Who can Identify and Initiate a Request for a Non-Conformance Report?

i have developed CA/PA procedure and control of non conforming procedure for my company. According to what I have understood and documented, non conformance can be identified by customers , management reviews , internal / external audits, internal employees etc and that person will be filling the NCR form. Department Head will validate and verify if nonconformance exists or not. If non conformance is not verified it is rejected else a CAR is raised. But my internal auditor does not agree and says that an observation can be identified by internal employees, customers etc but non conformance is to be raised only by an auditor (or someone with equivalent qualification / observation). Please help and explain!
I am also confused about nonconformance regarding supplier. What if supplier gives something that is not according to the requirements. Do we have to raise a NCR in our system or we just reject it in inspection.
Thanks in advance!

Re: Raising Non Conformance

MaryJames - you are correct. A non-conformance should raised whenever there is a 'non-fulfillment of a requirement'. When a supplier doesn't send you what you need, it should be recorded as a non-conformance, not 'rejected', as you describe. A 'reject' is a disposition, a non-conformance is a record of what was discovered - the reason, not what you do about it.

Your internal auditor is only partially correct.

Re: Raising Non Conformance

IMO your auditor is mistaken. He or she may believe that the official NC process should only respond to nonconformances with the standard found through official means like regular internal appraisals.

However, there are many "shall" requirements that can, and should be addressed when they are noticed to not be met, especially customer complaints.

Let's consider "ISO 9001:2002, 8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints)"

Since audits may not come around for a year or more, and since they are unlikely to be detailed enough to find all potential and actual nonconformances, a functional system should empower process owners to initiate NCs on their own.

Also, the organization is charged to develop a set of procedures for critical processes, follow them and update them as needed. If people notice internally that these procedures are not being followed and risk of product/service nonconformance is a result, arguably an internal NC should be initiated. I would surely hope they do not wait around for the auditor to find that.

Re: Raising Non Conformance

AndyN said:

MaryJames - you are correct. A non-conformance should raised whenever there is a 'non-fulfillment of a requirement'. When a supplier doesn't send you what you need, it should be recorded as a non-conformance, not 'rejected', as you describe. A 'reject' is a disposition, a non-conformance is a record of what was discovered - the reason, not what you do about it.

Your internal auditor is only partially correct.

Click to expand...

Just to expand a little on Andy's post: It really depends on how the CAPA/Nonconforming program has been defined.

He is also right when "Rejection" is a Disposition, and a "NCR" is the document that is used to define the discovery, in my opinion.

Re: Raising Non Conformance

MaryJames said:

i have developed CA/PA procedure and control of non conforming procedure for my company. According to what I have understood and documented, non conformance can be identified by customers , management reviews , internal / external audits, internal employees etc and that person will be filling the NCR form. Department Head will validate and verify if nonconformance exists or not. If non conformance is not verified it is rejected else a CAR is raised. But my internal auditor does not agree and says that an observation can be identified by internal employees, customers etc but non conformance is to be raised only by an auditor (or someone with equivalent qualification / observation). Please help and explain!
I am also confused about nonconformance regarding supplier. What if supplier gives something that is not according to the requirements. Do we have to raise a NCR in our system or we just reject it in inspection.
Thanks in advance!

Click to expand...

Dear Mary,

The flow of initiation of CAPA can be as follows:

1. The auditee collects a copy of the IA / EA report from the auditor.
2. This report is shared among the employees of the same department on which the audit was conducted and reports were generated.
3. A detailed root cause analysis is carried out against each of the NC's and Observations raised.
4.CAR / PAR is prepared based on the Root Cause analysis mentioning about the tentative dadeline of closure and the person(s) responsible by designation.
5.Submit the CAR / PAR to the auditor / Audit Team.
6.implement the plan into action.
7.Monitor the action
8.Invite the auditor / Audit Team for follow up audit.
9.Close the NC / Obs related issues.

Hope this solves the riddle to certain extent.


For the next part of ur posting, if the supplier supplies some error prone product to you if it is not as per you PO requirements, you can summarily reject that, or follow a specific sampling plan for acceptance. If you reject then GRN (Goods rejection note) has to be issued and the GRN becomes a purchase / stores document (Element no 7.4.2).

However, if this problem is recurring in nature, supplier evaluation can be carried out and proper corrective action can be initiated by QA if no action is taken by the puchase department despite repeated faliure by the supplier.


Cheers

Arindam

Re: Raising Non Conformance

A statement within 8.3

"The controls and related responsibilities and authorities for dealing with nonconforming products shall be defined in a documented procedure."

Allows your QMS to define who raises and reviews a NCR, however I’m personally unsure if the first assessment is the Departmental Head who validates and verify if non-conformance exists or not.

Is the occurrence recorded on instigation or after the Department Head confirms a problem exists?

I have made it clear within our company that anyone can raise a NCR, this is then documented and forwarded to QA for logging and progressing the corrective actions, some NCR have been raised, that following review / reviews have not failed to met current processes / customer requirements / quality standards etc .......

When this happens a reply is always communicated back to the instigator explaining the situation, however the NCR once logged remains in the system, possibility identifying training / addition communication needs etc.

A supplier delivery that fails at Goods Inward is processed as a "rejection" and reviewed within supplier appraisal, if the failed delivery or part delivery is found within the build process a NCR is raised and reviewed with both the supplier and internally (how did the part progress!) - this NCR remains live until evidence of the suppliers CAR is forwarded to our company.

Re: Raising Non Conformance

AndyN said:

MaryJames - you are correct. A non-conformance should raised whenever there is a 'non-fulfillment of a requirement'. When a supplier doesn't send you what you need, it should be recorded as a non-conformance, not 'rejected', as you describe. A 'reject' is a disposition, a non-conformance is a record of what was discovered - the reason, not what you do about it.

Your internal auditor is only partially correct.

Click to expand...

An excellent answer, but what we call things that go wrong is a matter of choice. I would also say that "reject" is a status rather than a disposition; disposition happens after a reject occurs. But I certainly agree about the record.

Re: Raising Non Conformance

Jim Wynne said:

An excellent answer, but what we call things that go wrong is a matter of choice. I would also say that "reject" is a status rather than a disposition; disposition happens after a reject occurs. But I certainly agree about the record.

Click to expand...

How very correct Jim!The most apposite and precise description.

Umang

it seems confusing.. we have an internal auditing teams who carry out auditing through the year.. they are responsible for raising NCR..

Dubai_capi said:

it seems confusing.. we have an internal auditing teams who carry out auditing through the year.. they are responsible for raising NCR..

Click to expand...

Hi

I would refer to my early post (6), correctly your auditing process team will identify issues arising against the documented “way of working”, however I strongly believe all employees can report NCR’s within the company, the old saying “every pair or hands comes with a free brain”, these extra surveillances can bring a sense of ownership for all, also adding value to your company.