FAI's for packaging materials?

stm55

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I am very familiar with FAI's being necessary for physical components of a finished product, however, I run into a bit of confusion when dealing with things like packages, labels, pouches, cartons, IFUs, etc.

Our current procedure requires an FAI for any custom part that is externally supplied. However suppliers of the aforementioned packaging type materials seem much less familiar with the FAI process compared to a supplier making a subcomponent for the physical device. Am I missing something? Should something like a carton not go through an FAI and if not, why? Or should they essentially go through a similar exercise-- check every dimension/requirement of the first piece(s) off of a line?
 

Jen Kirley

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I deal with packaging a lot more than I used to, based on various factors resulting in damaged or lost/partially lost items. When I say partially lost, I mean an item in a kit.

You don't say what industry you're in, where these items originate or are delivered to, or the means of transport used. I work in medical device. Some of our items are quite heavy or expensive or delicate, so they will need to successfully undergo a shock or vibration test. Things that get shipped by boat will need moisture or mold resistant packaging. As this goes, I am satisfied if the carton used has the stamp on the bottom indicating the packaging was engineered to pass industry tests. However, the carton also needs appropriate interior cushioning. Some items need ESD protection. A packaging plan is included in the PPAP - besides listing what is used, it might also show how the box is packed using images, as well as required labels and their needed positions.

Packaging is a big subject. Not knowing what you are selling and to whom etc. makes answering your question a hit-or-miss effort.
 

stm55

Involved In Discussions
I deal with packaging a lot more than I used to, based on various factors resulting in damaged or lost/partially lost items. When I say partially lost, I mean an item in a kit.

You don't say what industry you're in, where these items originate or are delivered to, or the means of transport used. I work in medical device. Some of our items are quite heavy or expensive or delicate, so they will need to successfully undergo a shock or vibration test. Things that get shipped by boat will need moisture or mold resistant packaging. As this goes, I am satisfied if the carton used has the stamp on the bottom indicating the packaging was engineered to pass industry tests. However, the carton also needs appropriate interior cushioning. Some items need ESD protection. A packaging plan is included in the PPAP - besides listing what is used, it might also show how the box is packed using images, as well as required labels and their needed positions.

Packaging is a big subject. Not knowing what you are selling and to whom etc. makes answering your question a hit-or-miss effort.
Thanks for the reply. I am also in medical devices... We essentially manufacture, package and market a product under our name and I am inquiring about the packaging material provided to us by a supplier (with regard to an FAI, which is typically used to confirm the supplier made it to our requirements). Yes, we would be doing a validation of the packaging to make sure it can withstand the stresses you describe.

What I am referring to is a first article inspection (FAI) of a supplier (which I believe is typically included in PPAP documentation). Essentially proving that your supplier has their equipment setup for the first piece(s) off their line to meet your requirements. In my understanding/experience, an FAI checks every single aspect/dimension of a supplier part (which differs from routine incoming inspection which may check only critical dimensions). It seems FAI's are quite common for things like molded components, where one part from the first shot of each cavity would be checked for all requirements on the drawing PRIOR to qualifying a supplier for a particular component (not for each lot of product provided). I see FAI's spoken about less frequently for things like packaging materials but I'm trying to understand why you wouldn't do something similar (check every dimension, every fold location, thickness, etc etc). As I mentioned, our procedure currently says FAI required for custom parts and our packaging is custom--- so trying to understand what others do for things like this.

This is a very different discussion than packaging validation which it seems you are talking about (i.e. proving the packaging design is capable of protecting the product etc, NOT that the supplier manufactured the product to the specs they were given).
 
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Jen Kirley

Quality and Auditing Expert
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We do PPAP on parts made with our drawing or the supplier drawing, but packaging is generally out of catalog so it does not require FAI. Is the packaging you refer to out of catalog or is it specially made for you? If it is the latter, FAI might be needed - and what about sterilization? I don't deal with that.
 

stm55

Involved In Discussions
This would be a custom part that we design.. if it was "out of catalog" (or off the shelf as we call it and I assume you mean), we would not need to do an FAI per our procedure.

So if you designed custom packaging, your saying it would go through your PPAP? Which would also include an FAI?

We do terminally sterilize our products, though I don't know how relevant that is to this discussion
 

Golfman25

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This would be a custom part that we design.. if it was "out of catalog" (or off the shelf as we call it and I assume you mean), we would not need to do an FAI per our procedure.

So if you designed custom packaging, your saying it would go through your PPAP? Which would also include an FAI?

We do terminally sterilize our products, though I don't know how relevant that is to this discussion
If it’s custom packaging, you should have a specification to meet. FAI would match that spec to the samples.
 

stm55

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If it’s custom packaging, you should have a specification to meet. FAI would match that spec to the samples.
That is my thinking too... I was just questioning it since custom packaging suppliers seem less familiar with doing FAI's whereas custom molding manufacturers for instance are much more familiar with it. so was wondering if there was a distinction
 

Jen Kirley

Quality and Auditing Expert
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Admin
Have you asked the custom packaging suppliers if they have experience with FAIs? Maybe they would surprise you.
 
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