Suppliers Starting to Charge A Fee for Customer Audits

[optomist1]

Hi Gstough, I may have missed it the above posts; any insight as to "justification(s)" for the excessive number or audits? From both sides of this equation, "sometimes" an OEM has specified number and frequency in the source package + Quality Requirements. The formal agreed to definition of "audit" may pose some challenges as well. And yes some OEMS may use the random audit for training newbie SQA folk...

And in other instances if there is a real or emerging quality or capacity issue with Vendor A's widget, then such unscheduled audits may be fully warranted. In very general terms once a supplier has been initially audited/assessed and passed (i.e. a Supplier Eligiability Assssment), then barring above such issues, annual audits at the customers discretion and supplier timing concurrnce, are "normal". This has been my experience; some of this may attirbuted to COVID remote impacts...catch up of sorts...my three Euros

Hope this helps...
Cheers, Optomist1

 

[ChrisM]

I've just posted similar to below in "the other thread" where this is being discussed; ISO13485 and MDSAP are even more rigorous that ISO9001, so there really should be very little need for chargeable customer audits over and above recognised international certification audits (IMHO). There may be a need for a customer audit to agree/verify that specific terms and conditions are being implemented, but otherwise ...... ??

In the EU I would think that these "mandatory paid customer audits" would be considered as "unfair business practices" and outlawed.

Take a step back, the main objective of ISO9001 (formerly BS5750) when it was introduced was that as a supplier, you were subjected to one set of totally independent audits every year (and that was it, as far as quality audits go) rather than having to host numerous audits from every customer and potential customer. Something has gone badly wrong when not only do you have the time/cost implications of the independent audits but also continuing customer audits, especially when customers start charging you for the "privilege" of going business with them

 

[planB]

For maybe the second or third time over the last 2-3 years, when reaching out to suppliers for audit dates I've received some push-back from them saying they've begun charging a fee for customer audits (usually in the $3k-4k range). Their reason is the same: it's expensive for them to host multiple audits throughout the year and they feel they need to recoup the cost from lost production time, resources, etc.

I'm just wondering if anyone else in the medical device industry has run into this and how have you addressed it? Did you pay the fee and move forward with the audit or did you manage it some other way?

Thanks in advance for sharing.

Have experienced the same in the ISO13485 world, typically for suppliers that host a large number of customer audits. In my view once you get such a quote, the supplier has already made up his mind, is not open for negotiation anymore and will not lower/erase the audit fee. You could try negotiating that they consider this audit fee in their price calculation for the parts/services they supply or that they do not raise this audit fee in the next 5 - 10 years. But otherwise, in my experience you would just take that fee and move on.

 

[ChrisM]

You can always just load your selling prices to the supplier to claw back the costs of their chargeable audits.....

 

[optomist1]

a bit more; I have seen instances where a supplier negotiates and treats "random audits" much like software re-flashes or updates (that are requested due to issues external to the suppliers module or sub-assembly) the supplier includes and clearly states "X" number of re-flashes or audtis are included...anything above that agreed to or stated number incurs a set charge.