Question

英语高手麻烦帮忙用英文回答以下4个问题。比较急、非常感谢！谢谢！！！

1，How are employee qualification and training requirements determined and documented?
2，How are specifications and procedures controlled to ensure that they are approved prior to use, and that only current revision documentation is used?
3，Describe any lot numbering or serial numbering conventions used to preserve product traceability.
4，What information is kept as manufacturing history for each product (e.g., describe contents of batch file, device history record, etc.)?

Answer 1

1 雇员资格和培训要求是怎样被确定和记录的?
2 怎样来控制规范和程序以确保它们在使用之前先得到认可，并且确保只能应用于目前修订文献呢？
3 描述任意可用于保持产品可追溯性的编号或者序列号规范
4 每一个产品都有怎样的信息作为该产品的制造史给保存下来了呢？（例如：可描述一下批处理文件的内容，设备的历史记录等等）

追问

不是翻译，是用英文回答。这四个问题。谢谢！

追答

抱歉啊 这个我回答不了……

Answer 2

These questions asked are linked with your actual quality management systems, covering the HR, DMR, Traceability and DHR which are required in CFR QSR 820.
There is no one who can answer these questions except you/your organization, becasue the people outside your system don't know how your processes are executed.
A suggestion is given that you translate these questions to your staffs responsible of QMS, and get the Chinese answers and then convert them into English.

Answer 3

你说你比较急，悬赏分又没有，谁会帮你啊！

追问

注册的新号。没有分数。不好意思

Answer 4

我忘了