ISO 9001 Certification Nonconformance Root Cause Help!

[bookcat]

This whole discussion goes on about the root cause, but lets accept you justed missed it. My question would be, how many non-conforming purchased materials are not handled appropiately?
If this audit finding was raised due to an example of non-conforming purchased materials not handled properly, then the root cause "I just missed it while drafting the procedure" is inadequate. Anyone who identified non-conforming purchased materials should have raised the fact that there was not an applicable procedure available. But why haven't they. If all non-conforming purchased materials were handled appropiately, why raise an audit finding as such an addition to the procedure does not improve quality. As stated before, there might be no necessity to identify all potential sources of nonconforming materials in your procedure.

Just hitting the bolded part. You will have an issue on Control of Non-conforming Product.

 

[Jim Wynne]

Originally Posted by jkuil

As stated before, there might be no necessity to identify all potential sources of nonconforming materials in your procedure.

Just hitting the bolded part. You will have an issue on Control of Non-conforming Product.

What would the issue be? There's no requirement to identify all potential sources of nonconformity. So long as you have a way to deal with nonconforming product, regardless of the source, and you use the method consistently, regardless of the source, there is no issue.

 

[bookcat]

What would the issue be? There's no requirement to identify all potential sources of nonconformity. So long as you have a way to deal with nonconforming product, regardless of the source, and you use the method consistently, regardless of the source, there is no issue.

Please provide example of a way to deal with nonconforming product without anticipating the sources of it. Let see if you cover everything and you would not have an issue.

 

[sunilbhai]

Re: ISO Certification Nonconformance Root Cause Help!

Yes, the truth is that you forgot but underlying that is that there was a 'failure in mapping non conformance from all areas that could arise in the procedure for control of non conforming products'.
Can this be the root cause ... ?
Now please identify as your corrective action if you have any other processes that could potentially get a non conforming product for you to address it in the procedure, purchased products being one among them.

Dear Sir,

Recently we had completed BVQI External Audit and they raised 5nos of Ncr, I closed two ncr but, one of them i have no idea how to close it. The Ncr as under .

NCR 1 : The internal audit plan does not cover the audit plan for MR function. No evidence was found for the internal audit conducted for MR function.

Corrective Action :
Correction


Root Cause/s :

Corrective Actions:


NCR No. 2 The calibration process, infrastructure & training function are found not audited and no evidence of audit reports of these processes was found.

Corrective Action :
Correction


Root Cause/s :

Corrective Actions:





Note : above both function are looking after by me. (Internal audit & calibration ) so , I not cover the MR function & calibration etc function not cover in audit by me. because both work are handle there why i not audited both function & auditor raised the both above ncrs.

Plz help how to close above ncrs.

 

[AndyN]

The auditors reporting of ncr needs to be improved a little - since 'functions' aren't audited, per se. However, they do seem justified and they do raise some points for you to take action on:

How do you audit the processes that you are responsible for, particularly if you do the work? You do have to have your processes audited - calibration would be pretty important - you can't just not audit them because you can't audit yourself! You have to find an alternative auditor - somehow - who isn't responsible for that work and have them audit it. Make sure, they're competent, of course!

 

[qusys]

Re: ISO Certification Nonconformance Root Cause Help!

Dear Sir,

Recently we had completed BVQI External Audit and they raised 5nos of Ncr, I closed two ncr but, one of them i have no idea how to close it. The Ncr as under .

NCR 1 : The internal audit plan does not cover the audit plan for MR function. No evidence was found for the internal audit conducted for MR function.

Corrective Action :
Correction


Root Cause/s :

Corrective Actions:


NCR No. 2 The calibration process, infrastructure & training function are found not audited and no evidence of audit reports of these processes was found.

Corrective Action :
Correction


Root Cause/s :

Corrective Actions:





Note : above both function are looking after by me. (Internal audit & calibration ) so , I not cover the MR function & calibration etc function not cover in audit by me. because both work are handle there why i not audited both function & auditor raised the both above ncrs.

Plz help how to close above ncrs.

To fix the problem you shall individuate the root cause of the problem.
The containement is to put them in the audit plan, while you shall individuate the corrective action after addressing the root cause.
This is the flow.
Some question: What are the reason why you did not audit Management review process ? It is very strange to me.
You can explain well. I have understood that you are the owner of some processes and so you cannot audit them. No problem. You shall appoint another competent auditor to do that, to assure the independency.
Let me know

 

[David Hartman]

Please provide example of a way to deal with nonconforming product without anticipating the sources of it. Let see if you cover everything and you would not have an issue.

As an example: A single procedure that reads "All nonconforming material is identified by whatever means appropriate, segregated (where practicable), and dispositioned as necessary." This blanket statement does include nonconforming materials coming from any source and excludes none. Why would you need any more than this?