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

质量风险管理的实施应包括对风险进行评估、控制、沟通和审核的系统过程。

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.

质量风险管理体系应以书面形式描述，包括但不限于，厂房、设备、物料、产品、生产、工艺、QC、确认、验证和技术转移过程等适当领域。

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

风险评估应以科学知识和经验为基础，包括公司和产品的知识和经验。

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

质量风险管理过程的努力水平、正式程度和文件化程度应该与风险水平相适应。

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

应保留质量风险管理的程序和记录。

7. Documentation

文件

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