Definition Non-Conformance vs. Deviation - Definitions and Differences please

L

LandA

#1
Hi,
I'm fairly experience with Deviations and am currently writing a "Deviation" procedure and I need to define Deviation etc- this definition was easy enough but then I got a bit confused with the use of the word "non-conformance" instead of Deviation in some instances.
I would like someone to define non-conformance, please? Is it a broader term for Deviation, in that Dev is more dev from procedures whereas non-conformance includes equipment failures as well?
Thanks
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Difference between Non-Conformance & Deviation-definitions please

When I did Non-Destructive Testing in the Navy, I would find "incontinuities" that I was not to reject as nonconformances unless they exceeded defined limits.

And so it goes: a deviation from a perfect state may not be a non-conformance if your specifications (drawings, manuals, procedures, and/or work instructions) address what is a deviation, what is a non-conformance and how a responsible person can tell the difference. That "responsible person" could be a line machinist, an inspector, a supervisor, or even a Material Review Board, if your process is set up to show them as the people with authority to accept or reject.

I hope this helps!
 

Jim Wynne

Staff member
Admin
#3
Re: Difference between Non-Conformance & Deviation-definitions please

Hi,
I'm fairly experience with Deviations and am currently writing a "Deviation" procedure and I need to define Deviation etc- this definition was easy enough but then I got a bit confused with the use of the word "non-conformance" instead of Deviation in some instances.
I would like someone to define non-conformance, please? Is it a broader term for Deviation, in that Dev is more dev from procedures whereas non-conformance includes equipment failures as well?
Thanks
They're two different categories. A nonconformance is failure to meet specifications or requirements, while (generally) a deviation is permission to proceed (ship product, do further processing, e.g.) when a nonconformance has been discovered. There's a third term that might be relevant: waiver. Some companies define a waiver as advance permission to produce nonconforming material, while deviation is used to describe a dispensation granted after nonconforming material has already been produced.
 
C

Chris Ford

#4
Re: Difference between Non-Conformance & Deviation-definitions please

They're two different categories. A nonconformance is failure to meet specifications or requirements, while (generally) a deviation is permission to proceed (ship product, do further processing, e.g.) when a nonconformance has been discovered. There's a third term that might be relevant: waiver. Some companies define a waiver as advance permission to produce nonconforming material, while deviation is used to describe a dispensation granted after nonconforming material has already been produced.
Hi Jim,

I disagree. I agree with your definition of a nonconformity, but the definition of deviation isn't, in my opinion, the "approval to use nonconforming material", which is in essence what you're saying.

I know of many situations where nonconforming material is accepted on concession. Sometimes it's "reworked" in house due to material shortage issues. Sometimes the nonconformity is aesthetic, and minor... the list goes on. But at the end of the day, after they've accepted the material on concession, the material is no longer non-conforming.

Deviation on the other hand, pertains to processes. The manufacturing department wants to continue production, despite some material shortages on the line. They write deviation plans that explain the nature of the deviation and detailing the revised process, including risk analysis when necessary, and it'll include the validation requirements. In my experience, this process is very closely mirrored to the document control process. Some companies use the document control department to manage the deviation system, as well. The deviation request form (or whatever you want to call it) looks exactly like a document change order, requires all of the same considerations, with only one real difference - it's temporary and has an expiration date.

There are some nuances in the processes... the system needs to account for adequate controls for the closure process of deviations.

So, in the case of a nonconforming part, a deviation might be appropriate if you accept the material on concession, and it will be reworked in house. In that case, you'll probably need to develop the procedures for the rework and inspection, etc. That process could be handled by the deviation system.
 

Jim Wynne

Staff member
Admin
#5
Re: Difference between Non-Conformance & Deviation-definitions please

Hi Jim,

I disagree. I agree with your definition of a nonconformity, but the definition of deviation isn't, in my opinion, the "approval to use nonconforming material", which is in essence what you're saying.

I know of many situations where nonconforming material is accepted on concession. Sometimes it's "reworked" in house due to material shortage issues. Sometimes the nonconformity is aesthetic, and minor... the list goes on. But at the end of the day, after they've accepted the material on concession, the material is no longer non-conforming.

Deviation on the other hand, pertains to processes. The manufacturing department wants to continue production, despite some material shortages on the line. They write deviation plans that explain the nature of the deviation and detailing the revised process, including risk analysis when necessary, and it'll include the validation requirements. In my experience, this process is very closely mirrored to the document control process. Some companies use the document control department to manage the deviation system, as well. The deviation request form (or whatever you want to call it) looks exactly like a document change order, requires all of the same considerations, with only one real difference - it's temporary and has an expiration date.

There are some nuances in the processes... the system needs to account for adequate controls for the closure process of deviations.

So, in the case of a nonconforming part, a deviation might be appropriate if you accept the material on concession, and it will be reworked in house. In that case, you'll probably need to develop the procedures for the rework and inspection, etc. That process could be handled by the deviation system.
What you're describing as a "concession" is in fact synonymous with "deviation" or "waiver" in many instances. These things are defined locally, and there is no universal definition for any of them. They can apply to products or processes.
 
