Quality Governance and the 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 management in how well the Quality Management System (QMS) is functioning. Today, with the rapidly changing regulatory environment and the adoption of ICH E6 R2, the concept of quality governance is being challenged across the entirety of organizations.1It is no longer adequate to assume quality governance is a process owned by quality, but rather it must be owned by the business.

To take active steps in establishing effective quality governance, it important to be able to establish a clear pathway for issue escalation and information flow coupled with the distribution of resources and support all while driving the idea of continuous improvement. This can be overwhelming when thinking about how quality plays a part in the different levels of an organization. So how can we start to build this process?

A critical first step would be to focus on the establishment of Quality Management Review (QMR).International Conference on Harmonization (ICH) Q10:Guideline for Pharmaceutical Quality Systemstates that it is essential for leadership to establish a company-wide commitment to quality.2It is through the evolution of QMRs 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 Quality Management System (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 grow the quality culture not only at an executive level, but throughout the organization. It is everyone’s responsibility to ensure quality, and by evolving QMR we are able to take a more strategic and meaningful approach to quality and oversight by keeping everyone engaged.

To evolve the QMR process, it is necessary to establish an organizational-wide QMR framework. The idea is to encourage quality governance at every level of the organization. A common pitfall when establishing a QMR framework is that it is only performed at higher levels of management. 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. Quality Management Review needs to be a cascading framework that includes involvement up and down the organization to guarantee that quality governance fits into organizational culture.

Depending on the size and complexity of the organization, QMR can be a series of reviews at various levels of management.This would also include a timely and effective communication and escalation process to raise appropriate quality issues to executive levels of management for review. However, if your organization is still fairly small, holding one QMR may be a suitable approach. An example of the QMR hierarchy could be defined as executive level QMR, moving down to a departmental level QMR (i.e., R&D) and then to functional level QMRs (i.e., Clinical, PV, Regulatory). The inputs and outputs of each QMR are hierarchal with key information from the functional levels being reported up to 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, quality culture is promoted at all levels of the organization in more specific ways.

Once you have developed the framework for QMR, 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 that you wish to achieve over a defined time period (typically annually). 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 we are 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.

What is important for one area of the business might not be important to another. For example, if we think about the departmental level being R&D, the R&D quality plan will have different quality focuses and areas of risk from the Manufacturing quality plan. This plan then cascades down to the functional areas of the operation (i.e., Clinical, PV, Regulatory, etc.) where the functional areas are able to further focus and establish their individual quality plans to be representative of the current objectives of that functional area. As an example, clinical may focus in on inspection readiness, risk-based auditing of sites, and protocol deviations while regulatory is more focused on 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 really performed in tandem, but the quality plan should ideally highlight focus and risk areas for the year, while your standardized metrics are going to help monitor your progress. To only incorporate performance metrics as part of your QMR without having a strategic quality plan, you may leave your organization in more of a reactive mode. You should strive to establish a quality plan that will drive the organization to reach a state of continuous improvement and standardized performance metrics, that allows for a measurement of that success and/or failure. Standardized quality metrics can include a variety of topics such as the number of regulatory inspections, audits findings, CAPAs, protocol deviations, serious safety issues, and training compliance.

It is good idea to define your standardized metrics within a level specific QMR charter. This ensures that you are stating your purpose as a QMR, and continue 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, the metrics begin to look more broad and give a better snapshot of the entire organization.

So, you have established a QMR framework, quality plans, and standardized metrics – what could you still have left to do?As your QMR framework matures and you get more sophisticated in using metrics, you can begin to start establishing Key Quality Indicators (KQIs). KQIs are a way to measure the overall success of an organization in meeting quality-based objectives. This 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.3By utilizing both KPIs and QTLs, companies are able to respond proactively to potential issues at all levels in the organization and utilize the QMR hierarchy to elevate these potential threats clearly and efficiently. This ensures appropriate risk-based action by the appropriate level of management.

By building a quality governance framework, organizations are enabled to continuing monitoring their QMS and focusing 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 quality culture, you begin to shift the view of the organization from being solely focused on compliance to that of more focused, quality goal setting – and the drive for continuous improvements.

References:

1. International Council for Harmonization Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2)
2. International Conference on Harmonization: ICH Q10: Guideline for Pharmaceutical Quality System
3. TransCelerate Biopharma, Inc. Risk-based quality management: quality tolerance limits and risk reporting. 2017