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发表于 2009-8-15 21:21:54
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本帖最后由 hnwang 于 2010-2-16 16:27 编辑
国际标准化组织和国际认可论坛审核实践小组有一篇关于如何审核持续改进的指导文章,摘录在此,供参考。从如何审核的反面也可以学习到,应当如何来做好持续改进。
International Organization for Standardization International Accreditation Forum
Date: 5 June 2009
ISO 9001 Auditing Practices Group Guidance on:Auditing Continual Improvement
ISO 9001审核实践小组关于审核持续改进的指南
How much improvement is “enough”?
改进多少算“够”了?
It should be emphasised that the requirement in ISO 9001 is for continual improvement of the effectiveness of the QMS.
应该强调的是:ISO 9001标准的要求是持续改进质量管理体系的有效性。
Continual improvement emanates from the objectives set by top management, which should (at least) address: the improvement of internal efficiency (for the organization to remain economically competitive), individual customer needs, and the level of performance that the market normally expects.
持续改进源自最高管理者设定的各种目标,这些目标应(至少)指明:组织内部效率的改进(以便为组织保持经济方面的竞争力)、单个顾客各种需求以及通常期望达到的市场绩效水平。
For example, in the aeronautical sector, the “acceptable rate” of non-conforming delivered product is zero percent, so it would not be useful for the organization to set objectives for an “improvement" in this rate. However, it would be useful for the organization to have objectives aimed in improving its internal efficiency and its competitiveness (e.g. through innovation).
例如,在航空、航天领域,交付产品不合格的“可接受率”是百分之零,所以组织在这个比率上再设定“改进”目标,将是毫无用途的。然而,组织设定目标,改进其内部效率以及(通过创新)来提高其竞争力,将是很有用的。
The auditor should seek to determine if the auditee has attempted to set objectives that establish the correlation between the 3 factors of: corporate objectives, customer needs, and market expectations. Thereafter, it is up to the organization to balance the need for improving internal efficiency and the need to progress with external performance (although the two are very often closely related). No one in isolation can ever be considered as being “enough” or “not enough”.
审核员应寻求证据确定,被审核方是否已经尝试设定各种目标。这些目标建立了以下三个因素的相互联系:公司的各种目标、顾客的各种需求以及市场的各种期望。然后,就由组织来平衡需要改进内部的效率还是需要发展外部市场开发的绩效(尽管这二者是非常密切相关的)。无法单独来考虑是“够”还是“不够”。
One area which can be problematic for the auditor to know is what a reasonable market benchmark is. Continuing the above aeronautical example, if the organization announced that it had improved from a level of 50% non-conforming product delivered to 40%, this would demonstrate continual improvement, but would hardly be acceptable, given the industry sector's zero percent normal rate. However, if it announced that it had set an objective to improve its performance from 0.50% to 0.40%, this would be much nearer the market norm.
对于审核员来说,要知道什么是用来合理判定市场水平用的基准,可能是一个问题。让我们继续采用上面航空、航天领域的例子来说,如果组织宣称它已经将交付产品不合格品率从50%改进到40%,也许这可以表明已经是持续改进,但是, 根据该行业正常的比率是百分之零的基准来看,这种改进根本是不能加以接受的。然而,如果他们宣布,已经设定了将其不合格品率从0.50%改进到0.40%的目标,这就更加贴近市场正常水平了。
The only real solution for the auditor is to verify how the organization has determined this proposed rate of improvement, how it has evaluated the associated risks, and how this relates to customer requirements and the monitoring of feedback on customer satisfaction.
对于审核员而言,真正的解决方案在于,去验证组织是如何确定好所要改进的比率、是如何评估相关风险的,以及是如何与顾客要求和对顾客感知满意的监控反馈信息相联系起来的。
It would be almost impossible to issue an NCR that stated “There was not enough continual improvement”.
几乎不可能开出宣称“持续改进不够”的不符合报告。
What sort of information is relevant and where can we find it?
