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Register a new userA suggested developed model for quality losses estimation
نموذج مطور مقترح لتقدير خسائر الجودة
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د.باسل مخائيل العسس( باحث )
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د.باسل العسس
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إن جودة المنتجات بشكل عام لها أهمية كبيرة في الوقت الحالي، كما أن تأثيرها على مختلف جوانب الحياة، مثل الاقتصاد و الصحة و رفاهية المجتمع ككل أمر بالغ الأهمية و واضح. من الضروري أن يكون لديك فهم عميق لعملية تحقيق المنتج، بما في ذلك فهم الديناميكيات التي تتغير بموجبها جودة المنتج في ظل ظروف التصنيع وقدرة (حساسية) العميل على التعرف على التغييرات في جودة المنتج. تهدف هذه المقالة إلى تطوير و تعديل نموذج تاجوتشي ليناسب حالة المنتجات الصيدلانية (الأدوية). يمكن اعتبار نموذج فقدان الجودة الصيدلانية المقترح في هذه الورقة مزيجًا من المفهوم التقليدي لنموذج الجودة و نموذج تاجوتشي المطور ليناسب حالة الجودة الصيدلانية. يمكن استخدام نموذج الجودة المقترح للتقييم الكمي لقيمة فقدان الجودة المرتبطة بكل انحراف عن منطقة التسامح المحددة وبالتالي تعزيز فهم عملية تصنيع الأدوية لتجنب ومنع حدوث مثل هذه الخسائر في الجودة الصيدلانية في المستقبل.
The quality of products in general is of great importance in the current time, and its impact on various aspects of life, such as economy, health and welfare of society as a whole is crucial and visible. It is vital to have a deep understanding of the product realization process, including understanding the dynamics under which the product quality changes under the manufacturing conditions and the customer’s (sensitivity) ability to recognize changes in product quality. This article aims to develop and modify the Taguchi model to suit the case of pharmaceutical products. The model of pharmaceutical quality loss suggested in this paper can be considered as a combination of the traditional concept of quality model and the Taguchi model, modified to suit the case of the pharmaceutical quality. The suggested quality model can be used to assess quantitatively the quality loss value that is associated with each deviation from the established tolerance zone; and accordingly to enhance the understanding of the pharmaceutical manufacturing process to avoid and prevent the occurrence of such loses of the pharmaceutical quality in the future.
References used
X. Y. Lawrence (2008). Pharmaceutical quality by design: product and process development, understanding, and control. Pharmaceutical research, 25 (4), 781-791.
T. Lofthouse (1999). The Taguchi loss function. Work Study, 48 (6), 218-223.
M. M. A. Potdar (2006). Pharmaceutical quality assurance. Pragati Books Pvt. Ltd.
A. Rostami-Hodjegan, P. R. Jackson, G. T. Tucker (1994). Sensitivity of indirect metrics for assessing «rate» in bioequivalence studies — moving the «goalposts» or changing the «game»//Journal of pharmaceutical sciences, 83 (11), 1554-1557.
R. K. Roy (2010). A primer on the Taguchi method. Society of Manufacturing Engineers.
G. Taguchi (1986). Introduction to quality engineering: designing quality into products and processes (No. 658.562 T3).
J. F. Van Leeuwen, M. J. Nauta, D. De Kaste, Y. M. Odekerken- Rombouts, M. T. Oldenhof, M. J. Vredenbregt, D. M. Barends (2009). Risk analysis by FMEA as an element of analytical validation//Journal of pharmaceutical and biomedical analysis, 50 (5), 1085-1087.
L. X. Yu, A. Raw, R. Lionberger, R. Rajagopalan, L. M. Lee, F. Holcombe, R. Adams (2007). US FDA question-based review for generic drugs: A new pharmaceutical quality assessment system// Journal of Generic Medicines, 4 (4), 239-246.
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The increased competition in the global pharmaceutical market and the necessity to reach higher levels of quality of the pharmaceutical products force the manufacturers to seek and adopt more effective and reliable quality management methods and tech
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2017 International Conference on Infocom Technologies and Unmanned Systems (Trends and Future Directions)(ICTUS)
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In the article introduced new classification of consumers. For modern quality management, it is important to understand the requirements of the consumer. In case of participation of outsourcers in the production processes, it is necessary to change t
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Improving the efficiency of quality management systems is an important challenge for the business sector and the economy as a whole. Based on the fact that the quality system is the most important tool on which companies are based, to achieve the des
ires and expectations of customers and consumers, as well as to achieve profitability and continuity in the labor market in the long term. This study contributes to the efforts made by researchers to find effective ways and means that allow companies to measure and improve the effectiveness of their quality management systems, benefiting from the internal audit process of ISO 9001 quality systems, expanding the scope of audit to include audit of quality indicators and key performance indicators for the performance of the quality system as a whole, combined with the verification of compliance of the system with ISO 9001: 2015. The aim of the study is to improve the efficiency of the quality management system through internal audit of QMS.
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enefits and obstacles could be appear during the application process . This research has been executed as a case study by implementing Six Sigma Methodology at Orient Pharma. Company to realize the benefits and obstacles of the implementation . In addition to that , the existence of the determined requirements for successful implementation of Six Sigma in the studied company has been measured .And a theoretical study including many of important researches that studied this research's problem has been done , to review the results achieved and benefit of them in executing this study. Then , a simplified conceptual framework about Six Sigma concepts and methods has been formed. After that , the research studied the matter of implementing Six Sigma in Syrian Pharmaceutical Companies , and why they need it , and the fields that’s could benefit from Six Sigma . A group of (16) requirements has been determined as a "must to be" available before stating the application process , these requirements are divided into three main categories : Managerial requirements , Technical requirements , and Human requirements , which create together the suitable environment for successful implementation of Six Sigma.The most important results this research achieved are : it is applicable to use Six Sigma as valuable approach to enhance quality of drug products of the studied company, whereas significant improvements have been achieved through the DMAIC project such as increased quality of the drug product involved in it , decreased variability in the manufacturing process , and enhanced process capability to meet the desired quality requirements of the drug . In addition to that , a significant differences have been detected between the existed requirements in the studied company , and the needed requirements for the successful implementation of Six Sigma . The required role of the company top management , and the resistance of employees are the main obstacles for the successful implementation of Six Sigma in the company.Finally , some recommendations have been suggested to the company such as : the importance of the full existence of the determined requirements for successful implementation of Six Sigma before starting the deployment process , and the viable role of the consultant party that could qualify the employees and provide the needed training about Six Sigma concepts and methods , and to save and sustain the improvements achieved from the DMAIC project executed in the studied company .
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