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Does 21 CFR 820.80 (b) require a Supplier to have Receiving Inspection?

M

MJW66

#1
So I have a supplier that is debating that they do not need to have a receiving inspection function to be compliant to 21CFR820.80(b).
21CFR820.80(b): Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.

The words that are the crux of the matter are "otherwise verified." Can they successfully argue that otherwise verification can occur in-process or even at final inspection? Can a company just put everything directly to inventory without having any verification activity? That is, no data from the supplier or any inspection data performed prior to the put away function.

At first glance, I would say "No." I would at least that you would need a CoC backed up by a supplier control process that shows that the supplier is producing conforming product.

Thoughts?
 
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M

maaquilino

#3
So I have a supplier that is debating that they do not need to have a receiving inspection function to be compliant to 21CFR820.80(b).
21CFR820.80(b): Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.

The words that are the crux of the matter are "otherwise verified." Can they successfully argue that otherwise verification can occur in-process or even at final inspection? Can a company just put everything directly to inventory without having any verification activity? That is, no data from the supplier or any inspection data performed prior to the put away function.

At first glance, I would say "No." I would at least that you would need a CoC backed up by a supplier control process that shows that the supplier is producing conforming product.

Thoughts?
Not sure I understand this completely, but it sounds like you?re asking if a supplier that you use, or are thinking of using, needs a receiving inspection function. If they?re your suppliers, they can essentially do what they want as you are still ultimately responsible for compliance to 820. That means if you have a supplier who doesn?t have a receiving inspection procedure that meets 820 then you have to ensure YOUR acceptance activities have the appropriate acceptance controls to meet compliance. You can require that your supplier does have a compliant receiving inspection process; but you can?t force them to have one. If they won?t do it, then you have to assess whether you want to do business with them. If you want your suppliers to be compliant to 820, the time to determine whether or not they are, or if they?ll do it for you, is when you select your suppliers and negotiate your contract with them.

If you look at the preamble to 820 and do a search on ?acceptance? and one on ?supplier?, you?ll find a lot of valuable information on how the FDA thinks when it comes to these subjects. I find the preambles invaluable whether I?m drafting policies and procedures or writing project documentation; they also come in handy during negotiations.

http://www.fda.gov/MedicalDevices/D...ments/QualitySystemsRegulations/ucm230127.htm
 
M

MIREGMGR

#4
For clarity: does this supplier provide you with components, or are they a contract manufacturer or responsible manufacturer?
 

Aphel

Involved In Discussions
#5
The QSR contains requirements for the medical device manufacturer... I guess in your case - you represent the manufacturer.

So - basically it is your duty to adress the requirements derived from ?820.80...

If you involve a supplier in manufacturing your devices - or components of your devices - you need to ensure, that the supplier monitors his processes - even his outsourced processes (e.g. incoming inspection). But you cannot force him to comply with ?820.80

Best regards,
Aphel
 

hogheavenfarm

Quite Involved in Discussions
#6
I have run into these word games before. If a supplier builds you an item, and does not inspect one of the components of that item as they receive them, they argue that the final product would not pass inspection if they component was faulty. This could be true, I suppose a part that had no real failure mode on its own would be "inspected during assembly" and could even be "tested at final". In effect creating a 100% inspection during assembly.
Does that qualify as "otherwise verified"? Maybe. Is it risky? Possibly.
 
M

MIREGMGR

#7
There's a semantics issue underlying this thread. Some of us are discussing whether the supplier, if what they supply is unregulated "components" as defined in 21CFR 807.65, is legally subject to 21CFR 820.80. Others are looking at the problem as a matter of good business practice. The discussion responses sound almost as if they're addressing the same issue, but they're not.
 
M

MJW66

#8
Let me try to add more clarity. This supplier is a contract manufacturer to us where we hold the design. There are approximately 5 components that are assembled into a finished unit which is then considered a component to the overall finished medical device. This component is sold to end users as a replacement component, not to the OEM of the overall device. We are not the OEM of the overall device. Thus, this component is regulated as it is being sold directly to the end user market.
 
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M

MJW66

#9
I have run into these word games before. If a supplier builds you an item, and does not inspect one of the components of that item as they receive them, they argue that the final product would not pass inspection if they component was faulty. This could be true, I suppose a part that had no real failure mode on its own would be "inspected during assembly" and could even be "tested at final". In effect creating a 100% inspection during assembly.
Does that qualify as "otherwise verified"? Maybe. Is it risky? Possibly.
I agree. How can "otherwise verified" listed in "820.80(b) Receiving acceptance activities:" be shown to be verified or tested later on? Later on is not within the scope of "Receiving acceptance activities" in my opinion.
 
M

MIREGMGR

#10
This supplier is a contract manufacturer to us where we hold the design.
As before, it's helpful to distinguish between usual business use of terms, and FDA language. They may be a contract manufacturer, but--if what they make is not a finished device when they ship to you, not counting labeling, packaging and if applicable, sterilization--they are not a Contract Manufacturer. A Contract Manufacturer makes finished devices. If what they make is not finished devices, they are a 21CFR807.65 Component Maker.

A Contract Manufacturer (usually, to some extent) is subject to 21CFR820. A component maker is not.

There's always an exception, and in this case, there are two. If the component they supply is not part of the original device at original manufacture but instead is an Accessory, then it is regulated as a Device. If when that part is sent out to an existing device user it's sent out as a new Accessory instead of as a replacement part, then again it's regulated as a Device. In either case, they are a Contract Manufacturer instead of a component maker. Usually, though, replacement parts are for the device itself, and therefore aren't Accessories.

You on behalf of the responsible Manufacturer/Specification Provider of course may contract with them to perform certain actions and keep certain records, but they're doing that for the responsible Manufacturer/Specification Provider, not FDA. FDA will see the responsibility for whatever they do or don't do as belonging to that Manufacturer/Specification Provider.
 
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