Verification of purchased product / supplier questionnaires

James

Involved In Discussions
#1
Hi folks

Just wondering how 'pragmatic' I can be with section 7.4

We are a small manufacturer of low risk devices; wheelchair seating and associated wheelchair aids. I'm thinking that a full-on supplier questionnaire is over-kill for most of our suppliers. A risk-based approach where we assess what the supplier product is for / what risks it poses, and define supplier expectations on that basis should suffice? Verification is largely by inspection and component testing (eg for electrical components used by one of our departments). Our material supplies include fabrics and foams (which we get fire retardancy test confirmation from our 9001 certified supplier); nuts, bolts, fixtures and fittings (9001 certified supplier); and components from a certified National supplier. If we use a 'one off' supplier for an urgent item, we risk assess the component / combination as part of the device build?

Thoughts appreciated!

James
 
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William55401

Quite Involved in Discussions
#2
I think you are on the right path. As long as your overall process addresses balance of controls (Supplier and Product), you should be OK. Recently, I have been getting deep into the supplier related GHTF (now IMDRF) and that flow is great. My current project requires speed and we are editing out deliverables that don't make sense. Consider the same approach for your org. For example, for my org, we do not care (no time to care) about formal business risk assessment (D &B for example) and we are skipping that deliverable for now. QMS 2.0 will be more robust. The regulators will like your GHTF (IMDRF) flow. You can use this as a model to flex for your org and unique product. Lite version is in your control. Go James!

Here's a link to the page of interest
GHTF Study Group 3 - Quality Systems
 
Last edited:

yodon

Staff member
Super Moderator
#3
Unless your INTERNAL procedures say that you have to do a supplier questionnaire (in which case you may want to change it!) then it's up to you how to qualify and approve a supplier. (If you search around here, you'll see plenty of rants about questionnaires being less-than-useful.) As you note, the higher the risk, the more scrutiny you should place on qualifying and approving.

I wouldn't forego the (qualification and approval) process for one-off buys. You can still qualify & approve the supplier and verify the purchase.
 
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