risk-management-specialist

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Risk Management Specialist

风险管理专员

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

在医疗器械全生命周期内落实ISO 14971:2019风险管理要求。

Risk Management Planning Workflow

风险管理规划流程

Establish risk management process per ISO 14971.

依据ISO 14971标准建立风险管理流程。

Workflow: Create Risk Management Plan

流程：制定风险管理计划

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

定义风险管理活动范围：
- 医疗器械识别
- 覆盖的生命周期阶段
- 适用的标准与法规
建立风险可接受性标准：
- 定义概率等级（P1-P5）
- 定义严重程度等级（S1-S5）
- 创建带有接受阈值的风险矩阵
分配职责：
- 风险管理负责人
- 主题专家
- 审批机构
定义验证活动：
- 控制验证方法
- 接受标准
规划生产及生产后活动：
- 信息来源
- 审核触发条件
- 更新流程
获取计划审批
建立风险管理文件
验证： 计划已获批；可接受性标准已定义；职责已分配；文件已建立

Risk Management Plan Content

风险管理计划内容

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

章节	内容	证据
范围	设备及覆盖的生命周期	范围说明
标准	风险可接受性矩阵	风险矩阵文档
职责	角色与权限	RACI矩阵
验证	方法与接受标准	验证计划
生产/生产后	监控活动	监督计划

Risk Acceptability Matrix (5x5)

风险可接受性矩阵（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

概率 \ 严重程度	可忽略	轻微	严重	危急	灾难性
频繁（P5）	中等	高	高	不可接受	不可接受
可能（P4）	中等	中等	高	高	不可接受
偶尔（P3）	低	中等	中等	高	高
极少（P2）	低	低	中等	中等	高
极不可能（P1）	低	低	低	中等	中等

Risk Level Actions

风险等级应对措施

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

等级	可接受	所需行动
低	是	记录并接受
中等	ALARP	若可行则降低；记录理由
高	ALARP	必须降低；证明已达ALARP
不可接受	否	强制要求设计变更

Risk Analysis Workflow

风险分析流程

Identify hazards and estimate risks systematically.

系统识别危害并估算风险。

Workflow: Conduct Risk Analysis

流程：开展风险分析

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

定义预期用途及可合理预见的误用：
- 医疗适应症
- 患者群体
- 用户群体
- 使用环境
选择分析方法：
- FMEA：组件/功能分析
- FTA：系统级故障分析
- HAZOP：流程偏差分析
- 使用错误分析：用户交互分析
按类别识别危害：
- 能量危害（电气、机械、热）
- 生物危害（生物负载、生物相容性）
- 化学危害（残留物、浸出物）
- 操作危害（软件、使用错误）
确定危险场景：
- 事件序列
- 可预见的误用场景
- 单一故障条件
估算伤害发生概率（P1-P5）
估算伤害严重程度（S1-S5）
记录在危害分析工作表中
验证： 所有危害类别已覆盖；所有危害已记录；已分配概率与严重程度

Hazard Categories Checklist

危害类别检查表

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	☐

类别	示例	是否已分析
电气	电击、烧伤、干扰	☐
机械	挤压、切割、被困	☐
热	烧伤、组织损伤	☐
辐射	电离、非电离	☐
生物	感染、生物相容性	☐
化学	毒性、刺激	☐
软件	输出错误、时序问题	☐
使用错误	误用、感知错误、认知错误	☐
环境	电磁兼容、机械应力	☐

Analysis Method Selection

分析方法选择

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

场景	推荐方法
组件故障	FMEA
系统级故障	FTA
流程偏差	HAZOP
用户交互	使用错误分析
软件行为	软件FMEA
早期设计阶段	PHA

Probability Criteria

概率标准

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

等级	名称	描述	频率
P5	频繁	预期会发生	>10⁻³
P4	可能	很可能发生	10⁻³ 至 10⁻⁴
P3	偶尔	可能发生	10⁻⁴ 至 10⁻⁵
P2	极少	不太可能发生	10⁻⁵ 至 10⁻⁶
P1	极不可能	非常不可能发生	<10⁻⁶

Severity Criteria

严重程度标准

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

等级	名称	描述	伤害
S5	灾难性	死亡	死亡
S4	危急	永久损伤	不可逆伤害
S3	严重	需干预的伤害	可逆伤害
S2	轻微	暂时不适	无需治疗
S1	可忽略	不便	无伤害

参考：references/risk-analysis-methods.md

Risk Evaluation Workflow

风险评估流程

Evaluate risks against acceptability criteria.

对照可接受性标准评估风险。

Workflow: Evaluate Identified Risks

流程：评估已识别的风险

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

根据概率×严重程度计算初始风险等级
与风险可接受性标准对比
针对每个风险确定：
- 可接受：记录并接受
- ALARP：进入风险控制环节
- 不可接受：强制风险控制
记录评估理由
识别需进行收益-风险分析的风险
若适用则完成收益-风险分析
编制风险评估摘要
验证： 所有风险已评估；已确定可接受性；理由已记录

Risk Evaluation Decision Tree

风险评估决策树

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

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

ALARP证明要求

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

标准	所需证据
技术可行性	替代控制措施分析
比例性	进一步降低的成本收益分析
现有技术水平	与同类设备对比
利益相关方意见	临床/用户视角

Benefit-Risk Analysis Triggers

收益-风险分析触发条件

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

场景	是否需要收益-风险分析
残余风险仍为高	是
无可行的风险降低措施	是
新型设备	是
存在不可接受风险但有临床收益	是
所有风险均为低	否

Risk Control Workflow

风险控制流程

Implement and verify risk control measures.

