请教：哪位能出来解读一下APIC质量风险管理方法学的系统评估方法

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请教：哪位能出来解读一下APIC质量风险管理方法学的系统评估方法

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毒手药王邓智先

您说的是这个吧。


PIC/S关于质量风险管理方法学中文译稿

















1. Introduction 介绍
Since a couple of years Quality Risk Management (or QRM) has become a mandatory regulatory requirement towards healthcare organizations either they are active in the sectors of Medical Devices* or in Pharmaceuticals†.
多年以来，质量风险管理已经成为对医疗卫生机构强制性的管理要求，无论他们是医疗器械部门还是制药部门。
The ICH-Q9 guideline concerning Quality Risk Management in thepharmaceutical field (active substances and medicinal products) was adopted by the European Union and PIC/S‡ in Annex 20 of the EU and PIC/S GMP Guides. It is gradually being applied by drug manufacturers in particular as regards sections 1.5 and 1.6 of part I of the aforementioned§.
ICH-Q9指南侧重于制药领域（活性成分和药物）的质量风险管理，曾被欧盟、PIC/S 在EU 、PIC/S 的GMP指南附录20中采用，尤其是一些药品生产商正在逐渐地使用这项指南，这部分可参考上文的第一部分的1.5和1.6的内容。
1.5 Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.
1.5 质量风险管理是一套为了评估，控制，沟通和回顾药品质量的风险的系统性流程，既可以用于前瞻预测，也可以用于事后回顾。
1.6 The quality risk management system should ensure that:
- the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient
1.6质量风险管理系统应该确保
--质量风险的评估要以科学的知识和丰富的生产经验为基础，并最终与保护病人的安全联系起来。
- the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk
However, the practical methods for the implementation of these new requirements are still perceived as being singularly difficult to interpret and implement.
--质量风险管理程序的执行力度、正式程度、文件化水平都应该和风险的程度相匹配。但是这些新要求的实际的推行方法的解释和实施还是应该被看作是相当困难的。
In this context, a small, informal Working Group within PIC/S has started to develop an objective and pragmatic example of methodology, directly usable by the widest audience. It is also able to meet the demands of both operators and inspectors and to comply with all regulatory requirements.
在此背景下，一个PIC/S内的非正式的工作小组已经开始开发一个可以直接供广大读者使用，客观实用的研究方法,它也能满足经营者和检查员的要求，并符合所有的管理要求。
This example of methodology is not intended to be issued later by PIC/S as a recommendation or as a guideline for industry and / or for GMP inspectors but it could be used by PIC/S for training purposes. Whether this example is used by industry for other purposes is of no concern to PIC/S and will not influence the outcome of PIC/S inspections.
此研究方法并非想要由PIC/S出版来推荐给产业或GMP巡查员，也不会作为指南，但是可以用作PIC/S的培训资料。




















