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[其他] 续2:欧盟风险评定和评价通用安全方法指南 CSM RA (基于GE/GN 8646 规范释义)



发表于 2018-11-19 10:13 | 显示全部楼层 |阅读模式

G1.3            Structureof this document
G1.3.1            Thefollowing parts of this document explain the context of risk assessment as partof a wider risk management framework, and relate to the main components of theCSM RA, which represent typical stages of a risk assessment process:
     Part 2: Riskmanagement and taking safe decisions: putting the risk assessment process incontext.
     Part 3: The CSM RArisk assessment process: a general overview of the CSM RA process.
     Part 4: The CSM RAsignificance assessment: how to decide whether a proposed change is‘significant’, therefore requiring formal application of the CSM RA.
     Part 5: Planning arisk assessment process: what will be done, when and by whom.
     Part 6: Systemdefinition: describing what will be changed and how it will be changed.
     Part 7: Hazardidentification: what can go wrong and how it might impact safety.
     Part 8: Riskevaluation and risk acceptance: analyzing risk and judging whether the changeis safe enough.
     Part 9: Safetyrequirements: identifying safety requirements to be implemented.
     Part 10: Hazardmanagement: recording the results of the hazard management process.
     Part 11: Independentassessment: reviewing the risk assessment process to be sure it is appropriate.
     Part 12: Completing arisk assessment process: how the process concludes and what outputs itproduces.
以下部分解释了风险评估(作为更广泛风险管理框架的一部分)的背景,及与CSM RA相关的代表风险评估过程的典型阶段的主要组成部分:
•         第2部分:风险管理及采取安全决策:风险评估过程作为背景;
•         第3部分:CSM RA风险评估过程:对CSM RA过程的总体概述;
•         第4部分:CSM RA重要性评估:如何判断提出的变更 “重要与否,这里需要正式应用CSM RA;
•         第5部分:规划风险评估过程:需要做什么,什么时候,谁来做;
•         第6部分:系统定义:表述变更内容及如何变更;
•         第7部分:危害识别:可能出现什么问题,如何影响安全;
•         第8部分:风险评价与风险接受:分析风险并判定变更是否足够安全;
•         第9部分:安全要求:确定需要实施的安全要求;
•         第10部分:危害管理:记录危害管理过程结果;
•         第11部分:独立评估:评价风险评估过程确定合理性;
•         第12部分:完成风险评估过程:如何结束过程,及输出是什么。

G1.3.2             Guidance is provided as a series ofsequentially numbered clauses.

G1.4            Approvaland Authorization
G1.4.1            Thecontent of this document was approved by a Multifunctional Standards Committeeon 23 October 2017.

G1.4.2              Thisdocument was authorized by RSSB on 21 November 2017.

Part 2       RiskManagement and Taking Safe Decisions
G2.1             Overviewof risk management and taking safe decisions

G2.1.1            Riskassessment activities, such as those outlined in the CSM RA, should form partof a wider risk management framework, and are used to ensure safety decisionmaking is done appropriately. The RSSB guidance document 'Taking Safe Decisions'sets out the industry consensus view of how safety is taken into account whentaking decisions. It is a risk management framework that describes theprinciples that companies apply to protect people's safety, satisfy the law,respect the interests of stakeholders and meet commercial objectives.
风险评估活动,如CSM RA中概述,应作为组成更广泛风险管理框架的一部分,并且被用来做适当的安全决策。RSSB知道文件采取安全决策,阐述了行业对于在决策时如何采取安全措施的共识。作为风险管理框架,描述了公司在保护民众安全,遵守法律,尊重干系人利益及达成商业目标的一些准则。

G2.1.2            Everyorganization needs to understand and manage its risks, both on an ongoing basisand when it changes something. Risk management can be thought of as comprisingthree related activities, which map to questions about safety-related change asshown in Figure 1:
a)    Monitoring: Is my operationsafe? What is my risk profile? Do indicators suggest itis changing? Do I needto take corrective or improvement actions?
b)   Analyzing and selectingoptions: What (if anything) should I change and what are the safetyimplications of making the change?
c)    Making a change: How do I makesure the change is acceptably safe?
a)       监视:我的操作安全吗?我的风险预测是什么?是否有指示支持变更?我是否需要采取改正和改进行动?
b)       分析和选择项:(如果有的话),我应当改变什么?形成变更的安全含义是什么?
c)       形成变更:我如何确保变更是可接受的安全?

G2.1.3            Theseactivities are explained in the 'Taking Safe Decisions'document, which broadly covers the aspects of the risk management framework asshown in Figure 1. The RSSB website contains further information on 'Taking Safe Decisions'. There is also guidance on aspects of SMSs, monitoring safety and CSMfor Monitoring.

G2.1.4            Thetechniques adopted during a risk assessment process may be used to supportmonitoring, to better understand an emerging risk issue. Once a risk issue isidentified it is usual to consider several options to address it. The riskassessment techniques are used to support analysis of these options tounderstand their risk implications, and help select the most appropriate optionto take forward for implementation.
风险评估过程中采用的技术可用于支持安全监测,更好地理解新的风险问题。 一旦识别到风险问题,通常会考虑几个解决方案的选项。风险评估技术用于支持分析这些选项以了解其风险影响,并帮助选择最适合的实施方案。

G2.1.5            Oncean option for a change has been selected, further risk assessment will be usedto understand the hazards and risk associated with that option, to identifysuitable safety requirements, and manage the risk associated with the hazards.The risk assessment process is used to demonstrate that the residual level ofrisk is acceptable.

G2.1.6            Figure 1 shows how the riskassessment process stages for implementing a change are integral to the 'taking safe decisions'cycle and indicates the parts of this guidance document where information canbe found on the various aspects:
a)            System definition (Part 6)
b)           Hazard identification (Part 7)
c)            Risk evaluation and riskacceptance (Part 8)
d)           Safety requirements (Part 9)
e)           Hazard management (Part 10)
f)             Independent assessment (Part 11).
图1显示实施变更的风险评估过程阶段是 “作为采取安全决策周期中的一部分,并且显示在本指导中可以看到相应的信息:
a)       系统定义(第6部分)
b)       危害识别(第7部分)
c)        风险评估及风险接受(第8部分)
d)       安全要求(第9部分)
e)       危害管理(第10部分)
f)      独立评估(第11部分)

G2.1.7            In addition, Part 4 of this document deals with the preliminary judgement on whether achange is significant, therefore requiring formal application of the CSM RArisk management process (the 'significance test'). Planning the risk assessmentprocess, in particular developing a safety plan, is dealt with in Part 5; Part 12 deals with completionand conclusion of the risk management process.

Figure 1: The Taking Safe Decisions risk managementframework

此外,本文档的第4部分设计到针对变更重要性的初步判断,因此需要正式应用CSM RA风险管理过程(重要性测试)。规划风险评估过程,尤其在制定安全计划是,在第5部分中有涉及;第12部分涉及到风险管理过程的完成与结论。

图1中描述的内容即风险管理框架。组织的商业运营行为是驱动活动的源动力,当经营行为属于目前持续存在的,那么“采取安全决策”确定其没有变更,采取了监视、分析的闭环;否则,进入CSM RA闭环。另外,当CSM RA闭环结束,进入监视、分析的闭环;而当监视、分析闭环发现安全相关问题,则结束转而进入CSM RA闭环。风险管理框架从组织经营管理的层面,着手对风险进行管理,而不仅仅是对风险的评价活动。图中蓝色阴影区域,则对应了当发生变更后,风险评价的过程(The CSM RA risk assessment process)。



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