diff --git a/ra-qm-team/quality-manager-qmr/SKILL.md b/ra-qm-team/quality-manager-qmr/SKILL.md index 2d4b7b9..b70b367 100644 --- a/ra-qm-team/quality-manager-qmr/SKILL.md +++ b/ra-qm-team/quality-manager-qmr/SKILL.md @@ -1,209 +1,488 @@ --- name: quality-manager-qmr -description: Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides overall quality system responsibility, regulatory compliance oversight, management accountability, and strategic quality leadership. Use for quality system governance, regulatory compliance oversight, management responsibility, and quality strategic planning. +description: Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2. +triggers: + - management review + - quality policy + - quality objectives + - QMR responsibilities + - quality system effectiveness + - quality KPIs + - cost of quality + - quality performance + - management accountability + - regulatory oversight + - quality culture + - quality governance --- # Senior Quality Manager Responsible Person (QMR) -Ultimate quality system accountability and regulatory compliance oversight with comprehensive responsibility for quality management system effectiveness and regulatory compliance across all jurisdictions. +Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements. -## Core QMR Responsibilities +--- -### 1. Overall Quality System Responsibility (ISO 13485 Clause 5.5.2) -Provide comprehensive oversight and accountability for quality management system effectiveness and regulatory compliance. +## Table of Contents + +- [QMR Responsibilities](#qmr-responsibilities) +- [Management Review Workflow](#management-review-workflow) +- [Quality KPI Management Workflow](#quality-kpi-management-workflow) +- [Quality Objectives Workflow](#quality-objectives-workflow) +- [Quality Culture Assessment Workflow](#quality-culture-assessment-workflow) +- [Regulatory Compliance Oversight](#regulatory-compliance-oversight) +- [Decision Frameworks](#decision-frameworks) +- [Tools and References](#tools-and-references) + +--- + +## QMR Responsibilities + +### ISO 13485 Clause 5.5.2 Requirements + +| Responsibility | Scope | Evidence | +|----------------|-------|----------| +| QMS effectiveness | Monitor system performance and suitability | Management review records | +| Reporting to management | Communicate QMS performance to top management | Quality reports, dashboards | +| Quality awareness | Promote regulatory and quality requirements | Training records, communications | +| Liaison with external parties | Interface with regulators, Notified Bodies | Meeting records, correspondence | + +### QMR Accountability Matrix + +| Domain | Accountable For | Reports To | Frequency | +|--------|-----------------|------------|-----------| +| Quality Policy | Policy adequacy and communication | CEO/Board | Annual review | +| Quality Objectives | Objective achievement and relevance | Executive Team | Quarterly | +| QMS Performance | System effectiveness metrics | Management | Monthly | +| Regulatory Compliance | Compliance status across jurisdictions | CEO | Quarterly | +| Audit Program | Audit schedule completion, findings closure | Management | Per audit | +| CAPA Oversight | CAPA effectiveness and timeliness | Executive Team | Monthly | + +### Authority Boundaries + +| Decision Type | QMR Authority | Escalation Required | +|---------------|---------------|---------------------| +| Process changes within QMS | Approve with owner | Major process redesign | +| Document approval | Final QA approval | Policy-level changes | +| Nonconformity disposition | Accept/reject with MRB | Product release decisions | +| Supplier quality actions | Quality holds, audits | Supplier termination | +| Audit scheduling | Adjust internal audit schedule | External audit timing | +| Training requirements | Define quality training needs | Organization-wide training budget | + +--- + +## Management Review Workflow + +Conduct management reviews per ISO 13485 Clause 5.6 requirements. + +### Workflow: Prepare and Execute Management Review + +1. Schedule management review (minimum annually, typically quarterly or semi-annually) +2. Notify all required attendees minimum 2 weeks prior +3. Collect required inputs from process owners: + - Audit results (internal and external) + - Customer feedback (complaints, satisfaction, returns) + - Process performance and product conformity + - CAPA status and effectiveness + - Previous review action items + - Changes affecting QMS (regulatory, organizational) + - Recommendations for improvement +4. Compile input summary report with trend analysis +5. Prepare presentation materials with supporting data +6. Distribute agenda and input package 1 week prior +7. Conduct review meeting per agenda +8. **Validation:** All required inputs reviewed; decisions documented with owners and due dates + +### Required Attendees + +| Role | Requirement | Input Responsibility | +|------|-------------|---------------------| +| CEO/General Manager | Required | Strategic decisions | +| QMR | Chair | Overall QMS status | +| Department Heads | Required | Process performance | +| RA Manager | Required | Regulatory changes | +| Production Manager | Required | Product conformity | +| Customer Quality | Required | Complaint data | + +### Management Review Input Template -**QMR Accountability Framework:** ``` -QMR RESPONSIBILITY MATRIX -├── Quality Management System Oversight -│ ├── QMS effectiveness monitoring -│ ├── Quality policy implementation -│ ├── Quality objectives achievement -│ └── Resource adequacy assessment -├── Regulatory Compliance Oversight -│ ├── Regulatory requirement monitoring -│ ├── Compliance status assessment -│ ├── Regulatory submission oversight -│ └── Authority relationship management -├── Management Responsibility -│ ├── Senior management reporting -│ ├── Quality performance communication -│ ├── Strategic quality planning -│ └── Organizational quality culture -└── Continuous Improvement Leadership - ├── Quality system enhancement - ├── Performance improvement initiatives - ├── Best practice implementation - └── Innovation and modernization +MANAGEMENT REVIEW INPUT SUMMARY + +Review Period: [Start Date] to [End Date] +Review Date: [Scheduled Date] +Prepared By: [QMR Name] + +1. AUDIT RESULTS + Internal audits completed: [X] of [X] planned + External audits completed: [X] + Total findings: [X] major / [X] minor + Open findings: [X] + Finding trends: [Analysis] + +2. CUSTOMER FEEDBACK + Complaints received: [X] + Complaint rate: [X per 1000 units] + Customer satisfaction score: [X.X/5.0] + Returns: [X] units ([X]%) + Top issues: [Categories] + +3. PROCESS PERFORMANCE + [Process 1]: [Metric] vs [Target] - [Status] + [Process 2]: [Metric] vs [Target] - [Status] + Out-of-spec processes: [List] + +4. PRODUCT CONFORMITY + First pass yield: [X]% + Nonconformance rate: [X]% + Scrap cost: $[X] + Top defect categories: [List] + +5. CAPA STATUS + Open CAPAs: [X] + Overdue: [X] + Effectiveness rate: [X]% + Average age: [X] days + +6. PREVIOUS ACTIONS + Total from last review: [X] + Completed: [X] | In progress: [X] | Overdue: [X] + +7. CHANGES AFFECTING QMS + Regulatory: [List changes] + Organizational: [List changes] + Process: [List changes] + +8. RECOMMENDATIONS + [Collected improvement opportunities] ``` -### 2. Regulatory Compliance Oversight -Ensure comprehensive regulatory compliance across all applicable jurisdictions and standards. +### Management Review Output Requirements -**Compliance Monitoring System:** -1. **Multi-jurisdictional Compliance Tracking** - - **EU MDR 2017/745** compliance status monitoring - - **FDA QSR 21 CFR 820** compliance verification - - **ISO 13485** certification maintenance - - **National regulatory requirements** adherence +| Output | Documentation | Owner | +|--------|---------------|-------| +| QMS improvement decisions | Action items with due dates | Assigned per item | +| Resource needs | Resource plan updates | Department heads | +| Quality objectives changes | Updated objectives document | QMR | +| Process improvement needs | Improvement project charters | Process owners | -2. **Compliance Risk Assessment** - - Regulatory risk identification and assessment - - Compliance gap analysis and remediation - - Regulatory change impact evaluation - - **Decision Point**: Escalate significant compliance risks to senior management +See: [references/management-review-guide.md](references/management-review-guide.md) -3. **Regulatory Authority Interface** - - **For EU Authorities**: Coordinate with Notified Bodies and Competent Authorities - - **For FDA**: Manage FDA communications and inspection readiness - - **For Other Markets**: Oversee international regulatory compliance - - Authority communication oversight and strategy +--- -### 3. Management Review and Reporting (ISO 13485 Clause 5.6) -Lead management review processes ensuring systematic quality system evaluation and strategic quality planning. +## Quality KPI Management Workflow -**Management Review Leadership:** -- **Quarterly Management Reviews** with C-level executives -- **Quality Performance Dashboards** with real-time KPIs -- **Annual Quality Strategy Planning** sessions -- **Regulatory Compliance Reports** to board and senior management +Establish, monitor, and report quality performance indicators. -**Key Review Topics:** -- Quality management system performance and effectiveness -- Regulatory compliance status and emerging requirements -- Customer satisfaction trends and market feedback -- Quality costs and return on quality investments -- Strategic quality initiatives and resource requirements +### Workflow: Establish Quality KPI Framework -### 4. Quality Culture and Leadership -Foster organizational quality culture ensuring quality excellence throughout the organization. +1. Identify quality objectives requiring measurement +2. Select KPIs per objective using SMART criteria: + - Specific: Clear definition and calculation + - Measurable: Quantifiable with available data + - Actionable: Team can influence results + - Relevant: Aligned to quality objectives + - Time-bound: Defined measurement frequency +3. Define target values based on baseline data and benchmarks +4. Assign data source and collection responsibility +5. Establish reporting frequency per KPI category +6. Configure dashboard displays and trend analysis +7. Define escalation thresholds and alert triggers +8. **Validation:** Each KPI has owner, target, data source, and escalation criteria -**Quality Culture Initiatives:** -- **Quality Leadership Development** programs -- **Quality Awareness Training** for all employees -- **Quality Recognition Programs** and incentives -- **Quality Communication** strategies and campaigns +### Core Quality KPIs -## Strategic Quality Management +| Category | KPI | Target | Calculation | +|----------|-----|--------|-------------| +| Process | First Pass Yield | >95% | (Units passed first time / Total units) × 100 | +| Process | Nonconformance Rate | <1% | (NC count / Total units) × 100 | +| CAPA | CAPA Closure Rate | >90% | (On-time closures / Due closures) × 100 | +| CAPA | CAPA Effectiveness | >85% | (Effective CAPAs / Verified CAPAs) × 100 | +| Audit | Finding Closure Rate | >90% | (On-time closures / Due closures) × 100 | +| Audit | Repeat Finding Rate | <10% | (Repeat findings / Total findings) × 100 | +| Customer | Complaint Rate | <0.1% | (Complaints / Units sold) × 100 | +| Customer | Satisfaction Score | >4.0/5.0 | Average of survey scores | -### Quality Strategic Planning -Develop and implement comprehensive quality strategies aligned with business objectives and regulatory requirements. +### KPI Review Frequency -**Strategic Planning Process:** -1. **Quality Strategy Development** - - Business objective alignment and integration - - Regulatory landscape analysis and planning - - Quality investment prioritization and ROI analysis - - Competitive quality positioning assessment +| KPI Type | Review Frequency | Trend Period | Audience | +|----------|------------------|--------------|----------| +| Safety/Compliance | Daily monitoring | Weekly | Operations | +| Production Quality | Weekly | Monthly | Department heads | +| Customer Quality | Monthly | Quarterly | Executive team | +| Strategic Quality | Quarterly | Annual | Board/C-suite | -2. **Quality Resource Management** - - Quality team capability assessment and development - - Quality technology and system modernization - - Quality infrastructure investment planning - - External quality resource utilization +### Performance Response Matrix -3. **Quality Performance Management** - - Quality KPI framework development and monitoring - - Quality scorecards and dashboard implementation - - Quality benchmarking and best practice identification - - Quality improvement initiative prioritization +| Performance Level | Status | Action Required | +|-------------------|--------|-----------------| +| >110% of target | Exceeding | Consider raising target | +| 100-110% of target | Meeting | Maintain current approach | +| 90-100% of target | Approaching | Monitor closely | +| 80-90% of target | Below | Improvement plan required | +| <80% of target | Critical | Immediate intervention | -### Cross-functional Quality Integration -Ensure quality considerations are integrated across all organizational functions and processes. +See: [references/quality-kpi-framework.md](references/quality-kpi-framework.md) -**Quality Integration Framework:** -- **R&D Integration**: Design quality and design controls oversight -- **Manufacturing Integration**: Production quality and process validation -- **Supply Chain Integration**: Supplier quality and supply chain risk management -- **Commercial Integration**: Customer quality and market quality feedback +--- -## Quality System Governance +## Quality Objectives Workflow -### Quality Policy and Objectives (ISO 13485 Clause 5.3 & 5.4.1) -Establish and maintain organizational quality policy and measurable quality objectives. +Establish and maintain measurable quality objectives per ISO 13485 Clause 5.4.1. -**Quality Governance Structure:** -- **Quality Policy**: Top-level quality commitment and direction -- **Quality Objectives**: Measurable quality targets and KPIs -- **Quality Planning**: Strategic and operational quality planning -- **Quality Communication**: Quality policy and objective communication +### Workflow: Annual Quality Objectives Setting -### Document and Change Control Oversight -Ensure robust document control and change management processes throughout the organization. +1. Review prior year objective achievement +2. Analyze quality performance trends and gaps +3. Align with organizational strategic plan +4. Draft objectives with measurable targets +5. Validate resource availability for achievement +6. Obtain executive approval +7. Communicate objectives organization-wide +8. **Validation:** Each objective is measurable, has owner, target, and timeline -**Document Control Oversight:** -- Document control system effectiveness monitoring -- Change control process compliance verification -- Document review and approval process optimization -- Configuration management and version control oversight +### Quality Objective Structure -### Quality Audit Program Oversight -Provide strategic oversight of internal and external audit programs ensuring comprehensive quality system assessment. +``` +QUALITY OBJECTIVE [Number] -**Audit Program Management:** -- **Internal Audit Program**: Strategic audit planning and resource allocation -- **External Audit Coordination**: Regulatory and certification body audit management -- **Audit Follow-up Oversight**: Corrective action effectiveness verification -- **Audit Performance Assessment**: Audit program effectiveness evaluation +Objective Statement: [Clear, measurable statement] +Aligned to Policy Element: [Quality policy section] +Target: [Specific measurable target] +Baseline: [Current performance] +Owner: [Name and title] +Due Date: [Target achievement date] -## Regulatory Interface Management +Success Criteria: +- [Criterion 1] +- [Criterion 2] -### Regulatory Authority Relationships -Maintain strategic relationships with regulatory authorities ensuring effective communication and collaboration. +Measurement Method: [How progress is tracked] +Reporting Frequency: [Monthly/Quarterly] -**Authority Relationship Management:** -- **Regulatory Authority Meetings**: Strategic regulatory discussions and planning -- **Regulatory Submission Oversight**: Quality and completeness verification -- **Regulatory Inspection Management**: Preparation, coordination, and follow-up -- **Regulatory Intelligence**: Authority position monitoring and trend analysis +Supporting Initiatives: +- [Initiative 1] +- [Initiative 2] -### Quality System Certification Management -Oversee all quality system certifications ensuring compliance and continuous improvement. +Resource Requirements: +- [Resource 1] +- [Resource 2] +``` -**Certification Management:** -- **ISO 13485 Certification**: Maintenance and continuous improvement -- **Regulatory Certifications**: FDA registration, CE marking, other market certifications -- **Quality Certifications**: Additional quality certifications and accreditations -- **Certification Strategy**: Multi-market certification planning and optimization +### Objective Categories -## Quality Performance Monitoring +| Category | Example Objectives | Typical Targets | +|----------|-------------------|-----------------| +| Customer Quality | Reduce complaint rate | <0.1% of units sold | +| Process Quality | Improve first pass yield | >96% | +| Compliance | Maintain certification | Zero major NCs | +| Efficiency | Reduce quality costs | <4% of revenue | +| Culture | Increase training completion | >98% on-time | -### Quality Key Performance Indicators (KPIs) -Monitor comprehensive quality performance metrics ensuring quality excellence and regulatory compliance. +### Quarterly Objective Review -**Quality