What is it about?

Shewhart Control Chart in Microbiological Quality Control of Purified Water and its Use in Quantitative Risk Evaluation is a research article that investigates the use of the Shewhart control chart in assessing the microbiological quality of purified water. The Shewhart control chart is a statistical tool that can be used to monitor the variation in a process over time. By plotting data points on a chart, it is possible to identify trends, patterns, or unusual variations that may indicate a process is out of control.   The article applies the Shewhart control chart to monitor the microbiological quality of purified water. The authors collected data on the number of microorganisms found in samples of purified water and plotted the data on a Shewhart control chart. They then used the chart to identify any trends or patterns in the data and to assess the microbiological quality of the purified water. Overall, the article found that the Shewhart control chart is a useful tool for monitoring the microbiological quality of purified water. By identifying trends and patterns in the data, the chart can help to identify potential problems with the water purification process and take corrective action.

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Why is it important?

The article "Shewhart Control Chart in Microbiological Quality Control of Purified Water and its Use in Quantitative Risk Evaluation" by Mostafa E. Eissa is important for several reasons: Quality Control in Purified Water: Purified water is critical in various industries, especially in pharmaceuticals, where microbiological quality is paramount. This study highlights the use of the Shewhart Control Chart as a tool for monitoring and ensuring microbiological quality, which is essential for product safety and compliance with regulatory standards. Statistical Process Control (SPC): The use of Shewhart Control Charts represents a systematic approach to quality control. By applying SPC methods, organizations can identify variations in water quality, allowing for proactive measures to address potential contamination issues before they pose a risk. Quantitative Risk Evaluation: The article discusses how the application of Shewhart Control Charts can assist in quantitatively evaluating risks associated with microbiological contamination. This is particularly relevant in risk management frameworks, helping organizations make data-driven decisions regarding water quality. Regulatory Compliance: Compliance with health and safety regulations is critical in the pharmaceutical industry. This research provides a practical method for companies to demonstrate their commitment to quality assurance processes and regulatory compliance regarding water purification. Framework for Future Studies: The methodologies and findings in this paper can serve as a foundation for future research in microbiological quality control and risk management. This can help advance the field and encourage further investigation into innovative quality assurance techniques. Overall, the significance of the article lies in its contributions to enhancing the reliability and safety of purified water in critical applications, which ultimately supports public health and safety.

Perspectives

The article by Mostafa E. Eissa (2015) presents a scientifically unique perspective by integrating Shewhart control charts—a classical statistical process control tool—into microbiological quality control of purified water within pharmaceutical manufacturing, while explicitly linking this methodology to quantitative risk evaluation. Traditionally, Shewhart charts are employed to monitor process stability by detecting deviations from statistical control limits, but their application here extends beyond routine monitoring. The study innovatively uses these charts to quantify microbial contamination risks, translating process variability data into actionable risk metrics. This approach bridges statistical process control with risk management frameworks (e.g., ICH Q9), enabling not only the detection of out-of-control microbial levels but also the assessment of their potential impact on product quality. By correlating deviations in microbial counts with probabilistic risk models, the method provides a structured way to prioritize corrective actions based on risk severity, enhancing decision-making in quality assurance. The focus on purified water—a critical yet vulnerable component in pharmaceutical systems—adds practical relevance, as microbial contamination in water systems poses significant regulatory and safety concerns. The article’s novelty lies in its dual emphasis on real-time process monitoring and quantitative risk analysis, offering a proactive, risk-based strategy aligned with modern regulatory expectations that emphasize risk mitigation and continuous quality improvement. This integration advances traditional quality control paradigms by embedding risk evaluation directly into statistical monitoring workflows, thereby strengthening pharmaceutical water system management.

Independent Researcher & Consultant Mostafa Essam Eissa

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This page is a summary of: Shewhart Control Chart in Microbiological Quality Control of Purified Water and its Use in Quantitative Risk Evaluation, Pharmaceutical and Biosciences Journal, December 2015, UK Journal of Pharmaceutical and Biosciences,
DOI: 10.20510/ukjpb/4/i1/87845.
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