9 June, 2015 Morris Sherwood Director, Regulatory Affairs and Quality Assurance Isolite Systems
|Sometimes it’s your company that forces
a new direction during the inspection,
sometimes it the auditor. Sometimes it’s both.
Adventures of a seasoned inspector. Really, what could go wrong?
So far in my 26 years of working in medical devices I have had many an adventure when it comes to FDA and Notified Body Inspections. I love inspections. I know it sounds crazy but there is this Zen place you get to during an inspection. You must practice patience. You must not think you know exactly what your inspector is thinking. At the same time, it is this amazing game of psychological chess whereby you watch your opponent’s moves and think five moves ahead, only to have your strategy thrown out the window when the inspection zigs rather than zags.
Sometimes it’s your company that forces a new direction during the inspection, sometimes it the auditor. Sometimes it’s both.
I picked up Saul, my inspector for my plant in Costa Rica, in the lobby of the hotel where we both were staying on a beautiful warm Monday morning. After welcoming him to Costa Rica and exchanging pleasantries we got in the car. I revved up the three-cylinder Toyota Yaris and off we sped (probably not an accurate term for the Yaris that had two speeds: accelerator to the floor or stopped). We wove through traffic and diesel black clouds from the buses with our radio on. Janis Joplin’s “Take another piece of my heart now baby!” was playing. “Turn it up” Saul said. I cranked it and he started singing along at the top of his lungs. “Well this should be an interesting inspection,” I thought and joined in at the top of my lungs.
We pulled up to the plant on the last chorus of the song “You know you got it, if it makes you feel good!” I actually felt pretty good. We entered the plant and I introduced Saul to management and the team. My management and the inspection team were pretty uptight (you know the feeling), trying to see if they could determine which way this inspection would go based on the vibe of the inspector. Saul got down to business and started asking for a ton of documents.
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We had folks from our parent company in the States helping with the inspection. This group of seasoned inspection veterans was there to provide explanations and guide the inspection (as much as anyone could possibly “guide” an inspection). Documents proceeded to flow and discussions ensued. Saul was a tough one to figure out. At times he would be laid back and barely glancing at the documents. Other times he would drill down to the nth detail and get really passionate about his perspective on the correct way to comply with the regs. We rapidly decided that this inspector was wholly unpredictable and we couldn’t figure out his rhythm or logic of progression from one area to the next.
Then he started finding things. A missing signature here or missing date there. A calibration record signed off by the wrong person but it was enough for him to pick up the scent. He was no longer inspecting the output of our quality system---he was now inspecting us. He watched to see how we answered these small issues that arose. He wanted to understand our conviction and knowledge. And that’s when it hit the fan.
Saul found a record where the dates signed off were non-linear or sequential. He would look at this one document, get up from the conference table, go stare out the window for about five minutes (all the while my team was looking at me like “What do we do? Where is he going with this?”) I motioned for everyone to relax, stay focused and roll with it. Meanwhile I went to the inspection logistics team to get the people that could explain this better. The data was legitimate but we were screwing up the explanation. Finally, after returning from staring out the window, he went to the production manager he had been interviewing about this document and started loudly exclaiming that the document appeared to be fraudulent based on the dates and that someone was in big trouble unless they could explain it now! The production manager lost it and she started crying. Something had to be done.
“Hey Saul, let’s go for a walk,” I said. “Clearly we are not doing an adequate job of educating you on this issue so I propose we take a 10-minute break, let everyone cool down and then come back and review it again.” So Saul and I sauntered out into the warm humid Costa Rican afternoon and began to walk down the street. Once outside, Saul’s whole demeanor changed. His body relaxed, his smile came back and he was jovial. I asked him what the deal was. He said that he didn’t think there was really a big deal but that we had better get our act together to succinctly describe what he saw as anomalies. We talked and then sat on the lawn and stared at leaf cutter ants carrying…uh…leaves. Our ten-minute break turned into 30 and of all that time we only talked for about ten minutes and the rest of the time was spent watching ants, clouds and passersby.
Finally we went back to the plant. Saul and I were totally relaxed but when we walked into the conference room, my team had so much tension it was totally palpable. I addressed the group that we wanted to review the item in question just one more time, that everyone should relax and explain in slow calm terms the information on the document. The production manager took a deep breath and calmly, logically and with conviction explained the document and sequence. “Oh” said Saul, “That makes sense, I get it now.” Phew!
Because this was a foreign inspection, it was legal to have Saul join us for dinner that evening. Everyone was being friendly but clearly Saul and his unpredictability freaked my team. I was okay with it. Again it was that Zen “just roll with it” frame of mind that allowed Saul and me to hit it off.
That night Saul and I sat poolside drinking and discussing the day’s events. The fact that we had some good documentation practice issues meant we were getting a 483, but it wouldn’t be a showstopper. This would be a good thing as next week Saul and I were to travel to Ireland to visit our other plant.
What could go wrong?
In the above occurrence, the events were factual but the names have been changed to protect the individuals. Likewise, companies have been bought and sold and no longer exist as depicted. Keep in mind the FDA is a dynamic organization that has changed and will continue to change. No one description of an inspection is representative of the agency or current inspectors. Such is our challenge to greet the new and continue our quest to educate others and demonstrate our pursuit of quality.
Have you had to intervene in a bad audit experience to turn it around? Share your story below. Remember to remain anonymous!
Morris Sherwood is a director of regulatory affairs and quality assurance of Isolite Systems in Santa Barbara, California. He also has a consulting company, Sherwood International Consulting Group, and worked in this field for five years prior to joining Isolite Systems. Morris still does consulting but on a limited basis.
Morris has facilitated/participated in more than 25 FDA inspections, numerous Notified Body inspections and many inspection trainings and inspection preparation in the US, France, Ireland, Costa Rica, Italy, Scotland and Germany. In that same vein, Morris has worked with a variety of domestic and offshore companies in responding to 483 observations and Warning Letters.