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Multivariate statistical process control in product quality review assessment – A case study Vrije Universiteit Brussel
According to the Food and Drug Administration and the European Good Manufacturing Practices (GMP) guidelines, Annual Product Review (APR) is a mandatory requirement in GMP. It consists of evaluating a large collection of qualitative or quantitative data in order to verify the consistency of an existing process. According to the Code of Federal Regulation Part 11 (21 CFR 211.180), all finished products should be reviewed annually for the ...
Detecting mean changes in experience sampling data in real-time: A comparison of univariate and multivariate statistical process control methods KU Leuven
Detecting early warning signals of developing mood disorders in continuously collected affective experience sampling (ESM) data would pave the way for timely intervention and prevention of a mood disorder from occurring or to mitigate its severity. However, there is an urgent need for online statistical methods tailored to the specifics of ESM data. Statistical process control (SPC) procedures, originally developed for monitoring industrial ...
PAT-based batch statistical process control of a manufacturing process for a pharmaceutical ointment Ghent University
Signaling changes in experience sampling data in real-time: Development and evaluation of statistical process control methods for detecting early warning signals of depression KU Leuven
Detecting early warning signals of impending depressive episodes would pave the way for timely intervention. Since depression is characterized by altered affective experiences, recent studies have investigated whether experience sampling (ESM) data regarding affective experiences in daily life may yield such early warning signals. In ESM studies, participants are instructed to report on their momentary affect at a number of measurement occasions ...
Nonstationarity in statistical process control - issues, cases, ideas KU Leuven
Statistical process control (SPC) is a powerful framework that is used in many industries to decrease process variability and to pinpoint special cause variation. Although a broad range of techniques have been developed to do so, often the real-life situation does not fully comply with the basic assumptions that are made in SPC resulting in poor results. One of the main violations against the assumptions is the fact that industrial processes ...
Analysis of smearing-out in contribution plot based fault isolation for Statistical Process Control KU Leuven
This paper studies the smearing effect encountered in contribution plot based fault isolation, i.e., the influence of faulty variables on the contributions of non-faulty variables. Since the generation of contribution plots requires no a priori information about the detected disturbance (e.g., historical faulty data), it is a popular fault isolation technique in Statistical Process Control (SPC). However, Westerhuis et al. (2000) demonstrated ...
Real-time detection of mean and variance changes in experience sampling data: A comparison of existing and novel statistical process control approaches. KU Leuven
Retrospective analyses of experience sampling (ESM) data have shown that changes in mean and variance levels may serve as early warning signs of an imminent depression. Detecting such early warning signs prospectively would pave the way for timely intervention and prevention. The exponentially weighted moving average (EWMA) procedure seems a promising method to scan ESM data for the presence of mean changes in real-time. Based on simulation and ...
Process monitoring and evaluation of a continuous pharmaceutical twin-screw granulation and drying process using multivariate data analysis Ghent University
The present study aims at acquiring an in-depth process knowledge about a twin-screw granulation and fluid bed drying process performed on the commercially available continuous line. Batch Statistical Process Monitoring (BSPM) principles are used to describe and monitor the variables with a relevant time-related trajectory. The continuous granulator operates in a truly continuous manner and variables logged by this unit do not present ...
Statistical Process Monitoring for Fault Detection & Diagnosis in (Bio)chemical Processes (Statistische procesopvolging voor foutdetectie en -diagnose van (bio)chemische processen) KU Leuven
This thesis investigates the application of Statistical Process Monitoring (SPM) for timely detection and diagnosis of process faults. Although early industrial implementations of SPM have confirmed its huge potential in terms of increased production efficiency, cost reduction, quality improvement, and waste reduction, several barriers against the successful implementation and operation of SPM systems still exist. The general objective of this ...