Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Many engineers request the use of large-scale distribution chains or even resellers (ebay, amazon, walmart, etc.) for use as suppliers due to the fact that what is being requested for procurement are very low risk products (i.e. tape, zip ties, etc.) that will be used within the medical device. Most supplier quality control programs find these suppliers unacceptable for use since there is no real control on the true source of the product. Knowing this - would you find these type suppliers acceptable as suppliers of extremely low risk product in regards to the overall device?

I am by no means a device expert but I would be a bit worried about using "Big Box" companies for this sort of thing.  There are a couple of reasons for my fear:

1. You never know where the material is coming from or the level of "quality control" exercised over the material before it is in your firm's product which makes for increased potential of failure ​of the part.  If this part failing causes a problem with the device that could be reportable, that would be a bridge too far for me to cross.

2. Because these companies often will take the "best price" option there is the potential for every purchase to be different unless there is some way for your company to contractually obligate (with sanctions for failure to abide by the contract) the retailer to provide material from the same source routinely or to obtain your prior approval before they ship you anything from a different source.  This is notoriously unlikely to happen and even if it were to be agreed to would require that your company take an even more active role in ensuring that contractual compliance is acceptable in the long term.

3. Let's think about a simple piece of coil that is inside a device that is used to monitor say - blood pressure on an out-patient basis.  The physician and the patient are using this information to further develop an individualized plan to manage the patient's hypertension.  This coil is used to simply hold a small sensor on the cuff hose to the cuff or to the display panel.  Something happens that causes the cuff to erroneously read lower pressures than actual and the cause is this small coil in the product.  You now have a potentially serious event because this could reasonably be expected to result in the patient and doctor choosing to change or lessen therapy for a medical condition that can cause all sorts of evils in the body (heart disease, heart attack, stroke, etc.) and now you have the potential for your device being implicated in that.  Yes, it is an extreme example but it is possible.  This obviously becomes a benefit-risk decision whether or not to use the material.

So even an "extremely low risk" product could cause you significant headaches.  And remember, you need to be able to pass the "red face test" when regulators or notified bodies audit your supplier control systems.  I'm not sure that FDA would be OK with Walmart as a supplier of components to a medical device although I guess that might go back to the device itself, the potential classification and any special controls required, the actual material used and for what purpose, etc.

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 02-May-2019 10:53
From: Anonymous Member
Subject: Supplier Quality Controls

This message was posted by a user wishing to remain anonymous

Many engineers request the use of large-scale distribution chains or even resellers (ebay, amazon, walmart, etc.) for use as suppliers due to the fact that what is being requested for procurement are very low risk products (i.e. tape, zip ties, etc.) that will be used within the medical device. Most supplier quality control programs find these suppliers unacceptable for use since there is no real control on the true source of the product. Knowing this - would you find these type suppliers acceptable as suppliers of extremely low risk product in regards to the overall device?

I could see using the inexpensive retailers for the design phase. When trying to make a prototype or playing around with different ideas, the quality and control of the materials may not matter as much. I do agree with Victor once it comes to development and beyond. It just would not be fun to sit with a auditor and explain how your quality agreement with Amazon is sufficient to maintain quality control of your medical device. The other question would be "what function is the part playing"? If it fails, what is the risk? There is potentially a rationale for why you don't need to have a high level control over the part if you really needed that as an option.

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States
------------------------------

Original Message:
Sent: 02-May-2019 10:53
From: Anonymous Member
Subject: Supplier Quality Controls

This message was posted by a user wishing to remain anonymous

Many engineers request the use of large-scale distribution chains or even resellers (ebay, amazon, walmart, etc.) for use as suppliers due to the fact that what is being requested for procurement are very low risk products (i.e. tape, zip ties, etc.) that will be used within the medical device. Most supplier quality control programs find these suppliers unacceptable for use since there is no real control on the true source of the product. Knowing this - would you find these type suppliers acceptable as suppliers of extremely low risk product in regards to the overall device?

