Incoming (Receiving) Inspection for Commodity Items used in Medical Devices

kansascitysteve

Starting to get Involved
#1
We currently are ISO 13485 and manufacture class I and Class II medical devices.

We perform incoming inspection of raw materials using ANSI Z1.4. We also have implemented a basic skip lot program.

My question is related to common commodity items such as screws, washers, nuts, bolts, couplings, adapters, hose clamps, tubing, etc. that can be purchased nearly anywhere. All of these items would be caught in the manufacturing process if they were defective and we have never had any failures from our incoming inspections.

Does any think its problematic to receive them directly into inventory without a receiving inspection? I do not see any value in inspecting numerous samples from a lot of commodity items each time they arrive.

Can anyone else give me an idea of how they handle basic commodity items and the incoming inspection process. Again, none of these items are critical to our product and are extremely low risk parts.

Any thoughts?
 
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pkost

Trusted Information Resource
#2
Re: Incoming (Receiving) Inspection for Commodity Items

I assume that you are referring to non implant commodity products (screws etc), my response works on this assumption, but could be applied to all goods in inspection.

I think it is entirely reasonable and justifiable to apply different inspection routines to different products in different risk groups; therefore a low risk item may just be counted in while a high risk item may undergo more rigorous inspection...counting, measuring critical dimensions etc.

ISO 13485 does not prescribe what inspection you must carry out on purchased items; it is left to the company to decide how to do that, just justify and document why you do what you do.
 

BradM

Leader
Admin
#4
Re: Incoming (Receiving) Inspection for Commodity Items

Hello Steve!:bigwave:

My question is related to common commodity items such as screws, washers, nuts, bolts, couplings, adapters, hose clamps, tubing, etc. that can be purchased nearly anywhere. All of these items would be caught in the manufacturing process if they were defective and we have never had any failures from our incoming inspections.
In this section, I have a question about this line:

All of these items would be caught in the manufacturing process
Are you suggesting that they would be caught in the supplier that made the product? So you are company B, and you're buying from company A. Company A would catch the failures? Are you sure?:D

I would think that any reduced sampling/ inspection plan would be dependant on historical performance, risk level, upstream quality programs, etc. If you have evaluated the sampling/quality/inspection plan for company A and have documented that evaluation, I would think you could demonstrate that a reduced sampling plan is justified.

If you can demonstrate that your upstream suppliers has sufficient sampling/inspection plans, then I would say that you could reduce your sampling plan. However, if they have no demonstrated sampling plan, then I would say you should have an adequate sampling plan based on your risk level. :)
 

kansascitysteve

Starting to get Involved
#5
Re: Incoming (Receiving) Inspection for Commodity Items

Thanks for the responses.

Are you suggesting that they would be caught in the supplier that made the product?
I was likely not clear enough. I was saying that if we received a bad batch of simple screws, then our production/assembly people would not be able to use them and we could route them through our nonconforming product process. It is a correct assumption that the commodity items I was referring to are non-implantable items and all things that could be purchased at nearly any hardware store.... I just was unsure if receiving these items straight to the shelf with no formal inspection would create any issues during an FDA or ISO audit.
 
T

tomvehoski

#6
Re: Incoming (Receiving) Inspection for Commodity Items

What is the risk to your product if you receive zinc coated screws instead of stainless and your operators don't catch it? Pan head vs. flat head? 3/16 instead of 1/4" length?

If no risk, send them straight to stock. If a little risk (like rusting 10 years down the road), do a basic verification on important parts like stainless (if any). Sampling plans and checking to make sure that there is not a screw with a miscut head are not going to add value.
 

kansascitysteve

Starting to get Involved
#7
Re: Incoming (Receiving) Inspection for Commodity Items

If we determine there is no risk and we send items straight to stock, do we still need a written inspection record showing that someone verified the correct part # ordered vs the packing slip?...and signature/date?
 

pkost

Trusted Information Resource
#8
Re: Incoming (Receiving) Inspection for Commodity Items

There is no such thing as "no risk"...never underestimate the ingenuity of fools.

I think it is appropriate to just sign off that you have received the goods and that they match the purchase order part#. I would consider this to be the absolute minimum for goods in inspection
 
#9
Re: Incoming (Receiving) Inspection for Commodity Items

Does any think its problematic to receive them directly into inventory without a receiving inspection? I do not see any value in inspecting numerous samples from a lot of commodity items each time they arrive.

Can anyone else give me an idea of how they handle basic commodity items and the incoming inspection process. Again, none of these items are critical to our product and are extremely low risk parts.
Any thoughts?
No problem at all. Why are you forcing yourself to inspect numerous samples ?
Original pack identification, Part number identification, Make identification, all these are inspection in its simplest form which even the inventory officer at stores can do with appropriate training.
 

kansascitysteve

Starting to get Involved
#10
Re: Incoming (Receiving) Inspection for Commodity Items

Why are you forcing yourself to inspect numerous samples ?
We have been using ANSI Z1.4 and typically looking at 20 samples and have never found any issues and seems to no longer have any value. I wasnt sure if simply receiving them into inventory based on correct packing list and item verification would cause any issues with FDA about inspections.

I appreciate all of the feedback and guidance!
 
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