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发表于 2008-6-7 18:06
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本帖最后由 hnwang 于 2009-7-10 21:17 编辑
本帖子2009年6 月5日有修改，请见后面帖子。
网站上常常见到有人问如何评审和关闭不符合报告。我从国际标准化组织网站上下载这篇指南，仅供参考。
日期Date: 10 February 2005
ISO 9001 Auditing Practices Group
ISO9001审核实践小组
Guidance for reviewing and closing nonconformities :
如何评审和关闭不符合报告指南
Introduction
引言
The value that can be provided to an organization can be enhanced or diminished by the review that an auditor conducts of the organization’s response to a nonconformity, as well as by the "close-out" process that is applied. An auditor will add value by ensuring that the organization has satisfactorily addressed correction/ analysis of the cause, and corrective action, as this will increase the likelihood of the organization achieving customer satisfaction.
审核员发现不符合，开出不符合报告后，如何对待组织针对不符合报告所采取的行动加以评审，以及关闭所开出的不符合报告，通过这样的行动可以帮助组织提高价值，也有可能降低价值。因为，审核员确保组织已经满意地描述了针对不符合项所采用的纠正行动、分析根本原因，再采取纠正措施，这样做以后会提高组织达到使顾客满意的可能性。这就是对组织起到了增值作用了。
This document provides guidance to help auditors in the process of reviewing and closing nonconformities arising from audits.
这份文件帮助审核员如何评审和关闭审核时候开出的不符合报告。
Review of actions in response to a Nonconformity
对组织针对不符合项所采取措施的评审
Management system auditors are responsible for reviewing the response to nonconformity and verifying the effectiveness of actions taken.
质量管理体系的审核员负责评审组织对不符合项所采取措施的评审工作，而且要验证所采取措施的有效性。
There should be three parts to the response of an organization to nonconformity:
一个组织针对不符合项所作的反映应当包括如下三部分：有两种类型：
• correction, or • analysis of cause,
• analysis of cause, and • correction, and
• corrective action. • corrective action.
一种是：1）纠正；2）分析原因，和3）纠正措施
另外一种是：1）先分析原因；2）采取纠正，和 3）纠正措施。
(Note; two different sequences are given as it may depend on the product type, or the situation of the nonconformity, as to which is the correct one to be followed. However, the three parts to resolving the nonconformity are the same in each case. For example, for software, it is inadvisable to implement a correction until the cause is known. Alternately, as a hardware example, if a "Low Brake-pad" warning light were to illuminate in a vehicle and you immediately implemented the correction of replacing the brake pads before examining if the sensor was faulty, you might fail to resolve the problem and would have wasted time and resources.)
（注：这两类不同类型应当根据产品的类型或者情况的不同来采取。但是，这三部分解决不符合问题的内容是相同的，只是次序有所不同。譬如，对软件的不符合项，如果原因不清楚是没有办法纠正的，反之，对硬件来说，可以先纠正再查原因。譬如，汽车上刹车片压力的警告灯亮，您不分析信号系统是否有问题，马上就更换刹车片，换了以后再检查信号是否还有问题。这样做可能不解决问题，会浪费资源的。）
The authoritative source for making the opening statement are some pertinent definitions in ISO 9000: 2000.
与不符合声明有关的一些定义可以从ISO9000：2000中得到：
Nonconformity: non-fulfillment of a requirement (ISO 9000:2000, clause 3.6.2)
不符合：不满足要求(ISO 9000:2000, 第3.6.2条)。
Correction: action to eliminate a detected nonconformity (ISO 9000:2000, clause 3.6.6)
纠正：消除发现不符合问题的措施(ISO 9000:2000, 第3.6.6条)。
Corrective action: action to eliminate the cause of a detected nonconformity or other undesirable situation (ISO 9000: 2000, clause 3.6.5)
纠正措施：消除发现不符合或者其他不希望发生情况的原因的措施(ISO 9000:2000, 第3.6.5条)。
Both correction and corrective action should be expected when there is a detected nonconformity.
当发现一个不符合项，应当具有纠正和纠正措施两项活动。
"Correction" is action to eliminate a detected nonconformity. For example, correction may involve replacing nonconforming product with conforming product or replacing an obsolete procedure with the current issue, etc.
“纠正”是消除已经发现不符合问题的措施。譬如说，用合格品替代不合格品，或者用现行有效的程序文件替代已经作废的程序文件。
The definition of "corrective action" is “action to eliminate the cause of a detected nonconformity.” Corrective action cannot be taken without first making a determination of the cause of nonconformity. There are many methods and tools available to an organization for determining the cause of a nonconformity, from simple brainstorming to more complex, systematic problem solving techniques (e.g. root cause analysis, fish-bone diagrams, “five whys", etc). An auditor should be familiar with the appropriate use of these tools. The extent and effectiveness of the corrective actions depends upon identifying the true cause. In some cases this will assist an organization to identify and minimize similar nonconformities in another areas.
