(校稿任务) 第100篇 Assessing the Risks of Risk Analysis
本帖最后由 小编D 于 2013-3-27 13:27 编辑
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翻译：gameoverztq
Assessing the Risks of Risk Analysis
风险分析中风险的评估
With APQC process engineering, we tend to start where it should end
根据美国生产力标杆协会的流程策划，我们倾向于防患于未然的思想。
Just a few reminders to start with: In the automotive supply chain, process failure mode and effects analysis (FMEA) must be based on—or at least must take into consideration—design FMEA. This is the case whether a given supplier is responsible for the design or not.
在开始前，我需要提醒你们: 汽车产业供应链中，在进行过程FMEA前，我们必须进行设计FMEA，或者应考虑设计FMEA的影响。所以，这就产生了一个问题：是否应邀请指定的供应商参与设计？
During an FMEA, severity (S) is ranked from 1 to 10, depending on the severity of an effect on a product, customer, manufacturing process, or operator.
在失效模式及影响分析中，我们根据失效模式对产品，顾客，生产过程及操作者产生影响的严重程度，将其分成10个分值尺度: 1、2、3、4………10;
Occurrence (O) is ranked from 1 to 10, based on the number of incidents per items per vehicles. It’s interesting to note that a rank of 1 (i.e., very low) is based on the criterion “failure is eliminated through preventive control.”
同样的，根据每辆车上每个零部件可能发生故障的频率，将发生率分为10个分值尺度；其中，我们需要关注标准中对分值尺度1的描述：“该失效可通过防错控制消除”
Detection (D) is also ranked from 1 to 10. A rank of 1 is based on error prevention, but a rank of 10 is assessed as “no current process control.” Curiously enough, ISO/TS 16949:2009 cites “error prevention” in the notes to clauses 7.1 and 7.3, but then switches to “error-proofing” in the note to clause 7.3.2.2 (“Manufacturing process design input”: mark it!), as well as for clauses 7.3.3.1, 7.3.3.2 (“Manufacturing process design output”), 8.5.2.2, and Annex A, Section A.2d.
还有探测率，也分为10个分值尺度。尺度1是建立在防错的基础上，尺度10被确定为“无现有过程控制”。令人感到好奇的是，ISO/TS 16949:2009在其7.1节和7.3节的注释中使用了“error prevention”这个词；而在7.3.2.2（制造过程设计输入）的注释中却使用了“error-proofing”这个词，同样的还有7.3.3.1、 7.3.3.2（制造过程设计输出）、8.5.2.2和附录A的A.2d部分，也使用了“error-proofing”
Now, if detection is ranked as 1 when errors are prevented, should it be ranked zero when error-proofing methods are in place?
现在，当防错控制已经生效时，我们定义探测率的分值尺度为1；那当错误预防方法已经确定时，是否可定义该处探测率的分值尺度为0？
There is something more to this. ISO/TS 16949 clause 7.6.1 states, “This requirement shall apply to measurement systems referenced in the control plan.” Since these systems shall be developed from the process FMEA, and clause 7.5.2.1 requires that “all process for production and service provision” be revalidated, doesn’t this mean that the process FMEA must be subjected to measurement system analysis and revalidation?
还有其他更多的问题。 ISO/TS 16949 7.6.1中讲到“此要求应使用于控制计划中所提到的测量系统”；既然这些系统开发于过程FEMA，并且7.5.2.1节中也要求了再确认“所有生产及服务提供过程”，那么，这难道不是表示过程FMEA需要进行测量系统分析及再确认？
It may sound a bit crazy, yet it isn’t really so when we consider the reality behind FMEA and observe how S, O, and, D rankings are personality-driven. As happens elsewhere in human interactions, the person who shouts the loudest, looks the fiercest, or whose fist hits the table first, is the “winner who takes all.”
