Risk Management Specialist ISO 14971:2019 risk management implementation throughout the medical device lifecycle. 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 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 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 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 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 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 Risk Assessment Templates Hazard Analysis Worksheet HAZARD ANALYSIS WORKSHEET Product: [Device Name] Document: HA-[Product]-[Rev] Analyst: [Name] Date: [Date] | 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] | FMEA Worksheet FMEA WORKSHEET Product: [Device Name] Subsystem: [Subsystem] Analyst: [Name] Date: [Date] | 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] | RPN Action Thresholds: 200: Critical - Immediate action 100-200: High - Action plan required 50-100: Medium - Consider action <50: Low - Monitor Risk Management Report Summary RISK MANAGEMENT REPORT 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 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