Quality Management Modernization

Within the last several decades, automobile engines have become more powerful, efficient… and incredibly complex as a result. It is no longer the case that a seventeen year old can rebuild these modern engines as easily they did in the past when they rebuilt the 283 V8 they pulled out of their 1966 Chevy Impala.  Modern engines are so incredibly complex that they require computers to run and specialized training to diagnose and repair them.

Quality Management Systems have also evolved and have become incredibly complex, making them more difficult to manage with outdated methods. It is time to refresh and modernize the strategic plan (assuming the organization has one) for measuring, managing and improving the Quality Management System (QMS).

Let’s pause here to first consider the definition of a QMS. Utilizing ASQ [1] as a resource, the definition of a Quality Management System [2] is as follows…

A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

While some use the term "QMS" to describe the ISO 9001 standard or the group of documents detailing the QMS, it actually refers to the entirety of the system. The documents only serve to describe the system.

What is important to understand from this definition is that the group of procedural documents that define the QMS processes are actually only a component of the QMS, and that everything that is utilized to manage quality is a part of the QMS. Without a strategic plan for actively managing the Quality System, another component of the QMS, the organization lacks the appropriate ‘spark’ (timing and strength), enabling the QMS to run optimally.

The requirements for medical device Quality Systems have been modernized…

-       EN ISO 14971:2012

-       13485:2016 

-       European Medical Device Requirements (EU MDR) 

-       More

The technology associated with other components of a QMS and associated business solutions have also been modernized…

-       eQMS solutions

-       Enterprise Resource Planning (ERP) 

-       Unique Device Identification (UDI) 

-       More

The complexity and challenge of managing medical device organizations has also changed due to merger and acquisition (M&A) activity …

-       Multiple QMS structures within/across a single Enterprise

-       Multiple eQMS solutions within/across a single Enterprise

-       Different Org and leadership structures within/across a single Enterprise

-       More

The responsibilities of Executive Management and accountable Chief Quality Officers (CQO) and Quality Management (QM) personnel have been increased …

-       Patient-centric market ramifications of poor-quality products

-       Business stakeholder ramifications in response to poor-quality processes

-       FDA CDRH Case for Quality, expectations of the medical device industry

-       EU MDR Person Responsible for Regulatory Compliance (PRRC)

  • Post Market Surveillance (PMS) and verification of product quality

  • Quality Management (QM) surveillance and verification of process quality

There has never been a better time to consider the ‘quality’ of the the Quality Management System (QMS) that the organization relies upon to ensure high-quality processes and products.

Mgmt-Ctrl offers a solution to enable the measurement, management and improvement the quality of products and processes, inclusive of addressing the cost of poor quality. This solution facilitates the Quality Management (QM) of the Quality Management System (QMS).  This is accomplished through the utilization of a strategic plan, best described as follows:

  1. The Mgmt-Ctrl Quality System(s) Management (QSM) methodology provides a strategic plan for medical device companies that creates a useful, concrete, and tangible result... management control of the 'quality’ of medical devices and the Quality Management System (QMS) processes that produce them. 

  2. The Mgmt-Ctrl QSM methodology is resultant from the combination of the varied skill-sets of those who developed the strategy, in addition to their professional experiences in association with unique medical device industry QMS improvement initiatives. 

  3. The Mgmt-Ctrl QSM methodology, when combined with underlying procedural structure and the interaction of organizing activities, define a service offering that uniquely supports the management of product and process quality that is different from anything else previously offered and/or available to manage ‘quality’ within the medical device industry today.

The Mgmt-Ctrl Quality System(s) Management (QSM) methodology does initially not focus upon improvement of the Design Control process and/or remediation of Design History Files (DHF). While necessary, this activity only improves future product quality.

Instead, the QSM strategically focuses upon the product that is currently marketed by medical device companies.  This patient-centric approach is accomplished by focusing first on high-harm product failure(s) and translating this data into the associated essential design outputs (EDO) that should have been transferred into production as critical to quality (CtQ) product quality attributes (CQA) and/or process quality attributes (CPP).

Once CtQ control for patient safety is assured, the QSM then addresses the quality of the Quality System (QS) processes utilized within 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.

Unlike a modern engine that measures, monitors and reports the ‘quality’ of the operation of the engine to an automotive technician through a computer, a Quality Management System (QMS) does not have that capability. People are still responsible for the measurement, monitoring, reporting, and review of the ‘quality’ of the QMS. Therefore, the QMS must contain as a component the strategic discipline of Quality System(s) Management (QSM). 

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

The discipline of 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? Can you read it? Does it measure the ‘quality’ of you Quality Management System? Is it working?

Please contact us at info@Mgmt-Ctrl.com to learn more about the strategic discipline of Quality System(s) Management for consideration in modernizing your ‘quality’ management strategy.

[1] About ASQ, https://asq.org/about-asq

[2] ASQ definition of Quality Management System, https:??asq.org/quality-resources/quality-management-system

Larry Mager