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

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

risk-management-specialist

Risk Management Specialist

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