Purchasing process needs for R&D department - IVD Medical Devices

[Vincnet]

Dear all
I have a question regarding purchases (clause 7.4).
We are Designing Manufacturing and Distributing IVD Medical Devices. Do we need to apply clause 7.4 to our R&D activities ?

The standard says:
7.4.1 Purchasing process
The organization shall establish documented procedures to ensure that
purchased product conforms to specified purchase requirements.
The type and extent of control applied to the supplier and the purchased product
shall be dependent upon the effect of the purchased product on subsequent
product realization or the final product.

At first my interpretation was: no need to apply purchasing controls to R&D activities, as design prossess follows verification and validation. But having a second thought, I am now wondering whether one could consider that not controlling R&D purchasing activities can affect the final product!

thanks in advance for bringing some light on this issue for me.

Vinc

 

[wrodnigg]

Hello Vincent,

Dear all
At first my interpretation was: no need to apply purchasing controls to R&D activities, as design prossess follows verification and validation. But having a second thought, I am now wondering whether one could consider that not controlling R&D purchasing activities can affect the final product!

Since you have to conduct D&D review, verification and validation, any adverse effect fom materials should be eliminated.

I do not see any "must have" requirement during R&D.
On the other hand all specifications of the product are developed by R&D.

In that sense I would say that purchasing controls are developed together with the product. So at the production kick-off all required purchasing controls are established.

 

[lindal]

Dear Vincent,

I have found that it is very helpful to begin purchasing activities as soon as a product moves from "R" to "D". After the pure research phase of product development is completed, one usually has a good idea what inputs are required to achieve the completed product. If you know you are working on building a stick, you can be reasonably sure it won't turn into a ball by release to market.

By the time you reach early development you will know what materials, packaging, labeling, accessories, and services that will be probably required. for example You may not know exactly what kind of tubing you will want for the outer lumen of a catheter, but you know that company X makes an enormous range of tube sizes, and their salesperson is very helpful. By the development phase of R&D you should also know your packaging and sterilization requirements, so you can begin identifying and conditionally approving vendors and identifying whether they need a site qualification visit (audit), a quality system certification, or just a cert of conformance.

While there is not a requirement that early in the process, it's much more helpful to start sooner rather than later. Vendor surveys are not usually filled out quickly and setting up site visits can take awhile to schedule.

Just a note, but be honest when you set up your qualification system. If you're using a certain supplier because Joe used to work with the owner, allow yourself to say that previous experience allows you to qualify that vendor with only a certificate of conformance and receiving inspection. Don't waste time looking for hollow justification. Either they're are qualified or not and your inspection records, verification, and validation will bear that out (or disqualify the vendor).

LSL

 

[Vincnet]

dear Linda and wrodnigg,

thanks for your feedback.

In fact what we do so far is very near what you suggest Linda we request from our providers certicates of analysis for all the incoming goods (even at R&D level) this allready helped sorting an issue with one product. And our first evaluation (done just right now) is based on a 2 step analysis:
1) if we had no problems recorded with a provider during the last 2 years we ask our staff some questions on their relation with the provider such as hability to repply to technical inquiries.
2) for the providers for which we have recorded non conformities we analyse how they were solved. If we are not happy with the resolution then they will be taken out of the list.

We've got a blank audit in oct and planned the certification audit in december, so it will keep me busy for those rainy autumn days ) And give me plenty of stupid questions to ask to my fellow cove members!

V