听起来有些疯狂，但是，当我们考虑到FMEA背后的实际情况和注意到S,O,D分值的人为驱动性时，一切就变的平常了。就像其它的人类活动一样，谁喊的响，谁看起来更有气势，或者谁最先拍的桌子，谁就是“大赢家”。
Let’s look at a typical production process. In the beginning, there’s a customer’s request for a quote, along with the usual deadline for submittal “yesterday.” Then the supplier’s top management—under time and budget constraints—comes up with a quote based on the criteria, “Let’s put the order in the box, then we’ll see; this widget is similar to what we’ve been doing for years.”
让我们看一下一个典型的生产流程。首先，我们接到顾客询价，同时还包括交货期及过去的产品信息；然后，供方开始报价，但是，由于时间及预算的限制，管理层产生了这样的想法：“这个产品和我们过去做的东西很像，先拿到订单再说”
The drawing comes in and is read as such, not as the design record that it actually is. There are also tests and their specifications, and these reference further standards, specifications, and customer-specific requirements.
当收到图纸，开始真正的审阅时，产品的实际情况与设计记录并不相同。同样需要试验及具体说明，需要更多的标准，技术参数和客户具体的要求。
A production part approval process (PPAP) package is hastily put together and submitted to the customer, together with an initial sampling. The customer’s quality manager, under similar time constraints as the supplier, signs the parts submission warrant, and there we are.
匆忙的做好PPAP文件后，连同初样品一同提交给顾客。同时，顾客的质量经理由于交期的影响，签署了PSW；不少人就是这样做的！
We then move to the ramp-up and mass production, where the only documentation is the setup and work instructions from the similar widget the company has already produced, and the drawing of the new one. But what about the records? Well, let’s not waste time making the line operators write down the measurements that they read; they take more measurements than what’s required, so an OK or a tick is more than enough. Plus there’s quality control at the end of the line; they will do offline controls with a CMM and all sorts of expensive devices.
然后，在只有新图纸，PPAP和过去类似产品的作业指导书的情况下，批量下单并开始大货生产。但是记录呢？好吧，不要浪费时间来记录产线上员工的实测值了，让他们测量更多次，这样合格数和记录量都会增加。并通过三坐标或其他类似的昂贵设备做线下控制，来代替产线上的质量控制。
Sooner or later, though, there’s a mess, a catch, be it an 8D or similar request, a CSL1 or CSL2, a new business hold (NBH), a customer audit, or the periodic registrar’s audit.
但是，迟早有一天，问题会爆发，被抓住，被确认；然后开始提交8D报告，CSL1或CSL2，停止新业务，客户审核，或其他阶段性的审核。
And the mess, whatever it is, highlights that the PPAP package is mostly comprised of counterfeits: process flowcharting, process FMEA, control plan, work instructions, measurement system analysis, training records, feasibility commitment, and so on.
但是，不管问题是什么，都会告诉我们：提交的过程流程图，过程FMEA，控制计划，作业指导书，MSA，培训记录，可行性报告这些PPAP文件都是瞎编的
Therefore—and now we’re back to time constraints—the business is at stake. The poor quality manager, who may have sounded the alarm well in advance of the quote and the PSW submittal, now bears all the weight on his shoulders.
因此，我们现在回过头来看盲目追求交期时间的后果就是业务濒临危机。可怜的质量经理，本可以在报价或提交PSW时候得到警报，现在只好承受所有的压力
Of course, this is a worst case scenario, yet many similarities are found in real cases, where control plans come after work instructions, FMEAs come after control plans, process flowcharting comes after PPAP—just the opposite of any golden rule for prevention.
当然，这是个最坏的剧本，但是类似的案例确实经常发生：过程指导书先于控制计划，控制计划先于各种FEMA，PPAP做好才考虑过程流程图，刚好和我们所知道的任何一条防错的重要原则相悖被。
It’s true the automotive supply chain is under a lot of pressure to save both money and meet deadlines. And I have no financial title to back my opinions about costing issues, yet I believe suppliers could and should do better, in terms of risk assessment, feasibility analysis, and prevention.
