Hi all,

I am attempting to write a top level CAPA proceudre to comply with ISO 13485 and the QSR. To be honest, I am so involved in the details of the CAPA process that I am having a tough time parring the details down to satisfy the top level content requirements of a procedure. (aka I am writing War and Peace) Can anyone provide me with an example of a top level CAPA procedure so I can calibrate myself to the level of content needed. I have already checked the cove attachments but did not find anything that "fit the bill"

Thanks

Hi all,

I am attempting to write a top level CAPA proceudre to comply with ISO 13485 and the QSR. To be honest, I am so involved in the details of the CAPA process that I am having a tough time parring the details down to satisfy the top level content requirements of a procedure. (aka I am writing War and Peace) Can anyone provide me with an example of a top level CAPA procedure so I can calibrate myself to the level of content needed. I have already checked the cove attachments but did not find anything that "fit the bill"

ThanksTry clinivation.com (http://www.clinivation.com/pages/resources/downloads.php#policies).

I looked around with a search and didn't see one here off hand, but I know there are. The think I don't know is of any that are specifically applicable to ISO 13485.

Al's link is a good one, but you do have to register and give them all sorts of information, including name, address, telephone, etc.

The attachments may give you some 'food for thought'.

Hi all,

I am attempting to write a top level CAPA proceudre to comply with ISO 13485 and the QSR. To be honest, I am so involved in the details of the CAPA process that I am having a tough time parring the details down to satisfy the top level content requirements of a procedure. (aka I am writing War and Peace) Can anyone provide me with an example of a top level CAPA procedure so I can calibrate myself to the level of content needed. I have already checked the cove attachments but did not find anything that "fit the bill"

Thanks
Try this one. This is from compnay I worked for about 2 years ago and it complied with 13485:2003.

Thank you all for your feedback!

Regards

Senna

Below is one of the audit findings during third party desk review.

"Procedure on preventive action did not clearly indicate what record will demonstrate recording results of actions taken. In addition, requirement for reviewing of effectiveness of actions taken is identified."

Can anyone shed light on this? Sample procedure will be highly appreciated.

Below is one of the audit findings during third party desk review.

"Procedure on preventive action did not clearly indicate what record will demonstrate recording results of actions taken. In addition, requirement for reviewing of effectiveness of actions taken is identified."

Can anyone shed light on this? Sample procedure will be highly appreciated.

We use an Action Item Log to list all our PAR's. It's also where any actions needed to be done from a Management Review Meeting are posted and just everyday reminders. Check it out.
Your effectiveness is documented right on the log and you just keep a running file. Works great for us and our auditor loved it. In your procedure indicate Preventive actions are documented on the Action Item Log and make it a form in your system. :rolleyes: