Quality Improvement in Routine Inspection and Control of Healthcare Products Using Statistical Intervention of Long-Term Data Trend

Yıl 2021, Cilt: 10 Sayı: 2, 163 - 184, 30.12.2021

Mostafa Eissa , Engy Rashed , Dalia Essam Eıssa

Öz

Commercial products in markets must meet the regulatory and quality control criteria to be acceptable for the intended use. While it is mandatory that each product batch must meet specification limits, the stability and efficiency over the long term are underestimated. The present study was conducted on the chronological trend of a healthcare product using a statistical software package, including correlation matrix and multivariate analysis. The investigated quality characteristics were the average filling weight, relative density, pH and the relative potency of three active components, in addition to a chemical preservative. The database was processed in an Excel sheet and was subjected to descriptive statistical overview, histogram plot, box plot diagram, time series plot, correlation matrix table and Principal Component Analysis. The investigation showed that despite all batches passed quality control tests successfully yet there were signs of instability, fluctuations or oscillations and drifts in all quality metrics, with outlier values that could be observed. Non-parametric correlation demonstrated some level of association between some inspection characteristic indicators. PCA illustrated the major variability influencer and clustering tendency among studied quality markers that guided the grouping of the dataset. The study pinpointed the improvement needed to ensure product stability, efficiency and quality.  

Anahtar Kelimeler

Box plot, Histogram, Normality test, Matrix plot, Outlier, Principal component analysis

Uzun Vadeli Veri Trendinin İstatistiksel Müdahalesi Kullanılarak Sağlık Ürünlerinin Rutin Muayenesi ve Kontrolünde Kalite İyileştirme

Öz

Piyasalardaki ticari ürünler, kullanım amacına uygun olarak kabul edilebilir olması için düzenleyici ve kalite kontrol kriterlerini karşılamalıdır. Her ürün serisinin spesifikasyon limitlerini karşılaması zorunlu olmakla birlikte, uzun vadede stabilite ve verimlilik hafife alınmaktadır. Bu çalışma, korelasyon matrisi ve çok değişkenli analiz içeren istatistiksel bir yazılım paketi kullanılarak bir sağlık ürününün kronolojik eğilimi üzerinde yürütülmüştür. Araştırılan kalite özellikleri, bir kimyasal koruyucuya ek olarak, ortalama dolum ağırlığı, bağıl yoğunluk, pH ve üç aktif bileşenin bağıl gücüydü. Veritabanı bir Excel sayfasında işlendi ve tanımlayıcı istatistiksel genel bakışa, histogram grafiğine, kutu grafiğine, zaman serisi grafiğine, korelasyon matrisi tablosuna ve Temel Bileşen Analizine tabi tutuldu. Araştırma, tüm serilerin kalite kontrol testlerini başarıyla geçmesine rağmen, tüm kalite ölçümlerinde gözlemlenebilen aykırı değerlerle birlikte istikrarsızlık, dalgalanmalar veya salınımlar ve sapmalar olduğunu gösterdi. Parametrik olmayan korelasyon, bazı denetim karakteristik göstergeleri arasında bir düzeyde ilişki olduğunu göstermiştir. PCA, veri kümesinin gruplandırılmasına rehberlik eden incelenen kalite belirteçleri arasındaki ana değişkenlik etkileyicisini ve kümelenme eğilimini gösterdi. Çalışma, ürün istikrarını, verimliliğini ve kalitesini sağlamak için gereken iyileştirmeyi belirledi.

Anahtar Kelimeler

Kutu Grafiği, Histogram, Normallik testi, Matris Grafiği, Aykırı, Temel bileşenler analizi

Kaynakça

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