Historically, and perhaps a harsh and simplistic assertion, is that the QMS has been managed as a function with a comprehensive set of instructions. However, more recently regulators, industry and quality professionals are looking at the QMS slightly differently. The QMS must be the heart and lungs of an organisation – it needs to breathe life into the organisation and must ensure that each operational part – from individuals, technology, equipment, to functions, teams, and the leadership – operate in unison. This shift in mindset recognises the need to understand the impact and risk of people and culture in the successful deployment of a mature QMS.
So, how does the QMS feed every part of the organisation with oxygen and that those within the organisation recognise the importance of the QMS? How do regulators assess the impact of these intangible elements on the effectiveness and robustness of a QMS, and therefore compliance?
The NSF QMM Assessment Model (developed and introduced in 2022, following the publication of the US FDA Drug Shortages Task Force report in 20191) responds directly to this challenge. It is a disruptive innovation tool to assess organisational quality maturity across the regulated landscape. It requires a different mindset, taking a holistic view of the QMS, in parallel to the traditional considerations of compliance.
The NSF model has been designed to align and respond to the FDA’s findings, to the assessment process considered by the Center for Drug Evaluation and Research (CDER), but importantly also takes into consideration other research on the impact of culture on the (quality) organisation, e.g., ISPE Cultural Excellence.
The NSF QMM model has gained interest and credibility among some of the world's largest and most dynamic pharmaceutical companies who want to ensure they have a positive quality culture, and that their quality functions are both effective and robust. Ultimately, it is also recognised that proactive action on maturing a QMS, supports a more robust supply chain and minimises supply disruption.
History of QMM
A 2019 US Federal Drug Shortages Task Force report concluded that, 62% of shortages between 2013 and 2017 were attributed to manufacturing or product quality problems.
The report concluded that manufacturers are not incentivised for enhancing the maturity of their Quality Systems beyond the bare minimum mandate.
As a result, the CDER (Center for Drug Evaluation and Research) recommended a rating system to assess Quality Management Maturity at Manufacturer’s facilities. This system could potentially inform regulators, and also customers, about the robustness and effectiveness of a supplier’s quality management system.
The potential benefits are illustrated alongside:
The FDA has run two QMM pilots (Domestic and International) to assess the feasibility of implementing the QMM rating system. This pilot was followed by an Industry Stakeholder discussion on the way forward.
