[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill-5c50f1a7-5a19-4b6e-94a8-a48b5c511fd9":3,"$f_o82IhX_mLjk8f5WhpwRRCWln1527bjfbA8nEgQhyTE":43},{"id":4,"title":5,"description":6,"categoryId":7,"moduleId":8,"tags":9,"prompt":10,"icon":11,"source":12,"sourceUrl":13,"authorId":14,"authorName":15,"isPublic":16,"stars":17,"runs":18,"createdAt":19,"updatedAt":19,"module":20,"category":27,"packages":34},"5c50f1a7-5a19-4b6e-94a8-a48b5c511fd9","capa-officer","医疗器械QMS的CAPA系统管理。涵盖根本原因分析、纠正措施计划、有效性验证和CAPA指标。用于CAPA调查、5-Why分析、鱼骨图、根本原因确定、纠正措施跟踪、有效性验证或CAPA程序优化。","cat_life_career","mod_other","alirezarezvani,other","---\nname: \"capa-officer\"\ndescription: CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.\ntriggers:\n  - CAPA investigation\n  - root cause analysis\n  - 5 Why analysis\n  - fishbone diagram\n  - corrective action\n  - preventive action\n  - effectiveness verification\n  - CAPA metrics\n  - nonconformance investigation\n  - quality issue investigation\n  - CAPA tracking\n  - audit finding CAPA\n---\n\n# 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\n---\n\n## Table of Contents\n\n- [CAPA Investigation Workflow](#capa-investigation-workflow)\n- [Root Cause Analysis](#root-cause-analysis)\n- [Corrective Action Planning](#corrective-action-planning)\n- [Effectiveness Verification](#effectiveness-verification)\n- [CAPA Metrics and Reporting](#capa-metrics-and-reporting)\n- [Reference Documentation](#reference-documentation)\n- [Tools](#tools)\n\n---\n\n## CAPA Investigation Workflow\n\nConduct systematic CAPA investigation from initiation through closure:\n\n1. Document trigger event with objective evidence\n2. Assess significance and determine CAPA necessity\n3. Form investigation team with relevant expertise\n4. Collect data and evidence systematically\n5. Select and apply appropriate RCA methodology\n6. Identify root cause(s) with supporting evidence\n7. Develop corrective and preventive actions\n8. **Validation:** Root cause explains all symptoms; if eliminated, problem would not recur\n\n### CAPA Necessity Determination\n\n| Trigger Type | CAPA Required | Criteria |\n|--------------|---------------|----------|\n| Customer complaint (safety) | Yes | Any complaint involving patient\u002Fuser safety |\n| Customer complaint (quality) | Evaluate | Based on severity and frequency |\n| Internal audit finding (Major) | Yes | Systematic failure or absence of element |\n| Internal audit finding (Minor) | Recommended | Isolated lapse or partial implementation |\n| Nonconformance (recurring) | Yes | Same NC type occurring 3+ times |\n| Nonconformance (isolated) | Evaluate | Based on severity and risk |\n| External audit finding | Yes | All Major and Minor findings |\n| Trend analysis | Evaluate | Based on trend significance |\n\n### Investigation Team Composition\n\n| CAPA Severity | Required Team Members |\n|---------------|----------------------|\n| Critical | CAPA Officer, Process Owner, QA Manager, Subject Matter Expert, Management Rep |\n| Major | CAPA Officer, Process Owner, Subject Matter Expert |\n| Minor | CAPA Officer, Process Owner |\n\n### Evidence Collection Checklist\n\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\n\n---\n\n## Root Cause Analysis\n\nSelect and apply appropriate RCA methodology based on problem characteristics.\n\n### RCA Method Selection Decision Tree\n\n```\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\u002Fproactive assessment → Use FMEA\n```\n\n### 5 Why Analysis\n\nUse when: Single-cause issues with linear causation, process deviations with clear failure point.\n\n**Template:**\n\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\n**Example - Calibration Overdue:**\n\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```\n\n### Fishbone Diagram Categories (6M)\n\n| Category | Focus Areas | Typical Causes |\n|----------|-------------|----------------|\n| Man (People) | Training, competency, workload | Skill gaps, fatigue, communication |\n| Machine (Equipment) | Calibration, maintenance, age | Wear, malfunction, inadequate capacity |\n| Method (Process) | Procedures, work instructions | Unclear steps, missing controls |\n| Material | Specifications, suppliers, storage | Out-of-spec, degradation, contamination |\n| Measurement | Calibration, methods, interpretation | Instrument error, wrong method |\n| Mother Nature | Temperature, humidity, cleanliness | Environmental excursions |\n\nSee `references\u002Frca-methodologies.md` for complete method details and templates.