Estee Lauder/雅诗兰黛验厂之过程控制

H. PROCESS CONTROL / IN PROCESS CONTROL   Estee Lauder/雅诗兰黛验厂之过程控制

1.  Is there evidence of a continuous process improvement program?
     是否有一个持续的流程改进项目

2.  Are any changes proposed as part of continual improvement subject to risk management?
     是否提出一些改变作为风险管理的持续改进的一部分

3.  Is Statistical Process Control (SPC) utilized where appropriate?
     统计过程控制是否被用在适当的地方

4.  Are documented procedures implemented for, inspection and testing of product during processing?
     在生产过程中是否有在执行关于检验和产品测试的成文流程

5.  Are sampling procedures defined to ensure samples are representative of the process being assessed and are samples not returned to the production area if removed to a separate testing location?
     打样的流程是否是限定的以确保样品是产品评估的代表以及样品不能回到生产区域

6.  Are retained samples taken in accordance with the organization's and/or customer requirements?
     是否根据公司或者客户要求保留样品

7.  Are there additional in-process controls after an equipment breakdown or an unscheduled interruption which stops the process?
     当设备故障或意外中断而停止后是否有过程控制程序？

8.  If final inspection is a requirement, is it completed and documented prior to batch release?
     如果有最终检查的必要，是否在批量发布之前完成和记录？

9.  Is a review of batch documentation performed in order to release the batch?
     释放一批文件是否进行文件的审查？

10.  Have critical processes that can influence the product quality been identified?
       能够影响产品质量的关键性流程是否被指定

11.  Are critical process control specifications established and maintained? (i.e., temperature measurement, weight measurement, flowmeters used, scales used, etc...?)
      是否有建立和维护关键过程控制规范？ （即，温度测量，重量测量，使用流量计，使用秤等...？）

12.  Is risk assessment used to determine which processes are quality critical (risk analysis shall be related to product quality related attributes) and to determine the extent of the qualification work to demonstrate control of the processes? (FMEA)

13.  Are technical systems (e.g. machines, lines, structural production components, etc.) used for manufacturing verified and/or qualified in accordance with a documented risk assessment? (FMEA)
      对于制造技术系统（如机器，生产线，生产结构组件等）的合格验证是否有风险评估记录？ （FMEA）

14.  Is verification and/or qualification performed when significant changes to facilities, equipment & process occur which may affect the quality of the product?
      当设备和生产发生重大改变并且会影响产品质量时是否要进行核实并限制

15.  Where appropriate is qualification of individual product carried out as agreed with the customer?

16.  Are the results of qualification recorded and records maintained throughout the life of the equipment and process and for a period of two years beyond retirement or as agreed with the customer?
      贯穿设备和生产的评定记录和记录保持的结果是否要保持2年以上或者与客户协商一致

17.  Are electronic records secured & protected against loss and accidental corruption & in a form that will permit regeneration, or if not, are hard copy prints retained for a period of 2 years beyond equipment retirement or as agreed with the customer?

18.  Does the organisation ensure qualification of outsourced quality critical processes?
      公司是否可以确保外发质量的关键性流程

19.  Are there regular, recorded challenge tests to automatic inspection equipment (e.g. 100 % camera inspection systems and barcode readers) to verify the continued functionality?
      是否有规律的，有记录的挑战测试，自动检测设备（如100%相机的检测系统和条形码阅读器）以进行功能的持续？

20.  Is test equipment used in determining the acceptance of quality critical starting materials, in-process or finished product, calibrated & additional qualification tests performed, if appropriate?
      测试设备是否合适用于测定质量和关键原料的验收，半成品或成品的校准和额外的资格测试？

21.  Is there a system in place to address out of specification (non conforming) product?
      是否有一个程序系统来处理不合格的产品？

22.  Is nonconforming product (NCP) indentified and quarantined pending determination of corrective or other actions
      不合格产品（NCP）是否采取隔离待测定待纠正或采取其他行动

23.  If NCP correction is via rework or reconditioning, is a risk assessment of any adverse affect of the reworking on the products performed and recorded?
      如果NCP修正通过返修或翻新改造的产品任何不利因素是否执行风险评估和记录？

24.  Is rework and/or reconditioning in accordance with a documented procedure that has been approved by the quality unit and also by the customer, if this is a specified requirement?
      返工或整修按照既定的程序，如果这是一个指定的要求？是否已经由质量部门或由客户批准，

25.  Is any proposal to release nonconforming product via a documented concession, authorized by the customer?

      出不良品的任何提议是否都是通过客户确认的并且是有文件证明让步的

26.  Following rejection, is product disposed of or destroyed in accordance with a documented procedure?
      产品处置或销毁是否按照文件程序执行？