B、MANAGEMENT RESPONSIBILITY 雅詩蘭黛驗廠之管理層職責(zé)

1.   Is there a periodic Management review conducted of the Quality system to assure its continuing adequacy, suitability and effectiveness?
是否對質(zhì)量體系有定期的管理評審以確保其持續(xù)的充分性，適宜性和有效性？

2.   Does this management review include:管理檢查包括：

     (1) training effectiveness培訓(xùn)效果

     (2) internal & external audits內(nèi)部和外部審查

     (3) quality problems質(zhì)量問題

      (4) complaints investigation意見調(diào)查

     (5) corrective and preventative actions (CAPA)糾正和預(yù)防措施

3.   Is there sufficient Engineering, Production, Quality Assurance and Customer Service support to meet customer requirements/needs?
有足夠的工程，生產(chǎn)，質(zhì)量保證和客戶服務(wù)來滿足客戶的需求？

4.   Are GMP, regulatory and customer requirements communicated, as appropriate to each level of the organization?
每一級組織是否有適當(dāng)?shù)腉MP，法規(guī)和顧客的要求傳達(dá)？

5.   Is top management notified of quality critical situations in a timely manner?
最高管理層及時通知質(zhì)量重要情況？

C、TRAINING 雅詩蘭黛驗廠之培訓(xùn)要求

1.   Is there a documented training program in GMP's, QA procedures and policies, equipment operation and safety?
是否有GMP的質(zhì)量保證程序和政策，設(shè)備運(yùn)行和安全的書面培訓(xùn)計劃？

2.   Is there a training program for new employees? 是否有新員工培訓(xùn)計劃？

3.   Are training records up to date? 培訓(xùn)記錄是最新的嗎？

4.   Is the effectiveness of training assessed? 評估培訓(xùn)的效果如何？

5.   Is refresher training conducted at defined intervals? 進(jìn)修培訓(xùn)是否在規(guī)定的時間間隔內(nèi)進(jìn)行？

6.   Are temporary personnel trained or under supervision of a trained person? 臨時人員培訓(xùn)或訓(xùn)練是否在受過訓(xùn)練的人監(jiān)督下？