A. QUALITY MANAGEMENT SYSTEM 雅詩蘭黛驗廠之質量管理系統(tǒng)

1.  Is there a documented statement of the corporate Quality policy and Quality objectives?
    是否有一個文件化的質量方針和質量目標？

2.  Is this policy distributed and adhered to by all employees?
    這項政策是否分發(fā)給所有員工并遵守？

3.  Is there a published Quality Manual? And is this Manual updated regularly?
    是否出版有質量手冊？并且保持本手冊定期更新？

4.  Does the Quality Manual outline the structure of the documentation?
    是否有文檔化的質量手冊大綱結構？

5.  Control of documents:文件管理
Are available documents controlled, periodically reviewed and approved?
    可用文件控制，是否定期審查和批準？

6.  Do controlled documents have unique identification – e.g. title/number, issue & page number?
    文件的管理是否有獨特的識別號碼（例如，標題和頁號）

7.  Control of records: 記錄管理
Are all records controlled documents? (no use of uncontrolled records or notes)
    是否都是受控記錄文件？（不能使用不受控制的記錄或筆記）

8.  Are entries in records clear, indelible, made directly after performing the activity (in the order performed), dated, initialled or signed by the person making the entry?
    正在執(zhí)行的活動（在執(zhí)行順序）后，是否有記錄清晰，不可磨滅的條目，還是直接進行日期，草簽或使入境的人簽署？

9.  Are corrections to entries performed in the correct way and dated, initialled or signed?
    是否以正確的方式進行修正和過時的條目，草簽或簽署？

10.  Are all manufacturing, control, testing, distribution and investigation records retained for at least 5 years?
      所有的生產，控制，檢驗，分布和調查記錄至少保留5年？

11.  Is the organization structure documented to define authority roles and responsibilities within the system? (organisation chart, job descriptions)
      是否在組織結構文件系統(tǒng)內定義權威角色和責任？（組織結構圖，崗位描述）

12.  Is there evidence an adequate internal audit program is in place?
      是否有證據充分的證明內部審計程序是否到位？

13.  Is there a documented change control procedure?
      是否有一個文件化的變更控制程序？

14.  Does the change control procedure include the evaluation of effectiveness of the change?
      變更控制程序是否包括改變效果的評估？

15.  Are changes identified, recorded, evaluated, reviewed and controlled in order to understand the effect on other processes?
      記錄，評估，審查被更改的識別，為了理解其他進程的影響對照

16.  Is authority for initiating, review and approval of changes defined?
      改變規(guī)定的審查是否由權威發(fā)起和批準？