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    "sections": [
      {
        "title": "QMS Audit Expert",
        "body": "ISO 13485 internal audit methodology for medical device quality management systems."
      },
      {
        "title": "Table of Contents",
        "body": "Audit Planning Workflow\nAudit Execution\nNonconformity Management\nExternal Audit Preparation\nReference Documentation\nTools"
      },
      {
        "title": "Audit Planning Workflow",
        "body": "Plan risk-based internal audit program:\n\nList all QMS processes requiring audit\nAssign risk level to each process (High/Medium/Low)\nReview previous audit findings and trends\nDetermine audit frequency by risk level\nAssign qualified auditors (verify independence)\nCreate annual audit schedule\nCommunicate schedule to process owners\nValidation: All ISO 13485 clauses covered within cycle"
      },
      {
        "title": "Risk-Based Audit Frequency",
        "body": "Risk LevelFrequencyCriteriaHighQuarterlyDesign control, CAPA, production validationMediumSemi-annualPurchasing, training, document controlLowAnnualInfrastructure, management review (if stable)"
      },
      {
        "title": "Audit Scope by Clause",
        "body": "ClauseProcessFocus Areas4.2Document ControlDocument approval, distribution, obsolete control5.6Management ReviewInputs complete, decisions documented, actions tracked6.2TrainingCompetency defined, records complete, effectiveness verified7.3Design ControlInputs, reviews, V&V, transfer, changes7.4PurchasingSupplier evaluation, incoming inspection7.5ProductionWork instructions, process validation, DHR7.6CalibrationEquipment list, calibration status, out-of-tolerance8.2.2Internal AuditSchedule compliance, auditor independence8.3NC ProductIdentification, segregation, disposition8.5CAPARoot cause, implementation, effectiveness"
      },
      {
        "title": "Auditor Independence",
        "body": "Verify auditor independence before assignment:\n\nAuditor not responsible for area being audited\n No direct reporting relationship to auditee\n Not involved in recent activities under audit\n Documented qualification for audit scope"
      },
      {
        "title": "Audit Execution",
        "body": "Conduct systematic internal audit:\n\nPrepare audit plan (scope, criteria, schedule)\nReview relevant documentation before audit\nConduct opening meeting with auditee\nCollect evidence (records, interviews, observation)\nClassify findings (Major/Minor/Observation)\nConduct closing meeting with preliminary findings\nPrepare audit report within 5 business days\nValidation: All scope items covered, findings supported by evidence"
      },
      {
        "title": "Evidence Collection",
        "body": "MethodUse ForDocumentationDocument reviewProcedures, recordsDocument number, version, dateInterviewProcess understandingInterviewee name, role, summaryObservationActual practiceWhat, where, when observedRecord traceProcess flowRecord IDs, dates, linkage"
      },
      {
        "title": "Audit Questions by Clause",
        "body": "Document Control (4.2):\n\nShow me the document master list\nHow do you control obsolete documents?\nShow me evidence of document change approval\n\nDesign Control (7.3):\n\nShow me the Design History File for [product]\nWho participates in design reviews?\nShow me design input to output traceability\n\nCAPA (8.5):\n\nShow me the CAPA log with open items\nHow do you determine root cause?\nShow me effectiveness verification records\n\nSee references/iso13485-audit-guide.md for complete question sets."
      },
      {
        "title": "Finding Documentation",
        "body": "Document each finding with:\n\nRequirement: [Specific ISO 13485 clause or procedure]\nEvidence: [What was observed, reviewed, or heard]\nGap: [How evidence fails to meet requirement]\n\nExample:\n\nRequirement: ISO 13485:2016 Clause 7.6 requires calibration\nat specified intervals.\n\nEvidence: Calibration records for pH meter (EQ-042) show\nlast calibration 2024-01-15. Calibration interval is\n12 months. Today is 2025-03-20.\n\nGap: Equipment is 2 months overdue for calibration,\nrepresenting a gap in calibration program execution."
