Background/Case Studies: Heavily regulated organizations require visibility to metrics to determine the overall health of the Quality System. This helps management make risk-based decisions based on the information provided. However, as organizations implement digital or automated solutions including electronic Quality Management Systems (eQMS), it can be difficult to analyze all the data necessary to drive change and improve compliance. The creation of a quadrant-based scorecard was implemented at our organization to provide more transparency and help drive improved compliance from all employees.
Study
Design/Methods: A quadrant-based scorecard was designed to differentiate the source of data. The X-axis was “People vs Process” while the Y-axis was “Internal vs External” allowing for the organization of data in an easily identifiable format. Metrics monitored included training, SOP periodic reviews, quality event closure time, audit response time, and complaint resolution. The bottom right quadrant was reserved for subsidiary-specific metrics that measured desired output such as testing turnaround time, blood on hand, and first-time right metrics. Each quadrant had a possible score of 25 points for a total possible score of 100 points. This scorecard was then distributed monthly to operational leadership and placed on the company intranet for visibility by all staff. July 2022 was the first month of scorecard use. The scorecard prioritized information that needed to be addressed by management and staff. Actions were created and followed up to improve the quality metrics.
Results/Findings: Over the first nine months of scorecard use, we saw improvement in all metrics, highlighted in Table 1. The audit response rate for blood operations showed an improvement of 51%. Periodic review improved by 88% for blood operations and decreased to 0 days in the processing lab. Overdue training decreased by 66% and 50% in biomanufacturing and blood operations, respectively. Deviation closure rates decreased by 40% in the Processing laboratory and 33% in blood operations. Conclusions: The implementation of the Quality scorecard led to deviations closing faster (40% and 33%), decreasing of training non-compliance (66% and 50%), and timelier review of SOPs (88% and 100%) allowing for updates to occur more readily. This increase in awareness and visibility has helped improve the established culture of quality.
Importance of research: Continuous quality improvement is a core pillar of the blood product industry. Tools that give better visibility and drive this improvement are always needed and this tool is one that could be adopted at any other institution regardless of whether they have electronic or paper systems.
