Well-Designed Quality Management Systems

For life science companies, a poorly designed Quality Management System (QMS) can ultimately result in non-compliance issues with the U.S. Food and Drug Administration (FDA), and other regulatory bodies, as well as current Good Manufacturing Practice (cGMP). However, the real cost of a poorly designed QMS happens long before enforcement or regulatory action.

A poorly designed QMS results in process stagnation, organizational frustration, and poor decision making, which can cause inefficiencies and added costs throughout your supply chain. More often than not, these inefficiencies lead to delays, and delays result in a lack of trust in your brand and can cause additional suffering while patients wait for your product.?

Companies often make the mistake of treating the symptoms of a poorly designed QMS rather than the cause. They reactively treat individual issues as they bubble up. Over time, this creates what I like to call a Frankenstein QMS. Like Frankenstein's monster, a Frankenstein QMS is a? patchwork effort that may technically operate but is clumsy at best and dangerous at worst.?

Nobody wants to release a Frankenstein monster to wreak havoc on the villagers—I mean the healthcare supply chain! Let’s look at how to prevent that with a well-designed Quality Management System.???

What is a Well-Designed QMS?

The goal of any life science Quality Management System is to ensure the quality, safety, and efficacy of a drug or medical device through an interconnected system of processes and procedures. However, your QMS strategy should also include data management, data integrity, quality culture, roles and responsibilities, documentation, and training.?

While the components are straightforward, how do you know if the components of your QMS are working together in the most seamless and efficient way? There are several key signs of a well-designed QMS:

Agility

Your QMS should be able to quickly and smoothly evolve with your business objectives, available resources, new regulations, and phase-appropriate needs. If your QMS hasn’t changed at all in the last one or two years, it’s likely outdated. Furthermore, your QMS shouldn’t require significant remediation or overhaul efforts in order to adapt to the constantly evolving regulatory landscape.?

Senior Management Engagement

The way executive leadership engages with your QMS is a clear indicator of its performance. A well-designed QMS should be built to support business objectives. The more engagement from senior management, the more aligned your QMS will be with your organization’s goals and objectives. Your QMS should be designed to signal to executive leadership when things are not working, and executive leadership should routinely evaluate the QMS to identify opportunities to optimize and improve.

User-Centered Documentation

The way in which procedures are written isn’t just for show. All procedures should not only be standardized but documented in a way that is easy for employees to understand and implement. After all, processes and procedures are only effective if your people are using them correctly and consistently. Not only that, but user-centered documentation empowers employees to be key decision-makers while minimizing the risk of errors.

Planning

Remember our Frankenstien QMS? Planning is essential to avoiding a clumsy, patchwork QMS. Whether you’re building your QMS from scratch or optimizing your current QMS, examine how quality is built into all aspects of your business, how your team is implementing your processes and procedures, and areas of your business that are delayed, stagnant, or slipping through the cracks. This diagnostic process is the foundation for a well-designed QMS.

When to Start Thinking About Your QMS Design

In general, it’s never too early to start thinking about your QMS strategy. However, the way you approach your QMS design may vary depending on your company size and business objectives.

Building a New QMS

For small to midsize companies pursuing your first product, you will need to develop your QMS strategy from the outset. At this stage, consider your current business, but also how your business will evolve and expand in the future. It’s important to know the quantity and types of products you will be developing. You’ll also want to consider your long-term vision, company culture, and how digital technology will integrate with processes described in your QMS.?

Optimizing Your Current QMS

For companies of any size who have an existing QMS that isn’t working well, you may need to optimize your QMS. Regardless of your company's size, be thorough when investigating problem areas. Be careful not to assume what’s broken. Instead, investigate inefficiencies or dysfunctions in your processes, data management, organizational structure, or team training. Rely on data to definitively diagnose issues, and remember to consider your long-term goals when optimizing your QMS for the future.

QMS Remediation

Sometimes remediation is necessary if you have received a warning letter or other enforcement action from a regulatory body. In this case, many companies make the mistake of patching the surface-level issue to rush remediation. However, you must prove to health authorities that problems have been thoroughly and permanently addressed. Investigate the root of the issue, rather than just fixing the symptoms. While urgency is important, it’s better to invest the necessary time to address the concern fully and avoid further remediation in the future.

The Future of Quality Management Systems?

Your QMS should be designed for the future of your business, but Quality Management Systems themselves are undergoing a massive shift to digital technology and platforms. Currently, many companies are using a hybrid system of paper and digital, but this comes with its own set of inefficiencies when the two systems don’t always speak to each other.?

Life science companies will have to navigate the transition to a fully digitized system. With this change, there are often concerns about digitized QMS replacing the human component of quality systems. However, eQMS will simply change the human role by filtering out the white noise in your processes and allowing people to readily identify and handle more complex issues as they arise.

So, how can you prepare to handle the transition smoothly? Start by building competence in your people. Compared to traditional training, building competence utilizes ongoing coaching and mentoring to empower employees to use complex, decision-making skills.?

Modern Quality Management Solutions

Nobody wants a Frankenstein QMS wreaking havoc on your supply chain. Whether you're building your QMS from scratch, optimizing your current system, or pursuing remediation, it’s never too early or too late to design a more efficient QMS. With thorough planning and engagement from senior management, you can design an agile, user-centered QMS that will streamline your supply chain and simplify your processes.?

Stephanie Gaulding serves as the Managing Director of Regulatory Compliance at Pharmatech Associates. She helps clients develop and sustain efficient, scalable modern Quality Management Systems that assure compliance with global regulatory requirements and industry best practices. She brings 25 years of experience in quality management systems and validation program management in the pharma, biotech, and medical device industries as she solves some of the most vexing challenges for start-ups as well as industry-leading companies. Stephanie has also held Quality Management leadership positions at Mediatech, Inc. and Boehringer Ingelheim Chemicals, Inc. She is an ASQ Certified Quality Auditor and Pharmaceutical GMP Professional. She holds a M.Sc. in Biotechnology from Johns Hopkins and a B.Sc. in Biology from Virginia Tech. Stephanie is also actively involved in PDA, ISPE, and ASQ serving in leadership and teaching roles, and enthusiastically develops other quality management professionals.

Pharmatech Associates helps life science companies bring products to market worldwide. Our team has decades of knowledge and experience in navigating the complex path required to deliver drugs and medical devices to the patients who need them. This is a challenging process that requires a framework that is up to the task and that’s why we developed the Pharmatech Ecosystem. Learn more at Pharmaceutical & Life Science Consulting Company | Pharmatech Associates.