哪种信息是有关的以及何处可以找到?
The auditor has to verify how the overall corporate objectives have been translated into internal requirements throughout the appropriate processes, and how these requirements are communicated and monitored. So, the auditor should look for evidence that the organization is analysing data from process monitoring, and is then taking the results forward for evaluating process efficiency and/or improving process output. One point that should be specifically examined is the consistency of the way in which the improvement of any one process contributes to meeting the overall objectives, in order to ensure that this will not cause conflict in the achievement of other objectives.
审核员必须验证,公司总的目标是如何从上到下分解和转化为内部相应过程的各项要求的,以及这些要求是如何加以沟通和监控的。于是,审核员应当寻找证据,表明组织正在对监视过程得到的数据进行分析、然后,把这些分析结果用于评估过程的效率和/或改进过程的输出。应特别注意检查的是,任一过程的改进对实现总体目标所起作用的协调一致性,用以确保不会引起实现其他目标的冲突。
The type of information that an auditor needs to look for, is evidence of how the corporate objectives are translated into specific QMS objectives. For example: an organization could set an objective to reduce customer complains by 30%. The top management analysis shows that 50% of the complaints concern overdue deliveries. The auditor should then look for evidence that the organization is monitoring and analysing key aspects of its scheduling and planning activities, throughout its processes, and the process interfaces, to reduce delays.
审核员必须寻找信息的类型是,公司总目标是如何分解、转化为特定质量管理体系目标的。例如:一个组织有可能设定目标,降低30%的顾客投诉。最高管理者的分析表明,50%的投诉是属于延误交货。审核员就应寻求证据,证明组织为了减少交货延误,正在监视和分析他们的计划安排和策划活动,从头到尾所有有关过程 以及过程和过程的交接方面存在什么关键问题。
Improvement of the process or improvement of the QMS?
过程的改进还是QMS的改进?
An auditor should remember that it would be unrealistic to expect an organization to make progress all potential improvements simultaneously. Each improvement will require the commitment of resources, which may need prioritisation by top management, especially where investments are needed. Instead, the auditor should seek to ensure that the improvement objectives are consistent overall, and are coherent with the trilogy of factors mentioned above. However, an organization that does not have a policy and objectives relating to continual improvement is clearly not complying with the standard. Similarly, the absence of any evidence of improvement on at least one of these aspects would have to be considered as indicating that an organization's quality policy is not in line with ISO 9001.
审核员应切记,不可能要求组织对所有潜在可以改进的地方同时都在改进,这是不现实的。每项改进都需要在资源方面的承诺,资源可能需要最高管理者区分优先次序,特别是需要投资的时候。取而代之的是,审核员应朝确保改进目标总体上是一致的,并且和前面所提及的三个方面是相互协调的方向去查询。但是,如果组织没有与持续改进相关的方针和目标的话,显然是不符合标准的。同样地,没有任何证据表明至少在一个方面进行了改进,这意味着组织的质量方针是不符合ISO 9001要求的。
One word of warning: There is no requirement that the organization should set objectives for improvement of all its processes at any one time. As in the above example on reducing customer complaints, some processes may not be deemed by top management to contribute significantly to the reduction of delays, and it is only normal therefore, that the organization would not concentrate on these areas.
提醒一句:标准并没有要求,组织应对某所有过程在同一时刻设定改进目标。在上面降低顾客投诉的例子里,有一些过程最高管理者认为对减少延误不会有显著贡献,因此组织不去关注这些领域也是正常的。[/color]
If the top management has set a (realistic) objective for a process, and there is no evidence of improvement, this information must be fed back into the management review so that top management can decide what type of action is appropriate - for example, re-adjusting the objective or providing other means to impact on the process.
假如最高管理者已经对某过程设定了(切实可行的)目标,并且没有改进的证据,那么,这种信息必须被反馈到管理评审,以便最高管理者能够决定采取何种适宜的措施,譬如,重新调整目标或者对该过程采取其他的措施。
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