Evaluation of Medical Device Suppliers - Categories when Initially Evaluated

P

Phil Fields

#11
We categorize our suppliers by the following:
• Key Suppliers: Suppliers that are Sole suppliers or are key due to $$$ volume
• Tier 1: Critical components as defined by Engineering, components that are critical to the safety and efficacy of the product/user/patient.
• Tier 2: Custom design material suppliers (machine shops)
• Tier 3: Commodity (nuts, bolts, material packaging etc)
• Others: Services
 
Elsmar Forum Sponsor
#12
We categorize our suppliers by the following:
• Key Suppliers: Suppliers that are Sole suppliers or are key due to $$$ volume
• Tier 1: Critical components as defined by Engineering, components that are critical to the safety and efficacy of the product/user/patient.
• Tier 2: Custom design material suppliers (machine shops)
• Tier 3: Commodity (nuts, bolts, material packaging etc)
• Others: Services
Hi Phil:
I guess I should say here that we already have our suppliers "classified". We currently do not have anything "formal" such as you've outlined above - although we base our categorization on a similar criteria.

Where I was heading to above was a means, through Risk Management, to document our qualifications process and show a reasonable means of justification as to why a given supplier is critical. I'm not picking on you, but you defined "Tier 1:" as "Critical components as defined by Engineer,..." I'm looking for a subjective way to document those engineering decisions by a defined set of criteria. "Because Engineering told me" is an acceptible reason - because I know they know what they're doing.:cool: I just want a tool to "prove them right on paper" so to speak...:agree1:
 
P

Phil Fields

#13
Hi Phil:
I guess I should say here that we already have our suppliers "classified". We currently do not have anything "formal" such as you've outlined above - although we base our categorization on a similar criteria.

Where I was heading to above was a means, through Risk Management, to document our qualifications process and show a reasonable means of justification as to why a given supplier is critical. I'm not picking on you, but you defined "Tier 1:" as "Critical components as defined by Engineer,..." I'm looking for a subjective way to document those engineering decisions by a defined set of criteria. "Because Engineering told me" is an acceptible reason - because I know they know what they're doing.:cool: I just want a tool to "prove them right on paper" so to speak...:agree1:
When you come up with the subjective way to classify please share. We have hit the same road block here with engineering. We have had to push back to define why some of the items are critical.

Phil
 
V

victoriab65

#14
On any supplier evaluation forms, I refer back to the FMEA(s) for the relevant product(s) where the supplied part or service is used. The FMEA, if done well, indicates the degree of control needed for the supplier. As noted above, this completes the loop of controlling the risk identified in FMEA (or whatever risk assessment tool you use).
 
G

Gert Sorensen

#15
On any supplier evaluation forms, I refer back to the FMEA(s) for the relevant product(s) where the supplied part or service is used. The FMEA, if done well, indicates the degree of control needed for the supplier. As noted above, this completes the loop of controlling the risk identified in FMEA (or whatever risk assessment tool you use).
Simple and efficient :) I like that!
 
M

Mrs Moloney

#16
Hi Steve,
Did you manage to develop the risk based supplier assessment. I was thinking of developing a standard assessment and using this together with catagorisation in order to give the supplier a rating. I wonder could you just use FMEA? Or maybe a correlation and matrix table like Quality Function Deployment could be employed?
 
#17
Hi Steve,
Did you manage to develop the risk based supplier assessment. I was thinking of developing a standard assessment and using this together with catagorisation in order to give the supplier a rating. I wonder could you just use FMEA? Or maybe a correlation and matrix table like Quality Function Deployment could be employed?
Hi Mrs. Moloney:

The short answer to your question is no. I was heading down the path of a risk-based supplier assessment, but in the end I abandoned the idea. It seemed to cumbersome. We've taken our current supplier classifications and sub-divided our "Critical" Suppliers into "Critical" and "Select" (our supplier classifications are based on a three-letter acronym - that's where "select" came from :notme:).

...anyway, the "Critical" Suppliers will be the ones that have the "Quarterly Supplier Assessment" due primarily based on dollars spent. "Select" suppliers will require all of the up-front evaluation and approval, but will be monitored primarily through our incoming inspection and our NC (non-conformance) system. Both categories supply critical parts and materials, but for the "select" suppliers - since they only supply parts/materials once or twice a Quarter - they will be monitored by a less time consuming part of our Quality System.

Just for information sake, the rest of our suppliers are categorized as "Approved" (i.e. everyone else we buy stuff from such as tape, non-critical supplies and services, etc.), "New" (suppliers we've had to put into our MRP System to generate a PO but have not completed the approval gauntlet), "Probationary" (those who just ain't cuttin' the mustard at the present time) and finally "Rejected" (...as the name implies). We decided to track rejected suppliers so that we don't go down this road again unless absolutely necessary - plus we'll have the history documented as to why we no longer deal with them and will document why we want to begin again.

I'm sure this doesn't help your endeavor, but I thought I'd give you a quick glance as to where we ended up from the "loft goal" I originally set.:cool:

FMEA's, to me, have always been a personal pet-peeve of mine. They are useful, but can be easily skewed since they are typically "subjective" instead of "Objective". As far as QFD - I really don't know much about that area so I don't know if it would be useful or not.

...More than you wanted to know, but that's my story...

-Steve
 
M

Mrs Moloney

#18
Hi Steve,

Thanks very much for your reply. I too was thinking of classifying the suppliers into critical and non-critical. There would have to be defined criteria in order to determine if the supplier is critical or not. Thats where I was thinking a risk assessment could play a part espically where it may not be obvious how to classify the supplier. I like your idea of critical and select, that makes sense. I dont get the acronym thing though.
I have the added problem in supplier control of being tied to corporate SOP's that do not really apply in some cases as its a distribution center and not a manufacturing site so the product is delivery.Incoming inspection and lot acceptance cannot be used to rate the suppliers.

regards
Mrs Moloney
 
#19
...I dont get the acronym thing though.
Sorry about that - I/We've defined our Supplier Classifications by a 3-letter acronym so that we can put this "tag" into their record in our MRP system. It makes it easier to search for a supplier and/or print out a list of suppliers that fit a certain category. So for our supplier lists, we have "CSL", "SSL", "ASL", "NSL", "PSL" and "RSL". I wanted to keep them all to three letters so there was less chance of input errors, consistency, etc.

Guess it's just a personal "quirk"... :rolleyes:

Just a "by the way" - for our suppliers who fall into the Distribution Center category, they are "ASL". But, our SOP is written that way - maybe once you come up with your classification scheme, it's time to revise the SOP?

-Steve
 
G

Gerry Quinn

#20
Steve,
I've attached a matrix that I have been playing with for a couple of years.
It's an attempt to provide risk based guidance to evaluating a supplier based on his current performance conditions and the risk associated with the specific product or service.
The supplier does not get a permanent classification because his performance may change and the risk associated with the product or service may change from project to project.
I took the risk categories from Mil-std-105E as a starting point.
I made up the supplier performance status categories.
 

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