There is some debate within our organization whether 1st piece approval process should be a line item in the control plan or a control. I would be nice to have a book that standardizes control plans,,

Since it is a part of a process step I would see it as a control. AIAG APQP book has an example (p. 51) that demonstrates this.

There is some debate within our organization whether 1st piece approval process should be a line item in the control plan or a control. I would be nice to have a book that standardizes control plans,,

How was it addressed in the PFMEA? If it was a separate item with its own potential failure modes (and controls), it should probably be carried forward to the control plan as a separate item. On the other hand, if it's referenced in the PFMEA as a current process control for another process, that's the way it should be addressed in the control plan.

Need some logical reasons for and against having it listed as a line item. AIAG does a very poor job at giving examples. Calling all moderators and gurus out there which is the right way to address 1st piece inspection in a control plan?

Need some logical reasons for and against having it listed as a line item. AIAG does a very poor job at giving examples. Calling all moderators and gurus out there which is the right way to address 1st piece inspection in a control plan?

What was it about my earlier answer that you're having trouble with? How is the inspection you're referring to addressed in your flow diagram and PFMEA?

Currently we have the 1st piece as line item in the flow, PFMEA, and control plan. Corporate Quality Director wants this as a control, not a line item. His argument is that 1st piece is not a process which I disagree with. Anything that is repetitive is considered a process. I have seen it done both ways line item and control I am looking for some feedback from others as to how they address it.

As you've recognized, it can be either. There's no right or wrong here. For me one of the issues to consider is whether it is a discrete manufacturing process, a batch process, or a continuous process. For discrete manufacturing I would treat it as a control, since it can be applied to each step of the process. For batch or continuous process, I might treat it as a step that is applied to the entire process.

The best option is for your organization to decide what are the relative advantages & disadvantages of doing it each way, and which will give you the best overall results (quality, cost, etc.). The learning that would result from this discussion could be quite valuable long term (e.g., do we now understand what we mean by process more consistently, do we recognize situations where we're spending a lot of time poring over something that isn't going to really matter, ...).

I would tend to agree with Duke Oakes on this matter. It is variable from item to item. Not knowing what you make or what it's for, makes for speculation either way.

My first port of call in this situation would be the contract/order from the customer to see what they ask for in their terms and conditions or additional instructions.

Next I would look at custom and practice within that specific industry. For example , if first article inspection is conducted, is the item to accompany the first batch or quarantined for a period of time for future reference?

Thirdly, I would want to know what the company policy is for new parts and what has been specified within the companies' written procedures (if you have any).

If there is still uncertainty then go to the top. Get the managing director to make a decision.

Have fun.

There is some debate within our organization whether 1st piece approval process should be a line item in the control plan or a control. I would be nice to have a book that standardizes control plans,,


I generally see it as a control item. It is not a process, it is merely a step within your manufacturing process (in most common scenarios).

However, make sure you understood Jim Wynne's answer. I think he gave you good advice. If it is a line item on your PFMEA, then carry it through the same way. If it is a control method in the PFMEA, then carry that through.

Either way, don't make this too complicated. Either way will accomplish the objective. Understand the objective, and it will lead to an appropriate solution.

I like the thrust of hjilling's response.

What struck me as I read through this thread today is that everyone seems to immediately assume the ONLY reason to do a FAI is if you are making a product to a customer's specifications. Same seemed to go for FMEA, PFMEA, etc.

Let me suggest it is a good manufacturing practice to perform FMEA, PFMEA, FAI, etc. even (or maybe ESPECIALLY) if you are making a proprietary product that you sell to multiple customers.

For my part, if I am a customer buying an off-the-shelf product, I have no sayso in what, how, why, or if the manufacturer goes through those processes, but the manufacturer should be vitally interested for the sake of efficiency in preventing recalls, returns, liability lawsuits, and in the positive aspects of bragging rights, offering such marketing enticements as "money back guarantees, etc.

When I was the customer buying something made to my specification, I was obsessive about every step of the supplier's process, to the point of assuring we were on the same page with inspection instruments and techniques. I had clauses in my contracts that said "Do not proceed until we have approved the First Article." I demanded the First Article AND the First Article Inspection report be forwarded to us so we could assure we were able to replicate the results within the normal variations of inspector, instrument, etc.

When I was the supplier (contract manufacturer) making something to a customer's specs, I ensured the customer looked at the process the same way I did when I was the customer. Sometimes, customers wouldn't have the instruments or expertise we had to inspect the products so we invited them to send a representative to watch over our shoulder as we performed the FAI.

My obsession always was "do it right the first time and you don't waste time or money on 'do overs'."

The positive effect this obsession had on our marketing was fantastic. We established the rep as "go to partners" instead of adversaries with our customers and our suppliers were happy because they knew we were more interested in seeing the product got made right than in playing "gotcha." (It helped that we negotiated a fair price which enabled suppliers to make a profit, never "auctioned" the work, and paid ahead of due dates.;) )

I don't recall once worrying whether I met a Standard, since I considered my own standards much more important and stringent.

I like the thrust of hjilling's response.

What struck me as I read through this thread today is that everyone seems to immediately assume the ONLY reason to do a FAI is if you are making a product to a customer's specifications. Same seemed to go for FMEA, PFMEA, etc.

Let me suggest it is a good manufacturing practice to perform FMEA, PFMEA, FAI, etc. even (or maybe ESPECIALLY) if you are making a proprietary product that you sell to multiple customers.

For my part, if I am a customer buying an off-the-shelf product, I have no sayso in what, how, why, or if the manufacturer goes through those processes, but the manufacturer should be vitally interested for the sake of efficiency in preventing recalls, returns, liability lawsuits, and in the positive aspects of bragging rights, offering such marketing enticements as "money back guarantees, etc.

When I was the customer buying something made to my specification, I was obsessive about every step of the supplier's process, to the point of assuring we were on the same page with inspection instruments and techniques. I had clauses in my contracts that said "Do not proceed until we have approved the First Article." I demanded the First Article AND the First Article Inspection report be forwarded to us so we could assure we were able to replicate the results within the normal variations of inspector, instrument, etc.

When I was the supplier (contract manufacturer) making something to a customer's specs, I ensured the customer looked at the process the same way I did when I was the customer. Sometimes, customers wouldn't have the instruments or expertise we had to inspect the products so we invited them to send a representative to watch over our shoulder as we performed the FAI.

My obsession always was "do it right the first time and you don't waste time or money on 'do overs'."

The positive effect this obsession had on our marketing was fantastic. We established the rep as "go to partners" instead of adversaries with our customers and our suppliers were happy because they knew we were more interested in seeing the product got made right than in playing "gotcha." (It helped that we negotiated a fair price which enabled suppliers to make a profit, never "auctioned" the work, and paid ahead of due dates.;) )

I don't recall once worrying whether I met a Standard, since I considered my own standards much more important and stringent.

excellent points, Wes...