Does there always have to be a "correction?"

M

MrOctober

I'm going through some RCA from a recent AS9100 audit.

They are requiring that I submit "corrections."

I've submitted the corrective actions and the root causes and all were accepted. There were no high risk findings just small procedural changes that did not require any containment action and had no effect on end product and did not effect our customers. I ended up having to remove or reword some clauses from our QMS system that painted ourselves in a corner for being too specific. The clauses were too specific in that they were required by our QMS system but not practiced because it was non value added essentially. The clauses also made it almost impossible to comply because they were written when our company was a lot smaller and we've nearly tripled in size since then. So the changes were just procedural and documentation.
 
M

MrOctober

Howste,

Is that not also the CA? That is what I did submit for the CA and it was accepted.

Is it possible for the CA to be the same as the correction?

Is there any instance where an NCR may not require a Correction? How would I go about defending the lack of action?
 

Marcelo

Inactive Registered Visitor
As Howste mentioned, what you did was a correction.

For a CA, you would have to ask "why clauses too specific that were required by our QMS system but not practiced because it was non value added essentially. and also made it almost impossible to comply" were there?

If the answer (root cause) was something like "the guy writing the procedure did not understand the requirements", you CA might be: make sure that anyone writing the procedure understood the requirements, probably including some specific additional competence requirements.

In your case, you already mentioned that they "were written when our company was a lot smaller and we've nearly tripled in size since then", so it seems that, with this root cause, there's nothing reasonable you can do, so you might have decided an escalation to CA was not required.

On the other hand, another possible conclusion would be that the root cause was that you did not revise your procedures to match your company "size" when it grew, so a CA would be to include a requirement in your system to revise all your procedures when you company triples its size (just a generic example using your comment).

Is it possible for the CA to be the same as the correction?
No.

Is there any instance where an NCR may not require a Correction? How would I go about defending the lack of action?

A NC requires an action, a correction is one of the possible actions. Another possible action is segregation, or concession.
 

mihzago

Trusted Information Resource
my opinion differs from howste and Marcelo, and I'm in agreement with Mr. October's assessment.

you can't do a correction to a process or a procedure. you can only correct a record. Correction is something you can do there and then. For example, a record was missing a required signature, a correction would be to have the appropriate individual review and sign the document at the time it was identified.

Marcelo wrote: "For the CA, you would have to ask..." - You don't ask anything for the CA, you first define the problem and identify the root cause. Then you ask what action is necessary.
Mr. October determined that the requirements defined in the procedure are no longer applicable because the company has evolved. The actual root cause may be that the procedure has not been periodically reviewed. So the corrective action, similar to what Marcelo has suggested, would be to update the procedure/process, and address the periodic review issue (e.g. update doc control procedure, training, etc.).
 

Marcelo

Inactive Registered Visitor
you can't do a correction to a process or a procedure. you can only correct a record. Correction is something you can do there and then. For example, a record was missing a required signature, a correction would be to have the appropriate individual review and sign the document at the time it was identified.

Correction is defined as as action to eliminate an identified non conformity. So it can be applied to any non conformity. For example, if you cut a part in a large size than intended, a correction can be to cut it a little more for it to be in compliance (this would also be a rework, in fact).

Marcelo wrote: "For the CA, you would have to ask..." - You don't ask anything for the CA, you first define the problem and identify the root cause. Then you ask what action is necessary.

I meant to ask "..If you want to arrive in a CA..", but thanks for the correction!
 
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howste

Thaumaturge
Trusted Information Resource
Let's look at the definitions of the terms used in AS9100, which are contained in ISO 9000:
Correction - action to eliminate a detected nonconformity
Corrective Action - action to eliminate the cause of a detected nonconformity or other undesirable situation

The correction removes the nonconformity, and the corrective action removes the cause of the nonconformity and will prevent recurrence.

By changing the requirements in the documentation, the nonconforming condition no longer exists, so it's a correction.

To decide the corrective action(s), the cause of the nonconformity needs to be determined. If changing the documentation would prevent a similar situation from happening in the future, then it might also be considered a corrective action. Usually the correction and corrective action are different. Marcelo has given some good guidance.
 
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M

MrOctober

Correction - action to eliminate a detected nonconformity

I would almost have to say then that our corrective action and correction are one in the same. I corrected the procedure to lessen the strain on our QMS but at the same time, it also will eliminate the NC from happening ever again. So, with our old procedure we did not comply with what we said we did/do. I modified it, we comply again and the way it was rewritten it wont happen again (I literally removed the requirement).
 

Marcelo

Inactive Registered Visitor
I corrected the procedure to lessen the strain on our QMS but at the same time, it also will eliminate the NC from happening ever again. So, with our old procedure we did not comply with what we said we did/do. I modified it, we comply again and the way it was rewritten it wont happen again (I literally removed the requirement).

How does correction of one procedure prevents the problem (to have non-value added and impossible to comply clauses on your QMS) from happening again?

What you did corrected the particular instance of the NC in that procedure, but unless you revise all procedures to check if the same problem happened, and also define a corrective action such as requiring a review of all your procedures when your company grows, or something like that, the problem will happen again.

What you are focusing at (and unfortunately most people do) is on the particular instance of a NC (symptom), instead of seeing the NC as a whole (which is is related to the root cause).
 

Ninja

Looking for Reality
Trusted Information Resource
Quote:
Is it possible for the CA to be the same as the correction?
No.

I would almost have to say then that our corrective action and correction are one in the same.
+++++++++++++++++++++++++++++++

The difference is subtle, and Marcelo is referencing the difference but not actually saying it...

Something CAUSED a non-conformance SITUATION.

Changing the wording of the document addresses the situation.
This is a correction of the current situation, but does nothing to prohibit it from happening again tomorrow.

Establishing/determining the root cause, and taking action to prohibit recurrence is your Corrective Action.

These are not the same thing...one handles the situation, the other handles the cause.

One is situational, the other is systemic...you need both (though I would handle both under a single CA to save time and paper).

HTH
 
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