In today’s rapidly evolving pharmaceutical industry, maintaining a high standard of quality management is crucial for achieving efficiency and stability of operations. As companies adjust to the changing environment around us, quality management practices become more than a means to maintain compliance with regulatory requirements and industry standards. They have become the framework for how we do business. Quality management remains the guiding light of stability, growth, and prosperity of a business, and so we must continue to invest in improving the maturity of our practices.
For this reason, the U.S. Food and Drug Administration (FDA) is establishing a quality management maturity (QMM) assessment process and associated scoring tool. Quality Management Maturity (QMM) is defined as “the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.”i The FDA seeks to better understand how companies are proactively managing their internal pharmaceutical quality system as a leading indicator for compliance and supply chain robustness. This assessment tool is also a key business tool to understand the health of your own quality management system (QMS). It proactively identifies areas where improvement will bring value to your business or enable future growth in alignment with business objectives.
Instead of waiting for the FDA to develop its QMM model and tool, there is a need to identify and utilize a standardized model sooner, rather than later. This would ensure a common language and allow any organization to promote internal quality management maturity improvements as part of an existing annual quality plan. The utilization of a structured QMM assessment process allows regular evaluation of current QMM levels, setting of future targets, development of a roadmap for QMM evolution, and alignment of these targets to organizational objectives and aspirations.
The use of a standard QMM framework that can be consistently applied to a pharma QMS on a routine basis has multiple benefits:
Each year, individual business units may separately define their own priorities and set goals for their contributions to the identified business objectives. When quality objectives are set separately from the rest of the business, there is a risk that they will not be in alignment with the rest of the organization. Questions may be raised such as “Why do we need to improve our deviation management process?” or “Isn’t our training program good enough?”. Unfortunately, it is not always clear how quality management-related improvements support the business and organizational needs.
If instead the goal setting was grounded in the shared aspirations of a QMM standard, and the results of an evaluation to this standard, it would be clear where to set near-term objectives and longer-term aspirations. This would illuminate where the focus of a pharma QMS on building new capabilities, improving processes, increasing stability of the supply chain or expanding services is needed in order to deliver on future business requirements. Companies will find themselves in unique situations as they progress through their product lifecycle. The maturity of quality management practices must remain aligned with the maturity of the business, however proactive enough to continue toward the desired state of quality management maturity so as not to be left behind as an afterthought.
Using a standardized framework to conduct your quality management maturity assessment as part of your quality planning cycle helps avoid bias in your priorities. Revisiting this foundation ensures that your quality management improvements continue to stay focused on what matters most for your business and not be distracted by the loudest voice in the room. Having the shared language and standardized assessment tool enables the evaluation team to have healthy discussion, debate, and even disagreement. The good news is that there is never a wrong answer; your current state maturity is what it is, based on the defined criteria. Only once you acknowledge reality can you begin to plan appropriately for what level of maturity you want to achieve in the future. And sometimes it turns out that where you are is exactly where you want to be…and that’s OK!
This benefit is the most important and valuable. By nature, a QMM assessment is meant to be cross-functional, ensuring participation from all key stakeholders from across the organization. It is a great reminder that quality management is not solely the responsibility of the quality organization and ensures that everyone shares accountability for the continual improvement of the pharmaceutical quality system. There is nothing like a shared experience to drive this point home, and everyone can leave the room feeling as if they have provided their input into both the assessment of the current state, as well as setting the future state targets. This is truly the heart of a healthy quality culture. To ensure everyone is involved in sharing the responsibility for quality, engaged in the improvement process, and accountable for delivering the results.
Whether the FDA will implement its own QMM model and requirement for recurrent assessment, the practice of self-assessing your quality management maturity on a regular basis makes good business sense. The ability to measure your current state, set targets for future improvement, and track your progress over the years ensures your quality priorities remain aligned across the organization, and can be sustained even in the event of reorganizations, product portfolio adjustments, and leadership changes. Organizations and business priorities will continue to change, but one thing that will not change is the importance of quality to protect patients and ensure the success of your business. Therefore, it is important that quality does not get left behind, and we continue to assess and invest in the continual maturity of our quality management practices to support the needs of the business as the regulations and expectations evolve throughout the product lifecycle.
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