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Supplier Auditing - No purchases from our key suppliers in the last 24 months

Ed Panek

QA RA Small Med Dev Company
We are a small class 2 FDA ISO 13485 facility. We have made no purchases from our key suppliers in the last 24 months as we overbought our initial order. My attempts to audit these suppliers has been met with resistance because they don't see a business case in responding. What should I do?


Involved In Discussions
Short answer: write a rationale. Longer answer: Keep in mind there is no explicit requirement to audit suppliers in the QSR. If you have created a written requirement, you must follow your procedures. If supplier say no / not now, define a plan on when it will be acceptable to them (when running your next order is likely outcome). Ensure you have escalated this supplier management challenge to your Purchasing / Supply chain team members. I would also be sure to have robust incoming / receiving inspection data to demonstrate balance of controls.

Sidney Vianna

Post Responsibly
Staff member
Rethink your process of a mandatory supplier audit. What are you trying to accomplish by auditing the supplier? Have the products you (over) bought from them performed well? Are there any concerns over the quality of their deliveries? If their products have been performing adequately, what is the rationale for demanding an audit that creates disruption for them?

Are they certified to relevant standards, such as ISO 9001 or 13485? Request copies of their CB audit reports, instead of demanding your own audit.

Good luck.
Agree with advice so far regarding re-assessing the need for audit.

However, if you determine it is appropriate (perhaps because it's a critical supplier, or because of the very isolated lots), I'd suggest revising your supplier approval criteria to associate the audits with orders. Perhaps some criteria like "a supplier audit shall be performed within X months of placing an order".

This way, audits are associated with purchases (which will mitigate supplier reluctance - supplier has something to gain), and you can confirm that all the quality controls from the last order are still in place (e.g. you can verify that they haven't changed any suppliers, equipment, processes in the interim).


Involved In Discussions
Very routine case and not to worry much as you already thought about this. You can follow up the guideline provided by William55401 also, I suppose, in your supplier OP you have listed a time frame to audit your supplier based on the product / supplier risk category (1 yr. 2yr, 3 yr etc.). If you haven't purchased any product from critical supplier within stipulated audit time frame, then in your 'Approved Supplier Register' state that audit shall be conducted prior to next purchase order placement from this supplier. You can also add a single line in your management review meeting report (as an input) that x supplier audit shall be conducted at this time (anticipated time frame) due to lack of PO. Alternatively, if you are doing supplier performance review on annual or bi-annual basis you can document the same.

If you have solid rationale and all reasoning in place, then regulator should able to accept it.

Ed Panek

QA RA Small Med Dev Company
Thanks all. I created a memo to file we can use that is risk based. It asks questions like - changes in materials, technology, facilities, locations, tooling. and then asks the lead time if we reorder. We then ask for their ISO certs and file it away.
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