Statistical Characterization and Process Control Assessment of Key Operational Parameters in Applied Engineering Systems
DOI:
https://doi.org/10.38032/jea.2025.03.004Keywords:
Statistical Process Control, Distribution Fitting, Chemical Purity, Control Charts, Specific Optical Rotation, Water ContentAbstract
Ensuring consistent raw material quality is a significant challenge in chemical manufacturing, particularly for medicinal compounds where safety and efficacy are paramount. In these situations, a unique methodology known as Statistical Process Control (SPC) come into play. This study provides statistical process control analysis of four critical operational parameters for most the raw chemical compounds, especially in the medicinal chemistry— Specific Optical Rotation (SOR), Water Content (WC), RI, and Chromatographic Purity (CP)—derived from a dataset of 26 observations in an applied engineering context. The methodology encompasses descriptive statistics, rigorous distribution identification using Goodness-of-Fit tests, and process stability assessment via Individual- Moving Range (I-MR) and Exponentially Weighted Moving Average (EWMA) control charts. Descriptive statistics revealed diverse data characteristics, notably the high positive skewness (2.623) and kurtosis (9.386) of WC (Mean ± Standard Deviation: 0.177±0.106987) and the presence of negative values for SOR (Mean: -0.1, Min: -2, Max: 2). Distribution fitting identified Logistic and Normal as the most suitable for SOR, while RI demonstrated a best fit for normal distribution with Johnson Transformation. WC and CP exhibited significant non-normality and challenges in fitting standard distributions, often accompanied by warnings regarding convergence or parameter estimation stability. Crucially, control chart analysis identified significant out-of-control conditions for SOR, WC, and RI, indicating inherent process instability. CP, conversely, demonstrated stability with the optimized EWMA chart. The findings underscore the necessity of tailored statistical approaches for diverse data characteristics in quality control. Implementation of Statistical Process Control should not be underestimated in the chemical manufacturing industry, notably in the developing nations.
References
[1] Eissa, M.E., Rashed, E.R. and Eissa, D.E., 2023. Case of preferential selection of attribute over variable control charts in trend analysis of microbiological count in water. Acta Natura et Scientia, 4(1), pp.1-9. DOI: https://doi.org/10.29329/actanatsci.2023.353.01
[2] Eissa, M., Rashed, E. and Eıssa, D.E., 2023. Microbiological stability assessment of municipal distribution line using control chart approach for total bioburden count. Health Academy Kastamonu, 8(2), pp.363-383. DOI: https://doi.org/10.25279/sak.1035879
[3] Eissa, M., 2018. Quality criteria establishment for dissolution of ascorbic acid from sustained release pellets. Novel Techniques in Nutrition & Food Science, 2(2). DOI: https://doi.org/10.31031/NTNF.2018.02.000531
[4] Eissa, M.E., 2024. Tracking Stability Using Shewhart Charts to Elucidate Trending Patterns in Glyceryl Guaiacolate Assay: Paving the Way for Quality Improvement in Medicinal Chemical Industry. Acta Natura et Scientia, 5(2), pp.119-124. DOI: https://doi.org/10.61326/actanatsci.v5i2.314
[5] Eissa, M.E., 2024. Statistical Process Control Implementation in Inspection of Active Medicinal Compound Quality: A Model of First-Generation Antihistaminics. Acta Natura et Scientia, 5(2), pp.96-105. DOI: https://doi.org/10.61326/actanatsci.v5i2.291
[6] Eissa, M.E., 2024. Current perspective in quality control examining and extended researching for certain aspects of active pharmaceutical ingredient using statistical process control. Acta Natura et Scientia, 5(1), pp.31-40. DOI: https://doi.org/10.61326/actanatsci.v5i1.4
[7] Eissa, M.E., 2023. Trending perspective in evaluation of inspection characteristics of pharmaceutical compound: comparative study of control charts. Universal Journal of Pharmaceutical Research, 8(5), pp.15-21. DOI: https://doi.org/10.22270/ujpr.v8i5.1006
[8] Eissa, M., Rashed, E. and Eıssa, D.E., 2021. Quality improvement in routine inspection and control of healthcare products using statistical intervention of long-term data trend. Dicle Üniversitesi Fen Bilimleri Enstitüsü Dergisi, 10(2), pp.163-184.