2. Description of the methodology 方法描述
2.1. Objective of the Quality Risk Management 质量风险管理的目标
For any pharmaceutical organization, Quality Risk Management should aim at raising the level of protection for the patient, by the reduction of the risk to which that patient is exposed at the time he receives a drug product.
对于任何药品生产企业来说，质量风险管理应该致力于通过降低病人接触到药品时出现的风险来提高保护病人的水平。
This general objective can only be achieved if the implemented policy of Quality Risk Management exceeds the unique intend of GMP compliance by increasing the control of the Organization on developed (or under development) processes to improve:
只有质量风险管理实施方针超出了GMP独特的意愿才可以实现总体目标，可要求GMP进一步提高对成熟或欠成熟相关机构的管理。
Relevance of implemented processes;推行这套流程的相关原则
Knowledge within the Organization;机构内部需要有足够的知识
Confidence in performed operations.对执行要充满信心
At the opposite, Quality Risk Management should not set for finality:
相反，质量风险管理不应该终止：
Adjustment of controls to the currently available resources in the Organization;
在组织机构内部对可利用的资源进行调控管理；
&#61472rovision of a wrongfully validated excuse not to comply with the regulatory requirements.
提供与监管要求不一致，经过不正当验证的理由。
2.2. General approach 常规方法
The scheme of a Quality Risk Management process as proposed by ICHQ9 is reproduced below:
该方案的质量风险管理过程ICHQ9重现了如下
For a practical implementation of this process, the guidance draws up the list of the principal known methods of risk analysis and gives a description of their specificities.
对具体实施过程中,该指南拟定了已知的风险识别列表，并给与特性描述。
Among those one will retain for example:
FMEA (Failure Mode Effect Analysis) 故障模式效应分析
FTA (Fault Tree Analysis) 故障树分析
HAZOP (Hazard Operability Analysis) 危害与可操作性分析
HACCP (Hazard Analysis and Critical Control Points) 危害分析与关键控制点
If these tools often proved to be efficient and reliable in risk assessment and/or risk control, they, by design, remain limited when they have to support a global policy of Risk Management. Moreover, it has been noticed that a systematic use of these tools to address all explicit and implicit issues of ICH-Q9 would generally be incompatible with available resources.
如果这些工具在风险评估或风险控制中表现为经常有效和可靠，那么当他们必须支持风险管理全球政策是就会被设定成维持有限。此外，已经注意到的是系统地使用这些工具去处理ICH-Q9中清晰或者含蓄的问题一般会和现有资源不兼容。
In this context, the example of methodology presented hereafter is aimed at providing training, help, inspiration or assistance to interested and volunteered stakeholders.
由此而论，以下呈现的研究方法例证旨在为感兴趣自愿的利益相关者提供培训，帮助，启发或者援助。
2.3. Description of QRM methodology 质量风险管理方法的描述
2.3.1. Preamble 序文
A Risk (R) is a mathematical expression with two parameters: severity (S) and Frequency (F). The risk is then expressed as: R = S x F.
风险是一个包含两个参数的数学表达式。所以风险被表达为：R = S x F.
A risk evaluation is then nothing but addressing a quantified answer to the double question:
风险评估也就是对两个问题寻求一个量化的解
What probability? 什么可能性？
Which consequences? 哪种后果？
Quantification should follow a qualitative step of hazards inventory. A hazard is defined as an event, which has the potential to have a negative impact on the considered objective (i.e.: patient safety). To comply with the ICH-Q9 diagram provided in scheme S1; hazards and risks have then to be considered in a two consecutive stages process with:
量化应该根据一个对危害清单的步骤。把一种危害定义为一个事件，这个事件对预想目标（病患的安全）会有消极影响。遵守计划S1当中的ICH-Q9；然后在两个连续阶段的流程中考虑危害和风险。
Risk Assessment (stage of qualitative categorization and
quantitative estimate of the identified hazards)
风险评估（对已识别的危害进行定性分类和定性估计的阶段）
Risk Control (stage of risk reduction and acceptance decision)
风险控制：风险减少和接受决定的阶段
Finally, Risk Management should integrate these stages of Risk Assessment and Risk Control in a policy established to maintain the relevance and the efficiency of the analytical work.
最后，风险管理应该整合既定政策下的风险评估和风险控制的这些不同阶段，来保持分析工作的关联和效率。
2.3.2. Design of methodology 方法设计
To meet the requirement of exhaustiveness of hazards and risks reviewing, the methodology should initially proceed to the inventory of all the activities
