High Level CAPA (Corrective Action Preventive Action) SOP Example Needed

[Calico]

Hi All,

I searched through many CAPA threads but it's a bit overwhelming!

I'm new to the Cove and am working for a medical device company. We are re-writing all the company's high level "SOP's" which right now are basically more procedures and work instructions. There is a lot of confusion as to how much information should go into a high level SOP. I've been given a new CAPA SOP that (to me) has way too much information in it and was wondering if anyone had a high level SOP that they could share?

Thanks,
Callie:

 

[qualityboi]

Re: Need Sample High Level CAPA SOP

I think the easiest way is to go to the CAPA thread here http://elsmar.com/Forums/forumdisplay.php?f=41 Find the topic for one or two procedures and click on the disk icon, there are 15 attachments, browse them. Some are excellent procedures.

 

[egarry]

Hi All,

I searched through many CAPA threads but it's a bit overwhelming!

I'm new to the Cove and am working for a medical device company. We are re-writing all the company's high level "SOP's" which right now are basically more procedures and work instructions. There is a lot of confusion as to how much information should go into a high level SOP. I've been given a new CAPA SOP that (to me) has way too much information in it and was wondering if anyone had a high level SOP that they could share?

Thanks,
Callie:

I have combined the CA and PA procedures for years. I think that a balance is important for high level SOPs. Enough information so everyone understands the process but not too complicated which handcuffs managements ability to use the system for a wide array of issues.
I have attached a example of a CAPA procedure which could give you some ideas.
Good luck.

 

[Calico]

Thanks so much, that is actually perfect. We have our CA/PA combined as well and the SOP that someone wrote is like a book. Your example is much appreciated

Best Regards,
Callie

 

[Sixsigma greenbelt]

Thanks this should be very useful.

 

[mudumbaiharikiran]

hi, i am a student studying MS from swinburne university, i am new to these topics. can anyone please post an example sop of CAPA giving a pharmaceutical example?
thank you

 

[harry]

hi, i am a student studying MS from swinburne university, i am new to these topics. can anyone please post an example sop of CAPA giving a pharmaceutical example?
thank you

Go to the 'post attachments list' (thin green bar within the header bar and at the top left hand corner of every page) and do a search using 'capa', 'corrective action' or 'preventive action'.