diff --git a/.codex/skills-index.json b/.codex/skills-index.json
index dc7f48a..0187498 100644
--- a/.codex/skills-index.json
+++ b/.codex/skills-index.json
@@ -255,7 +255,7 @@
       "name": "risk-management-specialist",
       "source": "../../ra-qm-team/risk-management-specialist",
       "category": "ra-qm",
-      "description": "Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance."
+      "description": "Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis."
     }
   ],
   "categories": {
diff --git a/ra-qm-team/risk-management-specialist/SKILL.md b/ra-qm-team/risk-management-specialist/SKILL.md
index c41223e..69cd6d9 100644
--- a/ra-qm-team/risk-management-specialist/SKILL.md
+++ b/ra-qm-team/risk-management-specialist/SKILL.md
@@ -1,225 +1,537 @@
 ---
 name: risk-management-specialist
-description: Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance.
+description: Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
+triggers:
+  - risk management
+  - ISO 14971
+  - risk analysis
+  - FMEA
+  - fault tree analysis
+  - hazard identification
+  - risk control
+  - risk matrix
+  - benefit-risk analysis
+  - residual risk
+  - risk acceptability
+  - post-market risk
 ---
 
-# Senior Risk Management Specialist
+# Risk Management Specialist
 
-Expert-level medical device risk management implementing ISO 14971 throughout the complete product lifecycle with comprehensive risk analysis, evaluation, control, and post-production monitoring capabilities.
+ISO 14971:2019 risk management implementation throughout the medical device lifecycle.
 
-## Core Risk Management Competencies
+---
 
-### 1. Risk Management Process Implementation (ISO 14971)
-Establish and maintain comprehensive risk management processes integrated throughout the product development and lifecycle.
+## Table of Contents
+
+- [Risk Management Planning Workflow](#risk-management-planning-workflow)
+- [Risk Analysis Workflow](#risk-analysis-workflow)
+- [Risk Evaluation Workflow](#risk-evaluation-workflow)
+- [Risk Control Workflow](#risk-control-workflow)
+- [Post-Production Risk Management](#post-production-risk-management)
+- [Risk Assessment Templates](#risk-assessment-templates)
+- [Decision Frameworks](#decision-frameworks)
+- [Tools and References](#tools-and-references)
+
+---
+
+## Risk Management Planning Workflow
+
+Establish risk management process per ISO 14971.
+
+### Workflow: Create Risk Management Plan
+
+1. Define scope of risk management activities:
+   - Medical device identification
+   - Lifecycle stages covered
+   - Applicable standards and regulations
+2. Establish risk acceptability criteria:
+   - Define probability categories (P1-P5)
+   - Define severity categories (S1-S5)
+   - Create risk matrix with acceptance thresholds
+3. Assign responsibilities:
+   - Risk management lead
+   - Subject matter experts
+   - Approval authorities
+4. Define verification activities:
+   - Methods for control verification
+   - Acceptance criteria
+5. Plan production and post-production activities:
+   - Information sources
+   - Review triggers
+   - Update procedures
+6. Obtain plan approval
+7. Establish risk management file
+8. **Validation:** Plan approved; acceptability criteria defined; responsibilities assigned; file established
+
+### Risk Management Plan Content
+
+| Section | Content | Evidence |
+|---------|---------|----------|
+| Scope | Device and lifecycle coverage | Scope statement |
+| Criteria | Risk acceptability matrix | Risk matrix document |
+| Responsibilities | Roles and authorities | RACI chart |
+| Verification | Methods and acceptance | Verification plan |
+| Production/Post-Production | Monitoring activities | Surveillance plan |
+
+### Risk Acceptability Matrix (5x5)
+
+| Probability \ Severity | Negligible | Minor | Serious | Critical | Catastrophic |
+|------------------------|------------|-------|---------|----------|--------------|
+| **Frequent (P5)** | Medium | High | High | Unacceptable | Unacceptable |
+| **Probable (P4)** | Medium | Medium | High | High | Unacceptable |
+| **Occasional (P3)** | Low | Medium | Medium | High | High |
+| **Remote (P2)** | Low | Low | Medium | Medium | High |
+| **Improbable (P1)** | Low | Low | Low | Medium | Medium |
+
+### Risk Level Actions
+
+| Level | Acceptable | Action Required |
+|-------|------------|-----------------|
+| Low | Yes | Document and accept |
+| Medium | ALARP | Reduce if practicable; document rationale |
+| High | ALARP | Reduction required; demonstrate ALARP |
+| Unacceptable | No | Design change mandatory |
+
+---
+
+## Risk Analysis Workflow
+
+Identify hazards and estimate risks systematically.
+
+### Workflow: Conduct Risk Analysis
+
+1. Define intended use and reasonably foreseeable misuse:
+   - Medical indication
+   - Patient population
+   - User population
+   - Use environment
+2. Select analysis method(s):
+   - FMEA for component/function analysis
+   - FTA for system-level analysis
+   - HAZOP for process deviations
+   - Use Error Analysis for user interaction
+3. Identify hazards by category:
+   - Energy hazards (electrical, mechanical, thermal)
+   - Biological hazards (bioburden, biocompatibility)
+   - Chemical hazards (residues, leachables)
+   - Operational hazards (software, use errors)
+4. Determine hazardous situations:
+   - Sequence of events
+   - Foreseeable misuse scenarios
+   - Single fault conditions
+5. Estimate probability of harm (P1-P5)
+6. Estimate severity of harm (S1-S5)
+7. Document in hazard analysis worksheet
+8. **Validation:** All hazard categories addressed; all hazards documented; probability and severity assigned
+
+### Hazard Categories Checklist
+
+| Category | Examples | Analyzed |
+|----------|----------|----------|
+| Electrical | Shock, burns, interference | ☐ |
+| Mechanical | Crushing, cutting, entrapment | ☐ |
+| Thermal | Burns, tissue damage | ☐ |
+| Radiation | Ionizing, non-ionizing | ☐ |
+| Biological | Infection, biocompatibility | ☐ |
+| Chemical | Toxicity, irritation | ☐ |
+| Software | Incorrect output, timing | ☐ |
+| Use Error | Misuse, perception, cognition | ☐ |
+| Environment | EMC, mechanical stress | ☐ |
+
+### Analysis Method Selection
+
+| Situation | Recommended Method |
+|-----------|-------------------|
+| Component failures | FMEA |
+| System-level failure | FTA |
+| Process deviations | HAZOP |
+| User interaction | Use Error Analysis |
+| Software behavior | Software FMEA |
+| Early design phase | PHA |
+
+### Probability Criteria
+
+| Level | Name | Description | Frequency |
+|-------|------|-------------|-----------|
+| P5 | Frequent | Expected to occur | >10⁻³ |
+| P4 | Probable | Likely to occur | 10⁻³ to 10⁻⁴ |
+| P3 | Occasional | May occur | 10⁻⁴ to 10⁻⁵ |
+| P2 | Remote | Unlikely | 10⁻⁵ to 10⁻⁶ |
+| P1 | Improbable | Very unlikely | <10⁻⁶ |
+
+### Severity Criteria
+
+| Level | Name | Description | Harm |
+|-------|------|-------------|------|
+| S5 | Catastrophic | Death | Death |
+| S4 | Critical | Permanent impairment | Irreversible injury |
+| S3 | Serious | Injury requiring intervention | Reversible injury |
+| S2 | Minor | Temporary discomfort | No treatment needed |
+| S1 | Negligible | Inconvenience | No injury |
+
+See: [references/risk-analysis-methods.md](references/risk-analysis-methods.md)
+
+---
+
+## Risk Evaluation Workflow
+
+Evaluate risks against acceptability criteria.
+
+### Workflow: Evaluate Identified Risks
+
+1. Calculate initial risk level from probability × severity
+2. Compare to risk acceptability criteria
+3. For each risk, determine:
+   - Acceptable: Document and accept
+   - ALARP: Proceed to risk control
+   - Unacceptable: Mandatory risk control
+4. Document evaluation rationale
+5. Identify risks requiring benefit-risk analysis
+6. Complete benefit-risk analysis if applicable
+7. Compile risk evaluation summary
+8. **Validation:** All risks evaluated; acceptability determined; rationale documented
+
+### Risk Evaluation Decision Tree
 
-**Risk Management Process Framework:**
 ```
-ISO 14971 RISK MANAGEMENT PROCESS
-├── Risk Management Planning
-│   ├── Risk management plan development
-│   ├── Risk acceptability criteria definition
-│   ├── Risk management team formation
-│   └── Risk management file establishment
-├── Risk Analysis
-│   ├── Intended use and reasonably foreseeable misuse
-│   ├── Hazard identification and analysis
-│   ├── Hazardous situation evaluation
-│   └── Risk estimation and documentation
-├── Risk Evaluation
-│   ├── Risk acceptability assessment
-│   ├── Risk benefit analysis
-│   ├── Risk control necessity determination
-│   └── Risk evaluation documentation
-├── Risk Control
-│   ├── Risk control option analysis
-│   ├── Risk control measure implementation
-│   ├── Residual risk evaluation
-│   └── Risk control effectiveness verification
-└── Production and Post-Production Information
-    ├── Information collection and analysis
-    ├── Risk management file updates
-    ├── Risk benefit analysis review
-    └── Risk control measure adjustment
+Risk Estimated
+      │
+      ▼
+Apply Acceptability Criteria
+      │
+      ├── Low Risk ──────────► Accept and document
+      │
+      ├── Medium Risk ───────► Consider risk reduction
+      │   │                    Document ALARP if not reduced
+      │   ▼
+      │   Practicable to reduce?
+      │   │
+      │   Yes──► Implement control
+      │   No───► Document ALARP rationale
+      │
+      ├── High Risk ─────────► Risk reduction required
+      │   │                    Must demonstrate ALARP
+      │   ▼
+      │   Implement control
+      │   Verify residual risk
+      │
+      └── Unacceptable ──────► Design change mandatory
+                               Cannot proceed without control
 ```
 
