Production Process Verification - AS9100 Clause 7.5.1.1

J

JTurner79

#1
7.5.1.1 States the organization shall use a representative item from the first production run of a new part or assembly to verify that production processes etc. are capable of meeting requirements.

We require first article inspections from our suppliers, as we are a distributor and authorized re-lubricator of ball bearings. My question is do we then have to perform one for our process?

I know we are altering the lubrication, and we certify that in our paperwork, but we do not really have new parts come through. There are not a lot of sizes that we have not already confirmed that we are capable of re-lubricating over the last 28 years. Is it possible to use previous orders for identical requirements as the verification for production processes and documentation?
 
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Stijloor

Staff member
Super Moderator
#2
7.5.1.1 States the organization shall use a representative item from the first production run of a new part or assembly to verify that production processes etc. are capable of meeting requirements.

We require first article inspections from our suppliers, as we are a distributor and authorized re-lubricator of ball bearings. My question is do we then have to perform one for our process?

I know we are altering the lubrication, and we certify that in our paperwork, but we do not really have new parts come through. There are not a lot of sizes that we have not already confirmed that we are capable of re-lubricating over the last 28 years. Is it possible to use previous orders for identical requirements as the verification for production processes and documentation?
Can someone with this expertise help?

Thank you!!

Stijloor.
 

howste

Thaumaturge
Super Moderator
#3
7.5.1.1 States the organization shall use a representative item from the first production run of a new part or assembly to verify that production processes etc. are capable of meeting requirements.

We require first article inspections from our suppliers, as we are a distributor and authorized re-lubricator of ball bearings. My question is do we then have to perform one for our process?

I know we are altering the lubrication, and we certify that in our paperwork, but we do not really have new parts come through. There are not a lot of sizes that we have not already confirmed that we are capable of re-lubricating over the last 28 years. Is it possible to use previous orders for identical requirements as the verification for production processes and documentation?
Having evidence that you've done something before isn't the same as having evidence that it was done correctly. However, if you've proven in the past that you've done it correctly, and the process is the same, there should be no need to re-do. Here's what AS9100 says: "This process shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, manufacturing process changes, tooling changes)."

Is your organization already certified to AS9100? This requirement is the equivalent of Rev B clause 8.2.4.2 (first article), so if you met that requirement you should already have a process in place.

One more question. Is re-lubrication all that your organization does? If all you do is work on existing parts, AS9110 is really the standard that should apply, not AS9100.
 
J

JTurner79

#4
Having evidence that you've done something before isn't the same as having evidence that it was done correctly. However, if you've proven in the past that you've done it correctly, and the process is the same, there should be no need to re-do. Here's what AS9100 says: "This process shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, manufacturing process changes, tooling changes)."

Is your organization already certified to AS9100? This requirement is the equivalent of Rev B clause 8.2.4.2 (first article), so if you met that requirement you should already have a process in place.

One more question. Is re-lubrication all that your organization does? If all you do is work on existing parts, AS9110 is really the standard that should apply, not AS9100.
Yes, our previous orders contain proof of conformance to the requirements of each order.

We are not currently certified to AS9100. That is part of my concern. Do we then have to treat each order as if it was new, because of the new certification?

According to my upper management, it was recommended that we do AS9100. My understanding is because we do precision lubrication of the parts to specific customer requirements and drawings, AS9110 would not be enough to cover it. We are not always re-lubricating the parts to the same lubricant they originally had, but are lubricating them to meet certain requirements.

Thank you for the help.
 

dsanabria

Quite Involved in Discussions
#5
7.5.1.1 States the organization shall use a representative item from the first production run of a new part or assembly to verify that production processes etc. are capable of meeting requirements.

We require first article inspections from our suppliers, as we are a distributor and authorized re-lubricator of ball bearings. My question is do we then have to perform one for our process?

I know we are altering the lubrication, and we certify that in our paperwork, but we do not really have new parts come through. There are not a lot of sizes that we have not already confirmed that we are capable of re-lubricating over the last 28 years. Is it possible to use previous orders for identical requirements as the verification for production processes and documentation?

Confusing...


Why are you as a distributor using AS9100. You should be working on AS9120 - Distributor, unless your chemist designs and develops (Clause 7.3) a re-lubricant for bearings. Then AS9100 is applicable but your questions still requires clarification.

Please do not confuse FAIR (AS9102) with first Piece article.

