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Case Study - Laboratory Quality System Requirements Overload

Updated: Oct 27

Written By: Todd Debaker, Consultant for QRx


The Problem

Two laboratories owned by the same company, one a biocompatibility testing laboratory following Good Laboratory Practice (GLP) requirements and the other, an Analytical Testing Laboratory (ATL) performing extracts on medical devices shared a Quality Management System (QMS). This situation created a particularly challenging environment for the Analytical Lab due to the overly burdensome GLP requirements they were expected to follow. In addition, the chemistry lab had little input into the QMS requirements both initially and as changes were processed, frustrating lab personnel as they had to follow processes that did not add value, were overly complicated, and did not apply to the activities they performed. The negative effect of this situation greatly impacted employee morale and laboratory efficiency.


The Solution

Creating a new and separate Quality Management System for the Analytical Testing Lab was the solution. Determining which regulatory requirements applied to the ATL and implementing a QMS that efficiently met the requirements was top priority. However, this situation provided a rare opportunity to focus on building a strong Quality Culture along with the new QMS. Low morale and a lack of personal ownership for QMS compliance due to the inability to provide input or feedback related to the QMS could be significantly improved by establishing clear processes aligned with ISO 17025 vs. GLP requirements, as well as engaging employees in developing the new QMS procedures. Involving laboratory personnel in establishing and monitoring performance metrics and creating a process oriented QMS structure provided additional engagement opportunities for employees to bring concerns and improvement opportunities to management’s attention.

The Results

A QMS framework utilizing the process approach was established to provide a foundation for the new QMS. The foundation consists of key processes utilized in the laboratory and/or required by ISO 17025. Stewards were designated for each process, trained on the regulatory requirements, and given the responsibility to develop efficient and compliant processes, in many cases with the input of laboratory personnel. The Process Stewards now provide oversite over their processes while also providing a focal point for laboratory personnel to communicate concerns and improvement suggestions. The overall result has been a significant reduction in wasted effort/resources via the implementation of compliant and efficient processes.

Metrics and KPI’s were established for process performance monitoring and reporting to Management on process performance. As a result, backlogs associated with some QMS activities have significantly reduced along with the quantity of resources required to maintain a compliant QMS. Morale also increased significantly due to higher levels of employee engagement and a reduction of non-value-added activity.

An efficient, effective, and compliant QMS should be a primary goal for all regulated companies. In some cases, this means there may be more than one QMS. If implemented correctly, it can foster team-building and higher levels of employee engagement. An approach that utilizes the knowledge and experience of personnel who follow the QMS every day while performing their roles will provide benefits to your company culture beyond simply having a compliant Quality Management System.

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