Ken Miles, Former FDA Inspector

Ken Miles, a 28 year veteran of the FDA, is today a widely-respected industry consultant to the medical device industry. He draws on his extensive experience to help firms effectively and efficiently comply with FDA requirements. Ken’s expertise includes evaluating Good Manufacture Practice (GMP) and Good Laboratory Practice (GLP) compliance, Quality System Regulations, and QSIT certification inspections (Management, Design, Process Controls, and CAPA).

In this multi-part series, we talked with Ken about FDA medical device inspections, CAPA, quality systems, audits, training and more.

Q: Where do you think companies fall short when it comes to implementing CAPA systems?

A: Some companies have a great CAPA program that is tied in with metrics, management reviews, etc., but ultimately may be only looking at trend analysis studies of post-production products. Unfortunately, they neglect trends with suppliers and internal production operations, or visa versa.  Valuable data can be obtained for correcting problems in their factory by looking at all trends: suppliers’ and in-house non-conforming materials and components, scrap rates, training issues, complaints, competitors’ non conformances (ie Warning Letter), etc.  Sometimes they’ll discover ”a peak in noncomformance with a certain product line”, but they fail to break it down to reveal that the nonconformance(s) only involve one or two models within the product line which is often the real culprit.

Company managers need to ask themselves, is it one model or all models? A certain shift? A certain part of the plant? Finding the root cause is very important in order to effectively resolve the problem(s). Companies need to isolate the problem and find out if it’s widespread, model specific, or a component. The big picture of using metrics is great, however, if you can’t drill down to the specific problem and root cause, then it’s really not solving the problem.

Q: Can you give us some examples of what you saw as an FDA inspector?

A: One time I was at a large global manufacturer and they had a lot of returned motherboards for ultrasound systems (hundreds of boards returned per month.) Instead of analyzing and finding the root cause of the problem of all these returned boards, they would simply rework and repair them – over and over again. These boards had a very high rate of return, but they would all just go into a big hopper for rework. They should’ve taken the time to do a root cause analysis, but they didn’t, preferring to continue to fix them. None of this was logged into a system, and no failure investigations were ever conducted.  Think of the risk to consumers and to the companies’ reputation and earnings! Think of the enormous waste in time and funds and other resources used for fixing the same problems over and over again.

This firm ended up having a major investigation by the FDA with recalls and monetary fines in the millions of dollars. If they had an effective CAPA system in place with root cause and failure investigations, they could’ve fixed the problem once and for all instead of reworking hundreds of motherboards per month.

Q: Why do you think medical device companies have such a problem with CAPA?

A: The biggest problem I see has to do with a lack of human resources. Typically a person in charge of CAPA has too many tasks and things tend to fall through the cracks. This generally happens to smaller companies with growing pains. That said, it also happens with the biggest ones, too. Bottom-line: the failure is about not devoting enough resources to CAPA, and letting other issues distract them because they are overworked.

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