implemented  in the processes covered by the quality system as applicable within the Organization. These activities should then be themselves divided into elementary steps, which are then individually introduced in the decisional diagram given below:
为了满足危害和风险评估的穷尽性的要求，此研究方法应该首先编制在有效的质量体系框架内实施全部活动的项目目录。然后这些活动应该被分成最初的步骤，之后这些步骤会被单独的引入到以下的决定性图表中。
Thus, for each elementary step, the method of Risk Management initially envisages an intrinsic evaluation of the primary risk, which, if it is not directly acceptable, will claim/require an iterative series of risk mitigation measures aiming at obtaining an acceptable residual risk.In this diagram, S indicates severity, F the frequency and D the detectability.
因此，在每个基本步骤中，起初风险管理方法假设主要风险的内在评估，如果只要风险不可直接受，就需要重复系列的只在获得一个可以接受的剩余风险的风险消减措施。在这个图标中S代表严重性，F代表频率，D代表可检验性。
In a traditional manner, the risk (R) is expressed as the multiplication of Severity (S) by the frequency (F) of occurrence of the hazard: R = S X F.
The detectability is not integrated in the calculation of the risk value and would only be considered under specific condition to decide whether the risk could be accepted or not.
在传统习惯中，风险是风险发生的严重性和频率的乘积:R=S X F.
可检测性不被计入到风险价值的计算中，只在要决定风险是否可接受的特定条件下才会考虑这个要素。
According to the diagram S2, there are two levels of risks, which are
submitted/proposed to acceptation:
primary Risks Rsp
residual Risks Rsr
根据图表S2，有两个水平的风险，它们被提交为接受：
主要风险Rsp
剩余风险Rsr
2.3.3. Input and output 输入和输出
The starting point of methodology thus consists in the inventory of all elementary steps entering the scope of Quality Risk Management. This inventory could be the result of the internal work of a multi-disciplinary team within the Organization or could be acquired from the “Shared Structure” platform according to the operating process described in paragraph 3 (or both).
研究方法的起点在于所有基本步骤要进入到质量风险管理的范围。基本步骤的确定应该是机构内部多学科团队内部工作的结果，或者是按照段落3中的操作流程，从“Shared Structure” 平台中获取。
Each elementary step treated according to the decision tree called “Risk Treatment Process” and depicted on Scheme 2 will allow to establish the risk assessment (relevant tools such as rationale, FMEA, FTA may be integrated here) through the implementation of reduction measures to primary risks related to elementary steps.
按照风险处理流程决策体系和计划2中描述的去处理基本步骤会允许通过图形减少与基本步骤相关的主要风险来建成风险评估（诸如基本原理，FMEA，FTA等相关工具会被整合到这里）。
If as for the inventory stage, primary risks may be originated from the results of multi-disciplinary working team or acquired from the database maintained by “Shared Structure” platform, reduction measures proposal and actual implementation will lie with the user.
假如在列清单的阶段，主要风险可能会来自于多学科工作小组的结果或者“shared Structure”平台中保留的数据，减少风险的措施的提出和措施实施将取决于使用者。
Risk assessment for a given elementary step is then documented as an output of the Risk Treatment Process.
既定基本步骤的风险评估会形成文件，作为风险处理流程输出。
The compilation of these outputs is permanently challenged for their capacity with being in adequacy with the evolutions of the regulatory framework applicable and periodically reviewed to take into consideration relevant new information coming generally from.
因为可应用的监管框架会在定期的评估中将相关的新信息纳入考虑，所以它是不断演变的，这些输出结果与这些演变的的适应能力会给输出结果的编制带来永久性的挑战。而这些新信息逐渐来自于：
CAPA: Corrective Action Preventive Action
纠正措施与预防措施
Internal Information: refers to relevant data coming from the Organization but not directly linked to the concerned.manufacturing process.
内部信息：指的是来自机构内部的相关数据，但是跟有关的生产流程并非直接相连。
External Information: refers to relevant data coming from the
outside of the Organization and related subsidiary; e.g.:guidance and regulatory notes issued from national agencies The result of an event or periodic revision (at least annual) is materialized
by a new version of the document compiling the output data of Quality Risk Management of the Organization.
外部信息：指的是来自机构外部和相关附属部门的相关数据；例如：国家学术机构的指导和监管记录。项目结果或定期修正（至少每年一次）被新版本的文件具体化，这个文件收集了机构质量风险管理的输出数据。
The permanent control of the outputs as described here constitutes the main difference between Risk Analysis and Risk Management and is essential to its efficiency.
永久性的控制这里描述的输出构成了风险分析和风险管理之间的主要区别，并且对它的功效有必不可少的作用。

