Performing PQ on a Small (tabletop) Air Heat Treating Oven


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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.


Starting to get Involved
I had a post earlier on employee competence. From what I got from that post was training does not equal competence. Experience with no rejections or complaints can
show competence.

You sound like everything in your paragraph is there other than documentation of it.


Involved In Discussions
Thanks Harley, I was thinking along the same lines regarding the competence question, I just wasn't sure if it was enough.

With regard to documenting PQ, how many samples would be sufficient? Keep in mind that testing heat treated parts would require hardness testing and render the parts unusable.

Thanks for your feedback in advance!


Quite Involved in Discussions
Do you have the option of letting dummy parts made from the same material with a greatly simplified geometry be heat treated and check hardness on those?
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