NCR & CAR - How to use & where to raise

Rajeeva

Quality Manager, CMQ/OE, CQA
Hi,

I would like to initiate a discussion on the usage of Non-conformance report forms and Corrective Action Request forms at appropriate forums. I am not sure whether this thread already exists. Inviting all to contribute

Rajeev
 

Sambasi

Involved - Posts
A "NC" can occur at any stage:right from suppliers, through process stages and from customers, besides audits.The observer of "NC" raises a NCR and asks for a "CAR" to the originator of the NC.The corrective action initiated can be a part of NCR/CAR.

A generic format applicable to all processes can be designed.

I am attaching a general format which is used for NCR/CAR containing corrective action initiated.
 

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Rajeeva

Quality Manager, CMQ/OE, CQA
Sambasi said:
A "NC" can occur at any stage:right from suppliers, through process stages and from customers, besides audits.The observer of "NC" raises a NCR and asks for a "CAR" to the originator of the NC.The corrective action initiated can be a part of NCR/CAR.

A generic format applicable to all processes can be designed.

I am attaching a general format which is used for NCR/CAR containing corrective action initiated.

I agree that anything which is not in compliance to the documented (internal or ISO 9001 or product specification) requirements is a non-conformance.

But the standard requires the non-conforming product should not be delivered to the Customer. So, raising non-conformance report must be restricted to materials or manufacturing processes. Where as the Corrective Action Request should be raised during the internal audits when there is a non-conformance in the system.

Any more light on this???


Rajeev
 

Helmut Jilling

Auditor / Consultant
Rajeeva said:
Hi,

I would like to initiate a discussion on the usage of Non-conformance report forms and Corrective Action Request forms at appropriate forums. I am not sure whether this thread already exists. Inviting all to contribute

Rajeev


Hello Rajeev,

A corrective action is a problem solving tool:
1. Failure Statement - Define and describe what is known about the problem,
2. Containment - Determine if any immediate action is needed to stop the bleeding,
3. Investigate and determine the Root Causes(s),
4. Determine what action(s) are needed to eliminate the Root Cause, and ensure the failure does not reoccur,
5. Verify the effectiveness in eliminating the Root Cause, and ensuring the failure does not reoccur.

IN TS, you must also evaluate whether this action should be applied to other similar processes.

This Corrective Action can be applied to any type of failure which you want to apply effective problem solving - Customer, Supplier, Internal Audit, External Audit, System failure.


A Nonconformance Report is generally used to identify an instance of nonconforming product. It usually identifies the failure, who and where identified, containment actions taken, disposition (what are we going to do with it), and rework instructions, if applicable.

It may or may not include the corrective action steps of root cause and actions, as described above.
 

Rajeeva

Quality Manager, CMQ/OE, CQA
hjilling said:
Hello Rajeev,

A corrective action is a problem solving tool:
1. Failure Statement - Define and describe what is known about the problem,
2. Containment - Determine if any immediate action is needed to stop the bleeding,
3. Investigate and determine the Root Causes(s),
4. Determine what action(s) are needed to eliminate the Root Cause, and ensure the failure does not reoccur,
5. Verify the effectiveness in eliminating the Root Cause, and ensuring the failure does not reoccur.

IN TS, you must also evaluate whether this action should be applied to other similar processes.

This Corrective Action can be applied to any type of failure which you want to apply effective problem solving - Customer, Supplier, Internal Audit, External Audit, System failure.


A Nonconformance Report is generally used to identify an instance of nonconforming product. It usually identifies the failure, who and where identified, containment actions taken, disposition (what are we going to do with it), and rework instructions, if applicable.

It may or may not include the corrective action steps of root cause and actions, as described above.

Hi,

Thanks for the detailed comments. Correct me if my interpretation is wrong; are you saying that in simple words, the non-conformance report will be raised for the non-conforming manufacturing process/ product/ material where as Corrective Action Request will be raised when the system non-conformances are identified?

Rajeev
 

Sambasi

Involved - Posts
But the standard requires the non-conforming product should not be delivered to the Customer. So, raising non-conformance report must be restricted to materials or manufacturing processes. Where as the Corrective Action Request should be raised during the internal audits when there is a non-conformance in the system.