Performance Dashboard:** -- **Quality System Effectiveness**: Process performance, audit results, nonconformity trends -- **Customer Quality**: Customer satisfaction, complaint rates, return rates -- **Product Quality**: Product conformity, defect rates, quality costs -- **Regulatory Compliance**: Compliance scores, submission success rates, inspection outcomes -- **Quality Culture**: Training completion, quality awareness, employee engagement +| Review Element | Assessment | Action | +|----------------|------------|--------| +| Progress vs. target | On track / Behind / Ahead | Adjust resources if behind | +| Relevance | Still valid / Needs update | Modify if conditions changed | +| Resources | Adequate / Insufficient | Request additional if needed | +| Barriers | Identified obstacles | Escalate for resolution | -### Quality Cost Management -Monitor and optimize quality costs ensuring cost-effective quality management. +--- -**Quality Cost Categories:** -- **Prevention Costs**: Quality planning, training, prevention activities -- **Appraisal Costs**: Inspection, testing, audit activities -- **Internal Failure Costs**: Rework, scrap, internal quality failures -- **External Failure Costs**: Returns, recalls, customer complaints, regulatory sanctions +## Quality Culture Assessment Workflow -## Resources +Assess and improve organizational quality culture. -### scripts/ -- `qmr-dashboard.py`: Comprehensive QMR performance monitoring and reporting -- `regulatory-compliance-tracker.py`: Multi-jurisdictional compliance status monitoring -- `quality-cost-analyzer.py`: Quality cost analysis and optimization tool -- `management-review-automation.py`: Management review preparation and follow-up automation +### Workflow: Annual Quality Culture Assessment -### references/ -- `qmr-responsibilities-matrix.md`: Comprehensive QMR responsibility framework -- `regulatory-compliance-requirements.md`: Multi-jurisdictional regulatory requirement library -- `quality-strategic-planning-guide.md`: Quality strategy development methodologies -- `quality-culture-development.md`: Quality culture assessment and development frameworks -- `quality-kpi-library.md`: Comprehensive quality performance indicator definitions +1. Design or select quality culture survey instrument +2. Define survey population (all employees or sample) +3. Communicate survey purpose and confidentiality +4. Administer survey with 2-week response window +5. Analyze results by department, role, and tenure +6. Identify strengths and improvement areas +7. Develop action plan for culture gaps +8. **Validation:** Response rate >60%; action plan addresses bottom 3 scores -### assets/ -- `qmr-templates/`: QMR reporting templates, quality policy templates, strategic planning tools -- `compliance-dashboards/`: Regulatory compliance monitoring dashboards -- `quality-communication/`: Quality communication templates and presentation materials -- `training-materials/`: QMR and quality leadership training programs +### Quality Culture Dimensions + +| Dimension | Indicators | Assessment Method | +|-----------|------------|-------------------| +| Leadership commitment | Management visible support for quality | Survey, observation | +| Quality ownership | Employees feel responsible for quality | Survey | +| Communication | Quality information flows effectively | Survey, audit | +| Continuous improvement | Suggestions submitted and implemented | Metrics | +| Training and competence | Employees feel adequately trained | Survey, records | +| Problem solving | Issues addressed at root cause | CAPA analysis | + +### Culture Survey Categories + +| Category | Sample Questions | +|----------|------------------| +| Leadership | "Management demonstrates commitment to quality" | +| Resources | "I have the tools and training to do quality work" | +| Communication | "Quality expectations are clearly communicated" | +| Empowerment | "I am encouraged to report quality issues" | +| Recognition | "Quality achievements are recognized" | + +### Culture Improvement Actions + +| Gap Identified | Potential Actions | +|----------------|-------------------| +| Low leadership visibility | Quality gemba walks, all-hands quality updates | +| Inadequate training | Competency-based training program | +| Poor communication | Quality newsletters, department huddles | +| Low reporting | Anonymous reporting system, no-blame culture | +| Lack of recognition | Quality award program, team celebrations | + +--- + +## Regulatory Compliance Oversight + +Monitor and maintain regulatory compliance across jurisdictions. + +### Multi-Jurisdictional Compliance Matrix + +| Jurisdiction | Regulation | Requirement | Status Tracking | +|--------------|------------|-------------|-----------------| +| EU | MDR 2017/745 | CE marking, Notified Body | Technical file, annual review | +| USA | 21 CFR 820 | FDA registration, QSR compliance | Annual registration, inspections | +| International | ISO 13485 | QMS certification | Surveillance audits | +| Germany | MPG/MPDG | National implementation | Competent authority filings | + +### Compliance Monitoring Workflow + +1. Maintain regulatory requirement register +2. Subscribe to regulatory update services +3. Assess impact of regulatory changes monthly +4. Update affected processes within 90 days of effective date +5. Verify training completion for regulatory changes +6. Document compliance status in management review +7. Maintain inspection readiness checklist +8. **Validation:** All applicable requirements mapped; no expired registrations + +### Regulatory Authority Interface + +| Activity | QMR Role | Preparation Required | +|----------|----------|---------------------| +| Notified Body audit | Primary contact | Audit package, personnel schedules | +| FDA inspection | Host, escort coordinator | Inspection readiness review | +| Competent Authority inquiry | Response coordinator | Technical file access | +| Regulatory meeting | Attendee or delegate | Briefing materials | + +### Inspection Readiness Checklist + +| Area | Ready | Action Needed | +|------|-------|---------------| +| Document control system current | ☐ | | +| Training records complete | ☐ | | +| CAPA system current, no overdue items | ☐ | | +| Complaint files complete | ☐ | | +| Equipment calibration current | ☐ | | +| Supplier qualification files complete | ☐ | | +| Management review records available | ☐ | | +| Internal audit program current | ☐ | | + +--- + +## Decision Frameworks + +### Escalation Decision Tree + +``` +Issue Identified + │ + ▼ +Is it a regulatory violation? + │ + Yes─┴─No + │ │ + ▼ ▼ +Escalate to Is it a safety issue? +Executive │ +immediately Yes─┴─No + │ │ + ▼ ▼ + Escalate to Does it affect + Safety Team multiple departments? + │ + Yes─┴─No + │ │ + ▼ ▼ + Escalate to Handle at + Executive department level +``` + +### Quality Investment Prioritization + +| Criteria | Weight | Score Method | +|----------|--------|--------------| +| Regulatory requirement | 30% | Required=10, Recommended=5, Optional=2 | +| Customer impact | 25% | Direct=10, Indirect=5, None=0 | +| Cost savings potential | 20% | >$100K=10, $50-100K=7, <$50K=3 | +| Implementation complexity | 15% | Simple=10, Moderate=5, Complex=2 | +| Strategic alignment | 10% | Core=10, Supporting=5, Peripheral=2 | + +### Resource Allocation Matrix + +| Resource Type | Allocation Authority | Escalation Threshold | +|---------------|---------------------|---------------------| +| Quality personnel | QMR | >1 FTE addition | +| Quality equipment | QMR | >$25K | +| External consultants | QMR | >$50K or >30 days | +| Quality systems | Executive approval | >$100K | + +--- + +## Tools and References + +### Scripts + +| Tool | Purpose | Usage | +|------|---------|-------| +| [management_review_tracker.py](scripts/management_review_tracker.py) | Track review inputs, actions, metrics | `python management_review_tracker.py --help` | + +**Management Review Tracker Features:** +- Track input collection status from process owners +- Monitor action item completion and aging +- Generate metrics summary for review +- Produce recommendations for review focus areas + +### References + +| Document | Content | +|----------|---------| +| [management-review-guide.md](references/management-review-guide.md) | ISO 13485 Clause 5.6 requirements, input/output templates, action tracking | +| [quality-kpi-framework.md](references/quality-kpi-framework.md) | KPI categories, targets, calculations, dashboard templates | + +### Quick Reference: Management Review Inputs (ISO 13485 Clause 5.6.2) + +| Input | Source | Required | +|-------|--------|----------| +| Feedback | Customer complaints, surveys | Yes | +| Audit results | Internal and external audits | Yes | +| Process performance | Process metrics | Yes | +| Product conformity | Inspection, NC data | Yes | +| CAPA status | CAPA system | Yes | +| Previous actions | Prior review records | Yes | +| Changes | Regulatory, organizational | Yes | +| Recommendations | All sources | Yes | + +### Quick Reference: Management Review Outputs (ISO 13485 Clause 5.6.3) + +| Output | Documentation Required | +|--------|----------------------| +| Improvement to QMS and processes | Action items with owners | +| Improvement to product | Project initiation if needed | +| Resource needs | Resource plan updates | + +--- + +## Related Skills + +| Skill | Integration Point | +|-------|-------------------| +| [quality-manager-qms-iso13485](../quality-manager-qms-iso13485/) | QMS process management | +| [capa-officer](../capa-officer/) | CAPA system oversight | +| [qms-audit-expert](../qms-audit-expert/) | Internal audit program | +| [quality-documentation-manager](../quality-documentation-manager/) | Document control oversight | diff --git a/ra-qm-team/quality-manager-qmr/assets/example_asset.txt b/ra-qm-team/quality-manager-qmr/assets/example_asset.txt deleted file mode 100644 index d0ac204..0000000 --- a/ra-qm-team/quality-manager-qmr/assets/example_asset.txt +++ /dev/null @@ -1,24 +0,0 @@ -# Example Asset File - -This placeholder represents where asset files would be stored. -Replace with actual asset files (templates, images, fonts, etc.) or delete if not needed. - -Asset files are NOT intended to be loaded into context, but rather used within -the output Claude produces. - -Example asset files from other skills: -- Brand guidelines: logo.png, slides_template.pptx -- Frontend builder: hello-world/ directory with HTML/React boilerplate -- Typography: custom-font.ttf, font-family.woff2 -- Data: sample_data.csv, test_dataset.json - -## Common Asset Types - -- Templates: .pptx, .docx, boilerplate directories -- Images: .png, .jpg, .svg, .gif -- Fonts: .ttf, .otf, .woff, .woff2 -- Boilerplate code: Project directories, starter files -- Icons: .ico, .svg -- Data files: .csv, .json, .xml, .yaml - -Note: This is a text placeholder. Actual assets can be any file type. diff --git a/ra-qm-team/quality-manager-qmr/references/api_reference.md b/ra-qm-team/quality-manager-qmr/references/api_reference.md deleted file mode 100644 index c62ccd9..0000000 --- a/ra-qm-team/quality-manager-qmr/references/api_reference.md +++ /dev/null @@ -1,34 +0,0 @@ -# Reference Documentation for Quality Manager Qmr - -This is a placeholder for detailed reference documentation. -Replace with actual reference content or delete if not needed. - -Example real reference docs from other skills: -- product-management/references/communication.md - Comprehensive guide for status updates -- product-management/references/context_building.md - Deep-dive on gathering context -- bigquery/references/ - API references and query examples - -## When Reference Docs Are Useful - -Reference docs are ideal for: -- Comprehensive API documentation -- Detailed workflow guides -- Complex multi-step processes -- Information too lengthy for main SKILL.md -- Content that's only needed for specific use cases - -## Structure Suggestions - -### API Reference Example -- Overview -- Authentication -- Endpoints with examples -- Error codes -- Rate limits - -### Workflow Guide Example -- Prerequisites -- Step-by-step instructions -- Common patterns -- Troubleshooting -- Best practices diff --git a/ra-qm-team/quality-manager-qmr/references/management-review-guide.md b/ra-qm-team/quality-manager-qmr/references/management-review-guide.md new file mode 100644 index 0000000..cb50e7e --- /dev/null +++ b/ra-qm-team/quality-manager-qmr/references/management-review-guide.md @@ -0,0 +1,378 @@ +# 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 | diff --git a/ra-qm-team/quality-manager-qmr/references/quality-kpi-framework.md b/ra-qm-team/quality-manager-qmr/references/quality-kpi-framework.md new file mode 100644 index 0000000..44933aa --- /dev/null +++ b/ra-qm-team/quality-manager-qmr/references/quality-kpi-framework.md @@ -0,0 +1,296 @@ +# 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 | diff --git a/ra-qm-team/quality-manager-qmr/scripts/example.py b/ra-qm-team/quality-manager-qmr/scripts/example.py deleted file mode 100755 index 0551a60..0000000 --- a/ra-qm-team/quality-manager-qmr/scripts/example.py +++ /dev/null @@ -1,19 +0,0 @@ -#!/usr/bin/env python3 -""" -Example helper script for quality-manager-qmr - -This is a placeholder script that can be executed directly. -Replace with actual implementation or delete if not needed. - -Example real scripts from other skills: -- pdf/scripts/fill_fillable_fields.py - Fills PDF form fields -- pdf/scripts/convert_pdf_to_images.py - Converts PDF pages to images -""" - -def main(): - print("This is an example script for quality-manager-qmr") - # TODO: Add actual script logic here - # This could be data processing, file conversion, API calls, etc. - -if __name__ == "__main__": - main() diff --git a/ra-qm-team/quality-manager-qmr/scripts/management_review_tracker.py b/ra-qm-team/quality-manager-qmr/scripts/management_review_tracker.py new file mode 100644 index 0000000..4c02029 --- /dev/null +++ b/ra-qm-team/quality-manager-qmr/scripts/management_review_tracker.py @@ -0,0 +1,580 @@ +#!/usr/bin/env python3 +""" +Management Review Tracker - QMS Management Review Preparation and Tracking + +Tracks management review inputs, action items, and generates review reports +for ISO 13485 compliance. + +Usage: + python management_review_tracker.py --data review_data.json + python management_review_tracker.py --interactive + python management_review_tracker.py --data review_data.json --output json +""" + +import argparse +import json +import sys +from dataclasses import dataclass, field, asdict +from datetime import datetime, timedelta +from typing import List, Dict, Optional +from enum import Enum + + +class ActionStatus(Enum): + NOT_STARTED = "Not Started" + IN_PROGRESS = "In Progress" + ON_HOLD = "On Hold" + OVERDUE = "Overdue" + COMPLETE = "Complete" + VERIFIED = "Verified" + + +class ActionPriority(Enum): + HIGH = "High" + MEDIUM = "Medium" + LOW = "Low" + + +class InputStatus(Enum): + NOT_COLLECTED = "Not Collected" + IN_PROGRESS = "In Progress" + COMPLETE = "Complete" + REVIEWED = "Reviewed" + + +@dataclass +class ReviewInput: + topic: str + responsible: str + status: InputStatus + data_period: str + summary: str = "" + concerns: List[str] = field(default_factory=list) + + +@dataclass +class ActionItem: + action_id: str + description: str + owner: str + due_date: str + priority: ActionPriority + status: ActionStatus + source_review: str + category: str = "Improvement" + completion_date: Optional[str] = None + notes: str = "" + + +@dataclass +class ReviewMetrics: + complaint_rate: float = 0.0 + complaint_count: int = 0 + capa_open: int = 0 + capa_overdue: int = 0 + capa_effectiveness: float = 0.0 + audit_findings_open: int = 0 + audit_findings_major: int = 0 + first_pass_yield: float = 0.0 + customer_satisfaction: float = 0.0 + training_compliance: float = 0.0 + + +@dataclass +class ManagementReview: + review_date: str + review_type: str + period_start: str + period_end: str + inputs: List[ReviewInput] + actions: List[ActionItem] + metrics: ReviewMetrics + decisions: List[str] = field(default_factory=list) + attendees: List[str] = field(default_factory=list) + + +class ManagementReviewTracker: + """Tracks and reports management review status.""" + + # Required ISO 13485 inputs + REQUIRED_INPUTS = [ + ("Audit Results", "QA Manager"), + ("Customer Feedback", "Customer Quality"), + ("Process Performance", "Operations"), + ("Product Conformity", "QC Manager"), + ("CAPA Status", "CAPA Officer"), + ("Previous Actions", "QMR"), + ("QMS Changes", "RA Manager"), + ("Recommendations", "All Managers"), + ] + + def __init__(self, review: ManagementReview): + self.review = review + self.today = datetime.now() + + def check_input_readiness(self) -> Dict: + """Check readiness of all required inputs.""" + readiness = { + "total_required": len(self.REQUIRED_INPUTS), + "complete": 0, + "in_progress": 0, + "not_started": 0, + "missing_topics": [], + "readiness_score": 0.0 + } + + input_topics = {inp.topic: inp for inp in self.review.inputs} + + for topic, responsible in self.REQUIRED_INPUTS: + if topic in input_topics: + inp = input_topics[topic] + if inp.status in [InputStatus.COMPLETE, InputStatus.REVIEWED]: + readiness["complete"] += 1 + elif inp.status == InputStatus.IN_PROGRESS: + readiness["in_progress"] += 1 + else: + readiness["not_started"] += 1 + else: + readiness["missing_topics"].append(topic) + readiness["not_started"] += 1 + + readiness["readiness_score"] = round( + (readiness["complete"] / readiness["total_required"]) * 100, 1 + ) + + return readiness + + def analyze_actions(self) -> Dict: + """Analyze action item status.""" + analysis = { + "total": len(self.review.actions), + "by_status": {}, + "by_priority": {}, + "overdue": [], + "due_soon": [], + "completion_rate": 0.0 + } + + completed = 0 + for action in self.review.actions: + # Count by status + status = action.status.value + analysis["by_status"][status] = analysis["by_status"].get(status, 0) + 