-### 2. Risk Analysis and Hazard Identification
-Conduct systematic risk analysis identifying all potential hazards and hazardous situations throughout device lifecycle.
+### ALARP Demonstration Requirements
 
-**Risk Analysis Methodology:**
-1. **Intended Use and Context Analysis**
-   - Medical indication and patient population
-   - Use environment and conditions
-   - User characteristics and training
-   - **Decision Point**: Define scope of risk analysis
+| Criterion | Evidence Required |
+|-----------|-------------------|
+| Technical feasibility | Analysis of alternative controls |
+| Proportionality | Cost-benefit of further reduction |
+| State of the art | Comparison to similar devices |
+| Stakeholder input | Clinical/user perspectives |
 
-2. **Hazard Identification Process**
-   - **For Hardware Components**: Mechanical, electrical, thermal, chemical hazards
-   - **For Software Components**: Software failure modes per IEC 62304
-   - **For Combination Products**: Drug-device interaction risks
-   - **For Connected Devices**: Cybersecurity and data privacy risks
+### Benefit-Risk Analysis Triggers
 
-3. **Hazardous Situation Analysis**
-   - Sequence of events leading to hazardous situations
-   - Foreseeable misuse and use error scenarios
-   - Single fault condition analysis
-   - Multiple fault condition evaluation
+| Situation | Benefit-Risk Required |
+|-----------|----------------------|
+| Residual risk remains high | Yes |
+| No feasible risk reduction | Yes |
+| Novel device | Yes |
+| Unacceptable risk with clinical benefit | Yes |
+| All risks low | No |
 
-### 3. Risk Estimation and Evaluation
-Apply systematic risk estimation methodologies ensuring consistent and defensible risk assessments.
+---
 
-**Risk Estimation Framework:**
-- **Probability Assessment**: Statistical data, literature, expert judgment
-- **Severity Assessment**: Clinical outcome evaluation and classification
-- **Risk Level Determination**: Risk matrix application and documentation
-- **Risk Acceptability Evaluation**: Criteria application and justification
+## Risk Control Workflow
+
+Implement and verify risk control measures.
+
+### Workflow: Implement Risk Controls
+
+1. Identify risk control options:
+   - Inherent safety by design (Priority 1)
+   - Protective measures in device (Priority 2)
+   - Information for safety (Priority 3)
+2. Select optimal control following hierarchy
+3. Analyze control for new hazards introduced
+4. Document control in design requirements
+5. Implement control in design
+6. Develop verification protocol
+7. Execute verification and document results
+8. Evaluate residual risk with control in place
+9. **Validation:** Control implemented; verification passed; residual risk acceptable; no unaddressed new hazards
+
+### Risk Control Hierarchy
+
+| Priority | Control Type | Examples | Effectiveness |
+|----------|--------------|----------|---------------|
+| 1 | Inherent Safety | Eliminate hazard, fail-safe design | Highest |
+| 2 | Protective Measures | Guards, alarms, automatic shutdown | High |
+| 3 | Information | Warnings, training, IFU | Lower |
+
+### Risk Control Option Analysis Template
 
-**Risk Evaluation Decision Tree:**
 ```
-RISK EVALUATION PROCESS
-├── Is Risk Acceptable? (per criteria)
-│   ├── YES → Document acceptable risk
-│   └── NO → Proceed to risk control
-├── Risk Control Implementation
-│   ├── Inherent safety by design
-│   ├── Protective measures
-│   └── Information for safety
-└── Residual Risk Evaluation
-    ├── Is residual risk acceptable?
-    ├── Risk benefit analysis
-    └── Final risk acceptability decision
+RISK CONTROL OPTION ANALYSIS
+
+Hazard ID: H-[XXX]
+Hazard: [Description]
+Initial Risk: P[X] × S[X] = [Level]
+
+OPTIONS CONSIDERED:
+| Option | Control Type | New Hazards | Feasibility | Selected |
+|--------|--------------|-------------|-------------|----------|
+| 1 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] |
+| 2 | [Type] | [Yes/No] | [H/M/L] | [Yes/No] |
+
+SELECTED CONTROL: Option [X]
+Rationale: [Justification for selection]
+
+IMPLEMENTATION:
+- Requirement: [REQ-XXX]
+- Design Document: [Reference]
+
+VERIFICATION:
+- Method: [Test/Analysis/Review]
+- Protocol: [Reference]
+- Acceptance Criteria: [Criteria]
 ```
 
-### 4. Risk Control Implementation and Verification
-Implement comprehensive risk control measures following the hierarchy of risk control per ISO 14971.
+### Risk Control Verification Methods
 
-**Risk Control Hierarchy:**
-1. **Inherent Safety by Design**
-   - Design modifications eliminating hazards
-   - Fail-safe design implementation
-   - Redundancy and diversity application
-   - Human factors engineering integration
+| Method | When to Use | Evidence |
+|--------|-------------|----------|
+| Test | Quantifiable performance | Test report |
+| Inspection | Physical presence | Inspection record |
+| Analysis | Design calculation | Analysis report |
+| Review | Documentation check | Review record |
 
-2. **Protective Measures in the Medical Device**
-   - Alarms and alert systems
-   - Automatic shut-off mechanisms
-   - Physical barriers and shields
-   - Software safety functions
+### Residual Risk Evaluation
 
-3. **Information for Safety**
-   - User training and education
-   - Labeling and instructions for use
-   - Warning systems and alerts
-   - Contraindications and precautions
+| After Control | Action |
+|---------------|--------|
+| Acceptable | Document, proceed |
+| ALARP achieved | Document rationale, proceed |
+| Still unacceptable | Additional control or design change |
+| New hazard introduced | Analyze and control new hazard |
 
-**Risk Control Verification:**
-- Risk control effectiveness testing and validation
-- Verification protocol development and execution
-- Test results analysis and documentation
-- Risk control performance monitoring
+---
 
-## Advanced Risk Management Applications
+## Post-Production Risk Management
 
-### Software Risk Management (IEC 62304 Integration)
-Integrate software lifecycle processes with risk management ensuring comprehensive software safety assessment.
+Monitor and update risk management throughout product lifecycle.
 
-**Software Risk Management Process:**
-- **Software Safety Classification**: Class A, B, or C determination
-- **Software Hazard Analysis**: Software contribution to hazardous situations
-- **Software Risk Control**: Architecture and design safety measures
-- **Software Risk Management File**: Integration with overall risk management file
+### Workflow: Post-Production Risk Monitoring
 
-### Cybersecurity Risk Management
-Implement cybersecurity risk management per FDA guidance and emerging international standards.
+1. Identify information sources:
+   - Customer complaints
+   - Service reports
+   - Vigilance/adverse events
+   - Literature monitoring
+   - Clinical studies
+2. Establish collection procedures
+3. Define review triggers:
+   - New hazard identified
+   - Increased frequency of known hazard
+   - Serious incident
+   - Regulatory feedback
+4. Analyze incoming information for risk relevance
+5. Update risk management file as needed
+6. Communicate significant findings
+7. Conduct periodic risk management review
+8. **Validation:** Information sources monitored; file current; reviews completed per schedule
 
-**Cybersecurity Risk Framework:**
-1. **Cybersecurity Threat Modeling**
-   - Asset identification and vulnerability assessment
-   - Threat source analysis and attack vector evaluation
-   - Impact assessment on patient safety and device functionality
-   - Cybersecurity risk estimation and prioritization
+### Information Sources
 
-2. **Cybersecurity Controls Implementation**
-   - **Preventive Controls**: Authentication, authorization, encryption
-   - **Detective Controls**: Monitoring, logging, intrusion detection
-   - **Corrective Controls**: Incident response, recovery procedures
-   - **Compensating Controls**: Additional safeguards and mitigations
+| Source | Information Type | Review Frequency |
+|--------|------------------|------------------|
+| Complaints | Use issues, failures | Continuous |
+| Service | Field failures, repairs | Monthly |
+| Vigilance | Serious incidents | Immediate |
+| Literature | Similar device issues | Quarterly |
+| Regulatory | Authority feedback | As received |
+| Clinical | PMCF data | Per plan |
 
-### Human Factors and Use Error Risk Management
-Integrate human factors engineering with risk management addressing use-related risks.
+### Risk Management File Update Triggers
 
-**Use Error Risk Management:**
-- **Use-Related Risk Analysis**: Task analysis and use scenario evaluation
-- **Use Error Identification**: Critical task and use error analysis
-- **Use Error Risk Estimation**: Probability and severity assessment
-- **Use Error Risk Control**: Design controls and user interface optimization
+| Trigger | Response Time | Action |
+|---------|---------------|--------|
+| Serious incident | Immediate | Full risk review |
+| New hazard identified | 30 days | Risk analysis update |
+| Trend increase | 60 days | Trend analysis |
+| Design change | Before implementation | Impact assessment |
+| Standards update | Per transition period | Gap analysis |
 
-## Risk Management File Management
+### Periodic Review Requirements
 
-### Risk Management Documentation
-Maintain comprehensive risk management files ensuring traceability and regulatory compliance.
+| Review Element | Frequency |
+|----------------|-----------|
+| Risk management file completeness | Annual |
+| Risk control effectiveness | Annual |
+| Post-market information analysis | Quarterly |
+| Risk-benefit conclusions | Annual or on new data |
 
