Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone,
Is there a defensible justification for excluding a third-party supplier that is recycling non-conforming product from the purchasing controls requirement of 820.50? I welcome any thoughts the community may have on this subject. Thank you! 

First, determine what you mean by third-party. Implicitly this means that you provide the non-conforming product to the recycler. In addition, there is a third-party involved, but you don't give their role.

 

The question is to determine what the recycler does for your company. For example, they could recover a coating and return it to you as material that could reenter your production process. In such a case, the recycler provides a service. You would write a PO, or some other equivalent document. In this case, the recycler would fall under 820.50 supplier controls for a service supplier.

 

If the recycler is the equivalent of trash pick-up and you never see the recycled material, then  they are probably not covered by 820.50.

 

There is an intermediate case. If you have, for example, hazardous waste and this is a disposal company, whether they recycle or not, then they are providing a regulated service and, in my opinion fall under 820.50. The service may not be regulated by FDA, but the principles of supplier evaluation and selection apply, so it more efficient to have only one system.

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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 06-Sep-2018 09:08
From: Anonymous Member
Subject: Recyclers and purchasing controls

This message was posted by a user wishing to remain anonymous

Hello everyone,
Is there a defensible justification for excluding a third-party supplier that is recycling non-conforming product from the purchasing controls requirement of 820.50? I welcome any thoughts the community may have on this subject. Thank you!

This message was posted by a user wishing to remain anonymous

Thank you. The medical devices in question are electronics, so this third-party is essentially recycling electronic waste. Certain materials are recovered from the recycling process and sold to other parties. The company I work for receives a certificate of destruction indicating that the product was properly recycled.
Original Message:
Sent: 09-Sep-2018 19:46
From: Dan O'Leary
Subject: Recyclers and purchasing controls

First, determine what you mean by third-party. Implicitly this means that you provide the non-conforming product to the recycler. In addition, there is a third-party involved, but you don't give their role.

 

The question is to determine what the recycler does for your company. For example, they could recover a coating and return it to you as material that could reenter your production process. In such a case, the recycler provides a service. You would write a PO, or some other equivalent document. In this case, the recycler would fall under 820.50 supplier controls for a service supplier.

 

If the recycler is the equivalent of trash pick-up and you never see the recycled material, then  they are probably not covered by 820.50.

 

There is an intermediate case. If you have, for example, hazardous waste and this is a disposal company, whether they recycle or not, then they are providing a regulated service and, in my opinion fall under 820.50. The service may not be regulated by FDA, but the principles of supplier evaluation and selection apply, so it more efficient to have only one system.

------------------------------
Dan O'Leary
Swanzey NH
United States

Original Message:
Sent: 06-Sep-2018 09:08
From: Anonymous Member
Subject: Recyclers and purchasing controls

This message was posted by a user wishing to remain anonymous

Hello everyone,
Is there a defensible justification for excluding a third-party supplier that is recycling non-conforming product from the purchasing controls requirement of 820.50? I welcome any thoughts the community may have on this subject. Thank you!