Estee Lauder验厂之生产要求

G. PRODUCTION    雅诗兰黛/Estee Lauder验厂之生产要求

1、 Is the manufacturing environment acceptable for the items produced?
      生产环境是否适合产品生产

2、 Are manufacturing operations orderly in flow and organization?
      生产操作是否有序流动和组织的吗

3、 Is PPE (personnel protective equipment) worn by all personnel and visitors where applicable?
      所有员工和访客是否都有适用的PPE（个人防护设备）。

4、 Is line clearance between different batches to remove all materials and documentation performed and recorded?
      不同批次生产的产线清洁(移除所材料和文件)都有在记录吗

5、 Is a first article inspection conducted prior to production start?
      在开始生产之前是否都会进行首件检验

6、 Are all component molds, cutting dies and printing plates properly marked and labelled?
      所有的组件模具，切割模具和印刷板是否有适当的标记？

7、 Are all component molds, cutting dies, printing plates checked against the approved blueprint/artwork prior to production run?
      在生产运行前所有部件的模具，切割模具，印刷板的设计图纸/样品是否经过检查与批准？

8、 Is there a procedure assuring only the correct component, die, mold, or printing plate is pulled from storage and released to manufacturing?
      是否有程序控制确保只有正确的组件，模具，模架，或打印板从存储并发布到制造生产？

9、 Are current color standards and customer approved defect range boards readily available for the manufacturing employees?
      目前的颜色标准和客户确认的不良限度板是否可以随时被生产员工所参照

10、 Based on risk assessment, has the organization established and maintained a system to trace all production materials from source to product?
       风险评估的基础上，所有生产材料从源头到产品的组织是否建立了系统跟踪？

11、 Is there adequate segregation to assure mixing of items does not occur?
       是否有充分的隔离区来确保型号不会被混淆

12、 Are batch production records identified with a unique batch or identification reference?
       生产记录是否与每个独特批次或者鉴定参考一致

13、 Are records of the use of quality critical equipment retained?
       质量关键的设备使用记录是否都有保留

14、 Are records kept of any cleaning and maintenance activities conducted in sequence with the manufacturing operations? Maintenance activities shall be documented and traceable to a particular manufacturing operation or piece of equipment.
       生产操作中的清洁和保养记录是否都有程序记录(保养记录应该要被记录做到有踪迹可查)

15、 Are documented procedures implemented to ensure product returned e.g. for reprocessing is identified and distinguished from normal production at all times?
       是否有文件化的程序以确保实施产品返回处理是区别于正常生产的时刻？

16、 If reprocessed materials are incorporated (e.g. in glass, aluminium, paper, thermoplastic processes), are the reprocessing parameters defined and agreed with the customer?
       如果掺入再加工的材料（如玻璃，铝，纸，热塑性工艺），是否是在后处理定义并且与客户商定的参数？

17、 Are deviations from the normal manufacturing procedures documented?
       与正常的生产程序文件是否有偏差？

18、 Are waste materials placed in containers clearly marked as "waste materials only"?
       废料是否放在明确标着“只是废料“的容器里面

19、 Are rejected items placed off-line and segregated away from the "good" material?
       不合格产品都会下线并且远离好的材料吗

20、 If in-process materials are rejected, is the reason indicated on the container and recorded on the line sheets?
       如果使用的材料被拒绝，表明在容器和记录在线路板的原因吗？

21、 Is packaging used to produce and contain the product clean and suitable?
       用于产生的产品和包装是否保持清洁？

22、 If packaging containers are reused, are previous labels removed or defaced and are the containers cleaned or verified as clean, in accordance with a documented procedure?
       如果包装容器可重复使用，是否按照既定的程序保持以前的标签删除或更新，以及保持容器清洗干净或得到验证？

23、 Are documented cleanliness requirements for products/components established when process agents are to be removed from product/component during manufacture.
       当加工剂是从产品/组件制造过程中被移除，要求建立产品/组件的洁净度，被记录在案。

24、 Are storage containers and their attendant manifolds, filling and discharge lines identified?
       随之而来的歧管，灌装，放线等储存容器是否被识别和确定？

25、 Are written procedures established for the cleaning of equipment used in the production, and records maintained?
       是否建立了用于生产设备的清洗程序，并保持记录？

26、 Is production equipment/area identified as to its content and cleaning status?
        是否保持生产设备/区域内容的清洁状态？