Acceptance Criteria - ISO 9001:2008 Clause 8.2.4 - Questionable Audit Finding?

[AshleyE]

Wes,
This is exactly the situation where the auditor raised the nonconformity.

 

[AndyN]

There's an issue here which is being lost - what's the point of doing the check? If it is to give confidence that the item meets spec, it was measured and a value derived, then write it down! If it was gauged, the result is in the calibration records, so we're speaking to variables now.

If there's no purpose in recording it for analysis and action, then there's no point in making the measurement - just go ahead and make the part! However, if the operator needs to know 'where' the part lays in terms of the spec, then record it.

BTW - Wes, the 'tech' of the place doesn't matter if you don't know the capability of the machines to hold a feature. I worked in such a 'hi-tech' shop - it didn't mean we were clever at using data! I'm also very familiar with the terminology and purpose. Doesn't make any difference when it comes to recording data...

 

[Big Jim]

There's an issue here which is being lost - what's the point of doing the check? If it is to give confidence that the item meets spec, it was measured and a value derived, then write it down! If it was gauged, the result is in the calibration records, so we're speaking to variables now.

If there's no purpose in recording it for analysis and action, then there's no point in making the measurement - just go ahead and make the part! However, if the operator needs to know 'where' the part lays in terms of the spec, then record it.

BTW - Wes, the 'tech' of the place doesn't matter if you don't know the capability of the machines to hold a feature. I worked in such a 'hi-tech' shop - it didn't mean we were clever at using data! I'm also very familiar with the terminology and purpose. Doesn't make any difference when it comes to recording data...

Although you have a point here Andy, you, as was the auditor, are going beyond the requirements of the standard.

For that matter, even beyond both standards. What the auditor wrote doesn't fly with AS9100C either.

The aerospace enhancement on this point is 8.2.4c and is as follows "required records of the measurement results (at a minimum, indication of acceptance or rejection)"

A sign off is a record of acceptance, pure and simple.

The only need for recording the actual numerical results is for first article (in aerospace), if a customer requires it, or if you as a shop have determined that you need to do so.

To the OP. The auditor was wrong unless you did not have some criteria present to check to. If you did, you should protest this finding. It has no substance.

 

[AndyN]

Although you have a point here Andy, you, as was the auditor, are going beyond the requirements of the standard.

For that matter, even beyond both standards. What the auditor wrote doesn't fly with AS9100C either.

The aerospace enhancement on this point is 8.2.4c and is as follows "required records of the measurement results (at a minimum, indication of acceptance or rejection)"

A sign off is a record of acceptance, pure and simple.

The only need for recording the actual numerical results is for first article (in aerospace), if a customer requires it, or if you as a shop have determined that you need to do so.

To the OP. The auditor was wrong unless you did not have some criteria present to check to. If you did, you should protest this finding. It has no substance.

So, what happened to one of the 8 principles? Factual approach to decision making? http://www.iso.org/iso/iso_catalogu...ip_standards/quality_management/qmp/qmp-7.htm

 

[Jen Kirley]

My understanding of First Piece is that it's the first in a process following a setup, tool change etc. As such, of course an inspection should take place and it makes sense to record its actual results - that is, if you want to know anything besides good/bad.

Inspection is so often treated like an accept/reject chore that it becomes hard to understand the point of taking down the data. Maybe you don't ever go back to learn something from the data. Maybe the customer doesn't ever ask for it. But the standard is written in such a way to allow for the potential of either or both occurring at some point (maybe we want to more tightly control our processes or eliminate causes when investigating a string of rejects) and our setting up a robust enough system to provide us the information to use as a tool if and when we want it.

It may help to consider the standard was written for industry, in which so many different manufacturing organizations would use it; the principle is to do the robust right thing, not just basing our process controls on what the customer asks for.

 

[Big Jim]

So, what happened to one of the 8 principles? Factual approach to decision making? http://www.iso.org/iso/iso_catalogu...ip_standards/quality_management/qmp/qmp-7.htm

Excellent question. Irrelevant to what is at hand. Simply a red herring.

