Toward an Integrated Product Quality System

2006 ◽  
pp. 147-153
Author(s):  
Yasser E. Tawfik

The purpose of issuing a quality manual for the radioisotope production plants is to define and describe the quality system implemented by the plant. It provides general procedures for all activities comprising the quality system, defines the authorities and responsibilities of all personnel affected by the system and provides a way to inform our customers of the specific controls that are in place at radioisotope production plants to assure continued product quality. Such a quality manual is regularly updated to depict the quality management system implemented by radioisotope production plant as accurately as possible. Example of this type of quality manual is developed for the radioisotope production facility (RPF) located in ETRR-2 Complex site – Egyptian Atomic Energy Authority – Inshas-EGYPT.


2021 ◽  
Vol 10 (2) ◽  
pp. 147-153
Author(s):  
I. E. Smekhova ◽  
L. V. Shigarova ◽  
I. A. Narkevich ◽  
E. V. Flisyuk ◽  
V. D. Meteleva

Introduction. In the process of pharmaceutical development of a medicinal product, it is necessary to substantiate the composition of the medicinal product; develop a technology for a finished dosage form (including a primary packaging system); create documentation for various stages of product development; validate analytical methods and technological processes. Information obtained in the course of experimental research and development of a medicinal product is included in the registration dossier. Documenting a pharmaceutical development allows you to systematize knowledge about monitoring technological processes, product quality indicators, and present the integrity of the data obtained.Aim. Creation of documentation for pharmaceutical development within the pharmaceutical quality system of the enterprise.Materials and methods. In the course of the research, the following methods were used: content analysis; system analysis; systems approach.Results and discussion. On the pharmaceutical development of two-component suppositories within the FGC, based on the knowledge gained about the process and the product and taking into account the risk analysis, we have created documents that were adapted to the enterprise's document flow to optimize the documentation process at the subsequent stages of the drug's life cycle. For optimal documentation of the first stage of drug development, a list of documents is proposed, including: Report on the pharmaceutical development of two-component suppositories; specifications for raw materials and materials, intermediate products, finished products; standard operating procedures during the pharmaceutical development phase; Guidelines for monitoring processes and product quality; Instructions for corrective and preventive actions (CAPA), change management, management review; report on the analysis of the effectiveness of the quality assurance system in the pharmaceutical development of two-component suppositories. The proposed set of documents makes it possible to form a single base of knowledge and results obtained at this stage, to systematize and structure them.Conclusion. In the course of the pharmaceutical development of two-component suppositories, knowledge has been generated about the process of creating a product of proper quality. A set of documents has been developed, consisting of reports, specifications, standard operating procedures, instructions, for an enterprise planning to produce two-component suppositories. Pharmaceutical development documentation is adapted to the enterprise document flow to optimize the documenting process at the subsequent stages of the drug product life cycle.


2020 ◽  
Vol 220 ◽  
pp. 01100
Author(s):  
Natalia Shchepkina ◽  
Natalia Meshkova

The scale and the level of the scientific developments in forming of the economic mechanism for managing innovative development, the search for the main factors that hinder the innovative activities of the enterprises and grounding of the mechanisms for attracting innovations into production remain insufficiently studied. The article presents recommendations on forming the economic mechanism for managing the innovative development of the construction enterprises. Quality assurance is understood as a system of measures that constantly maintain consumer confidence in the product quality. Accordingly, the role of the personnel of the enterprise increases significantly. Therefore, it is necessary to pay great attention to the functioning of the following principles: labor collective; machines; materials; method; sphere. Considering this fact, the mechanism for maximizing the management of the innovative development has been proposed, which is based on the principles of management, on the principles of the quality system and the improvement of the construction enterprises activities.


The main objective of this paper is to describe the state of the art of the calibration and certification of industrial sensors, giving an approach on how companies can manage the sensors’ calibration, namely the ones that are incorporated in the equipment. For any industry it is essential to make products that satisfy the customers in terms of quality and, simultaneously, to be competitive in the market. The data obtained from the sensors placed in the equipment is one of the sources that helps to increase the performance, adding value for the competitiveness of the company in the market. Sensors are responsible, in many sectors, to guarantee equipment availability and product quality. In this way, the certification of the company and of the equipment, not only guarantee quality and prevent unwanted and unforeseen costs, but also gives company credibility, namely from the customer's point of view. This paper focus on the state of art of industrial metrology, namely sensors, standards and measuring tools, calibrations and the certification of calibration. It also includes a theoretical section about sensors, types of sensors, their operation and characteristics. Next, it is presented the theme of metrology and the measurement science, responsible for ensuring the quality and veracity of the data sent by the reading equipment. It also addresses the importance of metrological traceability and certified management systems, which are required to certify the sensors calibration, in order to guarantee the effectiveness of the measurements and, consequently, the rigor of operation of the associated quality system.


2017 ◽  
Vol 24 (2) ◽  
pp. 144-153
Author(s):  
Yunita Fitri Wahyuningtyas

This research is conducted upon the emergence of many companies producing the same product of the same kind and function. It leads to the urgency of proper and well planned marketing strategy. This research aims to investigate how far the influence of branding, product quality, and price toward consumer’s satisfaction in beverage franchise business. This research utilizes 5 likert scale questionnaire which is tested by using multiple regression analysis to reveal whether or not there is partial and simultaneous influence of branding, product quality, and price toward consumer’s satisfaction in beverage franchise business. Sampling method is accidental sampling technique, in which sample of particular population is taken based on the accessibility and availability of the sample during the sampling process. Sample used is 100 samples among consumers or customers of Mang Endy Milkshake. The result shows that branding, product quality, and price influence consumer’s satisfaction in beverage franchise business.


Liquidity ◽  
2018 ◽  
Vol 7 (2) ◽  
pp. 97-107
Author(s):  
Esust Setiawati

This study aims to analyze how strategic management in the Firta Collection Boutique to develop its business, especially in providing services to customers. The method used in this research is a qualitative method that includes Marketing Mix (4P Analysis) and SWOT Analysis, to find out what external factors are opportunities or threats to the Firta Collection Boutique. The results of the study show that the strategies adopted by the Firta Collection Boutique are still inappropriate and need to use other strategies. Changes in the external environment have continued to increase so that it is an opportunity and anticipates threats by utilizing strengths and minimizing weaknesses by innovating and improving approaches and gaining customer trust in product quality, in order to compete in the fashion sector.


2016 ◽  
pp. 112-128
Author(s):  
A. Gnidchenko

The article surveys the literature that emphasizes the importance of comparative and absolute advantages for intra- and inter-industry trade. Two conclusions follow form the survey. First, unlike the traditional view, intra-industry trade is determined rather by technology than by increasing returns. Second, absolute advantages that have been ignored in international trade models for a long time play a vital role through their linkages with product quality and export diversification. We also discuss a new strand of literature that models international trade with the assumption of non-homothetic preferences.


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