确实，汽车产业面临着很多成本及交期上的压力，而且我也没有经济领域上的头衔来支持我关于成本问题的见解。但是我相信，供应商应该在风险评估，可行性分析及防错方面应做的更好。
For one thing, it’s the suppliers that own the knowledge of the machinery, materials, personnel, products, and processes. It’s useless to start a process FMEA at the same time as the incoming inspection, especially when incoming materials are inspected only for quantity and external appearance. The same holds true for sampling plans, both in-line and at the end of the line: The usual answer to the question, “Why every hour and not every four?” is, “We’ve always done it this way.”
举个例子来说，对于设备，材料，员工，产品或过程，供方应该有一定的了解；在来料检验的同时开展过程FMEA是达不到理想效果的，尤其是当来料检验只针对数量及外观的时候。同样对于抽样检验，包括线上抽样及生产完抽样，我们常常会有这样的疑问：“为什么是每小时进行一次抽样，而不是每四小时”，而得到的答案通常都是“我们一直是这样做的”
Process flows are charted with the same level of detail as the history of humankind, beginning with Adam and Eve. These charts don’t focus on risks and often are too generic to pinpoint what can—and will—make the process go wrong.
当我们谈到人类历史，只是笼统的知道它起源于亚当与夏娃；在绘制过程流程图的时候，也一样不会考虑太多可能出现风险细节，所以，很难通过过程成图指出什么过程可能出错及其原因。
Process FMEAs often suffer the same problem: All sorts of potential failure modes are listed, along with issues that have little to do with the operation in question, based on the criterion that “one never knows what can happen.” The redundancy is built in just to err on the safe side. (“Let’s see, belt and suspenders, what else?Fasteners on the waist?”)
过程FMEA通常也面临同样的问题，由于惯性的认为“预见未来是不可能的事情”，即使列出了所有潜在的失效模式，对于一些已经考虑到的问题，也很难着手处理。很多事情仅仅是为了保险起见。（就像腰带和吊带，都系在腰上，但是作用却是一样）
No wonder that “severities” are seldom ranked below 7. Is this effective risk analysis?
所以，我们规定的严重度几乎很少低于7，但这还是有效的风险分析吗？
The process of determining potential effect(s) of failure is based on the same criteria, but it’s made worse when FMEA-makers confuse product failure—and therefore design failure—with process operation failure.
对于决定风险的潜在影响，我们也有同样的担心。但是，当产品失效，设计失效及过程失效被混淆时，后果更加的严重。
To quantify these situations, Mr. Pareto would need to revise his famous 80-20 rule—where 80 percent of the effects come from 20 percent of the causes—to say that 99 percent of the effects of process failure are “human error”—i.e., humans who erred when they wrote the process FMEA, and humans who erred by endorsing it. This can extend even to high-severity rankings when no corrective action is determined. It seems these people adhere to the principle that “to err is human,” but forget that “to persist is the devil’s work.”
为了使这些情况更直观，柏拉图需要修改他著名的80-20理论，将“80%的结果归自于20%的原因”修改为“99%的过程失效是人为错误”-----例如那些在编写FMEA时犯错的人和那些在上面签字的人。当决定不了纠正措施的时候，可以扩展成更高等级的严重度。不过，这些人仍然在坚持“人都会犯错误”，却忘了“坚持是魔鬼”
Control plans, which should in principle originate from process FMEAs, often are mish-mashes of input from the FMEA, previous experience of the same or similar process, and a constraint to produce either stamp-sized or a monster-sized documents—in either case useless except for documentation purposes.
控制计划，理论上应来自于过程FMEAs，却经常被下面几种情况混淆：来自于FMEA的输入，过去相同或相近过程的经验，及无论大小，即使是无用也必须制作的文件---当然，文件化目的除外。
But there’s no need to drift into a Hamlet-type soliloquy here: It’s not a question of “to FMEA or not to FMEA.” Rather, how should we effectively assess risk, using FMEA or alternative methods? I find hazard analysis and critical control points (HACCP) a great, simple, and effective way. It’s still used chiefly in the food and cosmetic business, although its key principles pop up elsewhere occasionally. HACCP is based on FMEA, and in its simplest form states that, given any potential failure, if the downstream process will take care of it, then it's not critical, or a risk, anymore.