1 + + # Count by priority + priority = action.priority.value + analysis["by_priority"][priority] = analysis["by_priority"].get(priority, 0) + 1 + + # Check completion + if action.status in [ActionStatus.COMPLETE, ActionStatus.VERIFIED]: + completed += 1 + + # Check overdue + if action.due_date: + due = datetime.strptime(action.due_date, "%Y-%m-%d") + if due < self.today and action.status not in [ + ActionStatus.COMPLETE, ActionStatus.VERIFIED + ]: + days_overdue = (self.today - due).days + analysis["overdue"].append({ + "action_id": action.action_id, + "description": action.description[:50], + "owner": action.owner, + "days_overdue": days_overdue + }) + elif due <= self.today + timedelta(days=14) and action.status not in [ + ActionStatus.COMPLETE, ActionStatus.VERIFIED + ]: + days_until = (due - self.today).days + analysis["due_soon"].append({ + "action_id": action.action_id, + "description": action.description[:50], + "owner": action.owner, + "days_until_due": days_until + }) + + if analysis["total"] > 0: + analysis["completion_rate"] = round((completed / analysis["total"]) * 100, 1) + + return analysis + + def assess_metrics(self) -> Dict: + """Assess quality metrics against targets.""" + metrics = self.review.metrics + assessment = { + "metrics": [], + "alerts": [], + "overall_status": "On Track" + } + + # Define targets and assess + checks = [ + ("Complaint Rate", metrics.complaint_rate, 0.1, "lower"), + ("CAPA Overdue", metrics.capa_overdue, 0, "lower"), + ("CAPA Effectiveness", metrics.capa_effectiveness, 85.0, "higher"), + ("First Pass Yield", metrics.first_pass_yield, 95.0, "higher"), + ("Customer Satisfaction", metrics.customer_satisfaction, 4.0, "higher"), + ("Training Compliance", metrics.training_compliance, 95.0, "higher"), + ] + + warnings = 0 + critical = 0 + + for name, value, target, direction in checks: + if direction == "lower": + status = "Pass" if value <= target else "Fail" + threshold = target * 1.2 + warning = value > target and value <= threshold + else: + status = "Pass" if value >= target else "Fail" + threshold = target * 0.9 + warning = value < target and value >= threshold + + metric_result = { + "name": name, + "value": value, + "target": target, + "status": status + } + assessment["metrics"].append(metric_result) + + if status == "Fail": + if warning: + warnings += 1 + assessment["alerts"].append(f"WARNING: {name} at {value} (target: {target})") + else: + critical += 1 + assessment["alerts"].append(f"CRITICAL: {name} at {value} (target: {target})") + + if critical > 0: + assessment["overall_status"] = "Critical" + elif warnings > 0: + assessment["overall_status"] = "Needs Attention" + + return assessment + + def generate_recommendations(self) -> List[str]: + """Generate recommendations based on analysis.""" + recommendations = [] + + # Check input readiness + readiness = self.check_input_readiness() + if readiness["readiness_score"] < 100: + recommendations.append( + f"Complete remaining review inputs: {', '.join(readiness['missing_topics'])}" + ) + + # Check actions + action_analysis = self.analyze_actions() + if action_analysis["overdue"]: + recommendations.append( + f"Address {len(action_analysis['overdue'])} overdue action(s) immediately" + ) + + # Check metrics + metrics_assessment = self.assess_metrics() + if metrics_assessment["overall_status"] == "Critical": + recommendations.append( + "Escalate critical metric failures to senior management" + ) + + # CAPA specific + if self.review.metrics.capa_overdue > 0: + recommendations.append( + f"Expedite closure of {self.review.metrics.capa_overdue} overdue CAPA(s)" + ) + + if self.review.metrics.capa_effectiveness < 85: + recommendations.append( + "Review root cause analysis quality for ineffective CAPAs" + ) + + # Audit findings + if self.review.metrics.audit_findings_major > 0: + recommendations.append( + f"Prioritize resolution of {self.review.metrics.audit_findings_major} major audit finding(s)" + ) + + if not recommendations: + recommendations.append("Quality system performing within targets. Maintain monitoring.") + + return recommendations + + def generate_report(self) -> Dict: + """Generate complete review status report.""" + return { + "review_date": self.review.review_date, + "review_type": self.review.review_type, + "period": f"{self.review.period_start} to {self.review.period_end}", + "input_readiness": self.check_input_readiness(), + "action_analysis": self.analyze_actions(), + "metrics_assessment": self.assess_metrics(), + "recommendations": self.generate_recommendations() + } + + +def format_text_report(report: Dict) -> str: + """Format report as text output.""" + lines = [ + "=" * 70, + "MANAGEMENT REVIEW STATUS REPORT", + "=" * 70, + f"Review Date: {report['review_date']}", + f"Review Type: {report['review_type']}", + f"Period: {report['period']}", + "", + "INPUT READINESS", + "-" * 40, + f"Readiness Score: {report['input_readiness']['readiness_score']}%", + f"Complete: {report['input_readiness']['complete']} / {report['input_readiness']['total_required']}", + ] + + if report['input_readiness']['missing_topics']: + lines.append(f"Missing: {', '.join(report['input_readiness']['missing_topics'])}") + + lines.extend([ + "", + "ACTION STATUS", + "-" * 40, + f"Total Actions: {report['action_analysis']['total']}", + f"Completion Rate: {report['action_analysis']['completion_rate']}%", + ]) + + for status, count in report['action_analysis']['by_status'].items(): + lines.append(f" {status}: {count}") + + if report['action_analysis']['overdue']: + lines.extend([ + "", + "OVERDUE ACTIONS:", + ]) + for item in report['action_analysis']['overdue']: + lines.append(f" [{item['action_id']}] {item['description']} - {item['days_overdue']} days overdue") + + lines.extend([ + "", + "METRICS ASSESSMENT", + "-" * 40, + f"Overall Status: {report['metrics_assessment']['overall_status']}", + "", + f"{'Metric':<25} {'Value':<10} {'Target':<10} {'Status':<10}", + "-" * 55, + ]) + + for metric in