Robert Michalik is advisor (Quality and Corporate Compliance) at Shabas Solutions LLC.

Robert Michalik

Disclaimer: This article was not written by the FDA, and it does not necessarily reflect the views of the agency.

In recent months, FDA has begun championing Quality Management Maturity (QMM), a new quality surveillance initiative intended to raise awareness at all levels of management in the pharmaceutical industry as to how to best achieve quality objectives and improve manufacturing site quality and supply chain reliability in drug manufacturing processes. QMM follows a maturity modeling paradigm first developed and adopted by other high technology industries. The nexus between a clearly articulated mature quality culture, technical processes, and corporate-wide business practices that are integrated with quality objectives has crystallized into a viable roadmap for enhancing a drug manufacturer’s operations, while satisfying patient needs and corporate goals.

Since first introducing the proposed initiative, FDA has conducted two QMM pilots to measure quality management maturity levels at an establishment—one for domestic finished-product manufacturing sites and another aimed at overseas API manufacturing sites. Shabas Solutions LLC (Shabas) was selected to run the QMM pilot for overseas API manufacturers in which eight sites—of various sizes, location, age, and product focus—participated voluntarily (1). The Shabas team (including the authors of this article) collaborated with FDA to develop a comprehensive QMM assessment tool to inform FDA’s vision for the QMM program. The tool is characterized by four pillars and 15 practice areas, more than 60 QMM questions with accompanying interview guides, a 5-level rating system, and a scoring and reporting process.

The pilot program yielded findings that helped FDA and industry participants better understand what impact the QMM initiative might have to enhance quality management for a drug manufacturer, both at its corporate level and specific manufacturing site, and how adoption of QMM could eventually benefit the industry.

In this article (first of a multi-part series), the authors leverage insights gained from the FDA QMM pilot to explain what QMM means in practice to a firm’s management, trace its evolution, and explain the benefits of adopting it.

According to FDA, QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement (2). FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance (3).

In an earlier article, FDA officials noted: “A drug manufacturer is responsible for implementing dependable daily operations that assure consistent drug quality. Management’s daily decisions on myriad issues involving equipment, materials, maintenance, staff qualifications, supervision, process control, and investigations will ultimately determine the quality of the drugs that are shipped from a given facility” (4).

In other words, site management’s proficiency in governing a site’s business processes as well as their level of integration with quality objectives, influence the performance of the quality management system and technical processes involved in developing a product and, therefore, impacts product quality and availability.

In a competitive market, reliable delivery of high-quality product and reduced quality-related shortages sustainably over the long-term—the essence of QMM as identified by FDA—is a management concern in all industries, in which their lessons learned are also applicable to pharma. Shabas researched the pharma and other industries to identify key foundational competencies (“four pillars”) that undergird QMM for an organization aspiring to be “quality management mature”:

Compliance management: ability to consistently meet and/or
exceed compliance with applicable laws, regulations, and industry best practices

Risk management: ability to identify and manage organizational risks and build resilience

Quality culture: ability to develop and maintain an organizational mindset and behaviors that value continuous learning and improvement, and customer satisfaction

Sustainability: ability to successfully secure and manage appropriate technology, infrastructure, human capital, suppliers, customers, institutional knowledge, and other resources to
sustain the operations.

Achieving site QMM starts with understanding where an organization is in terms of QMM—thus the need for an assessment. Increased site maturity would be evident through improved quality metrics and other relevant, but carefully, chosen indicators. But a prerequisite to achieving an optimized site maturity is for site management to invest in establishing systematic business processes that are well integrated with quality objectives and committing to developing the culture—the two key facets of an “operations excellence” program. Such a demonstrated intent of management’s willingness could serve as useful evidence to a QMM assessor.

By integrating continuous improvement in the business processes as the focus of the organization as QMM seeks to do, management may successfully realize the potential of achieving long-term growth in line with corporate strategy.

A QMM assessment is not an FDA quality audit of an organization’s quality management system or products but should rather be viewed as an alignment check between an organization’s planned strategy and its actual execution. An independent pharmaceutical site QMM assessment would therefore inform site management with a “snapshot in time” as to its institutional capacity, culture, and knowledge related to manufacturing medicines, how well the organization is able to leverage them to guide the design and governance of the site business processes to produce high quality medicines reliably, and how committed the site management is to institutionalize a quality culture.

Brief history of quality management and its maturity

The fundamentals of modern quality management practices can be traced to innovative principles developed by Joseph Juran and Edward Deming. Juran’s model of quality, referred to as Total Quality Management (TQM), focused on prospective quality practices employed throughout a manufacturing process, rather than reactively weeding out non-conforming products during finished product quality control (QC) inspection (5).

By the 1960s and 1970s, manufacturers and regulators in various industries began to take notice of the impact that TQM practices were having on product quality and productivity in Japan (6). In 1978, FDA embedded TQM principles into GMP regulations (e.g., prospectively defined product and process specifications driven by written standard operating procedures [SOPs]). Globally, TQM practices were adopted by International Organization for Standardization (ISO 9000 series) and International Council for Harmonisation (ICH) in their pharmaceutical best practices related to technical and quality standards (Q, S, E, and M series). By 2000s, ICH became a leading standards organization for the development and manufacture of pharmaceuticals globally (e.g., Q7 through Q12 guidance) (7,8).

