Disagreement with NADCAP auditor...

.. and also with the quality department.....

(Internal Round Robin)（内部循环比对）

1. There were two testing equipment used for test codes G1/G5, but IRR/equipment was not performed as required by procedure YLZZ-QP709:2018.
2. IRR/Operator for test codes G1/G5 were performed separately, the two operators working in chemistry lab #1 were compared each other, another two operators working in chemistry lab #2 were compared each other, not "all operators, one machine" as required.

My lab (2) is located on a new site and is dedicated to production analysis and certification of the material my department produces we have our own staff lab 1 has theirs and we do not cross train.
I was not in the room when the NC was raised, if I had been then I would have argued it.
But since it was accepted by the quality manager the approach I would like to take is:

Since the NCR is against our own procedure, which was written before the MA lab was incorporated; I suggest that we just update it to match the current situation, using the justification below

Impact assessment
Question: What is the point of an IRR program?
Answer: To ensure that all operators of a piece of equipment are using it in the same way and there are no inter-operator biases.
As the operators of the equipment in lab 1 and lab 2 are two distinct groups, the instruments are different makes and have completely different SOPs and training, the operators and machines are located at different labs, there is no chance that an operator from one lab would operate the C/S machine in the other lab. Therefore an IRR and this NCR seek to address a problem which arises from a non-existent situation.
Since there are no potential biases which have not been tested there is no product impact.
Remedial action
The immediate corrective action would be to clarify the procedure – maybe put in an IRR schedule which reflects reality by including separate IRRs for the two C/S machines
Root cause
When lab 2 was incorporated a review of procedures to ensure they reflected new circumstances was not made
Preventative action
Full review of shared procedures to ensure clarity and compatibility for both laboratories

But the quality department want to just carry out more round robins.

My main problem with this is that it is pointless. Also important though is that to my mind at least; having an operator go over to a different lab to use a piece of equipment that they only see once a year and try to get the same results as the regular chemist seems to me to be asking for trouble.
And there is also no driving force for them to review their documents to ensure they reflect reality

Is this a battle worth fighting?

 

The issue is partly cultural:
We're in China and the quality department has two instincts, deference to auditors and haste. I was brought in from a company where the culture is/was diametrically opposed, not to work on quality per-se but as a technical and manufacturing expert (ahem)

I do not want to just bolt things on to the quality system in a hurry when 1/ they are irrelevant to the actual process and 2/ they could well bite us later or lead to incompatible requirements. I have seen it happen when things are not thought through.

The model response above is how I wanted to handle the NCR, the quality dept want to do the obvious thing and run a round robin