Q: We’ve run into an obstacle with our supplier audits. How would you handle suppliers who won’t let you audit their facilities because either you’re not a big enough customer or they say they don’t have the time?
A: First of all, remember FDA regulations don’t require supplier audits. But they do require you to do supplier assessments.
Begin by asking if the supplier offers any alternatives to audits. Some suppliers will be willing to provide you with detailed data on their processes. Others may provide a certificate of analysis or a certification that shows they operate in compliance with certain standards. In a few cases, you may find another company — one who is doing a lot of business with that supplier — who will share information with you.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Strengthen your own internal process for inspecting incoming components or ingredients from that supplier.[/pullquote]
Primarily, you should strengthen your own internal process for inspecting incoming components or ingredients from that supplier. Measure as much as you can, as frequently as you can. A rigorous and well-documented incoming inspection procedure, coupled with even a limited amount of assessment data, can help you convince FDA you’re doing everything in your power to ensure the supplier is meeting your standards and requirements.
Answered by Martin Browning, President and Co-Founder of EduQuest and author of the EduQuest Advisory, “The Hot Potato of Responsibility: How to Manage Outsourcing and Not Get Burned” and co-instructor for the Managing and Auditing Supplier Quality training class.