Beginning in the late 1980s and into 1990s, the US Department of Defense and military contractors engaged with the Carnegie Mellon Software Engineering Institute to propose a Capability Maturity Model assessment tool (now, CMM-Integration [CMMI] with 5-level maturity scale) to illuminate subtle issues at the senior management level which stymied TQM effectiveness (9). CMM assessments enabled management at companies in high-tech industries to discern whether its quality mission statement was effectively being communicated throughout the organization (10). In 2017, FDA’s Center for Devices and Radiological Health endorsed CMMI for their Voluntary Manufacturing and Product Quality Pilot Program aimed at medical device manufacturers (11,12).

Given the success of quality maturity modeling assessments seen in other high-tech industries—and driven by FDA’s Congressional enabling legislation (13) and its own policy initiative to address drug supply chain problems—in 2016 (3), FDA sponsored researchers at the University of Gallen’s Institute of Technology Management to conduct a study of Operational Excellence (OPEX) metrics to identify root causes of quality system problems that could lead to drug shortages for vulnerable patient populations.

A series of three reports issued by St Gallen Pharma OPEX Study demonstrated a remarkable correlation between the “assessed” level of quality management maturity and quality system effectiveness, or “operational excellence” (14). It addressed an important question: “To what extent does a pharmaceutical manufacturer’s quality management maturity affect its ability to convey a culture of quality throughout its organization?”

Not surprisingly during the QMM pilot assessment, sites that received higher QMM scores generally performed well in similar key performance areas as noted by Juran in 1946 (corporate culture, quality messaging, and communication throughout the organization).

Today, with the advent of the digital revolution and artificial intelligence (AI) machine learning capabilities, the quality landscape is once again being transformed. Conducting a QMM assessment becomes more critical than ever as a means to inform site management of their organization’s current maturity level and its ability to integrate changes.

Site management decisions related to various business processes often create a de facto quality culture that impacts product quality and availability. While FDA provides oversight of the site quality management processes and product quality via CGMP inspections and other surveillance methods, there are currently no comparable regulatory tools that examine a site’s business processes and how well they are integrated with quality objectives. QMM fills that much needed gap, as illustrated by 

Figure 1. Quality Management Maturity and Shabas Assessment Approach. Figure courtesy of the authors.

In a future article, the authors will cover typical symptoms of low and high QMM that were encountered while conducting the FDA QMM pilots.

Based on the authors’ experience from administering the FDA QMM foreign pilot, industry participants of any company size would benefit from adopting QMM by moving toward greater systemization and optimization of their business processes and their integration with quality objectives. This will result in improved investment decisions, risk-based redundancies, and enhanced operations in terms of resiliency, workforce efficiency and collaboration, customer and supplier relationships, management oversight of quality, and ultimately a robust quality culture at the site thereby paving the way to achieve targeted strategic objectives. As an example, the QMM assessment tool developed by Shabas demonstrated to the pilot participants how systemization can provide greater visibility of business processes and remove barriers to collaboration between different functional areas, ways to improve supplier and customer collaboration processes, and how to progressively fit quality into a site’s strategic plan.

The QMM initiative is squarely aimed at operationalizing the vision laid out in the FDA’s report on Pharmaceutical Quality for the 21st Century: “a maximally efficient, agile, flexible manufacturing sector that reliably produced high-quality drug products without extensive regulatory oversight” (7). It is a logical evolution in the history of pharma quality management to adopt principles of operations excellence to systematically link management proficiency, business process maturity including digitalization, corporate culture, and continuous improvement ethos to achieving long-term growth, quality goals and strategic corporate objectives.

Shabas Solutions LLC sincerely acknowledges the FDA CDER QMM team for their support and guidance during the QMM Pilot and for reviewing this article. We also wish to acknowledge and thank Major General (retired) John Handy, Mr. Joseph Delukey, and Dr. Clyde Schultz for their invaluable contribution to the FDA QMM Pilot project.

Shabas Solutions LLC (www.shabas.net), based in Fairfax, Virginia, USAis a small business provider of scientific and management consulting services to multiple US federal government agencies. Our experts and staff members bring decades of experience in Defense and Health Supply Chain Management, Pharmaceutical Quality Management, Pharmaceutical Research and Development, Federal Policy and Regulatory Operations, and Technology Integration.

 “Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program for Foreign Facilities; Program Announcement

“Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals

Drug Shortages: Root Causes and Potential Solutions A Report by the Drug Shortages Task Force 2019

J. Woodcock and M. Wosinska, “Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages,” 

American Society for Quality, The History of Quality available from asq.org [accessed Nov. 14, 2022].

INC Magazine, “Total Quality Management,” Article, Jan. 5, 2021.

Pharmaceutical Quality for the 21st Century: A Risk-Based

ICH, Quality Guidelines available from ich

Software Engineering Institute, CMMI: A Short History, Brochure, 

M.C. Paulk, et al., Capability Maturity Model for Software, Version 1.1, Technical Report, 

FDA, “Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program,” Notice, 

FDA, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, Guidance Document, 

FD&C Act, sec. 301(a); 21 U.S.C. 331(a);see also 

FDA Quality Metrics Research Final Report Year 1

,
University of St. Gallen (Switzerland), November 2017.

Somnath Mishra, Somnath.mishra@shabas.net, is president, William Hauck is senior associate, Zachary Royal, is senior consultant, and Robert Michalik is advisor (Quality and Corporate Compliance), all at Shabas Solutions LLC.


Vol. 46, No. 12
December 2022
Pages: 30–33

When referring to this article, please cite it as S. Mishra, W. Hauck, Z. Royal, and R. Michalik, “Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence,” 

Articles

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability. 