但是我们并不需要陷入哈姆雷特式的独白，“FMEA，做与不做？”这并不是一个问题，相反的，应该考虑是用FMEA还是其它办法来有效的评估风险。我发现危害分析和关键点控制是一种简单而有效的方法。虽然我们会偶然发现这种方法的痕迹，但是这种方法还是主要用于食品及化妆品企业。HACCP基于FMEA，在其简单的要求中规定：尽可能找出所有的潜在失效，如果下游的过程能够解决该失效，那么它就不重要，反之，这就是一种风险。
This is the closest to error-prevention I can think of—and to error-proofing, too, for that matter. The product-realization process can be so designed and engineered that it can take risks for various reasons (e.g., cost, cycle-time, tolerance, machinery age, shop-floor layout, operators’ skills), but there will always be an operation, or a device, that will correct or scrap the defect.
这是我心中最接近防错概念的理解了，当然，也包括预防等其它的概念。产品实现过程可以根据上面的原则进行设计及策划，以便它可以承担各种各样的风险（包括，预算，周期，公差，设备老化，工厂布局及操作者技巧等等）。但是通常我们只是通过操作者或设备来纠正缺陷或者报废
Those of you who are familiar with AIAG’s APQP manual may share my interest in it. I find it very valuable. The supplements J and K, and A-1 through A-8, pose stimulating, though sometimes redundant, questions. I particularly like the following from the A-7 Process FMEA checklist:
Do the effects consider the customer in terms of the subsequent operation assembly, and product?
Have the causes been described in terms of something that can be corrected or controlled?
Have provisions been made to control the cause of the failure mode prior to the subsequent or the next operation?
那些熟悉APQP手册的人可以分享我的心得，我觉得它非常有用。补充表格J，K，A-1至A-8
确实是有帮助，但是有时显得多余，或者让人迷惑。我特别喜欢A-7过程FMEA检查表中的几个问题：在以后的操作，组装和产品方面是否考虑了对顾客的影响；是否将以可以纠正或控制的方式描述原因；在下一操作进行前，是否为控制失效起因提供了必要的条件。
And the A-8 Control Plan checklist:
Are sample sizes based upon industry standards, statistical sampling plan tables, or other statistical process control methods or techniques?
还有A-8控制计划检查表中的：
我们选择的抽样数量是否根据行业标准，统计抽样计划表或其他的统计过程控制方法和技术？
ISO 31000:2009—“Risk Management—Principles and guidelines” is surely worth at least reading. Sections 4.3—“Design of framework for managing risk”; 4.4—“Implementing risk management”; and 4.5—“Monitoring and review of the framework” demonstrate that risk assessment and analysis, as part of risk management, is itself a process, and therefore worth investigating for stability, variability, and revalidation.
我们至少要读一读ISO 31000: 2009“风险管理原则及实施指南”。在4.3 节“风险管理框架的设计”，4.4节“风险管理实施”，与4.5节“框架的监督与检查”，这几节讲述了风险评估及分析，可以作为风险管理的一部分，也可以作为单独的一个过程，所以对其稳定性，变异及再验证进行投资是有必要的。
ABOUT THE AUTHOR
关于作者
Umberto Tunesi
Umberto Tunesi is a management system auditor for the quality, automotive, environment, social responsibility, and health and safety fields. He brings his natural and educational background to audit companies based on a continual process approach that confutes many-faced value management systems. He lives and works in northern Italy.
