Corrective Action Does Not Prevent Reocurrence!

R

randy04

#1
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:
 
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Coury Ferguson

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#2
Re: Action Does Not Prevent Reocurrence!

randy04 said:
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:

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:

RoxaneB

Super Moderator
Super Moderator
#3
Re: Action Does Not Prevent Reocurrence!

randy04 said:
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:
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.
 
R

randy04

#4
Re: Action Does Not Prevent Reocurrence!

RCBeyette said:
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. :confused:
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
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.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#6
Re: Action Does Not Prevent Reocurrence!

randy04 said:
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. :confused:

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.

Discordian said:
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.
 

tyker

Involved - Posts
#7
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.
 

Ajit Basrur

Staff member
Admin
#8
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.
 

Randy

Super Moderator
#9
You could use the Louisville Slugger approach on folks that violate your procedure.

BTW...Are the forms you listed actually "Quality" related, or are they just forms that are used for whatever?

Are they actually necessary? Is the data actually used for soemthing or are we just filling out forms?

Are they redundent? Are we recording the same information someplace else?
 
C

Craig H.

#10
A few observations, to be taken as my approach and not necessarily the "right" approach concerning ISO 9001.

We have several forms that we use for DNR (Dept. of Natural Resources) reporting. They are not "used" as part of our process, other than filling them out.

But, (changing gears here) is our doc control system a Quality Document Control System, or a Business Document Control System? Is our "ISO 9001" System a Quality Management System or a Business Management System?

If the main goal of the system is quality management only, then purge the non-quality documents ASAP. If, however, your system is for management of a large portion of the business, does it not make business sense to have ONE document management system, for quality, environmental reporting, safety, etc.? Why confuse things with 2 or more document systems?

If there is a document that is not worth controlling from a quality, safety, or other standpoint, rid yourself of the extra weight (during the annual review process?).

From a user standpoint, why should they have to guess which system to go to when they need to retrieve a document?

Just my thoughts. Remember, it is Monday morning.
 
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