I think most of the five questions are answered in the OP's two posts. The question wasn't about what to do about dealing with the customer, which seems to follow a standard process, but about how to internally characterize the nonconforming product.
Exactly. I was just wondering how to characterize this. The product I am talking about is bulk antisera and antibodies. This product is derived from an animal and requires different types of processing, depending on what raw material we receive. Animals change throughout time; so does our product.
Customer requested certain product, we started processing. Customer wanted it sooner than we could process it to a final state, we went sample. They wanted it NOW, despite being out of specification.
My question was, do I write this up as a nonconformance with a deviation in the disposition? Or just have a deviation form? The customer has signed the deviation and accepted the product. I'd just like to get an opinion on if a nonconformance is needed.
At my previous position, EVERYTHING that was out of spec, deviation from process, deviation from procedure, etc. was written up as a nonconformance for ease of traceability. My current facility does not think that way.
I really am just looking for an opinion...it is documented - just not sure if it's thorough enough.
Thank you, everyone!