-**Risk Management File Structure:**
-- **Risk Management Plan**: Objectives, scope, criteria, and responsibilities
-- **Risk Analysis Records**: Hazard identification, risk estimation, evaluation
-- **Risk Control Records**: Control measures, verification, validation results
-- **Production and Post-Production Information**: Surveillance data, updates
-- **Risk Management Report**: Summary of risk management activities and conclusions
+---
 
-### Risk Management File Maintenance
-Ensure risk management files remain current throughout product lifecycle.
+## Risk Assessment Templates
 
-**File Maintenance Protocol:**
-- **Design Change Impact Assessment**: Risk analysis updates for design changes
-- **Post-Market Information Integration**: Surveillance data incorporation
-- **Risk Control Effectiveness Review**: Ongoing effectiveness verification
-- **Periodic Risk Management Review**: Systematic file review and updates
+### Hazard Analysis Worksheet
 
-## Cross-functional Integration
+```
+HAZARD ANALYSIS WORKSHEET
 
-### Quality Management System Integration
-Ensure seamless integration of risk management with quality management system processes.
+Product: [Device Name]
+Document: HA-[Product]-[Rev]
+Analyst: [Name]
+Date: [Date]
 
-**QMS-Risk Management Interface:**
-- **Design Controls**: Risk management integration in design and development
-- **Document Control**: Risk management file configuration management
-- **CAPA Integration**: Risk assessment for corrective and preventive actions
-- **Management Review**: Risk management performance reporting
+| ID | Hazard | Hazardous Situation | Harm | P | S | Initial Risk | Control | Residual P | Residual S | Final Risk |
+|----|--------|---------------------|------|---|---|--------------|---------|------------|------------|------------|
+| H-001 | [Hazard] | [Situation] | [Harm] | [1-5] | [1-5] | [Level] | [Control ref] | [1-5] | [1-5] | [Level] |
+```
 
-### Regulatory Submission Integration
-Coordinate risk management documentation with regulatory submission requirements.
+### FMEA Worksheet
 
-**Regulatory Integration Points:**
-- **FDA Submissions**: Risk analysis and risk management summaries
-- **EU MDR Technical Documentation**: Risk management file integration
-- **ISO 13485 Certification**: Risk management process compliance
-- **Post-Market Requirements**: Risk management in post-market surveillance
+```
+FMEA WORKSHEET
 
-### Clinical and Post-Market Integration
-Integrate risk management with clinical evaluation and post-market surveillance activities.
+Product: [Device Name]
+Subsystem: [Subsystem]
+Analyst: [Name]
+Date: [Date]
 
-**Clinical-Risk Interface:**
-- **Clinical Risk Assessment**: Clinical data integration with risk analysis
-- **Clinical Investigation**: Risk management in clinical study design
-- **Post-Market Surveillance**: Risk signal detection and evaluation
-- **Clinical Evaluation Updates**: Risk-benefit analysis integration
+| ID | Item | Function | Failure Mode | Effect | S | Cause | O | Control | D | RPN | Action |
+|----|------|----------|--------------|--------|---|-------|---|---------|---|-----|--------|
+| FM-001 | [Item] | [Function] | [Mode] | [Effect] | [1-10] | [Cause] | [1-10] | [Detection] | [1-10] | [S×O×D] | [Action] |
 
-## Resources
+RPN Action Thresholds:
+>200: Critical - Immediate action
+100-200: High - Action plan required
+50-100: Medium - Consider action
+<50: Low - Monitor
+```
 
-### scripts/
-- `risk-assessment-automation.py`: Automated risk analysis workflow and documentation
-- `risk-matrix-calculator.py`: Risk estimation and evaluation automation
-- `risk-control-tracker.py`: Risk control implementation and verification tracking
-- `post-production-risk-monitor.py`: Post-market risk information analysis
+### Risk Management Report Summary
 
-### references/
-- `iso14971-implementation-guide.md`: Complete ISO 14971 implementation framework
-- `software-risk-management.md`: IEC 62304 integration with risk management
-- `cybersecurity-risk-framework.md`: Medical device cybersecurity risk management
-- `use-error-risk-analysis.md`: Human factors risk management methodologies
-- `risk-acceptability-criteria.md`: Risk acceptability frameworks and examples
+```
+RISK MANAGEMENT REPORT
 