Now show me where it is in ISO 9001:2008 or AS9100C.

 

[Big Jim]

My understanding of First Piece is that it's the first in a process following a setup, tool change etc. As such, of course an inspection should take place and it makes sense to record its actual results - that is, if you want to know anything besides good/bad.

Inspection is so often treated like an accept/reject chore that it becomes hard to understand the point of taking down the data. Maybe you don't ever go back to learn something from the data. Maybe the customer doesn't ever ask for it. But the standard is written in such a way to allow for the potential of either or both occurring at some point (maybe we want to more tightly control our processes or eliminate causes when investigating a string of rejects) and our setting up a robust enough system to provide us the information to use as a tool if and when we want it.

It may help to consider the standard was written for industry, in which so many different manufacturing organizations would use it; the principle is to do the robust right thing, not just basing our process controls on what the customer asks for.

Please remember that first piece is not a requirement of ISO 9001:2008 or for that matter AS9100C. Don't confuse first piece with first article.

AS9100C does require a first article inspection (7.5.1.1) on a representative sample of the first production run and any time something changes that invalidates the original first article. ISO 9001:2008 does not have that requirement.

Customers can, of course, require first article inspection even if the standard doesn't. They can even require the stricter use of AS9102 which has more requirements for first article than AS9100C.

 

[Jen Kirley]

Please remember that first piece is not a requirement of ISO 9001:2008 or for that matter AS9100C. Don't confuse first piece with first article.

AS9100C does require a first article inspection (7.5.1.1) on a representative sample of the first production run and any time something changes that invalidates the original first article. ISO 9001:2008 does not have that requirement.

Customers can, of course, require first article inspection even if the standard doesn't. They can even require the stricter use of AS9102 which has more requirements for first article than AS9100C.

Yes thank you, that's why I described "first piece" the way I did. No it's not specifically required - but it's being done anyway, perhaps as a good practice or a simple step to avoid making a bunch of scrap after a tool change.

And, since the inspection is being performed and the first piece accepted (as a part of the informal sampling plan) it does qualify to be an inspection, monitoring the process as per 8.2.3, "demonstrating the process's ability to achieve planned results." If that wasn't the intended purpose of the inspection, I'd like to be corrected but if I was auditing I would then ask how 8.2.3 is being done, if not through inspection.

So, since it is an inspection I would expect it to adhere to 8.2.4.

I think the center of our discussion is the defense of doing only what the standard/customer requires, versus the kind of good practices that can actually help us keep tight control of our processes and improve our bottom line. The standard is designed to provide a framework for a management system to do that, not just provide a set of requirements to be met.

 

[AndyN]

Excellent question. Irrelevant to what is at hand. Simply a red herring.

Now show me where it is in ISO 9001:2008 or AS9100C.

So, Jim. As a Certification Body auditor, the fundamental principles on which ISO 9001 is built are a "red herring" and "irrelevant"? You, as an auditor, never let them enter into the thought process of evaluating a QMS for effectiveness?

I wonder, then, if so deemed irrelevant to a question about ISO 9001, why did the folks at TC 176 write the 8 Principles? Do you know more than they do?

 

[Big Jim]

So, Jim. As a Certification Body auditor, the fundamental principles on which ISO 9001 is built are a "red herring" and "irrelevant"? You, as an auditor, never let them enter into the thought process of evaluating a QMS for effectiveness?

I wonder, then, if so deemed irrelevant to a question about ISO 9001, why did the folks at TC 176 write the 8 Principles? Do you know more than they do?

Perhaps you would like to tell us, and while you are at it, explain why they left it out of the standard. I have not found any material on the topic. If you have some, please share it, but open another thread to do so.

My comment on irrelevance only applies to the discussion at hand. You have broadened it far beyond there. A discussion of the eight principles don't belong in a discussion about requirements of the standard when they are not addressed in the standard. That's what made it a red herring. Attempting to amplify the red herring does not remove it. It is nothing more than a continued attempted of a smoke screen. Creating a bigger diversion is just that, amplifying the diversion.

Let's stay on topic.