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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
niques which allow them to introduce products with the highest possible quality level and reduced quality costs while maintaining conformance to the pharmaceutical GMPs, technical and legislative requirements. One of the popular modern quality management methodologies is Six Sigma, which proved its high ability to increase business profits and competitiveness within more than 30 years of implementation in manufacturing and service sectors. Recently, Six Sigma methodology has been adopted by global pharmaceutical companies such as Baxter, Eli Lilly, Johnson & Johnson and Novartis and obtained considerable benefits from its abilities. This research aims at investigating the possibility to improve the quality of medications through implementing the six sigma methodology, and to find out what benefits a pharmaceutical company can get through the implementation of this methodology. A case study was conducted in a pharmaceutical company in Syria (Orient-Pharma) in order to examine the effectiveness and advantages of Six Sigma methodology. For this purpose, a quality improvement project was conducted using DMAIC roadmap to enhance the quality for one of the main products of the company. The obtained results of DMAIC project showed an enhanced process capability, an enhanced process Sigma level, decreased variability in the process outputs, as a result the quality of the medication had been enhanced sufficiently. As a conclusion, considerable benefits can be obtained through implementing Six Sigma methodology in the pharmaceutical industry to improve the medications quality and the production processes as well.
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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
he existing classification of consumers. This change is necessary because the outsourcer cannot directly interact with the consumer, whereas the consumer interacts with the producer. Consequently, there is another link for interaction between customer and outsourcer that is the manufacturer.Because of this link, it is possible to lose the customer's requirements, which the outsourcer must fulfill.Therefore, we can say that there is a new type of consumer – "concealed customer"
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2017 IEEE VI Forum Strategic Partnership of Universities and Enterprises of Hi-Tech Branches (Science. Education. Innovations)(SPUE)
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Professional-public accreditation is aimed at developing a system of recommendations for improving the quality of educational programs in higher education. As is known in experts on professional-public accreditation includes representatives of employ
ers, education and students. Nevertheless, due to the lack of regulations and forms of reports, it can be observed that in a number of reporting documents there is no information about the relationship of the educational institution with employers. In addition, there is no single database on which educational programs and in which professional and public expert communities have been accredited. Thus, the effectiveness of professional-public accreditation is currently low. To increase the importance of this procedure, it is necessary to increase the importance of employers 'and students' unions when implementing procedures or professional and public accreditation.
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.
This research is aimed at studying the matter of Six Sigma implementation in The Syrian Pharmaceutical Companies as a way to enhance the quality of drug products , and to determine the requirements for successful implementation Six Sigma , and what b
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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