Any Suggestions Will Be Welcomed

jam325

Starting to get Involved
The auditor had us reference the 9100-2016 Series Clarifications document which can be found on the IAQG website. On page 16 it 'clarifies' section 8.7 as follows:
View attachment 29836
The auditor's determination is "lockable" boxes for our material. We have a 3rd party company pick up or 'scrap' or material we cannot use and this company has provided us with a certificate of destruction for years.

The "unauthorized personnel" may be the point where you can make your argument that the red bins are indeed positively controlled. Are you able to show access is controlled to the production floor or controlled on who is allowed to remove the product from the red bins?

As an auditor myself, looking at your replies, it certainly seems you have addressed and minimized the risk of NC product reentering the value stream with extensive inspections and product testing.

You could relabel the red bins as "potentially NC Material" and have those go through a disposition process. However, if the part has already failed testing it probably does not add value to your process to look at a failed part twice.

If this was my facility I would be appealing and getting some second opinions from the CB. If a process has been in place for 15 years, and you can show that it is controlled, and the only solution the auditor will accept is causing more risk for NC product then it is not a solution that needs to implemented. In my opinion.

Good luck! I hope the one bad audit doesn't scare your whole facility off the audit process.
 

qualityegghead

Lives from Inspector to Director of Quality
The "unauthorized personnel" may be the point where you can make your argument that the red bins are indeed positively controlled. Are you able to show access is controlled to the production floor or controlled on who is allowed to remove the product from the red bins?

As an auditor myself, looking at your replies, it certainly seems you have addressed and minimized the risk of NC product reentering the value stream with extensive inspections and product testing.

You could relabel the red bins as "potentially NC Material" and have those go through a disposition process. However, if the part has already failed testing it probably does not add value to your process to look at a failed part twice.

If this was my facility I would be appealing and getting some second opinions from the CB. If a process has been in place for 15 years, and you can show that it is controlled, and the only solution the auditor will accept is causing more risk for NC product then it is not a solution that needs to implemented. In my opinion.

Good luck! I hope the one bad audit doesn't scare your whole facility off the audit process.
Thanks Jam!
"Aint Skeered!" ;)
 

qualityegghead

Lives from Inspector to Director of Quality
It's humbling to be on the receiving end of the wolf-pack responses, all of which are extremely well thought out and valuable to me.
My heartfelt thanks to all of you esteemed colleagues!

Walt
 

Cari Spears

Super Moderator
Leader
Super Moderator
All we do is stick a red dot sticker on nonconforming details. No locked bins, no locked cages, etc. Some of our work is mounted to the floor - definitely not able to be moved out of the manufacturing area - so we put a big laminated sign on it. We make tooling - what we do to identify, and segregate if possible, is commensurate with the risk involved.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
What Cari said. Show them the risk and controls you have in place to catch that risk. An auditor can make a finding you are not in compliance but to assert how you contain and respond to that finding is consulting.
 

Golfman25

Trusted Information Resource
Sounds to me like complete stupidity caused by an auditor over interpreting the requirements when he/she doesn't know squat about the product. OP says that, in the unlikely event any motors use non-conforming parts, they wont pass testing and will be scrapped. Has it, does it, happen? As others have indicated, change the name to "suspect parts," then let someone come around with the locked bin, review the suspect parts, and make a disposition determination to call them non-conforming, and dump them into the locked bin.

Your only recourse is to somehow figure out a way to get over and above your auditor, with or preferably without an appeal. Ask for him/her to be removed from the corrective action process as she has shown bias in not approving several containment actions. It is not for her to tell you "locked containers" are required because the clarification does not even come close to saying that.

I recently had one of "those" auditors. What if the parts where over there? What if someone did this? What if blah, blah, blah. Well the parts aren't "over there." Someone didn't do this? They are a PIA.
 

MVladimir

Involved - Posts
Hi, qualityegghead!
I recommend you carefully study page 47 of AS/EN/JISQ 9100:2016 (Rev D) AUDITOR GUIDANCE MATERIAL (regarding implementation of clause 8.7.1). You will find the clarification. In particular:
Control of products dispositioned as scrap including:
Positive control (e.g. segregation, dedicated holding areas (floor space, racking, quarantine bonds, cages etc.), annotation
of documented information, electronic system (MRP) updates.
So it's up to you to establish the control measures taking into consideration the risks.
As for your case, this is the PERSONAL SUBJECTIVE opinion of the auditor. I have confidence that she has never worked in a real business.
 

qualityegghead

Lives from Inspector to Director of Quality
Hi, qualityegghead!
I recommend you carefully study page 47 of AS/EN/JISQ 9100:2016 (Rev D) AUDITOR GUIDANCE MATERIAL (regarding implementation of clause 8.7.1). You will find the clarification. In particular:
Control of products dispositioned as scrap including:
Positive control (e.g. segregation, dedicated holding areas (floor space, racking, quarantine bonds, cages etc.), annotation
of documented information, electronic system (MRP) updates.
So it's up to you to establish the control measures taking into consideration the risks.
As for your case, this is the PERSONAL SUBJECTIVE opinion of the auditor. I have confidence that she has never worked in a real business.
To clarify ;) further, again she pulls the 9100-2016 Series-Clarification document like a gunslinger. She accepts nothing less, regardless of the product and niche, than that which satisfies the 'Clarifications' in her opinion. Here is a cut-n-paste of an email I received from her when I let her know she was the first 3rd party auditor that has ever let me know, my responses would be rejected before I ever submit them:
Any Suggestions Will Be Welcomed
The Clarification document states:
Any Suggestions Will Be Welcomed
 
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