Marlous van der Hooft In many organizations, routines are fiercely defended—even when they are inefficient, resource-draining, or outdated. Change is often met with skepticism, not because the ideas are flawed, but because they challenge the status quo. This resistance is not a personal failing; it’s a structural pattern. And it costs companies billions. At Qualificiency Consulting, we believe the solution isn’t to push harder—it’s to support smarter. According to McKinsey (2023), 70% of change initiatives fail—not due to poor strategy, but because of internal resistance. Leaders cite a lack of buy-in; employees feel overwhelmed. But beneath the surface lies a deeper truth: people want things to improve, but often without having to change themselves. This is where we come in. Improvement That Starts With Ownership We coach, mentor, and train organizations to build a culture where improvement is not imposed—it’s owned. When people understand the “why” behind change and are given the too

Marlous van der Hooft Recently, I had the pleasure of delivering a training session at Sure Laboratories in Helmond—a company led by Frank van der Zanden, who I’ve known since our microbiology days at Fontys University in Eindhoven. Frank and I reconnected through LinkedIn, and when he reached out to ask if I could support his team , I was immediately intrigued. The training was designed for his QA and project engineering team, focusing on the practical and theoretical foundations of their testing services. We covered a wide range of topics—from GMP to process setup, risk management, registration requirements, and regulatory timelines. What made this training truly special was the depth of interaction. We shifted focus toward the thinking behind integrating or updating processes into existing systems and organizations. Through exercises and open discussions, the team explored how to align compliance with performance in a way that makes sense for their context. The questions were sharp,

When starting and growing a business, many companies hit a wall around the 100-employee mark. Why? Because they resist change—especially the kind that affects culture, structure, and operational systems. The Startup Phase: Informal and Agile In the early days, everything is informal. You know your team. Communication is direct. Decisions are fast. Strategy is shared intuitively. But as your company grows, this model breaks down. You can’t talk to everyone anymore. You don’t know every new hire. And your once-shared vision becomes fragmented. The Growth Barrier: What Got You Here Won’t Get You There Research shows that companies often stall after rapid growth because they fail to evolve their internal systems (1) .They scale revenue, headcount, and markets—but not their organizational design. According to MIT Sloan, companies that restructure—flattening hierarchies or formalizing roles—see shifts in workforce engagement and performance (2) Forbes adds that without scalable systems, even

Marlous van der Hooft When a new product category emerges, it sparks excitement and innovation. But as the market matures, the rules of the game change—and companies that don’t adapt risk being left behind. At Qualificiency Consulting, we help radiopharma companies stay ahead by understanding where they are in the market lifecycle—and where they need to go next. The Four Stages of Market Maturity 1. Engineering-Driven Market: The Age of Invention Innovation is king. Products are new, exciting, and scarce. Customers buy because they want access to something novel. The market is driven by technical excellence—who can invent the next big thing? Think of the early days of theranostics or alpha emitters. The focus was on what the product could do, not how it was delivered or priced. 2. Manufacturing-Driven Market: The Race to Scale As demand grows, the challenge shifts from invention to production and distribution. Customers now ask: “Who can deliver this product fast, reliably, and complia

Marlous van der Hooft In my previous articles, I explored the Montesquieu Triangle of Powers—a lens through which we can understand the dynamics of influence and control in GMP environments. I spoke about the importance of transparency and the factors increasing risk for fraud. Today, I want to shift the focus from power to performance, and from control to collaboration. Let’s talk about trust—the foundation of high-performing teams—and how Patrick Lencioni’s Five Dysfunctions of a Team model can be applied to GMP organizations striving for excellence. The GMP Triangle of Trust In GMP environments, compliance is non-negotiable. But compliance alone doesn’t drive results. What does? Trust, transparency, and teamwork. Lencioni’s model outlines five key behaviors that build functional teams: Trust – Vulnerability-based trust, where team members feel safe to admit mistakes or ask for help. Conflict – Healthy, productive conflict around ideas, not personalities. Commitment – Clarity and buy

Marlous van der Hooft The Hidden Cost of Poor Culture in Pharma In highly regulated environments like pharmaceuticals, we often assume that compliance is enough. But what if the real risk isn’t just in the SOPs we write—but in the culture we tolerate? Let’s talk about the hidden costs of poor culture in GMP environments: Compliance Failures Even with robust systems, a disengaged or fearful workforce can lead to data integrity issues, deviations, and audit findings. Culture is the invisible hand behind every checklist. And the consequences are real: These issues don’t just stay on paper. They lead to higher operational costs, delays in batch release, regulatory penalties, and even unsafe working conditions. Most critically, they can compromise patient safety and erode trust. Poor culture directly impacts “hard” KPIs like Right First Time (RFT), batch rejection rates, CAPA cycle times, and employee turnover. Fraud and Ethical Drift Donald Cressey’s Fraud Triangle reminds us: when pressur