A cross-industry forum on benchmarking critical quality attribute identification and linkage to process

Sarah Demmon1, Swapnil Bhargava2, Doreen Ciolek3

  • 1Bioproduct Research and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.

Related Concept Videos

Quality Control01:05

Quality Control

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
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Quality Assurance01:19

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
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Interpreting R Charts01:22

Interpreting R Charts

R chart, or range chart, is a fundamental tool in statistical process control used to monitor the variability within a process. It complements the X-bar (x̄) chart by focusing on the range of the data, rather than individual values, providing a clear picture of the process dispersion over time.
An R chart plots the range of subsets of measurements collected from a process. Each point on the chart represents the range—defined as the difference between the maximum and minimum...
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Interpreting Run Charts01:25

Interpreting Run Charts

Run charts, essentially line graphs plotted over time, serve as fundamental yet effective tools for process analysis. They chronicle data sequentially, facilitating the identification of trends, shifts, or cyclical movements. This graphical representation is instrumental in determining whether a process is stable or exhibits signs of potential instability indicative of special cause variation. In the healthcare domain, run charts depict infection rates over time, enabling hospitals to monitor...
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Run Charts01:12

Run Charts

Run charts serve as an essential instrument for visualizing the performance of various processes over time, enabling the identification of trends and patterns crucial for quality improvement. These charts map out a series of data points chronologically, offering insights into the stability and efficiency of a process. A run chart's creation involves plotting data points on a graph, with the time intervals on the horizontal axis and the specific measurements on the vertical axis. For...
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