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

質(zhì)量風(fēng)險(xiǎn)管理的實(shí)施應(yīng)包括對風(fēng)險(xiǎn)進(jìn)行評(píng)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(fēng)險(xiǎn)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(rèn),、驗(yàn)證和技術(shù)轉(zhuǎn)移過程等適當(dāng)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(fēng)險(xiǎn)評(píng)估應(yīng)以科學(xué)知識(shí)和經(jīng)驗(yàn)為基礎(chǔ)，包括公司和產(chǎn)品的知識(shí)和經(jīng)驗(yàn),。

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(fēng)險(xiǎn)管理過程的努力水平,、正式程度和文件化程度應(yīng)該與風(fēng)險(xiǎn)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(fēng)險(xiǎn)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.