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PHILIPS验厂辅导---PHILIPS质量介绍(四)

E02.03  Review of requirements related to the product

The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that: 组织应评审与产品有关的要求。这检讨应在本组织将供应的产品给客户承诺之前 (例如提交投标、接受合同或订单,接受合同或订单的更改),并应确保︰

a) Product requirements are defined and documented, 定义并记录,a)产品要求

b) Contract or order requirements differing from those previously expressed are resolved, and b)合同或顺序不同于那些以前表示要求是解决,和

c) The organization has the ability to meet the defined requirements. c)本组织有能力满足规定的要求。

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements审查和行动所作的检讨结果的记录应予保持(见4.2.4)。

若顾客提供的要求没有形成的文件,应由组织验收前证实客户的要求。

若产品要求发生变更,组织应确保相关文件得到修改,并确保相关人员知道已变更的要求


E03.18  Control of design and development changes

After the design has been "frozen" changes still may be necessary during the project phase. A systematic change process and subsequent implementation approach must be in place设计已被"冻结后"仍可能必须更改项目阶段。制度变迁过程和随后的实施方法必须到位


E05.05  Control Plans

Preferably "Control plans" should contain the following items: 最好是"控制计划"应包含下列项目

- Sample size样本大小

- Measuring devices to use要使用的测量设备

- Frequency of testing进行测试的频率

- Upper and lower limits for passing传递的上限和下限

- Work instructions to perform the measurements作业指导书执行测量

- Out of control instructions从控制指令

Good practices can be found in other industries (Automotive: (QS 9000). The information may be contained in more than one document. 良好做法可以发现在其他行业 (汽车: (QS 9000)。信息可能包含多个文档中。


E05.07  Defining Maintenance and Repair requirements

Already during the product design phase, the policies on preventive maintenance on machines and equipment need to be defined in order to support quality control during the production phase已经在产品设计阶段,对机器和设备的预防性维修政策需要定义以支持在生产阶段的质量控制。


E06.01  Production Approval new parts

Before parts or products may be used in regular production, they have to go through a systematic release process. This release must deliver evidence that the manufacturing process is capable to produce repetitive parts that meet customer requirements. 零件或产品可能在正常生产中使用之前,他们必须通过系统的发布过程。此版本必须提供证据的制造过程是能够生产出满足客户要求的重复部分。


E06.02  Qualification of Processes

Before parts or products may be used in regular production, they have to go through a systematic release process. This release must deliver evidence that the manufacturing process is capable to produce repetitive parts that meet customer requirements. 零件或产品可能在正常生产中使用之前,他们必须通过系统的发布过程。此版本必须提供证据的制造过程是能够生产出满足客户要求的重复部分。


E14.01  The development process ensures reliable products in the market place

Designing reliable products means that analytical techniques, experience with predecessor products, failure mode analysis, testing, HALT, etc are combined to take care that the product operates reliable in the market place设计可靠的产品意味着分析技术,经验与前任产品,失效模式分析、测试、停止等联合照顾工作可靠,在市场上的产品。



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