Deviation/Waiver Requiring a Nonconformance?

[Stijloor]

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.

Scope drift of posts..

 

[TPMB4]

We sometimes find in the early samples we produce some requirement or specification of the product is not possible to achieve. We tell the customer who decides the implications and usually changes the print accordingly so the NC is no longer an NC. This is a more permanent solution IMHO than a waiver/deviation. It is only possible in our case because these NC are not critical and indeed the characteristic that can no be achieved is usually wrong anyway. If this characteristic is critical then we would have to find a way to meet it of course and we would have done so already so no NC.

Sorry long last sentence. What I mean is if deviation is not important then customer most likely change it on print (better than a waiver). If it is critical then you need to resolve the issue in your process. Basically the customer can take the NC away by changing the print or you have to prevent it with a change to the process than prevents it in the first place.

Just my (why can't we have an icon for two-penneth for the English here? )

 

[Tara Monson]

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!

 

[Big Jim]

What you described sounds like it is documented enough with or without writing a nonconformance.

This is certainly not like a machined part that had a non-significant or even a significant dimension that wasn't hit.

 

[JaneB]

Sounds as though writing it up as an NC wouldn't have any internal value, so why do such a futile exercise ? NCs etc are supposed to be about preventing something reaching a customer that doesn't conform and improving your system, not about creating paperwork for the sake of it.

If neither of those would be achieved, I'd review your NC process and ensure it covers (meaning allows for) this kind of issue.

 

[Wes Bucey]

Sounds as though writing it up as an NC wouldn't have any internal value, so why do such a futile exercise ? NCs etc are supposed to be about preventing something reaching a customer that doesn't conform and improving your system, not about creating paperwork for the sake of it.

If neither of those would be achieved, I'd review your NC process and ensure it covers (meaning allows for) this kind of issue.

Nice, common sense response, Jane.

 

[Tara Monson]

Sounds as though writing it up as an NC wouldn't have any internal value, so why do such a futile exercise ? NCs etc are supposed to be about preventing something reaching a customer that doesn't conform and improving your system, not about creating paperwork for the sake of it.

If neither of those would be achieved, I'd review your NC process and ensure it covers (meaning allows for) this kind of issue.

Thank you, Jane! I completely agree.

Thanks for your help everyone.

Tara