      },
      {
        "title": "Nonconformity Management",
        "body": "Classify and manage audit findings:\n\nEvaluate finding against classification criteria\nAssign severity (Major/Minor/Observation)\nDocument finding with objective evidence\nCommunicate to process owner\nInitiate CAPA for Major/Minor findings\nTrack to closure\nVerify effectiveness at follow-up\nValidation: Finding closed only after effective CAPA"
      },
      {
        "title": "Classification Criteria",
        "body": "CategoryDefinitionCAPA RequiredTimelineMajorSystematic failure or absence of elementYes30 daysMinorIsolated lapse or partial implementationRecommended60 daysObservationImprovement opportunityOptionalAs appropriate"
      },
      {
        "title": "Classification Decision",
        "body": "Is required element absent or failed?\n├── Yes → Systematic (multiple instances)? → MAJOR\n│   └── No → Could affect product safety? → MAJOR\n│       └── No → MINOR\n└── No → Deviation from procedure?\n    ├── Yes → Recurring? → MAJOR\n    │   └── No → MINOR\n    └── No → Improvement opportunity? → OBSERVATION"
      },
      {
        "title": "CAPA Integration",
        "body": "Finding SeverityCAPA DepthVerificationMajorFull root cause analysis (5-Why, Fishbone)Next audit or within 6 monthsMinorImmediate cause identificationNext scheduled auditObservationNot requiredNoted at next audit\n\nSee references/nonconformity-classification.md for detailed guidance."
      },
      {
        "title": "External Audit Preparation",
        "body": "Prepare for certification body or regulatory audit:\n\nComplete all scheduled internal audits\nVerify all findings closed with effective CAPA\nReview documentation for currency and accuracy\nConduct management review with audit as input\nPrepare facility and personnel\nConduct mock audit (full scope)\nBrief personnel on audit protocol\nValidation: Mock audit findings addressed before external audit"
      },
      {
        "title": "Pre-Audit Readiness Checklist",
        "body": "Documentation:\n\nQuality Manual current\n Procedures reflect actual practice\n Records complete and retrievable\n Previous audit findings closed\n\nPersonnel:\n\nKey personnel available during audit\n Subject matter experts identified\n Personnel briefed on audit protocol\n Escorts assigned\n\nFacility:\n\nWork areas organized\n Documents at point of use current\n Equipment calibration status visible\n Nonconforming product segregated"
      },
      {
        "title": "Mock Audit Protocol",
        "body": "Use external auditor or qualified internal auditor\nCover full scope of upcoming external audit\nSimulate actual audit conditions (timing, formality)\nDocument findings as for real audit\nAddress all Major and Minor findings before external audit\nBrief management on readiness status"
      },
      {
        "title": "ISO 13485 Audit Guide",
        "body": "references/iso13485-audit-guide.md contains:\n\nClause-by-clause audit methodology\nSample audit questions for each clause\nEvidence collection requirements\nCommon nonconformities by clause\nFinding severity classification"
      },
      {
        "title": "Nonconformity Classification",
        "body": "references/nonconformity-classification.md contains:\n\nSeverity classification criteria and decision tree\nImpact vs. occurrence matrix\nCAPA integration requirements\nFinding documentation templates\nClosure requirements by severity"
      },
      {
        "title": "Audit Schedule Optimizer",
        "body": "# Generate optimized audit schedule\npython scripts/audit_schedule_optimizer.py --processes processes.json\n\n# Interactive mode\npython scripts/audit_schedule_optimizer.py --interactive\n\n# JSON output for integration\npython scripts/audit_schedule_optimizer.py --processes processes.json --output json\n\nGenerates risk-based audit schedule considering:\n\nProcess risk level\nPrevious findings\nDays since last audit\nCriticality scores\n\nOutput includes:\n\nPrioritized audit schedule\nQuarterly distribution\nOverdue audit alerts\nResource recommendations"
      },
      {
        "title": "Sample Process Input",
        "body": "{\n  \"processes\": [\n    {\n      \"name\": \"Design Control\",\n      \"iso_clause\": \"7.3\",\n      \"risk_level\": \"HIGH\",\n      \"last_audit_date\": \"2024-06-15\",\n      \"previous_findings\": 2\n    },\n    {\n      \"name\": \"Document Control\",\n      \"iso_clause\": \"4.2\",\n      \"risk_level\": \"MEDIUM\",\n      \"last_audit_date\": \"2024-09-01\",\n      \"previous_findings\": 0\n    }\n  ]\n}"