“纠正措施”是“消除发现不符合或者其他不希望发生情况的原因的措施”。如果不是先确定不符合问题的原因，也就没有办法采取纠正措施。
可以采用很多工具和方法来确定不符合问题的原因，最简单的是脑力风暴法，还有复杂的，譬如系统解决问题技术（例如根本原因分析、鱼刺图、“五个为什么”等），作为审核员应当熟悉如何适当地采用这些工具和方法。纠正措施的有效程度取决于对根本原因的识别。在某些情况下，这样做还能帮助组织去发现和消除其他部位类似的不符合问题。
In reviewing the response of an organization to a nonconformity, the auditor should confirm that documentation and objective evidence for all three parts—correction/ analysis of the cause, and corrective action—are provided by the organization, and are appropriate, before accepting the response. Important elements to verify in the review process include:
对组织针对不符合问题所做措施的评审的时候，审核员应当肯定（纠正/原因分析和纠正措施）以上三方面的客观证据，而且组织都必须提供书面的文件，而且要适当。当审核员接受这些措施之前，。必须验证以下各个方面：
• statements of actions; are they clear and concise ?
对措施的声明：描述是否清楚而且简要？
• descriptions of actions; are they thorough and do they accurately reference specific documents, procedures etc., as appropriate?
措施的描述：是否从头到底加以描述了，是否准确地引用了规定的文件、程序，是否适当？
• the use of the past tense (was, has or have been, were), as an indicator that the actions taken have been completed.
是否采用过去式来描述的：这说明这些措施实际上已经得到贯彻执行了。
• the date of completion of the corrective actions; past dates should be found that indicate that the actions have been taken (dates indicating future action are not good practice).
纠正措施完成的日期：应当用已经过去的日期来说明这些纠正措施已经执行，不能用以后打算如何做来描述。
• evidence supporting the claim that a corrective action has been fully and effectively implemented and that the corrective action has been performed in the way that it was described.
要用客观证据来支持纠正措施已经完全贯彻而且有效，而且纠正措施已经如描述的那样得到贯彻执行。
Additionally, the auditor should verify that the organization has ensured that the corrective action taken does not itself create further problems relating to product quality or to implementation of the QMS.
另外，审核员 应当验证组织已经确保所采取的纠正措施并没有引起进一步产生的有产品质量或者质量管理体系的执行有关的其他问题。
It should be noted that both correction and corrective action are not always appropriate and that either correction or corrective action may be sufficient on their own. This may happen, for example, in cases in which it can be demonstrated that the nonconformity was absolutely accidental, and the probability of re-occurrence is very low.
应当指出，尽管纠正或者纠正措施本身都是很充分的，纠正和纠正措施不会总是很适当的。这种问题是会发生的。譬如，某些情况下，尽管再发生的概率是非常低的，但是，不符合问题还是会发生的。
Effective corrective action should prevent the recurrence of the nonconformity, by eliminating the cause. However, corrective action should not be confused with preventive action. The definition for preventive action is as follows:
有效的纠正措施应当通过消除原因，预防不符合问题的再次发生。但是，纠正措施不要和预防措施相混淆了。预防措施的定义如下：
Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable situation (ISO 9000:2000, clause 3.6.4)
预防措施：消除发现潜在不符合或者其他不希望发生情况的原因的措施(ISO 9000:2000, 第3.6.4条)。
It should be noted that preventive action, by the nature of its definition, is not applicable to already detected nonconformities. However, an analysis of the causes of detected nonconformities may identify potential nonconformities on a wider scale in other areas of the organization and provide input for preventive action.
应当指出，预防的本质是不适用于已经发生不符合问题的。但是，对已经发现的不符合问题进行原因分析也有可能从组织的更大范围其他部位识别出潜在的不符合问题的原因，把它作为预防措施的输入。
Closing nonconformities
关闭不符合报告
As nonconformities tend to be individual in their nature, a variety of methods or activities may be used to close them off. For example, some will require direct examination on site (which may require the need for additional site visits), while others may be closed-off remotely (by review of submitted documentary evidence).
鉴于不符合的本质趋势来说是单个性质的，针对它有好多方法来关闭这份报告的。譬如，有些会要求到现场进行直接的检查（这样就要求另外的现场审核了），而其他那些不符合报告可以通过远距离方式（通过送证据文件来加以评审）来关闭的。
Before deciding to agree to close-off a nonconformity, an Audit Team Leader (or the Auditor, in sole auditor situations) should review what the organization did in respect of correction/analysis of the cause, and the results it achieved through corrective action. The Audit Team Leader/Auditor needs to ensure that there is objective evidence (including supporting documentation) to demonstrate that the described corrective action has been fully implemented and is effective in preventing the nonconformity from re-occurring. Only once the situation is satisfactory, should the nonconformity be closed-off.
在决定关闭不符合报告之前，审核团队的组长（如果只有一个审核员组成的团队的话就是审核员）应当评审肯定组织已经对原因做了分析，采取了纠正和纠正措施，而且得到了预期的结果。审核团队组长必须确保有客观证据（包括支持性文件）来证实所描述的纠正措施已经完全得到贯彻，而且有效，相信能预防不符合问题不可能再次重复发生，只有具备这样的条件下，才能关闭不符合报告。（完） |
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