ISO9001:2008 7.5.2条款的应用 特殊过程能力确认常见误区及改进
ISO9001: 2008 7.5.2 in terms of the application of special process capability validation errors and improvement
特殊过程能力确认是ISO9001标准提出的一项重要要求，同时它又是国内认证界最令人困惑的事项之一，笔者在多年的审核实践中发现，这一问题在实践中仍存在一些明显的误区。
Special process capability is confirmed to ISO9001 standards put forward an important requirement, at the same time it is the certification industry 's most perplexing one, based on years of audit practice, this problem in practice there are still some obvious errors.
　　误区之一：认证误区
One of errors: authentication error
　　将标准7.5.2条款用于日常监测。
The standard 7.5.2 articles for daily monitoring.
　　在审核中，经常看到受审核方甚至审核员将7.5.2条款用于日常监测。其实，所有生产和服务提供过程的日常控制都在7.5.1条款的调整范围内，7.5.2条款则只用于对特殊过程的能力进行确认。
In the audit, often see the auditee auditor will even 7.5.2 terms used for daily monitoring. In fact, all processes for production and service provision of routine control in 7.5.1 terms within its range of adjustment, 7.5.2 clause is only used on special process capability for confirmation.
　　以重要性作为特殊过程的识别依据。
In importance as a special process identification based on.
　　特殊过程的特点就在于它的结果不能或不易精确测定。我们知道，所有的结果都由造成这一结果的过程的因素决定，过程影响因素控制在一定范围内，就可以确保结果在期望范围内，而怎样才能将这些过程影响因素控制在合理范围内，正是特殊过程能力确认的任务。
Special features of the process is that it results not easy precise determination. As we know, all the results from the process factors, factors affecting the process control in a certain range, can ensure that the results within a desired range, and how these factors affecting the process control in the reasonable scope, it is a special process capability recognition task.
　　其实，特殊过程是一种客观存在，而不是由人们规定的。如，焊接汽车大梁显然比焊接一个碗柜重要，但焊接的过程没有区别，重要性取决于过程结果可能产生的风险。因而，某个过程是否是特殊过程，只存在能否识别，而不存在是否规定。
In fact, the special process is a kind of objective existence, rather than by the provisions of the people. Such as, welding automobile crossbeam than welding a cupboard, but no difference in welding process, importance depends on the process may result in risk. Therefore, whether a process is a special process, only in the presence of the identification, and there is no provision.
　　是否识别出特殊过程是无所谓的事。
Whether the identification of particular process is a matter of indifference.
　　正确识别特殊过程至少有两个用处：一是如果不能正确识别特殊过程，就不可能系统地分析其过程影响因素，造成主要过程影响因素控制的不足或缺失；二是标准对特殊过程确认有明确要求，若实际存在特殊过程而又未能识别出来，可能造成特殊过程确认活动的缺失，给认证注册带来影响。
Correct identification of special process at least two: one is useless if not properly identify special process, is impossible to systematically analyze the factors affecting the process, the main factors affecting the process of control is inadequate or missing; two is the standard for validation of special process clear, if the actual existence of special process but cannot be identified, may cause validation of special process activity loss, impact to registration.
　　确认对象的困惑。
The recognition of objects.
　　按照标准要求，所有的特殊过程均应予以确认，但确认的要求因过程及其重要性的不同而不同。
In accordance with the standard requirements, all of the special process should be recognized, but confirmed the requirement for process and the importance of different.
　　目前，公认的过程影响因素是人、机、料、法、环五大因素，对于不同的特殊过程，五大因素的影响程度有主次之分。如对于焊接过程，主要影响因素是人员技能和工艺方法，而对于热处理过程，主要影响是工艺方法和设备能力。因此，对于不同的特殊过程，首先应识别出主要影响因素，有重点地予以系统、全面地确认，其他次要因素则只需要一般地进行确认即可。
At present, recognized process influence factor is a person, machine, material, method, central five big factors, for different special process, five main factors have a distinction between primary and secondary. As for the welding process, main influencing factors are the staff skills and technology, and for the heat treatment process, the major influence is process and equipment capacity. Therefore, for different special process, should first recognize the main influence factors, key ground to system, fully recognized, other minor factors are just generally confirm to.
　　特殊过程能力确认应以证实过程能力充足为确认的最终目的，确认的方法和要求应与确认的目的相匹配。不同的过程，其影响因素有主要和次要之分；同样的过程，因其重要性不同，确认的程度有复杂和简单之分。所以，在正式确认前应予以充分策划。
Special process ability confirmation should be to confirm adequate process capability for the confirmation of the ultimate goal, confirmation method and requirements should confirm the purpose of matching. Different processes, the influencing factors of primary and secondary branch; the same process, because of the importance of different, confirm the degree of complex and simple points. So, in the formal confirmation should be fully orchestrated.
　　误区之二：策划误区
Zone two: planning errors
　　确认方案策划不合理。
Confirm the plan is not reasonable.
　　确认方案策划不合理有多种表现形式：
Confirm the plan is not reasonable has a variety of forms:
　　一种是以日常生产参数监测代替过程确认，因这种情况较少见，其原因是没有理解标准的要求，因篇幅所限，这里不多作分析。
Is a daily monitoring of production parameter instead of process validation, because this condition is rare, its causes are not understood standards, because length place is restricted, not much here for analysis.