Let us know which one is applicable - we could provide a better opinion.
 
J

JTurner79

#6
Confusing...


Why are you as a distributor using AS9100. You should be working on AS9120 - Distributor, unless your chemist designs and develops (Clause 7.3) a re-lubricant for bearings. Then AS9100 is applicable but your questions still requires clarification.

Please do not confuse FAIR (AS9102) with first Piece article.

Let us know which one is applicable - we could provide a better opinion.
It was recommended to us that since we re-lubricate the bearings and change the enclosures when specified, that we should use AS9100 and exclude 7.3. We are not simply re-lubricating with the same lubricant the bearings originally had. We precision clean and lubricate the parts to whatever specifications the customer requires. I do not believe that is covered in AS9120. However I am open to suggestions.

I have not confused the two, but since we do not make the parts we require the FAIR from the manufacturer and then, when necessary perform our own here to indicate the changes made.

We have performed this process for years and have plenty of documentation indicating that they were processed correctly.
Do we need more than that for verification?
Do we have to do each size as if it was the first time to satisfy the requirement?
The bigger question for me is, does the process have to be broken down between the sizes for verification? It still remains the same process regardless of how much lubricant is required.

I hope that clears some of it up. And thank you for the help.
 

howste

Thaumaturge
Super Moderator
#7
Yes, our previous orders contain proof of conformance to the requirements of each order.

We are not currently certified to AS9100. That is part of my concern. Do we then have to treat each order as if it was new, because of the new certification?
You need to have a process for "first article" (if that's what you call it), and before certification, you need to have evidence that it's being used for all new or changed processes. You shouldn't have to go back and re-verify processes that have already been established and qualified though.


According to my upper management, it was recommended that we do AS9100. My understanding is because we do precision lubrication of the parts to specific customer requirements and drawings, AS9110 would not be enough to cover it. We are not always re-lubricating the parts to the same lubricant they originally had, but are lubricating them to meet certain requirements.

Thank you for the help.
9120 certainly doesn't apply to what you're doing, but 9110 seems like a good fit based on what you've said unless the parts are new. You know more about what your organization does than I do though. Here's what AS9100 says about which standard should apply:
AS9100 Rev C said:
This standard is intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own products.

Organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operate autonomously, or that are substantially different from their manufacturing/production operations; should use the IAQG-developed 9110 standard.

Organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defense industries, including organizations that procure products and split them into smaller quantities for resale, should use the IAQG-developed 9120 standard.
 
J

JTurner79

#8
You need to have a process for "first article" (if that's what you call it), and before certification, you need to have evidence that it's being used for all new or changed processes. You shouldn't have to go back and re-verify processes that have already been established and qualified though.


9120 certainly doesn't apply to what you're doing, but 9110 seems like a good fit based on what you've said unless the parts are new. You know more about what your organization does than I do though. Here's what AS9100 says about which standard should apply:
Thank you Howste. That is what I was hoping to confirm. This process has been performed for longer than I have been here.

As for AS9110, the problem is we are not repairing, maintaining or overhauling anything. We are taking an original part with, lets say, Grease A at 25% fill. We clean and re-lubricate that bearing with Grease B at 15% +/- 4% fill, and if required change enclosures, say from steel shields to teflon seals. It gets more complicated than that, but I think that goes beyond 9110 or 9120.
 

howste

Thaumaturge
Super Moderator
#9
Thanks for the clarification. I thought the re-lubrication of bearings was of used bearings, not new ones. I agree that AS9100 seems appropriate.
 

dsanabria

Quite Involved in Discussions
#10
It was recommended to us that since we re-lubricate the bearings and change the enclosures when specified, that we should use AS9100 and exclude 7.3. We are not simply re-lubricating with the same lubricant the bearings originally had. We precision clean and lubricate the parts to whatever specifications the customer requires. I do not believe that is covered in AS9120. However I am open to suggestions.

I have not confused the two, but since we do not make the parts we require the FAIR from the manufacturer and then, when necessary perform our own here to indicate the changes made.

We have performed this process for years and have plenty of documentation indicating that they were processed correctly.
Do we need more than that for verification?
Do we have to do each size as if it was the first time to satisfy the requirement?
The bigger question for me is, does the process have to be broken down between the sizes for verification? It still remains the same process regardless of how much lubricant is required.

I hope that clears some of it up. And thank you for the help.
howste gave you an excellent response :)
 
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