Audit Findings - The Process/Clause Matrix does not identify all the processes

[qusys]

Agree with AndyN.
Pls, provide the verbiage of the non conformities.
As to Quality mgmt as a process, it is not a requirement.
Clause 4.1 is very clear : it is up the organization to identify processes for their QMS and show their interactions

 

[JaneB]

having the Process Approach Matrix not completed to his satisfaction was on the list of Stage 2 non conformances that we have to raise a corrective action for....

it was only that we didn't have Quality Management as a key process, which of course it is. We agreed to include this on the chart for the sake of progress....

Other items, (again this would appear to be opinion driven) were relating to lack of specifics noted in our Safety Statement.

Also with regards to vendor Approval, not specifying exactly we had approved a vendor to sell us was a non conformance. We must apparently identify other products that they sell, which we may/would not approve for purchases (from the same supplier).

All in all, an amount of small NC's we feel, but nevertheless, perhaps this was justification for his days pay claimed. We dont want to be setting precedence though for follow on audits with regards to some thing that we could argue as being not requirements....

Comments please. Do you think that this Auditor is OTT, or that perhaps this approach would enhance us as being more disciplined.

As others have said, without having more information - including the actual wording of the NCs raised and against which clause/s, it's scarcely possible to comment.

I would add, however, that if this is how it started, it's extremely unlikely to get better from here.

You should feel, after an audit:

1. The auditor was firm, but fair
2. The auditor did not audit according to opinion, but against the Standard
3. The auditor made a genuine attempt to consider any evidence offered of compliance, even if it wasn't what he 'usually sees' or is accustomed to
4. You should be clear about what each NC is, why it was raised and what the evidence or lack of it was that caused it to be raised

Are you?

As for 'not having QM as a key process'... words fail me. That's what the whole system is for!

 

[XIO549]

Qusys, JaneB, AndyN,

I totally accept how its hard to comment when you don't have the initial NC wording. I have given 2 NC's below for your comment.

We have since had Stage 2 audit and have subsequently been recommended by the auditor for certification by the CB. I think we managed this by demonstrating that we can jump through the suggested hoops for the auditor.
These NC's are from the Stage 2 audit.

1. Clause 4.1/8.2.3.
"QMS/Management has not been identified as a process, and need to identify inputs, outputs, measurements and targets."
I know you guys reckon I should tell this Auditor that we're not happy with the Process/Clause Matrix chart given to us, (to include as part of our documentation - and we're not), but we decided to roll with the punches on this and get certification for the sake of it, and then revise shortly after (with advice) to a sys that does not rely on this chart. ?

2. Clause 5.6 The Process Metrics were not produced or discussed at the Management Review held."
At this stage we had little or no records of how each process in the firm performs, so without this record, it was hard to proceed with a Management Review (which is required before an audit I think) so we generated a performance chart for each process, that was rated/scored by our factory supervisor - this was the process metrics - (open to interpretation I know, but it was an agreed discussion document for this part of the Management review nonetheless. This chart was provided at Stage 1 Audit. The NC note was the same then.
Since then, we have purchased and installed a project tracking software which records the time taken for each process, and now we have measurable records to discuss at the next MR. However, we haven't had a MR since Stage 1 audit, so this NC not of 'No Process Metrics produced' stands for this Stage 2 audit.

Perhaps you can comment on the above and we may progress through other items that I think are opinion driven after?

Thanks for the view points guys.

Xio

 

[JaneB]

... we decided to roll with the punches on this and get certification for the sake of it, and then revise shortly after (with advice) to a sys that does not rely on this chart.

That sounds like a pragmatic approach and one that I'd go with too.

I still find that first NC you've listed a very strange one for all kinds of reasons (not least the clauses referenced) and have about 20 more questions, but then I'm not there....

