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Corrective Action Does Not Prevent Reocurrence!
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Corrective Action Does Not Prevent Reocurrence!
Corrective Action Does Not Prevent Reocurrence!
Corrective Action Does Not Prevent Reocurrence!
Corrective Action Does Not Prevent Reocurrence!
Corrective Action Does Not Prevent Reocurrence!
Corrective Action Does Not Prevent Reocurrence!
Corrective Action Does Not Prevent Reocurrence!
Corrective Action Does Not Prevent Reocurrence!
Corrective Action Does Not Prevent Reocurrence!
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Corrective Action Does Not Prevent Reocurrence!


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form(s), quality records, corrective action (ca), forms and templates (general), procedures (general)
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  Post Number #1  
Old 31st July 2006, 07:23 AM
randy04

 
 
Total Posts: 7
Unhappy Corrective Action Does Not Prevent Reocurrence!

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?

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  Post Number #2  
Old 31st July 2006, 07:35 AM
Coury Ferguson's Avatar
Coury Ferguson

 
 
Total Posts: 4,542
Re: 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 believe that you only corrected the issue (Corrective Action) and did not state how you would prevent this issue was re-occurring. The auditor, I believe was right. What else did you do to prevent this from happening again? Did you review existing procedures to see if similar issues exist?

See other threads regarding CA and PA by performing a search. There has been numerous discussions regarding CA and PA in the cove.

Last edited by Coury Ferguson; 31st July 2006 at 04:30 PM.
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  Post Number #3  
Old 31st July 2006, 07:41 AM
RoxaneB's Avatar
RoxaneB

 
 
Total Posts: 2,984
Re: 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'm with Coury on this. If all you did was train people on how not to use forms that aren't in procedures, that's only a partial fix. Did you train them on how to ensure that forms are set-up properly to become Quality Records.

Of course, this may sound silly, but why do you list all of your forms in that Procedure? I like have a matrix where such things are listed and it is the responsibility of the department to keep it current and up-to-date.
  Post Number #4  
Old 31st July 2006, 07:46 AM
randy04

 
 
Total Posts: 7
Re: Action Does Not Prevent Reocurrence!

Quote:
In Reply to Parent Post by RCBeyette

I'm with Coury on this. If all you did was train people on how not to use forms that aren't in procedures, that's only a partial fix. Did you train them on how to ensure that forms are set-up properly to become Quality Records.

Of course, this may sound silly, but why do you list all of your forms in that Procedure? I like have a matrix where such things are listed and it is the responsibility of the department to keep it current and up-to-date.

We also have like a matrix where all forms are listed and who has control over them. Maybe I am making this harder than what it is but I still don't see how that would keep people from using forms that are not listed in a procedure or on a matrix.
  Post Number #5  
Old 31st July 2006, 08:03 AM
ScottK's Avatar
ScottK

 
 
Total Posts: 2,584
Re: Action Does Not Prevent Reocurrence!

Does your quality records procedure specifically state that all forms have to be listed in it?

If not, and if this is an ISO9001 audit, then he's got no finding as ISO does not specifically require all forms to be listed in a the control of records procedure.

simply reference the master document list and point out to the auditor that not all forms result in quality records.
  Post Number #6  
Old 31st July 2006, 08:05 AM
Coury Ferguson's Avatar
Coury Ferguson

 
 
Total Posts: 4,542
Re: Action Does Not Prevent Reocurrence!

Quote:
In Reply to Parent Post by randy04

We also have like a matrix where all forms are listed and who has control over them. Maybe I am making this harder than what it is but I still don't see how that would keep people from using forms that are not listed in a procedure or on a matrix.

I guess my question would be: Why do you have forms out there that are not listed in the matrix or procedure?

The only forms that should be out and being used, are forms that have been listed in the matrix/procedure. The forms that are not listed need to be removed from the floor to prevent usage.

Quote:
In Reply to Parent Post by Discordian

Does your quality records procedure specifically state that all forms have to be listed in it?

If not, and if this is an ISO9001 audit, then he's got no finding as ISO does not specifically require all forms to be listed in a the control of records procedure.
Discordian has a good point here.
  Post Number #7  
Old 31st July 2006, 08:33 AM
tyker

 
 
Total Posts: 422
Re: Action Does Not Prevent Reocurrence!

Don't let the auditor control your system.

ISO 9001 only requires you to control those records which "provide evidence of conformity to requirements and of the effective operation of the quality management system".

If your records procedure defines which records come into this category, people can create any other forms or records they like and these are outside the auditor's scope.

There can be many reasons for forms being created and not listed in the quality procedure. For example, we have a form used at reception for recording visitors on site. It's only purpose is for health and safety and I'm certainly not going to include that in my quality records procedure.

If your procedure defines the records needed for your system and specifies the authority for adding or deleting from that list and it is effectively communicated, you have addressed the requirement of the standard and addressed preventive action too.
  Post Number #8  
Old 31st July 2006, 08:41 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,073
Re: Corrective Action Does Not Prevent Reoccurance!

Hi Randy,

I totally agree with the auditor and also with other Cove members. Training in no way ensures that the discrepancy might be corrected.

I suggest that for this observation, you can amend your "Document Change Request" to include a check box at the final stage to ensure that all the new records are being included in the Quality Records procedure.

So this last person in the chain (usually the Doc Control Centre) can make the record effective after ensuring that the Qual records procedure makes a mention of the new record.
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