claude-code-arcane 1.0.0

package/skills/quality-manager-qmr/references/management-review-guide.md

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+# Management Review Guide
+
+ISO 13485 Clause 5.6 management review requirements, inputs, outputs, and action tracking.
+
+---
+
+## Table of Contents
+
+- [Review Requirements](#review-requirements)
+- [Required Inputs](#required-inputs)
+- [Review Agenda](#review-agenda)
+- [Required Outputs](#required-outputs)
+- [Action Tracking](#action-tracking)
+- [Documentation Templates](#documentation-templates)
+
+---
+
+## Review Requirements
+
+### ISO 13485:2016 Clause 5.6
+
+| Requirement | Specification |
+|-------------|---------------|
+| Frequency | Planned intervals (typically quarterly or semi-annually) |
+| Participants | Top management involvement required |
+| Documentation | Records must be maintained |
+| Inputs | All required inputs must be reviewed |
+| Outputs | Decisions and actions documented |
+
+### Review Schedule
+
+| Review Type | Frequency | Focus | Participants |
+|-------------|-----------|-------|--------------|
+| Full Management Review | Semi-annual or Annual | Complete QMS performance | CEO, QMR, all department heads |
+| Quarterly Quality Review | Quarterly | Key metrics and actions | QMR, Quality team, affected managers |
+| Monthly Quality Update | Monthly | Operational metrics | QMR, Quality team leads |
+
+### Planning Checklist
+
+- [ ] Review date scheduled and communicated
+- [ ] Previous review actions status updated
+- [ ] All input data collected and analyzed
+- [ ] Presentation/report prepared
+- [ ] Attendee availability confirmed
+- [ ] Meeting room and resources arranged
+- [ ] Agenda distributed 1 week in advance
+
+---
+
+## Required Inputs
+
+### ISO 13485 Required Input Topics
+
+| Input | Source | Data Period | Responsible |
+|-------|--------|-------------|-------------|
+| Audit results | Internal and external audits | Since last review | QA Manager |
+| Customer feedback | Complaints, surveys, returns | Since last review | Customer Quality |
+| Process performance | Process metrics, yields | Since last review | Process owners |
+| Product conformity | Inspection data, NCRs | Since last review | QC Manager |
+| CAPA status | Open/closed CAPAs | Current status | CAPA Officer |
+| Previous review actions | Action item tracker | Since last review | QMR |
+| Changes to QMS | Regulatory, standard changes | Since last review | RA Manager |
+| Recommendations | Improvement opportunities | Ongoing collection | All managers |
+
+### Input Data Collection Template
+
+```
+MANAGEMENT REVIEW INPUT SUMMARY
+
+Review Period: [Start Date] to [End Date]
+Prepared By: [Name]
+Date Prepared: [Date]
+
+1. AUDIT RESULTS
+Internal Audits Completed: [Number]
+External Audits Completed: [Number]
+Major Findings: [Number] | Minor Findings: [Number]
+Open Audit Actions: [Number]
+Summary: [Brief narrative]
+
+2. CUSTOMER FEEDBACK
+Total Complaints: [Number]
+Complaint Rate: [X per 1000 units]
+Customer Satisfaction Score: [Score]
+Top Complaint Categories:
+- [Category 1]: [Count]
+- [Category 2]: [Count]
+Trend: [Improving/Stable/Declining]
+
+3. PROCESS PERFORMANCE
+| Process | Target | Actual | Status |
+|---------|--------|--------|--------|
+| [Process 1] | [Target] | [Actual] | [Met/Not Met] |
+
+4. PRODUCT CONFORMITY
+First Pass Yield: [%]
+Nonconformance Rate: [%]
+Reject/Scrap Cost: [$]
+Top NC Categories:
+- [Category 1]: [Count]
+
+5. CAPA STATUS
+Open CAPAs: [Number]
+Overdue CAPAs: [Number]
+Effectiveness Rate: [%]
+Average Closure Time: [Days]
+
+6. PREVIOUS ACTIONS
+Total Actions from Last Review: [Number]
+Completed: [Number] | In Progress: [Number] | Overdue: [Number]
+
+7. QMS CHANGES
+Regulatory Changes: [List]
+Standard Updates: [List]
+Internal Changes: [List]
+
+8. RECOMMENDATIONS
+[List improvement opportunities collected]
+```
+
+### Data Analysis Guidelines
+
+| Input | Analysis Required | Red Flags |
+|-------|------------------|-----------|
+| Audit results | Trend by area, repeat findings | Major NC in same area twice |
+| Complaints | Pareto analysis, rate trending | Increasing rate, safety issues |
+| Process performance | Control charts, capability | Out of control, Cpk <1.33 |
+| Product conformity | Defect Pareto, yield trending | Declining yield, new defect types |
+| CAPA | Aging analysis, effectiveness | >10% overdue, <80% effective |
+
+---
+
+## Review Agenda
+
+### Standard Agenda Template
+
+```
+MANAGEMENT REVIEW AGENDA
+
+Date: [Date]
+Time: [Start] - [End]
+Location: [Room/Virtual Link]
+Chair: [QMR Name]
+
+1. OPENING (10 min)
+   - Call to order and attendance
+   - Approval of previous meeting minutes
+   - Review of previous action items
+
+2. QMS PERFORMANCE (30 min)
+   - Audit results summary
+   - Process performance metrics
+   - Product conformity data
+   - Customer feedback analysis
+
+3. COMPLIANCE STATUS (20 min)
+   - Regulatory compliance status
+   - Certification status
+   - Changes affecting QMS
+
+4. CAPA AND IMPROVEMENT (20 min)
+   - CAPA status and trends
+   - Improvement initiatives status
+   - Recommendations for improvement
+
+5. RESOURCE REVIEW (15 min)
+   - Resource adequacy assessment
+   - Training and competency status
+   - Infrastructure needs
+
+6. STRATEGIC ITEMS (15 min)
+   - Quality objectives progress
+   - Quality policy adequacy
+   - Strategic quality initiatives
+
+7. DECISIONS AND ACTIONS (15 min)
+   - Decisions required
+   - New action items
+   - Next review planning
+
+8. CLOSING (5 min)
+   - Summary of decisions
+   - Action item review
+   - Adjournment
+```
+
+### Time Allocation by Review Type
+
+| Review Type | Duration | Focus Areas |
+|-------------|----------|-------------|
+| Full Annual Review | 3-4 hours | All inputs, strategic planning |
+| Semi-annual Review | 2-3 hours | All inputs, trend analysis |
+| Quarterly Review | 1.5-2 hours | Key metrics, action tracking |
+
+---
+
+## Required Outputs
+
+### ISO 13485 Required Output Topics
+
+| Output | Description | Documentation |
+|--------|-------------|---------------|
+| Improvement decisions | QMS and process improvements | Action items with owners |
+| Resource decisions | Changes to resource allocation | Resource plan updates |
+| Quality objectives | Changes to objectives or targets | Updated objectives document |
+| QMS changes | Decisions on system modifications | Change requests initiated |
+
+### Output Documentation Template
+
+```
+MANAGEMENT REVIEW OUTPUTS
+
+Review Date: [Date]
+Review Type: [Annual/Semi-annual/Quarterly]
+
+DECISIONS MADE:
+
+1. QMS IMPROVEMENT DECISIONS
+| Decision | Rationale | Owner | Due Date |
+|----------|-----------|-------|----------|
+| [Decision 1] | [Why] | [Who] | [When] |
+
+2. RESOURCE DECISIONS
+| Decision | Resources Required | Budget Impact | Owner |
+|----------|-------------------|----------------|-------|
+| [Decision 1] | [What needed] | [$] | [Who] |
+
+3. QUALITY OBJECTIVES
+| Objective | Current | Target | Change | Rationale |
+|-----------|---------|--------|--------|-----------|
+| [Objective 1] | [Current target] | [New target] | [+/-] | [Why] |
+
+4. QMS CHANGES APPROVED
+| Change | Scope | Implementation Date | Owner |
+|--------|-------|---------------------|-------|
+| [Change 1] | [Affected areas] | [Date] | [Who] |
+
+CONCLUSIONS:
