Minor nonconformance seems more opinion

[BradM]

Shawnann, you stated this as your procedure:

Process Sheets are only created for production jobs, after the purchase order is approved and when the absence of such process sheet would affect the quality of the product or service, or when requested by the customer. Process Sheets, if required, should be created within one month of the production job taking off and Company is sure as to how the parts are to be processed and packed.

There is some subjectivity in there which might lead, IMHO, to an auditor possibly observing a NC. Is it possible the auditor was viewing a particular job that should have had a process sheet? Was there some items left to interpretation that could produce bad product, that should have been documented on a process sheet? Who makes the call about quality being affected?

I think you might want to better define when a sheet is implemented, and when it is not, maybe.

 

[AndyN]

Shawnann, you stated this as your procedure:

There is some subjectivity in there which might lead, IMHO, to an auditor possibly observing a NC. Is it possible the auditor was viewing a particular job that should have had a process sheet? Was there some items left to interpretation that could produce bad product, that should have been documented on a process sheet? Who makes the call about quality being affected?

I think you might want to better define when a sheet is implemented, and when it is not, maybe.

Brad, with respect........you're at risk of doing what the auditor has done. There's a dimension missing here, which we can't grasp - and apparently the auditor didn't either:

What does the 'process owner' and 'processors' say about this creation or not of sheets? Is their story similar? Has there been any systemmic quality problems of folks not getting instructions when they really would have benefitted? Of course, that relies on a robust non-conformance procedure to report (which I'd be inclined to check into)

Now, the risk then becomes if you replace someone in the process....

One thing that does occur to me is that this is a great opportunity to do an internal audit! If the internal auditor has a clue about what this situation is all about, there maybe a big improvement opportunity sitting there - which is, in all reality what the CB auditor should have done......

 

[BradM]

Good morning, Andy.

Brad, with respect........you're at risk of doing what the auditor has done. There's a dimension missing here, which we can't grasp - and apparently the auditor didn't either:

What does the 'process owner' and 'processors' say about this creation or not of sheets? Is their story similar? Has there been any systemmic quality problems of folks not getting instructions when they really would have benefitted? Of course, that relies on a robust non-conformance procedure to report (which I'd be inclined to check into)

Now, the risk then becomes if you replace someone in the process....

One thing that does occur to me is that this is a great opportunity to do an internal audit! If the internal auditor has a clue about what this situation is all about, there maybe a big improvement opportunity sitting there - which is, in all reality what the CB auditor should have done......

I agree wholeheartedly here; no disagreements. I was merely pointing out, though, that the procedure has a generic statement in there about "affecting quality" that may leave some interpretation. Your point is precisely what I am suggesting, in that they may have a good process of determining when a sheet is needed, and when it is not.

The deed is done, and the NC is written. By understanding why the auditor wrote what they did, then (like you're saying) actually find out what is in place, then reasonable dialogue can be opened up with the auditor, and better understanding can be in place between the two.

It's just a personal thing, but aside from the finding, I still might change or modify the one line in the procedure so that it is a little more clear how the organization determines when a sheet is needed or not.

 

[shawnann]

How do you do contract review?

We don't really have contracts with our customers. We may get a purchase order (usually blanket) from our customer but it doesn't say anything other than the part number, what the process is (which is the same for all our customers) and if there is any special handling (masking, packing, etc). We continue the job as long as our customer has the job.

I'm having a hard time understanding where your system is non-conforming. It sounds like an observation; which should be implemented, or dismissed. But I would encourage good communication with the auditor on this, so that there is mutual understanding.

If it should be an observation, than why wasn't it written as one?

Is it possible the auditor was viewing a particular job that should have had a process sheet? Was there some items left to interpretation that could produce bad product, that should have been documented on a process sheet? Who makes the call about quality being affected?

I could argue this until we're all dead, but I'll leave it at...who's to say the auditor knows when quality would be affected? He truly does not know our process therefore he has no knowledge of what is or is not a quality issue. Yes, the job probably should have a process sheet, but is it the auditors call to make that decision or the supplier and/or customer?

The deed is done, and the NC is written. By understanding why the auditor wrote what they did, then (like you're saying) actually find out what is in place, then reasonable dialogue can be opened up with the auditor, and better understanding can be in place between the two.

It's just a personal thing, but aside from the finding, I still might change or modify the one line in the procedure so that it is a little more clear how the organization determines when a sheet is needed or not.

This is exactly why I came here with the "problem". You guys are always helpful whenever I have a questions/concern and that has been the case again Since I write the procedures, I will definitely take another look at modifying it.

 

[Jim Wynne]

We don't really have contracts with our customers. We may get a purchase order (usually blanket) from our customer but it doesn't say anything other than the part number, what the process is (which is the same for all our customers) and if there is any special handling (masking, packing, etc). We continue the job as long as our customer has the job.

The purchase order is a contract. Take a confirming copy of a PO and look at the back of it--you're almost sure to find boilerplate contractual requirements. The way to make sure that customer requirements are (a) communicated and (b) clearly stated is to capture the relevant information in the PO, at least by reference.

 

[BradM]

I could argue this until we're all dead, but I'll leave it at...who's to say the auditor knows when quality would be affected? He truly does not know our process therefore he has no knowledge of what is or is not a quality issue. Yes, the job probably should have a process sheet, but is it the auditors call to make that decision or the supplier and/or customer?

Spot on, Shawnann, and to me, this is the point that Andy eloquently made. The auditor is there to improve your process; not to tell you how to run your business.

If your existing process is working, then that should be sufficient.

 

[AndyN]

Shawnann, you wrote:

...who's to say the auditor knows when quality would be affected? He truly does not know our process therefore he has no knowledge of what is or is not a quality issue. Yes, the job probably should have a process sheet, but is it the auditors call to make that decision or the supplier and/or customer?

You make a great point and this is the key differentiator of a good auditor vs a no so good one.......

An auditor who understands processes - and they are generally picked because they are pretty familiar with what they're auditing - will be able to look at the results and do a 'differential diagnosis' (yes, just like Dr. House) and make a determination of the probable cause. The person clearly didn't do that, so you don't have any useful audit report to work on........Please go back to your CB and let them know. I'd even like to suggest they tell you of their corrective action with the auditor, not that you want them back, of course!

And Jim W's correct, and this type of misunderstanding is why they removed the terminology from the 2000 version!

 

[JaneB]

If it should be an observation, than why wasn't it written as one?

Yes, exactly. Why wasn't it? As you point out, he doesn't know your process - you do. And unless there is any real evidence (not opinions, not belief, not guesswork, not preference) to indicate that there are some problems which could be resolved by providing a process sheet, say, he ought not to be writing this up. And I'd protest and/or consider a change of auditor.

It's your company - not the auditors. And I dislike auditors who think they can't leave without finding something wrong. All the good auditors I have seen at work don't do this. If they find things are all good, they will say so, and leave it at that. This kind of silly 'opinion presented as nonconformity' without any evidence is a waste of everyone's time.

 

[Big Jim]

He wrote it as a nonconformance because he is accustomed to making his own rules, and you should not let him.

It is an easy trap for an auditor to write a nonconformance simply because he finds something to be different from what he expects. He needs to go a step further and confirm that it really is a nonconformance.