H. PROCESS CONTROL / IN PROCESS CONTROL   Estee Lauder/雅詩蘭黛驗廠之過程控制

1.  Is there evidence of a continuous process improvement program?
     是否有一個持續(xù)的流程改進項目

2.  Are any changes proposed as part of continual improvement subject to risk management?
     是否提出一些改變作為風險管理的持續(xù)改進的一部分

3.  Is Statistical Process Control (SPC) utilized where appropriate?
     統(tǒng)計過程控制是否被用在適當?shù)牡胤?/span>

4.  Are documented procedures implemented for, inspection and testing of product during processing?
     在生產(chǎn)過程中是否有在執(zhí)行關(guān)于檢驗和產(chǎn)品測試的成文流程

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?
     打樣的流程是否是限定的以確保樣品是產(chǎn)品評估的代表以及樣品不能回到生產(chǎn)區(qū)域

6.  Are retained samples taken in accordance with the organization's and/or customer requirements?
     是否根據(jù)公司或者客戶要求保留樣品

7.  Are there additional in-process controls after an equipment breakdown or an unscheduled interruption which stops the process?
     當設(shè)備故障或意外中斷而停止后是否有過程控制程序？

8.  If final inspection is a requirement, is it completed and documented prior to batch release?
     如果有最終檢查的必要，是否在批量發(fā)布之前完成和記錄？

9.  Is a review of batch documentation performed in order to release the batch?
     釋放一批文件是否進行文件的審查？

10.  Have critical processes that can influence the product quality been identified?
       能夠影響產(chǎn)品質(zhì)量的關(guān)鍵性流程是否被指定

11.  Are critical process control specifications established and maintained? (i.e., temperature measurement, weight measurement, flowmeters used, scales used, etc...?)
      是否有建立和維護關(guān)鍵過程控制規(guī)范？ （即，溫度測量，重量測量，使用流量計，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)
      對于制造技術(shù)系統(tǒng)（如機器，生產(chǎn)線，生產(chǎn)結(jié)構(gòu)組件等）的合格驗證是否有風險評估記錄？ （FMEA）

14.  Is verification and/or qualification performed when significant changes to facilities, equipment & process occur which may affect the quality of the product?
      當設(shè)備和生產(chǎn)發(fā)生重大改變并且會影響產(chǎn)品質(zhì)量時是否要進行核實并限制

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?
      貫穿設(shè)備和生產(chǎn)的評定記錄和記錄保持的結(jié)果是否要保持2年以上或者與客戶協(xié)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?
      公司是否可以確保外發(fā)質(zhì)量的關(guān)鍵性流程

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?
      是否有規(guī)律的，有記錄的挑戰(zhàn)測試，自動檢測設(shè)備（如100%相機的檢測系統(tǒng)和條形碼閱讀器）以進行功能的持續(xù)？

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?
      測試設(shè)備是否合適用于測定質(zhì)量和關(guān)鍵原料的驗收，半成品或成品的校準和額外的資格測試？

21.  Is there a system in place to address out of specification (non conforming) product?
      是否有一個程序系統(tǒng)來處理不合格的產(chǎn)品？

22.  Is nonconforming product (NCP) indentified and quarantined pending determination of corrective or other actions
      不合格產(chǎn)品（NCP）是否采取隔離待測定待糾正或采取其他行動

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修正通過返修或翻新改造的產(chǎn)品任何不利因素是否執(zhí)行風險評估和記錄？

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，如果這是一個指定的要求？是否已經(jīng)由質(zhì)量部門或由客戶批準，

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

      出不良品的任何提議是否都是通過客戶確認的并且是有文件證明讓步的

26.  Following rejection, is product disposed of or destroyed in accordance with a documented procedure?
      產(chǎn)品處置或銷毀是否按照文件程序執(zhí)行？