Non Conformance vs Compliance

[Tidge]

In my view if the requirement is not met or if the non-conformance is not closed properly then the design is not compliant because the design controls was not followed. its a compliance issue. Its not just a non-conformance issue.

In development, it isn't a design non-conformance to failure to meet a requirement (welcome to engineering)... this is a development issue that requires resolution. In other words: in the medical device industry we don't start a NCR because something goes wrong in development.

It is almost certainly a QMS non-conformance to not address the failure to meet a requirement.

 

[Bev D]

IF that is the hypothetical/philosophical detail. We don’t know yet.

IF the design fails to meet a regulatory requirement (as in a certain material strength, over voltage protection, or allowable porosity, etc) then it is likely a product nonconformance (as in fails to meet a regulatory requirement or specification) and there is perhaps a non compliance to the procedure (as in failed to follow one or procedures)

Too many people make up their own definitions of words and don’t disclose their definitions.

 

[Tidge]

The point I keep repeating about "in development" is this: prior to design transfer and launch, there aren't any meaningful product/design non-conformances because no one has attested that the device has met its requirements. If during development if every time a design output was observed to fail to meet a design input became an NCR, every NCR would have the same target endpoint: get the outputs to meet the input requirements. The company is working towards having a medical device on the market, but it isn't one yet.

This is why I keep emphasizing that it will typically be QMS non-conformances (doing development wrong) and not product non-conformances... at least not until the product is past the design verification stage. Obviously if something is on-market and hasn't been verified to meet its design input requirements... it is a product non-conformance.

 

[Bev D]

I get that.

It seems that the OP has a poorly articulated hypothetical philosophical question that is (maybe) about a released product that they feel is noncompliant. Their wording can be inferred to be that by “a design” they mean “an actual released product”

This is my point: There are so many possible scenarios that without the OP stating a specific detailed example all we are doing is ‘spitting’ into the wind.

 

[Ed Panek]

This was my perception. It depends in what stage the "Problem" was found. Problems or errors occur frequently in the design sandbox. It could occur before you even formally start design controls, but the term 'non-compliant' is new to me. Ive seen products fail EMC testing in development where they needed to add some RF dampening coils to pass but its not being non compliant. Its just normal development.

 

[Randy]

In the end nonconformance vs noncompliance, nobody really, really cares as long as you can define what it is that's wrong and you fix it in the manner required of you for that particular problem. I'm nowhere near as senior in this stuff as others here, only 22+ years of 3rd party auditing myself, and I've taught this "stuff from here in Arkansas, around the world and back, and I told folks that paid good money, it doesn't mean a crap what you call something as long as you can define it, say what it is, and do the correct thing with it.

What's really the difference in plain English between "noncompliance", "nonconformance" and "something we didn't get right"?