Objecting to Registrar Audit Non-conformances

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pkost

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#22
Re: Objecting to Non-conformances

I think that it is inevitable that there will be differences, sometimes significant, and it is important that these be reduced. From my perspective in a regulated industry where the CB is also the notified body I think it is doubly important as the role of the NB is to ensure the safety of medical devices.

I am too new to the world of quality and industry to have any experience outside of my own CB/NB and so have no ability to judge their performance. From discussions with other colleagues there is certainly a range of good NB's down to a few where I look at the CE mark and question whether it should really have been applied.
 
#25
I'd be interested to see what would happen, Scott, if you pulled the auditor to one side (at the next visit) and explained that if they didn't do things 'properly' (per 19011 etc) you'd be calling their management on it!

This kind of slack behaviour needs to be stopped and of course, if they have a 'shadow' they'll do everything by the book. Putting his boss on a conference call would help either, so it's up to customers to jolt them out of their complacency...
 

Howard Atkins

Forum Administrator
Staff member
Admin
#26
Re: Objecting to Non-conformances

Not informing a client about the right to appeal? That's a crappy practice...


Here is an item on the meeting checklist that I must follow and complete that becomes part of the audit record..." Explain Appeals process ".

I've been taught to let the client know up front about Appeals, NC's and eveything else they have a right to know.
We have the same in our checklist and I always make sure that the customer knows and repeat this at the closing meeting
Even if I have not found a NC I remind them that they can appeal.

I am going to start a poll on this in a separate thread.
Here is the poll Poll
 

Randy

Super Moderator
#27
Re: Objecting to Non-conformances

We have the same in our checklist and I always make sure that the customer knows and repeat this at the closing meeting
Even if I have not found a NC I remind them that they can appeal.

I am going to start a poll on this in a separate thread.
That always gets a chuckle when you tell them they have a right to appeal when there isn't a NC, but I do it as well:lol:
 
T

tomvehoski

#30
I believe they did mention the appeal process both in the opening and closing meeting, but I choose to fight before it can get to an appeal.

I had a AS9100B surveillance audit last week. One auditor wanted to write a NC for not internal auditing every process in the system within the last year. I asked where is it required that audits must be conducted annually, because it is not in the standard. Six months ago I took a hit on the same issue as I had just adopted a messed up system and was in the process of revamping it, so it was not a big deal to me. I'm in a very smalls shop and know where our issues are. My audit schedule shows my rationale for pushing some internal audits out. Filling out records to make an external auditor happy is not my idea of value added.

He claimed it was in our contract (via standard polices) with the registrar. As strange as I thought that would be, I printed off a copy of their policies from our account on their website. He was not able to find it there, nor could I. He then claimed that it was in the signed contract, and I didn't have a copy handy. Ended up in a closed door meeting with the lead auditor, who then asked why I was being so difficult. I basically said, they make me produce evidence my system complies to the standard, I am simply asking for evidence that the requirement exists. If they could produce the requirement, I would be happy to accept the NC.

He decided to "give me a break" and not write it, but he would get me the information that showed the requirement later. Then he said he could also write a NC because one of the auditors took their notes in pencil, and since it was a record and that was not allowed. Thought he was going to explode when I asked where that requirement was. :lol:
 
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