Corrective Action Does Not Prevent Reocurrence!

OMG:mg: It's Monday again? Another travel day. Let's see, this week Fitzgerald, Georgia.

Back on topic........

If you are controlling all your business doc's with your system, just provide a mechanism (like your list) to tell the difference between the Q stuff and all the rest. If it ain't related to customer satisfaction, planning and all that other stuff show it and move on to more important stuff like planning a great lunch for you auditor.

Hey everyone,

Just to reiterate some of the points made, I agree that you need to decide which forms are quality related or required records and only control those. When I first started here, every piece of paper generated seemed to be controlled! This included a fractional to decimal conversion chart!

Anyway, keeping your forms to a managable level will help in keeping contol over them. Auditors I've delt with really want to see a master list of ALL controlled documents and if your forms are controlled then they need to be on the list. This would also mean that the forms would fall under you controlled document proceedure (which you MUST have) and can address the issue of when a form needs to be controlled and therefore why it does or does not need to be on the list.

OK the finding was that not all 'forms' in use were listed the Quality Records procedure.

If the froms in question were NOT quality records, the original finding is invalid.

If some were in fact quality records then we do need a Corrective Action that will prevent reoccurrence.

Some of the condidtions that makes this error so possible is that the quality record index is a SEPARATE document form the procedures that reference forms. It is often viewed as Quality's job to keep the index up to date - it is typically not viewed as the originator's responsibility and ti aslo not typically viewed as the approvers responsibility to check if the new form is a quality record and if the index has been updated. (Qualityalways mentions this!)

Some actions we can take:

A checklist for those who initiate or revise existing procedures that requires that all forms be identified as a qualty record or not. (Having the definition of a quality record on the checklist is helpful)
the checklist can also include the responsibility of the originator to revise the qulaity record index as a requirement of the change.

Add a checklist for reviewers including QA asking and requiring the same thing.

The above are preventive actions although not mistake proof.

If you have control over your doc control software you may want to make forms separate documetnt types. each form must have a checkbox indicating if it is a quality record or not. (TWO Boxes, not just one - that way the software can be made to force the selection of one box or the other). Teh software can then check for those forms that are qulaty records and automatically initiate a change for the quality record index. (this is what I did in one company I was at. no more out of synch indexes!) when forms were reviewed, QA always checked (they had an electronic checklist that they had to complete prior to approving a change) if the form was a properl identified as a quality record or not...

Of course all of the above just gets me started on the value add of ISO, but that's one thing I can't control...

lrowe said:

When I first started here, every piece of paper generated seemed to be controlled! This included a fractional to decimal conversion chart!

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I'm building a QMS right now and my jaw hit the floor a few weeks ago when the owner told everyone at a production meeting - before consulting with me - to give me a copy of every single form they use so I "can put it into the document control system" I recently wrote and haven't trained anyone in yet.

Tomorrow he's receiving training on document control.

Bev D said:

OK the finding was that not all 'forms' in use were listed the Quality Records procedure.

If the froms in question were NOT quality records, the original finding is invalid.

If some were in fact quality records then we do need a Corrective Action that will prevent reoccurrence.

Some of the condidtions that makes this error so possible is that the quality record index is a SEPARATE document form the procedures that reference forms. It is often viewed as Quality's job to keep the index up to date - it is typically not viewed as the originator's responsibility and ti aslo not typically viewed as the approvers responsibility to check if the new form is a quality record and if the index has been updated. (Qualityalways mentions this!)

Some actions we can take:

A checklist for those who initiate or revise existing procedures that requires that all forms be identified as a qualty record or not. (Having the definition of a quality record on the checklist is helpful)
the checklist can also include the responsibility of the originator to revise the qulaity record index as a requirement of the change.

Add a checklist for reviewers including QA asking and requiring the same thing.

The above are preventive actions although not mistake proof.

If you have control over your doc control software you may want to make forms separate documetnt types. each form must have a checkbox indicating if it is a quality record or not. (TWO Boxes, not just one - that way the software can be made to force the selection of one box or the other). Teh software can then check for those forms that are qulaty records and automatically initiate a change for the quality record index. (this is what I did in one company I was at. no more out of synch indexes!) when forms were reviewed, QA always checked (they had an electronic checklist that they had to complete prior to approving a change) if the form was a properl identified as a quality record or not...

Of course all of the above just gets me started on the value add of ISO, but that's one thing I can't control...

