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本帖最后由 郦无悔 于 2013-3-27 14:00 编辑
曾经在单位听到有人在讨论纠正与纠正措施这俩东东到底是不是一回事,时间久远,忘了当时的讨论结果。
今天找一些辐照灭菌的东东,仔细看了ISO 11137(医疗保健产品灭菌-辐射 ),发现里面有这两个名词的解释,这两个词,还真是不太一样哦~~
ISO的名词解释,不一定适用于GMP,仅当参考,仅当学习啦~~~
名词
terms | | |
| action to eliminate a detected nonconformity | action to eliminate the cause of a detected nonconformity or other undesirable situation | | A correction can be made in conjunction with corrective action. | There can be more than one cause for a nonconformity. 2. 纠正措施是用来预防不符合重新复发,而预防措施是用来预防不符合发生 Corrective action is taken to prevent recurrence whereas “preventive action” is taken to prevent occurrence. There is a distinction between correction and corrective action. |
PS:ISO 11137的中英文在百度文库或是新浪爱问上都能找到,就不附啦
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