Why the quality of your complaint intake process determines the quality of your root cause investigations If your company has received an FDA observation related to complaint handling, your first instinct may be to focus on the investigation itself. Common observations include: Failure to investigate customer complaints Failure to determine root cause during complaint investigations The typical response is to strengthen root cause analysis tools, perform additional testing, o

In pharmaceutical and medical device companies, the phrase “quality system” often triggers frustration instead of confidence. Executives think about delayed product launches, excessive documentation, endless approvals, and teams spending more time managing procedures than solving problems. Quality leaders frequently inherit systems that were built reactively over time — layered with disconnected processes, redundant reviews, and workflows that no longer support how the compan

Not long ago, I was on a call with a company that was convinced their quality system had failed them. They used words like broken , messy , unmanageable . They told me about audit findings, recurring complaints, and a general sense that nothing was working the way it should. And then they said what I hear almost every time: “We think we need to tighten everything up. Add more procedures. Maybe restructure the whole system.” I paused for a moment, because I’ve learned this is

One of the things I’ve noticed over the years working with pharmaceutical and medical device companies is this: no matter the size of the organization, the same complaint handling challenges tend to show up again and again. It doesn’t matter if I’m partnering with a startup preparing for its first product launch or supporting a more established company refining its quality system. When we take a closer look at complaint handling processes, a few consistent gaps almost always

I can usually tell within the first fifteen minutes of a conversation. A founder is walking me through their processes. An operations lead pauses before answering a simple question. Someone eventually says, “Well… that’s what the SOP says, but that’s not really how we do it.” And there it is. They didn’t build their quality system. They adopted it. Sometimes it came from a previous company. Sometimes it was purchased as a template package. Sometimes a consultant installed it

I was scrolling on Instagram this week when I came across a post from a man who very articulately and honestly, pretty wittily described his frustration with calling companies for help or to file a complaint. As he walked through his experience, I found myself nodding along. He explained how the automated system asked for his information upfront: account details, the reason for the call, sometimes even a short description of the issue. After carefully providing everything, he

I’ve seen this story play out more times than I can count. A product starts in R&D with a lot of excitement and momentum. Smart scientists and engineers are focused on innovation, performance, and getting something new into the world. Quality gets involved later, sometimes much later, often when timelines are tight and decisions feel locked in. That gap between R&D and Quality is where many companies unknowingly create risk. Not because anyone is doing a bad job, but because

Every November, somewhere between planning holiday travel, juggling year-end projects, and wondering if I made enough applesauce, I find myself slowing down just long enough to reflect on the year. And every time I do, I come back to the same feeling:deep gratitude for the work I get to do and the people I get to do it with. Quality isn’t flashy. It isn’t loud.It certainly isn’t the first department mentioned in a press release. But it is the backbone of trust — trust in prod

Outsourcing has become the backbone of modern pharmaceutical and medical device operations. Sponsors increasingly rely on Contract Development and Manufacturing Organizations (CDMOs) for speed, expertise, and scalability. But as outsourcing continues to expand, so does regulatory oversight. The FDA and EMA have made it clear: while CDMOs perform the work, sponsors remain ultimately responsible for the quality and compliance of their products. Outsourced does not mean out of s

When people think about building a compliant quality system, their minds often go straight to procedures, documentation, and audits....

I know what you’re thinking: Complaint handling? That’s hardly the most exciting part of running a business. But here’s the truth --...

If you're part of a small team in a regulated industry, you’ve probably felt the tension between wanting to build a robust quality system...

When it comes to inspections, most teams fall into one of two camps: those who panic when someone in a suit shows up at the door, and...

When most people hear the word complaint , their first instinct is to brace for impact. It’s easy to view customer complaints as burdens...

In today’s fast-paced and highly regulated industries, especially pharmaceuticals and medical devices, risk-based thinking has become a...

Quality metrics are more than just numbers on a report—they tell the story of your business. They show where things are running smoothly,...

If you work in the pharmaceutical or medical device industry, you know that problems will pop up, it’s just a reality of manufacturing...

In regulated industries such as pharmaceuticals and medical devices, document control is a critical component of compliance and...

As the holiday season sparkles with lights and festive cheer, many of us reflect on the year gone by while planning for what lies ahead....

Navigating FDA compliance can feel like a daunting task for small businesses, especially those operating in regulated industries like...