毒手药王邓智先

At this stage, it is important to note that the manufactured product has not been considered yet. The following paragraph will show the approach adopted for its integration in order to limit the volume of required resources.
在这个阶段，注意到生产出来的产品还没被纳入到考虑是很重要的。接下来的一段内容会显示为整合而采纳的方法，整合的目的在于限制所需资源的量。
2.3.4. Dissociating approach   
The implementation of Risk Management will be effective only if this
requires a volume of resources compatible with the possibilities of the Organization. Therefore, the approach developed consists in dissociating the constants from the variables in the policy of Quality Risk Management.
只有风险的推行需要大量与机构的可能性兼容的资源，才会有效。因此，这个方法的形成在于分解从质量风险管理方针中的变量得到的常量。
Constants encompass all areas, except products, which are implemented by the Organization including processes, facilities, equipment, personnel; they are indicated in a generic way under
name of “System”;
常量包含除了产品之外的所有领域，这些领域包括被机构推行的流程，设施，设备，人员；他们以一般的方式被表现为“系统”。
Variables are given by the specific characteristics of the products manufactured, handled or even simply harvested by the System; these variables are indicated by “Product”
变量为成品的特点所赋予，受系统的影响甚至直接从系统中获取。这些变量被表示为“产品”。
According to the approach, Global Risk determination (Rg), as required by the regulatory ramework, corresponds to the risk of manufacturing the considered product in the existing system. The Global Risk (Rg) is then obtained as a result of the multiplication of the System Risk (Rs) (corresponding then to the description given in paragraph 2.3.3.) by a modulating factor called “Product factor” (P).
根据这个方法，按照监管框架的要求，整体风险决策(Rg)会与在现有系统里生产既定产品的风险相对应。通过一种被称为“产品因子”的调节因子，就会获得整体风险(Rg)，Rg也是系统风险的乘积。
One has then: Rg = Rs x P
This dissociating approach thus proposes to the Organization to initially evaluate its systemic risk (Rs) independently of the products, which are manufactured. This approach is placed under permanent control according to the principle describes in section 2.3.3. The introduction of the product as a factor (P) avoids reworking all elementary steps for each different product.
因此这种分解方法会使机构对它的成品的系统性风险进行评估。根据2.3.3部分的描述，这个方法会被置于永久的控制中。把产品作为一个因素避免了重复评估每个不同产品时的所有基本步骤。
Moreover, the dissociating approach makes it possible to define the limits of acceptability of the system and authorizes the prospective and retrospective analyzes. These limits will be given in specific documents, called “rational techniques” which will support the decisions of acceptance of the risk by the Organization.
此外，这个分解方法使系统可容性极限的确定成为可能，并且认可了前瞻性和回顾性分析。这些限度将会被递交到特定的文件中，被称机构为合理的技术，将会支持接受风险的决定。
It is interesting to stress that technical rationales could advantageously be established on recurring questions (such as the prevention of the airborne contaminations, the performances of cleanings, etc.) to avoid the repetition of specific studies.
强调技术原理可以建立在重复出现的问题上，去避免重复进行特定研究是很有趣的事情。
The integration of the diagram given to section 2.3.3 with the principle of the dissociating approach led to the establishment of the complete diagram given below:
用分解方式的原则整合2.3.3部分的图表形成了下面的这个完整的图表。
This diagram thus combines the evaluation of the systemic risk, placed in a process of permanent control, and the Product factor produced for a total management of the risk.
因此，这个图表结合了系统风险的评估，永久控制的流程以及风险整体管理的产品因素
2.3.5. Quantification量化
For its implementation, the example of methodology requires to define the rules of quantification for the different parameters Severity (S), Frequency (F) and Detectability (D) entering calculation of the systemic risk (Rs):
为了实施，这个研究方法案例需要确定量化的规则，因为不同的参数进入了系统性风险的计算。
Severity (S):
0; Not addressed explicitly or implicitly by the applicable GMP
0;没有被可应用的GMP明确地或含蓄的强调
1; Addressed by applicable GMP, but without possible impact on the manufactured product
被可应用的GMP所强调，到那时对成品不存在影响的可能性
2; Possible impact on the manufactured product but without risk for the patient (end user)
可能会对成品产生影响，但是对病患（最终适用者）没有危害。
3; Possible impact on the manufactured product and with possible hazard for the patient (end user)
可能会对成品有影响，并且对病患（最终适用者）存在危害。
Frequency (F):
0; Event intervening with a frequency lower than 10e-6 事件以低于10e-6的频率介入
1; Accidental event, occurrence exceptional 例外发生的偶然事件
2; Frequent but non-systematic event 频繁但是不是系统性事件
3; Event noted each time or almost 事件每次都发生或者几乎都发生
Detectability (D):可检测性
a; Undetectable 不可检测
b; Absence of system of detection but detection is still possible by Chance
缺少检测系统，但仍然会偶然检测
c; Presence of a single system of detection which is not 100% Reliable
只存在一个并非100%可靠的检测系统
d; System of multiple and independent detection tools or a single system of detection which is 100% reliable
许多相互独立的检测工具的系统或者有一个100%可靠的检测系统。
Factor (N):
参数N
In complement of these parameters, the example of methodology envisages also the integration of a parameter (N) taking into account the experience gained by the Organization on its systemic environment.
This factor (N) which modules the expression of the risk is defined in the following way:
为了弥补这些参数的不足，研究方法案例假设参数（N）的整合也将机构在它系统性环境中获得的经验考虑进去。因素N将风险表现出来，按照以下的方式来确定。

