风险管理工具

原因的一个方法。-system
failures one at a time, but can
combine multiple causes of failure by
identifying causal chains.
用于同时评估系统/子系统故障，不过通
危害分析和关键控制点
Failure Mode and Effects Analysis (FMEA)
失败模型和效果分析 （FMEA）
关系。
Tool assumes that risk events are
Assess manufacturing
caused by deviations from the design
简单工具，一般用于收集/组织数据，构
deviations, complaints, defects,
建风险管理流程，便于做出决定。
or other circumstances.
将观察项，趋势或其他经验性信
息汇总以支持各种不复杂的偏
差，投诉，缺陷或其他情况。
Method to compare and rank risks Prioritize operating areas /
风险管理工具
Risk Management Tool
风险管理工具
Basic Tools
基本工具
Diagram Analysis
图表分析
Flowcharts
流程图
Check Sheets
检查单
Process Mapping
工艺图
Cause/Effect Diagrams
原因/效果图例
Risk Ranking and Filtering
地预防危害情况出现
to process validation
Bottom-up approach that considers
工艺验证的前工作或补充。
how to prevent hazards from
Assessment of the efficacy of
occurring and/or propagating
Better for preventive
controls that consistently and
applications rather than
effectively prevent hazard conditions
reactive
from occurring
非被动，更多是预防性应用。
确定和执行工艺控制，其能持续和有效 Great precursor or complement
weighting factors and risk scores.
risks and underlying
一般来说，采用各种定性和定量因子对
consequences are diverse and
风险进行评估并且衡量每个因子并得出
difficult to compare using a
分数。
single tool
identify potential deviations from
process safety hazards.
normal use or design intentions.
常用来评估安全危害
使用系统的技术以帮助他们确定在正常
使用或设计意图下可能发生的偏差。
Identify and implement process
processes, facilities, and
and operating intentions
equipment
该工具可以分析出由于设计和操作原因
评估生产工艺，厂房设施和设
导致偏差而产生的风险事件。
备。
Uses a systematic technique to help Commonly used to evaluate
used to gather/organize data,
trends, or other empirical
structure risk management processes,
information to support a
and facilitate decision making.
variety of less complex
过确定因果链而合并各种故障原因
Relies heavily on full process
understanding to identify causal
factors.
必须具备全面的工艺知识才能确定因果
Hazard Operability Analysis (HAZOP)
危害和可操作性分析
Hazards Analysis and Critical Control Points (HACCP)
CPPs and the ability to
逆序方法，其考虑如何防止危害出现和/
consistently execute them for
当风险和其可能的后果多种多样
难以使用一个工具进行比较时。
Method used to identify all root
Investigate product
causes of an assumed failure or
complaints
problem.
调查产品投诉
用于确定一个假定故障或问题所有根本 Evaluate deviations.
比较风险和排列风险的方法
sites for audit/assessment.
Typically involves evaluation of
将审计/评估的操作区域/地点进行
multiple diverse quantitative and
优先排序。
qualitative factors for each risk, and Useful for situations when the
风险排序和过滤
Advanced Tools
高级工具
Fault Tree Analysis (FTA) 失败树（FTA）
Description/Attributes
描述/特点
Potential Applications
潜在的应用
Simple techniques that are commonly Compilation of observations,