D

ddunn

#6
Re: Difference between Non-Conformance & Deviation-definitions please

They're two different categories. A nonconformance is failure to meet specifications or requirements, while (generally) a deviation is permission to proceed (ship product, do further processing, e.g.) when a nonconformance has been discovered. There's a third term that might be relevant: waiver. Some companies define a waiver as advance permission to produce nonconforming material, while deviation is used to describe a dispensation granted after nonconforming material has already been produced.
Jim,
I agree with you on the use of deviations and waivers except the definitions are reversed (a common mistake).

From MIL-STD-973 (yes I know it's obsolete but it's still used a lot)

Deviation. A specific written authorization, granted prior to the
manufacture of an item, to depart from a particular requirement(s) of an
item's current approved configuration documentation for a specific number of
units or a specified period of time. (A deviation differs from an
engineering change in that an approved engineering change requires
corresponding revision of the item's current approved configuration
documentation, whereas a deviation does not.)

Waiver. A written authorization to accept an item, which during
manufacture, or after having been submitted for Government inspection or
acceptance, is found to depart from specified requirements, but nevertheless
is considered suitable for use "as is" or after repair by an approved method.
 

Jim Wynne

Staff member
Admin
#7
Re: Difference between Non-Conformance & Deviation-definitions please

Jim,
I agree with you on the use of deviations and waivers except the deffinitions are reversed (a common mistake).

From MIL-STD-973 (yes I know it's obsolete but it's still used a lot)

Deviation. A specific written authorization, granted prior to the
manufacture of an item, to depart from a particular requirement(s) of an
item's current approved configuration documentation for a specific number of
units or a specified period of time. (A deviation differs from an
engineering change in that an approved engineering change requires
corresponding revision of the item's current approved configuration
documentation, whereas a deviation does not.)

Waiver. A written authorization to accept an item, which during
manufacture, or after having been submitted for Government inspection or
acceptance, is found to depart from specified requirements, but nevertheless
is considered suitable for use "as is" or after repair by an approved method.
I've seen the two used both ways, but the way I defined them has been more common in my experience. The important thing is that no matter what definitions are used, they're used consistently and that the people who use them understand what they mean.
 
C

Chris Ford

#8
Re: Difference between Non-Conformance & Deviation-definitions please

What you're describing as a "concession" is in fact synonymous with "deviation" or "waiver" in many instances. These things are defined locally, and there is no universal definition for any of them. They can apply to products or processes.
I just don't see how "conceding" and "deviating" could be synonymous, and I didn't mean to use the words synonymously in my previous post.

The word "concession" is used throughout the ISO 9001 and 13485 standards (the two quality systems standards I work with) relative to nonconforming product. Neither standard discusses deviation. The FDA Quality System Regulation discusses deviation relative to process, however.

I define "concession" as a granting waiver, while "deviation" is the departure from a process or standard. In other words, the specification tells me that the part is nonconforming, but I concede and accept the nonconformity. The nonconforming material procedures should define the requirements for acceptance of materials on concession.

Like I said earlier, I agree with your definition of nonconformity - a failure to meet a specification. A nonconformity could exist in a product or a process. In either case, nonconformities result from the failure of an existing system. You could say that the definitions for nonconformity and deviation are very similar, but deviation doesn't always result from or even relate to a nonconformity.

I've seen "acceptance on concession" called, "Use As Is", "Conditional Approval", "Waiver" and the list goes on. So, I agree that some companies will call this "Accept on Deviation". My point was that once any of these are executed, the parts in question are no longer nonconforming, but I don't believe that this is the type of "deviation" that the OP is trying to address in a deviation procedure.

In my industry, medical device manufacturing, a "Deviation Procedure" typically addresses how the company will handle planned deviations from procedures - or specifications.

There could be a need for a temporary deviation from a specification for a raw component. Or, there could be a need for a temporary deviation from a procedure like I described earlier.

In either case, the deviation procedure should provide for an adequate review and approval of the deviation and include a review of the possible impact the deviation could have on the product as well as any validation requirements.
 

Jim Wynne

Staff member
Admin
#9
Re: Difference between Non-Conformance & Deviation-definitions please

I just don't see how "conceding" and "deviating" could be synonymous, and I didn't mean to use the words synonymously in my previous post.
I didn't say that "conceding" is synonymous with "deviating"; I said that "deviation" and "concession" can be synonymous depending on local usage. Many companies use "deviation" to mean the same thing you mean by "concession." They aren't incorrect in doing so, just different.
 
D

ddunn

#10
Re: Difference between Non-Conformance & Deviation-definitions please

A non-conformance may be against a process or a product. A deviation or waiver is a response to a non-conformance. Other responses to non-conformities may be "scrap", "accepted on concession", "use-as-is", "repair" or "rework". The response to a product non-conformity is usually determined by a material review board. The response to a process non-conformity is usually determined by a QM, process review team, the process owner or who ever is in charge of process control.
 
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