[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"skill-165dbfd0-f295-427a-baad-428106b056d6":3,"$fnwxTvI1VqYNy6UlzljmATPaSTtN8e3jkYj5dXpIjRmE":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},"165dbfd0-f295-427a-baad-428106b056d6","fda-qsr-audit-prep","\u002Ffda-qsr-audit-prep \u003C范围> — FDA 21 CFR 820（QSR \u002F QMSR）审计6问强制式询问。2026年2月后与ISO 13485实质性协调。用于年度内部QSR审计前、FDA检查准备前或483表回复前。","cat_coding_review","mod_coding","alirezarezvani,coding","---\nname: \"fda-qsr-audit-prep\"\ndescription: \"\u002Fcs:fda-qsr-audit-prep \u003Cscope> — FDA 21 CFR 820 (QSR \u002F QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.\"\n---\n\n# \u002Fcs:fda-qsr-audit-prep — FDA QSR Forcing Questions\n\n**Command:** `\u002Fcs:fda-qsr-audit-prep \u003Cscope>`\n\nThe FDA QSR auditor pressure-tests any US medical-device QSR work. Six questions before any internal audit, FDA inspection, Form 483 response, or recall decision.\n\n## When to Run\n\n- Before annual internal QSR audit\n- Before pre-FDA-inspection readiness review (any device commercially distributed in US)\n- After receiving Form 483 observations\n- After Warning Letter receipt\n- After MDR-reportable event\n- Before recall decision (voluntary vs FDA-initiated)\n- Before submitting 510(k) \u002F PMA (where QSR posture affects approval timeline)\n\n## The Six QSR Questions\n\n### 1. Show me the complaint files from the last quarter — and the corresponding MDR reports.\n**21 CFR 820.198 + 21 CFR 803 — most-cited FDA inspection area.**\n- Complaint log complete: who \u002F what \u002F when \u002F device \u002F batch\n- Investigation closure within reasonable timeline\n- MDR-reporting decision tree applied: death OR serious injury OR malfunction-that-could-cause = MDR\n- 30-day timeline for most MDR reports; 5 days for certain serious events\n- Complaint trending input to management review\n\n### 2. When was process validation (IQ\u002FOQ\u002FPQ) last revalidated per 21 CFR 820.75?\n**Cross-walks ISO 13485 Clause 7.5.6 (substantially harmonized post-Feb 2026).**\n- Initial validation at process introduction\n- Revalidation triggers: process \u002F equipment \u002F material change OR periodic schedule\n- Statistical techniques per 21 CFR 820.250 where applicable\n- Cross-check with cs-cqm-iso13485 for ISO 13485 alignment\n\n### 3. Show me the DHRs for products commercially distributed in last 2 years.\n**21 CFR 820.180 — 2-year retention from commercial distribution; check sampling for completeness.**\n- Device History Record (DHR) for each unit\u002Flot\u002Fbatch\n- Must include: dates of manufacture, quantity manufactured, quantity released, acceptance records, primary identification label, device identification, control number\n- Sample stratified by product class\n- Verify DHR closeness to DHF (design history file)\n\n### 4. Show me CAPAs from the last 6 months with effectiveness verification.\n**21 CFR 820.100 = ISO 13485 8.5.2 substantially harmonized.**\n- Root cause analysis depth (5 Why minimum)\n- Effectiveness verification = measurable evidence, not \"we updated the procedure\"\n- Containment \u002F correction \u002F corrective action distinction documented\n- Closure approval by appropriate authority\n- Aging CAPAs > 90 days flagged\n\n### 5. Show me labeling (21 CFR 801) review for the most recent product launch.\n**FDA-specific overlay not in ISO 13485.**\n- Labeling per 21 CFR 801 requirements\n- For specific device types: also 21 CFR 800 series sectoral overlays\n- UDI (Unique Device Identification) per 21 CFR 830\n- Promotional materials reviewed for accuracy + non-misleading\n\n### 6. If a Form 483 was issued in the last 3 years, show me the closure status.\n**Form 483 = FDA observation; not equivalent to ISO nonconformity.**\n- Response within 15 working days\n- Each observation has documented corrective + preventive action with timeline\n- Effectiveness verification evidence\n- For Warning Letters: separate response track + potentially FDA meeting\n\n## Workflow\n\n```bash\n# 1. QSR compliance posture\npython ..\u002F..