Supplier Quality level category help - high level

[duff999]

Hi Folks

Wondering if anyone can provide insight at a high level for how to categorize supplier levels. Currently I am listing these as follows:

1. Level 1 suppliers provide a product that can be fully verified through receiving inspection, additional testing, or other methods. Level 1 suppliers are required to be maintained on the Approved Supplier List.
2. Level 2 suppliers provide a service that cannot be fully verified upon receipt, such as calibration service, consultants, shipping companies or outside laboratory services.
3. Level 3, Conditional suppliers are categorized as a Level 3 Supplier. Conditional suppliers are suppliers that are in the process of being approved or for suppliers that have not complied with purchase requirements and are being re-evaluated. Level 3 suppliers may be used to purchase goods for R&D purposes.

I would like to add more detail in these categories - such as identifying critical suppliers. Or should these categories be named something like....Critical Supplier, General Supplier, Conditional Supplier.

Any help would be appreciated, thank you

 

[normzone]

Having recently trod in this territory myself, and having decided to dial it back and simplify it, I want to ask -

What requirements are influencing your thinking?
What benefit of this approach are you looking for?
What are your risks you are attempting to mitigate?

 

[duff999]

Having recently trod in this territory myself, and having decided to dial it back and simplify it, I want to ask -

What requirements are influencing your thinking?
What benefit of this approach are you looking for?
What are your risks you are attempting to mitigate?

Thank you for your reply.

I am currently in the process of releasing our procurement procedure and have a section regarding supplier quality (ISO 13485) We do have a supplier quality module built into our QMS and I would like to classify certain levels based on what is supplied to us. I would like to leave some room for suppliers we purchase R&D material from (maybe a conditional supplier).

I guess I am having difficulty rating these suppliers to know what category they fit into.

 

[normzone]

Any categorization system will always have some overlaps - there will be some suppliers that will not fit perfectly into one category because they do a little of something in another category also.

As an example you could verify some calibration items if you chose to.

And conditional suppliers - that's fine for trying out a supplier, or R&D, but moving suppliers in and out of that category as they improve or err sounds like a chore.

Of course, you're in the medical field and I am not. Somebody who knows what they're talking about will be along shortly to offer a qualified opinion.

 

[silentmonkey]

Perhaps you could build in some way to assess criticality of a supplier. For me, criticality is based on whether the performance of the supplier has an impact on the quality and safety of the end product. This would not be the same as your Supplier Level 1 because even though the supplier's performance might be poor, you fully verify the output and hence eliminate non-conformities anyway within your own QMS, and therefore protect your customer from the risk.

How would you categorise suppliers where the output cannot be fully verified and there is an impact on product quality/safety?

 

[duff999]

Perhaps you could build in some way to assess criticality of a supplier. For me, criticality is based on whether the performance of the supplier has an impact on the quality and safety of the end product. This would not be the same as your Supplier Level 1 because even though the supplier's performance might be poor, you fully verify the output and hence eliminate non-conformities anyway within your own QMS, and therefore protect your customer from the risk.

How would you categorize suppliers where the output cannot be fully verified and there is an impact on product quality/safety?

For supplier that cannot be fully verified I would rely on the calibration certs for calibration services, or possibly the resume for consultants

 

[Matt's Quality Handle]

From an automotive background, your level 2 suppliers aren't what we call "suppliers".

What we considered suppliers were companies that provided material that ended up in our finished goods and were managed by the Quality department. The caveat is that I've never worked with a company that made product with embedded software, so that's a wrinkle.

But service providers were managed separately, and could vary in criticality from manufacturing equipment service and calibration providers to inconsequential services like managing the vending machines and landscapers.