Audit Program and CAPA (Corrective Action - Preventive Action) Effectiveness

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e006823

I'm wondering what others are measuring in order to assess the effectiveness of the Audit and CAPA systems. Are these measurements the same items that are reported at the managemnt review?

At present the system I've inherited reports the ontime completion rate of both audits/CAPA, I don't believe that this really helps us in anyway. Any suggestions on effectiveness measurements for both the Audit and CAPA systems?

Bob
 

Douglas E. Purdy

Quite Involved in Discussions
Does every process have to have a measure?

First off, I do not read that every process has to have a measure to "demonstrate the ability of the processes to achieve planned results (8.2.3)." But I may be wrong. As for Internal Audit and CA processes, I would think that Management Reviews, customer feedback, and your registrar would be giving you an over-all measure of their effectiveness. Other than that it would depend on the criteria that you have established for these processes, which is what you are asking for. Personally, the outcomes from these processes are being used to measure the effectiveness of the Quality Management System. I do not set any criteria for these processes.

Doug
 
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C Emmons

Dont know if this helps or not but, my IT department now has a "graphs" on the fly program built into our online Internal audit program. Our processes are standard in all locations, so we measure our selves based on error percetage rates detected in each process overall all as a facility, as a region, as a system etc. We are in the process of applying this same methodology to our CA program so that we can easiliy look at CA initiated as a result of Customer Complaints, as a result of IA, etc etc. We can then break this down in the same format and compare to previous time frames to determine if we are improving.
 
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C Emmons

I can tell you it something to do with "Cold Fusion" and "Flash". (only because he metnioned it in conversation, not that I know what it is" He did say Cold Fusion is the programmin language? (I think) I dont work in IT, but the guy who does is a genius! I am amazed at how I tell him what I need, and he makes it happen!
 
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