U.S. Food and Drug Administration (FDA) inspections or customer audits are some of the most stressful experiences from working in the life sciences industry. I worked for medical device manufacturers before joining MasterControl in 2006 and I’ve been through more than my fair share of audits and inspections. The FDA inspector always seemed to magically know where our weakest area was and hit us there. Even though we had good systems in place and strived for compliance, we still frequently weren’t prepared. That’s largely due to the fact that we were using a paper-based system, but a lot of these problems still apply to hybrid or even electronic systems today. My most gut-wrenching experience was the time our audit facilitator called on the head of development to bring in an implant associated with a customer complaint that was being questioned by the inspector, to which he glibly replied, “Which one?” To that point, the inspector only knew of one.
It’s been over 15 years since I had to deal with an FDA inspection, but I wanted to show you a before and after of what inspections typically look like and what they can look like given the right technology.
Calling it a formula might be a bit of a stretch, but it’s no secret that certain aspects of compliance are harder than others. And those are the areas the FDA tends to address. Unfortunately, if you start off on the wrong foot in an inspection, things just tend to snowball out of control from there. It’s like a shark that smells blood in the water! The first sign of trouble is when the inspector asks to see device history records (DHRs) from a few lots of product.
During my time working in medical device, this request inevitably meant searching through physical paper records. We’re talking binders, filing cabinets, banker’s boxes and sometimes having to send for a document held by our archival vendor. We’d be frantically searching through all this paper and with an inspector, every minute of delay feels like an eternity when you’re trying to find what’s been requested. The search always seemed to take the longest either right before lunch when the inspector was getting hangry, or right at the end of the day when they were itching to get back to the hotel. If we couldn’t produce the requested DHRs, we knew we were in big trouble. And even if we could find them, that didn’t mean we were out of the woods. The inspector was usually just getting started. Finding the DHR was just the warmup. After that the inspector would want to see the training records of those that had signed something on the record.
That means you have to decipher the initials of everyone who contributed to the DHR. These are handwritten initials and they aren’t always on a neat little line that says “Initial Here.” There are also revisions to the DHR that were written in the margins and initialed there. That cramped writing is its own challenge. Once you do identify everyone, if that’s even possible, you’re back to those filing cabinets and banker’s boxes, but this time you’re looking for training records. Which takes even longer. That’s all assuming everything is in order and you can find the training records. In the meantime, you’ve got an auditor that is growing more and more suspicious as the minutes and hours pass. If something wasn’t filled out on the DHR or you can’t locate someone’s training, that’s a finding or potentially something worse.
When the inspection’s finally over, how much time was spent on it? Paper presents a huge opportunity cost and a huge risk for a poor outcome in these situations. How much could your quality department have accomplished if they hadn’t just spent hours searching through paper? How much did it slow down production when you had to pull employees off the line to figure out if a scribble was their initials? Inspections are a days-long process, but when you take paper out of the equation you are able to save time and increase the inspector’s confidence that your ship is in order.
When you bring digitization into the picture, so many of those inspection or audit problems go away. At MasterControl we don’t create a regulated product, so we don’t have FDA inspections. But we do have audits related to our ISO certifications and our customers regularly audit us for their own compliance. Training always gets brought up during those audits and it’s never been a problem. That’s because all our training records are in a centralized location and in just a few clicks you can find any employee’s training.
With MasterControl Manufacturing Excellence, the DHR is no longer a problem either. The indecipherable handwriting is gone, the notes in the margin are gone, and the system prevents operators from moving ahead with blank or out-of-spec entries. Again, the records are right there. With a few clicks or a quick search, you can pull them all up. Training is also tied into Manufacturing Excellence and that prevents operators from completing a step if they haven’t completed their training. The system has prevented the problem before it ever had the chance to occur.
Something we’re working on that’s going to make audits and inspections even easier is MasterControl Insights. Insights is a new data analytics product that incorporates all the data in your MasterControl system to give you immediate business insights via charts, graphs, and other data visualizations. In the example of training, we have persona-based dashboards that show you which of your employees are overdue on training and who will be overdue soon. This is in addition to the prompts and alerts a user receives via email and within the system. And that’s going to be available to our cloud customers at the end of the year. We’re also working on interesting ways to leverage artificial intelligence (AI) that will use data in your system to point out bottlenecks in your lines and tell you how to optimize your processes for better quality and yield.
Following good manufacturing practices (GMP) and other regulations doesn’t just keep you compliant. It’s the key to offering consumers a safe and effective product. In medical devices, that product could be a literal life saver. Generally speaking, companies are trying their best to follow regulations. Demonstrating that is what proves to be so difficult. Managing documentation and processes, especially on paper, drains resources. And that drain on resources is entirely unnecessary. The technology to manage training documents and DHRs connects everything together and, whether it’s an FDA inspection or a customer audit, makes it easy to pull up what you need immediately when you need it without having to cross your fingers behind your back.
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