From a regulatory/compliance perspective the biggest item I could see would be material traceability and handling. I would suggest that the first step would be to include them in the audit program (even if it is the parent company to the local warehouses) and clearly lay out the scope of what is needed from them. It may benefit to start with a supplier self/desk audit of their systems so there is at least a level of comfort when adding them to an approved supplier list. This can be seen as a less intrusive audit and at least opens the door to a future, potential site audit.
Without knowing the supplier relationship that you have it can be difficult to gain access to some distributors. Often, especially if you are a smaller operation, it can be difficult to gain access to a supplier that you do not have a large volume of business with. From a logistics standpoint it does not make sense for them to host every small customer for an audit and they would focus on supporting key accounts (we have run into a similar issue). Our solution has always been to show our due diligence and effort to conduct a site audit but if we are unable we supplement with a supplier self/desk audit.
Hope this helps and I am also interested to hear feedback from others as well.
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Michael Gerhard
Quality Manager
Putnam CT
United States
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Original Message:
Sent: 14-Nov-2019 11:24
From: Anonymous Member
Subject: Distributor controls and site visits
This message was posted by a user wishing to remain anonymous
Hello,
From a medical device perspective in the US, any guidance documents or words of advice based on experience that can be provided the question below would be greatly appreciated!
I want to create a program for better oversight of our local distributor warehouses but today they are not a part of the supplier audit program. What reasonable justifications from a regulatory/compliance perspective can I use to build this process out as well as gain acceptance from the distributors to do site visits?
Thank you.