Customer complaint (arising out of standard product supplied) is also a NC. In this case, the dept. which receives the complaint (sales or marketing) can raise a NCR/CAR to manufacturing
 
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RoxaneB

Change Agent and Data Storyteller
Super Moderator
Personally, my organization takes a much more simple approach to this...one system, no matter the failure. Any failure be it a customer complaint, product discrepancy, process abnormality, audit finding...whatever...is a nonconformance. The process to resolve it (i.e., corrective action) is the same no matter the failure.

Why have two forms if the essence of the methodology to resolve it is the same?

One company...one methodology...one tool...one language...one culture.
 

Rajeeva

Quality Manager, CMQ/OE, CQA
RCBeyette said:
Personally, my organization takes a much more simple approach to this...one system, no matter the failure. Any failure be it a customer complaint, product discrepancy, process abnormality, audit finding...whatever...is a nonconformance. The process to resolve it (i.e., corrective action) is the same no matter the failure.

Why have two forms if the essence of the methodology to resolve it is the same?

One company...one methodology...one tool...one language...one culture.

Hi,

Nice to see your comments!

I think it is necessary to have two different forms because the objectives are different. In the first one, the objective is to prevent the shipping/ handing over of non-conforming product to the Customer. Accordingly, the resolution may be repair to full conformance, reject or accept as is. So, when the resolution is accept as is or repair not meeting the full conformance, you require customer's permission.

In the second case (using CAR form), your intention is to ensure system compliance. In some cases, you can not take any remidial action as the activity might have completed long time back. So, at that time you can accept as is (because the system non-compliance might have not affected the product) and concerntrate on corrective action.

Regards,

Rajeev
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
Rajeeva said:
I think it is necessary to have two different forms because the objectives are different. In the first one, the objective is to prevent the shipping/ handing over of non-conforming product to the Customer. Accordingly, the resolution may be repair to full conformance, reject or accept as is. So, when the resolution is accept as is or repair not meeting the full conformance, you require customer's permission.

In the second case (using CAR form), your intention is to ensure system compliance. In some cases, you can not take any remidial action as the activity might have completed long time back. So, at that time you can accept as is (because the system non-compliance might have not affected the product) and concerntrate on corrective action.

The objective in both cases is to address an abnormal situation/occurence. Why does it matter if it system-based, process-based or product-based?

To fix something which is product-based, can take a long time to address. My own company will fixed the immediate problem, but our verification plan is dependent upon the schedule for when we will next make the product and this could be 6, 8 or even 12 months down the road. The issue remains open until the verification plan is executed and we are satisfied that the root cause has been addressed appropriately.

I don't understand why the timeline prevents you from taking any form of action. If it happened in the past, you acknowledge it and fix the system to reduce the liklihood of the situation occurring again. The action plan may have steps which can be done immediately or have steps which will take a long time to implement.

If having 2 forms works for your organization, Rajeeva, that's great. It will not work for mine. We like to get our operators involved. They want things as simple and straightforward as possible. One form accomplishes this. They check off the appropriate boxes, complete the suitable fields and at a glance I can tell if the issue is product, process, or system related...what the root cause...and what's being done (and by whom and by when). Simple and effective...for my organization.
 

Helmut Jilling

Auditor / Consultant
Rajeeva said:
...
are you saying that in simple words, the non-conformance report will be raised for the non-conforming manufacturing process/ product/ material where as Corrective Action Request will be raised when the system non-conformances are identified?

non-conformance report will be raised for the non-conforming manufacturing process/ product/ material

This part is correct. Mostly product and material. Sometimes process. But, the non-conformance report is basically to identify a failure, and document the record of what was done to rework it.

Corrective Action Request will be raised when the system non-conformances are identified

Corrective Action Request can be raised for any failure of any type when you want to do formal problem solving, because it identifies and eliminates root causes. It is a higher level tool than a non-conformance report. Some people add corrective action questions to the non-conformance report. Then it is higher level too.
 
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