FDA Expectations: Overcoming Supply Chain Weaknesses

FDA expectations of supplier management will continue to evolve as pressures are applied to the agency, device recalls are issued and outsourcing continues to expand. To ensure that quality is maintained, it’s important to understand where weaknesses often are found in the device manufacturer/supplier relationship, and know how to build solid partnerships.

Martin Browning, President and Co-Founder of EduQuest, a global team of FDA compliance experts, will speak at OMTEC 2014 about FDA’s expectations and regulatory authority over supplier management. In anticipation of the session, BONEZONE spoke to Mr. Browning about steps that orthopaedic device companies can take today.

BONEZONE: What are orthopaedic device companies’ weaknesses when it comes to meeting FDA supply chain management expectations?

Martin Browning: There are quite a number. One is the simple recognition that you have to control the external manufacturing operation, just as you would control manufacturing internally. That sounds like it wouldn’t be hard. In reality, it’s quite hard.

A lot of companies suffer from a weak process of receiving inspection. They believe that when they outsource something and they’ve checked it a few times, the receiving inspection process can be relaxed. In reality, you’re likely receiving something that you know very little about; it was made by someone else. You don’t necessarily have the manufacturing data. So your receiving inspection process has to be careful, especially because you’re putting your name on the products that result from it.

Another issue is that the companies to which you outsource have their own internal problems, such as management and change to the product they’re manufacturing, as well as change to personnel and the internal operating structure.

Yet another area of weakness is what suppliers do— or, more problematically, don’t do—to validate their processes and activities. Everyone should understand that processes have to be validated. What’s not so easy to understand is that when the process changes, your suppliers should make sure that the process is revalidated before they produce the product. In addition, you and your suppliers need to understand that many of your procedures, things like your CAPA system, also need to be validated to show that they actually do work.

Overall, CAPA is a weakness for many orthopaedic device companies. Quite often the supplier’s CAPA system and the device company’s CAPA system are two different systems, so they don’t interface well. It’s difficult to make sure that your supplier is in fact doing the corrective action—particularly the right corrective action—and doing it in the right time frame, while ensuring it’s effective.

BONEZONE: Let’s focus on your comment about two different CAPA systems. How do OEMs and suppliers come together to ensure that the correct processes are taking place?

Browning: In some cases, the most practical thing that an orthopaedic manufacturer can do is to provide the supplier with the processes they are expected to use. But that only works with certain companies, because many of the contract companies work with four, five or many more device manufacturers, each of which have their own systems.

What you want is a supplier with a quality system that’s compliant. You have to understand what the system is and what it’s supposed to do. You want to verify through contracts and agreements that your supplier knows exactly what to expect relative to the data it should provide you—no matter the interface—so the data can be something both companies can use. The supplier can use the data to support the fact that, “Yes, we’re supplying you with things that meet your specification,” and the device maker can look at the data that comes through that interface and say, “Yes, this appears to satisfy everything we want.” The clarity of the interfaces is very, very important. Sometimes companies have gotten to the point where they’ve actually provided interfaces to the other company.

 Martin Browning will provide OMTEC attendees with tools for FDA compliance regarding supplier management and design controls. Learn more about his sessions,
FDA Expectations for Supplier Quality” and “Best Practices for Design Verification and Validation".

OMTEC-2014-Presenter-Badge Web

BONEZONE: What can companies do today to improve supplier quality?

Browning: Collect more data from suppliers. The data needs to be relative to the ongoing processes used to manufacture whatever is supplied. That’s the first thing.

The second thing is to take time to review that data. Make sure there’s a link between the information you’re getting and your decision to accept the incoming components, accessories or whatever the product may be. Then you want to test for conformance. You want an incoming inspection that checks and confirms that, in fact, the specifications are being met. That doesn’t mean you have to test 100 percent of incoming product. You base the amount on history; you base that on science.

Fundamentally, that’s what device companies should do: collect data, review and analyze that data and then make sure that their acceptance is based on the data and the actual product received. And, they should link all these together by testing the products that they receive.

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..