nACTION PLAN TEMPLATE\n\nCAPA Number: [CAPA-XXXX]\nRoot Cause: [Identified root cause]\n\nACTION 1: [Specific action description]\n- Type: [ ] Containment [ ] Correction [ ] Corrective [ ] Preventive\n- Responsible: [Name, Title]\n- Due Date: [YYYY-MM-DD]\n- Resources: [Required resources]\n- Success Criteria: [Measurable outcome]\n- Verification Method: [How success will be verified]\n\nACTION 2: [Specific action description]\n...\n\nIMPLEMENTATION TIMELINE:\nWeek 1: [Milestone]\nWeek 2: [Milestone]\nWeek 4: [Milestone]\nWeek 8: [Milestone]\n\nAPPROVAL:\nCAPA Owner: _____________ Date: _______\nProcess Owner: _____________ Date: _______\nQA Manager: _____________ Date: _______\n\nAction Effectiveness Indicators\nIndicator\tTarget\tRed Flag\nAction scope\tAddresses root cause completely\tTreats only symptoms\nSpecificity\tMeasurable deliverables\tVague commitments\nTimeline\tAggressive but achievable\tNo due dates or unrealistic\nResources\tIdentified and allocated\tNot specified\nSustainability\tPermanent solution\tTemporary fix\nEffectiveness Verification\n\nVerify corrective actions achieved intended results:\n\nAllow adequate implementation period (minimum 30-90 days)\nCollect post-implementation data\nCompare to pre-implementation baseline\nEvaluate against success criteria\nVerify no recurrence during verification period\nDocument verification evidence\nDetermine CAPA effectiveness\nValidation: All criteria met with objective evidence; no recurrence observed\nVerification Timeline Guidelines\nCAPA Severity\tWait Period\tVerification Window\nCritical\t30 days\t30-90 days post-implementation\nMajor\t60 days\t60-180 days post-implementation\nMinor\t90 days\t90-365 days post-implementation\nVerification Methods\nMethod\tUse When\tEvidence Required\nData trend analysis\tQuantifiable issues\tPre/post comparison, trend charts\nProcess audit\tProcedure compliance issues\tAudit checklist, interview notes\nRecord review\tDocumentation issues\tSample records, compliance rate\nTesting/inspection\tProduct quality issues\tTest results, pass/fail data\nInterview/observation\tTraining issues\tInterview notes, observation records\nEffectiveness Determination\nDid recurrence occur during verification period?\n├── Yes → CAPA INEFFECTIVE (re-investigate root cause)\n└── No → Were all effectiveness criteria met?\n    ├── Yes → CAPA EFFECTIVE (proceed to closure)\n    └── No → Extent of gap?\n        ├── Minor gap → Extend verification or accept with justification\n        └── Significant gap → CAPA INEFFECTIVE (revise actions)\n\n\nSee references/effectiveness-verification-guide.md for detailed procedures.\n\nCAPA Metrics and Reporting\n\nMonitor CAPA program performance through key indicators.\n\nKey Performance Indicators\nMetric\tTarget\tCalculation\nCAPA cycle time\t<60 days average\t(Close Date - Open Date) / Number of CAPAs\nOverdue rate\t<10%\tOverdue CAPAs / Total Open CAPAs\nFirst-time effectiveness\t>90%\tEffective on first verification / Total verified\nRecurrence rate\t<5%\tRecurred issues / Total closed CAPAs\nInvestigation quality\t100% root cause validated\tRoot causes validated / Total CAPAs\nAging Analysis Categories\nAge Bucket\tStatus\tAction Required\n0-30 days\tOn track\tMonitor progress\n31-60 days\tMonitor\tReview for delays\n61-90 days\tWarning\tEscalate to management\n>90 days\tCritical\tManagement intervention required\nManagement Review Inputs\n\nMonthly CAPA status report includes:\n\nOpen CAPA count by severity and status\nOverdue CAPA list with owners\nCycle time trends\nEffectiveness rate trends\nSource analysis (complaints, audits, NCs)\nRecommendations for