Nonconformance for not closing an NC (Corrective Action)

[qusys]

I was constantly following-up with process owner to close the NC and their response was they need to discuss with their seniors on the corrective action. seniors were not available most of the time as they were travelling.

Currently, there is no process or guidelines for postponment of action against an NC

This was informed in the Management Meeting and it was acknowledged that there is a delay, but seniors are required to make the decision on corrective action.

Which was the previous non conformity to which the process owner did not provide the action?

 

[Ninja]

Currently, there is no process or guidelines for postponment of action against an NC

Could be bad...could be good.
The point here is that the company recognizes a non-conformance and is handling it with the priority and timliness that the company feels is warranted. If there is no guideline, then you have quite a bit of freedom, no?

If appropriate in the eyes of management, this could be as simple as pushing out the planned closure date with a note that this non-conformance, while recognized, requires participation of personnel not readily available...and that this postponement was a conscious and documented management decision, not an oversight.

If management wants the behavior corrected, get on it. If it is something to put on a to-do list to get to someday, push the date out. Either way, it is a management decision. It seems that the problem here is that the choice has not been made, or that the records haven't caught up to the choice being made.

Note: If you push the date out two years...that's sorta unreasonable. It's not a hard choice, follow the procedure or change the procedure. This is a 10 minute + 15mpp meeting (10 minutes plus 15 minutes per person attending)

 

[AndyN]

I was constantly following-up with process owner to close the NC and their response was they need to discuss with their seniors on the corrective action. seniors were not available most of the time as they were travelling.

Currently, there is no process or guidelines for postponment of action against an NC

This was informed in the Management Meeting and it was acknowledged that there is a delay, but seniors are required to make the decision on corrective action.

What was the nature of the audit non-conformance that needed corrective action. Usually, when management fail to take corrective action, it's because they don't understand what they're being asked to do...

 

[qusys]

What was the nature of the audit non-conformance that needed corrective action. Usually, when management fail to take corrective action, it's because they don't understand what they're being asked to do...

Agree with you, AndyN.
I would like to know which the corrective action plan was for the raised ncn as well as the root cause identification.
It could also be interesting to know which the containment action was and if it is still effective or not .

 

[JaneB]

Hello,
Sorry, if my question posted was not clear and did not sufficient data.

1. It was an internal Audit
2. Process audited was: Document & Record Control

NC raised was on the process: Document & Record Control. Internal auditor checked if to ensure previous NC's raised during inter audit were closed and found one NC that was raised to Marketing Dept still open. Marketing dept had mentioned the implementation date to close the date, but failed to meet the date for reasons unknown.
Hence NC was raised to MR reporting previous NC was still open.

No where we have mentione din any our process on the time lines for closing the NC.

Hope the information helps.
Anand

Thanks Anand, as you can see, the better the information and the background provided, the more it is possible to provide targeted information. (And avoid endless guessing)

So, the auditor raised an NC on just one single unclosed NC? This seems possibly a bit over-zealous and rather thin on the evidence side to me.

As audit manager,I would be asking the auditor:
* Is this the only evidence you have?
* On what basis is the NC issued (if there's no timing guidelines in the procedure for example)? Anything to quote or is it simply auditor belief/preference?
* How important was this particular NC? eg, was it a high risk item that should have been actioned promptly? Or not? Is there a risk? If so, what is it, and how much of a risk?
* Have other NCs been closed in a timely fashion?
* Is there an apparent pattern of lengthy/untimely closure? What's the evidence for that?
* What action was required to close this one?
* Is there reasonable evidence (eg, executive away) of difficulty in closing/actioning this particular one?
* Why is one single unclosed NC considered important enough to raise another NC on?

As you can see - there's no single, simple answer.

But I would be very wary of turning NCs into an endless vicious circle - eg, 1 NC not closed, then raising new NC to report previous one not closed, etc. Why not simply escalate and action this one? Also, sounds distinctly like you need some better guidelines.

 

[6-Sigma]

Hello,
Sorry, if my question posted was not clear and did not sufficient data.

1. It was an internal Audit
2. Process audited was: Document & Record Control

NC raised was on the process: Document & Record Control. Internal auditor checked if to ensure previous NC's raised during inter audit were closed and found one NC that was raised to Marketing Dept still open. Marketing dept had mentioned the implementation date to close the date, but failed to meet the date for reasons unknown.
Hence NC was raised to MR reporting previous NC was still open.

No where we have mentione din any our process on the time lines for closing the NC.

Hope the information helps.
Anand

Hi Anand,

I believe that a NC should be closed only when the corrective action applied to the NC is proven to be effective. I would discourage assigning a time frame to have a NC closed. The end goal is to fix the NC so that its reoccurrence is not possible or at least minimized and the risks to the non conformance mitigated.

I have attached for your benefit a Root-Cause-Analysis tool hoping that with the proper use of this tool you will reach a different conclusion:

1) I believe that the NC remaining open is a symptom (low hanging fruit) of a much larger problem.
2) The open NC is simply an audit trail that should have been followed upwards
3) The NC should not have been issued to MR (There is no time frame in your QMS for closing a NC)
4) There should have been an additional NC against section 4.1 of the standard issued to XXXX (This will materialize when the proper RCA is done)
5) Internal auditors need to learn to identify and follow the audit trails
6) NC can only be issued against a stated requirement

Keep up the good work.

 

[6-Sigma]

Thanks Anand, as you can see, the better the information and the background provided, the more it is possible to provide targeted information. (And avoid endless guessing)

So, the auditor raised an NC on just one single unclosed NC? This seems possibly a bit over-zealous and rather thin on the evidence side to me.

As audit manager,I would be asking the auditor:
* Is this the only evidence you have?
* On what basis is the NC issued (if there's no timing guidelines in the procedure for example)? Anything to quote or is it simply auditor belief/preference?
* How important was this particular NC? eg, was it a high risk item that should have been actioned promptly? Or not? Is there a risk? If so, what is it, and how much of a risk?
* Have other NCs been closed in a timely fashion?
* Is there an apparent pattern of lengthy/untimely closure? What's the evidence for that?
* What action was required to close this one?
* Is there reasonable evidence (eg, executive away) of difficulty in closing/actioning this particular one?
* Why is one single unclosed NC considered important enough to raise another NC on?

As you can see - there's no single, simple answer.

But I would be very wary of turning NCs into an endless vicious circle - eg, 1 NC not closed, then raising new NC to report previous one not closed, etc. Why not simply escalate and action this one? Also, sounds distinctly like you need some better guidelines.

Excellent post