-### assets/
-- `risk-templates/`: Risk management plan, risk analysis, and risk control templates
-- `risk-matrices/`: Standardized risk estimation and evaluation matrices
-- `hazard-libraries/`: Medical device hazard identification libraries
-- `training-materials/`: Risk management training and competency programs
+Product: [Device Name]
+Date: [Date]
+Revision: [X.X]
+
+SUMMARY:
+- Total hazards identified: [N]
+- Risk controls implemented: [N]
+- Residual risks: [N] Low, [N] Medium, [N] High
+- Overall conclusion: [Acceptable / Not Acceptable]
+
+RISK DISTRIBUTION:
+| Risk Level | Before Control | After Control |
+|------------|----------------|---------------|
+| Unacceptable | [N] | 0 |
+| High | [N] | [N] |
+| Medium | [N] | [N] |
+| Low | [N] | [N] |
+
+CONTROLS IMPLEMENTED:
+- Inherent safety: [N]
+- Protective measures: [N]
+- Information for safety: [N]
+
+OVERALL RESIDUAL RISK: [Acceptable / ALARP Demonstrated]
+BENEFIT-RISK CONCLUSION: [If applicable]
+
+APPROVAL:
+Risk Management Lead: _____________ Date: _______
+Quality Assurance: _____________ Date: _______
+```
+
+---
+
+## Decision Frameworks
+
+### Risk Control Selection
+
+```
+What is the risk level?
+        │
+        ├── Unacceptable ──► Can hazard be eliminated?
+        │                    │
+        │                Yes─┴─No
+        │                 │     │
+        │                 ▼     ▼
+        │            Eliminate  Can protective
+        │            hazard     measure reduce?
+        │                           │
+        │                       Yes─┴─No
+        │                        │     │
+        │                        ▼     ▼
+        │                   Add       Add warning
+        │                   protection + training
+        │
+        └── High/Medium ──► Apply hierarchy
+                            starting at Level 1
+```
+
+### New Hazard Analysis
+
+| Question | If Yes | If No |
+|----------|--------|-------|
+| Does control introduce new hazard? | Analyze new hazard | Proceed |
+| Is new risk higher than original? | Reject control option | Acceptable trade-off |
+| Can new hazard be controlled? | Add control | Reject control option |
+
+### Risk Acceptability Decision
+
+| Condition | Decision |
+|-----------|----------|
+| All risks Low | Acceptable |
+| Medium risks with ALARP | Acceptable |
+| High risks with ALARP documented | Acceptable if benefits outweigh |
+| Any Unacceptable residual | Not acceptable - redesign |
+
+---
+
+## Tools and References
+
+### Scripts
+
+| Tool | Purpose | Usage |
+|------|---------|-------|
+| [risk_matrix_calculator.py](scripts/risk_matrix_calculator.py) | Calculate risk levels and FMEA RPN | `python risk_matrix_calculator.py --help` |
+
+**Risk Matrix Calculator Features:**
+- ISO 14971 5x5 risk matrix calculation
+- FMEA RPN (Risk Priority Number) calculation
+- Interactive mode for guided assessment
+- Display risk criteria definitions
+- JSON output for integration
+
+### References
+
+| Document | Content |
+|----------|---------|
+| [iso14971-implementation-guide.md](references/iso14971-implementation-guide.md) | Complete ISO 14971:2019 implementation with templates |
+| [risk-analysis-methods.md](references/risk-analysis-methods.md) | FMEA, FTA, HAZOP, Use Error Analysis methods |
+
+### Quick Reference: ISO 14971 Process
+
+| Stage | Key Activities | Output |
+|-------|----------------|--------|
+| Planning | Define scope, criteria, responsibilities | Risk Management Plan |
+| Analysis | Identify hazards, estimate risk | Hazard Analysis |
+| Evaluation | Compare to criteria, ALARP assessment | Risk Evaluation |
+| Control | Implement hierarchy, verify | Risk Control Records |
+| Residual | Overall assessment, benefit-risk | Risk Management Report |
+| Production | Monitor, review, update | Updated RM File |
+
+---
+
+## Related Skills
+
+| Skill | Integration Point |
+|-------|-------------------|
+| [quality-manager-qms-iso13485](../quality-manager-qms-iso13485/) | QMS integration |
+| [capa-officer](../capa-officer/) | Risk-based CAPA |
+| [regulatory-affairs-head](../regulatory-affairs-head/) | Regulatory submissions |
+| [quality-documentation-manager](../quality-documentation-manager/) | Risk file management |
diff --git a/ra-qm-team/risk-management-specialist/assets/example_asset.txt b/ra-qm-team/risk-management-specialist/assets/example_asset.txt
deleted file mode 100644
index d0ac204..0000000
--- a/ra-qm-team/risk-management-specialist/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/risk-management-specialist/references/api_reference.md b/ra-qm-team/risk-management-specialist/references/api_reference.md
deleted file mode 100644
index a2c821a..0000000
--- a/ra-qm-team/risk-management-specialist/references/api_reference.md
+++ /dev/null
@@ -1,34 +0,0 @@
-# Reference Documentation for Risk Management Specialist
-
-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/risk-management-specialist/references/iso14971-implementation-guide.md b/ra-qm-team/risk-management-specialist/references/iso14971-implementation-guide.md
new file mode 100644
index 0000000..c801176
--- /dev/null
+++ b/ra-qm-team/risk-management-specialist/references/iso14971-implementation-guide.md
@@ -0,0 +1,468 @@
+# ISO 14971:2019 Implementation Guide
+
+Complete implementation framework for medical device risk management per ISO 14971:2019.
+
+---
+
+## Table of Contents
+
+- [Risk Management Planning](#risk-management-planning)
+- [Risk Analysis](#risk-analysis)
+- [Risk Evaluation](#risk-evaluation)
+- [Risk Control](#risk-control)
+- [Overall Residual Risk Evaluation](#overall-residual-risk-evaluation)
+- [Risk Management Report](#risk-management-report)
+- [Production and Post-Production Activities](#production-and-post-production-activities)
+
+---
+
+## Risk Management Planning
+
+### Risk Management Plan Content
+
+| Element | Requirement | Documentation |
+|---------|-------------|---------------|
+| Scope | Medical device and lifecycle stages covered | Scope statement |
+| Responsibilities | Personnel and authority assignments | Organization chart, RACI |
+| Review Requirements | Timing and triggers for reviews | Review schedule |
+| Acceptability Criteria | Risk acceptance matrix and policy | Risk acceptability criteria |
+| Verification Activities | Methods for control verification | Verification plan |
+| Production/Post-Production | Activities for ongoing risk management | Surveillance plan |
+
+### Risk Management Plan Template
+
+```
+RISK MANAGEMENT PLAN
+
+Document Number: RMP-[Product]-[Rev]
+Product: [Device Name]
+Revision: [X.X]
+Effective Date: [Date]
+
+1. SCOPE AND PURPOSE
+   1.1 Medical Device Description: [Description]
+   1.2 Intended Use: [Statement]
+   1.3 Lifecycle Stages Covered: [Design/Production/Post-Market]
+   1.4 Plan Objectives: [Objectives]
+
+2. RESPONSIBILITIES AND AUTHORITIES
+   | Role | Responsibility | Authority |
+   |------|----------------|-----------|
+   | Risk Management Lead | Overall RM process | RM decisions |
+   | Design Engineer | Risk identification | Design changes |
+   | QA Manager | RM file review | File approval |
+   | Clinical | Clinical input | Clinical risk assessment |
+
+3. RISK ACCEPTABILITY CRITERIA
+   3.1 Risk Matrix: [Reference to matrix]
+   3.2 Acceptability Policy: [Acceptable/ALARP/Unacceptable definitions]
+   3.3 Benefit-Risk Considerations: [When applicable]
+
+4. VERIFICATION ACTIVITIES
+   4.1 Risk Control Verification Methods: [Test, Analysis, Review]
+   4.2 Verification Timing: [Design phase, V&V]
+   4.3 Acceptance Criteria: [Pass/fail criteria]
+
+5. PRODUCTION AND POST-PRODUCTION
+   5.1 Information Collection: [Sources]
+   5.2 Review Triggers: [Events requiring review]
+   5.3 Update Process: [RM file update procedure]
+
+6. REVIEW AND APPROVAL
+   Prepared By: _________________ Date: _______
+   Reviewed By: _________________ Date: _______
+   Approved By: _________________ Date: _______
+```
+
+### Risk Acceptability Criteria Definition
+
+| Risk Level | Definition | Action Required |
+|------------|------------|-----------------|
+| Broadly Acceptable | Risk so low that no action needed | Document and monitor |
+| ALARP (Tolerable) | Risk reduced as low as reasonably practicable | Verify ALARP, consider benefit |
+| Unacceptable | Risk exceeds acceptable threshold | Risk control mandatory |
+
+### Risk Matrix Example (5x5)
+
+| Probability \ Severity | Negligible | Minor | Serious | Critical | Catastrophic |
+|------------------------|------------|-------|---------|----------|--------------|
+| Frequent | Medium | High | High | Unacceptable | Unacceptable |
+| Probable | Low | Medium | High | High | Unacceptable |
+| Occasional | Low | Medium | Medium | High | High |
+| Remote | Low | Low | Medium | Medium | High |
+| Improbable | Low | Low | Low | Medium | Medium |
+
+**Risk Level Actions:**
+- **Low (Acceptable):** Document, no action required
+- **Medium (ALARP):** Consider risk reduction, document rationale
+- **High (ALARP):** Risk reduction required unless ALARP demonstrated
+- **Unacceptable:** Risk reduction mandatory before proceeding
+
+---
+
+## Risk Analysis
+
+### Hazard Identification Methods
+
+| Method | Application | Standard Reference |
+|--------|-------------|-------------------|
+| FMEA | Component/subsystem failures | IEC 60812 |
+| FTA | System-level failure analysis | IEC 61025 |
+| HAZOP | Process hazard identification | IEC 61882 |
+| PHA | Preliminary hazard assessment | - |
+| Use FMEA | Use-related hazards | IEC 62366-1 |
+
+### Intended Use Analysis Checklist
+
+| Category | Questions to Address |
+|----------|---------------------|
+| Medical Purpose | What condition is treated/diagnosed? |
+| Patient Population | Age, health status, contraindications? |
+| User Population | Healthcare professional, patient, caregiver? |
+| Use Environment | Hospital, home, ambulatory? |