+- Overall QMS effectiveness: [Effective/Needs Improvement]
+- Quality policy adequacy: [Adequate/Needs Update]
+- Quality objectives progress: [On Track/Behind/Ahead]
+
+NEXT REVIEW:
+Date: [Date]
+Special Focus Areas: [Areas requiring attention]
+```
+
+---
+
+## Action Tracking
+
+### Action Item Format
+
+```
+ACTION ITEM
+
+ID: MR-[Year]-[Number]
+Source: Management Review [Date]
+Category: [ ] Improvement [ ] Resource [ ] Compliance [ ] Other
+
+Description: [Specific action to be taken]
+Owner: [Name, Title]
+Due Date: [Date]
+Priority: [ ] High [ ] Medium [ ] Low
+
+Success Criteria: [How completion will be verified]
+Resources Required: [People, budget, equipment]
+Dependencies: [Other actions or conditions]
+
+Status Updates:
+| Date | Update | Updated By |
+|------|--------|------------|
+| [Date] | [Progress note] | [Name] |
+
+Completion:
+Completed Date: [Date]
+Evidence: [Reference to evidence of completion]
+Verified By: [Name, Date]
+```
+
+### Action Status Categories
+
+| Status | Definition | Color Code |
+|--------|------------|------------|
+| Not Started | Assigned but work not begun | Gray |
+| In Progress | Work underway | Blue |
+| On Hold | Blocked, awaiting dependency | Yellow |
+| Overdue | Past due date, not complete | Red |
+| Complete | Finished, pending verification | Green |
+| Verified | Completion verified | Dark Green |
+| Cancelled | No longer required | Strikethrough |
+
+### Action Tracking Dashboard
+
+```
+MANAGEMENT REVIEW ACTION TRACKER
+
+Review: [Date]
+Last Updated: [Date]
+
+SUMMARY:
+Total Actions: [Number]
+| Status | Count | % |
+|--------|-------|---|
+| Complete/Verified | [N] | [%] |
+| In Progress | [N] | [%] |
+| Not Started | [N] | [%] |
+| Overdue | [N] | [%] |
+| On Hold | [N] | [%] |
+
+OVERDUE ACTIONS (Requires Escalation):
+| ID | Description | Owner | Due Date | Days Overdue |
+|----|-------------|-------|----------|--------------|
+| [ID] | [Brief] | [Name] | [Date] | [Days] |
+
+UPCOMING DUE (Next 30 Days):
+| ID | Description | Owner | Due Date |
+|----|-------------|-------|----------|
+| [ID] | [Brief] | [Name] | [Date] |
+```
+
+---
+
+## Documentation Templates
+
+### Meeting Minutes Template
+
+```
+MANAGEMENT REVIEW MEETING MINUTES
+
+Date: [Date]
+Time: [Start] - [End]
+Location: [Location]
+Chair: [Name]
+Recorder: [Name]
+
+ATTENDEES:
+| Name | Title | Present |
+|------|-------|---------|
+| [Name] | [Title] | ☑ Yes / ☐ No |
+
+AGENDA ITEMS REVIEWED:
+
+1. [Topic]
+   Discussion: [Summary of discussion]
+   Decision: [Decision made, if any]
+   Action: [Action assigned, if any]
+
+2. [Topic]
+   ...
+
+DECISIONS SUMMARY:
+1. [Decision 1]
+2. [Decision 2]
+
+ACTIONS ASSIGNED:
+| ID | Action | Owner | Due Date |
+|----|--------|-------|----------|
+| MR-XX-01 | [Action] | [Name] | [Date] |
+
+NEXT MEETING:
+Date: [Date]
+Preliminary Agenda Items: [Topics to cover]
+
+APPROVAL:
+Chair: _________________ Date: _______
+QMR: _________________ Date: _______
+```
+
+### Review Effectiveness Metrics
+
+| Metric | Target | Calculation |
+|--------|--------|-------------|
+| Action completion rate | >90% | Completed on time / Total actions |
+| Review attendance | 100% required | Required attendees present / Required |
+| Input completeness | 100% | Inputs provided / Required inputs |
+| Decision documentation | 100% | Documented decisions / Decisions made |
+| Time to complete review | Per schedule | Actual date - Planned date |

package/skills/quality-manager-qmr/references/quality-kpi-framework.md

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+# Quality KPI Framework
+
+Quality performance indicators, targets, and monitoring guidelines for QMS effectiveness.