Umberto Tunesi是一名管理系统审核员，工作的领域包括：质量，汽车，环境，社会责任，健康与安全。他以不同于社会主流管理系统的持续过程方法来审核企业。Umberto Tunesi居住并工作在意大利
来自http://www.qualitydigest.com
请对以下文章有翻译兴趣的组员留下你的预计完成时间和邮箱地址，以便小编登记翻译者信息以及文章最终完成时间。
翻译：gameoverztq
Assessing the Risks of Risk Analysis
风险分析中风险的评估
With APQC process engineering, we tend to start where it should end
根据美国生产力标杆协会的流程策划，我们倾向于防患于未然的思想。
Just a few reminders to start with: In the automotive supply chain, process failure mode and effects analysis (FMEA) must be based on—or at least must take into consideration—design FMEA. This is the case whether a given supplier is responsible for the design or not.
在开始前，我需要提醒你们: 汽车产业供应链中，在进行过程FMEA前，我们必须进行设计FMEA，或者应考虑设计FMEA的影响。所以，这就产生了一个问题：是否应邀请指定的供应商参与设计？
During an FMEA, severity (S) is ranked from 1 to 10, depending on the severity of an effect on a product, customer, manufacturing process, or operator.
在失效模式及影响分析中，我们根据失效模式对产品，顾客，生产过程及操作者产生影响的严重程度，将其分成10个分值尺度: 1、2、3、4………10;
Occurrence (O) is ranked from 1 to 10, based on the number of incidents per items per vehicles. It’s interesting to note that a rank of 1 (i.e., very low) is based on the criterion “failure is eliminated through preventive control.”
同样的，根据每辆车上每个零部件可能发生故障的频率，将发生率分为10个分值尺度；其中，我们需要关注标准中对分值尺度1的描述：“该失效可通过防错控制消除”
Detection (D) is also ranked from 1 to 10. A rank of 1 is based on error prevention, but a rank of 10 is assessed as “no current process control.” Curiously enough, ISO/TS 16949:2009 cites “error prevention” in the notes to clauses 7.1 and 7.3, but then switches to “error-proofing” in the note to clause 7.3.2.2 (“Manufacturing process design input”: mark it!), as well as for clauses 7.3.3.1, 7.3.3.2 (“Manufacturing process design output”), 8.5.2.2, and Annex A, Section A.2d.
还有探测率，也分为10个分值尺度。尺度1是建立在防错的基础上，尺度10被确定为“无现有过程控制”。令人感到好奇的是，ISO/TS 16949:2009在其7.1节和7.3节的注释中使用了“error prevention”这个词；而在7.3.2.2（制造过程设计输入）的注释中却使用了“error-proofing”这个词，同样的还有7.3.3.1、 7.3.3.2（制造过程设计输出）、8.5.2.2和附录A的A.2d部分，也使用了“error-proofing”
Now, if detection is ranked as 1 when errors are prevented, should it be ranked zero when error-proofing methods are in place?
现在，当防错控制已经生效时，我们定义探测率的分值尺度为1；那当错误预防方法已经确定时，是否可定义该处探测率的分值尺度为0？
There is something more to this. ISO/TS 16949 clause 7.6.1 states, “This requirement shall apply to measurement systems referenced in the control plan.” Since these systems shall be developed from the process FMEA, and clause 7.5.2.1 requires that “all process for production and service provision” be revalidated, doesn’t this mean that the process FMEA must be subjected to measurement system analysis and revalidation?
还有其他更多的问题。 ISO/TS 16949 7.6.1中讲到“此要求应使用于控制计划中所提到的测量系统”；既然这些系统开发于过程FEMA，并且7.5.2.1节中也要求了再确认“所有生产及服务提供过程”，那么，这难道不是表示过程FMEA需要进行测量系统分析及再确认？
It may sound a bit crazy, yet it isn’t really so when we consider the reality behind FMEA and observe how S, O, and, D rankings are personality-driven. As happens elsewhere in human interactions, the person who shouts the loudest, looks the fiercest, or whose fist hits the table first, is the “winner who takes all.”