2. Clause 5.6 The Process Metrics were not produced or discussed at the Management Review held."
At this stage we had little or no records of how each process in the firm performs, so without this record, it was hard to proceed with a Management Review (which is required before an audit I think)

If you only did a single MR (which this seems to indicate) then I strongly suggest you do some more research and thinking to learn better what management review is and requires, because this answer appears to indicate some lack of understanding on it. (There's a whole heap of threads in the Cove on it - searches should throw up plenty).

You must definitely have a functioning system which includes the function of management review. Saying 'oh well, our system was too new so we didn't really havwe the reocrds, so we didn't consider how our processes were doing ' a/isn't meeting the requirements, presumably 5.6b and b/indicates that lack of understanding I've already mentioned.

I'm confused as to why would you not have any management review after the Stage 1 audit? Apart from anything else, it would have beenadvisable to look at the results and figure out if you needed to do anything before the Stage 2.

But bottom line: yes, get certified first, then sort it out - and argue it out if need be - later. It's not ideal (you should NOT have to implement some document in a particular format etc. just because your auditor wants it!!) but it's pragmatic

 

[XIO549]

Yes Jane,

Management Review was successful and a clear set of inputs and outputs were prescribed and achieved.

However the point made was that whilst a Management Review was required to be carried out before Stage 1 Audit, one of the inputs was process analysis and as such, this being a new system; there were no process records to analyse. Top Management has a good understanding of the QMS requirements, but had to conceed that no actual measurements were present before the MR, so had to agree that for that time, a subjective process metric was discussed.

Since then, we have accurate process metrics to discuss at the next MR. This was demonstrated to the auditor. However the NC was still raised as we had not had a Management Review in between the audits.

I certainly take your point that we could have had one in between, but hind sight is a powerful tool we didnt have the luxury of back then.

Another Non Conformance raised, that we thought was opinionated, was as follows:

Clause 8.2.4 Vendor Assessment.
"Vendor Assessment Record showing late deliveries, does not show the actual date that the late delivery was actually required for."

The record from in place records Name of purchaser, name of supplier, and has a Good/Fair/Poor rating tick box for the vendor under the headings of Quality and On Time Delivery, with a signature box for reporting personnel.
The Auditor raised this NC saying that the record does not show an actual due date. - Is this in the standard? or an auditors opinion of what should be in the standard perhaps?

We have the procedures in place and they work.

This appears (whilst we don't disagree with it) to be splitting hairs in terms of deciding on our compliance, and it typical of the type of items raised in NC's.

What do you think about that Jane?

Xio

 

[qusys]

Clause 8.2.4 Vendor Assessment.
"Vendor Assessment Record showing late deliveries, does not show the actual date that the late delivery was actually required for."

The record from in place records Name of purchaser, name of supplier, and has a Good/Fair/Poor rating tick box for the vendor under the headings of Quality and On Time Delivery, with a signature box for reporting personnel.
The Auditor raised this NC saying that the record does not show an actual due date. - Is this in the standard? or an auditors opinion of what should be in the standard perhaps?

We have the procedures in place and they work.

This appears (whilst we don't disagree with it) to be splitting hairs in terms of deciding on our compliance, and it typical of the type of items raised in NC's.

What do you think about that Jane?

Xio

Hi Xio,
what the auditor says it is not a requirement of ISO 9001.
I do not know what kind of evidence he took to raise this non conformity, given that you are saying you are respecting the procedures you set.
I would like to know if you have some issue for your supplier in terms of their delivery and if you have actions on this. This is the classical incident of premium freight.

 

[XIO549]

qusys

Yes, I think you are getting the picture - opinions on what's required V's actual compliance items.

The problem now (since we have gone along with these NC's) is that we have to respond the the NC's with a Chart showing what we thought the Cause was for the NC, the Correction to fix each NC raised and then the Corrective Action for each NC. Certification Issue is pending receipt of this response.

So, now that we've jumped through the hoops, what do we say is the cause of the non conformance? ; when really we think that there is no Non conformance.

We will be stating that we had inadequate procedures or some thing of that nature, which will be conceding to jumping through more hoops.

