Objecting to Registrar Audit Non-conformances

[pkost]

I apologise if this has been answered before however:

There are many threads on this forum where the OP poses a situation in which they received a non conformance from their registrar and the responses are that the non conformance was inappropriate or incorrect.

My question is, what do you do then?

Invariably we are audited by a single auditor who is on his/her own and on the occasions when I have felt that a NC is inappropriate we have ended up going round in circles with a person that refuses to back down from their position despite efforts to help them see the error of their ways. I'm sure there are many reasons for this, the two most obvious being they are certain they are right and the other being that their pride prevents them from backing down.

Does anyone have any advice or experience with how to handle this?

[AndyN]

In Reply to Parent Post by pkost

I apologise if this has been answered before however:

There are many threads on this forum where the OP poses a situation in which they received a non conformance from their registrar and the responses are that the non conformance was inappropriate or incorrect.

May question is, what do you do then?

Invariably we are audited by a single auditor who is on his/her own and on the occasions when I have felt that a NC is inappropriate we have ended up going round in circles with a person that refuses to back down from their position despite efforts to help them see the error of their ways. I'm sure there are many reasons for this, the two most obvious being they are certain they are right and the other being that their pride prevents them from backing down.

Does anyone have any advice or experience with how to handle this?

The swiftest way to deal with this is to inform your CBs management. May I ask if they contact you about your satisfaction with your auditor? Are you aware that you can change your auditor to find a better fit?

If the auditor doesn't possess the competencies of being able to explain 'why something is', then you shouldn't have to pay for it. Pride has no place in this service - it's a matter of being objective and showing evidence why they have something to report. Often they don't, so when 'challenged', they get defensive. If the auditor has facts, they don't need to do anything else but draw your attention to them!

Ask for a change of auditor. Tell your CB why and move on. It might be time for a change of CB if they don't know this person acts like this (feedback from others in your situation)

[pkost]

I believe we may have received a single satisfaction survey in the past number of years that I have been here - I responded appropriately!

Unfortunately as a medical device company changing CB is a last resort due to the cost and complications involved in such an action. I will admit that at one point it was a serious consideration but we felt that it was worth sticking out.

Although this was more of an academic thread with no specific issue now, in the past I have suggested to the auditor that he leave and then promptly arranged a meeting with his managers which resulted in our numerous major non conformances being struck off. I think the owner had a few sleepless nights while I sorted that out!

Despite the successful outcome I do have regrets that I could have handled the situation better, throwing out the auditor was obviously a last resort and maybe if I had known how else to proceed we could have avoided the chaos that resulted.

[SteelMaiden]

I believe that Andy was suggesting to request a different auditor, not a different CB. Surely, your CB has more than one auditor that is qualified to audit your industry? I have had few problems in the past 10 years, but prior to that I kept a list of every auditor, along with my own evaluation of them. If someone I didn't think was a proper fit for us was assigned, I would contact the registrar and ask them to assign a different auditor.

[pkost]

Requesting a change of auditor is certainly a step that can be taken. After the incident I described, we debated requesting a new auditor a decided not to instead taking the wait and see approach. the next audit was much better and the auditor had obviously had their wrist slapped and received retraining.

In retrospect it may have been a mistake not to change as we completely lost trust in the auditor and I'm sure this was to the detriment of future audits.

With regards to JRKH's comment, I think this is a good idea, certainly with a the first few NC's I wouldn't do it repeatedly though as it demonstrates the auditor is incompetent and shows the CA's lack of ability to address the issue. I particularly like this because I'm a fan of documenting in writing - if it isn't written it never happened!

[JRKH]

There are, of course, many different ways that this can be handled. When the NC is first proposed, you can raise your concerns, provide additional documentation, interpretation of the standard etc. If the Auditor is not satisifed, the next best thing might be to allow it to stand but verbally let the auditor know that, while you will investigate further, you do not agree with his/her assessment. Then wait for the audit report.

Now - you can address, offically and in writing, why the NC is incorrect, based on your investigation of your system as it relates to the appropriate element. The great thing about this is that, you have their written objection and you can then file your, very carefully written, response.
If they come back with something unsatisfactory, then the matter can be kicked upstairs to their managers...If this happens repeatedly where the NC's are shot down by the managers of your auditor, they may make a change themselves just to avoid the extra work....
The above avoids arguing, lowers your stress level, gets everything in writing, and forces the auditor to justify the NC, not just to you, but to their own management.

Peace
James

[AndyN]

In Reply to Parent Post by JRKH

There are, of course, many different ways that this can be handled. When the NC is first proposed, you can raise your concerns, provide additional documentation, interpretation of the standard etc. If the Auditor is not satisifed, the next best thing might be to allow it to stand but verbally let the auditor know that, while you will investigate further, you do not agree with his/her assessment. Then wait for the audit report.

Now - you can address, offically and in writing, why the NC is incorrect, based on your investigation of your system as it relates to the appropriate element. The great thing about this is that, you have their written objection and you can then file your, very carefully written, response.
If they come back with something unsatisfactory, then the matter can be kicked upstairs to their managers...If this happens repeatedly where the NC's are shot down by the managers of your auditor, they may make a change themselves just to avoid the extra work....
The above avoids arguing, lowers your stress level, gets everything in writing, and forces the auditor to justify the NC, not just to you, but to their own management.

Peace
James

Apart from the first few points, why should anyone have to go through this? The auditor has blotted their copybook, get another and see how they approach this. The auditor has poor technique and, apparently, it's not the CBs concern since they don't follow up frequently...

[Ajit Basrur]

I have shifted to ISO 19001 section for getting better responses.

Thanks Andy for suggesting this.