实施并验证风险控制措施。

Workflow: Implement Risk Controls

流程：实施风险控制

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

识别风险控制选项：
- 固有安全设计（优先级1）
- 设备防护措施（优先级2）
- 安全信息（优先级3）
遵循优先级选择最优控制措施
分析控制措施是否引入新危害
在设计要求中记录控制措施
在设计中实施控制措施
制定验证方案
执行验证并记录结果
评估控制措施实施后的残余风险
验证： 控制措施已实施；验证通过；残余风险可接受；无未处理的新危害

Risk Control Hierarchy

风险控制优先级

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

优先级	控制类型	示例	有效性
1	固有安全	消除危害、故障安全设计	最高
2	防护措施	防护装置、警报、自动停机	高
3	安全信息	警告、培训、使用说明书（IFU）	较低

Risk Control Option Analysis Template

风险控制选项分析模板

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 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

风险控制验证方法

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

方法	使用场景	证据
测试	可量化性能	测试报告
检查	物理存在	检查记录
分析	设计计算	分析报告
审核	文档检查	审核记录

Residual Risk Evaluation

�残余风险评估

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

控制后情况	行动
可接受	记录，继续推进
已达ALARP	记录理由，继续推进
仍不可接受	额外控制措施或设计变更
引入新危害	分析并控制新危害

Post-Production Risk Management

生产后风险管理

Monitor and update risk management throughout product lifecycle.

在产品全生命周期内监控并更新风险管理。

Workflow: Post-Production Risk Monitoring

流程：生产后风险监控

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

识别信息来源：
- 客户投诉
- 服务报告
- 警戒/不良事件
- 文献监测
- 临床研究
建立收集流程
定义审核触发条件：
- 识别新危害
- 已知危害发生频率增加
- 严重事件
- 监管反馈
分析 incoming information 与风险的相关性
按需更新风险管理文件
传达重要发现
定期开展风险管理审核
验证： 信息来源已监控；文件为最新状态；已按计划完成审核

Information Sources

信息来源

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

来源	信息类型	审核频率
投诉	使用问题、故障	持续监控
服务	现场故障、维修	每月
警戒	严重事件	即时
文献	同类设备问题	每季度
监管	机构反馈	收到即处理
临床	PMCF数据	按计划

Risk Management File Update Triggers

风险管理文件更新触发条件

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

触发条件	响应时间	行动
严重事件	即时	全面风险审核
识别新危害	30天内	更新风险分析
趋势上升	60天内	趋势分析
设计变更	实施前	影响评估
标准更新	按过渡期	差距分析

Periodic Review Requirements

定期审核要求

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

审核内容	频率
风险管理文件完整性	每年
风险控制有效性	每年
上市后信息分析	每季度
收益-风险结论	每年或有新数据时

Risk Assessment Templates

风险评估模板

Hazard Analysis Worksheet

危害分析工作表

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] |

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工作表

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

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

风险管理报告摘要

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: _______

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

决策框架

Risk Control Selection

风险控制选择

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

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

新危害分析

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

问题	若是	若否
控制措施是否引入新危害？	分析新危害	继续推进
新风险是否高于原风险？	拒绝该控制选项	可接受的权衡
新危害是否可被控制？	添加控制措施	拒绝该控制选项

Risk Acceptability Decision

风险可接受性决策

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

条件	决策
所有风险均为低	可接受
中等风险且已达ALARP	可接受
高风险且已记录ALARP证明	若收益大于风险则可接受
存在不可接受的残余风险	不可接受 - 重新设计

Tools and References

工具与参考资料

Scripts

脚本

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

工具	用途	使用方法
risk_matrix_calculator.py	计算风险等级及FMEA RPN	`python risk_matrix_calculator.py --help`

风险矩阵计算器功能：

ISO 14971 5x5风险矩阵计算
FMEA RPN（风险优先级数）计算
交互式引导评估模式
显示风险标准定义
JSON输出用于集成

References

参考资料

Document	Content
iso14971-implementation-guide.md	Complete ISO 14971:2019 implementation with templates
risk-analysis-methods.md	FMEA, FTA, HAZOP, Use Error Analysis methods

文档	内容
iso14971-implementation-guide.md	ISO 14971:2019完整实施指南及模板
risk-analysis-methods.md	FMEA、FTA、HAZOP、使用错误分析方法

Quick Reference: ISO 14971 Process

快速参考：ISO 14971流程

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

阶段	关键活动	输出
规划	定义范围、标准、职责	风险管理计划
分析	识别危害、估算风险	危害分析
评估	对照标准、ALARP评估	风险评估
控制	实施优先级措施、验证	风险控制记录
残余风险	整体评估、收益-风险分析	风险管理报告
生产	监控、审核、更新	更新后的风险管理文件

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

技能	集成点
quality-manager-qms-iso13485	QMS集成
capa-officer	基于风险的CAPA
regulatory-affairs-head	监管申报
quality-documentation-manager	风险文件管理