improvement\nReference Documentation\nRoot Cause Analysis Methodologies\n\nreferences/rca-methodologies.md contains:\n\nMethod selection decision tree\n5 Why analysis template and example\nFishbone diagram categories and template\nFault Tree Analysis for safety-critical issues\nHuman Factors Analysis for people-related causes\nFMEA for proactive risk assessment\nHybrid approach guidance\nEffectiveness Verification Guide\n\nreferences/effectiveness-verification-guide.md contains:\n\nVerification planning requirements\nVerification method selection\nEffectiveness criteria definition (SMART)\nClosure requirements by severity\nIneffective CAPA process\nDocumentation templates\nTools\nCAPA Tracker\n# Generate CAPA status report\npython scripts/capa_tracker.py --capas capas.json\n\n# Interactive mode for manual entry\npython scripts/capa_tracker.py --interactive\n\n# JSON output for integration\npython scripts/capa_tracker.py --capas capas.json --output json\n\n# Generate sample data file\npython scripts/capa_tracker.py --sample > sample_capas.json\n\n\nCalculates and reports:\n\nSummary metrics (open, closed, overdue, cycle time, effectiveness)\nStatus distribution\nSeverity and source analysis\nAging report by time bucket\nOverdue CAPA list\nActionable recommendations\nSample CAPA Input\n{\n  \"capas\": [\n    {\n      \"capa_number\": \"CAPA-2024-001\",\n      \"title\": \"Calibration overdue for pH meter\",\n      \"description\": \"pH meter EQ-042 found 2 months overdue\",\n      \"source\": \"AUDIT\",\n      \"severity\": \"MAJOR\",\n      \"status\": \"VERIFICATION\",\n      \"open_date\": \"2024-06-15\",\n      \"target_date\": \"2024-08-15\",\n      \"owner\": \"J. Smith\",\n      \"root_cause\": \"Procedure review gap\",\n      \"corrective_action\": \"Updated SOP-EQ-001\"\n    }\n  ]\n}\n\nRegulatory Requirements\nISO 13485:2016 Clause 8.5\nSub-clause\tRequirement\tKey Activities\n8.5.2 Corrective Action\tEliminate cause of nonconformity\tNC review, cause determination, action evaluation, implementation, effectiveness review\n8.5.3 Preventive Action\tEliminate potential nonconformity\tTrend analysis, cause determination, action evaluation, implementation, effectiveness review\nFDA 21 CFR 820.100\n\nRequired CAPA elements:\n\nProcedures for implementing corrective and preventive action\nAnalyzing quality data sources (complaints, NCs, audits, service records)\nInvestigating cause of nonconformities\nIdentifying actions needed to correct and prevent recurrence\nVerifying actions are effective and do not adversely affect device\nSubmitting relevant information for management review\nCommon FDA 483 Observations\nObservation\tRoot Cause Pattern\nCAPA not initiated for recurring issue\tTrend analysis not performed\nRoot cause analysis superficial\tInadequate investigation training\nEffectiveness not verified\tNo verification procedure\nActions do not address root cause\tSymptom treatment vs. cause elimination"
  },
  "trust": {
    "sourceLabel": "tencent",
    "provenanceUrl": "https://clawhub.ai/alirezarezvani/capa-officer",
    "publisherUrl": "https://clawhub.ai/alirezarezvani/capa-officer",
    "owner": "alirezarezvani",
    "version": "2.1.1",
    "license": null,
    "verificationStatus": "Indexed source record"
  },
  "links": {
    "detailUrl": "https://openagent3.xyz/skills/capa-officer",
    "downloadUrl": "https://openagent3.xyz/downloads/capa-officer",
    "agentUrl": "https://openagent3.xyz/skills/capa-officer/agent",
    "manifestUrl": "https://openagent3.xyz/skills/capa-officer/agent.json",
    "briefUrl": "https://openagent3.xyz/skills/capa-officer/agent.md"
  }
}