听起来有些疯狂，但是，当我们考虑到FMEA背后的实际情况和注意到S,O,D分值的人为驱动性时，一切就变的平常了。就像其它的人类活动一样，谁喊的响，谁看起来更有气势，或者谁最先拍的桌子，谁就是“大赢家”。
Let’s look at a typical production process. In the beginning, there’s a customer’s request for a quote, along with the usual deadline for submittal “yesterday.” Then the supplier’s top management—under time and budget constraints—comes up with a quote based on the criteria, “Let’s put the order in the box, then we’ll see; this widget is similar to what we’ve been doing for years.”
让我们看一下一个典型的生产流程。首先，我们接到顾客询价，同时还包括交货期及过去的产品信息；然后，供方开始报价，但是，由于时间及预算的限制，管理层产生了这样的想法：“这个产品和我们过去做的东西很像，先拿到订单再说”
The drawing comes in and is read as such, not as the design record that it actually is. There are also tests and their specifications, and these reference further standards, specifications, and customer-specific requirements.
当收到图纸，开始真正的审阅时，产品的实际情况与设计记录并不相同。同样需要试验及具体说明，需要更多的标准，技术参数和客户具体的要求。
A production part approval process (PPAP) package is hastily put together and submitted to the customer, together with an initial sampling. The customer’s quality manager, under similar time constraints as the supplier, signs the parts submission warrant, and there we are.
匆忙的做好PPAP文件后，连同初样品一同提交给顾客。同时，顾客的质量经理由于交期的影响，签署了PSW；不少人就是这样做的！
We then move to the ramp-up and mass production, where the only documentation is the setup and work instructions from the similar widget the company has already produced, and the drawing of the new one. But what about the records? Well, let’s not waste time making the line operators write down the measurements that they read; they take more measurements than what’s required, so an OK or a tick is more than enough. Plus there’s quality control at the end of the line; they will do offline controls with a CMM and all sorts of expensive devices.
然后，在只有新图纸，PPAP和过去类似产品的作业指导书的情况下，批量下单并开始大货生产。但是记录呢？好吧，不要浪费时间来记录产线上员工的实测值了，让他们测量更多次，这样合格数和记录量都会增加。并通过三坐标或其他类似的昂贵设备做线下控制，来代替产线上的质量控制。
Sooner or later, though, there’s a mess, a catch, be it an 8D or similar request, a CSL1 or CSL2, a new business hold (NBH), a customer audit, or the periodic registrar’s audit.
但是，迟早有一天，问题会爆发，被抓住，被确认；然后开始提交8D报告，CSL1或CSL2，停止新业务，客户审核，或其他阶段性的审核。
And the mess, whatever it is, highlights that the PPAP package is mostly comprised of counterfeits: process flowcharting, process FMEA, control plan, work instructions, measurement system analysis, training records, feasibility commitment, and so on.
但是，不管问题是什么，都会告诉我们：提交的过程流程图，过程FMEA，控制计划，作业指导书，MSA，培训记录，可行性报告这些PPAP文件都是瞎编的
Therefore—and now we’re back to time constraints—the business is at stake. The poor quality manager, who may have sounded the alarm well in advance of the quote and the PSW submittal, now bears all the weight on his shoulders.
因此，我们现在回过头来看盲目追求交期时间的后果就是业务濒临危机。可怜的质量经理，本可以在报价或提交PSW时候得到警报，现在只好承受所有的压力
Of course, this is a worst case scenario, yet many similarities are found in real cases, where control plans come after work instructions, FMEAs come after control plans, process flowcharting comes after PPAP—just the opposite of any golden rule for prevention.
当然，这是个最坏的剧本，但是类似的案例确实经常发生：过程指导书先于控制计划，控制计划先于各种FEMA，PPAP做好才考虑过程流程图，刚好和我们所知道的任何一条防错的重要原则相悖被。
It’s true the automotive supply chain is under a lot of pressure to save both money and meet deadlines. And I have no financial title to back my opinions about costing issues, yet I believe suppliers could and should do better, in terms of risk assessment, feasibility analysis, and prevention.