+
+---
+
+## Table of Contents
+
+- [KPI Categories](#kpi-categories)
+- [Core Quality KPIs](#core-quality-kpis)
+- [Customer Quality KPIs](#customer-quality-kpis)
+- [Compliance KPIs](#compliance-kpis)
+- [Cost of Quality](#cost-of-quality)
+- [Dashboard Templates](#dashboard-templates)
+
+---
+
+## KPI Categories
+
+### KPI Hierarchy
+
+| Level | Audience | Update Frequency | Example |
+|-------|----------|------------------|---------|
+| Strategic | Board, C-suite | Quarterly | Quality cost ratio |
+| Tactical | Department heads | Monthly | CAPA closure rate |
+| Operational | Team leads | Weekly/Daily | First pass yield |
+
+### KPI Selection Criteria
+
+| Criterion | Requirement |
+|-----------|-------------|
+| Measurable | Quantifiable with available data |
+| Actionable | Team can influence the metric |
+| Relevant | Aligned to quality objectives |
+| Timely | Can be measured at useful frequency |
+| Owned | Clear accountability assigned |
+
+---
+
+## Core Quality KPIs
+
+### Process Performance
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| First Pass Yield | % units passing without rework | >95% | (Units passed first time / Total units) × 100 |
+| Process Capability (Cpk) | Process performance vs. spec | >1.33 | min((USL-μ)/(3σ), (μ-LSL)/(3σ)) |
+| Nonconformance Rate | NC events per production volume | <1% | (NC count / Total units) × 100 |
+| Right First Time | % activities completed correctly first time | >98% | (Correct completions / Total attempts) × 100 |
+
+### CAPA Effectiveness
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| CAPA Closure Rate | % CAPAs closed on time | >90% | (On-time closures / Due closures) × 100 |
+| CAPA Effectiveness Rate | % CAPAs effective at verification | >85% | (Effective CAPAs / Verified CAPAs) × 100 |
+| Average CAPA Age | Mean days from open to close | <60 days | Sum(Close date - Open date) / Count |
+| Overdue CAPA Rate | % CAPAs past due date | <10% | (Overdue CAPAs / Open CAPAs) × 100 |
+| Recurrence Rate | % issues recurring after CAPA | <5% | (Recurred issues / Closed CAPAs) × 100 |
+
+### Audit Performance
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Audit Schedule Compliance | % audits completed per schedule | >95% | (Audits completed / Audits scheduled) × 100 |
+| Finding Closure Rate | % findings closed on time | >90% | (On-time closures / Due closures) × 100 |
+| Repeat Finding Rate | % findings recurring from prior audits | <10% | (Repeat findings / Total findings) × 100 |
+| Major NC Rate | Major NCs per audit | <1 | Total major NCs / Total audits |
+
+### Document Control
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Document Review Compliance | % documents reviewed on schedule | >95% | (On-time reviews / Due reviews) × 100 |
+| Change Request Cycle Time | Days from request to implementation | <30 days | Average(Implementation - Request date) |
+| Obsolete Document Incidents | Uses of obsolete documents | 0 | Count of incidents |
+
+---
+
+## Customer Quality KPIs
+
+### Complaint Management
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Complaint Rate | Complaints per units sold | <0.1% | (Complaints / Units sold) × 100 |
+| Complaint Response Time | Days to acknowledge complaint | <24 hours | Average(Response date - Receipt date) |
+| Complaint Investigation Time | Days to complete investigation | <30 days | Average(Close date - Receipt date) |
+| Complaint Closure Rate | % complaints closed on time | >90% | (On-time closures / Due closures) × 100 |
+
+### Customer Satisfaction
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Customer Satisfaction Score | Survey-based satisfaction rating | >4.0/5.0 | Average of survey scores |
