Quality Governance and Evolution of Quality Management Review 

Quality governance can be defined as an overarching framework that provides assurance of compliance with regulatory requirements, industry standards, and continuous quality improvement while enabling the risk and issue escalation process. Quality governance structures and processes provide transparency to an organization’s leadership on how well the Quality Management System (QMS) is functioning. It is through the evolution of Quality Management Review (QMR) that we can ensure continuing suitability and effectiveness by assessing an organization’s performance quality.

Today, with the rapidly changing regulatory environment and the upcoming adoption of ICH E6(R3)¹, the concept of quality governance is being challenged across all organizations. It is no longer adequate to assume quality governance is a process owned by quality, but rather, it must be a responsibility retained by the entire organization. 

To take active steps in establishing effective quality governance, it is important to establish a clear pathway for issue escalation and information flow, paired with the distribution of adequate resources and support while driving the idea of continuous improvement.  

While acknowledging this can be overwhelming, here are essential considerations as you begin to build out your quality governance processes.  

Focus on Establishing a Quality Management Review (QMR) 

International Conference on Harmonisation (ICH) Q10: Guideline for Pharmaceutical Quality System states that it is essential for leadership to establish a company-wide commitment to quality.² It is through the evolution of Quality Management Reviews that we can ensure continuing suitability and effectiveness by assessing the organization’s performance quality.  

It is a great forum to be able to evaluate the health of the QMS, review key quality metrics, discuss emerging trends, drive continuous improvements, assess resourcing, and share best practices. It is also an effective way to promote quality from top to bottom across an organization.  

The goal is to implement a culture of quality not only at an executive level, but throughout the entire organization. Proactively establishing a quality culture, where it’s recognized quality is everyone’s responsibility, will help the business to achieve and sustain compliance. A key foundation of establishing a culture of quality is by evolving a QMR, which allows organizations to take a more strategic and meaningful approach to quality and oversight by keeping everyone engaged. 

To evolve the Quality Management Review process, it is necessary to establish an organizational-wide QMR framework. A common pitfall when establishing a QMR framework is that it is only performed at higher levels of management. But when companies only have QMR at higher levels, there is no functional level transparency, and teams may have no interest because it is not apparent that quality is something for which everyone is responsible.  

A Quality Management Review needs to be a cascading framework that includes involvement up and down the organization to guarantee that quality governance fits into the organizational culture. 

QMR Can Be a Series of Reviews at Various Management Levels  

Holding a series of reviews at various management levels is an approach that allows timely and effective communication across the organization, creating an escalation process to raise appropriate quality issues to executive levels of management for review. However, if your organization is small, holding one QMR may be suitable.  

An example of the QMR hierarchy could be defined as executive level QMR, moving down to a departmental level QMR (i.e., research and development) and then to functional level QMRs (i.e., clinical, manufacturing, and regulatory). The inputs and outputs of each QMR are hierarchal with key information from the functional levels being reported up to a particular departmental level, and then again to executive levels. Quality initiatives and objectives are then disseminated from executive levels back down through the functional levels. In creating this framework, a culture of quality is promoted at all levels of the organization and incorporates all key stakeholders.

Once the QMR framework is established, the development of a quality plan is crucial to drive the process. Developing a quality plan at the executive management level allows for prioritization of key critical quality objectives for the organization. The quality objectives establish clear goals for the organization to achieve over a defined period, typically on an annual basis.  

At the executive level, the quality plan should be more strategic, focusing on overall organizational quality objectives, standardized quality metrics, identified risks, and continuous improvement initiatives. Once a quality plan is developed at the executive level, that strategic plan can then cascade down through departmental levels and then to functional levels. It is here that you will be able to take the strategic plan and adapt it to be more focused and tactical so that it is meaningful for each level of the organization. 

 Consider Differences in Priorities Across Business Areas  

For example, if a department area is Research and Development (R&D), the R&D quality plan will have different quality focuses and areas of identified risk than the next level quality plan for the functional area of Manufacturing. The department level plan will cascade down to the functional areas of the operation, with the flexibility for functional areas to further focus and establish their individual quality plans to be representative of the current objectives of that functional area.  

Functional area quality plans will differ based on their operations and risk evaluation. For example, clinical may focus on inspection readiness, risk-based auditing of sites, and protocol deviations, while regulatory may be more focused on Standard Operating Procedure (SOP) revisions for new regulatory requirements. 

Once your QMR framework and quality plans are established, you can also create standardized quality metrics for review during QMR. These actions are performed in tandem, but the quality plan should ideally highlight focus and risk areas for the year, while the standardized metrics are going to help monitor progress.  

To only incorporate performance metrics as part of a QMR without having a strategic quality plan may leave an organization in more of a reactive mode. 

Instead, strive to establish a quality plan that will drive the organization to reach a state of continuous improvement and standardized performance metrics, allowing for a measurement of that success or failure. Standardized quality metrics can include a variety of topics such as the number of regulatory inspections, audits findings, corrective and preventative actions (CAPAs), protocol deviations, serious safety issues, and training compliance. 

It is a good idea to define standardized metrics within a level specific QMR charter because that will ensure the organization states its purpose as a QMR and continues to observe and measure the same standardized metrics.  

At the functional levels, metrics will be more specific, and as outputs are rolled up throughout the QMR hierarchy, metrics begin to look broader and provide a better snapshot of the entire organization. 

So, You Have Established a QMR Framework, Quality Plans, and Standardized Metrics, Now What?

As the QMR framework matures and the organization becomes more sophisticated in using metrics, begin to establish Key Quality Indicators (KQIs) – a way to measure the overall success of an organization in meeting quality-based objectives. 

KQIs can also promote the development of Quality Tolerance Limits (QTLs) which is a level, point, or value associated with a parameter that, when deviation is detected, should trigger an evaluation to determine if there is a possible systemic issue.³ By utilizing both KQIs and QTLs, companies are able to respond proactively to potential issues at all levels in the organization and utilize the QMR hierarchy to elevate potential threats clearly and efficiently, ensuring appropriate risk-based action by the appropriate level of management. 

By building a quality governance framework, organizations are enabled to continue monitoring their QMS and focus on critical processes, championing continuous improvement. QMR allows organizations to reach their quality goals, concurrently enabling them to align with regulatory expectations. By building this QMR framework, and simultaneously promoting a culture of quality, they will begin to shift the view of the organization from being solely focused on compliance to that of more focused, quality goal setting, adopting a proactive posture and driving for continuous improvements.  

Need assistance with your Quality and Compliance program? Halloran teams provide QMS assessments, and design right-sized QMS’ to document processes, procedures, and responsibilities for achieving quality policies and objectives based on the size and operating model of their clients.  

Contact Halloran today. 

References: 

1. International Council for Harmonisation Harmonised Guideline: Good Clinical Practice (GCP) E6(R3). May 19, 2023. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf  
2. International Conference on Harmonisation Harmonised Tripartite Guideline: Pharmaceutical Quality System: Q10. June 4, 2008. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf  
3. International Conference on Harmonisation Guideline Q9 (R1) on Quality Risk Management. February 3, 2023. https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-r1-quality-risk-management-step-5-revision-1_en.pdf  
4. TransCelerate Biopharma, Inc. Risk-based quality management: quality tolerance limits and risk reporting. 2017.