[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill:01M6AF17482HK6AB9GX2DFYZWX":3,"skill-same:01M6AF17482HK6AB9GX2DFYZWX":111},{"skillNo":4,"name":5,"nameZh":6,"description":7,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":16,"categories":17,"keywords":18,"publishedAt":40,"linkOnly":41,"markdownContent":42,"markdownBody":43,"frontMatter":44,"refName":45,"commitSha":46,"skillDirectory":47,"forksCount":48,"repositoryHtmlUrl":49,"repositoryHomepageUrl":50,"ownerHtmlUrl":51,"ownerBlogUrl":52,"ownerDescription":53,"updatedAt":54,"install":55,"resources":68},"01M6AF17482HK6AB9GX2DFYZWX","capa-officer",null,"Senior CAPA Officer specialist for managing Corrective and Preventive Actions within Quality Management Systems. Provides CAPA process management, root cause analysis, effectiveness verification, and continuous improvement coordination. Use for CAPA investigations, corrective action planning, preventive action implementation, and CAPA system optimization.","davila7\u002Fclaude-code-templates","davila7","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F6216945?v=4","01M6ADEWWFPS191NFM0Y1EX1JH","Daniel Avila","01M6ADJHGM78PHQRD3XZTFDVKK",33481,"MIT","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fenterprise-communication\u002Fcapa-officer\u002FSKILL.md",[],[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"capa officer","process","senior","investigations","root cause","process management","improvement","for","action","preventive action","corrective action","use","root cause analysis","coordination","system","continuous improvement","analysis","Optimization","actions","verification","planning","2026-11-10 10:12:30",false,"---\nname: capa-officer\ndescription: Senior CAPA Officer specialist for managing Corrective and Preventive Actions within Quality Management Systems. Provides CAPA process management, root cause analysis, effectiveness verification, and continuous improvement coordination. Use for CAPA investigations, corrective action planning, preventive action implementation, and CAPA system optimization.\n---\n\n# Senior CAPA Officer\n\nExpert-level Corrective and Preventive Action (CAPA) management within Quality Management Systems, specializing in systematic problem-solving, root cause analysis, and sustainable corrective action implementation.\n\n## Core CAPA Competencies\n\n### 1. CAPA Process Management\nLead comprehensive CAPA processes from initiation through effectiveness verification ensuring sustainable problem resolution.\n\n**CAPA Lifecycle Management:**\n```\nCAPA PROCESS WORKFLOW\n├── CAPA Initiation and Evaluation\n│   ├── Trigger event documentation\n│   ├── Preliminary investigation\n│   ├── Significance assessment\n│   └── CAPA necessity determination\n├── Investigation and Root Cause Analysis\n│   ├── Investigation team formation\n│   ├── Data collection and analysis\n│   ├── Root cause identification\n│   └── Risk assessment integration\n├── Corrective and Preventive Action Planning\n│   ├── Action plan development\n│   ├── Resource allocation\n│   ├── Timeline establishment\n│   └── Responsibility assignment\n├── Implementation and Monitoring\n│   ├── Action execution oversight\n│   ├── Progress monitoring\n│   ├── Milestone verification\n│   └── Documentation maintenance\n└── Effectiveness Verification\n    ├── Verification planning\n    ├── Data collection and analysis\n    ├── Effectiveness assessment\n    └── CAPA closure or escalation\n```\n\n### 2. Root Cause Analysis (RCA) Methodologies\nApply systematic root cause analysis techniques ensuring thorough problem investigation and sustainable solutions.\n\n**RCA Method Selection:**\n1. **5 Why Analysis** - For straightforward process issues\n2. **Fishbone Diagram** - For complex multi-factor problems\n3. **Fault Tree Analysis** - For safety-critical system failures\n4. **Human Factors Analysis** - For procedure or training-related issues\n5. **Failure Mode and Effects Analysis (FMEA)** - For systematic risk assessment\n\n**Investigation Protocol:**\n1. **Problem Definition and Scoping**\n   - Clear problem statement development\n   - Impact assessment and scope definition\n   - Investigation team establishment\n   - **Decision Point**: Select appropriate RCA methodology\n\n2. **Data Collection and Analysis**\n   - **For Quality Issues**: Follow references\u002Fquality-investigation-guide.md\n   - **For Safety Issues**: Follow references\u002Fsafety-investigation-guide.md\n   - **For Process Issues**: Follow references\u002Fprocess-investigation-guide.md\n   - Evidence gathering and documentation\n\n3. **Root Cause Identification**\n   - Multi-level cause analysis (immediate, contributing, root)\n   - Human factors and system factors evaluation\n   - Verification of root cause validity\n   - Risk assessment integration\n\n### 3. Corrective Action Planning and Implementation\nDevelop and oversee implementation of effective corrective actions addressing identified root causes.