by Federico Perez, Senior Quality and Compliance Manager
Today, most medical device manufacturers (and most organizations in general) don’t think of quality as an aspect of company culture. It is seen as one department’s responsibility. For some, the only time leadership really dives into questions of quality is when there’s a problem. Especially a problem that could impact market reputation or increase attention from regulatory bodies.
This can leave quality professionals feeling like they’re working in a silo, separately from the rest of the organization. Driving true quality and convincing peers and executives of its importance beyond just cost can feel like an uphill battle.
The organizations that stand out in the medical device industry and truly dominate their markets are the ones who recognize that quality should be top of mind for the entire organization -- starting with leadership and extending all the way down. Quality is not just about technology and guidelines, it's about driving it as one of the core values that defines your organizational culture. Creating a true quality minded culture starts with the people. Many companies start with this concept, but fall short when it comes to implementation.
However, changing your culture is a major task to take on. It certainly can’t be done overnight and may seem impossible to achieve at all. But quality professionals just like you are taking this challenge on and finding that they can make a real difference in the way their organizations view quality.
How are they doing it? We’ve put together a guide below to help you put together a plan to drive a quality minded culture throughout the entire organization.
How to create a culture of quality.
First, how do we define a quality minded culture -- what does that really mean and what specific goals are you aiming for?
We think of a quality minded organization as one that’s filled with people who truly understand that quality starts with each of them personally. They embody quality in each of their actions because they have a true passion for it as a personal value. It’s a mindset that sees quality as having just as much importance as any other departmental goal.
Most importantly, a culture of quality is one that inspires people to care about quality not just because leadership has encouraged it but because they want to drive the highest possible value for the organization. Simply put, they’re wholeheartedly invested in quality because they know that it will help the organization reach its goals -- and they understand the impact that poor quality can have on the end user.
What could that look like? Is it worth putting in the time? Imagine that, instead of scrambling to respond to fire drills, you’re empowered to take all the necessary steps involved in ensuring not only FDA compliance but the highest quality possible at a reasonable cost. A company with a highly developed culture of quality spends millions of dollars less annually fixing mistakes than a company with a poorly developed quality culture. And instead of your peers and executive leadership viewing your department as a cost center with competing goals, they celebrate and embrace quality in all they do because they see the value it has in achieving long-term goals. Imagine that quality is no longer solely your department’s responsibility, but an essential part of the entire company’s culture.
Now that you know what you’re aiming for, let’s get started with a step-by-step rundown of how to begin inspiring a company-wide culture of quality:
1. Commit to your own quality mindset.
Your first step should be committing to your own quality mindset so you’re primed and ready to set the best example for your organization.
It’s easy to get caught up in an organization’s focus on quality as primarily a cost.
With a limited, cost-focused view of quality, you lose sight of the impact true quality can have on your organization. It doesn’t allow you to embrace quality as the way of life and philosophy of doing business that it truly is.
A good concrete step in this stage is to begin preparing your “quality elevator speech” that aligns with the organization’s commitment to quality.
Messaging is pivotal to cultivate a quality driven mindset within an organization. Most companies promote messages about the importance of quality, but their efforts are wasted if the messages are not believed.
With a thoughtful and consistent pitch, you’ll be establish a concise message that conveys the overall concept of quality throughout your organization and help everyone see the benefits of having a quality focused mindset. Preparing yourself ahead of time can really improve your chances of success.
2. Find your cheerleaders.
Now that you have your elevator speech ready, it’s time to launch your quality-first campaign!
It may be tempting to start with a presentation to leadership, and if you truly feel they’re ready to hear it, give it a shot. But for most organizations, especially larger ones, a grassroots campaign (starting at the most basic level of your organization) can be more effective early in the process.
Rather than organizing yet another meeting, start with simple, more casual tactics that put your passion for quality on display. Have quality focused discussions with your peers and executives over lunch or during impromptu conversations whenever possible.
Don’t be afraid to become a “broken record” -- over time, you want your colleagues to become so familiar with your company's stance on quality that they can easily recite the quality policy.
The most important thing to remember when talking to your colleagues about quality is to focus on their concerns and goals. Show them how a quality mindset can benefit them and help them reach their goals, and you’ll begin building an audience eager to hear what you have to say.
3. Set the example.
As you build your audience and identify cheerleaders who want to support your efforts to drive quality, it’s important to “walk the walk” as much as you “talk the talk.” You must demonstrate the quality mindset in a concrete, specific way -- otherwise, peers may dismiss your efforts as just another culture initiative with vague goals bound to burn out in a few months.
Fostering peer engagement is a balancing act. If leaders become overly involved in the project too early, impact and authenticity suffer. If too little support is shown, important opportunities are missed. This means showcasing achievements and results to promote engagement.
Becoming your own quality cheerleader with measurable goals will show others how serious you are and inspire them to join you on board the quality first train. It may even inspire their own new and innovative ideas to promote a quality mindset in their respective departments. This is a sure sign that your quality-first efforts are taking root.