+| Net Promoter Score (NPS) | Customer loyalty indicator | >50 | % Promoters - % Detractors |
+| Return Rate | % units returned by customers | <1% | (Units returned / Units sold) × 100 |
+| Warranty Claim Rate | Warranty claims per units sold | <0.5% | (Claims / Units under warranty) × 100 |
+
+### Field Quality
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Field Failure Rate | Failures in customer use | <0.1% | (Field failures / Units in field) × 100 |
+| Mean Time Between Failures | Average operating time before failure | Varies | Total operating hours / Number of failures |
+| Service Call Rate | Service calls per installed base | <5%/year | (Service calls / Installed units) × 100 |
+
+---
+
+## Compliance KPIs
+
+### Regulatory Compliance
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Regulatory Submission Success | % submissions accepted first time | >90% | (Accepted submissions / Total submissions) × 100 |
+| Inspection Readiness Score | Self-assessment compliance score | >90% | (Compliant items / Total items) × 100 |
+| Reportable Event Timeliness | % events reported within required time | 100% | (On-time reports / Required reports) × 100 |
+| Registration Currency | % registrations current | 100% | (Current registrations / Required registrations) × 100 |
+
+### Certification Status
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Certification Maintenance | Active certifications vs. required | 100% | (Active certs / Required certs) × 100 |
+| Surveillance Audit Outcomes | Pass rate on surveillance audits | 100% | (Passed audits / Conducted audits) × 100 |
+| Certification NC Rate | NCs per certification audit | <3 minor, 0 major | Count per audit |
+
+### Training Compliance
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Training Completion Rate | % required training completed | >95% | (Completed / Required) × 100 |
+| Training Currency | % employees with current training | >98% | (Current / Total requiring) × 100 |
+| Training Effectiveness | % passing competency assessments | >90% | (Passed / Assessed) × 100 |
+
+---
+
+## Cost of Quality
+
+### Cost Categories
+
+| Category | Definition | Examples |
+|----------|------------|----------|
+| Prevention | Costs to prevent defects | Training, quality planning, process validation |
+| Appraisal | Costs to detect defects | Inspection, testing, audits, calibration |
+| Internal Failure | Costs of defects found internally | Rework, scrap, re-inspection, downgrading |
+| External Failure | Costs of defects found by customer | Returns, complaints, warranty, recalls |
+
+### Cost of Quality KPIs
+
+| KPI | Definition | Target | Calculation |
+|-----|------------|--------|-------------|
+| Total Cost of Quality | Sum of all quality costs | <5% of revenue | Prevention + Appraisal + Failure costs |
+| Prevention/Appraisal Ratio | Prevention vs. detection investment | >1.0 | Prevention costs / Appraisal costs |
+| Failure Cost Ratio | Failure costs as % of CoQ | <30% | (Internal + External failure) / Total CoQ |
+| Quality Cost Trend | Change in CoQ over time | Decreasing | (Current CoQ - Prior CoQ) / Prior CoQ |
+
+### Cost Collection Categories
+
+```
+COST OF QUALITY WORKSHEET
+
+Period: [Start] to [End]
+
+PREVENTION COSTS:
+| Category | Description | Amount |
+|----------|-------------|--------|
+| Quality planning | QMS development, quality planning | $ |
+| Training | Quality training programs | $ |
+| Process validation | Validation activities | $ |
+| Supplier qualification | Supplier quality programs | $ |
+| Preventive maintenance | Equipment maintenance | $ |
+| SUBTOTAL PREVENTION | | $ |
