Nonconformance for not closing an NC (Corrective Action)

Hello,
Recently the auditor issues an NC to MR when his Documents and Record Control was audited. Reason for the NC was that earlier NC issues to other depratment was not yet closed.
1. Can such an NC be issuued?
2. Are there any clause under ISO 9001:2008 stating NC's MSUT be closed within x days?

Thanks
Anand

Hi, the Auditor shall exactly identify the requirement was not fulfilled. Do you have only this information?
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Sz.

Add a complete text of the NC.

However, The statement of NC is not very clear..... I will point out that 1) Its must that the status of all identified NCs is monitored and all NCs are closed after reviewing the effectiveness of the implemented measures.
2) No standard shall ever tell the exact time of closing a NC as the planned or identified measures and the associated time will be always different for different cases, however planning of the measures can be time bound, that too as defined by the individual organization.

AnandR said:

Hello,
Recently the auditor issues an NC to MR when his Documents and Record Control was audited. Reason for the NC was that earlier NC issues to other depratment was not yet closed.
1. Can such an NC be issuued?
2. Are there any clause under ISO 9001:2008 stating NC's MSUT be closed within x days?

Thanks
Anand

Click to expand...

1. It depends.
Was there available a plan to close the non confirmity by the audited process owner? If yes, was it overdue ? Which were the motivations?
Again, was the due date in schedule? Did process owner show some progress on the closure of NC?
Pls, let us know additional detail taking into account my suggestions.
In any case , to respon to the other Covers, the violeted clause could be 8.2.2 of ISO 9001 where in the last 4 rows are reported clear responsibility about the closure of NC. In any case , pls, write the nonc conformtity.
I would only add that the nc has been elevated to the organization and not to the Managemet Representative
2. The ISO 9001 does not state any number of day to close NC coming from internal audit. This could be reported in own mandatory procedure for internal audit. If so, you shall conform to what you have established.
As a suggestion , you could follow the same rules that your Registrar has for minor and major non conformities.

By my opinion the auditor is right.

The N/C had to (should have) been based on something more than just not having an N/C closed out. While no time requirement is specifically outlined most organizations define a time-frame for response, verification, follow-up & extensions in the CA procedure.

What besides an open N/C was the finding based upon?

The organization got the NC, not the MR.

Corrective action time will be stipulated in the body of the audit report and becomes a requirement that must be fulfilled and that's where the date comes from.

Perfectly acceptable and also required by the CB's Accreditation Body

Or....

The organization has a requirement it has set for action to be taken that stipulates a time frame

Both cases would be self inflicted wounds

AnandR said:

Hello,
Recently the auditor issues an NC to MR when his Documents and Record Control was audited. Reason for the NC was that earlier NC issues to other depratment was not yet closed.
1. Can such an NC be issuued?
2. Are there any clause under ISO 9001:2008 stating NC's MSUT be closed within x days?

Thanks
Anand

Click to expand...

I agree with Randy. The NC is legitimate since the management of the area concerned didn't keep his commitments of closing the NC within the stipulated time. If findings are not addressed timely, what's the use of conducting audits? This is a case of resolute negligence and should be dealt appropriately. Atleast the process owner should have reviewed and recorded the rationale why s/he didn't consider it necessary to take an action.

Any CB auditor would raise an NC on such issues under clause 8.2.2 that reads:

The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.

Click to expand...

I agree that it's an N/C as well, I'm just curious as to what it was based on besides an open N/C. If a specific time-frame is outlined then it's hands down, if not & depending on how old, it could be an OFI.