This message was posted by a user wishing to remain anonymous

I agree that during development, the quality and supplier control of the materials may not matter as much as during the manufacturing phase. But in my past experience, for manufacturing, we only used Amazon and other online whole retailers for off-the-shelf components. Part of supplier qualification is also knowing whether these components are easily replaceable or not. OTS components pose less risk than say manufactured components that need to be meet certain specs.  So OTS suppliers would be considered non-critical, so I don't think a quality agreement is needed. Has anyone really obtained a quality agreement with Amazon?  Thanks.
Original Message:
Sent: 06-May-2019 10:55
From: Maddi Myers
Subject: Supplier Quality Controls

I could see using the inexpensive retailers for the design phase. When trying to make a prototype or playing around with different ideas, the quality and control of the materials may not matter as much. I do agree with Victor once it comes to development and beyond. It just would not be fun to sit with a auditor and explain how your quality agreement with Amazon is sufficient to maintain quality control of your medical device. The other question would be "what function is the part playing"? If it fails, what is the risk? There is potentially a rationale for why you don't need to have a high level control over the part if you really needed that as an option.

------------------------------
Maddi Myers
Regulatory and Quality Project Manager
Edina MN
United States

Original Message:
Sent: 02-May-2019 10:53
From: Anonymous Member
Subject: Supplier Quality Controls

This message was posted by a user wishing to remain anonymous

Many engineers request the use of large-scale distribution chains or even resellers (ebay, amazon, walmart, etc.) for use as suppliers due to the fact that what is being requested for procurement are very low risk products (i.e. tape, zip ties, etc.) that will be used within the medical device. Most supplier quality control programs find these suppliers unacceptable for use since there is no real control on the true source of the product. Knowing this - would you find these type suppliers acceptable as suppliers of extremely low risk product in regards to the overall device?

There are a few parts of this question to address.

It says, "Many engineers request …". Request is fine, they can ask for anything. The problem occurs when it becomes "many engineers require…". I have dealt with many companies in which the engineering department believes they have the responsibility for all supplier selection. It may be true that in some cases engineering designs in a sole-source part. However, before making the decision there are multiple considerations.

When engineering wants to make the decision, my first question to the engineer is the grade they got in the supplier management course they took as part of the engineering degree. Unless it is higher than A+, I ask why their judgement is better than the professionals with degrees and professional certifications in purchasing management or materials management.

Without painting a broad brush, engineers typically focus on technological issues without consideration of financial stability, on-time delivery, and ability to respond to corrective action requests.

The second statement is "Most supplier quality control programs find these suppliers unacceptable …". I'm having a hard time understanding the basis for this statement. In particular, I'm concerned about large-scale distribution chains. (I'll leave resellers aside.) In many cases, medical device manufacturers, especially smaller companies, are low volume customers and must procure through distribution. In my experience, most programs do not find distributors unacceptable.

However, working through distributors can have difficulties. For example, a requirement to sole source a manufacturer but purchase through a distributor requires attention to detail in specification, purchasing, and incoming acceptance activities. If engineering needs to sole source a component manufacturer, then the purchasing experts should determine the best supply chain.

An interesting question comes up with the Approved Supplier List. Should a company that specifies a manufacturer but buys through distribution have the manufacturer on the ASL, even if they don't place POs with the manufacturer?

To say that most supplier quality control programs find these suppliers (distributors) unacceptable is to say that they fail to meet the manufacturers specified requirements as established by purchasing professionals implementing 820.50. That has not been my experience.
 

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 02-May-2019 10:53
From: Anonymous Member
Subject: Supplier Quality Controls

This message was posted by a user wishing to remain anonymous

Many engineers request the use of large-scale distribution chains or even resellers (ebay, amazon, walmart, etc.) for use as suppliers due to the fact that what is being requested for procurement are very low risk products (i.e. tape, zip ties, etc.) that will be used within the medical device. Most supplier quality control programs find these suppliers unacceptable for use since there is no real control on the true source of the product. Knowing this - would you find these type suppliers acceptable as suppliers of extremely low risk product in regards to the overall device?