无论是FDA，还是EU，还是国内GMP中，其实提到纠正和预防措施CAPA时，基本上只有一句话。
比如EU中，只提到了最严重的偏差和不符合应该进行纠正和预防措施：A reviewof all significant deviations or non-conformances, their relatedinvestigations, and the effectiveness of resultant corrective and preventativeactions taken.
具体应该如何执行？说得非常模糊。。。
在ISO9000中更具体一点，将CAPA分为纠正、纠正措施和预防措施，然后，就没有然后了。。。
当然，也有不某寂寞的组织，如医疗器械全球协调工作组Global Harmonisation Task Force出版了一个最详尽的CAPA指导，目前看来，没有之一。
http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n18-2010-qms-guidance-on-corrective-preventative-action-101104.doc
整份指南将整个CAPA分为四部分，非常详尽
Phase I: Planning 计划
☛ Planning for Measurement, Analysis and Improvement Processes
☛ Establish Data Sources and Criteria
Phase II: Measurement and Analysis within and across Data Sources 测量和分析
☛ Measurement
☛ Analysis
Phase III: Improvement 改进
☛ Investigate
☛ Identify Root Cause
☛ Identify Action
☛ Verification of identified action
☛ Implement Actions
☛ Determine Effectiveness of ImplementedActions
Phase IV: Input to Management 汇报
☛ Reporting to Management
☛ Management Review
