How CAPA's are trended in Management Review

patilrahuld

Starting to get Involved
#1
Can anyone share an example of how CAPA's are trended in Management review? We are trying to get FDA registered and want to set up management review work instruction as per QSR guidelines. Not knowing how CAPA's are trended, i am seeking some help in getting an example so that we can comply.
 
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isoalchemist

#2
Re: CAPA trending Example

:2cents: You get to chose how and what you trend, the real question is what do you want to show and determining the best way to show it. I always did a couple of different cuts, one was raw numbers did they increase or decrease from the previous year(s) and have an answer why because that is more important is your system improving or unused, have you changed your evaluation "process" and are things that were CAPA's not anymore or vice versa.

The second cut was a categorization of the CAPA's in broad categories and changes over time. If training is always your number one, you probably have not addressed the root cause of your problem. If process not documented rose over time you may not be reviewing your system frequently enough for changes. A third cut was External Audit, Internal Audit and other generated. In short who is finding the issue.

I had to lead my management to the water and knock them over the head for change. This was effective in building the story I was trying to tell. Over ways certainly do exist and no single way is right IMHO
 
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