The word “quality” is synonymous with medical, pharmaceutical and diagnostic device design, development and manufacturing. Government and third-party organizations, as well as more than 1,400 International Organization for Standardization (ISO) standards, focus on ensuring consistency, quality and safety.1 Those numbers, however, don’t include critical certifications and registrations to which these companies also must adhere, such as current Good Manufacturing Practice (cGMP), European Union Medical Device Regulation (EU) No. 2017/745, Medical Device Single Audit Program (MDSAP), National Medical Products Administration (NMPA), and Ministry of Health, Labour and Welfare (MHLW).
While most healthcare device companies can point to their list of certifications and registrations, these represent the bare minimum of what a healthcare company must do to meet the industry standards for quality. For a quality commitment to be truly authentic in healthcare, it must be all encompassing and reflected in the organization’s vision, values, culture, employees, products and services.
Exceeding Quality Expectations
At Phillips-Medisize, a Molex company, quality personifies everything we do. As a contract design and manufacturing organization, we work closely with our customers to design, engineer and manufacture pharmaceutical drug delivery devices, medical devices and in vitro diagnostic products that help millions of people live healthier, more productive lives. Every product we deliver is made with the life of the patient in mind, so we have long held that the minimum is never enough and that compliance with regulatory bodies and standards are simply table stakes in healthcare – they get you in the game, but they are rarely enough to win.
Based on our philosophy that the minimum is never enough, we require every facility across our organization to be audit-ready at all times. This ensures our manufacturing facilities are in full compliance every day of the year rather than just the days on which inspections and assessments might occur. As a result, Phillips-Medisize medical sites have not had a critical finding from a notified body in the past several years.
Ultimately, for us, quality is not a department. It is a companywide, cohesive culture that is grounded in policies and values that guide everything we do. Every member of the Phillips-Medisize organization is committed to building a quality culture for our healthcare manufacturing by supporting shared quality objectives and continually improving our processes and removing siloed mentalities. The secret sauce behind our quality success is rooted in three main principles:
- Quality in everything we do starts with me
- Embrace global consistency
- Lead with our strengths
Quality in Everything We Do Starts with Me
No company can expect to be a high-performing, quality organization if only a handful of people are tasked with maintaining quality processes and goals. To truly be a quality-driven organization, a company must accept that quality is not an action, but an attitude that permeates the entire culture and drives every step in its operation.
At Phillips-Medisize, we believe people are our most valuable asset, and ultimately, people are at the heart of our quality commitment. If our team isn’t dedicated to attaining and sustaining a world-class quality culture, then we will never achieve it.
Building a culture dedicated to quality starts with each individual. From the moment they walk through the door for the first time, every member of the Phillips-Medisize team is taught to see the products we develop and manufacture as a representation of their commitment to excellence. This ideology is reinforced in daily meetings, where team members discuss opportunities to continually improve our systems and processes, and through recognition of people for their quality commitment.
As part of the company’s dedication to continued improvement, each team member is responsible for elevating issues when they see them. While we aim to achieve perfection, we know that issues arise and manufacturing defects are bound to happen along the way. But we also know that what sets a quality company apart is how we react when an issue is discovered. At Phillips-Medisize, that means responding quickly to identify and implement long-term solutions and working transparently with our customers – from the time we first identify the issue to when we fix it.
Simultaneously, we have reinforced the importance of overall timeliness and attentiveness across the organization because we know that issues are less likely to arise if people are working on projects well before they are due.
Above all, we know quality takes the right mindset. It requires everyone to be a problem solver who can imagine what is possible. That kind of culture is only feasible when you are surrounded by optimistic, encouraging and affirming people. Negative people simply cannot promote a positive culture.
Embrace Global Consistency
Even as a global organization, it can be easy to focus on meeting only the regulatory requirements of the region in which a manufacturing facility is located or where the product will be used. But this is a myopic view that can keep a company from attaining global excellence.
At Phillips-Medisize, we realized that to develop the highest quality, most consistent products possible, we needed to implement a global quality management system. Much like rebuilding a house, this required taking our site-based quality systems to 20 different production facilities around the world and stripping them down to the studs – the most basic elements required to run a quality global organization.
Once we were down to the essentials, we implemented a new enterprise resource planning system, established an international team to lead the shift to a global quality management structure and wrote a new charter for the organization. We then redefined and standardized processes and implemented a new electronic quality system to ensure everyone was aligned with best practices. We call the system MyQMS to further enforce the culture and behavior that everyone owns and is a part of quality.
When we had the basic walls of the new global structure in place, we returned to each site to assess if they had local processes that could provide an even higher level of quality worldwide. These have become the finishing touches on the new quality structure.
The shift from regional to global quality systems took two years, during which we had to pass all regulatory audits and inspections. While the new system has been in place since 2020, our work isn’t done. We continue to look for ways to further improve our processes and procedures. As part of this effort, we have established a team dedicated solely to finding ways to improve our practices, which has improved our efficiency.
Lead with Our Strengths
Ensuring quality requires knowing what you do well. It may seem lucrative to take on every project that comes your way, but if you take on work that isn’t part of your core competencies, you can dilute your focus, which can undermine every endeavor.
Phillips-Medisize focuses on choosing projects where we can add value and maintain compliance. For example, we don’t currently work on U.S. Drug Enforcement Agency–controlled substances or aseptic fill because they require additional quality systems on top of our existing system.
Conversely, we offer legal manufacturing services because we have expertise in early design and development of products, submission to regulatory authorities and commercialization. This has been beneficial for companies of all sizes. For small customers, this is particularly important because we can offer regulatory expertise they often can’t afford to invest in themselves. For large pharmaceutical customers, we can offer the device experience they need for combination products. Coupled with our expertise supporting various jurisdictions globally, we can offer significant value to companies of all sizes around the world.
As an organization, we are open to expanding, but we won’t take every project that comes our way. Our integrity requires us to evaluate every project based on risk and knowledge rather than value of the program and profit.
Putting Quality First Yields Results
Quality is not a simple or short-term project. It is a continual commitment to excellence. People are a major part of the commitment. A company can write all the quality management policies it wants, but unless their employees are invested in the process, it will never succeed.
We know that we ask a lot of Phillips-Medisize employees, but the result has been ongoing improvement in every area of our organization. Based on our key performance indicators, we have continually improved the quality of our products while reducing costs. We have less scrap overall because team members see issues and react faster. They also identify and work on projects before they become issues because they know timeliness is a key element of quality assurance. All of these efforts result in fewer audit findings because our sites are much more prepared and always audit-ready.
While embodying quality in every part of an organization isn’t easy, it is a commitment we will continue to pursue because it is the right thing to do for everyone touched by healthcare products – patients, healthcare providers, customers, team members and the company itself.