Process Correction vs. Corrective Action - Failure to React when Out of Control

[qsmso]

Dear the Cove friends,
Regarding Correction and Corrective Action that we need to provide to our registrar when they audited and raised NC to us, I would like to ask a question.
If the content of NC was that “Auditor found on X-MR chart that there was not any of correction taken when the chemical composition (desire to be Special Characteristic item) was out control”, how to write correction and corrective action properly?
IMO, the corrective action might be training that operator for more understanding about SPC concept and guidance to take action when something abnormal. However, what about CORRECTION? Do we have to do anything about that X-MR chart? Or do we have to track back to the product to validate and assure product quality doesn’t have any effect.

Best regards,
QSMSO

[Claes Gefvenberg]

Hello QSMSO,

I'm not sure I understand your distinction between corrective action and correction, but:

I think you are correct about the suggested training. It may very well be part of the corrective action regarding the root cause. What is your current procedure when the process goes out of control? In a case like this one, the registrar (as well as yourself) obviously wants to see that action is taken to get the process back on track and that the action is somehow registered.

As for the product in question: If you in fact determine that it was affected in a negative way, you need to look at (if we are talking about ISO 9001:2000) clause 8.3, control of nonconforming product..

/Claes

[qsmso]

Thank you Claes,
I forgot to explain more details that the X-MR chart the auditor found was the quliaty record of the week prior to the audit. (Out of control happenned on Dec 10th, but auditor audited on Dec 16th.
So, we are not really know how to take correction, whether with the control chart, the product or either.

Thank you

[M Greenaway]

qsmo

I would say it is your choice on whether or not you correct the product and/or the chart - only you know how important it is, and the associated risks.

[D.Scott]

qsmo - The advice given is very good. I think you should look at this nonconformance as something deeper than just the control chart being out of control. Claes touched on the current procedure for OOC. I think you need to be sure there IS a procedure for taking action, and that it gets the results you want.

Training the operator won't solve the problem if another operator can make the same mistake. Training of all operators may be needed.

I also agree that the effect on the product has to be reviewed and a decision made as to effect.

When I have a nonconformance I try to address the immediate problem, determine a root cause and initiate a corrective action, train the affected people, then confirm the problem is fixed by auditing.

Dave

[Marc]

I may have missed something, but the two aspects are:<ol><li>Correction - What did you do to correct the problem at the time (also known as Reaction on a control plan), and <li>Corrective Action - An 8-D or whatever you want to call it which includes determining root cause and preventive action.</ol>

[gpainter]

Correction- Immediate fix More than likely 100% inspection, Non-value added
CA- Permanent fix No more problem Value added

[Raffy]

Does the definition for corrective and preventive action evolving through times? What I mean, when the transition to iSO9001:2000, does the definition for the Corrective and Preventive Action change?

Please comment.

Thanks and best regards,
Raffy