Okay, I was discussing this problem with someone here and now I am sitting on the fence between it's procedure-controlled rework and it's not.
These boards were built by my supplier. My supplier is not registered to ISO 13485. The supplier was in error and the supplier reworked the board. So it's a question of should this be viewed from the assembly (the board goes in a medical device therefore rework to approved procedures) OR view it from the supplier (he is just building a board and will rework to his own internal methods).
If I was building the board at my facility, it's cut & dried - rework procedure required. Having a supplier build, I'm confused as to what is applicable.
Hi,
Now that you've clarified that the component replacement was due to an initial error, I agree that in general this would fall under "rework". The previous description was not as clear.
It is totally legitimate to qualify and utilize suppliers not certified to 13485; as long as your evaluation and qualification processes are adequate, and the supplier continuously meets the requirements set out in these processes. Thus, as long as the supplier acts according to their own QMS (I assume you didn't qualify a supplier who doesn't have a QMS at all...), and your supplier qualification process has (in the past) resulted in this supplier -- including their QMS -- being acceptable, I see no regulatory / QA / control failure. If you have any reasons to suspect that this supplier's performance is less than adequate, I recommend you have another look at their qualification (as your supplier) process records, and maybe reconsider their status.
I do agree that since it's an outsourced part, the applicable controls would be Purchasing controls. In that sense, your main concern should be -- does this part meet its specifications in full? And, how & to what extent would you verify that? Whether or not your own internal processes (e.g. non-conforming product) should be involved as well, depends, IMO, on whether the defect was discovered at the supplier (before ever getting to you), or was it your own inspection/testing that revealed it.
Cheers,
Ronen.