[9] Eissa, M.E., 2025. Modeling microbiological counts in purified water at a healthcare facility using arima. Quantum Journal of Medical and Health Sciences, 4(3), pp.56-68. DOI: https://doi.org/10.55197/qjmhs.v4i3.158
[10] British Pharmacopoeia Commission. British Pharmacopoeia. 2025 ed. London: The Stationery Office; 2025.
[11] United States Pharmacopeial Convention. The United States Pharmacopeia and The National Formulary (USP-NF). Current Edition. Rockville (MD): U.S. Pharmacopeial Convention; 2025.
[12] Eissa, M.E., 2025. Enhancing Process Efficiency in Industry Through Statistical Process Control: Study of Aspartyl Phenylalanine Methyl Ester. Acta Natura et Scientia, 6(1), pp.37-45.
[13] Eissa, M., 2024. Statistical process control and capability six-pack for conductivity measurement in medicinal chemical industry. J Pharmacol Pharmaceut Res, 1(1), pp.9-14. DOI: https://doi.org/10.5455/JPPR.20240111092356
[14] Eissa, M.E.A., 2025. COVID-19 Impact on Public Health in Bangladesh: A Comprehensive Analysis of Morbidity, Mortality and Future Scenarios. Acta Natura et Scientia, 6(1), pp.55-65.
[15] Rashed, E.R. and Eissa, M.E., 2020. Long-Term quantitative assessment of women survivability from cancer: a unique descriptive analysis. Highlights Biosci, 3, pp.1-8. DOI: https://doi.org/10.36462/H.BioSci.20208
[16] Rashed, E.R. and Eissa, M.E., 2020. Global assessment of morbidity and mortality pattern of CoVID-19: Descriptive statistics overview. Iberoamerican Journal of Medicine, 2(2), pp.68-72. DOI: https://doi.org/10.53986/ibjm.2020.0014
[17] Eissa, M.E.A.M., 2024. Statistical analysis of the critical quality attributes of 1, 2-dihydroxypropane as a pharmaceutical excipient. German Journal of Pharmaceuticals and Biomaterials, 3(3), pp.9-17. DOI: https://doi.org/10.5530/gjpb.2024.3.8
[18] George, F. and Ramachandran, K.M., 2011. Estimation of parameters of Johnson’s system of distributions. Journal of Modern Applied Statistical Methods, 10(2), p.9. DOI: https://doi.org/10.22237/jmasm/1320120480
[19] Figueiredo, F.E.R.N.A.N.D.A. and Gomes, M.I., 2006. Box-Cox transformations and robust control charts in SPC. Advanced Mathematical and Computational Tools in Metrology, 7, pp.35-46. DOI: https://doi.org/10.1142/9789812774187_0004
[20] Standard, A.S.T.M., 2016. Standard Practice for Use of Control Charts in Statistical Process Control. Designation: E2587-16, Printed by Missouri.
[21] Katz, P. and Campbell, C., 2012. FDA 2011 process validation guidance: Process validation revisited. Journal of Validation Technology, 18(4), p.33.
[22] ASTM International. ASTM E2500-07, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. West Conshohocken, PA: ASTM International; 2007.
[23] ASTM International. ASTM E2709-09, Standard Practice for Demonstrating Capability to Assure High Quality Pharmaceutical Products. West Conshohocken, PA: ASTM International; 2009.
[24] Montgomery, D.C., 2020. Introduction to statistical quality control. John wiley & sons.
[25] Western Electric Company, 1958. Statistical quality control handbook. The Company. New York, USA.
[26] Lawless, J.F., 2011. Statistical models and methods for lifetime data. John Wiley & Sons.