When it comes to review these 'Corrective Actions' raised - Top Management will be asking questions as to the validity of them, I'm sure.

Xio

 

[qusys]

qusys

Yes, I think you are getting the picture - opinions on what's required V's actual compliance items.

The problem now (since we have gone along with these NC's) is that we have to respond the the NC's with a Chart showing what we thought the Cause was for the NC, the Correction to fix each NC raised and then the Corrective Action for each NC. Certification Issue is pending receipt of this response.

So, now that we've jumped through the hoops, what do we say is the cause of the non conformance? ; when really we think that there is no Non conformance.

We will be stating that we had inadequate procedures or some thing of that nature, which will be conceding to jumping through more hoops.

When it comes to review these 'Corrective Actions' raised - Top Management will be asking questions as to the validity of them, I'm sure.

Xio

Take this as an opportunity to improve and not as a burden.
Whan you write the root cause, I would suggest to mention a process issue not clear or not completely defined as well as records not clearly analized rather than procedures.
Pls, consider my questions of the previous post. Given that I have only the elements that you described, I do not what the auditor sees on his eyes and check vs audit criteria. Hope this helps

 

[XIO549]

qusys

Good suggestion on the Root cause. This is the item that I need to be careful with so as not to give the auditor a stick to beat me with at the next inspection audit.

Yes, another colleague here commented on petty NC's and so to look at it more like OFI rather than NC's. Its just to follow the rule book now and structure the documentation so that it does what its supposed to - create improvement.

Cheers mate.


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Other NC for discussion? -
Client gives us a sample of their paint for trial use on product at trial stage before product is allowed to be shipped.
We keep old tins of this material supplied.
This paint is worthless - kept only in case it may be needed again.
It has a 1 yr shelf life.

When we establish that a sample (which the customer has disregard at this stage) is now past its shelf life, we are advised by the auditor that we must (a) notify the customer of our intention to bin this 'customer property' and
(b) fill out a scrap record for allowing the material to be binned (this happens perhaps 5-6 time per year, maybe).

Does this seem extreme on the auditors part to bring this up as a non-conformance?

Extreme or well founded? You tell me.

We're doing it any way to ensure compliance, but it will be up for review at next Management Review meeting and will no doubt be revised at that stage.

Xio.

 

[qusys]

qusys

Good suggestion on the Root cause. This is the item that I need to be careful with so as not to give the auditor a stick to beat me with at the next inspection audit.

Yes, another colleague here commented on petty NC's and so to look at it more like OFI rather than NC's. Its just to follow the rule book now and structure the documentation so that it does what its supposed to - create improvement.

Cheers mate.


=========================

Other NC for discussion? -
Client gives us a sample of their paint for trial use on product at trial stage before product is allowed to be shipped.
We keep old tins of this material supplied.
This paint is worthless - kept only in case it may be needed again.
It has a 1 yr shelf life.

When we establish that a sample (which the customer has disregard at this stage) is now past its shelf life, we are advised by the auditor that we must (a) notify the customer of our intention to bin this 'customer property' and
(b) fill out a scrap record for allowing the material to be binned (this happens perhaps 5-6 time per year, maybe).

Does this seem extreme on the auditors part to bring this up as a non-conformance?

Extreme or well founded? You tell me.

We're doing it any way to ensure compliance, but it will be up for review at next Management Review meeting and will no doubt be revised at that stage.

Xio.

Appreciated to have been of help for you, thanks!
As to the other NC what was the violeted clause? Was it 7.5.4?
I do not know if the sample of paint can be considered as a customer property, it depends on what you have established with your customer in the contract or in the purchase order. As per my understanding on what you wrote, the sample of the paint is not incorporated in the final producu you supply. Again, based upon the contact with, the sample could be yours.
Did the auditor verify this?
I do not know if you have also established with your customer that you shall use the sample paint with due date not expired. This could be a requirement.
I should have more detail and make other question to see if this is a ncn.
Hope this helps