Supplier Evaluation - *ALL* Suppliers to business?

[ThatSinc]

Hi All,

Looking at supplier management and trying to rationalise the number of non-device/production related suppliers that are needing to be managed;

For suppliers of office stationery, domestic appliances (kitchen microwave and freezer), janitorial services (for non-production areas), bookkeeping services (external contract labour in accounts), municipal supplies, or anything else that doesn't have an impact, directly or indirectly, on the devices manufactured by the company - is there still an expectation that these are evaluated and monitored as per 7.4.1

The definition of "product" as per 13485 doesn't explicitly link it to devices and only points c and d from 7.4.1 are linked to the devices being manufactured.

I appreciate that criteria could be defined to state that these types of product being purchased require only acceptable pricing & delivery to be considered approved, but these suppliers would still require monitoring and having records generated in accordance with 7.4.1.
I don't see how it would be acceptable to say that these suppliers require no monitoring, considering 13485 states you *shall* monitor the performance.

How do you manage suppliers of these types of product?

Thanks,

TS.

 

[yodon]

Per points c and d from 7.4.1, if the services do not pose any risk to the product, those suppliers need not be qualified, approved, or monitored.

 

[Tidge]

We manage suppliers by putting them into one of three different tiers. There is an assessment of potential impact that sorts the suppliers into the different tiers; each tier has different requirements to be met. This is true for suppliers of services and materials.

A subtle but sharp edge that is present with "unmanaged" suppliers is that it is straightforward to use an "unmanaged" supplier in an area where they really ought to be managed (to guarantee safe and effective medical devices). Typically this happens for trivial reasons along the lines of "we already have an account with Joe's Discount paper, how 'bout we use some of their stock for the pH strips?" (for material) or an equivalent argument for services.

 

[ThatSinc]

We manage suppliers by putting them into one of three different tiers. There is an assessment of potential impact that sorts the suppliers into the different tiers; each tier has different requirements to be met. This is true for suppliers of services and materials.

This is how it's currently set up, in 4 tiers; negligible, low, medium, high, critical. These are based on points c and d of 7.4.1
Each supplier approval has a defined scope of what they're approved to supply - based on the evaluation process.
E.g. if a supplier provides painting, plating, and anodising services - but only the anodising services have been verified, they won't get approved for painting or plating at that time.

The approval is based on points a and b of 7.4.1.


The trouble isn't necessarily approving the suppliers of the "negligible" risk items - all they have to be able to do is get it shipped at a good cost - though it is mundane and tiresome as there could be a new supplier each month depending on who is selling blue roll or mop-heads the cheapest.

The trouble is the "monitoring" of these suppliers, unless it's possible to carte blanche just say that negligible risk items can be purchased as necessary without any further approval or monitoring as @yodon states - I think any pragmatic auditor would accept this, despite not following the exact wording of the standard.
I don't think this would necessarily increase the risk of purchasing managed parts from an unmanaged supplier than if they were approved and managed as a negligible risk supplier.

 

[indubioush]

unless it's possible to carte blanche just say that negligible risk items can be purchased as necessary without any further approval or monitoring as @yodon states

Yes, this is possible. Add a statement to your SOP that states something like this, and there is nothing further you will need to do regarding these suppliers. No need to have them on an approved supplier list either.

 

[Tidge]

I don't think this would necessarily increase the risk of purchasing managed parts from an unmanaged supplier than if they were approved and managed as a negligible risk supplier.

Yes, this is possible. Add a statement to your SOP that states something like this, and there is nothing further you will need to do regarding these suppliers. No need to have them on an approved supplier list either.

My current company uses an "Approved Supplier List" for two different purposes:

1. It serves a business purpose to arrange payments to (all) suppliers
2. It serves a quality purpose by flagging the assessed tier each supplier

It's basically second nature to ask "which tier of supplier are they?" when trying to arrange payment for goods/services. We don't disallow ad hoc purchases of items, but purchases that don't go through the ASL automatically have all sorts of extra checks. This system doesn't put any practical burden on the low-impact suppliers or on managing the ASL. It's just that by formally connecting the sometimes esoteric philosophy of quality compliance to the mundane and practical concept of money we get near total compliance without much thought or objection. Every once in a blue moon a new hire with a personal attitude of heroism takes a semi-antagonistic approach to this smooth running process (e.g. "I could buy all you want much cheaper at the local flea market!") but the groupthink is strong (and well-motivated) against this. If such a person really wants to go the flea-market approach, they can follow the process to get their preferred vendors on the ASL.