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.
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.
Sidney and Jim W. make some points, but Big Jim is on point in remarking the auditor in this thread's case has not cited a valid clause in either the Standard, the supplier's processes, or the customer's requirements which were violated.
Andy is absolutely accurate in pointing out that "good practice" would/should suggest the kind of record-keeping my own shop did routinely, but at best, the auditor "might" suggest an Opportunity For Improvement (OFI), not an N/C, but then he might run up against the Kwality Kops who recoil in horror if an auditor says anything which might be even remotely construed as consulting.
My advice to Ashley remains:
Pick up the phone Monday and ask the auditor for clarification and an absolute citation to the clause in
- Standard,
- Supplier QMS
- Customer written requirements
If he can't do that, ask him to remove the N/C in writing with copies to your manager, you, and HIS boss.
Benefits of rigorous and systematic inspection and record-keeping:
That all said, your organization might (no guarantees) benefit from a more rigorous system of inspection and record-keeping for ALL your production, not just to adhere to the narrow requirements of a Standard or of your current customers. Such a system will enable your organization to have a better chance to market your services to higher profit customers.
If your productions are running more than a day or two, the efficiencies from incorporating SPC
will result in internal savings which will result in increased profit.
If your organization intends to penetrate the aerospace or medical device markets, it will be necessary to impress such customers with the RECORD of your control system so they will feel assured they will get consistent good product time after time, eventually trusting your organization to a "dock to stock" or "dock to production line" status.
These, of course, are long term improvements/changes to your organization and will require the understanding and action of your top management to implement.
We're not sure where you, Ashley, stand in the food chain of your own organization, but passing on these tips to your top management in a non-accusatory manner may benefit your own career.
