IRIS内审员培训教材.ppt

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * 8.3.2 客户让步放行Customer Concession The organization shall obtain a customer Concession or Deviation Permit prior to further Processing, whenever the Product or Production differs from what has been approved. 当发现产品或生产过程与目前批准的要求有偏差时，组织必须得到顾客让步认可或偏差许可后才能进行后续作业。 Penalties due to Concessions and Deviation Permits should be collected, analyzed and assigned to causers. 让步放行和偏差许可应收缴罚款，分析原因并确定引起者。 NOTE1 Penalties due to Concessions and Deviation Permits may be considered as part of Quality Deficiency Cost. 注1：由于让步放行和偏差许可产生的罚款则可视为质量缺陷成本的一部分。 The organization shall maintain a record of the expiration date of such a concession and /or quantity authorized. 组织必须保持这样的让步放行的期限和／或批准放行的数量的记录。 8.3.2 客户让步放行Customer Concession The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires. 当顾客让步放行的授权到期后，组织必须确保与初始的或代替的规范相符合。 ? Material shipped, which is subject to such a concession, shall be clearly and appropriately identified. This applies equally to purchased products. 所装运的材料涉及让步放行时，必须适当清楚地标识。这同样适用于采购的产品。 The organization should define and implement a customer Concession Process. 组织应该确定并实施顾客让步放行过程。 The organization shall reach agreement with such a request from suppliers before submission to the customer. 在向顾客交付前，组织必须确保供方让步放行请求已得到批准。 8.4 数据分析Analysis of Data In addition to ISO 9001:2008, the organization should ensure that a Process for the analysis of data is in place (see clause 8.2.2) and the performance of this Process should be measured by a KPI (see annex 3). 除ISO 9001:2008的要求外 ，组织应确保制定数据分析的过程（见8.2.2），且此过程的绩效应通过关键绩效指标来测量（见附件3 ）。 In addition to the ISO 9001:2008, the analysis of data shall provide information relating to: 除ISO9001:2008的要求外，数据分析应提供以下有关方面的信息： e) external incident reports associated with the org