Internal Approval of Deviations - ISO 9001:2008 & ISO 13485:2003

W

WilBryan

Jim -
We have discussed both of these solutions and will likely use a combination of approaches that leverage a written release or assignment of responsibility during project kickoff some kind of request/response. Each customer is different and so each time it may be different (which presents an entirely new set of complications).
For discussion - here are the issues we are facing.
Customer engineers are given a standard tolerance to create drawings with. This tolerance is the tightest it needs to be for the most precise part but 95% of the parts dont need anywhere near the +/- called out. Its just a lean approach to engineering management (though not a good one).
Once the drawings are created, engineers are out of the picture and the info is passed to us via the company's proj mngr. The PM woudl be responsible for a waiver but will likely not sign off on any blanket deviations because they do not want to be accountable for letting us off leash.
If we find a part that requires deviation, the PM will have to receive the info, take it to their engineers who refuses to modify their tolerances because of their department directive to remain in tolerance. They ask 'why they are paying us?'
Eventually, they may return to us with a relaxed deviation, but this process could be two weeks to navigate. Meanwhile we are holding up a half-million dollar piece of equipment over a ten-thousandth too wide dowl-pin hole on a $100.00 part that everyone knows will fit onto the machine just fine.
The worst part is that we are allowed to exempt parts from inspection which means that if we had simply exempted this part prior to purchasing (as we did with 70% of the parts) it would never have been on radar.

If we are not required to dimensionally inspect 100% of every part that goes onto a machine and it is part of our expressed duty to determine what does and does not get inspected, based on supplier performance and a posteriori knowledge of the design and function, then why would we not also be permitted the bandwidth to make minor deviations?
If we added a hole, trimmed a tab on a piece or some other change beyond saying "it will fit" then we have a robust system for effecting change where everyone signs off.

This is certainly not what the standard intends and is just an area that is subjective enough that it is difficult to write to.

Not being obtuse here. I understand the fundamentals of the standard and I get the reasoning behind it. I am just also seeing a very clear sector of the real-world where this become very murky.

Interestingly enough... the auditor wrote the NC on 8.3 which has almost nothing to do with the subject of design change.
 

Big Jim

Admin
Your company is in a catch 22 position, and that is never a good place to be.

It allows them to never accept accountability for their actions.
 
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