\n\n### Root 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\n\n---\n\n## Corrective Action Planning\n\nDevelop effective actions addressing identified root causes:\n\n1. Define immediate containment actions\n2. Develop corrective actions targeting root cause\n3. Identify preventive actions for similar processes\n4. Assign responsibilities and resources\n5. Establish timeline with milestones\n6. Define success criteria and verification method\n7. Document in CAPA action plan\n8. **Validation:** Actions directly address root cause; success criteria are measurable\n\n### Action Types\n\n| Type | Purpose | Timeline | Example |\n|------|---------|----------|---------|\n| Containment | Stop immediate impact | 24-72 hours | Quarantine affected product |\n| Correction | Fix the specific occurrence | 1-2 weeks | Rework or replace affected items |\n| Corrective | Eliminate root cause | 30-90 days | Revise procedure, add controls |\n| Preventive | Prevent in other areas | 60-120 days | Extend solution to similar processes |\n\n### Action Plan Components\n\n```\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```\n\n### Action Effectiveness Indicators\n\n| Indicator | Target | Red Flag |\n|-----------|--------|----------|\n| Action scope | Addresses root cause completely | Treats only symptoms |\n| Specificity | Measurable deliverables | Vague commitments |\n| Timeline | Aggressive but achievable | No due dates or unrealistic |\n| Resources | Identified and allocated | Not specified |\n| Sustainability | Permanent solution | Temporary fix |\n\n---\n\n## Effectiveness Verification\n\nVerify corrective actions achieved intended results:\n\n1. Allow adequate implementation period (minimum 30-90 days)\n2. Collect post-implementation data\n3. Compare to pre-implementation baseline\n4. Evaluate against success criteria\n5. Verify no recurrence during verification period\n6. Document verification evidence\n7. Determine CAPA effectiveness\n8. **Validation:** All criteria met with objective evidence; no recurrence observed\n\n### Verification Timeline Guidelines\n\n| CAPA Severity | Wait Period | Verification Window |\n|---------------|-------------|---------------------|\n| Critical | 30 days | 30-90 days post-implementation |\n| Major | 60 days | 60-180 days post-implementation |\n| Minor | 90 days | 90-365 days post-implementation |\n\n### Verification Methods\n\n| Method | Use When | Evidence Required |\n|--------|----------|-------------------|\n| Data trend analysis | Quantifiable issues | Pre\u002Fpost comparison, trend charts |\n| Process audit | Procedure compliance issues | Audit checklist, interview notes |\n| Record review | Documentation issues | Sample records, compliance rate |\n| Testing\u002Finspection | Product quality issues | Test results, pass\u002Ffail data |\n| Interview\u002Fobservation | Training issues | Interview notes, observation records |\n\n### Effectiveness Determination\n\n```\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\u002Feffectiveness-verification-guide.md` for detailed procedures.\n\n---\n\n## CAPA Metrics and Reporting\n\nMonitor CAPA program performance through key indicators.\n\n### Key Performance Indicators\n\n| Metric | Target | Calculation |\n|--------|--------|-------------|\n| CAPA cycle time | \u003C60 days average | (Close Date - Open Date) \u002F Number of CAPAs |\n| Overdue rate | \u003C10% | Overdue CAPAs \u002F Total Open CAPAs |\n| First-time effectiveness | >90% | Effective on first verification \u002F Total verified |\n| Recurrence rate | \u003C5% | Recurred issues \u002F Total closed CAPAs |\n| Investigation quality | 100% root cause validated | Root causes validated \u002F Total CAPAs |\n\n### Aging Analysis Categories\n\n| Age Bucket | Status | Action Required |\n|------------|--------|-----------------|\n| 0-30 days | On track | Monitor progress |\n| 31-60 days | Monitor | Review for delays |\n| 61-90 days | Warning | Escalate to management |\n| >90 days | Critical | Management intervention required |\n\n### Management Review Inputs\n\nMonthly CAPA status report includes:\n- Open CAPA count by severity and status\n- Overdue CAPA list with owners\n- Cycle time trends\n- Effectiveness rate trends\n- Source