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Corrective Action Does Not Prevent Reocurrence!

#21
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
 
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Helmut Jilling

Auditor / Consultant
#22
Bridget said:
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.
 
P

Pazuzu - 2009

#23
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? :mg:
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.
 
R

rfisher

#24
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
 
#25
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
Roger:

Welcome to the Cove.

I'm surprised to see you appending your comments to such an old thread. There is a sub forum for dealing with document control issues. We had some lively debate over this very topic recently which you may wish to check out here http://elsmar.com/Forums/showthread.php?t=31314

The one you connected to is about Corrective action, as the main "theme'.

You may have to change your decision though, because you run the risk of not being in compliance with many QMS standards.....

Come back soon and tell us what else you've been up to!:agree1:
 
Last edited:

Helmut Jilling

Auditor / Consultant
#26
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

Ummm...the standard requires "Documents required by the quality management system shall be controlled." Cl 4.2.3.

If there are forms in your QMS, they would need to be controlled just like any other document. This is pretty well established.
 
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