\n\n**Corrective Action Development:**\n- **Immediate Actions**: Contain the problem and prevent recurrence\n- **Corrective Actions**: Address root causes systematically\n- **Verification Actions**: Ensure effectiveness and sustainability\n- **Preventive Actions**: Prevent similar issues in other areas\n\n**Action Plan Components:**\n- Specific, measurable actions with clear deliverables\n- Responsible person assignment and accountability\n- Resource requirements and availability\n- Timeline with key milestones and dependencies\n- Success criteria and measurement methods\n\n### 4. Preventive Action Implementation\nProactively identify and address potential issues before they impact quality or patient safety.\n\n**Preventive Action Sources:**\n- Trend analysis of quality data\n- Risk assessment outcomes\n- Industry best practices and lessons learned\n- Regulatory guidance and warning letters\n- Internal audit findings and observations\n\n**Preventive Action Workflow:**\n1. **Potential Issue Identification**\n2. **Risk Assessment and Prioritization**\n3. **Preventive Action Planning**\n4. **Implementation and Monitoring**\n5. **Effectiveness Verification**\n\n## CAPA System Optimization\n\n### CAPA Performance Metrics\nMonitor key performance indicators ensuring CAPA system effectiveness and continuous improvement.\n\n**Key CAPA Metrics:**\n- **CAPA Cycle Time**: Average time from initiation to closure\n- **First-Time Effectiveness**: Percentage of CAPAs effective on first implementation\n- **Recurrence Rate**: Percentage of issues that recur after CAPA closure\n- **Overdue CAPA Rate**: Percentage of CAPAs exceeding planned timelines\n- **Investigation Quality**: Thoroughness and accuracy of root cause analysis\n\n### Trend Analysis and Reporting\nConduct systematic trend analysis identifying patterns and opportunities for systemic improvement.\n\n**Trend Analysis Framework:**\n1. **Data Aggregation and Categorization**\n   - CAPA source categorization (complaints, audits, nonconformances)\n   - Product line and process area analysis\n   - Time-based trending and seasonal patterns\n   - Severity and impact assessment\n\n2. **Pattern Identification**\n   - Statistical analysis and correlation identification\n   - Root cause pattern recognition\n   - System-level issue identification\n   - Preventive action opportunity assessment\n\n3. **Management Reporting**\n   - **Monthly CAPA Status Reports** for operational management\n   - **Quarterly Trend Analysis Reports** for senior leadership\n   - **Annual CAPA Effectiveness Reviews** for strategic planning\n   - Ad-hoc escalation reports for critical issues\n\n## Cross-functional Integration\n\n### Risk Management Integration\nEnsure seamless integration between CAPA processes and risk management activities.\n\n**CAPA-Risk Interface:**\n- Risk assessment updating based on CAPA findings\n- Risk control effectiveness verification through CAPA\n- Residual risk evaluation and acceptance\n- Risk management file maintenance and updates\n\n### Quality System Interface\nCoordinate CAPA activities with broader quality system processes ensuring systematic improvement.\n\n**Quality System Touchpoints:**\n- **Management Review**: CAPA effectiveness reporting and trends\n- **Internal Audit**: CAPA-generated audit findings and follow-up\n- **Document Control**: Procedure and work instruction updates\n- **Training**: Competency requirements and training effectiveness\n- **Supplier Quality**: Supplier CAPA coordination and monitoring\n\n### Regulatory Compliance\nEnsure CAPA processes meet regulatory requirements and inspection readiness.\n\n**Regulatory CAPA Requirements:**\n- **ISO 13485 Clause 8.5.2 & 8.5.3**: Corrective and preventive action requirements\n- **FDA 21 CFR 820.100**: QSR CAPA requirements\n- **EU MDR Article 10.9**: Post-market surveillance and CAPA integration\n- **Regulatory Inspection Readiness**: Documentation and process compliance\n\n## Resources\n\n### scripts\u002F\n- `capa-tracker.py`: Comprehensive CAPA management and tracking system\n- `rca-analysis-tool.py`: Root cause analysis methodology selection and documentation\n- `capa-metrics-dashboard.py`: CAPA performance monitoring and reporting\n- `trend-analysis-automation.py`: Automated trend identification and reporting\n\n### references\u002F\n- `quality-investigation-guide.md`: Systematic quality issue investigation procedures\n- `safety-investigation-guide.md`: Safety incident investigation methodologies\n- `process-investigation-guide.md`: Process deviation investigation frameworks\n- `rca-methodologies.md`: Comprehensive root cause analysis technique library\n- `effectiveness-verification-guide.md`: CAPA effectiveness assessment procedures\n\n### assets\u002F\n- `capa-templates\u002F`: CAPA form, investigation report, and action plan templates\n- `rca-tools\u002F`: Root cause analysis worksheets and decision trees\n- `investigation-checklists\u002F`: Investigation completeness and quality checklists\n- `training-materials\u002F`: CAPA process training and competency materials\n","# Senior CAPA Officer\n\nExpert-level Corrective and Preventive Action (CAPA) management within Quality Management Systems, specializing in systematic problem-solving, root cause analysis, and sustainable corrective action implementation.\n\n## Core CAPA Competencies\n\n### 1. CAPA Process Management\nLead comprehensive CAPA processes from initiation through effectiveness verification ensuring sustainable problem resolution.\n\n**CAPA Lifecycle Management:**\n```\nCAPA PROCESS WORKFLOW\n├── CAPA Initiation and Evaluation\n│   ├── Trigger event documentation\n│   ├── Preliminary investigation\n│   ├── Significance assessment\n│   └── CAPA necessity determination\n├── Investigation and Root Cause Analysis\n│   ├── Investigation team formation\n│   ├── Data collection and analysis\n│   ├── Root cause identification\n│   └── Risk assessment integration\n├── Corrective and Preventive Action Planning\n│   ├── Action plan development\n│   ├── Resource allocation\n│   ├── Timeline establishment\n│   └── Responsibility assignment\n├── Implementation and Monitoring\n│   ├── Action execution oversight\n│   ├── Progress monitoring\n│   ├── Milestone verification\n│   └── Documentation maintenance\n└── Effectiveness Verification\n    ├── Verification planning\n    ├── Data collection and analysis\n    ├── Effectiveness assessment\n    └── CAPA closure or escalation\n```\n\n### 2. Root Cause Analysis (RCA) Methodologies\nApply systematic root cause analysis techniques ensuring thorough problem investigation and sustainable solutions.\n\n**RCA Method Selection:**\n1. **5 Why Analysis** - For straightforward process issues\n2. **Fishbone Diagram** - For complex multi-factor problems\n3. **Fault Tree Analysis** - For safety-critical system failures\n4. **Human Factors Analysis** - For procedure or training-related issues\n5. **Failure Mode and Effects Analysis (FMEA)** - For systematic risk assessment\n\n**Investigation Protocol:**\n1. **Problem Definition and Scoping**\n   - Clear problem statement development\n   - Impact assessment and scope definition\n   - Investigation team establishment\n   - **Decision Point**: Select appropriate RCA methodology\n\n2. **Data Collection and Analysis**\n   - **For Quality Issues**: Follow references\u002Fquality-investigation-guide.md\n   - **For Safety Issues**: Follow references\u002Fsafety-investigation-guide.md\n   - **For Process Issues**: Follow references\u002Fprocess-investigation-guide.md\n   - Evidence gathering and documentation\n\n3. **Root Cause Identification**\n   - Multi-level cause analysis (immediate, contributing, root)\n   - Human factors and system factors evaluation\n   - Verification of root cause validity\n   - Risk assessment integration\n\n### 3. Corrective Action Planning and Implementation\nDevelop and oversee implementation of effective corrective actions addressing identified root causes.\n\n**Corrective Action Development:**\n- **Immediate Actions**: Contain the problem and prevent recurrence\n- **Corrective Actions**: Address root causes systematically\n- **Verification Actions**: Ensure effectiveness and sustainability\n- **Preventive Actions**: Prevent similar issues in other areas\n\n**Action Plan Components:**\n- Specific, measurable actions with clear deliverables\n- Responsible person assignment and accountability\n- Resource requirements and availability\n- Timeline with key milestones and dependencies\n- Success criteria and measurement methods\n\n### 4. Preventive Action Implementation\nProactively identify and address potential issues before they impact quality or patient safety.