毒手药王邓智先

N Description  N描述
1.0
Existence of documented evidence, established by an independent entity, proving the ongoing  compliance to regulatory requirements during more than 36 months.
存在记录在案的证据，由独立的实体确定，在多于36个月的时间里不间断的服从监管要求。
1.1
Existence of documented evidence, established by an independent entity, proving the ongoing compliance to regulatory requirements since less than 36 months.
存在记录在案的证据，由独立的实体确定，在少于36个月的时间里不间断的服从监管要求。
1.2
Absence of documented evidence, established by an independent entity, proving the compliance to regulatory requirements or existence of a nonaddressed on-conformity.
缺少记录在案的证据，不间断的服从监管要求或者未被处理的不一致的情况
Systemic risk (Rs):系统性风险
The quantification of the systemic risk will be then based on the following
expression:然后系统性风险的量化会以下面的表达式为基础：
Rs = S x F x N
According to whether it is of a primary risk or a residual risk one then obtains with the indices “p” and “r” the following expressions:
primary Risk: Rsp = Sp x Fp x N
residual Risk: Rsr = Sr x Fr x N
根据是主要风险还是残余风险，分别用指数“p”和“r”来进行区分，如下所示：
主要风险：Rsp = Sp x Fp x N
残余风险：Rsr = Sr x Fr x N
The parameter of detectability  (D) is not directly included in the calculation of the risk. It intervenes as a conditional parameter for the decision of acceptance of the risk (Boolean operator). This aspect will be described in a more complete way in the following section of the document.
检测性参数D没有直接被包含在风险的计算中。它作为决定风险（布尔操作符）是否可接受时的条件性参数介入。这一方面将会在接下来的部分中做一个完整的描述。
Product factor (P):产品因素
The Product factor (P) balances the systemic risk Rs to give the global risk
Rg according to:
产品因素平衡了系统性风险和整体风险，公式表达为：Rg = P x Rs
The values taken by the factor (P) are increasing and monotonous; they
take their origin with P = 1.000.
因素P占有的价值正在增加，并且是无变化的，把它的初始值设定为P=1.000.
This means that for product having a value of (P) equal to 1.000 one will
have: Rg = Rs
这就意味着产品有了一个值1.000，使得Rg=Rs
The factor (P) is defined as being the addition of a component (E) and a component (C) increased by 1.000.P = E + C + 1.000
The component (E) represents the experience gained by the Organization with the product considered; it takes into account parameters such as:
Development or clinical phase of the product;
Number of occurrence for successful manufacturing of the product within the organization;
Origin of the product;
…
成分（E）代表机构从考虑过的产品中获得经验，它将一些参数考虑进来，比如：
---产品的研发或临床阶段；
---机构内部产品成功生产的次数；
---产品的来源
The component (C) translated the intrinsic characteristics of the product; it takes into account parameters such as:
成分C解释了产品的内在特征，它将下列参数纳入考虑：
&#61472harmacological and toxicological data
o NOEL ; NOAEL
o Physiologically active dosage
o Bioavailability
o …
药理学和毒物学的数据
o NOEL ; 未观察到损害作用的剂量
o生理有效剂量
o 生物利用度
&#61472hysicochemical data
o Solubility
o Granulometry (particle size distribution)
o Density
o …
物理化学特征
O溶解度
O粒度测定（粒度分布）
O密度
O……
API manufacturing process
o Chemical synthesis
o Animal origins
o …
API生产流程
O 化学合成
O 动物源
O ……
Miscellaneous
o Class of therapeutic indication
o …
其他
O 治疗适应证的种类
Each parameter included in calculations of components (E) and (C) for the determination of factor (P) has been worked out considering scientific literature and published results. This approach allows an objective determination of the factor (P).
根据科学文献和出版结果，因素P的决定成分E和C的计算中的每个参数都已经被就算出来。
In order to rationalize the capture of information using the calculation of the factor (P), a table of acquisition of entering parameters was established (cf paragraph 3.2) allowing automatic calculations of the values of (E) and (C) and by consequence of (P).
为了使用在因素P的计算中的信息的获取合理化，建了一个获取输入参数的表格（cf 第3自然段 3.2）可以自动计算E和C的价值和结果P。


