Do nonconformances always result in corrective action

Big Jim

Super Moderator
#21
I'm with Jane on this one. If you tried to applie full blown correctivie action on every minute nonconformance you would get nothing else done. Forget about making money so you can survive.

To add to the discussion, from ISO 9000:2005, Quality management systems -- Fundimentals and vocabulary:

3.6.5
corrective action
action taken to eliminate the cause of a detected nonconformity or other undesirable situation

NOTE 1 There can be more than one cause for a nonconformity.

NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.

NOTE 3 There is a distinction between correction and corrective action.

3.6.6
correction
action taken to eliminate a detected nonconformity

NOTE 1 A correction can be made in conjunction with a corrective action.

NOTE 2 A correction can be, for example, rework or regrade.

I should add that the audit nonconformance form used by some certification bodies requires the auditor to describe the nonconformance including objective evidence and a citation of the applicable element of the standard. The form then requires the auditee to respond with 1) correction, 2) root cause, and 3) corrective action. The corrective action is to speak to the root cause.

Many companies procedures provide for an appropriate authority to determine if a discrepant material report (DMR) (or whatever term your company uses) requires elevation to a corrective action report (CAR).

I guess that this whole thing turns on how you read element 8.5.2. "The organization shall take action to eliminate the cause of nonconformities . . . " Perhaps if you read that as ALL nonconformities you will have a different opinion than me.
 
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J

joshua_sx1

#22
…I do agree with most posters here… for me, nonconformance requires either correction or corrective action itself, to eliminate the cause of a detected nonconformity or other undesirable situation - if it is really a nonconformance

:2cents:
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#23
OK - let's step back. Big Jim is correct to bring up the following:

there is a difference between a nonconformance to the QMS and a product that has is nonconforming to specifications. both are being discussed here without clear distinction.

there is a difference between a simple ISO9000 QMS and all the others up to and including the FDA. the requirements are not the same...

and the old bugaboo of definitions comes into play with differering meanings of the word "correct".

let's be clear about which QMS system and which type of nonconformity and which definition of the word correction we are discussing.
 
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Big Jim

Super Moderator
#24
OK - let's step back. Big Jim is correct to bring up the following:

there is a difference bewteen a noncormance to the QMS and a product that has is nonconforming to specifications. both are being discussed here without clear distinction.

there is a difference between a simple ISO9000 QMS and all the others up to and including the FDA. the requriements are not the same...

and the old bugaboo of definitions comes into play with differering meanings of the word "correction".

let's be clear about which QMS system and which type of nonconformity and which definition of the word correction we are discussing.
Could you expand on that? I picture a product nonconformance as a QMS nonconformance, especially in the light of element 8.3, control of nonconforming product.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#25
Could you expand on that? I picture a product nonconformance as a QMS nonconformance, especially in the light of element 8.3, control of nonconforming product.
This section of ISO9000 only addresses what to do with the product that is found to be nonconforming to specifications (i.e. defective); it does not in any way deal with actions related to the cause of the nonconforming or defective product.

The mere fact that defective product exists is not a nonconformance to the QMS; in fact the existance of 8.3 is a testament to the fact that some amount of nonconforming or defective product is to be expected. Section 8.3 addreses what to do with it when it occurs.
Failure to control defective product would be a nonconformance to the QMS (e.g. not identifying NC product as NC, knowingly shipping to a customer without the customers' agreement - or concession, etc.

There is no QMS that I am aware of that states that a defective product is a nonconformance to the QMS itself. The design and development section only requires that product be capable of meeting requirements - there is no statement about how capable it must be and certainly it never says that the product must be capable of meetign requirements 100% of the time. Section 8.2.4 does require testign to verify product conformance to requriements but does not say that all product must meet the requirements; in fact, this section is directly followed by 8.3 which addresses what to do with product that doesn't meet requirements.
There is no QMS that I am aware of that requires corrective action as to cause for every instance of a defective product or defect type. This would surely cripple an organization.

The phrase "Corrective action" as applied to internal audit findings (nonconformances to the QMS) or certain types of defective product as addressed by section 8.5 in ISO9000 is meant to be corrective action as to cause in order to prevent reocurrence....section 8.3 does not address this at all.
 

howste

Thaumaturge
Super Moderator
#26
The way I read it, ISO 13485 gives us the flexibility to determine when we will take corrective action. Clause 8.5.2c says we must be:
...evaluating the need for action to ensure that nonconformities do not recur...
I'm a big proponent of using the corrective action process effectively when it's needed. Prioritize how you'll use your limited resources. I think the type of nonconformity and the effects of the nonconformity will help us to decide if taking corrective action is appropriate. If it's a significant customer contract requirement or regulation that's being violated, yes. If it's a safety issue, definitely.

However, if we impose a non-value-added requirement on ourselves, then find a nonconformity against it, it would be better to eliminate the requirement (correction) instead of wasting time evaluating root cause of why the requirement wasn't met. Also, a $10,000 solution to a $10 a year problem would be rediculous. Use common sense! (Even though sometimes it's not so common...)
 
