Quality Management Maturity (QMM): The FDA’s blueprint for pharmaceutical excellence

Lindsey Howard Date published: Jun 07, 24

Long before the COVID-19 pandemic underscored vulnerabilities in the drug market, the US faced a looming crisis of drug shortages. In June 2018, a bipartisan group of Senators and House members reached out to Scott Gottlieb, MD, then Commissioner of Food and Drugs, urging action to address this critical issue. This call to action led to the formation of the Drug Shortages Task Force, which conducted an in-depth analysis of drug shortages from 2013 to 2017.

The resulting 2019 report, titled "Drug shortages: root causes and potential solutions," identified several contributing factors, chief among them being the market's failure to reward manufacturers for mature quality management systems.

The FDA's Center for Drug Evaluation and Research (CDER) took a proactive stance by formulating its quality management maturity (QMM) approach, detailed in a 2022 whitepaper. This initiative was further elaborated upon in a QMM public workshop in May, followed by the October publication of an article in the AAPS Journal titled "Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience." The culmination of these efforts was a unanimous vote by the FDA Advisory Committee in November to establish a QMM program aimed at:

• Fostering a strong quality culture mindset
• Recognizing establishments with advanced quality management practices
• Identifying areas for quality management enhancement and providing growth opportunities
• Minimizing risks to product availability to ensure a reliable market supply

The quality management maturity (QMM) blueprint

Quality management maturity is defined by CDER through five key areas of operational excellence:

1. Management commitment to quality
2. Business continuity
3. Advanced pharmaceutical quality system (PQS)
4. Technical excellence
5. Employee engagement and empowerment

These elements form the bedrock of a mature quality management system, ensuring that both the organization and the products it manufactures meet the highest standards of quality and reliability.

 Understanding the principles of QMM is enhanced by revisiting the work of industry pioneers like W. Edwards Deming. His transformative efforts with Japanese industry post-WWII and later with Ford Motor Company laid the foundation for modern quality management practices. Deming's seminal work, "out of the crisis," introduced 14 points for management commitments that remain relevant today:

1. Create constancy of purpose for improving products and services
2. Adopt the new philosophy
3. Cease dependence on inspection to achieve quality
4. End the practice of awarding business on price alone; instead, minimize total cost by working with a single supplier
5. Improve constantly and forever every process for planning, production and service
6. Institute training on the job
7. Adopt and institute leadership
8. Drive out fear
9. Break down barriers between staff areas
10. Eliminate slogans, exhortations and targets for the workforce
11. Eliminate numerical quotas for the workforce and numerical goals for management
12. Remove barriers that rob people of pride of workmanship and eliminate the annual rating or merit system
13. Institute a vigorous program of education and self-improvement for everyone
14. Put everybody in the company to work accomplishing the transformation

These principles underscore the importance of management commitment and employee empowerment, foundational elements that are integral to achieving QMM.

The role of risk management and supply chain resilience

Fundamental to business continuity within the QMM framework is the science of risk management. Evolving significantly post-WWII, risk management became crucial to space exploration and was incorporated into the “project management body of knowledge” in the late '80s. For the pharmaceutical industry, standards like ISO 14971 and ICH Q9 define risk management practices, providing a holistic approach to managing risks across mature organizations.

In addition to robust risk management, a strong focus on supply chain resilience is essential. The American Society for Quality (ASQ) recognized the importance of the customer-supplier relationship in the '80s, establishing the Customer-Supplier Division. Pioneers like Richard A. Maas, John O. Brown and James L. Bossart developed methodologies to strengthen these relationships, emphasizing that suppliers are customers too.

Achieving QMM: A roadmap for quality directors and compliance directors

For quality directors and compliance directors in the life sciences industry, achieving quality management maturity requires a comprehensive approach that integrates historical insights with modern practices. Here are actionable steps to guide your journey:

Strengthen management commitment: Ensure that leadership is visibly committed to quality improvement initiatives. This can involve setting clear quality objectives, providing necessary resources and fostering a culture of quality throughout the organization.

Implement robust risk management: Adopt and continuously refine risk management practices to anticipate and mitigate potential disruptions in the supply chain and production processes.

Enhance employee engagement: Invest in training and development programs that empower employees to contribute to quality improvements. Encourage open communication and collaboration across all levels of the organization.

Leverage technology: Utilize advanced Pharmaceutical Quality Systems (PQS) and quality management software to streamline processes, enhance data accuracy and improve decision-making.

Foster supplier partnerships: Develop strong, collaborative relationships with suppliers to ensure a resilient and reliable supply chain. Focus on long-term partnerships that prioritize quality over cost.

Next steps towards QMM

The FDA's Quality Management Maturity Program represents a strategic framework designed to elevate the quality standards within the pharmaceutical industry. By fostering a culture of continuous improvement, robust risk management, technical excellence and active employee engagement, organizations can achieve operational excellence and ensure a reliable supply of high-quality products.

As we navigate the complexities of modern pharmaceutical manufacturing, the principles of QMM provide a roadmap for success. By embracing these principles, Quality Directors and Compliance Directors can lead their organizations toward a future defined by resilience, innovation and sustained excellence.

Ready to take the next step in your quality management journey? Watch our webinar on quality management maturity to gain deeper insights and practical strategies for implementing QMM in your organization.