When purchasing equipment, we ensure that the vendor is listed on our ASL as required by our purchasing procedure. We have been approached by manufacturing with a request to purchase used machinery from an auction. I don't have a problem with the purchase because we will validate it as if it were new, but our procedure does not have a work around for this situation. Does anyone have any guidance to offer related to one-time buys of equipment?

When purchasing equipment, we ensure that the vendor is listed on our ASL as required by our purchasing procedure. We have been approached by manufacturing with a request to purchase used machinery from an auction. I don't have a problem with the purchase because we will validate it as if it were new, but our procedure does not have a work around for this situation. Does anyone have any guidance to offer related to one-time buys of equipment?

Change the procedure?

Change the procedure?
We are looking to change the procedure, but I was hoping for some input from others regarding how they address situations like this.

Machinery and other capital purchases are not in the scope of our Purchasing procedure.

We are looking to change the procedure, but I was hoping for some input from others regarding how they address situations like this.

I didn't mean it to sound smart-alecky, but if your documentation says you must purchase from approved suppliers, and you want to purchase from non-approved suppliers, you've allowed the tail to wag the dog. There really isn't a way to violate the rules without violating the rules.

One way to avoid this is to separate MRO purchasing requirements from those for purchasing production materials, and structure the requirements to allow for wiggle-room and bargain hunting.

I changed the title some. My question is what do you do with your approved suppliers for annual documentation? We are a biomedical company following the ISO 13485 standard, some of the companies we buy from are ISO certified but most are not. Here is my issue, its not pratical for us to do an on-site audit to keep them qualified but the flip side is that a supplier evaluation questionnaire never gets returned. Any thoughts??

I agree with Cari - we do not include capitol equipment in our purchasing procedure. I look at it this way: For most of the machinery we buy, service (other than actual delivery) is not much of an issue. Once the equipment is on site, up and running, its our baby.

Conversely, raw materials almost all will have at least some service issues that come along with them. The relationship is ongoing, and can be quite important.

So, why treat raw materials purchases and capitol equipment purchases the same? I agree with Jim here: revise the procedure to reflect what it is you want to do. In the long run it is what makes sense.

I changed the title some. My question is what do you do with your approved suppliers for annual documentation? We are a biomedical company following the ISO 13485 standard, some of the companies we buy from are ISO certified but most are not. Here is my issue, its not pratical for us to do an on-site audit to keep them qualified but the flip side is that a supplier evaluation questionnaire never gets returned. Any thoughts??

Audits are costly. Questionnaires are not returned. So assess them on their performance to criteria which is important to your organization...delivery time, paperwork, in spec, etc.

Our Purchasing policy is geared towards consumables and services. However it does have a tie-in to larger purchases or those organizations which are not on the Approved Vendor List.

I believe that we agree that there is usually an exception to the established rule (in this case, the documented procedure). As Jim says, change the procedure to address this situation.

I assume that that any equipment or supplies obtained at an auction undergo close scrutiny by your own people or an approved 3rd party to assess their viability? I hope so!...especially as this thread is in the medical devices forum. :mg:

Add this process into your procurement policy. Pre-start inspections could be used to indicate that all is well and good with your newest purchase.