4. Define a team action plan with clear responsibilities.
With specific, measurable actions and goals to report on, colleagues who may have remained skeptical will start coming around to your way of thinking, and you’ll find yourself with a list of people who want to support your quality efforts to drive a quality minded culture.
Again, this isn’t the time to rely on vague promises to “keep quality top of mind” -- it’s time to sit down with your cheerleaders and make a plan. Walk them through your process to create your measurable actions and goals, and empower them to create ones specific to their own department.
Working together to choose specific, trackable tasks will keep your efforts on target and build even more goodwill among your peers. You’ll be able to start moving the quality needle in a more meaningful direction.
One of the defining traits of an organization with a true culture of quality is that employees are free to apply judgment to situations that fall outside the norm. Providing the right level of guidance is key. Too much hinders creativity and discretionary action, while too little leaves employees unclear about their authority to make decisions and carry them out.
If those conversations don’t happen organically,encourage them -- never back off from your dedication to being a quality cheerleader for your organization.
5. Get leadership involved.
At this point, you may find leadership beginning to pay more attention.
Even when executives have the best intentions, there are often gaps between what they say and what they do. As a result, employees get mixed messages about the true importance of quality to the organization.
Now is the time to sit down with the appropriate leaders and create a specific plan just like you did with your peers. Talk specifically about how they can begin implementing actions to drive a culture of quality from the top down -- at the same time you’re driving it from the bottom up.
See if you can get enough buy-in to implement regular check-ins on progress. If you decide on a standard meeting format, offer to provide lunch to build even more goodwill and motivation to contribute to your quality campaign. Keep the cadence reasonable, taking into account your leaders’ busy schedules.
And don’t forget -- focus again on how well-defined quality goals will benefit them and your organization as well as specific departments.
6. Support your goals with the right processes and technology.
What if you could continuously monitor key metrics around high-risk issues within your organization through optimal data visualization? Visualizing your Quality Systems and Compliance status provides an enhanced means of assessing your data to develop a clearer understanding of areas that contribute to compliance risk, allowing you to address them before they become costly issues.
Embracing analytics and maintaining key metrics with visualizations will allow you to quickly monitor and identify trends that may be harmful to your Quality System. Now that you’ve got the people on board, this is where you can find the momentum to update and improve your processes and technology. Leadership and peers will both have a clearer understanding of how and why this is important.
This is where most companies in the medical device industry need improvement. It’s rare to see companies spend the time and resources to improve the way they collect, analyze, and present important quality systems performance data. Most data collection and analysis is conducted manually using OTS software applications like Excel by assigned personnel responsible for specific areas within the organization. Standardizing the way you collect and analyze key quality metrics data data can greatly improve the reaction time to potential underlying quality issues. Standardization also establishes a more reliable method of data analytics that isn’t highly dependent on tribal knowledge. In this case, a third-party consultant can be the answer that helps you achieve your long- and short-term quality and compliance goals.
We’re here to help!
With over a decade of industry expertise, Onebridge provides a structured, risk-based approach to assessing the health of your Quality System. Our people have an extraordinary level of expertise with all aspects of quality and compliance and have worked hand-in-hand with hundreds of companies to diagnose, solve, and prevent quality issues.
Our quality and compliance team offers more than 2 decades of experience in Life Sciences with a special focus on FDA requirements and quality systems. Our data visualization experts also offer simple, easy to read dashboards that completely revolutionize the way you share quality data across your organization.
Through an exhaustive compliance assessment of the current state of your Quality System, we can visualize your data to diagnose the health of the system and help you make better decisions that provide early treatment options for any symptoms detected.
Example of a quality and compliance data visualization dashboard
After all, more compliance efficiency can lead to an increase in time to focus on your long-term goals. Your business goals and expectations are built directly into the treatment options we offer to mitigate any compliance risk we identify and establish solutions that are sustainable through time.
Interested in learning more about how this works? Check out our Quality and Compliance homepage to learn more about us and Download “Diagnose and Prevent: Increase Compliance and Efficiency in Your Quality System” to learn about our approach to assessing the health of your Quality System. You’ll see how, using specific data points, we can visualize the health of your system, show you exactly what changes are needed, and prioritize those changes so you reach your goals faster.
With information about your organization’s quality systems health available in simple dashboards, creating a company-wide culture of quality first becomes much easier. We’d love to hear about your goals and challenges and help in any way we can -- contact us today.
About Federico Perez
Federico has 15+ years of professional experience in process validations, project management, and process/quality engineering within the FDA-regulated industry. He has extensive knowledge of FDA regulations (21 CFR Part 820, Part 11), ISO standards (13485, 14971), process control using statistical methods (SPC, ANOVA, DOE, and more), statistical based sampling, and process improvement. Federico also has vast experience in the validation of a diverse variety of manufacturing processes and equipment for the medical device industry.