+
+APPRAISAL COSTS:
+| Category | Description | Amount |
+|----------|-------------|--------|
+| Incoming inspection | Supplier material inspection | $ |
+| In-process inspection | Production quality checks | $ |
+| Final inspection | Finished goods testing | $ |
+| Audit costs | Internal and external audits | $ |
+| Calibration | Equipment calibration | $ |
+| SUBTOTAL APPRAISAL | | $ |
+
+INTERNAL FAILURE COSTS:
+| Category | Description | Amount |
+|----------|-------------|--------|
+| Scrap | Scrapped materials and product | $ |
+| Rework | Labor and materials to correct | $ |
+| Re-inspection | Repeat inspection costs | $ |
+| Downgrading | Revenue loss from downgrading | $ |
+| Root cause analysis | Investigation costs | $ |
+| SUBTOTAL INTERNAL FAILURE | | $ |
+
+EXTERNAL FAILURE COSTS:
+| Category | Description | Amount |
+|----------|-------------|--------|
+| Returns processing | Handling returned product | $ |
+| Warranty costs | Warranty claims and repairs | $ |
+| Complaint handling | Investigation and resolution | $ |
+| Recalls | Recall execution costs | $ |
+| Liability | Legal and settlement costs | $ |
+| SUBTOTAL EXTERNAL FAILURE | | $ |
+
+TOTAL COST OF QUALITY: $
+AS % OF REVENUE: %
+```
+
+---
+
+## Dashboard Templates
+
+### Executive Quality Dashboard
+
+```
+EXECUTIVE QUALITY DASHBOARD
+Period: [Month/Quarter]
+
+KEY METRICS AT A GLANCE:
+┌─────────────────┬─────────┬─────────┬─────────┐
+│ Metric          │ Target  │ Actual  │ Trend   │
+├─────────────────┼─────────┼─────────┼─────────┤
+│ Customer Sat    │ >4.0    │ [X.X]   │ [↑/↓/→] │
+│ Complaint Rate  │ <0.1%   │ [X.XX%] │ [↑/↓/→] │
+│ First Pass Yield│ >95%    │ [XX%]   │ [↑/↓/→] │
+│ CAPA Closure    │ >90%    │ [XX%]   │ [↑/↓/→] │
+│ Audit Findings  │ <3/audit│ [X.X]   │ [↑/↓/→] │
+│ Quality Cost    │ <5%     │ [X.X%]  │ [↑/↓/→] │
+└─────────────────┴─────────┴─────────┴─────────┘
+
+ALERTS:
+[ ] Critical: [Any critical issues requiring immediate attention]
+[ ] Warning: [Issues approaching threshold]
+[ ] Info: [Notable improvements or changes]
+
+QUALITY OBJECTIVES PROGRESS:
+| Objective | Target | YTD | Status |
+|-----------|--------|-----|--------|
+| [Obj 1] | [Target] | [Actual] | [On Track/Behind] |
+```
+
+### Operational Quality Dashboard
+
+```
+OPERATIONAL QUALITY DASHBOARD
+Week/Month: [Period]
+
+PRODUCTION QUALITY:
+├── First Pass Yield: [XX%] (Target: 95%)
+├── Rework Rate: [X.X%] (Target: <2%)
+├── Scrap Rate: [X.X%] (Target: <1%)
+└── NC Count: [XX] (Prior: [XX])
+
+CAPA STATUS:
+├── Open CAPAs: [XX]
+│   ├── Critical: [X]
+│   ├── Major: [XX]
+│   └── Minor: [XX]
+├── Overdue: [X] [!ALERT if >0]
+├── Avg Age: [XX] days
+└── Closed This Period: [XX]
+
+AUDIT STATUS:
+├── Audits Completed: [X] of [X] scheduled
+├── Open Findings: [XX]
+│   ├── Major: [X]
+│   └── Minor: [XX]
+└── Overdue Actions: [X]
+
+COMPLAINTS:
+├── Received: [XX]
+├── Open: [XX]
+├── Avg Response Time: [X.X] days
+└── Top Category: [Category]
+```
+
+### KPI Target Setting Guidelines
+
+| Performance Level | Action |
+|-------------------|--------|
+| >110% of target | Consider raising target |
+| 100-110% of target | Maintain current target |
+| 90-100% of target | Monitor closely |
+| 80-90% of target | Improvement plan required |
+| <80% of target | Immediate intervention |
+
+### Review Frequency by KPI Type
+
+| KPI Type | Review Frequency | Trend Period |
+|----------|------------------|--------------|
+| Safety/Compliance | Daily monitoring | Weekly |
+| Production | Daily/Weekly | Monthly |
+| Customer | Weekly/Monthly | Quarterly |
+| Strategic | Monthly/Quarterly | Annual |
+| Cost | Monthly | Quarterly |