A preliminary analysis shall be per

A preliminary analysis shall be performed on the manufacturing activities, focused to the identification and prevention of defects.

There shall be a Productive Process Flow Chart: analysis activity cannot leave out of consideration the whole Productive Flow, starting from the material arrival and ending with the shipment and delivery of finished Product to the Customer.

When the technical documentation provided by the Customer does not indicate the existence of significant characteristics, the Organization’s personnel shall be trained and able to identify those characteristics important to the Customer or Product by means of techniques such as Process FMEA, assembling FMEA c/o Customer’s plant, DOE, knowledge of their processes, and/or knowledge of how the product is used.

At least the Organization should analyze characteristics that affect close tolerances, fit, function, finish, reliability, durability and/or that affect both internal Process parameters and following / final Process (see point 1.3).

Organization shall be able to describe how the design significant characteristics that affect Product function have been took in account during the development of Process FMEA.

Process FMEA shall analyze the whole Productive Flow starting from the material arrival and ending with the shipment and delivery of finished Product to the Customer.

Non-conformities arisen on Product / Process shall be used to update continuously the preventive analyses such as FMEA.

NB: auditor shall have the Process FMEA during the audit, even if it has been shared in a previous phase.

結果 (中文) 1:

须对制造业活动，集中在识别和预防缺陷进行初步的分析。应生产工艺流程图： 分析活动离不开考虑整个生产流，从材料的到来开始和结束与装运和交付给客户的成品。当由客户提供的技术文档并不表示存在的显著特点时，组织的工作人员应受过训练，能够识别这些特征对客户或产品的重要手段等过程 FMEA，装配 FMEA 转交客户的植物、 能源部、 他们的流程，知识和/或产品如何使用的知识技术。在至少组织应分析影响密切的公差，身体健康，功能，完成的特性、 可靠性、 耐久性和/或，影响内部的工艺参数及以下 / 最后的过程 （见点 1.3）。组织应能够描述过程 FMEA 的发展帐户在如何影响产品功能的显著特性进行了设计。过程 FMEA 应分析从物质到达起始和结束与装运和交付给客户的成品的整个生产流。非合格出现在产品 / 过程应当用来不断更新 FMEA 预防性分析。注： 审计员须过程 FMEA 在审计中，即使它已在前一阶段共享。

結果 (中文) 3:

初步分析应在制造活动，聚焦和预防缺陷的识别。

应当有生产工艺流程图：分析活动不能离开的代价的整个生产流程，从材料到最后成品的发运和交付给客户。

当提供的技术文件，客户不显示显着存在的特点，组织人员必须经过培训，能够识别这些特征的技术如FMEA过程意味着重要的客户或产品，组装FMEA的C / O的客户工厂，DOE，其过程的知识，和/或知识产品如何使用。

至少组织应分析影响密切的公差，特征匹配，功能，完成，可靠性，耐久性和/或影响内部的工艺参数和后/最后的过程（见1.3点）。

组织应能够描述如何设计的重要特征，影响产品的功能已在考虑过程FMEA的发展过程中。

过程FMEA应分析整个生产流程从材料的到来和结束与装运和成品交付给客户。

不合格出现在产品/过程应用于连续预防分析如FMEA的更新。

Nb：审计人员应在审计过程FMEA，即使它已被共享在前一个阶段。