+| Duration | Single use, repeated, continuous? |
+| Body Contact | External, internal, implanted? |
+
+### Hazard Categories (Informative Annex C)
+
+| Category | Examples |
+|----------|----------|
+| Energy | Electrical, thermal, mechanical, radiation |
+| Biological | Bioburden, pyrogens, biocompatibility |
+| Chemical | Residues, degradation products, leachables |
+| Operational | Incorrect output, delayed function, unexpected operation |
+| Information | Incomplete instructions, inadequate warnings |
+| Use Environment | Electromagnetic, mechanical stress |
+
+### Hazardous Situation Documentation
+
+```
+HAZARD ANALYSIS WORKSHEET
+
+Product: [Device Name]
+Analyst: [Name]
+Date: [Date]
+
+| ID | Hazard | Hazardous Situation | Sequence of Events | Harm | P1 | P2 | Initial Risk |
+|----|--------|--------------------|--------------------|------|----|----|--------------|
+| H-001 | [Hazard] | [Situation] | [Sequence] | [Harm] | [Prob] | [Sev] | [Level] |
+
+P1 = Probability of hazardous situation occurring
+P2 = Probability of harm given hazardous situation
+Initial Risk = Risk before controls
+```
+
+### Risk Estimation
+
+**Probability Categories:**
+
+| Level | Term | Definition | Frequency |
+|-------|------|------------|-----------|
+| 5 | Frequent | Expected to occur | >10⁻³ |
+| 4 | Probable | Likely to occur | 10⁻³ to 10⁻⁴ |
+| 3 | Occasional | May occur | 10⁻⁴ to 10⁻⁵ |
+| 2 | Remote | Unlikely to occur | 10⁻⁵ to 10⁻⁶ |
+| 1 | Improbable | Very unlikely | <10⁻⁶ |
+
+**Severity Categories:**
+
+| Level | Term | Definition | Patient Impact |
+|-------|------|------------|----------------|
+| 5 | Catastrophic | Results in death | Death |
+| 4 | Critical | Results in permanent impairment | Permanent impairment |
+| 3 | Serious | Results in injury requiring intervention | Injury requiring treatment |
+| 2 | Minor | Results in temporary injury | Temporary discomfort |
+| 1 | Negligible | Inconvenience or temporary discomfort | No injury |
+
+---
+
+## Risk Evaluation
+
+### Evaluation Workflow
+
+1. Apply risk acceptability criteria to estimated risk
+2. Determine if risk is acceptable, ALARP, or unacceptable
+3. For ALARP risks, document ALARP demonstration
+4. For unacceptable risks, proceed to risk control
+5. Document evaluation rationale
+6. **Validation:** All risks evaluated against criteria; rationale documented
+
+### Risk Acceptability Decision
+
+| Initial Risk | Benefit Available | Decision |
+|--------------|-------------------|----------|
+| Acceptable | N/A | Accept, document |
+| ALARP | No | Verify ALARP |
+| ALARP | Yes | Include in benefit-risk |
+| Unacceptable | No | Design change required |
+| Unacceptable | Yes | Benefit-risk analysis |
+
+### ALARP Demonstration
+
+| Criterion | Evidence Required |
+|-----------|-------------------|
+| Technical feasibility | Analysis of alternatives |
+| Economic proportionality | Cost-benefit assessment |
+| State of the art | Review of similar devices |
+| User acceptance | Stakeholder input |
+
+---
+
+## Risk Control
+
+### Risk Control Hierarchy
+
+| Priority | Control Type | Examples |
+|----------|--------------|----------|
+| 1 | Inherent safety by design | Remove hazard, substitute material |
+| 2 | Protective measures in device | Guards, alarms, software limits |
+| 3 | Information for safety | Warnings, training, IFU |
+
+### Risk Control Option Analysis
+
+```
+RISK CONTROL OPTION ANALYSIS
+
+Hazard ID: [H-XXX]
+Risk Level: [Unacceptable/High]
+
+| Option | Control Type | Effectiveness | Feasibility | New Risks | Selected |
+|--------|--------------|---------------|-------------|-----------|----------|
+| Option 1 | [Type] | [H/M/L] | [H/M/L] | [Yes/No] | [Yes/No] |
+| Option 2 | [Type] | [H/M/L] | [H/M/L] | [Yes/No] | [Yes/No] |
+
+Selected Option: [Option X]
+Rationale: [Justification]
+```
+
+### Risk Control Implementation Record
+
+```
+RISK CONTROL IMPLEMENTATION
+
+Control ID: RC-[XXX]
+Related Hazard: H-[XXX]
+
+Control Description: [Description]
+Control Type: [ ] Inherent Safety [ ] Protective Measure [ ] Information
+
+Implementation:
+- Specification/Requirement: [Reference]
+- Design Document: [Reference]
+- Verification Method: [Test/Analysis/Review]
+- Verification Criteria: [Pass criteria]
+
+Verification:
+- Protocol Reference: [Document]
+- Execution Date: [Date]
+- Result: [ ] Pass [ ] Fail
+- Evidence Reference: [Document]
+
+New Risks Introduced: [ ] Yes [ ] No
+If Yes: [New Hazard ID references]
+
+Residual Risk:
+- P1: [Probability]
+- P2: [Severity]
+- Residual Risk Level: [Level]
+
+Approved By: _________________ Date: _______
+```
+
+### Risk Control Verification Methods
+
+| Method | Application | Evidence |
+|--------|-------------|----------|
+| Test | Quantifiable control effectiveness | Test report |
+| Inspection | Physical control presence | Inspection record |
+| Analysis | Design analysis confirmation | Analysis report |
+| Review | Document/drawing review | Review record |
+
+---
+
+## Overall Residual Risk Evaluation
+
+### Evaluation Process
+
+1. Compile all individual residual risks
+2. Consider cumulative effects of residual risks
+3. Assess overall residual risk acceptability
+4. Conduct benefit-risk analysis if required
+5. Document overall evaluation conclusion
+6. **Validation:** All residual risks compiled; overall evaluation complete
+
+### Benefit-Risk Analysis
+
+| Factor | Assessment |
+|--------|------------|
+| Clinical Benefit | Documented therapeutic benefit |
+| State of the Art | Comparison to alternative treatments |
+| Patient Expectation | Benefit patient would accept |
+| Medical Opinion | Clinical expert input |
+| Risk Quantification | Residual risk characterization |
+
+### Benefit-Risk Documentation
+
+```
+BENEFIT-RISK ANALYSIS
+
+Product: [Device Name]
+Date: [Date]
+
+BENEFITS:
+1. Primary Clinical Benefit: [Description]
+   - Evidence: [Reference]
+   - Magnitude: [Quantification]
+
+2. Secondary Benefits: [List]
+
+RISKS:
+1. Residual Risks Summary:
+   | Risk Category | Count | Highest Level |
+   |---------------|-------|---------------|
+   | Acceptable | [N] | Low |
+   | ALARP | [N] | Medium/High |
+
+2. Cumulative Considerations: [Assessment]
+
+COMPARISON:
+- State of the Art: [How device compares]
+- Alternative Treatments: [Risk comparison]
+- Patient Acceptance: [Expected acceptance]
+
+CONCLUSION:
+[ ] Benefits outweigh risks - Acceptable
+[ ] Benefits do not outweigh risks - Not Acceptable
+
+Rationale: [Justification]
+
+Approved By: _________________ Date: _______
+```
+
+---
+
+## Risk Management Report
+
+### Report Content Requirements
+
+| Section | Content |
+|---------|---------|
+| Results of Risk Analysis | Summary of hazards and risks identified |
+| Risk Control Decisions | Controls selected and implemented |
+| Overall Residual Risk | Evaluation and acceptability conclusion |
+| Benefit-Risk Conclusion | If applicable |
+| Review and Approval | Formal sign-off |
+
+### Risk Management Report Template
+
+```
+RISK MANAGEMENT REPORT
+
+Document Number: RMR-[Product]-[Rev]
+Product: [Device Name]
+Date: [Date]
+
+1. EXECUTIVE SUMMARY
+   - Total hazards identified: [N]
+   - Risk controls implemented: [N]
+   - Residual risks: [N] acceptable, [N] ALARP
+   - Overall conclusion: [Acceptable/Not Acceptable]
+
+2. RISK ANALYSIS SUMMARY
+   - Methods used: [FMEA, FTA, etc.]
+   - Scope coverage: [Lifecycle stages]
+   - Hazard categories addressed: [List]
+
+3. RISK EVALUATION SUMMARY
+   | Risk Level | Before Control | After Control |
+   |------------|----------------|---------------|
+   | Unacceptable | [N] | [N] |
+   | High | [N] | [N] |
+   | Medium | [N] | [N] |
+   | Low | [N] | [N] |
+
+4. RISK CONTROL SUMMARY
+   - Inherent safety controls: [N]
+   - Protective measures: [N]
+   - Information for safety: [N]
+   - All controls verified: [Yes/No]
+
+5. OVERALL RESIDUAL RISK
+   - Individual residual risks: [Summary]
+   - Cumulative assessment: [Conclusion]
+   - Acceptability: [Acceptable/ALARP demonstrated]
+
+6. BENEFIT-RISK ANALYSIS (if applicable)
+   - Conclusion: [Statement]
+
+7. PRODUCTION AND POST-PRODUCTION
+   - Monitoring plan: [Reference]
+   - Review triggers: [List]
+
+8. CONCLUSION
+   [Statement of overall risk acceptability]
+
+9. APPROVAL
+   Risk Management Lead: _________________ Date: _______
+   Quality Assurance: _________________ Date: _______
+   Management Representative: _________________ Date: _______
+```
+
+---
+
+## Production and Post-Production Activities
+
+### Information Sources
+
+| Source | Information Type | Review Frequency |
+|--------|------------------|------------------|
+| Complaints | Use-related issues, failures | Continuous |
+| Service Reports | Field failures, repairs | Monthly |
+| Vigilance Reports | Serious incidents | Immediate |
+| Literature | Similar device issues | Quarterly |
+| Regulatory Feedback | Authority communications | As received |
+| Clinical Data | Post-market clinical follow-up | Per PMCF plan |
+
+### Risk Management File Update Triggers
+
+| Trigger | Action Required |
+|---------|-----------------|
+| New hazard identified | Risk analysis update |
+| Control failure | Risk control reassessment |
+| Serious incident | Immediate risk review |
+| Design change | Impact assessment |
+| Standards update | Compliance review |
+| Regulatory feedback | Risk evaluation update |
+
+### Risk Management Review Record
+
+```
+RISK MANAGEMENT REVIEW RECORD
+
+Review Date: [Date]
+Review Type: [ ] Periodic [ ] Triggered
+Trigger (if applicable): [Description]
+
+INFORMATION REVIEWED:
+| Source | Period | Findings |
+|--------|--------|----------|
+| Complaints | [Period] | [Summary] |
+| Vigilance | [Period] | [Summary] |
+| Literature | [Period] | [Summary] |
+
+RISK MANAGEMENT FILE STATUS:
+- Current and complete: [ ] Yes [ ] No
+- Updates required: [ ] Yes [ ] No
+
+ACTIONS:
+| Action | Owner | Due Date |
+|--------|-------|----------|
+| [Action 1] | [Name] | [Date] |
+
+CONCLUSION:
+[ ] No changes to risk profile
+[ ] Risk profile updated - see [Document Reference]
+[ ] Further investigation required
+
+Reviewed By: _________________ Date: _______
+```
diff --git a/ra-qm-team/risk-management-specialist/references/risk-analysis-methods.md b/ra-qm-team/risk-management-specialist/references/risk-analysis-methods.md
new file mode 100644
index 0000000..e1ac146
--- /dev/null
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@@ -0,0 +1,415 @@
+# Risk Analysis Methods
+
+Systematic techniques for hazard identification and risk analysis in medical device development.
+
+---
+
+## Table of Contents
+
+- [Method Selection Guide](#method-selection-guide)
+- [FMEA - Failure Mode and Effects Analysis](#fmea---failure-mode-and-effects-analysis)
+- [FTA - Fault Tree Analysis](#fta---fault-tree-analysis)
+- [HAZOP - Hazard and Operability Study](#hazop---hazard-and-operability-study)
+- [Use Error Analysis](#use-error-analysis)
+- [Software Hazard Analysis](#software-hazard-analysis)
+
+---
+
+## Method Selection Guide
+
+### Method Application Matrix
+
+| Method | Best For | Standard | Complexity |
+|--------|----------|----------|------------|
+| FMEA | Component/process failures | IEC 60812 | Medium |
+| FTA | System-level failure analysis | IEC 61025 | High |
+| HAZOP | Process deviations | IEC 61882 | Medium |
+| PHA | Early hazard screening | - | Low |
+| Use FMEA | Use-related hazards | IEC 62366-1 | Medium |
+| STPA | Software/system interactions | - | High |
+
+### Selection Decision Tree
+
+```
+What is the analysis focus?
+        │
+        ├── Component failures → FMEA
+        │
+        ├── System-level failure → FTA
+        │
+        ├── Process deviations → HAZOP
+        │
+        ├── User interaction → Use Error Analysis
+        │
+        └── Software behavior → Software FMEA/STPA
+```
+
+### When to Use Each Method
+
+| Project Phase | Recommended Methods |
+|---------------|---------------------|
+| Concept | PHA, initial FTA |
+| Design | FMEA, detailed FTA |
+| Development | Use Error Analysis, Software HA |
+| Verification | FMEA review, FTA validation |
+| Production | Process FMEA |
+| Post-Market | Trend analysis, FMEA updates |
+
+---
+
+## FMEA - Failure Mode and Effects Analysis
+
+### FMEA Overview
+
+| Aspect | Description |
+|--------|-------------|
+| Purpose | Identify potential failure modes and their effects |
+| Approach | Bottom-up analysis from component to system |
+| Output | Failure mode list with severity, occurrence, detection ratings |
+| Standard | IEC 60812 |
+
+### FMEA Process Workflow
+
+1. Define scope and system boundaries
+2. Develop functional block diagram
+3. Identify failure modes for each component/function
+4. Determine effects of each failure mode (local, next level, end)
+5. Assign severity rating
+6. Identify potential causes
+7. Assign occurrence rating
+8. Identify current controls (detection)
+9. Assign detection rating
+10. Calculate Risk Priority Number (RPN) or use risk matrix
+11. Determine actions for high-priority items
+12. **Validation:** All components analyzed; RPNs calculated; actions assigned for high risks
+
+### FMEA Worksheet Template
+
+```
+FMEA WORKSHEET
+
+Product: [Device Name]
+Subsystem: [Subsystem]
+FMEA Lead: [Name]
+Date: [Date]
+
+| ID | Item/Function | Failure Mode | Effect (Local) | Effect (End) | S | Cause | O | Controls | D | RPN | Action |
+|----|---------------|--------------|----------------|--------------|---|-------|---|----------|---|-----|--------|
+| FM-001 | [Item] | [Mode] | [Local Effect] | [End Effect] | [1-10] | [Cause] | [1-10] | [Detection] | [1-10] | [S×O×D] | [Action] |
+
+S = Severity (1=None, 10=Catastrophic)
+O = Occurrence (1=Remote, 10=Frequent)
+D = Detection (1=Certain, 10=Cannot Detect)
+RPN = Risk Priority Number
+```
+
+### Severity Rating Scale
+
+| Rating | Severity | Criteria |
+|--------|----------|----------|
+| 10 | Hazardous | Death or regulatory non-compliance |
+| 9 | Serious | Serious injury, major function loss |
+| 8 | Major | Significant injury, major inconvenience |
+| 7 | High | Minor injury, significant inconvenience |
+| 6 | Moderate | Discomfort, partial function loss |
+| 5 | Low | Some performance loss |
+| 4 | Very Low | Minor performance degradation |
+| 3 | Minor | Noticeable effect, no function loss |
+| 2 | Very Minor | Negligible effect |
+| 1 | None | No effect |
+
+### Occurrence Rating Scale
+
+| Rating | Occurrence | Probability |
+|--------|------------|-------------|
+| 10 | Almost Certain | >1 in 2 |
+| 9 | Very High | 1 in 3 |
+| 8 | High | 1 in 8 |
+| 7 | Moderately High | 1 in 20 |
+| 6 | Moderate | 1 in 80 |
+| 5 | Low | 1 in 400 |
+| 4 | Very Low | 1 in 2,000 |
+| 3 | Remote | 1 in 15,000 |
+| 2 | Very Remote | 1 in 150,000 |
+| 1 | Nearly Impossible | <1 in 1,500,000 |
+
+### Detection Rating Scale
+
+| Rating | Detection | Likelihood of Detection |
+|--------|-----------|------------------------|
+| 10 | Absolute Uncertainty | Cannot detect |
+| 9 | Very Remote | Very remote chance |
+| 8 | Remote | Remote chance |
+| 7 | Very Low | Very low chance |
+| 6 | Low | Low chance |
+| 5 | Moderate | Moderate chance |
+| 4 | Moderately High | Moderately high chance |
+| 3 | High | High chance |
+| 2 | Very High | Very high chance |
+| 1 | Almost Certain | Will detect |
+
+### RPN Action Thresholds
+
+| RPN Range | Priority | Action |
+|-----------|----------|--------|
+| >200 | Critical | Immediate action required |
+| 100-200 | High | Action plan required |
+| 50-100 | Medium | Consider action |
+| <50 | Low | Monitor |
+
+---
+
+## FTA - Fault Tree Analysis
+
+### FTA Overview
+
+| Aspect | Description |
+|--------|-------------|
+| Purpose | Determine combinations of events leading to top event |
+| Approach | Top-down deductive analysis |
+| Output | Fault tree diagram with cut sets |
+| Standard | IEC 61025 |
+
+### FTA Process Workflow
+
+1. Define top event (undesired system state)
+2. Identify immediate causes using logic gates
+3. Continue decomposition to basic events
+4. Draw fault tree diagram
+5. Identify cut sets (combinations causing top event)
+6. Calculate probability if quantitative analysis required
+7. Identify single points of failure
+8. **Validation:** All branches complete; cut sets identified; single points documented
+
+### Fault Tree Symbols
+
+| Symbol | Name | Meaning |
+|--------|------|---------|
+| Rectangle | Intermediate Event | Event resulting from other events |
+| Circle | Basic Event | Primary event, no further development |
+| Diamond | Undeveloped Event | Not analyzed further |
+| House | House Event | Event expected to occur (condition) |
+| AND Gate | AND | All inputs required for output |
+| OR Gate | OR | Any input causes output |
+
+### FTA Worksheet Template
+
+```
+FAULT TREE ANALYSIS
+
+Top Event: [Description of undesired state]
+System: [System name]
+Analyst: [Name]
+Date: [Date]
+
+BASIC EVENTS:
+| ID | Event | Description | Probability | Control |
+|----|-------|-------------|-------------|---------|
+| BE-001 | [Event] | [Description] | [P] | [Control] |
+
+CUT SETS:
+| Cut Set | Events | Order | Probability |
+|---------|--------|-------|-------------|
+| CS-001 | BE-001 | 1 | [P] |
+| CS-002 | BE-001, BE-002 | 2 | [P] |
+
+SINGLE POINTS OF FAILURE:
+| Event | Risk | Mitigation |
+|-------|------|------------|
+| [Event] | [Risk assessment] | [Mitigation strategy] |
+```
+
+### Cut Set Analysis
+
+| Cut Set Order | Meaning | Criticality |
+|---------------|---------|-------------|
+| First Order | Single event causes top event | Highest - single point of failure |
+| Second Order | Two events required | High |
+| Third Order | Three events required | Moderate |
+| Higher Order | Four+ events required | Lower |
+
+---
+
+## HAZOP - Hazard and Operability Study
+
+### HAZOP Overview
+
+| Aspect | Description |
+|--------|-------------|
+| Purpose | Identify deviations from intended operation |
+| Approach | Systematic examination using guide words |
+| Output | Deviation analysis with consequences and safeguards |
+| Standard | IEC 61882 |
+
+### HAZOP Guide Words
+
+| Guide Word | Meaning | Example Application |
+|------------|---------|---------------------|
+| NO/NOT | Complete negation | No flow, no signal |
+| MORE | Quantitative increase | More pressure, more current |
+| LESS | Quantitative decrease | Less flow, less voltage |
+| AS WELL AS | Qualitative increase | Extra component, contamination |
+| PART OF | Qualitative decrease | Missing component |
+| REVERSE | Logical opposite | Reverse flow, reverse polarity |
+| OTHER THAN | Complete substitution | Wrong material, wrong signal |
+| EARLY | Time-related | Early activation |
+| LATE | Time-related | Delayed response |
+
+### HAZOP Process Workflow
+
+1. Select study node (process section or component)
+2. Describe design intent for the node
+3. Apply guide words to identify deviations
+4. Determine causes of each deviation
+5. Assess consequences
+6. Identify existing safeguards
+7. Recommend actions if needed
+8. **Validation:** All nodes analyzed; all guide words applied; actions assigned
+
+### HAZOP Worksheet Template
+
+```
+HAZOP WORKSHEET
+
+System: [System Name]
+Node: [Node Description]
+Design Intent: [What the node is supposed to do]
+Team Lead: [Name]
+Date: [Date]
+
+| Guide Word | Deviation | Causes | Consequences | Safeguards | Actions |
+|------------|-----------|--------|--------------|------------|---------|
+| NO | [No + parameter] | [Causes] | [Consequences] | [Existing] | [Recommendations] |
+| MORE | [More + parameter] | [Causes] | [Consequences] | [Existing] | [Recommendations] |
+| LESS | [Less + parameter] | [Causes] | [Consequences] | [Existing] | [Recommendations] |
+```
+
+---
+
+## Use Error Analysis
+
