AS9100 Clause 8.5.1.3 Production Run Verification

#1
We are a machine shop currently ISO9001:2008 registered. We plan to have our AS9100D audit this September. In our machine shop, we have 25+ CNC machines. The machines can be grouped in work centers, or types: 3-axis, 5-axis, horizontal, lathe. Our machines are made by the same manufacturer and the fixturing and tooling can be interchanged within work centers.

My question is about the 8.5.1.3 Production Process Verification requirement.

The parts we make typically have multiple operations and can be any combination of machine type/work center. The first time we run a job, we will do a full documented FAI and send to the customer. The next time we run the job, we may run one or more of the machine operations in a different machine- but the machine is the same type and same work center (as the first run). For every machine operation, we verify the setup with dimensional checks and record that the setup has been verified, but we do not do a formal FAI. Do we need to do a formal documented FAI if we change machines (within the same work center)? In our experience, changing machines in this manner would not invalidate the original results because we consider the machines to be equivalent and we are checking the setup and doing in process inspection to verify that the parts meet print each time we run the part. Will this meet the AS9100 requirement? Thank you.
 
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dsanabria

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#2
Re: Please help: Clarification of AS9100 first production run verification 8.5.1.3

We are a machine shop currently ISO9001:2008 registered. We plan to have our AS9100D audit this September. In our machine shop, we have 25+ CNC machines. The machines can be grouped in work centers, or types: 3-axis, 5-axis, horizontal, lathe. Our machines are made by the same manufacturer and the fixturing and tooling can be interchanged within work centers.

My question is about the 8.5.1.3 Production Process Verification requirement.

The parts we make typically have multiple operations and can be any combination of machine type/work center. The first time we run a job, we will do a full documented FAI and send to the customer. The next time we run the job, we may run one or more of the machine operations in a different machine- but the machine is the same type and same work center (as the first run). For every machine operation, we verify the setup with dimensional checks and record that the setup has been verified, but we do not do a formal FAI. Do we need to do a formal documented FAI if we change machines (within the same work center)? In our experience, changing machines in this manner would not invalidate the original results because we consider the machines to be equivalent and we are checking the setup and doing in process inspection to verify that the parts meet print each time we run the part. Will this meet the AS9100 requirement? Thank you.
First - What is your customer requiring. This needs to be clarified at contract review.

Second - There is a difference between first piece and first Piece Inspection report.

Third - If your customer invokes AS9102 - FAIR, then you need to comply with those requirements.
 

Mike S.

Happy to be Alive
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#3
Do we need to do a formal documented FAI if we change machines (within the same work center)? In our experience, changing machines in this manner would not invalidate the original results because we consider the machines to be equivalent and we are checking the setup and doing in process inspection to verify that the parts meet print each time we run the part. Will this meet the AS9100 requirement? Thank you.
To answer your question, IMO what you are doing will meet AS9100 8.5.1.3 requirements IF there are no overriding additional customer requirements.
 
J

joburum

#4
Depends on the customer. The larger companies may go deep enough to require a delta FAI be complete with any machine change whereas others may only need process and material specification.
 
#5
Thank you for your responses. This forum is very helpful. I'm trying to delve a little further for clarification.

AS9100C had clause 7.5.1.2 Control of Production Process Changes, which is no longer in AS9100D. Does the removal of this clause change the interpretation of the FAI requirement?

AS9100C had provision for making process changes. I'm trying to understand how removal of that provision affects the FAI requirement, if at all.

In other words, per AS9100D, and if the customer does not invoke AS9102 or a similar requirement, is there any justification for which we can make process changes and not have to redo the FAI? If ,due to our knowledge/expertise of our processes and methods, we can justify that the change does not invalidate the original FAI, will that satisfy the requirement?
 

sunnycosta

Starting to get Involved
#6
I was wondering if anyone could share, a procedure or flowchart, to cover the following new clauses:
8.1.4 Prevention of Counterfeit parts,
8.1.3 Product Safety,
8.1 Integrated Phased Processes,
7.1.4 Human Factors.

I just cannot understand what is meant by:
8.1 Integrated Phased Processes,
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
Thank you for your responses. This forum is very helpful. I'm trying to delve a little further for clarification.

AS9100C had clause 7.5.1.2 Control of Production Process Changes, which is no longer in AS9100D. Does the removal of this clause change the interpretation of the FAI requirement?

AS9100C had provision for making process changes. I'm trying to understand how removal of that provision affects the FAI requirement, if at all.

In other words, per AS9100D, and if the customer does not invoke AS9102 or a similar requirement, is there any justification for which we can make process changes and not have to redo the FAI? If ,due to our knowledge/expertise of our processes and methods, we can justify that the change does not invalidate the original FAI, will that satisfy the requirement?
Have a look at 8.5.1.3 and see if your answer is not in there.
 

Big Jim

Super Moderator
#9
We are a machine shop currently ISO9001:2008 registered. We plan to have our AS9100D audit this September. In our machine shop, we have 25+ CNC machines. The machines can be grouped in work centers, or types: 3-axis, 5-axis, horizontal, lathe. Our machines are made by the same manufacturer and the fixturing and tooling can be interchanged within work centers.

My question is about the 8.5.1.3 Production Process Verification requirement.

The parts we make typically have multiple operations and can be any combination of machine type/work center. The first time we run a job, we will do a full documented FAI and send to the customer. The next time we run the job, we may run one or more of the machine operations in a different machine- but the machine is the same type and same work center (as the first run). For every machine operation, we verify the setup with dimensional checks and record that the setup has been verified, but we do not do a formal FAI. Do we need to do a formal documented FAI if we change machines (within the same work center)? In our experience, changing machines in this manner would not invalidate the original results because we consider the machines to be equivalent and we are checking the setup and doing in process inspection to verify that the parts meet print each time we run the part. Will this meet the AS9100 requirement? Thank you.
Most of the time what you are doing would not trigger the need for another "first article". What it hinges on is when there is a change that invalidate the previous one, and that would depend on circumstances. It is possible, in some limited situations, that simply breaking set-up would trigger the need for another first article.

What is in AS9100 C and AS9100D about first article is very limited or very brief. You would be required to always live to what is there. What you need to be aware of is that customer requirements could over-ride that. Customers could add pretty much anything they want. What they usually do add (if anything) is AS9102, a separate and stiffer standard about first article.

First piece is not necessarily first article. First article is a representative sample of the first production run. It may or may not be the first piece. First piece is exactly that, the first piece, which is often confirmed as being correct before building more.
 
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