This blog proposes a simple solution for how to qualify a supplier that doesn’t have a quality management system.
You are ignoring the obvious question of why doesn’t a medical device supplier have a quality management system. If you are a contract manufacturer, you should ensure that you have a clause in your supplier qualification procedure that says you don’t need to qualify suppliers that are mandated by your customers. If your response to this suggestion is “Duh,” you haven’t conducted many supplier audits of contract manufacturers. As my buddy, Tim says, “You need to leave some ‘wiggle room’ in your procedures.” This is also good advice for all 19 of your top-level procedures that get audited each year.
For the remaining suppliers you are considering to add to your Approved Supplier List (ASL), you need a SIMPLE set of criteria for how you qualified the supplier. Guess what that magical document should be? (Answer to be provided shortly)
Many companies use a supplier self-evaluation survey. I’m almost certain that I have bashed these nearly useless documents before, but if I failed to do this, …most of them are problematic. A one-page supplier information form seems more appropriate. No signature required! And please make it a Word document.
The supplier qualification procedure needs to be generic for all raw materials and services you purchase. The problem is that everything you purchase has different requirements. So instead of wasting your time with writing one procedure that has wiggle room for every single product or service, you will ever purchase, don’t even try. Instead, write a SIMPLE procedure. This procedure needs only to be one page long. It needs four requirements:
1) New suppliers must complete a supplier information form and submit it to the company. This should be updated at least once every 12 months and whenever there is a change to the information provided (i.e., – notification of change).
2) You need at least two people to approve the addition to the Quality Management System. This can be done on your ECO or DCO form for changing the ASL. If the supplier is customer-mandated, you need the customer’s approval and the purchasing managers. If the supplier is internally selected, you need at least purchasing and QA to approve it.
3) You should have an objective criterion (probably more than one requirement) that is product/service-related for acceptance of the supplier. This criterion SHALL be under document control, and the revision shall be communicated to the supplier when orders are placed. See ISO 13485:2003, section 7.4.2 (Purchasing Information).
4) Finally, you need a reference to your purchasing procedure (one of the required 19 documents) and your supplier re-evaluation procedure.
If you have not already guessed, the “magical” document is called a purchasing specification or raw material specification for raw material items. For capital equipment, you may require that a capital expenditure justification be completed instead of the purchasing specification. For a calibrated instrument, tool, or fixture, you may request that requirements of the instrument/tool/fixture are documented in the applicable procedure or work instruction. For example, for measurement of this cannula, a calibrated optical comparator is required with 20x magnification. Reference the inspection procedure or drawing, and you are done.
For those of you that would like to keep your ASL shorter, which I recommend, if you don’t think you will be using the supplier more than once, you might want to give the buyer the option of documenting the purchasing specification on the purchasing requisition instead. This might be very helpful for those engineers that are doing R&D or validation work. For example, I need a bag of resin that meets the following raw material specifications—but we don’t currently use this material, and I’m not ready to submit one for approval. That’s why the engineer is ordering the bag of resin. She needs to test the material in the application and gather some preliminary data as justification for the new raw material specification.
There are 100’s of other ways to qualify your suppliers, and many of them work well if you follow your procedure. If your procedure is SIMPLE, your Monday’s will be better.