[27] Johnson, N.L., 1949. Systems of frequency curves generated by methods of translation. Biometrika, 36(1/2), pp.149-176. DOI: https://doi.org/10.1093/biomet/36.1-2.149
[28] Roberts, S.W., 2000. Control chart tests based on geometric moving averages. Technometrics, 42(1), pp.97-101. DOI: https://doi.org/10.1080/00401706.2000.10485986
[29] Borror, C.M., Montgomery, D.C. and Runger, G.C., 1999. Robustness of the EWMA control chart to non-normality. Journal of quality technology, 31(3), pp.309-316. DOI: https://doi.org/10.1080/00224065.1999.11979929
[30] Horng Shiau, J.J. and Ya-Chen, H., 2005. Robustness of the EWMA control chart to non-normality for autocorrelated processes. Quality Technology & Quantitative Management, 2(2), pp.125-146. DOI: https://doi.org/10.1080/16843703.2005.11673089
[31] Resilience insights [Internet]. Maersk.com. 2025 [cited 2025 Jul 28]. Available from: https://www.maersk.com/insights/resilience?gad_source=1&gad_campaignid=22629942176&gbraid=0AAAAAC7YVf3NGK-VL3FHHhTRrmJW4_rqu&gclid=CjwKCAjwv5zEBhBwEiwAOg2YKOPJjfgcau5JMZFPxeQsgWIM7xBCe3twHDhBJyC4v2Wa6LjwtQanmxoC
[32] Garcia G. Strategies for Supply Chain Diversification [Internet]. The International Trade Council. 2025. Available from: https://tradecouncil.org/strategies-for-supply-chain-diversification/
[33] Wolfe W. Challenges in Achieving Full Supply Chain Transparency in Developing Countries [Internet]. Watson & Wolfe. 2024 [cited 2025 Jul 28]. Available from: https://www.watsonwolfe.com/2024/06/16/challenges-in-achieving-full-transparency-in-supply-chains-especially-in-developing-countries/?srsltid=AfmBOoohv39PgegTltBaKuojKkL0FYepOxz53IACm9B-l4BnsATYy6-m
[34] Challenges in Product Quality? Let’s Find the Solution - Grove Green Global [Internet]. Grove Green Global. 2025 [cited 2025 Jul 28]. Available from: https://www.grovegreenglobal.com/blog/challenges-in-product-quality-lets-find-the-solution/
[35] Eissa, M.E., 2024. Assessment of some inspection properties of commonly used medicinal excipients using statistical process control for monitoring of manufacturer quality. Acta Natura et Scientia, 5(1), pp.19-30. DOI: https://doi.org/10.61326/actanatsci.v5i1.3
[36] Duncan, A.J., 1974. Quality control and industrial statistics, 5th. Ed. Irwin, Homewood, IL: Richard D Irvin. 1986.
[37] Razali, N.M. and Wah, Y.B., 2011. Power comparisons of shapiro-wilk, kolmogorov-smirnov, lilliefors and anderson-darling tests. Journal of statistical modeling and analytics, 2(1), pp.21-33.
[38] D'Agostino, R., 2017. Goodness-of-fit-techniques. Routledge. CRC press. DOI: https://doi.org/10.1201/9780203753064
[39] U.S. Food and Drug Administration, 2011. Process Validation: General Principles and Practices. Silver Spring (MD): U.S. Food and Drug Administration.
[40] Roberts, S.W., 2000. Control chart tests based on geometric moving averages. Technometrics, 42(1), pp.97-101. DOI: https://doi.org/10.1080/00401706.2000.10485986
[41] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q3C(R9) Impurities: Guideline for Residual Solvents. Geneva: ICH; 2017.
[42] Cowden, D.J., 1957. Statistical methods in quality control. Englewood Cliffs (NJ): Prentice-Hall.
[43] ASTM International. ASTM E2587-16, Standard Practice for Use of Control Charts in Statistical Process Control. West Conshohocken, PA: ASTM International; 2016.
[44] Ryan, T.P., 2011. Statistical methods for quality improvement. John Wiley & Sons. DOI: https://doi.org/10.1002/9781118058114
[45] Abbasi, S.A. and Miller, A., 2012. On proper choice of variability control chart for normal and non‐normal processes. Quality and Reliability Engineering International, 28(3), pp.279-296. DOI: https://doi.org/10.1002/qre.1244
Downloads
Published
Data Availability Statement
The data will be made available upon reasonable request.
Issue
Section
License
Copyright (c) 2025 Mostafa Eissa

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All the articles published by this journal are licensed under a Creative Commons Attribution-NonCommercial 4.0 International License