Case Study: How NSF Experts Deployed QMM

May 8, 2023

NSF experts explain how they worked with a pharmaceutical company to deploy QMM across global sites.

In this extract from the NSF white paper on the Quality Management Maturity model, NSF experts explain how they recently worked with a global pharmaceutical company to deploy the QMM tool to assess current state and to outline a “future target state” on the QMM scale. Read the case study and then get the white paper via the link below.

The Brief/Objective of the Project

A leading, fully integrated biopharmaceutical company contracted NSF to holistically assess their quality organization’s functions and their effectiveness in response to repeat regulatory deficiencies. The objective of the client was to holistically assess their quality organization’s current capability and to understand the risks in their QMS and the opportunities for enhancement.

Background and Scope

The scope of the assessment encompassed quality organizations at three different sites across two countries, with a combined employee strength of over 3,000 individuals, as well as the corporate quality organization. The site operations were a mix of drug substances and drug products manufacturing, with multiple units within each of the sites consisting of their own captive quality control laboratories. Over the past decade, the company had experienced exponential growth and had invested in expanding its manufacturing footprint. Despite operations growing organically, the quality organization had struggled to keep up, due to the inherent challenges in scaling elements of QMS quickly. This led to a huge influx of external hiring of talent in a short span of time. As a result, each site had its own organizational culture and climate, with myriad complexities. Some sites were old and had a legacy equipment train prone to repeat breakdowns, while others were relatively new and had a modern, automated equipment train. These operations, despite their differences, were subject to the same quality systems and oversight. The individual sites had their own quality organizations, and each of these organizations had an above-site reporting structure. Supporting the site and above-site quality organizations was the corporate quality organization that owned the common organizational QMS.

Methodology

NSF deployed the Quality Management Maturity tool and tailored it to focus on four assessment areas of the quality organization: strategy, process, people and organization. The multisite assessment was conducted across multiple geographies, leveraging NSF’s international network. A consultant familiar with the geography and culture of each of the sites was deputed to perform the assessment on-site.

Structured assessments were carried out at each site, using a multimodal information gathering approach that included:

Documentation Reviews
The consultants reviewed site-specific and pertinent corporate quality documentation to understand key processes and systems.
Key Personnel Interviews
Based on the organogram, key personnel across all levels of hierarchy within the quality organization and other cross-functions, such as manufacturing, engineering, human resources, etc., were interviewed. The interviews were conducted with a questionnaire developed based on the assessment areas. Over 100 personnel were interviewed for the assessment across all the sites over a period of three weeks.
Process Walk-Throughs
A key element of the assessment was to understand the implementation of processes and systems. Specifically, processes and systems were assessed to better understand consistency of application, i.e., whether a procedure was “in place,” “in use” or “reality.” To enable this, the consultants conducted walk-throughs and observed key processes as they happened.

Outcome

Each of the site assessment findings was collated, and the QMM tool was used to rate the maturity of each of the systems at the site. The qualitative ratings were then translated to a quantitative scale for ease of visualization and benchmarking. The assessment output illustrated a “current state” of maturity and also described a “future target state” of maturity if the recommendations were to be implemented.

Risks Identified

While the primary objective of the maturity assessment is to understand the current capability state, a critical byproduct is the holistic appreciation of inherent risks associated with lower maturity levels. The illustration of risks across all the areas presented the senior management with a bird’s-eye view of these risks and their criticality relative to each other. Unlike traditional audits or inspections, the assessment also articulates the relationship between the data collected and the actual operational influences, including human factors, holistically measuring the health of the quality system. Specifically, the correlation of documentation reviews, personnel interviews and process walk-throughs provides a unique yet complementary insight into the current state of both the effectiveness and the robustness of the quality systems.

Recommendations

Several recommendations were made to achieve a target future state of maturity, and the recommendations from the assessment can be grouped into two categories:

Common recommendations were made for all the site quality organizations as well as the corporate quality organization.
Site-specific recommendations, given that each site had its unique set of risks and challenges.

The assessment report also included a prioritization of the recommendations from a QMM perspective, to aid the client in developing an action plan for implementation. In conclusion, the assessment report provided a baseline for the client to embark on a Quality Management Maturity journey toward a proactive and self-sustaining quality ecosystem. After implementation of the recommendations, the assessment will be repeated to track the progress made from the baseline state and to identify laggards or actions that were not implemented effectively.