report['metrics_assessment']['metrics']: + lines.append( + f"{metric['name']:<25} {metric['value']:<10} {metric['target']:<10} {metric['status']:<10}" + ) + + if report['metrics_assessment']['alerts']: + lines.extend([ + "", + "ALERTS:", + ]) + for alert in report['metrics_assessment']['alerts']: + lines.append(f" ! {alert}") + + lines.extend([ + "", + "RECOMMENDATIONS", + "-" * 40, + ]) + + for i, rec in enumerate(report['recommendations'], 1): + lines.append(f"{i}. {rec}") + + lines.append("=" * 70) + return "\n".join(lines) + + +def interactive_mode(): + """Run interactive review data entry.""" + print("=" * 60) + print("Management Review Tracker - Interactive Mode") + print("=" * 60) + + review_date = input("\nReview Date (YYYY-MM-DD): ").strip() + review_type = input("Review Type (Annual/Semi-annual/Quarterly): ").strip() + period_start = input("Period Start (YYYY-MM-DD): ").strip() + period_end = input("Period End (YYYY-MM-DD): ").strip() + + print("\nEnter Quality Metrics:") + metrics = ReviewMetrics( + complaint_rate=float(input("Complaint Rate (%): ") or 0), + complaint_count=int(input("Complaint Count: ") or 0), + capa_open=int(input("Open CAPAs: ") or 0), + capa_overdue=int(input("Overdue CAPAs: ") or 0), + capa_effectiveness=float(input("CAPA Effectiveness (%): ") or 0), + audit_findings_open=int(input("Open Audit Findings: ") or 0), + audit_findings_major=int(input("Major Audit Findings: ") or 0), + first_pass_yield=float(input("First Pass Yield (%): ") or 0), + customer_satisfaction=float(input("Customer Satisfaction (1-5): ") or 0), + training_compliance=float(input("Training Compliance (%): ") or 0) + ) + + # Create review with sample inputs + inputs = [ + ReviewInput(topic=topic, responsible=resp, status=InputStatus.COMPLETE, data_period=f"{period_start} to {period_end}") + for topic, resp in ManagementReviewTracker.REQUIRED_INPUTS + ] + + review = ManagementReview( + review_date=review_date, + review_type=review_type, + period_start=period_start, + period_end=period_end, + inputs=inputs, + actions=[], + metrics=metrics + ) + + tracker = ManagementReviewTracker(review) + report = tracker.generate_report() + print("\n" + format_text_report(report)) + + +def main(): + parser = argparse.ArgumentParser( + description="Management Review Tracker" + ) + parser.add_argument( + "--data", + type=str, + help="JSON file with review data" + ) + parser.add_argument( + "--output", + choices=["text", "json"], + default="text", + help="Output format" + ) + parser.add_argument( + "--interactive", + action="store_true", + help="Run in interactive mode" + ) + parser.add_argument( + "--sample", + action="store_true", + help="Generate sample review data" + ) + + args = parser.parse_args() + + if args.interactive: + interactive_mode() + return + + if args.sample: + sample = { + "review_date": "2024-06-30", + "review_type": "Semi-annual", + "period_start": "2024-01-01", + "period_end": "2024-06-30", + "inputs": [ + {"topic": "Audit Results", "responsible": "QA Manager", "status": "Complete", "data_period": "H1 2024"}, + {"topic": "Customer Feedback", "responsible": "Customer Quality", "status": "Complete", "data_period": "H1 2024"}, + {"topic": "Process Performance", "responsible": "Operations", "status": "In Progress", "data_period": "H1 2024"}, + {"topic": "CAPA Status", "responsible": "CAPA Officer", "status": "Complete", "data_period": "Current"} + ], + "actions": [ + { + "action_id": "MR-2024-001", + "description": "Implement enhanced CAPA tracking system", + "owner": "QA Manager", + "due_date": "2024-09-30", + "priority": "High", + "status": "In Progress", + "source_review": "2024-Q1" + } + ], + "metrics": { + "complaint_rate": 0.08, + "complaint_count": 12, + "capa_open": 8, + "capa_overdue": 2, + "capa_effectiveness": 88.0, + "audit_findings_open": 5, + "audit_findings_major": 1, + "first_pass_yield": 96.5, + "customer_satisfaction": 4.2, + "training_compliance": 97.0 + } + } + print(json.dumps(sample, indent=2)) + return + + # Create sample review if no data provided + if args.data: + with open(args.data, "r") as f: + data = json.load(f) + + inputs = [ + ReviewInput( + topic=inp["topic"], + responsible=inp["responsible"], + status=InputStatus[inp["status"].upper().replace(" ", "_")], + data_period=inp.get("data_period", "") + ) + for inp in data.get("inputs", []) + ] + + actions = [ + ActionItem( + action_id=act["action_id"], + description=act["description"], + owner=act["owner"], + due_date=act["due_date"], + priority=ActionPriority[act["priority"].upper()], + status=ActionStatus[act["status"].upper().replace(" ", "_")], + source_review=act.get("source_review", "") + ) + for act in data.get("actions", []) + ] + + metrics_data = data.get("metrics", {}) + metrics = ReviewMetrics(**metrics_data) + + review = ManagementReview( + review_date=data["review_date"], + review_type=data["review_type"], + period_start=data["period_start"], + period_end=data["period_end"], + inputs=inputs, + actions=actions, + metrics=metrics + ) + else: + # Demo data + review = ManagementReview( + review_date="2024-06-30", + review_type="Semi-annual", + period_start="2024-01-01", + period_end="2024-06-30", + inputs=[ + ReviewInput("Audit Results", "QA Manager", InputStatus.COMPLETE, "H1 2024"), + ReviewInput("Customer Feedback", "Customer Quality", InputStatus.COMPLETE, "H1 2024"), + ReviewInput("CAPA Status", "CAPA Officer", InputStatus.COMPLETE, "Current"), + ], + actions=[ + ActionItem("MR-2024-001", "Implement CAPA tracking", "QA Mgr", "2024-09-30", + ActionPriority.HIGH, ActionStatus.IN_PROGRESS, "2024-Q1"), + ], + metrics=ReviewMetrics( + complaint_rate=0.08, capa_open=8, capa_overdue=2, + capa_effectiveness=88.0, first_pass_yield=96.5, + customer_satisfaction=4.2, training_compliance=97.0 + ) + ) + + tracker = ManagementReviewTracker(review) + report = tracker.generate_report() + + if args.output == "json": + print(json.dumps(report, indent=2)) + else: + print(format_text_report(report)) + + +if __name__ == "__main__": + main()