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Internal Audit Nonconformances - Your opinion?

LesPiles

Involved In Discussions
#1
Hello!


We?re conducting an internal audit and I have 2 cases.

1) A "guide" exists for assembling a serie of products. This guide has not be maintained. Replaced by pictures but has no approvals, no id, not being archived, etc.


2) A welder machine was replaced but the procedure describing how to use the equipment has not been written and the document for the old one no longer applies.


These are "non-conformities" but yet the business has been able to ride without.


Would you advocate the issuance of two CARs?


Thank you in advance!


LesPiles
 

John Broomfield

Staff member
Super Moderator
#3
Hello!


We?re conducting an internal audit and I have 2 cases.

1) A "guide" exists for assembling a serie of products. This guide has not be maintained. Replaced by pictures but has no approvals, no id, not being archived, etc.


2) A welder machine was replaced but the procedure describing how to use the equipment has not been written and the document for the old one no longer applies.


These are "non-conformities" but yet the business has been able to ride without.


Would you advocate the issuance of two CARs?


Thank you in advance!


LesPiles
LesPiles,

Are you saying the process and its undocumented procedure remain effective even though someone has yet to update the documented procedure?

...in both cases?

Since bringing these nonconformities to the attention of management have they corrected them?

Did they also correct the reason for the documented procedure(s) not being kept up to date?

Investing the removal of the root causes to stop recurrence may not be required but this rather depends on whether nonconformities of this nature are chronic.

John
 
#4
Hello!


We’re conducting an internal audit and I have 2 cases.

1) A "guide" exists for assembling a serie of products. This guide has not be maintained. Replaced by pictures but has no approvals, no id, not being archived, etc.


2) A welder machine was replaced but the procedure describing how to use the equipment has not been written and the document for the old one no longer applies.


These are "non-conformities" but yet the business has been able to ride without.


Would you advocate the issuance of two CARs?


Thank you in advance!


LesPiles
If I was using a standard like ISO 9001:2008:

1. If the guide is defined in the process as being the instructions to be used to assemble the product, then I would argue that production is not being carried out under controlled conditions. Control of documents would also need to be investigated, due to the lack of approval or identification.

2. A procedure for using the new welding equipment would only be required if the organization requires it (it's not a requirement of the standard). Competency of personnel (in this case, welders) would indicate that if a person is approved by the organization to weld, they would have the skill necessary to read the manual if they had any concerns with operating the gear (in order to produce compliant product).

Both of these situations are dependent on the organization - does it require these items? If it does, it makes no difference what the standard says.
 
#5
Hello!


We?re conducting an internal audit and I have 2 cases.

1) A "guide" exists for assembling a serie of products. This guide has not be maintained. Replaced by pictures but has no approvals, no id, not being archived, etc.


2) A welder machine was replaced but the procedure describing how to use the equipment has not been written and the document for the old one no longer applies.


These are "non-conformities" but yet the business has been able to ride without.


Would you advocate the issuance of two CARs?


Thank you in advance!


LesPiles
In the first case - do the people need the guide? It sounds as if not. So, would a simple correction be to remove it? You might ask yourself why this even exists if people are aware of the need for formal "controlled" documents? What are your management and supervision thinking,? Did they know about it?

In the second case - almost the same thing. As welders, controls are pretty much the same, so a "procedure" isn't going to bring much value. It's a bit like a car handbook - you drive, but you don't need the handbook, really - and all cars basic controls are somewhat in the same place. Does it affect driving? No....

BTW - doesn't matter "what standard?" There's nothing much in there to help you!

I'd check at another audit to see how "aware" management and supervision are about the availability of these types of documents and the need for control...
 
#6
From the guide:

The auditor should requests information on the auditee's operating processes and subsequently ask questions, record answers and observe staff at all levels (including administrative personnel, process owners and operators), to confirm that the actual working status conforms to the descriptions given.

Thereafter, the necessity for any documentation should be evaluated in the light of the observed need for consistency, and the role that any documentation could play in avoiding any significant, identified risks.
So, if the processes are consistently achieving their objectives without the documentation, probably the documentation is not needed.

If that?s the case for the OP, there would be no NCs in principle.
 
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kgott

Quite Involved in Discussions
#7
Hello!


We’re conducting an internal audit and I have 2 cases.

1) A "guide" exists for assembling a serie of products. This guide has not be maintained. Replaced by pictures but has no approvals, no id, not being archived, etc.


2) A welder machine was replaced but the procedure describing how to use the equipment has not been written and the document for the old one no longer applies.


These are "non-conformities" but yet the business has been able to ride without.


Would you advocate the issuance of two CARs?


Thank you in advance!


LesPiles

If it was me, I would not care whether or not we are certified or not certified to a standard, I would write some opportunities for improvement on this because there are opportunities to strengthen the processes and documentation used for delivering products and or services.

For me ISO 9001 requirements do not come into it.
 
Last edited by a moderator:
#8
If it was me, I would not care whether or not we are certified or not certified to a standard, I would write some opportunities for improvement on this because there are opportunities to strengthen the processes and documentation used for delivering products and or services.

For me ISO 9001 requirements do not come into it.
What's necessary to improve here? You're falling into the trap that lots of auditors do by assuming something needs improvement. I don't see anything other than a couple of documents need throwing in the trash. Hardly "improvement"...
 
#9
The similarity does smell a little bit...If I came across this in an audit, I'd check into the doc control and the change management process. If that does not reveal a systematic root cause then this is rather an individual mistake thing that does not need more than simple correction...
 
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