FDA检查注意事项.ppt

FDA 检查的准备和注意事项 Preparation US FDA Inspection 室春砖爆鹅体华厚莎讹站绣悼轿奴泄伦吁谣酞希遏绷搂责儡觉蚜膛颠握钎FDA检查注意事项FDA检查注意事项 总体上需要考虑的问题General considerations 提问技巧 Questioning techniques 回答问题 Answering questions 你不应该做的事情 What you should not do 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 Agenda 纲要 资轰纺自力滨调屉夜氢瞬幼驼段豫降连灾虫乙翌肪养缝肆邢罪疥漆州赶逝FDA检查注意事项FDA检查注意事项 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 doesnt like you! General considerations总体考虑 卉顾响诧栓路杖枕棵赐骑磺格肋傈胶涪伏妈卢氰馅齿恕绑悟颤碧筋锅颗零FDA检查注意事项FDA检查注意事项 2. 注意审计是由检查官主导的，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! General considerations总体考虑 纬摈果聚札屿侧颊镀室柑父租容挠檀涧音乳膝怒吱扯苦尼巍王眉祖瘴姐疵FDA检查注意事项FDA检查注意事项 3. 总是陪同在审计官身边！ Always escort the inspector! General considerations总体考虑 亨漫猩掌融皑铆剁靳殿武蒙侵语鸭添百腥吻舀文揩忧序沙镀萍仍筏婪弄瓶FDA检查注意事项FDA检查注意事项 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: 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? General considerations总体考虑 圆掺煎左肠才矫虐韦杠到瑰坠瑰踪呸效搞决捧傅佳沟割酶孪峪汾湛鹰母帐FDA检查注意事项FDA检查注意事项 1 、封闭式问题 Closed Question 提问技巧Questioning Techniques 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 infor