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FDA Expectations: Overcoming Supply Chain Weaknesses

BONEZONE: Data can be endless. Where do you start with data collection?

Browning: Let’s say that this is part of the manufacturing process. When validating that process, one of the outputs should be the information that will tell us, in an ongoing way, whether that process is still in a state of control when it’s executed. There is a subset of data generated during the manufacturing process. It’s not all the data in the process, and it’s not the entire device history record or the history of the component manufacturer, but it’s certain aspects. On an accessory, for example, it might be one or two key measurements. If these measurements lie within a specified tolerance, it’s likely that everything else is within tolerance, too. Those are the things we want to check during acceptance, and those are the things we want the supplier to check.

Fundamentally, it’s part of the output of the validation process itself. That means that you don’t have to look at 100 percent of the data. In general, you might be looking at only two or three percent of the data.

BONEZONE: The topic of supplier management can be quite involved, and you’ll certainly cover multiple aspects of these expectations during your presentation. Until then, is there anything I haven’t asked that you would like to mention?

Browning: I focus a lot on monitoring and making sure that device companies are fully aware of what’s going on at their suppliers. That doesn’t mean that they need to know every single thing going on at the supplier level, because quite often the supplier is making many things for many people. But device companies do need to know about the health of their outsource partners, financially as well as the personnel. The more you know about a company and the more comfortable you are with them, the better fit you are when you outsource.

Also, in our industry, there’s probably too much reliance on the auditing process to assess suppliers. We need to communicate more before and after audits. Audits are necessary, and I’ve done audits all of my life, but an audit is just a snapshot in time. You need to look for other ways to assess the health of a relationship between the contract company and its outsourced suppliers. Audits are just one part of that, and the other communication aspects are much more important.

It’s knowing people and being able to pick up the phone and talk to them. It’s critical to make sure you have good contracts and agreements between the companies. You have to be proactive; otherwise, the communication doesn’t begin until after there’s a problem.

Martin Browning is President and Co-Founder of EduQuest, a global team of FDA compliance experts based near Washington, D.C. His 22-year career at FDA included work in field offices as an expert investigator and as a senior manager in the Office of Regulatory Affairs at FDA headquarters. He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs. He also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, Mr. Browning was a member of the FDA committee that developed the medical device Quality System Regulation (QSR) and served as chair of the U.S. government’s ISO 9000 committee. He is the chairman of many of EduQuest’s classroom training classes, including “The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management.” In addition, he has written an EduQuest Advisory on “The Hot Potato of Responsibility: How to Manage Outsourcing and Not Get Burned,” available for free by emailing This email address is being protected from spambots. You need JavaScript enabled to view it..