analysis (complaints, audits, NCs)\n- Recommendations for improvement\n\n---\n\n## Reference Documentation\n\n### Root Cause Analysis Methodologies\n\n`references\u002Frca-methodologies.md` contains:\n\n- Method selection decision tree\n- 5 Why analysis template and example\n- Fishbone diagram categories and template\n- Fault Tree Analysis for safety-critical issues\n- Human Factors Analysis for people-related causes\n- FMEA for proactive risk assessment\n- Hybrid approach guidance\n\n### Effectiveness Verification Guide\n\n`references\u002Feffectiveness-verification-guide.md` contains:\n\n- Verification planning requirements\n- Verification method selection\n- Effectiveness criteria definition (SMART)\n- Closure requirements by severity\n- Ineffective CAPA process\n- Documentation templates\n\n---\n\n## Tools\n\n### CAPA Tracker\n\n```bash\n# Generate CAPA status report\npython scripts\u002Fcapa_tracker.py --capas capas.json\n\n# Interactive mode for manual entry\npython scripts\u002Fcapa_tracker.py --interactive\n\n# JSON output for integration\npython scripts\u002Fcapa_tracker.py --capas capas.json --output json\n\n# Generate sample data file\npython scripts\u002Fcapa_tracker.py --sample > sample_capas.json\n```\n\nCalculates and reports:\n- Summary metrics (open, closed, overdue, cycle time, effectiveness)\n- Status distribution\n- Severity and source analysis\n- Aging report by time bucket\n- Overdue CAPA list\n- Actionable recommendations\n\n### Sample CAPA Input\n\n```json\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```\n\n---\n\n## Regulatory Requirements\n\n### ISO 13485:2016 Clause 8.5\n\n| Sub-clause | Requirement | Key Activities |\n|------------|-------------|----------------|\n| 8.5.2 Corrective Action | Eliminate cause of nonconformity | NC review, cause determination, action evaluation, implementation, effectiveness review |\n| 8.5.3 Preventive Action | Eliminate potential nonconformity | Trend analysis, cause determination, action evaluation, implementation, effectiveness review |\n\n### FDA 21 CFR 820.100\n\nRequired CAPA elements:\n- Procedures for implementing corrective and preventive action\n- Analyzing quality data sources (complaints, NCs, audits, service records)\n- Investigating cause of nonconformities\n- Identifying actions needed to correct and prevent recurrence\n- Verifying actions are effective and do not adversely affect device\n- Submitting relevant information for management review\n\n### Common FDA 483 Observations\n\n| Observation | Root Cause Pattern |\n|-------------|-------------------|\n| CAPA not initiated for recurring issue | Trend analysis not performed |\n| Root cause analysis superficial | Inadequate investigation training |\n| Effectiveness not verified | No verification procedure |\n| Actions do not address root cause | Symptom treatment vs. cause elimination |\n","","imported","https:\u002F\u002Fgithub.com\u002Falirezarezvani\u002Fclaude-skills","user_system_seed","SkillOPIC",true,248,2094,"2026-05-16 14:05:57",{"id":8,"name":21,"slug":22,"icon":23,"description":24,"sort":25,"createdAt":26},"其他","other","mdi-page-next-outline","其他类型Skill",5,"2026-05-16 12:53:40",{"id":7,"name":28,"slug":29,"icon":30,"description":31,"moduleId":8,"sort":32,"skillCount":33,"createdAt":26},"职场发展","career","mdi-briefcase-outline","面试准备、简历优化、职业规划",4,575,[35],{"id":36,"skillId":4,"version":37,"fileName":38,"fileSize":39,"filePath":40,"fileHash":41,"manifest":42,"createdAt":19},"61d39e1f-bb4f-46d2-8565-34c84a5cbfdf","1.0.0","capa-officer.zip",26731,"uploads\u002Fskills\u002F5c50f1a7-5a19-4b6e-94a8-a48b5c511fd9\u002Fcapa-officer.zip","0e076798a6b433a07f8ec200174f5b9e15eb22419dab7d4d293805abba5ce9ec","[{\"path\":\"SKILL.md\",\"isDirectory\":false,\"size\":14850},{\"path\":\"references\u002Feffectiveness-verification-guide.md\",\"isDirectory\":false,\"size\":13611},{\"path\":\"references\u002Frca-methodologies.md\",\"isDirectory\":false,\"size\":15808},{\"path\":\"scripts\u002Fcapa_tracker.py\",\"isDirectory\":false,\"size\":20986},{\"path\":\"scripts\u002Froot_cause_analyzer.py\",\"isDirectory\":false,\"size\":17812}]",{"code":44,"message":45,"data":46},200,"success",{"items":47,"stats":48,"page":51},[],{"averageRating":49,"totalRatings":49,"ratingCounts":50},0,[49,49,49,49,49],{"limit":52,"offset":49,"hasMore":53,"nextOffset":52,"ratedOnly":16},15,false]