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Bev, you have some valid points in the dissertation. I am not challenging your post, nor am I saying that you are wrong. Now let us look at the OP's statement, sentence by sentence:

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.

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This sentence identifies that there was a minor NC generated by the Registrar for not listing all of the forms in the Quality Records Procedure (as Bev stated). So, I guess this really means that the Auditor went out on the floor and found that there were some forms being used that were not listed in the Quality Procedure. Therefore, the finding would be valid. Reference ISO9001:2000, Paragraphs 4.2.3, 4.2.4, 7.2.1, 7.2.2, 7.5.1 (e), and 7.3.6 (if design responsible), and maybe ones that I have missed.

randy04 said:

I went through all of our forms and updated the procedure accorddingly and retrained everyone to the procedure.

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This sentence states that the procedures were updated identifying the forms and retrained. This is Corrective Action. At this point the decision should be made if the records or forms that were identified during the audit are "Quality Related." The forms which are not quality related should not be identified in the Quality Records Procedures. Still part of the Corrective Action plan.

randy04 said:

When I submitted the corrective action our auditor rejected it saying that this action would not prevent reoccurance.
What the .....?

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ISO9001:2000 said:

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventative actions shall be appropriate to the effects of the potential problems

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It is apparent that the response only addressed Corrective Action as you can see by the previous statements. There is no Preventative Action identified in the response. Therefore, the Auditor should have rejected the CA because the Preventative Action was not addressed. Reference ISO9001:2000, Paragraph 8.5.3 above.

randy04 said:

Other than training, how are you supposed to keep forms from being used that aren't in the procedures?

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This is just a simple matter of removing the forms that aren't listed in their Quality Records Procedure. The Quality forms and what every Business forms they want to control would have to be identified in their Quality Records Procedure.

Coury Ferguson said:

This sentence identifies that there was a minor NC generated by the Registrar for not listing all of the forms in the Quality Records Procedure. So, I guess this really means that the Auditor went out on the floor and found that there were some forms being used that were not listed in the Quality Procedure. Therefore, the finding would be valid. Reference ISO9001:2000, Paragraphs 4.2.3, 4.2.4, 7.2.1, 7.2.2, 7.5.1 (e), and 7.3.6 (if design responsible), and maybe ones that I have missed.

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Actually, not all forms are quality records and so not all forms are subject to the requirement for control of quality records. Randy04 only talks about all forms – he didn’t specifically clarify if all of the forms in question were truly quality records or if they were other types of forms. So the finding may in fact not be valid.
Additionally, it’s important to note at this time that a record INDEX is not necessary, the applicable section of the ISO9000 standard states:

“4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection ,retrieval, retention time and disposition of records.”

Most companies choose to use a quality record index to achieve this control because they believe it is the easiest, or at least the most common method…but it is not required.

Coury Ferguson said:

This sentence states that the procedures were updated identifying the forms and retrained. This is Corrective Action. At this point the decision should be made if the records or forms that were identified during the audit are "Quality Related." The forms which are not quality related should not be identified in the Quality Records Procedures. Still part of the Corrective Action plan.

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Again – it’s quality RECORDS not quality related forms. Quality related forms require some form of document control but do not require the same level of retention control as a quality record. Not all quality related forms are quality records.

Coury Ferguson said:

It is apparent that the response only addressed Corrective Action as you can see by the previous statements. There is no Preventative Action identified in the response. Therefore, the Auditor should have rejected the CA because the Preventative Action was not addressed. Reference ISO9001:2000, Paragraph 8.5.3 above.

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Actaully, in an audit only Corrective Action (section 8.5.2) is required. NOT Preventive Action (section 8.5.3). Preventive Action (8.5.3) can only be doen for problems that haven't occured - in an audit, the auditor is identifying existing nonconformances, not potential nonconformances. This is the standard confusion around corrective and preventive action that has been discussed in this forum to death. And 8.5.2 states:

"8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities encountered."

Some interpret the second sentence as meaning that not all corrective actions require the elimination of the cause and prevention of recurrence. So that some nonconformnaces can simply be repaired – such as updating the record index and nothing else. However, some registrars will require elimination of the cause to prevent recurrence…it looks like Randy04’s auditor is requesting this level of corrective action.

Coury Ferguson said:

This is just a simple matter of removing the forms that aren't listed in their Quality Records Procedure. The Quality forms and what every Business forms they want to control would have to be identified in their Quality Records Procedure.

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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…

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

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:

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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

Bev D said:

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…

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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...

howste said:

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...

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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.