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Corrective Action Does Not Prevent Reocurrence! - Page 3


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Some Related Topic Tags (Not all threads are Tagged)
form(s), quality records, corrective action (ca), forms and templates (general), procedures (general)
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  Post Number #17  
Old 31st July 2006, 06:57 PM
silly girl's Avatar
silly girl

 
 
Total Posts: 40
Re: Corrective Action Does Not Prevent Reocurrence!

Yes, what the auditor seems to be looking for is 'how are quality records created and controlled' - in other words, how do you make sure that new quality records are added to the system according to your own procedures. If a number of quality records were not added to the index (assuming that is your method of control), there is indeed a problem that still needs to be resolved.

Silly Girl

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  Post Number #18  
Old 31st July 2006, 07:02 PM
silly girl's Avatar
silly girl

 
 
Total Posts: 40
Re: Corrective Action Does Not Prevent Reocurrence!

Quote:
In Reply to Parent Post by randy04

We recently had our yearly audit here at Britt Tool, one of our minors was due to not listing all of our forms in our Quality Records Procedure. I went through all of our forms and updated the procedure accorddingly and retrained everyone to the procedure. When I submitted the corrective action our auditor rejected it saying that this action would not prevent reoccurance.
What the .....? Other than training, how are you supposed to keep forms from being used that aren't in the procedures?
I hope my previous post makes sense in the context of your experience. I admit that I have some trouble interpreting your meaning... so if it is not useful, please ignore it

By the way, we often use auditing as a tool to look for 'unauthorized' documents. Internal audits, process audits, 5S activities, supervisors/managers MBWA, etc. All can be tools for keeping the message alive that unauthorized documents are not allowed. If this is an issue that keeps cropping up, it may be time to ask yourself why people feel the need to subvert the process...

Silly Girl
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  Post Number #19  
Old 31st July 2006, 09:38 PM
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howste

 
 
Total Posts: 4,500
Re: Corrective Action Does Not Prevent Reocurrence!

Quote:
In Reply to Parent Post by Bev D

Simply removing the forms that were in use but not in the quality record index, will NOT prevent new forms from being generated and used but not listed in the index…some additional action is necessary to ensure that new forms are properly assessed and where necessary the index is revised to add the form as a quality record…OR come up with a different way of complying the quality record requirement that doesn’t involve an INDEX…
You've hit the nail on the head, Bev. The corrective action (that prevents recurrence) needs to be an action that will eliminate the possibility of the index conflicting with the forms in use.


Hi Silly Girl. I see from your profile you were in one of my auditing classes. I suspect that you went by a different name there though...
  Post Number #20  
Old 1st August 2006, 02:27 PM
silly girl's Avatar
silly girl

 
 
Total Posts: 40
Re: Corrective Action Does Not Prevent Reocurrence!

Quote:
In Reply to Parent Post by howste

Hi Silly Girl. I see from your profile you were in one of my auditing classes. I suspect that you went by a different name there though...
Yes, I certainly did. I was in a class you instructed in Tualatin, OR when the company I work for was seeking registration to ISO13485. The good news was that our registration audit went very well. I think I talked too much in class.
  Post Number #21  
Old 1st August 2006, 03:45 PM
Bridget's Avatar
Bridget

 
 
Total Posts: 96
Re: Corrective Action Does Not Prevent Reocurrence!

Hi, Just thought I would let you know how I resolved this issue since I was always forgetting to change the master records or doc control list. I put check boxes on our change order forms for adding or changing the rev level for documents to the document control list and the records list. I also created an ECO project sheet that addresses these so when I start a project I check off that I have to update the list. I feel your auditor wanted to see how you will control the list.
If you need any examples send me a private email since I might not get back to the cove yet this week. Good luck
Bridget
  Post Number #22  
Old 1st August 2006, 09:24 PM
Helmut Jilling

 
 
Total Posts: 4,358
Re: Corrective Action Does Not Prevent Reocurrence!

Quote:
In Reply to Parent Post by Bridget

Hi, Just thought I would let you know how I resolved this issue since I was always forgetting to change the master records or doc control list. I put check boxes on our change order forms for adding or changing the rev level for documents to the document control list and the records list. I also created an ECO project sheet that addresses these so when I start a project I check off that I have to update the list. I feel your auditor wanted to see how you will control the list.
If you need any examples send me a private email since I might not get back to the cove yet this week. Good luck
Bridget
That works, but what about this idea.

We don't have a master list, we use the doc list in the computer folder as a master list.

When a change is needed, we change it right in the sole copy of the master document (When there is only one copy, there is nothing to get out of sync).

The revision date is the computer file save date.

Real time doc control without hardly any effort? What do you folks think?

PS: this paradigm is very similar to what the fancy doc control software programs do. Short, sweet, simple, and it can be done in MS Office.
  Post Number #23  
Old 4th May 2007, 11:58 AM
Pazuzu - 2009

 
 
Total Posts: 151
Re: Corrective Action Does Not Prevent Reocurrence!

Quote:
In Reply to Parent Post by randy04 View Post

We recently had our yearly audit here at Britt Tool, one of our minors was due to not listing all of our forms in our Quality Records Procedure. I went through all of our forms and updated the procedure accorddingly and retrained everyone to the procedure. When I submitted the corrective action our auditor rejected it saying that this action would not prevent reoccurance.
What the .....? Other than training, how are you supposed to keep forms from being used that aren't in the procedures?
Whoa...nowhere that I know of does ISO9001 state that you must list all your forms in your records or documents procedures. (If you have written in that you do thats a different story and I'd suggest revising it NOT to say that).

We have a listing of the TYPES of records and the info applicable to them (retention, filing, responsibility etc...) but nowhere should you have a list stating every single form you use...some comapnies will have thousands.
  Post Number #24  
Old 1st January 2009, 05:40 PM
rfisher's Avatar
rfisher

 
 
Total Posts: 10
Re: Corrective Action Does Not Prevent Reocurrence!

I am in agreement that forms are not required to be controlled, only records. However, if your procedures statethat you will control all forms, then "do what yu say". I have begun to "separate" the forms from the procedure. I do keep them controlled but not to the requirement of any procedure.

Roger
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