IdentifyingcGMPIssuesCausedBy"ManagementProblems"
识别管理问题引起的GMP问题
Source:PharmaceuticalOnline
ByJoannaGallant,owner/president,JoannaGallantTrainingAssociates,LLC
Usingthehierarchyofrootcauses(Figure1),Iasktwoquestionsandgetthesameanswers—everytime:
使用根本原因的层次结构(图1)，我提出了两个问题，并且每次都得到相同的答案:
Whichisthemostfrequentlyidentifiedrootcause?It’salways“PersonnelError”(usedforanywherefrom25-50+%ofrootcauses!).
你最常用到的根本原因是什么?答案通常是“人为错误”(占所有根本原因的25~50%+!)
Whichistheleastfrequentlyidentifiedrootcause?It’salways“ManagementProblem”(usedfor10%ofrootcauses).Some