+### Use Error Analysis Overview
+
+| Aspect | Description |
+|--------|-------------|
+| Purpose | Identify use-related hazards and mitigations |
+| Approach | Task analysis combined with error prediction |
+| Output | Use error list with risk controls |
+| Standard | IEC 62366-1 |
+
+### Use Error Categories
+
+| Category | Description | Examples |
+|----------|-------------|----------|
+| Perception Error | Failure to perceive information | Missing alarm, unclear display |
+| Cognition Error | Failure to understand | Misinterpretation, wrong decision |
+| Action Error | Incorrect physical action | Wrong button, slip, lapse |
+| Memory Error | Failure to recall | Forgotten step, omission |
+
+### Use Error Analysis Process
+
+1. Identify user tasks and subtasks
+2. Identify potential use errors for each task
+3. Determine consequences of each use error
+4. Estimate probability of use error
+5. Identify design features contributing to error
+6. Define risk control measures
+7. Verify control effectiveness
+8. **Validation:** All critical tasks analyzed; errors identified; controls defined
+
+### Use Error Worksheet Template
+
+```
+USE ERROR ANALYSIS
+
+Device: [Device Name]
+Task: [Task Description]
+User: [User Profile]
+Analyst: [Name]
+Date: [Date]
+
+| Step | User Action | Potential Use Error | Error Type | Cause | Consequence | S | P | Risk | Control |
+|------|-------------|--------------------| -----------|-------|-------------|---|---|------|---------|
+| 1 | [Action] | [Error] | [Type] | [Cause] | [Harm] | [S] | [P] | [Level] | [Control] |
+
+Error Types: Perception (P), Cognition (C), Action (A), Memory (M)
+```
+
+### Human Factors Risk Controls
+
+| Control Type | Examples |
+|--------------|----------|
+| Design | Forcing functions, constraints, affordances |
+| Feedback | Visual, auditory, tactile confirmation |
+| Labeling | Clear instructions, warnings, symbols |
+| Training | User education, competency verification |
+| Environment | Adequate lighting, noise reduction |
+
+---
+
+## Software Hazard Analysis
+
+### Software Hazard Analysis Overview
+
+| Aspect | Description |
+|--------|-------------|
+| Purpose | Identify software contribution to hazards |
+| Approach | Analysis of software failure modes and behaviors |
+| Output | Software hazard list with safety requirements |
+| Standard | IEC 62304 |
+
+### Software Safety Classification
+
+| Class | Contribution to Hazard | Rigor Required |
+|-------|------------------------|----------------|
+| A | No contribution possible | Basic |
+| B | Non-serious injury possible | Moderate |
+| C | Death or serious injury possible | High |
+
+### Software Hazard Categories
+
+| Category | Description | Examples |
+|----------|-------------|----------|
+| Omission | Required function not performed | Missing safety check |
+| Commission | Incorrect function performed | Wrong calculation |
+| Timing | Function at wrong time | Delayed alarm |
+| Value | Function with wrong value | Incorrect dose |
+| Sequence | Functions in wrong order | Steps reversed |
+
+### Software FMEA Worksheet
+
+```
+SOFTWARE FMEA
+
+Software Item: [Module/Function Name]
+Safety Class: [A/B/C]
+Analyst: [Name]
+Date: [Date]
+
+| ID | Function | Failure Mode | Cause | Effect on System | Effect on Patient | S | P | Risk | Mitigation |
+|----|----------|--------------|-------|------------------|-------------------|---|---|------|------------|
+| SW-001 | [Function] | [Mode] | [Cause] | [System effect] | [Patient effect] | [S] | [P] | [Level] | [Control] |
+
+Failure Mode Types: Omission, Commission, Timing, Value, Sequence
+```
+
+### Software Risk Controls
+
+| Control Type | Implementation |
+|--------------|----------------|
+| Defensive Programming | Input validation, range checking |
+| Error Handling | Exception handling, graceful degradation |
+| Redundancy | Dual channels, voting logic |
+| Watchdog | Timeout monitoring, heartbeat |
+| Self-Test | Power-on diagnostics, runtime checks |
+| Separation | Independence of safety functions |
+
+### Traceability Requirements
+
+| From | To | Purpose |
+|------|------|---------|
+| Software Hazard | Software Requirement | Hazard addressed |
+| Software Requirement | Architecture | Requirement implemented |
+| Architecture | Code | Design realized |
+| Code | Test | Verification coverage |
+| Test | Hazard | Control verified |
diff --git a/ra-qm-team/risk-management-specialist/scripts/example.py b/ra-qm-team/risk-management-specialist/scripts/example.py
deleted file mode 100755
index a6218fc..0000000
--- a/ra-qm-team/risk-management-specialist/scripts/example.py
+++ /dev/null
@@ -1,19 +0,0 @@
-#!/usr/bin/env python3
-"""
-Example helper script for risk-management-specialist
-
-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 risk-management-specialist")
-    # 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/risk-management-specialist/scripts/risk_matrix_calculator.py b/ra-qm-team/risk-management-specialist/scripts/risk_matrix_calculator.py
new file mode 100644
index 0000000..958b55b
--- /dev/null
+++ b/ra-qm-team/risk-management-specialist/scripts/risk_matrix_calculator.py
@@ -0,0 +1,419 @@
+#!/usr/bin/env python3
+"""
+Risk Matrix Calculator
+
+Calculate risk levels based on probability and severity ratings per ISO 14971.
+Supports multiple risk matrix configurations and FMEA RPN calculations.
+
+Usage:
+    python risk_matrix_calculator.py --probability 3 --severity 4
+    python risk_matrix_calculator.py --fmea --severity 8 --occurrence 5 --detection 6
+    python risk_matrix_calculator.py --interactive
+    python risk_matrix_calculator.py --list-criteria
+"""
+
+import argparse
+import json
+import sys
+from typing import Tuple, Optional
+
+
+# Standard 5x5 Risk Matrix per ISO 14971 common practice
+PROBABILITY_LEVELS = {
+    1: {"name": "Improbable", "description": "Very unlikely to occur", "frequency": "<10^-6"},
+    2: {"name": "Remote", "description": "Unlikely to occur", "frequency": "10^-5 to 10^-6"},
+    3: {"name": "Occasional", "description": "May occur", "frequency": "10^-4 to 10^-5"},
+    4: {"name": "Probable", "description": "Likely to occur", "frequency": "10^-3 to 10^-4"},
+    5: {"name": "Frequent", "description": "Expected to occur", "frequency": ">10^-3"}
+}
+
+SEVERITY_LEVELS = {
+    1: {"name": "Negligible", "description": "Inconvenience or temporary discomfort", "harm": "No injury"},
+    2: {"name": "Minor", "description": "Temporary injury not requiring intervention", "harm": "Temporary discomfort"},
+    3: {"name": "Serious", "description": "Injury requiring professional intervention", "harm": "Reversible injury"},
+    4: {"name": "Critical", "description": "Permanent impairment or life-threatening", "harm": "Permanent impairment"},
+    5: {"name": "Catastrophic", "description": "Death", "harm": "Death"}
+}
+
+# Risk matrix: RISK_MATRIX[probability][severity] = risk_level
+RISK_MATRIX = {
+    1: {1: "Low", 2: "Low", 3: "Low", 4: "Medium", 5: "Medium"},
+    2: {1: "Low", 2: "Low", 3: "Medium", 4: "Medium", 5: "High"},
+    3: {1: "Low", 2: "Medium", 3: "Medium", 4: "High", 5: "High"},
+    4: {1: "Medium", 2: "Medium", 3: "High", 4: "High", 5: "Unacceptable"},
+    5: {1: "Medium", 2: "High", 3: "High", 4: "Unacceptable", 5: "Unacceptable"}
+}
+
+# Risk level definitions and required actions
+RISK_ACTIONS = {
+    "Low": {
+        "acceptable": True,
+        "action": "Document and accept. No further action required.",
+        "color": "green"
+    },
+    "Medium": {
+        "acceptable": "ALARP",
+        "action": "Reduce risk if practicable. Document ALARP rationale if not reduced.",
+        "color": "yellow"
+    },
+    "High": {
+        "acceptable": "ALARP",
+        "action": "Risk reduction required. Must demonstrate ALARP if residual risk remains high.",
+        "color": "orange"
+    },
+    "Unacceptable": {
+        "acceptable": False,
+        "action": "Risk reduction mandatory. Design change required before proceeding.",
+        "color": "red"
+    }
+}
+
+# FMEA scales (1-10)
+FMEA_SEVERITY = {
+    1: "No effect",
+    2: "Very minor effect",
+    3: "Minor effect",
+    4: "Very low effect",
+    5: "Low effect",
+    6: "Moderate effect",
+    7: "High effect",
+    8: "Very high effect",
+    9: "Hazardous with warning",
+    10: "Hazardous without warning"
+}
+
+FMEA_OCCURRENCE = {
+    1: "Remote (<1 in 1,500,000)",
+    2: "Very low (1 in 150,000)",
+    3: "Low (1 in 15,000)",
+    4: "Moderately low (1 in 2,000)",
+    5: "Moderate (1 in 400)",
+    6: "Moderately high (1 in 80)",
+    7: "High (1 in 20)",
+    8: "Very high (1 in 8)",
+    9: "Extremely high (1 in 3)",
+    10: "Almost certain (>1 in 2)"
+}
+
+FMEA_DETECTION = {
+    1: "Almost certain detection",
+    2: "Very high detection",
+    3: "High detection",
+    4: "Moderately high detection",
+    5: "Moderate detection",
+    6: "Low detection",
+    7: "Very low detection",
+    8: "Remote detection",
+    9: "Very remote detection",
+    10: "Cannot detect"
+}
+
+
+def calculate_risk_level(probability: int, severity: int) -> dict:
+    """Calculate risk level from probability and severity ratings."""
+    if probability < 1 or probability > 5:
+        return {"error": f"Probability must be 1-5, got {probability}"}
+    if severity < 1 or severity > 5:
+        return {"error": f"Severity must be 1-5, got {severity}"}
+
+    risk_level = RISK_MATRIX[probability][severity]
+    risk_info = RISK_ACTIONS[risk_level]
+
+    return {
+        "probability": {
+            "rating": probability,
+            **PROBABILITY_LEVELS[probability]
+        },
+        "severity": {
+            "rating": severity,
+            **SEVERITY_LEVELS[severity]
+        },
+        "risk_level": risk_level,
+        "acceptable": risk_info["acceptable"],
+        "action_required": risk_info["action"],
+        "risk_index": probability * severity
