What is it about FDA inspections that cause medical device companies to go to red-alert status? Should that really be necessary, especially if the inspection is supposedly routine in nature? Certainly, there is a lot at stake for the company, as the FDA has the power to seize product, prohibit shipment, and even physically padlock your place of business.
But, if a device company has been making an honest effort to meet the requirements of the FDA’s Quality System Regulation (QSR), what is there to hide? During my career, I have seen the inspection preparation process progress from the days when a document-runner would be designated to gather paperwork requested by the FDA investigator, to the popular front-room/back-room strategy often employed today. At times, the back room looks like the NASA flight control center in Houston, with a team of document-scrubbers and runners, audio hook-ups to the front room for additional staff to monitor the discussion with the FDA investigator, and even large remote monitors connected to the front room, monitoring what is being looked at on the computers there.
Who are these monsters that invade our places of business, where we strive to design and manufacture devices that improve the quality of peoples’ lives? Well, they are not monsters at all! They are federal employees who are hired and trained to make sure medical devices will be safe and effective for those who need them. In a webinar on the inspection process, the FDA specified the qualities of a good Consumer Safety Officer (CSO) — the people who inspect medical device manufacturers:
Reviewing this list caused me to reflect on my own experiences during FDA inspections, and to think whether the CSOs that sat opposite me at the inspection table possessed these qualities.
Who Needs Interpersonal Skills?
I’m not sure why excellent interpersonal skills are a priority for CSOs. Sure, they need to be able to communicate and interact effectively, but excellent interpersonal skills seem to be a “nice-to-have,” rather than a necessity. I would estimate that less than half of the CSOs I have encountered had excellent interpersonal skills, yet I feel all of them were able to communicate effectively.
CSOs are not motivational speakers, nor are they sales people. They only need to effectively ask for the information they need and properly explain their reasoning if they believe something does meet the requirements of the QSR. They certainly need to clearly explain when they will document an observation but, in my experience, every CSO has been able to do this.
Knowledgeable And Organized? Yes. Dependable? Not So Much…
CSOs follow a formal process, prescribed in their inspection manual, which helps to keep them organized. I also have found them to be very knowledgeable on requirements of the regulations. I have often observed CSOs looking up sections of the Code of Federal Regulations to verify their thinking, rather than going from memory, which is laudable. However, I also have observed several instances where the CSO has not been very dependable.
One such instance involved a CSO who pre-announced an inspection and showed up for day one, but left before the end of the day, indicating they would return the next day. But the CSO did not return for several days and, upon finally returning, left before completing the inspection. This pattern continued for several weeks and was incredibly disruptive for the device company. Inspections tie up resources and interfere with day-to-day business and, recognizing this, CSOs must perform their duty as efficiently as possible to minimize business impact.
In my 25 years working in the medical device industry, every CSO I have encountered has been absolutely professional. I have formed relationships with them that helped to expedite the inspections and lasted beyond those inspections. This is an area where it appears the FDA’s selection process and training is highly effective.
Perceptive And Intuitive, But Sometimes Trapped In The Small Picture
I also have found CSOs to have excellent perception and intuition. They seem to quickly grasp complex systems and processes, and ask great questions to uncover the information they seek. What does seem to be lacking, at times, is a view of the big picture.
I have seen this play out especially when a CSO has experience or knowledge in a particular technical area. Their strength becomes an area of focus for the inspection, and the larger picture of how all the processes come together to produce the end product can get lost. If this happens during one of your inspections, it can be helpful to try to pull the focus upward, gently reminding the CSO that your device is much more than the technical area they specialize in.
Sound Science And Technical Tenacity
The CSOs I’ve encountered have been very competent in the areas of science and technical knowledge necessary to complete their inspections. I have found it refreshing when, in planning for a particular inspection that will include specialty knowledge, the CSO has talked with another resource within the FDA to gather background information in advance of the inspection. I also have appreciated when CSOs ask for a demonstration or explanation of the medical device company’s technology at the beginning of an inspection. By doing so, they grow their own knowledge and open the door to a more informed and efficient inspection. This also shows a measure of respect for the work that the medical device company does.
The School Of Hard Knocks
It seems a bit of a misnomer that the FDA looks for educator and teacher qualities in their CSOs. Inspectors are performing an official governmental function for the purpose of ensuring public health and safety; they should not be spending time educating the business on what it is supposed to be doing. CSOs bear the burden of clearly explaining violations they observe, but they should not be taking time to teach an organization what it needs to do to be compliant. This remains the device company’s responsibility, and information abounds on the FDA website regarding these requirements.
Lowering The Boom On The Back Room
I firmly believe that it is time to eliminate the practice of front-room/back-room, at least for routine inspections. Have you ever wondered what FDA CSOs think of the process? I asked a CSO that very question once. The CSO replied that the process has become commonplace and they accept it, but it makes them feel like there is something to hide. It creates an environment of distrust. A routine inspection should be just that – routine. Perhaps the legalities of protecting your business mandate the back room in ‘for-cause’ inspections, but it’s time to get everyone in the front room for routine inspections.