确实，汽车产业面临着很多成本及交期上的压力，而且我也没有经济领域上的头衔来支持我关于成本问题的见解。但是我相信，供应商应该在风险评估，可行性分析及防错方面应做的更好。
For one thing, it’s the suppliers that own the knowledge of the machinery, materials, personnel, products, and processes. It’s useless to start a process FMEA at the same time as the incoming inspection, especially when incoming materials are inspected only for quantity and external appearance. The same holds true for sampling plans, both in-line and at the end of the line: The usual answer to the question, “Why every hour and not every four?” is, “We’ve always done it this way.”
举个例子来说，对于设备，材料，员工，产品或过程，供方应该有一定的了解；在来料检验的同时开展过程FMEA是达不到理想效果的，尤其是当来料检验只针对数量及外观的时候。同样对于抽样检验，包括线上抽样及生产完抽样，我们常常会有这样的疑问：“为什么是每小时进行一次抽样，而不是每四小时”，而得到的答案通常都是“我们一直是这样做的”
Process flows are charted with the same level of detail as the history of humankind, beginning with Adam and Eve. These charts don’t focus on risks and often are too generic to pinpoint what can—and will—make the process go wrong.
当我们谈到人类历史，只是笼统的知道它起源于亚当与夏娃；在绘制过程流程图的时候，也一样不会考虑太多可能出现风险细节，所以，很难通过过程成图指出什么过程可能出错及其原因。
Process FMEAs often suffer the same problem: All sorts of potential failure modes are listed, along with issues that have little to do with the operation in question, based on the criterion that “one never knows what can happen.” The redundancy is built in just to err on the safe side. (“Let’s see, belt and suspenders, what else?Fasteners on the waist?”)
过程FMEA通常也面临同样的问题，由于惯性的认为“预见未来是不可能的事情”，即使列出了所有潜在的失效模式，对于一些已经考虑到的问题，也很难着手处理。很多事情仅仅是为了保险起见。（就像腰带和吊带，都系在腰上，但是作用却是一样）
No wonder that “severities” are seldom ranked below 7. Is this effective risk analysis?
所以，我们规定的严重度几乎很少低于7，但这还是有效的风险分析吗？
The process of determining potential effect(s) of failure is based on the same criteria, but it’s made worse when FMEA-makers confuse product failure—and therefore design failure—with process operation failure.
对于决定风险的潜在影响，我们也有同样的担心。但是，当产品失效，设计失效及过程失效被混淆时，后果更加的严重。
To quantify these situations, Mr. Pareto would need to revise his famous 80-20 rule—where 80 percent of the effects come from 20 percent of the causes—to say that 99 percent of the effects of process failure are “human error”—i.e., humans who erred when they wrote the process FMEA, and humans who erred by endorsing it. This can extend even to high-severity rankings when no corrective action is determined. It seems these people adhere to the principle that “to err is human,” but forget that “to persist is the devil’s work.”
为了使这些情况更直观，柏拉图需要修改他著名的80-20理论，将“80%的结果归自于20%的原因”修改为“99%的过程失效是人为错误”-----例如那些在编写FMEA时犯错的人和那些在上面签字的人。当决定不了纠正措施的时候，可以扩展成更高等级的严重度。不过，这些人仍然在坚持“人都会犯错误”，却忘了“坚持是魔鬼”
Control plans, which should in principle originate from process FMEAs, often are mish-mashes of input from the FMEA, previous experience of the same or similar process, and a constraint to produce either stamp-sized or a monster-sized documents—in either case useless except for documentation purposes.
控制计划，理论上应来自于过程FMEAs，却经常被下面几种情况混淆：来自于FMEA的输入，过去相同或相近过程的经验，及无论大小，即使是无用也必须制作的文件---当然，文件化目的除外。
But there’s no need to drift into a Hamlet-type soliloquy here: It’s not a question of “to FMEA or not to FMEA.” Rather, how should we effectively assess risk, using FMEA or alternative methods? I find hazard analysis and critical control points (HACCP) a great, simple, and effective way. It’s still used chiefly in the food and cosmetic business, although its key principles pop up elsewhere occasionally. HACCP is based on FMEA, and in its simplest form states that, given any potential failure, if the downstream process will take care of it, then it's not critical, or a risk, anymore.