      },
      {
        "title": "Audit Program Metrics",
        "body": "Track audit program effectiveness:\n\nMetricTargetMeasurementSchedule compliance>90%Audits completed on timeFinding closure rate>95%Findings closed by due dateRepeat findings<10%Same finding in consecutive auditsCAPA effectiveness>90%Verified effective at follow-upAuditor utilization4 days/monthAudit days per qualified auditor"
      }
    ],
    "body": "QMS Audit Expert\n\nISO 13485 internal audit methodology for medical device quality management systems.\n\nTable of Contents\nAudit Planning Workflow\nAudit Execution\nNonconformity Management\nExternal Audit Preparation\nReference Documentation\nTools\nAudit Planning Workflow\n\nPlan risk-based internal audit program:\n\nList all QMS processes requiring audit\nAssign risk level to each process (High/Medium/Low)\nReview previous audit findings and trends\nDetermine audit frequency by risk level\nAssign qualified auditors (verify independence)\nCreate annual audit schedule\nCommunicate schedule to process owners\nValidation: All ISO 13485 clauses covered within cycle\nRisk-Based Audit Frequency\nRisk Level\tFrequency\tCriteria\nHigh\tQuarterly\tDesign control, CAPA, production validation\nMedium\tSemi-annual\tPurchasing, training, document control\nLow\tAnnual\tInfrastructure, management review (if stable)\nAudit Scope by Clause\nClause\tProcess\tFocus Areas\n4.2\tDocument Control\tDocument approval, distribution, obsolete control\n5.6\tManagement Review\tInputs complete, decisions documented, actions tracked\n6.2\tTraining\tCompetency defined, records complete, effectiveness verified\n7.3\tDesign Control\tInputs, reviews, V&V, transfer, changes\n7.4\tPurchasing\tSupplier evaluation, incoming inspection\n7.5\tProduction\tWork instructions, process validation, DHR\n7.6\tCalibration\tEquipment list, calibration status, out-of-tolerance\n8.2.2\tInternal Audit\tSchedule compliance, auditor independence\n8.3\tNC Product\tIdentification, segregation, disposition\n8.5\tCAPA\tRoot cause, implementation, effectiveness\nAuditor Independence\n\nVerify auditor independence before assignment:\n\n Auditor not responsible for area being audited\n No direct reporting relationship to auditee\n Not involved in recent activities under audit\n Documented qualification for audit scope\nAudit Execution\n\nConduct systematic internal audit:\n\nPrepare audit plan (scope, criteria, schedule)\nReview relevant documentation before audit\nConduct opening meeting with auditee\nCollect evidence (records, interviews, observation)\nClassify findings (Major/Minor/Observation)\nConduct closing meeting with preliminary findings\nPrepare audit report within 5 business days\nValidation: All scope items covered, findings supported by evidence\nEvidence Collection\nMethod\tUse For\tDocumentation\nDocument review\tProcedures, records\tDocument number, version, date\nInterview\tProcess understanding\tInterviewee name, role, summary\nObservation\tActual practice\tWhat, where, when observed\nRecord trace\tProcess flow\tRecord IDs, dates, linkage\nAudit Questions by Clause\n\nDocument Control (4.2):\n\nShow me the document master list\nHow do you control obsolete documents?\nShow me evidence of document change approval\n\nDesign Control (7.3):\n\nShow me the Design History File for [product]\nWho participates in design reviews?\nShow me design input to output traceability\n\nCAPA (8.5):\n\nShow me the CAPA log with open items\nHow do you determine root cause?\nShow me effectiveness verification records\n\nSee references/iso13485-audit-guide.md for complete question sets.\n\nFinding Documentation\n\nDocument each finding with:\n\nRequirement: [Specific ISO 13485 clause or procedure]\nEvidence: [What was observed, reviewed, or heard]\nGap: [How evidence fails to meet requirement]\n\n\nExample:\n\nRequirement: ISO 13485:2016 Clause 7.6 requires calibration\nat specified intervals.\n\nEvidence: Calibration records for pH meter (EQ-042) show\nlast calibration 2024-01-15. Calibration interval is\n12 months. Today is 2025-03-20.\n\nGap: Equipment is 2 months overdue for calibration,\nrepresenting a gap in calibration program execution.