3. Implementation of methodology 方法实施
3.1. Determination of the systemic risk系统性风险的决定
Each elementary step for each stage included in these processes is submitted to the system risk assessment according to a standardized mode as represented in the following form:
流程中所包含的每个阶段的每个基本步骤，根据下表描绘的标准模式，被提交给系统风险评估。
The document developed as a database where the selection of a single step loads all data (such as compiled primary risks) related to that step will facilitate the systematic review and risk assessment for every activities and every process of the Organization.Basically, a working group will select the step and recorded data will be loaded.
这个文件形成了一个数据库，在这里每一个步骤的选择负担了所有跟步骤相关的数据（比如编制的主要风险），这个文件会促进机构每项活动和每个流程的系统的回顾和风险评估。
从根本上说，工作小组会选择每一个步骤，并将记录的数据装载。
1) Select Process选择流程
2) Select Sub-Process选择子过程
Selection of the elementary stage:选择主要阶段
The selection of an elementary step will cause the automatic loading of the harmonized primary risks to which the Organization will add, if necessary, risks specific to its environment:
主要阶段的选择会导致自动加载机构会加上去的协调过的主要风险，如果需要的话，环境不同，风险不同。
The blue square is automatically filled out from the database with the harmonized risks; the red square is dedicated to the specific risks.
蓝色区域被协调过的风险的数据库自动填满；红色区域表示特定风险
Each primary risk is referenced and can be evaluated in an independent way.
每个主要风险被作为参考，并且能以独立的方式进行评估。
By definition, it is agreed that a level of risk R is:
按照定义，风险R的水平是：
&#61535;&#61472;low if: 0 =< R < 3
&#61535;&#61472;Moderate if: 3 =< R < 5
&#61535;&#61472;High if: R >= 5
it is also agreed that:
&#61535;&#61472;a risk is acceptable if it is low
如果结果是低，则风险可以接受
&#61535;&#61472;a risk is also acceptable if it is moderate and detection is certain
(D = d)若结果是中等，并且检测是确定的（D=d），那么风险也是可接受的。
&#61535;&#61472;a risk which is not acceptable is unacceptable.
风险不是可接受的情况不能接受。

