When QualityHub Principal Consultant Phil Parsons walks into a medical device manufacturing facility for the first time, he’s not looking at procedures, opening binders, or reviewing audit reports. Rather, he’s paying attention to how people communicate, how openly problems are raised, and whether leadership decisions match what the company claims to value.
Such early signals can reveal whether a manufacturer has a true Culture of Quality or if it’s still developing, says Parsons, who’s a longtime QHub subject matter expert. He noted that while experienced industry professionals can form an early impression of a firm’s overall quality and compliance health during an initial walkthrough, it takes time and trust to gain a more complete picture.
“You have to do some digging to get that fuller view,” he said. “An audit is just a snapshot in time. These companies are putting their best foot forward. What you are seeing is often just the tip of the iceberg. If I go in and find a few problems, there is probably much worse that I’m not yet seeing.”
Over time, as Parsons works more closely with manufacturer teams on projects or improvement efforts, employees often become more candid about their work and how the firm operates. This is also an opportunity to gauge quality culture.
“If employees don’t believe leadership is on board when it comes to a Culture of Quality, then they probably won’t be on board, either.” – Phil Parsons
“As an auditor/consultant, you might be there a couple of weeks, and you start getting to know all the key players,” he said. “You start getting to know what their concerns are, and then all the puzzle pieces begin to fall into place.”
Parsons said the clearest indicator of a strong Culture of Quality is how leaders behave when faced with difficult choices. Written policies and stated goals matter, but employees ultimately evaluate leadership based on actions.
A Culture of Quality “absolutely comes from top management,” he said. “It has to be reflected in the goals that filter down through the organization.”
That said, “people can put anything in writing; what matters more is consistency over time,” Parsons noted. “When it comes to decision-making over time, if quality culture takes a back seat, that’s when problems will begin to crop up. That’s where the rubber meets the road and when it becomes obvious that company leadership might not be invested in a Culture of Quality.”
Such decision-making might include whether to release a borderline product batch, invest in a higher performing supplier, or allocate resources to quality systems. Parsons said each choice sends a signal about priorities, and whether one of those priorities is a quality culture.
Equally important is whether employees feel safe raising concerns. “You want a culture where people can come in and tell you that there is a problem that needs to be dealt with,” he said. “And you have to show them that you are willing to do something about it.”
Without that trust, communication breaks down.
“If employees don’t believe leadership is on board when it comes to a Culture of Quality, then they probably won’t be on board, either,” Parsons said. “Or they get burned out very quickly because they feel like they’re pushing a stone up a hill.”
Building Culture Takes Time and Intentional Hiring
Strengthening a Culture of Quality requires both leadership commitment and intentional hiring practices. Parsons pointed to the importance of selecting leaders with proven experience and allowing them to shape teams aligned with quality values. (Related QHub Expert White Paper: “Building a Culture of Quality in Medical Device Organizations: Best Practices for QMSR Compliance,” QualityHub, March 2026.)
“Hiring the right management – that is, people who have a proven track record in quality culture – is a great step to take,” he said. “But it’s only a first step. Giving that management the latitude to go out and find the right people and sort through their organization to find quality-minded people who share their culture and their values is absolutely vital.”
Companies that embed quality into everyday decision-making are better positioned to succeed.
Parsons also emphasized the importance of hiring employees who are willing to raise issues rather than avoid them. “Hire people who are not ‘yes men’ who will escalate issues and let you know if there are problems,” he said.
Quality culture, Parsons stressed, isn’t built through documentation alone; instead, it’s a mindset reflected in how people respond when something is not working. “It is absolutely an attitude,” he said. “You need to have the ability to tell people, ‘This is not working and we must find a better way to do this.’”
That shift does not happen quickly. “It takes time,” Parsons said. “Most of my projects with manufacturers are longer term, and it does take time to do this.”
The Business Case for Quality
Parsons said executives often respond most strongly when quality is tied to measurable business impact. Understanding the Cost of Quality can help organizations see it as an investment rather than a requirement.
“They usually talk about money,” he said. “They need to understand the Cost of Quality, particularly poor quality.”
That cost includes more than direct expenses such as scrap, rework, or recall management. It also includes operational disruption, delayed product launches, and the internal resources required to investigate and correct issues. Over time, these pressures can reduce efficiency and strain organizations.
The reputational impact can be even more significant. “Poor quality isn’t only a direct cost. It also costs reputation,” Parsons said. “It’s bad press.”
In highly regulated industries such as MedTech, reputation is closely tied to regulatory confidence and customer trust. Companies that repeatedly struggle with quality issues may face increased scrutiny, which can further amplify operational demands.
The bottom line? As FDA expectations under QMSR continue to evolve, Parsons said companies that embed quality into everyday decision-making are better positioned to succeed. When quality is treated as a core function of how the business operates rather than a compliance exercise, manufacturers tend to see fewer disruptions, stronger alignment, and more consistent performance over time.
