We have a very small (tabletop) air heat treating oven and an observation was made that this needs to be validated as a special process. We have no hardness tester, but one is available to us. How many samples are sufficient to demonstrate the process has been validated? IQ and OQ have been completed and I need to perform and document PQ.
Additionally, the employee operating this oven has no formal training, and we only operate one material at two temperatures for one customer. How do we demonstrate the "competence" of this employee? Our customer has never made a complaint or rejected product.
Any suggestions/ideas would be greatly appreciated.
Additionally, the employee operating this oven has no formal training, and we only operate one material at two temperatures for one customer. How do we demonstrate the "competence" of this employee? Our customer has never made a complaint or rejected product.
Any suggestions/ideas would be greatly appreciated.