quality-manager-qmr

Malicious tool definition detected

Tool: SKILL.md [1/3] Description: --- name: quality-manager-qmr description: Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies.

Tool: SKILL.md [2/3] Description: | 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 | ### KPI Review Frequency | KPI Type | Review Frequency | Trend Period | Audience | |-

Tool: SKILL.md [3/3] Description: | ☐ | | | 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?

Malicious tool definition detected

Tool: references/management-review-guide.md [1/2] Description: # Management Review Guide ISO 13485 Clause 5.6 management review requirements, inputs, outputs, and action tracking.

Tool: references/management-review-guide.md [2/2] Description: target] | [+/-] | [Why] | 4.

Malicious tool definition detected

Tool: references/quality-kpi-framework.md [1/2] Description: # Quality KPI Framework Quality performance indicators, targets, and monitoring guidelines for QMS effectiveness.

Description: | (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 | Rewo

Malicious tool definition detected

Tool: scripts/management_review_tracker.py [1/2] Description: #!/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.

Tool: scripts/management_review_tracker.py [2/2] Description: * 70) return " ".join(lines) def interactive_mode(): """Run interactive review data entry.""" print("=" * 60) print("Management Review Tracker - Interactive Mode") print("=" * 60) review_date = input("