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High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
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High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
High Level CAPA (Corrective Action Preventive Action) SOP Example Needed
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  Post Number #1  
Old 10th December 2007, 05:41 PM
Calico

 
 
Total Posts: 30
Please Help! High Level CAPA (Corrective Action Preventive Action) SOP Example Needed

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:

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  Post Number #2  
Old 10th December 2007, 07:05 PM
qualityboi's Avatar
qualityboi

 
 
Total Posts: 359
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.
Thank You to qualityboi for your informative Post and/or Attachment!
  Post Number #3  
Old 10th December 2007, 11:50 PM
egarry's Avatar
egarry

 
 
Total Posts: 31
Re: High Level CAPA (Corrective Action Preventive Action) SOP Example Needed

Quote:
In Reply to Parent Post by brecksnowshoer View Post

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.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf CAPA Flow Procedure.pdf (66.7 KB, 4618 views)
Thank You to egarry for your informative Post and/or Attachment!
  Post Number #4  
Old 11th December 2007, 10:50 AM
Calico

 
 
Total Posts: 30
Re: High Level CAPA (Corrective Action Preventive Action) SOP Example Needed

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
Thanks to Calico for your informative Post and/or Attachment!
  Post Number #5  
Old 2nd October 2009, 09:45 AM
Sixsigma greenbelt

 
 
Total Posts: 1
Re: High Level CAPA (Corrective Action Preventive Action) SOP Example Needed

Thanks this should be very useful.
  Post Number #6  
Old 31st October 2009, 08:25 PM
mudumbaiharikiran

 
 
Total Posts: 1
Re: High Level CAPA (Corrective Action Preventive Action) SOP Example Needed

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
  Post Number #7  
Old 31st October 2009, 09:45 PM
harry

 
 
Total Posts: 6,291
Re: High Level CAPA (Corrective Action Preventive Action) SOP Example Needed

Quote:
In Reply to Parent Post by mudumbaiharikiran View Post

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'.
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