FDA检查的注意事项

General considerations总体考虑
3. 总是陪同在审计官身边！ Always escort the inspector!
General considerations总体考虑
An inspector is someone who arrives after the battle and bayonets all the wounded ： 4. 有时检查官也会处于特殊情况下。他可能问自己这些问题 Consider that also the inspector is in an exceptional situation. He might ask himself the questions:
不希望引起审计官关注的事项 Unwanted attention 在车间和实验室里的行为 Behavior for the shop floor and laboratory 每个员工的行为 Behavior for everybody
General considerations总体考虑
1. 审计期间，对人际关系的应对。如果审计官不喜欢或喜 欢我们团队中的某一主要人员时，我们需要做一些内部 调整。如果审计官不喜欢你，你也不要生气或者觉得是 对自己的一种冒犯，团队会对人员做适当调整。 React to interpersonal relationships during the inspection. If the inspector dislikes / likes a key player of your team take appropriate internal actions. Don„t be offended if the inspector doesn't like you!
提问技巧Questioning Techniques
2、开放式问题Open Question 这类问题常常有很多种答案，回答者可以选择如何回答. So called because the number of possible answers is great and person can choose response, 比如e.g. 问题：变更控制SOP的批准过程是什么？ Q: What is the approval process for SOPs such as Change Control? -越是开放的问题，获得的信息在质量和数量上就越丰富。 •The more open questions asked, the greater the quality and quantity of information received. -一般回答开放式问题，可以从 ‘谁，做什么，在哪里，为什么，什么时 候，以及怎么做’出发来回答。 -Typically open questions start with: who, what, were, why, when and how. 危险级别Danger level：低/中等Low/Medium
提问技巧Questioning Techniques
4、给我看实物 (show me)
确认问题应答的真实性 Verification of response being ask edquestion.
对提出的‘封闭式问题’的确认- 有，还是没有？ Represents a closed question–the item is either there or not there! 使回答的人员感受到压力 Puts person under pressure. 可能需要时间来收集这些实物数据 Time maybe needed to gather data. 太多‘给我看实物’往往是破坏性的，给人一种缺乏信任的感觉。 Too many “show me„s” can be disruptive and might demonstrate lack of trust. 危险级别：低 Danger Level :Low
提问技巧Questioning Techniques
1 、封闭式问题 Closed Question
一般回答这类问题的答案数目很少，经常可以推测出来 So called because the number of possible answers is very small and often able to predict
举例Example： Q： 变更控制程序是由QA批准的吗？ Is the change control procedure approved by Quality Assurance? A： 是 或 否 Yes or No. -不要给出其他很多回答或者信息，除非被要求继续给出。 Unlikely to give much information, therefore least appropriate for obtaining a quantity of information. -像这类问题，审计过程中多多关注其他人的回答，这样可以做到前后回答 不矛盾。 Good to verify what other person has done, said or thinks 危险级别Danger level：低low
提问技巧Questioning Techniques
7.无声提问 Silent Question
‘。。。。。’
有时候应答者认为审计官会对我们的回复有些反馈--事实上审计官 没有继续提任何问题！ The interviewee is led to believe that some response is expected –even though no question is actually posed!
危险级别： 高 Danger Level: High
提问技巧Questioning Techniques
8.“我是专家”型问题 “Iamtheexpert”Question 审计官总是诱导人员暴露出弱点或缺陷-- „„钓鱼’。 Inspector goes “fishing” where the person is encouraged to show his or her weakness or deficiencies.
-考验应答者的知识面 -Tests the knowledge of the interviewee. -体现被审计方的风险分析形式 -Represents a form of risk analysis. -确认该公司已经意识到可能的风险且有适当的防范措施 -Demonstrates the company is aware of possible risks and has made proper arrangements. -探测体系的可靠性。 •Probes the robustness of a system. 危险级别： 中等/高 Danger Level: Medium/High

我能做好吗？ Will I perform well? 我能达到我的目标吗？ Will I achieve my objectives? 如果被检查的工厂有出人意料的反应，我是否能应对？ Will there be unexpected reactions and will I cope with them? 我是否能信赖这个人所说的话？ Can I rely on what this person is saying?
FDA 检查的准备和注意事项 Preparation US FDA Inspection
总体上需要考虑的问题 General considerations 提问技巧
Agenda 纲要
Questioning techniques 回答问题 Answering questions
你不应该做的事情 What you should not do
提问技巧Questioning Techniques
6. 理论性问题Theory Question 假设某一情形，要求给出可能的结果。 Expects the person to provide possible outcomes to a situation 举例Example 问题：如果在处理时突然断电，会发生什么情况？ Q: What would happen if the power failed during this transaction?
危险级别： 非常高 Danger Level:VeryHigh
提问技巧Questioning Techniques
问题类型 Question Type 封闭型Closed 典型问题 Typical Question 你负责本部门的变更控制程 序的管理吗？ “You are responsible for managing the Change Control procedure in this department” 提问目的 Purpose of question 检察官确定提问的范围 Defines boundaries for the inspector –determines the playing field 危险程度 Level of danger 低 Low
提问技巧Questioning Techniques
3、审计官为获得更多信息设计的问题 Question design to get more information 对开放式问题的追问，对他感兴趣的内容提问，获得更多信息问题： Follow-up to open questions, focus on area of interest and gives more information.
提问技巧Questioning Techniques
5审计官会说„我不明白的问题 “I don‟t understand ”Question 这是为了确认我们的回答与实际操作的一致性 Questions the consistency of an explanation 举例Example 问题1: 我不确定我是否明白，你能再解释一下吗？ Q:I am not sure I understand, could you please explain it again? 问题2：我不太明白，能给我举另外一个例子吗？ Q:I am not clear on this matter, could you show me another example? 危险级别： 中等 Danger Level: Medium
举例Example 问题：这是一个看起来计划的非常好，很详细的变更控制体系。但在让 人员执行的过程中不会有困难吗？ Q:This looks like a very well planned out and detailed change control system. Don‟t you have difficulty in getting people to follow this?
General consideration而不是你。你可以管理协调 检查工作，但不要尝试去控制它。
Respect that the inspector is in charge and not you! Manage the inspection but do not try to take control of it!
问题：请告诉我再更改控制程序中一共有哪些不同类型？ Q:Tell me more about the different types of change covered by your Change Control procedure?
一般回答也可以从‘谁，做什么，在哪里，为什么，什么时候，以及 怎么做’开始。 •More fluent versions again begin with: who, what, where, why, when and how. 危险级别： 中等 Danger Level: Medium