\n\n**Preventive Action Sources:**\n- Trend analysis of quality data\n- Risk assessment outcomes\n- Industry best practices and lessons learned\n- Regulatory guidance and warning letters\n- Internal audit findings and observations\n\n**Preventive Action Workflow:**\n1. **Potential Issue Identification**\n2. **Risk Assessment and Prioritization**\n3. **Preventive Action Planning**\n4. **Implementation and Monitoring**\n5. **Effectiveness Verification**\n\n## CAPA System Optimization\n\n### CAPA Performance Metrics\nMonitor key performance indicators ensuring CAPA system effectiveness and continuous improvement.\n\n**Key CAPA Metrics:**\n- **CAPA Cycle Time**: Average time from initiation to closure\n- **First-Time Effectiveness**: Percentage of CAPAs effective on first implementation\n- **Recurrence Rate**: Percentage of issues that recur after CAPA closure\n- **Overdue CAPA Rate**: Percentage of CAPAs exceeding planned timelines\n- **Investigation Quality**: Thoroughness and accuracy of root cause analysis\n\n### Trend Analysis and Reporting\nConduct systematic trend analysis identifying patterns and opportunities for systemic improvement.\n\n**Trend Analysis Framework:**\n1. **Data Aggregation and Categorization**\n   - CAPA source categorization (complaints, audits, nonconformances)\n   - Product line and process area analysis\n   - Time-based trending and seasonal patterns\n   - Severity and impact assessment\n\n2. **Pattern Identification**\n   - Statistical analysis and correlation identification\n   - Root cause pattern recognition\n   - System-level issue identification\n   - Preventive action opportunity assessment\n\n3. **Management Reporting**\n   - **Monthly CAPA Status Reports** for operational management\n   - **Quarterly Trend Analysis Reports** for senior leadership\n   - **Annual CAPA Effectiveness Reviews** for strategic planning\n   - Ad-hoc escalation reports for critical issues\n\n## Cross-functional Integration\n\n### Risk Management Integration\nEnsure seamless integration between CAPA processes and risk management activities.\n\n**CAPA-Risk Interface:**\n- Risk assessment updating based on CAPA findings\n- Risk control effectiveness verification through CAPA\n- Residual risk evaluation and acceptance\n- Risk management file maintenance and updates\n\n### Quality System Interface\nCoordinate CAPA activities with broader quality system processes ensuring systematic improvement.\n\n**Quality System Touchpoints:**\n- **Management Review**: CAPA effectiveness reporting and trends\n- **Internal Audit**: CAPA-generated audit findings and follow-up\n- **Document Control**: Procedure and work instruction updates\n- **Training**: Competency requirements and training effectiveness\n- **Supplier Quality**: Supplier CAPA coordination and monitoring\n\n### Regulatory Compliance\nEnsure CAPA processes meet regulatory requirements and inspection readiness.\n\n**Regulatory CAPA Requirements:**\n- **ISO 13485 Clause 8.5.2 & 8.5.3**: Corrective and preventive action requirements\n- **FDA 21 CFR 820.100**: QSR CAPA requirements\n- **EU MDR Article 10.9**: Post-market surveillance and CAPA integration\n- **Regulatory Inspection Readiness**: Documentation and process compliance\n\n## Resources\n\n### scripts\u002F\n- `capa-tracker.py`: Comprehensive CAPA management and tracking system\n- `rca-analysis-tool.py`: Root cause analysis methodology selection and documentation\n- `capa-metrics-dashboard.py`: CAPA performance monitoring and reporting\n- `trend-analysis-automation.py`: Automated trend identification and reporting\n\n### references\u002F\n- `quality-investigation-guide.md`: Systematic quality issue investigation procedures\n- `safety-investigation-guide.md`: Safety incident investigation methodologies\n- `process-investigation-guide.md`: Process deviation investigation frameworks\n- 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Use when an agent runs caller-supplied SQL against a production\u002FERP\u002Fanalytics database (a \"query\" MCP tool, text-to-SQL, an admin console), or when reviewing DB-access code for write\u002FDDL\u002Fside-effect\u002Ftransaction-escape risks. Checks what a statement CALLS, not just its shape.","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fdatabase\u002Freadonly-sql-guard\u002FSKILL.md",[175,178,179],{"categoryNo":176,"categoryName":177,"taxonomyType":121,"taxonomyTypeDesc":122},"01JBSEEDCAT000000000000010","后端与接口",{"categoryNo":119,"categoryName":120,"taxonomyType":121,"taxonomyTypeDesc":122},{"categoryNo":180,"categoryName":181,"taxonomyType":182,"taxonomyTypeDesc":183},"01JBSEEDCAT000000000000033","数据分析师","PROFESSION","适用职业",[185,186,187,188,189,190,191,26,192,193,194,195,196,197,198,30,199,200,131,201],"readonly","guard","sql