Supplier Controls we can place on Single-Source Suppliers

R

racglobal

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#1
#1
Hello everyone. I am in the medical device industry and I find supplier management to be an area where the answers are not too clear-cut. I have some questions. What sorts of supplier controls can we place on single-source suppliers? If they are the only supplier available for the particular critical component we are looking for, what controls are available? On the other hand, for a critical component for which there are many suppliers, what sorts of controls can we place? Thanks. I look forward to any insight.
 
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Bev D

Bev D

Heretical Statistician
Staff member
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#2
#2
Starting fairly high level as I'm sure others will chime in:
Sole source suppliers
- it is best to ensure that your design is fairly robust and forgiving to variation from the supplier.
- if possible, ask for their inspection and monitoring data or at least have an effective IQA plan in place.
- shortages could be a problem so be very diligent around business continuity plans: floods, earthquakes, political upheaval for OUS, etc are a fact of life, how will you deal with this? (for example, excess inventory?)
- have a robust and well documented policy in your contract that explains the supplier change notification process and a robust validation process for any changes.
- How can you design a sole source parts out? this is long term but may be the only real protection you may have.
Critical Components, multiple suppliers: I assume these are 'off the shelf' parts?
- if off the shelf then again making sure your design is robust to variation
- if not off shelf, then ensure that you have identified all of the important characteristics, you have a good MSA with the supplier and yourself, the supplier(s) processes are capable, use SPC or other process controls as appropriate.
- have a robust and well documented policy in your contract that explains the supplier change notification process and a robust validation process for any changes.
 
M

Mike S.

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#3
#3
Sole source is tough unless your supplier is great. In addition to Bev's great suggestions, you can do on-site audits and source inspection.

If they are a crappy supplier you should really design them out if at all possible. There is always risk, but more so when there is a sole source in the mix.
 
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