但是我们并不需要陷入哈姆雷特式的独白，“FMEA，做与不做？”这并不是一个问题，相反的，应该考虑是用FMEA还是其它办法来有效的评估风险。我发现危害分析和关键点控制是一种简单而有效的方法。虽然我们会偶然发现这种方法的痕迹，但是这种方法还是主要用于食品及化妆品企业。HACCP基于FMEA，在其简单的要求中规定：尽可能找出所有的潜在失效，如果下游的过程能够解决该失效，那么它就不重要，反之，这就是一种风险。
This is the closest to error-prevention I can think of—and to error-proofing, too, for that matter. The product-realization process can be so designed and engineered that it can take risks for various reasons (e.g., cost, cycle-time, tolerance, machinery age, shop-floor layout, operators’ skills), but there will always be an operation, or a device, that will correct or scrap the defect.
这是我心中最接近防错概念的理解了，当然，也包括预防等其它的概念。产品实现过程可以根据上面的原则进行设计及策划，以便它可以承担各种各样的风险（包括，预算，周期，公差，设备老化，工厂布局及操作者技巧等等）。但是通常我们只是通过操作者或设备来纠正缺陷或者报废
Those of you who are familiar with AIAG’s APQP manual may share my interest in it. I find it very valuable. The supplements J and K, and A-1 through A-8, pose stimulating, though sometimes redundant, questions. I particularly like the following from the A-7 Process FMEA checklist:
Do the effects consider the customer in terms of the subsequent operation assembly, and product?
Have the causes been described in terms of something that can be corrected or controlled?
Have provisions been made to control the cause of the failure mode prior to the subsequent or the next operation?
那些熟悉APQP手册的人可以分享我的心得，我觉得它非常有用。补充表格J，K，A-1至A-8
确实是有帮助，但是有时显得多余，或者让人迷惑。我特别喜欢A-7过程FMEA检查表中的几个问题：在以后的操作，组装和产品方面是否考虑了对顾客的影响；是否将以可以纠正或控制的方式描述原因；在下一操作进行前，是否为控制失效起因提供了必要的条件。
And the A-8 Control Plan checklist:
Are sample sizes based upon industry standards, statistical sampling plan tables, or other statistical process control methods or techniques?
还有A-8控制计划检查表中的：
我们选择的抽样数量是否根据行业标准，统计抽样计划表或其他的统计过程控制方法和技术？
ISO 31000:2009—“Risk Management—Principles and guidelines” is surely worth at least reading. Sections 4.3—“Design of framework for managing risk”; 4.4—“Implementing risk management”; and 4.5—“Monitoring and review of the framework” demonstrate that risk assessment and analysis, as part of risk management, is itself a process, and therefore worth investigating for stability, variability, and revalidation.
我们至少要读一读ISO 31000: 2009“风险管理原则及实施指南”。在4.3 节“风险管理框架的设计”，4.4节“风险管理实施”，与4.5节“框架的监督与检查”，这几节讲述了风险评估及分析，可以作为风险管理的一部分，也可以作为单独的一个过程，所以对其稳定性，变异及再验证进行投资是有必要的。
ABOUT THE AUTHOR
关于作者
Umberto Tunesi
Umberto Tunesi is a management system auditor for the quality, automotive, environment, social responsibility, and health and safety fields. He brings his natural and educational background to audit companies based on a continual process approach that confutes many-faced value management systems. He lives and works in northern Italy.
Umberto Tunesi是一名管理系统审核员，工作的领域包括：质量，汽车，环境，社会责任，健康与安全。他以不同于社会主流管理系统的持续过程方法来审核企业。Umberto Tunesi居住并工作在意大利
来自http://www.qualitydigest.com
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寒风梦竹 (威望:3) (北京 ) 汽车制造相关 工程师 - 质量工程师
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