guard","sql","readonly sql guard","erp","effect","read-only","db","just","tool","calls","only","MCP","access","database","query",{"skillNo":203,"name":204,"nameZh":6,"description":205,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":206,"licenseFileUrl":207,"sourceHtmlUrl":208,"categories":209,"keywords":213,"publishedAt":40},"01M6AFY6F7CC2BBZP1QD6VTNVC","web-artifacts-builder","Suite of tools for creating elaborate, multi-component claude.ai HTML artifacts using modern frontend web technologies (React, Tailwind CSS, shadcn\u002Fui). Use for complex artifacts requiring state management, routing, or shadcn\u002Fui components - not for simple single-file HTML\u002FJSX artifacts.","Apache-2.0","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Futilities\u002Fweb-artifacts-builder\u002FLICENSE.txt","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Futilities\u002Fweb-artifacts-builder\u002FSKILL.md",[210],{"categoryNo":211,"categoryName":212,"taxonomyType":121,"taxonomyTypeDesc":122},"01JBSEEDCAT000000000000009","前端开发",[214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,26,236],"artifacts builder","web","web artifacts builder","artifacts","builder","state","routing","state management","component","css","frontend","ui","Tools","file","components","shadcn","react","Tailwind","suite","jsx","html","single-file","ui components",{"skillNo":238,"name":239,"nameZh":6,"description":240,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":206,"licenseFileUrl":241,"sourceHtmlUrl":242,"categories":243,"keywords":248,"publishedAt":40},"01M6AFWF33SFV9Z3SF4PEEE4BF","webapp-testing","Toolkit for interacting with and testing local web applications using Playwright. Supports verifying frontend functionality, debugging UI behavior, capturing browser screenshots, and viewing browser logs.","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fsecurity\u002Fwebapp-testing\u002FLICENSE.txt","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fsecurity\u002Fwebapp-testing\u002FSKILL.md",[244,247],{"categoryNo":245,"categoryName":246,"taxonomyType":121,"taxonomyTypeDesc":122},"01JBSEEDCAT000000000000008","测试与质量",{"categoryNo":211,"categoryName":212,"taxonomyType":121,"taxonomyTypeDesc":122},[249,250,251,252,253,215,254,224,225,255,256,257,258,26,259,133,260],"webapp testing","testing","webapp","browser","playwright","applications","debugging","toolkit","logs","screenshots","local","behavior",{"skillNo":262,"name":263,"nameZh":6,"description":264,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":206,"licenseFileUrl":265,"sourceHtmlUrl":266,"categories":267,"keywords":275,"publishedAt":40},"01M6AF67Q67JJJ5V51JR2P52KA","discernment-nudge","After you give a substantive answer or draft that the user may act on — advice or recommendations, drafted artifacts such as goals, plans, pitches, proposals, or emails, estimates or projections, analysis or interpretation of data, factual claims they may rely on, or a multi-step argument — invoke this skill BEFORE finalizing your reply and then, if it applies, append 2-3 short follow-up questions, each tied to something specific in what you just produced, that help the user check key facts, probe the reasoning or assumptions, and notice missing context. Do this at most once per conversation. Skip it when the user asked a trivial how-to or simple lookup, wants a purely educational explanation, asked you only to format, convert, or assemble a file from content they provided, is writing code they will run, is doing creative writing or casual chat, or already asked you to double-check, cite, or review — the skill file explains these boundaries and the exact output format.","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fproductivity\u002Fdiscernment-nudge\u002FLICENSE.txt","https:\u002F\u002Fgithub.com\u002Fdavila7\u002Fclaude-code-templates\u002Fblob\u002Fmain\u002Fcli-tool\u002Fcomponents\u002Fskills\u002Fproductivity\u002Fdiscernment-nudge\u002FSKILL.md",[268,271,272],{"categoryNo":269,"categoryName":270,"taxonomyType":121,"taxonomyTypeDesc":122},"01JBSEEDCAT000000000000018","写作与文案",{"categoryNo":119,"categoryName":120,"taxonomyType":121,"taxonomyTypeDesc":122},{"categoryNo":273,"categoryName":274,"taxonomyType":182,"taxonomyTypeDesc":183},"01JBSEEDCAT000000000000036","内容创作者",[276,277,278,279,280,281,282,283,217,284,227,161,285,286,287,288,289,197,290,131,291,35,292,293,294,139,295],"discernment nudge","nudge","interpretation","help","run","reasoning","data","writing","lookup","content","review","conversation","short","up","invoke","you","claims","argument","assemble","recommendations"]