人妻秘书ol中文字幕星空传媒影视公司|中文字幕人妻中文字幕成人性电影|国产精品美女久久久久久免费亚洲国产精品中文字幕一区久久|中文字幕在线天堂中文字幕一区一区二区三区|91丨九色丨国产熟女a|亚洲国产精品91|91极品国产|色悠悠国产精品|亚洲av一线二线久久性色|9区中文字幕在线,999中文字幕精品,成人久久不卡一区二区三区,国产av专区网站大全

6.5. Quality risk management should be implemented as a systematicprocess for the assessment, control, communication and review of risks.

質(zhì)量風險管理的實施應(yīng)包括對風險進行評估、控制、溝通和審核的系統(tǒng)過程。

6.6. The system for quality risk management should be described inwriting and cover appropriate areas such as, but not limited to, premises,equipment, materials, products, production, processes, QC, qualification,validation and the process of technology transfer.

質(zhì)量風險管理體系應(yīng)以書面形式描述，包括但不限于，廠房、設(shè)備、物料、產(chǎn)品、生產(chǎn)、工藝、QC、確認、驗證和技術(shù)轉(zhuǎn)移過程等適當領(lǐng)域。

6.7. The evaluation of the risk should be based on scientificknowledge and experience including that of the process and product.

風險評估應(yīng)以科學知識和經(jīng)驗為基礎(chǔ)，包括公司和產(chǎn)品的知識和經(jīng)驗。

6.8. The level of effort, formality and documentation of thequality risk management process should be commensurate with the level of risk.

質(zhì)量風險管理過程的努力水平、正式程度和文件化程度應(yīng)該與風險水平相適應(yīng)。

6.9. The procedures and records for quality risk management shouldretained.

應(yīng)保留質(zhì)量風險管理的程序和記錄。

7. Documentation

文件

Note: A list with examples ofdocuments commonly required in technology transfer is presented in Appendix 1.