The difference between Deviation and Failure - Creating an SOP to handle them

[sfkevin]

As Randy stated keep it simple. I would follow Q9000-20005 QMS Fundamentals and vocabulary that does not reference deviation & Failure only nonconformity 3.6.2.

 

[Jim Wynne]

The deviation is a formal recognition of an authorised change, you can call it a non conformity if you want - but its just a recognition of an authorised change (displays some form of admission of control).

While this use of "deviation" is common, it's far from being a universally-accepted definition. We don't know what the OP was referring to.

 

[Randy]

"Deviation" might be being used in the sense of using NC material with permission (from a customer, e.g.), in which case a nonconformity is involved, but the problem is disposition.

In that case it would be handled under the nonconforming product requirement

 

[Denis]

I'll defer to my standard answer

"Different strokes for different folks"

 

[Matt M - 2009]

I would have to agree with Denis on this. In our organization if we have a deviation, it is something that is customer approved and therefore we do not catagorize it as a nonconformance. But it is really up to the company or specific industry to define.

 

[Jim Wynne]

I would have to agree with Denis on this. In our organization if we have a deviation, it is something that is customer approved and therefore we do not catagorize it as a nonconformance. But it is really up to the company or specific industry to define.

How do you categorize it before the customer approves?

 

[Matt M - 2009]

It would start as a nonconformance for sure. So we do handle it under our non conforming process as an "accept as is" or "customer approved".

 

[75alum]

I agree that in most cases a deviation would be a non-conformance. However, a deviation under a controlled and documented situation could be considered conforming. The deviation might include a product characteristic that does not meet a design bill yet is acceptable per the standards agreed to by the customer. Further testing could prove the deviation as good design and therefore would no longer be a deviation. Failure disregards critical characteristics while testing has shown that they cannot be deviated without unwanted consequence.

 

[Coury Ferguson]

I agree that in most cases a deviation would be a non-conformance. However, a deviation under a controlled and documented situation could be considered conforming. The deviation might include a product characteristic that does not meet a design bill yet is acceptable per the standards agreed to by the customer. Further testing could prove the deviation as good design and therefore would no longer be a deviation. Failure disregards critical characteristics while testing has shown that they cannot be deviated without unwanted consequence.

It is still a nonconformity no matter what you want to call it. It does not meet design characteristic, even though the Customer has accepted it.

 

[bobdoering]

Let me take a whack at this dead horse.

A condition starts out as suspect, pending disposition.

The dispostion can be:

-Scrap (Failure)
-Us as is, no issue, no nonconformity (e.g. measurement error resolved)
-Deviation (approved for use after customer approval per statutory limitations) after:
--Rework
--As-is