Supplier Selection and Evaluation - Raw Material Manufacturer vs. Distributor

[leroybrown]

Hi there,

We manufacture low risk medical devices (primarily FDA Class I) and currently purchase the same raw material from multiple distributors. Since the raw material is made by one manufacturer, is the same grade and is packaged the same way; is it possible to qualify the manufacturer as the supplier through the full-blown supplier evaluation/selection process and qualify the distributors through a much much less strenuous evaluation/selection process?

All help is greatly appreciated!

 

[somashekar]

Re: Supplier Selection/Evaluation - manufacturer versus distributor

Hi there,

We manufacture low risk medical devices (primarily FDA Class I) and currently purchase the same raw material from multiple distributors. Since the raw material is made by one manufacturer, is the same grade and is packaged the same way; is it possible to qualify the manufacturer as the supplier through the full-blown supplier evaluation/selection process and qualify the distributors through a much much less strenuous evaluation/selection process?

All help is greatly appreciated!

Hi leroybrown.
Why do you want to strangle yourself too much.
By deciding the manufacturer and the raw material and grade, you have already qualified him. This forms a part of the design output.
Just ensure that you get the same raw material by working with one or more authorized distributors, who can link you well with the manufacturer by proper traceability and corrective actions in case you face any problem.
What I have put in bold is one of your selection / evaluation criteria.

 

[MIREGMGR]

Re: Supplier Selection/Evaluation - manufacturer versus distributor

Since the raw material is made by one manufacturer, is the same grade and is packaged the same way; is it possible to qualify the manufacturer as the supplier through the full-blown supplier evaluation/selection process and qualify the distributors through a much much less strenuous evaluation/selection process?

Yes.

 

[Statistical Steven]

Re: Supplier Selection/Evaluation - manufacturer versus distributor

Hi there,

We manufacture low risk medical devices (primarily FDA Class I) and currently purchase the same raw material from multiple distributors. Since the raw material is made by one manufacturer, is the same grade and is packaged the same way; is it possible to qualify the manufacturer as the supplier through the full-blown supplier evaluation/selection process and qualify the distributors through a much much less strenuous evaluation/selection process?

All help is greatly appreciated!

Agree with the others that the answer is YES, but be careful. If you qualify the manufacturer using your internal supplier controls systems, you will need to ensure that ALL POs with ALL distributors are specific to the material you qualified. If any distributor repackages or "adds value" to the raw material, you could have issues. For example, you qualify the manufacturer of sodium chloride salt. Which they sell to distributors in 55 gallon drums. If the distributor than repackages into 1 quart jars for sale, you need to qualify their process of packaging into the jars.

I hope this makes sense.