　　一种是以日常生产参数作为确认参数，这在申请认证的企业中比较普遍。从表面上看，企业进行了确认，但这一确认只能证实平时使用的参数可以保证质量，但不能证实规定的参数都能确保结果满足要求。
Is a daily production parameters as recognition parameters, this certification enterprises generally. On the surface, the enterprise was confirmed, but this confirmation only confirm usually used parameter can assure the quality, but not that specified parameters can ensure the results meet the requirements.
　　还有一种常见的策划不合理方案是，规定每次试验只做一个样件，这样的试验结果易受偶发因素干扰，而具有再现性的试验才能充分证实某种内在的规律性。况且，对于有些过程的结果评定还需要作各种破坏性试验，这也要求每组试验应产生足够多的样件。
There is also a common planning unreasonable plan is provided for each test, only a prototype, the test results are susceptible to accidental factors interference, and has the reproducibility of the test can be fully confirmed some immanent regularity. Moreover, for some of the process evaluation of results is also a need for all kinds of destructive test, which also requires each test should have enough samples.
　　以日常使用的检验规程代表过程确认的评定标准。
Rules for the inspection of daily use to represent process validation evaluation standard.
　　过程确认的评定不同于日常产品检验，它应包括产品评定和综合评定。在日常生产中，由于检测手段的限制和考虑到检验成本，很多企业简化了产品评定的检验要求，如许多小企业，对于特殊过程往往只检验产品外观质量，但在过程确认时也这样做，就无法作出产品是否满足要求的合面评价。所以，产品评定应尽可能多地包含产品特性值。
Process validation evaluation differs from the daily product inspection, it should include product assessment and comprehensive assessment. In the daily production, as a means of detecting limit and considering the inspection costs, many enterprises simplifies product evaluation testing requirements, such as many small businesses, for special process often only test appearance of the quality of the product, but in the process of recognition to do the same, will fail to make the products meet the requirements of the occlusal surface evaluation. Therefore, product assessment should be as much as possible including product characteristics value.
　　综合评定准则包括的面则更广一些，除了对各样品组进行综合评价外，还应包括对确认条件的适宜性、确认过程的可信性、确认记录的证实性等进行综合评价，最终得出过程是否通过确认的结论。
Comprehensive evaluation criteria include faces are more widespread, in addition to the variety of products group comprehensive evaluation, should also include the conditions for the recognition of the suitability, the validation process credibility, confirm the record confirmed synthetically evaluation, finally obtains the process by confirming the conclusion.
　　以日常使用的过程监测记录或检验记录代替过程确认纪录。
With the routine use of process monitoring records and inspection records instead of process validation records.
　　确认要求比日常生产要求要全得多，所记录的确认信息应能描述确认的试验过程和评定过程，而日常生产监测或检验记录中所设计的栏目不能容纳确认所需要的信息，如各样品组不同的生产条件/设备/人员、各样品组及每个样品所有评定项目的测量结果、综合评定的信息等，将造成确认记录的证实性不足。所以，标准 7.5.2d条款规定要对确认记录的内容进行策划。
Confirm daily production requirements requirements than to the more, the recorded validation information should be able to describe the confirmation of the test process and evaluation process, and daily production monitoring and inspection records the column cannot accommodate to confirm the required information, such as the sample groups of different production conditions / equipment / personnel, all kinds of goods and each sample all evaluation measurement result, comprehensive evaluation of information, will cause the validation records confirmed the lack of. Therefore, the standard provisions of 7.5.2d to confirm the record content planning.
　　误区之三：应用的误区
Zone Three: application error
　　确认与应用脱节。
Validation and application of disconnection.
　　特殊过程确认的目的是为了应用过程控制，所以确认的结果应对过程控制的策划和实施起到指导作用，但笔者在审核中经常看到，即使是正确地进行了过程确认的组织，在应用确认结果时也会出现脱节现象。如编制的工艺文件未按确认结果作必要修改；未经再次确认而盲目扩大应用范围。这样，已做的确认活动就失去了意义。
Validation of special process in order to application process control, so confirming the results to process control planning and implementation plays a guiding role, but the author in the audit often see, even if it is properly for the process of confirming the organization, application validation results can also occur when the disconnection. Such as the preparation of process document fails to confirm the results for necessary amendments; without once again confirmed the blind expansion of scope of application. So, have confirmed the activity lost significance.
　　再确认需求。
Reconfirm demand.
　　再确认需求方面的问题主要有两种情况，一种是规定一个再确认的时间间隔（如一年），而没有考虑是否真的需要。这种规定的不合理性在于它将增加不必要的成本。其实，只有当过程影响因素发生重大变化时，才存在再确认的需求。
Revalidation requirements issues mainly to have two kind of situations, one is to set a then confirmed time interval ( such as a year ), and did not consider whether you really need. This kind of unreasonable is that it adds unnecessary cost. In fact, only when the process factors affecting the occurrence of major changes, there was a demand for confirmation of again.
　　另一种再确认需求的规定是合理的，但实际上却没有进行再确认，如手工电弧焊改为二氧化碳气体保护焊，热处理加热炉进行了大修等，却没有进行确认，这就是实施失控的问题了。
Another reconfirmation requirement requirement is reasonable, but actually it is not recognised, such as manual arc welding for carbon dioxide gas shielded arc welding, heat treatment furnace has been overhauled, but not confirmed, it is implementation of out of the question.