B

Bob Bonville

#27
Howste, you have wisdom beyond your years. I couldn't agree with you more.

Right ON!

Bob
 

Big Jim

Super Moderator
#28
This section of ISO9000 only addresses what to do with the product that is found to be nonconforming to specifications (i.e. defective); it does not in any way deal with actions related to the cause of the nonconforming or defective product.

The mere fact that defective product exists is not a nonconformance to the QMS; in fact the existance of 8.3 is a testament to the fact that some amount of nonconforming or defective product is to be expected. Section 8.3 addreses what to do with it when it occurs.
Failure to control defective product would be a nonconformance to the QMS (e.g. not identifying NC product as NC, knowingly shipping to a customer without the customers' agreement - or concession, etc.

There is no QMS that I am aware of that states that a defective product is a nonconformance to the QMS itself. The design and development section only requires that product be capable of meeting requirements - there is no statement about how capable it must be and certainly it never says that the product must be capable of meetign requirements 100% of the time. Section 8.2.4 does require testign to verify product conformance to requriements but does not say that all product must meet the requirements; in fact, this section is directly followed by 8.3 which addresses what to do with product that doesn't meet requirements.
There is no QMS that I am aware of that requires corrective action as to cause for every instance of a defective product or defect type. This would surely cripple an organization.

The phrase "Corrective action" as applied to internal audit findings (nonconformances to the QMS) or certain types of defective product as addressed by section 8.5 in ISO9000 is meant to be corrective action as to cause in order to prevent reocurrence....section 8.3 does not address this at all.
Thank you for helping me to better understand 8.3.

In light of 8.5.2 I still don't see how product nonconformance is not a QMS nonconformance. I think you comment about 8.3 being a testiment that junk happens when dealing with product is correct, but I think a similar argument can be made about QMS nonconformances as well in that the entire standard helps provide remedy when QMS nonconformances are found.

So perhaps we are still centered on how you read the opening of 8.5.2. "The orgainzation shall take action to eliminate the cause of nonconformities in order to prevent recurrence." If you read that as ALL nonconformities then it would be very difficult to live with.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#29
Thank you for helping me to better understand 8.3.

In light of 8.5.2 I still don't see how product nonconformance is not a QMS nonconformance. I think you comment about 8.3 being a testiment that junk happens when dealing with product is correct, but I think a similar argument can be made about QMS nonconformances as well in that the entire standard helps provide remedy when QMS nonconformances are found.

So perhaps we are still centered on how you read the opening of 8.5.2. "The orgainzation shall take action to eliminate the cause of nonconformities in order to prevent recurrence." If you read that as ALL nonconformities then it would be very difficult to live with.
I think you're over thinking this. defective product in and of itself has never been interpreted to be a nonconformance to the QMS. a corrective action as to cause to prevetn reocurrence for every defect would be completely onerous and absurd. the entire purpose of 8.3 is to deal with the inevitability that defective product will be made. 8.5.2 does not say ALL. in fact the second sentence says "Corrective actions shall be appropriate to the effects of the nonconformities encountered", meaning that sometimes corrective action is simply rework or throw away and move on...teh nonconformities in this case refer to both QMS and product requirements. you must read the standard as a whole and not as stand alone bits and pieces.
 

RoxaneB

Super Moderator
Super Moderator
#30
A nonconformance with the product or the process or the QMS is irrelevant. A failure is a failure...end of story. Which path we follow in the treatment or the resolution of the failure is key to ensure that we add value to our Stakeholders (of which the Customer is one).

There are times when Corrective Action is required...a full blown root cause analysis, an action plan, a verification plan, etc.

There are times when (working for a steel mill) I say it's a 'quick wham-bam-let's-get-back-to-making-steel' approach. This means we implement a correction and get back to making our product.

The question becomes, however, when is Corrective Action required and when is a Correction appropriate?

The answer is..."What ever works for your organization." Data analysis will tell you where your largest problems are occurring. I'd adopt Correction Action for the top 20% of the problems and Corrections for the remaining 80.

To ensure consistency, develop, document and implement Nonconformance Triggers. This is a matrix that shows for each process/department within your organization when a failure requires a Correction or Corrective Action.

For example, in your manufacturing process, you may deem that less that 5 pieces scrapped on one order will result in a Correction but >= 5 will prompt Corrective Action. In your Customer Complaint process, you may state that any complaint < x $ is a Correction but anything higher will be a Corrective Action.

Each process owner(s)/department should define their own set of triggers, but it is great to consolidate this information. By structuring the processes/departments in a sequential flow that mimics the creation of your product or service, this Matrix helps to show how a failure in one process can adversely impact their internal Customer (i.e., the next process/department in line).

The good part about this approach is that if you focus and properly apply your problem solving skills and resources on those top issues, your organization will get them under control and they will cease to be problems. As part of a regular data analysis program (e.g., annual review of trends, indicators, etc.), a new "top 20" list may arise and you can revise your triggers for the following cycle.
 
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