如何处理偏差管理、纠正和预防程序之间的关系？

最后一根腿毛

capa是果，偏差，oos，自检缺陷，投诉等是因

beiwei5du

大呆子 发表于 2014-6-18 08:07
一般来说，纠正与预防措施属于嵌入式管理，也就是不是独立存在的而是与其它如出现偏差或OOS、OOT、外部检查 ...

也不一定需要镶嵌进去，可以独立出来，个人也赞成独立出来好管理一些。

beiwei5du

幻影 发表于 2014-6-18 08:35
基本重叠，相比而言，偏差的更倾向针对此次事件，而CAPA更倾向系统运行。

Understand and integrate systems
For starters, it is important that companies understand the difference between a CAPA system and a deviation system and how they work together. The CAPA system is intended to manage the correction or prevention identified to resolve the deviation, whereas the deviation system is to be used for the identification of a variation and the subsequent investigation, explains Judy O'Hara, senior consultant at Parexel Consulting, a business unit of Parexel International and a global consultancy serving the biopharmaceutical and medical-device industries .
"Resolving an issue identified through the deviation system begins with the discovery of an issue and ends with the identification of the root cause(s)," she says. "The CAPA system picks up from there. Too many times, there is a disconnect between the deviation, the root cause, and CAPA. It is important that the department responsible for the investigation, along with the Quality department, make certain that the root cause addresses the deviation and that the CAPA addresses the root cause.