毒手药王邓智先

For a given elementary step, the value of risk associated with this step is the highest S x F, value of the identified/indexed primary risks combined with the value of the factor of experience (N) according to the definition: Rs = S x F x N
对于一个既定的基本步骤，这个步骤的相关风险价值是最高的S X F，根据定义：Rs = S x F x N， 这个价值是被鉴定或者被索引的主要风险的价值和因素经验N的结合。
The values of the risk are discrete values belonging to the explicit series:
风险的值是属于明确系列的离散值。
[0.0; 1.0; 1.1; 1.2; 2.0; 2.2; 2.4; 3.0; 3.3; 3.6; 4.0; 4.4; 4.8; 6.0; 6.6; 7.2; 9.0; 9.9; 10.8].
These values define the zones of acceptance according to the rules given above with:
根据以上给出的原则，这些值明确了可接受的范围：
&#61535;&#61472;In green; the zone of direct acceptance 绿色：直接接受的区域
&#61535;&#61472;In red; the non acceptable zone 红色：不可接受的范围
&#61535;&#61472;In yellow; the zone subject to condition of detection 黄色：根据检测条件来确定的范围
The highest calculated value of the primary risk for an elementary step is indicated in the upper part of the form:
对于基本步骤来说，主要风险的最高可计算值显示在这个表格的上部分：
As soon as the section of the primary risks is completed in the form, methodology invites the users to introduce the implemented measures of risk reduction.
主要风险的部分一完成，研究方法就会邀请用户引进减少风险的实施措施。
Implemented measures of risk reduction are brought for each primary risk. These measures of risk reduction make it possible to calculate a new value for the parameters S, F, D associated with this risk and thus establish the value of the residual risk.
减少风险的措施的提出主要是为了主要风险。这些减少风险的措施使得计算风险附带的参数S，F，D的新值成为可能，因此去建立残余风险的值。
Ideally, it is expected that measures of risk reduction is supported by documented evidence quoted within the section “Related references”.
观念上讲，期望减少风险的措施由“相关参考”部分引证的文件性证据
The global value of the residual risk is calculated according to a principle identical to that used for the globalized value of the primary risk. It should be noted that the value of the factor of experience (N) remains the same one for the calculation of the primary and residual risks.The results obtained for the whole of the elementary steps are then compiled in a synoptic table according to the model given below:
残余风险的整体价值是根据一个原则来计算的，这个原则和曾经用于主要风险价值整体化的原则一致。应该注意到该经验因素的价值应该和计算主要风险和残余风险的经验因素的价值相同。
This table gives synoptic systemic risk (Rs).
3.2. Product factor 产品因素
Product factor is then assessed for the considered product. Results are presented in a standardized table as shown below:
产品因素是对既定产品的评估。
结果被列到一个标准化的表格中，如下所示：
The fact of ticking off the boxes corresponding to specificities of the product generates in a transparent way for the operator a value of Product factor (P).
根据产品的特性标记处盒子的事实以一个易懂的方式为操作者生成了产品因素的价值
As for the evaluation of the systemic risk, the computation charts of the factor (P) are organized in databases from which the parameters of calculation are accessible to the database administrators.
至于系统性风险的评估，因素P的计算表从数据库中组织出来，计算参数容易进入到数据管理程序中。
3.3. Determination of the total risk 整体风险的确定
The determination of the total risk is obtained by the multiplication of the systemic risk (Rs) by weighting produced (P).
整体风险的决定来自于系统性风险（Rs）和weighting produced (P)的乘积。
A synoptic table of the risk total for a particular product is then produced with the following format:
单个产品的所有风险一览表，会随着以下的格式形成。
This table gives the decisional tool for the acceptability of the global risk.
这个表格为整体风险的可接受性提供了决定性工具。

毒手药王邓智先

4. Deployment of methodology 方法开发
The developed example of methodology provides for the means of its implementation by making training tools available as well as a starting kit with all the primary risks harmonized for the activity developed by the Company. The methodology relies on an interactive database, which is accessible to the users. This service, expected to be soon available, should then be developed, hosted and maintained on an independent platform bringing together the different partners such as industry, professional associations, etc. The Company will then integrate the system on a voluntary “Customer - Supplier” basis. The operation of the service is demonstrated in the diagram below:
成熟的研究方法案例，通过制作可利用的训练工具和一套启动工具，通过公司的开发活动，为质量风险管理的实施提供所有的主要风险。 这个研究方法依赖于一个互动式的用户可用的数据库。希望尽快得到这个服务，然后应该进一步发展，在一个独立的平台上进行托管和维护，这个平台应该可以将企业、专业组织等不同的合作伙伴聚到一起。然后公司会在一个自愿的“消费者-供应者”的基础上整合这个系统。这项服务的操作如下表所示：
The platform will make available the assistance necessary to implement the method, guarantee confidentiality and use the information supplied exclusively for implementing the Risk Management methodology and nothing else. The platform will not interfere with free choice or the responsibility of the Company itself as regards its Risk Management by providing dedicated sections intended to include primary risks specific to her environment.
这个平台会为实施提供需要的援助，保证机密性，并将所提供的信息专用于实施风险管理方法，不会用于其他方面。通过提供专用的部分，这个平台将不会干涉公司本身鉴于风险管理的自由选择和责任，这些专用的部分将会包含根据具体环境的主要风险。
(备注：原文中的图表在这里省略，可参照原文。)

zl1964

是这篇文章，P是怎么得来的？

青城/怒云

药王的手真毒辣，方法学都能贴出来。{:soso_e183:}

coriolan

药王牛人啊

zl1964

毒手药王 发表于 2013-8-14 06:48
4. Deployment of methodology 方法开发
The developed example of methodology provides for the means o ...

你上传的中文译稿就是我以前翻译的，里面有我的邮箱。

清露紫苏

感谢药王的分享！赞一个！{:soso_e163:}