risk-management-specialist

Risk Management Specialist

ISO 14971:2019 risk management implementation throughout the medical device 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:
2. Medical device identification
3. Lifecycle stages covered
4. Applicable standards and regulations
5. Establish risk acceptability criteria:
6. Define probability categories (P1-P5)
7. Define severity categories (S1-S5)
8. Create risk matrix with acceptance thresholds
9. Assign responsibilities:
10. Risk management lead
11. Subject matter experts
12. Approval authorities
13. Define verification activities:
14. Methods for control verification
15. Acceptance criteria
16. Plan production and post-production activities:
17. Information sources
18. Review triggers
19. Update procedures
20. Obtain plan approval
21. Establish risk management file
22. 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:
2. Medical indication
3. Patient population
4. User population
5. Use environment
6. Select analysis method(s):
7. FMEA for component/function analysis
8. FTA for system-level analysis
9. HAZOP for process deviations
10. Use Error Analysis for user interaction
11. Identify hazards by category:
12. Energy hazards (electrical, mechanical, thermal)
13. Biological hazards (bioburden, biocompatibility)
14. Chemical hazards (residues, leachables)
15. Operational hazards (software, use errors)
16. Determine hazardous situations:
17. Sequence of events
18. Foreseeable misuse scenarios
19. Single fault conditions
20. Estimate probability of harm (P1-P5)
21. Estimate severity of harm (S1-S5)
22. Document in hazard analysis worksheet
23. 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:
4. Acceptable: Document and accept
5. ALARP: Proceed to risk control
6. Unacceptable: Mandatory risk control
7. Document evaluation rationale
8. Identify risks requiring benefit-risk analysis
9. Complete benefit-risk analysis if applicable
10. Compile risk evaluation summary
11. Validation: All risks evaluated; acceptability determined; rationale documented

Risk Evaluation Decision Tree

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

ALARP Demonstration Requirements

| 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 |

Benefit-Risk Analysis Triggers

| 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 |

Risk Control Workflow

Implement and verify risk control measures.

Workflow: Implement Risk Controls

1. Identify risk control options:
2. Inherent safety by design (Priority 1)
3. Protective measures in device (Priority 2)
4. Information for safety (Priority 3)
5. Select optimal control following hierarchy
6. Analyze control for new hazards introduced
7. Document control in design requirements
8. Implement control in design
9. Develop verification protocol
10. Execute verification and document results
11. Evaluate residual risk wi