\n\nNonconformity Management\n\nClassify and manage audit findings:\n\nEvaluate finding against classification criteria\nAssign severity (Major/Minor/Observation)\nDocument finding with objective evidence\nCommunicate to process owner\nInitiate CAPA for Major/Minor findings\nTrack to closure\nVerify effectiveness at follow-up\nValidation: Finding closed only after effective CAPA\nClassification Criteria\nCategory\tDefinition\tCAPA Required\tTimeline\nMajor\tSystematic failure or absence of element\tYes\t30 days\nMinor\tIsolated lapse or partial implementation\tRecommended\t60 days\nObservation\tImprovement opportunity\tOptional\tAs appropriate\nClassification Decision\nIs required element absent or failed?\n├── Yes → Systematic (multiple instances)? → MAJOR\n│   └── No → Could affect product safety? → MAJOR\n│       └── No → MINOR\n└── No → Deviation from procedure?\n    ├── Yes → Recurring? → MAJOR\n    │   └── No → MINOR\n    └── No → Improvement opportunity? → OBSERVATION\n\nCAPA Integration\nFinding Severity\tCAPA Depth\tVerification\nMajor\tFull root cause analysis (5-Why, Fishbone)\tNext audit or within 6 months\nMinor\tImmediate cause identification\tNext scheduled audit\nObservation\tNot required\tNoted at next audit\n\nSee references/nonconformity-classification.md for detailed guidance.\n\nExternal Audit Preparation\n\nPrepare for certification body or regulatory audit:\n\nComplete all scheduled internal audits\nVerify all findings closed with effective CAPA\nReview documentation for currency and accuracy\nConduct management review with audit as input\nPrepare facility and personnel\nConduct mock audit (full scope)\nBrief personnel on audit protocol\nValidation: Mock audit findings addressed before external audit\nPre-Audit Readiness Checklist\n\nDocumentation:\n\n Quality Manual current\n Procedures reflect actual practice\n Records complete and retrievable\n Previous audit findings closed\n\nPersonnel:\n\n Key personnel available during audit\n Subject matter experts identified\n Personnel briefed on audit protocol\n Escorts assigned\n\nFacility:\n\n Work areas organized\n Documents at point of use current\n Equipment calibration status visible\n Nonconforming product segregated\nMock Audit Protocol\nUse external auditor or qualified internal auditor\nCover full scope of upcoming external audit\nSimulate actual audit conditions (timing, formality)\nDocument findings as for real audit\nAddress all Major and Minor findings before external audit\nBrief management on readiness status\nReference Documentation\nISO 13485 Audit Guide\n\nreferences/iso13485-audit-guide.md contains:\n\nClause-by-clause audit methodology\nSample audit questions for each clause\nEvidence collection requirements\nCommon nonconformities by clause\nFinding severity classification\nNonconformity Classification\n\nreferences/nonconformity-classification.md contains:\n\nSeverity classification criteria and decision tree\nImpact vs. occurrence matrix\nCAPA integration requirements\nFinding documentation templates\nClosure requirements by severity\nTools\nAudit Schedule Optimizer\n# Generate optimized audit schedule\npython scripts/audit_schedule_optimizer.py --processes processes.json\n\n# Interactive mode\npython scripts/audit_schedule_optimizer.py --interactive\n\n# JSON output for integration\npython scripts/audit_schedule_optimizer.py --processes processes.json --output json\n\n\nGenerates risk-based audit schedule considering:\n\nProcess risk level\nPrevious findings\nDays since last audit\nCriticality scores\n\nOutput includes:\n\nPrioritized audit schedule\nQuarterly distribution\nOverdue audit alerts\nResource recommendations\nSample Process Input\n{\n  \"processes\": [\n    {\n      \"name\": \"Design Control\",\n      \"iso_clause\": \"7.3\",\n      \"risk_level\": \"HIGH\",\n      \"last_audit_date\": \"2024-06-15\",\n      \"previous_findings\": 2\n    },\n    {\n      \"name\": \"Document Control\",\n      \"iso_clause\": \"4.2\",\n      \"risk_level\": \"MEDIUM\",\n      \"last_audit_date\": \"2024-09-01\",\n      \"previous_findings\": 0\n    }\n  ]\n}\n\nAudit Program Metrics\n\nTrack audit program effectiveness:\n\nMetric\tTarget\tMeasurement\nSchedule compliance\t>90%\tAudits completed on time\nFinding closure rate\t>95%\tFindings closed by due date\nRepeat findings\t<10%\tSame finding in consecutive audits\nCAPA effectiveness\t>90%\tVerified effective at follow-up\nAuditor utilization\t4 days/month\tAudit days per qualified auditor"
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