This makes me laugh. Thank you, but I'm just a hack compared with some of the Covers. Anyway, Crusader provided the original version.DAMN!!! You're good!!!!!!!!
I think I would have found it hard to come up with such a nice design.
Managing and Reporting Audits with an Excel .xls spreadsheet
- Thread starter Jen Kirley
- Start date
I think I would have found it hard to come up with such a nice design.
P
Pazuzu - 2009
Well hats off to both of you!! 
A
auditnovice
Hi!
Great job on the spreadsheet, it's wonderful. I do have a question. I'd like to see if I can apply it to the medical device industry. Are there clear criteria for the difference between systemic issue vs gap in process vs process disconnect vs audit readiness? And what is the justification for the points that are deducted? FDA can be pretty picky if things appear ambiguous or not clearly defined.
Thanks,
Auditnovice
Great job on the spreadsheet, it's wonderful. I do have a question. I'd like to see if I can apply it to the medical device industry. Are there clear criteria for the difference between systemic issue vs gap in process vs process disconnect vs audit readiness? And what is the justification for the points that are deducted? FDA can be pretty picky if things appear ambiguous or not clearly defined.
Thanks,
Auditnovice
Crusader
Trusted Information Resource
I created this spreadsheet (based on ISO 9001:2000) to help me "score" my QMS implementation and maintenance - to provide a numerical point status. Otherwise, no clear criteria as you describe. Jennifer might have some input on her version. Points deducted? Well, I selected those myself for my use. You could change the points for your application. I am not familiar with the FDA requirements. Sorry, I am not much help.
H
helvry
Thanks for your sharing bro and sister.
For those of us who want a simpler approach to counting elements audited, I have attached the slimmed down "compliance based" version.
You are welcome Sandro, and welcome to the Cove! 
