Criteria for not rising NCR's in 8.3 of ISO 9001:2008

Q

QAMTY

#1
Hi everybody

Could you give some ideas as to how can I manage minor nonconformities?.
I try to raise NCR's for everything I have in front of me in the production area.

But I think it will take a lot of time to resolve the nc's, documenting everything, doing the follow up, the closeout, beside of that, such minor nonconformities cost very, very little to my bussiness.Will cost me too much $$ spending resources in solving them vs the cost of lost product.

Obviously such nc's are solved although they are not documented.

From time to time I'll check all these nc's and will do some CA in order eliminate the cause.

Meanwhile I want to focus muy efforts in the nc's which more affect my bussiness.

Could I define a criteria ? e.g. only will be rised nc's according to quality engineer criteria when a nc is found?

I want to avoid nc's rised by the auditors.

I base my argument on the next clause 8.3 d

d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.


Thanks​
 
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dsanabria

Quite Involved in Discussions
#2
Hi everybody

Could you give some ideas as to how can I manage minor nonconformities?.
I try to raise NCR's for everything I have in front of me in the production area.

But I think it will take a lot of time to resolve the nc's, documenting everything, doing the follow up, the closeout, beside of that, such minor nonconformities cost very, very little to my bussiness.Will cost me too much $$ spending resources in solving them vs the cost of lost product.

Obviously such nc's are solved although they are not documented.

From time to time I'll check all these nc's and will do some CA in order eliminate the cause.


Meanwhile I want to focus muy efforts in the nc's which more affect my bussiness.

Could I define a criteria ? e.g. only will be rised nc's according to quality engineer criteria when a nc is found?

I want to avoid nc's rised by the auditors.

I base my argument on the next clause 8.3 d

d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.


Thanks​


First - Definition of Minor NCR:

A non-fulfillment of a requirement which is not likely to result in the failure of the quality management system or reduce its ability to assure controlled processes or compliant products/services; it can be either one of the following situations:
• a single system failure or lapse in conformance with a ISO standard or customer quality management system requirement; or
• a single system failure or lapse in conformance with a procedure associated to the organization's quality management system.

NOTE: A number of minor nonconformities against one requirement (e.g., similar nonconformities associated to different sites or different departments/functions/processes within a single site) can represent a total breakdown of the system and thus be considered a major nonconformity.

First - So if what your saying is true, you need to make a list and have a conversation with upper Management as to how to correct the issues.

Second - you need to have a refresher with the auditors to see if they understand the difference between a comment / observation / opportunity for improvement and an NCR.

Third - if you are register - why is it that the auditors and customers have not found them
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Good day QAMTY,

I want to understand if you are talking about all NCs or only product NCs, as you listed 8.3d which is addressing product NCs detected after the product is delivered or its use has begun. This clause is not about system NCs.

Of course we should correct causes of nonconformity in product, but it may not be possible to eliminate everything. Nor should everything get the same extent of energy.

- Can your NCs be categorized based on their severity in terms of cost, including the cost of recall?
- Would the NCs render the product unsafe or raise the risk of harm to users?
- Might the NCs affect your organization's reputation in the market?

I would worry less about what auditors think and more about what paying customers think, and regulators if that applies.
 

Big Jim

Super Moderator
#4
You get to determine when nonconforming product rises to the point of needing a full blown corrective action. You can treat it with a simple correction when appropriate, which is likely most of the time.

I suggest that your procedure for 8.3 include that all of these incidents either be logged or have a form completed such as a DMR (Discrepant Material Report), or NCMR (Nonconforming Material Report).

Then in your procedure include that a member of the quality team (or however you have your organization set up) review each one to determine if it should be escalated to a full blown corrective action or not. A sign-off line for escalate or not could be used.

Criteria for escalation would probably include if it is a repeat issue, could have allowed bad product to escape, or if it was significant enough for further attention.

Keep in mind two definitions from ISO 9000. Correction is what is needed to overcome a nonconformance. Corrective action is what is needed to overcome the CAUSE of a nonconformance.

If the issue is insignificant, not likely to repeat, and had minimal impact, a correction is all that is really needed.

Attempting to apply a full blown corrective action to all incidents will wear you out and likely dull you ability to respond to the critical ones.
 
Q

QAMTY

#5
Thanks Jeniffer
My answers in red
Good day QAMTY,

I want to understand if you are talking about all NCs or only product NCs, as you listed 8.3d which is addressing product NCs detected after the product is delivered or its use has begun. This clause is not about system NCs.
I'm considering all nc's, according to vocabulary, services is category of products, and I consider internal services (Service that one process provides to other processes)
Im I right?
But anyway I consider nc's of products as well.
Of course we should correct causes of nonconformity in product, but it may not be possible to eliminate everything. Nor should everything get the same extent of energy.
OK
- Can your NCs be categorized based on their severity in terms of cost, including the cost of recall? Really very low cost
- Would the NCs render the product unsafe or raise the risk of harm to users? No harm nor unsafe
- Might the NCs affect your organization's reputation in the market? Not really

I would worry less about what auditors think and more about what paying customers think, and regulators if that applies.

I agree with you, Thanks
 
Q

QAMTY

#6
Thanks Big Jim

I really appreciate all feedback I 've received from all the Elsmar Cove members
all the ideas were very helpful, is excelent your proposal.

Thanks a lot
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Okay. let us be clear that 8.3d is a clause specific for nonconforming product that has already been delivered. This means recalls or other actions as appropriate. If your product is low cost and nonconformities present no risk to users, recalls are probably not a good idea.

Both product and system nonconformities are expected to be addressed. At minimum, it is expected that we will correct a problem so the nonconformities will not continue. There is also an expectation that problems will not recur over and over. But the standard does not ask us to have the same approach to all nonconformities. It makes sense to include your organization's business case when deciding course of action. This might include your reputation among customers and the associated market share impact a loss of confidence might have.
:2cents:
 

somashekar

Staff member
Super Moderator
#8
I base my argument on the next clause 8.3 d

d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
8.3 is about product NC control
so the 8.3 d) also applies to same, your product, specifically the finished goods.

This 8.3 d) is about actions that you plan for when the product is out of your gates, and the NC is detected.

Just address what steps you will take in your documented procedure with due considerations to effects or potential effects due to the NC product.
Such a procedure may ask for traceability requirements of your products.

This d) was not in the ISO 9001:2000. In the ISO 9001:2008, this has come in more specifically towards product NC detected after delivery or NC detected after product use.

When you further analyze the data from such a NC product situation, you then decide what correction / corrective action must be taken up.
 
Last edited:
#9
it's good to document minor non-conformities and you can do it without regular NCR/DMR process .Create observation logs to document minor discrepancies with comments sections to justify why you accept it ( ex: defect rate with in AQL Accept /reject criteria, or no product impact etc...)
-----------------
Best Regards
Biju Joseph
 
P

PaulJSmith

#10
I agree with all of the above advice. You should definitely find a way to document all of these Nonconformities, though. It will help you get a better picture of trends and what may be real problems in disguise. If your NCR process allows for this, that might be the way to go. If not, you might consider amending it to allow for easy disposition of "minor" Non-Cons (this is how we do it). Or, as Biju-Joseph suggested, just start keeping a log. It can give you the same information without the need for formality unless you find it justified.
 
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