AMA on Supplier Management

  • 10 August 2022
  • 5 replies
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We invited Greg Lyons from LGD Ventures for an exclusive AMA (ask me anything) session to talk Supplier Management!
 


If you have run into problems, send a message directly to @Etienne and let us know!


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How are SaMD companies supposed to put a Supplier Quality Agreement together for a “supplier” like AWS? Best practices on this?

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Do you guys have any stories on how you’ve handled supply issues during the pandemic? I know, I know, it’s 2022 and we should have figured this out by now, but we still have hiccups in our supply chain.

I heard a story from one company (Company A) of how they had an agreement with a supplier that allowed Company A employees to be trained on and operate the suppliers equipment as a night shift when the supplier did not have the capacity to produce Company A’s product. 

Stories like that are really interesting to me, because they challenge the creative side of Quality… seems like every medical device company struggles to be the low-man on the totem pole when it comes to a suppliers prioritization. 

Having said that, are there lines we can’t cross? What are they, and why?

Good afternoon, I have three primary questions when it comes to supplier management.

 

First, what differences should there be in supplier quality agreements for distributors vs manufacturers?  Specifically, when the supplier you purchase from does no manufacturing of the part and simply purchases and resales.  I have personally only seen one supplier quality agreement other than the one my company uses and both of those and most of my research seems heavily focused on purchasing from manufacturers. 

 

Second, what sections of a supplier quality agreement should always be included and which are most important?  Again my experience is limited, but I have seen, almost always, a section for QMS standard/regulatory compliance and then further sections relating to CAPA, inspection, testing, etc.  Why can we not say that those actions are implied in the contract since the contract requires QMS standard/regulatory compliance and those actions are required by those standards/regulations?

 

Finally, how can deal with suppliers who seem to not care about your business because your order volumes are too low?  For example, a supplier will not allow you to exercise the appropriate levels of control due to your sales volume but all similar suppliers are either not financially accessible to your business or same the same attitude.

 

Thank you for taking the time to give this webinar, it is a much needed resource!  

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I think we were able to provide some insights to each of the questions that were posted during the AMA.  if have any follow up questions, feel free to message me directly.

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The video of today’s session is up, so let me know if you have any issues accessing it

Also, I’d love to hear any additional feedback on the remote vs. in-person audits - I started a new thread at this link:

 

 

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