+    }
+
+
+def calculate_rpn(severity: int, occurrence: int, detection: int) -> dict:
+    """Calculate FMEA Risk Priority Number."""
+    if not all(1 <= x <= 10 for x in [severity, occurrence, detection]):
+        return {"error": "All FMEA ratings must be 1-10"}
+
+    rpn = severity * occurrence * detection
+
+    # Determine priority level
+    if rpn > 200:
+        priority = "Critical"
+        action = "Immediate action required"
+    elif rpn > 100:
+        priority = "High"
+        action = "Action plan required"
+    elif rpn > 50:
+        priority = "Medium"
+        action = "Consider risk reduction"
+    else:
+        priority = "Low"
+        action = "Monitor"
+
+    return {
+        "severity": {
+            "rating": severity,
+            "description": FMEA_SEVERITY[severity]
+        },
+        "occurrence": {
+            "rating": occurrence,
+            "description": FMEA_OCCURRENCE[occurrence]
+        },
+        "detection": {
+            "rating": detection,
+            "description": FMEA_DETECTION[detection]
+        },
+        "rpn": rpn,
+        "priority": priority,
+        "action_required": action,
+        "max_rpn": 1000,
+        "rpn_percentage": round(rpn / 10, 1)
+    }
+
+
+def display_risk_matrix():
+    """Display the full risk matrix."""
+    print("\n" + "=" * 70)
+    print("ISO 14971 RISK MATRIX (5x5)")
+    print("=" * 70)
+
+    # Header
+    print("\n" + " " * 15, end="")
+    for s in range(1, 6):
+        print(f"S{s:^10}", end="")
+    print()
+
+    print(" " * 15, end="")
+    for s in range(1, 6):
+        print(f"{SEVERITY_LEVELS[s]['name'][:10]:^10}", end="")
+    print()
+
+    print("-" * 70)
+
+    # Matrix rows
+    for p in range(5, 0, -1):
+        print(f"P{p} {PROBABILITY_LEVELS[p]['name'][:10]:>10} |", end="")
+        for s in range(1, 6):
+            level = RISK_MATRIX[p][s]
+            print(f"{level:^10}", end="")
+        print()
+
+    print("\n" + "-" * 70)
+    print("Risk Levels: Low (Acceptable) | Medium (ALARP) | High (ALARP) | Unacceptable")
+    print("=" * 70)
+
+
+def display_criteria():
+    """Display probability and severity criteria."""
+    print("\n" + "=" * 70)
+    print("PROBABILITY CRITERIA")
+    print("=" * 70)
+    for level, info in PROBABILITY_LEVELS.items():
+        print(f"\nP{level}: {info['name']}")
+        print(f"   Description: {info['description']}")
+        print(f"   Frequency: {info['frequency']}")
+
+    print("\n" + "=" * 70)
+    print("SEVERITY CRITERIA")
+    print("=" * 70)
+    for level, info in SEVERITY_LEVELS.items():
+        print(f"\nS{level}: {info['name']}")
+        print(f"   Description: {info['description']}")
+        print(f"   Harm: {info['harm']}")
+
+    print("\n" + "=" * 70)
+    print("RISK LEVEL ACTIONS")
+    print("=" * 70)
+    for level, info in RISK_ACTIONS.items():
+        acceptable = "Yes" if info['acceptable'] == True else ("ALARP" if info['acceptable'] == "ALARP" else "No")
+        print(f"\n{level}:")
+        print(f"   Acceptable: {acceptable}")
+        print(f"   Action: {info['action']}")
+
+
+def format_result_text(result: dict, analysis_type: str) -> str:
+    """Format result for text output."""
+    lines = []
+    lines.append("\n" + "=" * 50)
+
+    if analysis_type == "risk":
+        lines.append("RISK ASSESSMENT RESULT")
+        lines.append("=" * 50)
+        lines.append(f"\nProbability: P{result['probability']['rating']} - {result['probability']['name']}")
+        lines.append(f"  {result['probability']['description']}")
+        lines.append(f"\nSeverity: S{result['severity']['rating']} - {result['severity']['name']}")
+        lines.append(f"  {result['severity']['description']}")
+        lines.append(f"\n{'-' * 50}")
+        lines.append(f"RISK LEVEL: {result['risk_level']}")
+        lines.append(f"Risk Index: {result['risk_index']} (P × S)")
+        lines.append(f"Acceptable: {result['acceptable']}")
+        lines.append(f"\nAction Required:")
+        lines.append(f"  {result['action_required']}")
+
+    elif analysis_type == "fmea":
+        lines.append("FMEA RPN CALCULATION")
+        lines.append("=" * 50)
+        lines.append(f"\nSeverity: {result['severity']['rating']}/10")
+        lines.append(f"  {result['severity']['description']}")
+        lines.append(f"\nOccurrence: {result['occurrence']['rating']}/10")
+        lines.append(f"  {result['occurrence']['description']}")
+        lines.append(f"\nDetection: {result['detection']['rating']}/10")
+        lines.append(f"  {result['detection']['description']}")
+        lines.append(f"\n{'-' * 50}")
+        lines.append(f"RPN: {result['rpn']} / {result['max_rpn']} ({result['rpn_percentage']}%)")
+        lines.append(f"Priority: {result['priority']}")
+        lines.append(f"\nAction Required:")
+        lines.append(f"  {result['action_required']}")
+
+    lines.append("=" * 50)
+    return "\n".join(lines)
+
+
+def interactive_mode():
+    """Run interactive risk assessment."""
+    print("\n" + "=" * 50)
+    print("RISK MATRIX CALCULATOR - Interactive Mode")
+    print("=" * 50)
+
+    print("\nSelect analysis type:")
+    print("1. Risk Matrix (ISO 14971 style)")
+    print("2. FMEA RPN Calculation")
+    print("3. Display Risk Matrix")
+    print("4. Display Criteria")
+    print("5. Exit")
+
+    choice = input("\nEnter choice (1-5): ").strip()
+
+    if choice == "1":
+        display_criteria()
+        print("\n" + "-" * 50)
+        try:
+            p = int(input("Enter Probability (1-5): "))
+            s = int(input("Enter Severity (1-5): "))
+            result = calculate_risk_level(p, s)
+            if "error" in result:
+                print(f"\nError: {result['error']}")
+            else:
+                print(format_result_text(result, "risk"))
+        except ValueError:
+            print("Invalid input. Please enter numbers.")
+
+    elif choice == "2":
+        print("\nFMEA Scales:")
+        print("  Severity: 1 (No effect) to 10 (Hazardous without warning)")
+        print("  Occurrence: 1 (Remote) to 10 (Almost certain)")
+        print("  Detection: 1 (Almost certain) to 10 (Cannot detect)")
+        print("-" * 50)
+        try:
+            s = int(input("Enter Severity (1-10): "))
+            o = int(input("Enter Occurrence (1-10): "))
+            d = int(input("Enter Detection (1-10): "))
+            result = calculate_rpn(s, o, d)
+            if "error" in result:
+                print(f"\nError: {result['error']}")
+            else:
+                print(format_result_text(result, "fmea"))
+        except ValueError:
+            print("Invalid input. Please enter numbers.")
+
+    elif choice == "3":
+        display_risk_matrix()
+
+    elif choice == "4":
+        display_criteria()
+
+    elif choice == "5":
+        print("Exiting.")
+        return
+
+    else:
+        print("Invalid choice.")
+
+
+def main():
+    parser = argparse.ArgumentParser(
+        description="Calculate risk levels per ISO 14971 or FMEA RPN",
+        formatter_class=argparse.RawDescriptionHelpFormatter,
+        epilog="""
+Examples:
+  # ISO 14971 risk matrix calculation
+  python risk_matrix_calculator.py --probability 3 --severity 4
+
+  # FMEA RPN calculation
+  python risk_matrix_calculator.py --fmea --severity 8 --occurrence 5 --detection 6
+
+  # Interactive mode
+  python risk_matrix_calculator.py --interactive
+
+  # Display risk matrix
+  python risk_matrix_calculator.py --show-matrix
+
+  # Display criteria definitions
+  python risk_matrix_calculator.py --list-criteria
+
+  # JSON output
+  python risk_matrix_calculator.py -p 4 -s 3 --output json
+        """
+    )
+
+    parser.add_argument("-p", "--probability", type=int, help="Probability rating (1-5)")
+    parser.add_argument("-s", "--severity", type=int, help="Severity rating (1-5 for risk, 1-10 for FMEA)")
+    parser.add_argument("-o", "--occurrence", type=int, help="FMEA occurrence rating (1-10)")
+    parser.add_argument("-d", "--detection", type=int, help="FMEA detection rating (1-10)")
+    parser.add_argument("--fmea", action="store_true", help="Use FMEA RPN calculation")
+    parser.add_argument("--output", choices=["text", "json"], default="text", help="Output format")
+    parser.add_argument("--show-matrix", action="store_true", help="Display risk matrix")
+    parser.add_argument("--list-criteria", action="store_true", help="Display probability and severity criteria")
+    parser.add_argument("--interactive", action="store_true", help="Run in interactive mode")
+
+    args = parser.parse_args()
+
+    if args.interactive:
+        interactive_mode()
+        return
+
+    if args.show_matrix:
+        display_risk_matrix()
+        return
+
+    if args.list_criteria:
+        display_criteria()
+        return
+
+    if args.fmea:
+        if not all([args.severity, args.occurrence, args.detection]):
+            parser.error("FMEA requires --severity, --occurrence, and --detection")
+
+        result = calculate_rpn(args.severity, args.occurrence, args.detection)
+        if "error" in result:
+            print(f"Error: {result['error']}")
+            sys.exit(1)
+
+        if args.output == "json":
+            print(json.dumps(result, indent=2))
+        else:
+            print(format_result_text(result, "fmea"))
+
+    else:
+        if not all([args.probability, args.severity]):
+            parser.error("Risk calculation requires --probability and --severity")
+
+        result = calculate_risk_level(args.probability, args.severity)
+        if "error" in result:
+            print(f"Error: {result['error']}")
+            sys.exit(1)
+
+        if args.output == "json":
+            print(json.dumps(result, indent=2))
+        else:
+            print(format_result_text(result, "risk"))
+
+
+if __name__ == "__main__":
+    main()