Risk Management Specialist

ISO 14971:2019 risk management implementation throughout the medical device lifecycle.

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Table of Contents

• Risk Management Planning Workflow
• Risk Analysis Workflow
• Risk Evaluation Workflow
• Risk Control Workflow
• Post-Production Risk Management
• Risk Assessment Templates
• Decision Frameworks
• Tools and References

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Risk Management Planning Workflow

Establish risk management process per ISO 14971.

Workflow: Create Risk Management Plan

• Define scope of risk management activities:

- Medical device identification

- Lifecycle stages covered

- Applicable standards and regulations

• Establish risk acceptability criteria:

- Define probability categories (P1-P5)

- Define severity categories (S1-S5)

- Create risk matrix with acceptance thresholds

• Assign responsibilities:

- Risk management lead

- Subject matter experts

- Approval authorities

• Define verification activities:

- Methods for control verification

- Acceptance criteria

• Plan production and post-production activities:

- Information sources

- Review triggers

- Update procedures

• Obtain plan approval
• Establish risk management file
• 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 |

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Risk Analysis Workflow

Identify hazards and estimate risks systematically.

Workflow: Conduct Risk Analysis

• Define intended use and reasonably foreseeable misuse:

- Medical indication

- Patient population

- User population

- Use environment

• Select analysis method(s):

- FMEA for component/function analysis

- FTA for system-level analysis

- HAZOP for process deviations

- Use Error Analysis for user interaction

• Identify hazards by category:

- Energy hazards (electrical, mechanical, thermal)

- Biological hazards (bioburden, biocompatibility)

- Chemical hazards (residues, leachables)

- Operational hazards (software, use errors)

• Determine hazardous situations:

- Sequence of events

- Foreseeable misuse scenarios

- Single fault conditions

• Estimate probability of harm (P1-P5)
• Estimate severity of harm (S1-S5)
• Document in hazard analysis worksheet
• 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

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Risk Evaluation Workflow

Evaluate risks against acceptability criteria.

Workflow: Evaluate Identified Risks

• Calculate initial risk level from probability × severity
• Compare to risk acceptability criteria
• For each risk, determine:

- Acceptable: Document and accept

- ALARP: Proceed to risk control

- Unacceptable: Mandatory risk control

• Document evaluation rationale
• Identify risks requiring benefit-risk analysis
• Complete benefit-risk analysis if applicable
• Compile risk evaluation summary
• 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 |

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Risk Control Workflow

Implement and verify risk control measures.

Workflow: Implement Risk Controls

• Identify risk control options:

- Inherent safety by design (Priority 1)

- Protective measures in device (Priority 2)

- Information for safety (Priority 3)

• Select optimal control following hierarchy
• Analyze control for new hazards introduced
• Document control in design requirements
• Implement control in design
• Develop verification protocol
• Execute verification and document results
• Evaluate residual risk with control in place
• 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 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]

Risk Control Verification Methods

| 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 |

Residual Risk Evaluation

| 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 |

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Post-Production Risk Management

Monitor and update risk management throughout product lifecycle.

Workflow: Post-Production Risk Monitoring

• Identify information sources:

- Customer complaints

- Service reports

- Vigilance/adverse events

- Literature monitoring

- Clinical studies

• Establish collection procedures
• Define review triggers:

- New hazard identified

- Increased frequency of known hazard

- Serious incident

- Regulatory feedback

• Analyze incoming information for risk relevance
• Update risk management file as needed
• Communicate significant findings
• Conduct periodic risk management review
• Validation: Information sources monitored; file current; reviews completed per schedule

Information Sources

| 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 |

Risk Management File Update Triggers

| 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 |

Periodic Review Requirements

| 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 |

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Risk Assessment Templates

→ See references/risk-assessment-templates.md for details

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 |

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Tools and References

Scripts

| Tool | Purpose | Usage |

|------|---------|-------|

| 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 | Complete ISO 14971:2019 implementation with templates |

| 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 |

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Related Skills

| Skill | Integration Point |

|-------|-------------------|

| quality-manager-qms-iso13485 | QMS integration |

| capa-officer | Risk-based CAPA |

| regulatory-affairs-head | Regulatory submissions |

| quality-documentation-manager | Risk file management |