Quality System(s) Management — Mgmt-Ctrl

Quality System(s) Management (QSM) = Measure | Manage | Improve

The concept of Quality System(s) Management (QSM) is fundamentally about management responsibility for quality management. The CQO is accountable for focusing on stakeholder expectations of executive management; that patient safety and user satisfaction objectives are obtained through the active management of product and process ‘quality’ strategies… equivalent to the accountability of a Chief Financial Officer to focus on stakeholder expectations of fiscal responsibility. The CQO is responsible for the system(s) utilized to manage the ‘quality’ of the organization’s products and processes. Obtaining and sustaining a high-quality outcome doesn’t just happen, it requires focused leadership.

EU MDR has now defined significant responsibilities associated with the verification of product & process ‘quality’ through the PMS & QMS surveillance activities utilized within a medical device company. The accountability for doing so resides within the designated role of Person Responsible for Regulatory Compliance (PRRC). The CQO of an Enterprise must now consider the responsibilities of this role, and that the capability to satisfy the obligations of the PRRC role must be ‘built’ into the Quality Management System (QMS).

The quality of the product provided to the market is a ‘reflection’ of the quality of the operations of the Enterprise. The quality of operations is, in turn, a ‘reflection’ of the quality of the Quality Management System (QMS) the Enterprise utilizes to manage product and process quality. To achieve sustained success, in terms of managing product and process quality, it is imperative that the management of quality is prioritized, strategically planned and executed for results. This is the discipline of Quality Management. To facilitate this, the Chief Quality Officer role should be considered as having ownership of two separate, and distinctly different, disciplines:

1) Quality Operations (Q-Ops) is responsible for the organizational support and management oversight of the compliant, effective and efficient execution of the Quality System(s) utilized by the Enterprise, for the attainment of product and process quality.

2) Quality System(s) Management (QSM) is accountable for measuring, managing, and improving the quality of the Quality System(s) utilized by the Enterprise, to ensure sustained success in the achievement of product and process quality.

Quality Management (QM) = Quality Operations + Quality System(s) Management.  Together, these disciplines form the basis of the Quality Management System (QMS) of the Enterprise.

Otherwise stated… a Quality Management System (QMS) requires the ability to manage quality (QM) through the traditional management of Quality Operations (Q-Ops) in addition to the strategic discipline of Quality System(s) Management (QSM). Within an Enterprise, the Chief Quality Officer (CQO) is accountable for Quality Management… the ongoing measurement, monitoring and improvement of a compliant, effective and efficient Quality System(s) to ensure the capability for good people to execute good processes for the provision of good products, providing sustained success in satisfying the needs of all stakeholders. 

This holistic view of ‘quality’ management facilitates the development of a strong culture of quality, which is decidedly a competitive market advantage. What has traditionally been missing in Quality organizations is the existence of a focus on Quality System(s) Management (QSM).  Quality organizations are typically built as quality assurance and quality control entities who facilitate the compliant execution of the existing Quality System, Quality Operations (Q-Ops).

Managing the ‘quality’ of the Quality System is not typically a strong discipline within Quality organizations. There exists an Internal Auditing organization, focused primarily upon compliance to regulation, and reporting upwards in the organization, into a VP or Director who also focuses upon other Q-Ops functional groups.  Where is the singular focus on managing the ‘quality’ of the Quality System?  If there is none, than it is clear that managing the ‘quality’ of the Quality System is a part time (at best) effort of a Q-Ops functional manager who is focused on the daily pressure to deliver near-term operational results. This nearsighted and myopic approach to quality management will eventually result in revenue loss for the company as a result of the incurred cost of poor quality.

Why does such an environment currently exist within the medical device industry? The answer resides in the same rationale for executive leadership teams that do not currently have a Chief Quality Officer in membership of the C-Suite leadership. Quality professionals have been primarily focused on Quality operations, and as a result the Quality organization is often aligned with the Operations organization. Additionally, Quality System(s) management is not well understood as a strategic discipline within the medical device industry. The concept, however, is basic…

Quality System(s) Management (QSM) = Measure | Manage | Improve

The discipline of Quality System(s) Management (QSM) is foundational in providing the management control necessary to measure, manage and improve the compliance, effectiveness and efficiency of an organizations’ people, processes and product.

Does your organization have a focused strategy for Quality System(s) Management?

Mgmt-Ctrl offers a strategic solution for the measurement, management and improvement of product and process quality within the medical device industry. To acquire copy of our comprehensive plan for Quality System(s) Management, simply send an e-mail to [email protected] or me to learn more about the strategic discipline of Quality System(s) Management for your EU MDR ‘quality’ management strategy.

Larry Mager | (844) 349-2272