\u002Fra-qm-team\u002Fskills\u002Ffda-consultant-specialist\u002Fscripts\u002Fqsr_compliance_checker.py compliance_state.json\n\n# 2. FDA submission tracking (510(k) \u002F PMA \u002F IDE)\npython ..\u002F..\u002Fra-qm-team\u002Fskills\u002Ffda-consultant-specialist\u002Fscripts\u002Ffda_submission_tracker.py submissions.json\n\n# 3. HIPAA overlap (if connected device handles PHI)\npython ..\u002F..\u002Fra-qm-team\u002Fskills\u002Ffda-consultant-specialist\u002Fscripts\u002Fhipaa_risk_assessment.py phi_inventory.json\n\n# 4. Mock FDA inspection\npython ..\u002F..\u002Fskills\u002Fcompliance-os\u002Fscripts\u002Faudit_simulator.py fda_qsr_scope.json\n```\n\n## Output Format\n\n```markdown\n# FDA QSR Audit Prep: \u003Cscope>\n**Date:** YYYY-MM-DD\n\n## The Decision Being Made\n[programme-plan | inspection-readiness | 483-response | MDR-decision | recall]\n\n## Complaint + MDR Posture\n- Complaints last quarter: N\n- MDR-reportable events: M\n- MDR reports filed within timeline: % (target 100%)\n- Complaint trending review at management level: yes\u002Fno\n\n## Process Validation Status (21 CFR 820.75)\n- Validations on schedule: %\n- Stale validations: \u003Clist>\n- Statistical techniques applied: yes\u002Fno per process\n\n## DHR Completeness (21 CFR 820.180)\n- DHRs sampled: N\n- Completeness rate: %\n- 2-year retention compliant: yes\u002Fno\n- Stratified by product class: yes\u002Fno\n\n## CAPA Health (21 CFR 820.100)\n- CAPAs sampled: N\n- Root cause analysis depth: adequate\u002Finadequate\n- Effectiveness verification: complete\u002Fincomplete\n- Aging CAPAs > 90 days: N\n\n## Labeling (21 CFR 801)\n- Recent products reviewed: \u003Clist>\n- Labeling accurate + non-misleading: yes\u002Fno\n- UDI compliance per 21 CFR 830: yes\u002Fno\n\n## Form 483 \u002F Warning Letter History\n- Form 483s last 3 years: N (each: closed\u002Fin-progress)\n- Warning Letters last 5 years: N (each: closed\u002Fin-progress)\n- Pattern across observations: \u003Cthematic>\n\n## ISO 13485 Cross-Walk (post-Feb 2026 harmonization)\n- ISO 13485 audit findings: \u003Clink to cs-cqm-iso13485 output>\n- FDA-specific overlays remaining: labeling + complaint handling + MDR reporting + recall procedures\n- Cross-framework reuse: % of evidence shared\n\n## Verdict\n🟢 INSPECTION-READY | 🟡 GAPS-IDENTIFIED | 🔴 NOT-READY\n\n## Top 3 Actions\n[3 concrete next steps with owner + FDA-cited timeline (15 days \u002F 30 days \u002F etc.)]\n\n## Outside Counsel Required\n[For Warning Letter response, recall decisions, or 510(k) \u002F PMA strategy disputes]\n```\n\n## Routing\n\n- `\u002Fcs:compliance-readiness` — for multi-framework view\n- `\u002Fcs:iso13485-audit-prep` — for ISO 13485 cross-walk pair (substantially harmonized)\n- `\u002Fcs:gdpr-audit-prep` — if connected device handles personal data\n- `\u002Fcs:gc-review` — for Warning Letter response coordination\n\n## Related\n\n- Agent: [`cs-fda-qsr-auditor`](..\u002F..\u002Fagents\u002Fcs-fda-qsr-auditor.md)\n- Skill: [`fda-consultant-specialist`](..\u002F..\u002F..\u002Fra-qm-team\u002Fskills\u002Ffda-consultant-specialist\u002FSKILL.md)\n- Adjacent: `..\u002Fiso13485-audit-prep\u002F`, `..\u002Fcompliance-readiness\u002F`\n\n---\n\n**Version:** 1.0.0\n","","imported","https:\u002F\u002Fgithub.com\u002Falirezarezvani\u002Fclaude-skills","user_system_seed","SkillOPIC",true,197,1397,"2026-05-16 13:52:42",{"id":8,"name":21,"slug":22,"icon":23,"description":24,"sort":25,"createdAt":26},"编程开发","coding","mdi-code-braces","代码生成、调试、审查，提升开发效率",2,"2026-05-16 12:53:40",{"id":7,"name":28,"slug":29,"icon":30,"description":31,"moduleId":8,"sort":32,"skillCount":33,"createdAt":26},"代码审查","review","mdi-magnify-scan","代码质量分析、安全审查",4,145,[35],{"id":36,"skillId":4,"version":37,"fileName":38,"fileSize":39,"filePath":40,"fileHash":41,"manifest":42,"createdAt":19},"35b99e3b-1ad1-4272-8d56-57633ff38ce5","1.0.0","fda-qsr-audit-prep.zip",2835,"uploads\u002Fskills\u002F165dbfd0-f295-427a-baad-428106b056d6\u002Ffda-qsr-audit-prep.zip","3170d42b3f6d3d7d21d02d077a9107062b5e9ba8db41438bb3081d88eb534e7b","[{\"path\":\"SKILL.md\",\"isDirectory\":false,\"size\":6437}]",{"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]