claude-code-arcane 1.0.0

package/skills/risk-management-specialist/references/iso14971-implementation-guide.md

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+# 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: _______
+```