Can we close an audit NCR by not taking any action?

[anil2187]

Can we close an audit NCR by not taking any action:

Clause 8.2.2 Internal Quality audit requires action taken without undue delay.

My question is is it neccessary / possible to take corrective action for every NCRs?
If auditee feels the NCR refers to a less priority area as per his scheme of thinking can "inaction" be an action to facilitae closure of an NCR? In such a situation what precautions must be taken by the auditor prior to closing such NCRs?

Looking forward to the experience and comments of list members.


Anilkumar

 

[barb butrym]

This is a ticklish situation, not knowing the details........and all depends on the details and such,,,But that said... YES ....a consious decision can be made to do nothing, but must be clearly documented.....and cannot be a NC to a shall of the standard. An example I can site is: A NC was issued where a door to the cleanroon gowning area didn't shut properly ( a slight gap in the seal)...to prelace the door would have cost thousands of $$$. the particle counts were well below the control limit (other factors too, that i left out like they had already tried to fix it) So the company decided to do nothing until triggered by a raise in particle count...taking a calculated risk that the cost of inaction was much lower than the cost of action, and wouldn't effect product... then was bumped up and approved at management review.

Another option is to have the nc proven invalid....if its not an important issue...as in more of a PA from an observation?

 

[Kevin Mader]

Ticklish to say the least.

Here is a thought or two:

First, if an auditor issues a deviation request, the auditor must be certain one exists. As such, corrective action is required.

In Barb's example, the deviation request may have been issued too quickly (taking a risk here without the facts). For instance, the crack existed but did a nonconforming situation exist (were partical counts different than a week/month ago)? Perhaps this is a PA opportunity? If a problem did exist but the cost too excessive and available tracking (back up system) system in place, then a letter to the file stating that operations are minorly impacted and does not present a dangerous environment (controlled environment).

Second, many organizations issue deviation requests too liberally. This generally leads to an overburdened CA program. People are trying to eliminate everything as if each case were caused by a Special Cause. As such, many deviation requests go unanswered and before long, the CA administrator begins to close out the requests without action. Honestly, it is the right thing to do provided each is reviewed for merit and is done after Management Review agrees that this is the right thing to do. Nonetheless, it makes for an awkward moment or two when the registrar comes by for a visit. I should mention that those deviation requests that are closed out are almost always those not related to an audit. As I stated earlier, auditor's need to be sure that a problem exists before issuing a request for action. As Barb noted, those that tie into the standard or your own procedures should never be closed out without action.

Regards,

Kevin

 

[anil2187]

ISO 9001:2000 CL 8.2.2 - .... ACTIONS ARE TAKEN ... TO ELIMINATE DETECTED NON CONFORMITIES..."

So if audit report gives in addition to NCRs other observations - say opportunities for improvement" how is it generally handled?

Anilkumar

 

[M Greenaway]

No action on an NC is OK so long as the justification is documented and is valid, and possibly accepted by the person raising the NC. If this came out of audit the auditor perhaps should look at how he decides on when to raise NC's, and curb his over zealous pen accordingly.

Jim and Kevin are both right, corrective action should not be required on every single instance of non-conformity detected (whether concessed or not). Pareto analysis is a valid quality method for targeting corrective action. Also as Kevin stated common and special causes of non-conformance are two distinct different animals and require a different approach.

 

[M Greenaway]

P.S. an opportunity for improvent is by definition not a non-conformity, as such does not HAVE to be tackled in the same way.

 

[JRKH]

anil2187


I agree with the others here. But do be careful.

You stated:
"If auditee feels the NCR refers to a less priority area as per his scheme of thinking can "inaction" be an action to facilitae closure of an NCR?"

I think "inaction" would be the wrong approach however. This implys ignoring the concern. Look at how you review your NCR and use this as your action. For instance (using Barb's "door" example):

"Reviewed NCR with appropriate management personnel. Air quality records have been reviewed. Records indicate low risk in this situation and monitoring schedule is appropriate. No further action is required at this time."

Such an answer demonstrates that you have addressed the concern without actually having to spend a large amount of time and money fixing something that isn't critical.

One thing I learn more about every day is the effective use of verbiage. It is a lot of what all of this is about.

James:thedeal:

 

[Mike S.]

anil2187 said:

If auditee feels the NCR refers to a less priority area as per his scheme of thinking can "inaction" be an action to facilitae closure of an NCR? In such a situation what precautions must be taken by the auditor prior to closing such NCRs?

Anilkumar

I agree with James. To me "inaction" means the NCR was given to you and you threw it away without reading it. Reviewing it, and mybe investigating a little, and deciding that no further action or specific corrective action is required is not "inaction". There is a rock and roll song in the US that has the following line which I think applies here "If you choose not to decide you still have made a choice".

We've tackled this one in the Cove before in the last few months -- maybe a search will help you find other info.

 

[JodiB]

anil2187 said:

ISO 9001:2000 CL 8.2.2 - .... ACTIONS ARE TAKEN ... TO ELIMINATE DETECTED NON CONFORMITIES..."

Anilkumar

I think you have this mixed up with 8.3 (a) under Control of nonconforming product. Non-conforming product must be dealt with according to your procedure for this : scrap, rework, repair, use with concession...

Our CA procedure allows for a postponement of "long-term corrective action" which is kin to "no action". After taking short-term corrective action (which is in actuality a correction) , the nonconformance is reviewed for long-term corrective action (to prevent the recurrence - which is what CA is all about). After determining what it would take to accomplish this, the mgt. team can decide to take a "sit back and watch" approach rather than implement the changes. Too $$ or too much effort vs. results...the typical reasons. This is shown on our process chart as well as written into the procedure.

The CA procedure has not been implemented yet (long story), but after reading everyone's posts here in the Cove, I think it is on target and is workable.

 

[M Greenaway]

Yes Lucinda.

In a previous life we used to escalate corrective actions for which there was no quick fix, due to requiring significant resource or finiancial input, into Quality Improvement Programmes.

It was a bit of a bottomless pit however !