Critical Action Limits (CAL) for All Internal and External Audit Findings

B

bigup1ca

#11
Bev D,
Yes the intent is to create an enterprise wide action level for audit findings. The situation is currently very fluid so I do not have all details to share just yet, but my understanding is, yes, once a limit is triggered, then corporate office initiates CAPA to all sites.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#13
Bev D,
Yes the intent is to create an enterprise wide action level for audit findings. The situation is currently very fluid so I do not have all details to share just yet, but my understanding is, yes, once a limit is triggered, then corporate office initiates CAPA to all sites.
Before issuing a CAPA to all sites based on the findings of a critical issue at one or even two of them, I would want to know some things.
  • Do all the sites do the same thing, or does output from one serves as input to another site?
  • How uniform are the operations at all sites - do methods, equipment and outcomes differ? In what way?
  • To what extent is the central quality management system managing these assessment programs as a central organizational performance learning tool?
I have written a white paper on this subject and attached it in a thread called Global Performance Auditing. I think that paper will fully explain my views on this subject.
 

Raffy

Quite Involved in Discussions
#14
Hi Jennifer,
Is it possible to save the attached file in .xls? My apology, Im still using the old version of excel.
Thank you very much in advance.
Best regards,
Raffy
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#17
Thank you to Ajit for posting a version in .xls! :thanx:

Someone has reported having trouble using the tracking log. It's time to point out a couple of limitations.

1) The QMS Database only shows nonconformances, in which an entry is made in the "DIS number" column. It doesn't show Observations.

2) The QMS Database will only show nonconformances in which a date entered in the "Date published" column is within the past year. That can be changed but doing so requires changing formulas in the section of Columns C through L. I tried simpler methods and couldn't get them to work.

Does this help anyone?
 
N

nadrojh

#18
Thanks for posting the spreadsheet jennifer, looks like a lot of work has gone into it and that it could be extemely useful.

I am however having a bit of trouble figuring out meaning to some of the columns (i am new QMS), if you could possible give me some help into what information should be entered where it would be much appeciated!:D
 
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