quality-manager-qmr

What this skill does

# Senior Quality Manager Responsible Person (QMR)

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.

---

## 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

The agent conducts management reviews per ISO 13485 Clause 5.6 requirements.

### Workflow: Prepare and Execute Management Review

1. **Schedule management review** -- minimum annually per ISO 13485; quarterly or semi-annual cadence recommended for active QMS.
2. **Notify required attendees** minimum 2 weeks prior -- CEO/GM, department heads, RA Manager, Production Manager, Customer Quality lead.
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 covering the review period.
5. **Prepare presentation materials** with supporting data and visualizations.
6. **Distribute agenda and input package** 1 week prior to the meeting.
7. **Conduct review meeting** per agenda -- ensure all required inputs are discussed.
8. **Validation checkpoint:** All ISO 13485 Clause 5.6.2 inputs reviewed; decisions documented with owners and due dates; outputs satisfy Clause 5.6.3 requirements.

### Example: Management Review Input Summary

```
MANAGEMENT REVIEW INPUT SUMMARY

Review Period: 2025-Q3 to 2025-Q4
Review Date: 2026-01-20
Prepared By: J. Mueller, QMR

1. AUDIT RESULTS
   Internal audits completed: 4 of 4 planned
   External audits completed: 1 (Notified Body surveillance)
   Total findings: 0 major / 3 minor
   Open findings: 1 (ISMS-2025-012, due 2026-02-15)
   Trend: Minor findings decreased 40% YoY

2. CUSTOMER FEEDBACK
   Complaints received: 12
   Complaint rate: 0.08 per 1000 units (target: <0.1)
   Customer satisfaction score: 4.2/5.0 (target: >4.0)
   Returns: 3 units (0.02%)
   Top issues: Labeling clarity (5), packaging damage (3)

3. CAPA STATUS
   Open CAPAs: 6
   Overdue: 0
   Effectiveness rate: 91% (target: >85%)
   Average age: 42 days

4. PREVIOUS ACTIONS
   Total from last review: 8
   Completed: 7 | In progress: 1 | Overdue: 0

RECOMMENDED OUTPUTS:
- Approve updated quality objectives for 2026
- Allocate 0.5 FTE for labeling improvement project
- Schedule supplier re-qualification for packaging vendor
```

### Management Review Output Requirements

| 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 |

See: [references/management-review-guide.md](references/management-review-guide.md)

---

## Quality KPI Management Workflow

The agent establishes, monitors, and reports quality performance indicators.

### Workflow: Establish Quality KPI Framework

1. **Identify quality objectives** requiring measurement -- align each KPI to a specific objective.
2. **Select KPIs** per objective using SMART criteria: Specific (clear calculation), Measurable (quantifiable), Actionable (team can influence), Relevant (aligned to objectives), Time-bound (defined frequency).
3. **Define target values** based on baseline data and industry benchmarks.
4. **Assign data source** and collection responsibility for each KPI.
5. **Establish reporting frequency** per KPI category (see table below).
6. **Configure dashboard** displays and trend analysis views.
7. **Define escalation thresholds** and alert triggers for each KPI.
8. **Validation checkpoint:** Each KPI has an assigned owner, measurable target, identified data source, and documented escalation criteria.

### Core Quality KPIs

| Category | KPI | Target | Calculation |
|----------|-----|--------|-------------|
| Process | First Pass Yield | >95% | (Units passed first time / Total units) x 100 |
| Process | Nonconformance Rate | <1% | (NC count / Total units) x 100 |
| CAPA | CAPA Closure Rate | >90% | (On-time closures / Due closures) x 100 |
| CAPA | CAPA Effectiveness | >85% | (Effective CAPAs / Verified CAPAs) x 100 |
| Audit | Finding Closure Rate | >90% | (On-time closures / Due closures) x 100 |
| Audit | Repeat Finding Rate | <10% | (Repeat findings / Total findings) x 100 |
| Customer | Complaint Rate | <0.1% | (Complaints / Units sold) x 100 |
| Customer | Satisfaction Score | >4.0/5.0 | Average of survey scores |

### KPI Review Frequency

| 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 |

### Performance Response Matrix

| 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 |

See: [references/quality-kpi-framework.md](references/quality-kpi-framework.md)

---

## Quality Objectives Workflow

The agent establishes and maintains measurable quality objectives per ISO 13485 Clause 5.4.1.

### Workflow: Annual Quality Objectives Setting

1. **Review prior year** objective achievement -- document status of each objective.
2. **Analyze quality performance** trends and gaps from KPI data.
3. **Align with organizational strategic plan** -- map objectives to business priorities.
4. **Draft objectives** with measurable targets using the structure below.
5. **Validate resource availability** for achievement of each objective.