COMPLEX RESEARCH AMONG PHARMACY PRODUCTS' CONSUMERS FROM THE POSITION OF THE QUALITY MANAGEMENT SYSTEM

2021 ◽  
pp. 103-109
Author(s):  
Filina I.A. ◽  
Ustinova L.P. ◽  
Fomicheva S.I. ◽  
Varenyk G.V.
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Storage Conditions ◽  
Pharmaceutical Products ◽  
Maximum Efficiency ◽  
Normative Documents ◽  
Decisive Importance ◽  
International Nonproprietary Name ◽  
Questionnaire Method

The Quality Management System is a universal set of tools that helps to achieve maximum efficiency of any enterprise in all aspects. In order for the Quality Management System in the pharmacy to work effectively for the consumer of pharmaceutical goods, it is necessary to periodically conduct research among the clients of the pharmacy organization. The aim of the work was a comprehensive research among consumers of pharmacy products from the standpoint of the Quality Management System. Normative documents regulating pharmaceutical activities, works of domestic and foreign scientists were adopted as the information base. The questionnaire method was used to tackle the assigned tasks. The objects of the research were the visitors of the pharmacy organizations of the Oryol region. As a result of the study, it was found that efficacy, safety and price are of decisive importance for pharmacy visitors when choosing a drug; the majority of consumers pay attention to the shelf life of a drug when purchasing it (83.0%), however, only 47.0% of respondents attach importance to storage conditions; most pharmacy clients don’t know anything about the list of vital and essential drugs, the minimum range, the international nonproprietary name of the drug; the majority of visitors to pharmacy organizations don’t distinguish between the following concepts: falsified, substandard and counterfeit medicines; some respondents found adverse reactions after taking a drug that weren’t specified in the instructions, some consumers when purchasing drugs faced their defective forms. Thus, on the basis of a comprehensive study carried out among consumers of pharmaceutical products, it can be concluded that it is necessary to develop a system of measures that increase the literacy of the population in the field of the quality of medicines.

scholarly journals AUTOMATED DOCUMENT MANAGEMENT SYSTEM OF PHARMACEUTICAL MANUFACTURER’S QUALITY MANAGEMENT SYSTEM IN ACCORDANCE WITH REQUIREMENTS OF GMP

2017 ◽  
Vol 72 (2) ◽  
pp. 126-133
Author(s):  
N. V. Pyatigorskaya ◽  
V. V. Beregovykh ◽  
Zh. I. Aladysheva ◽  
Vasiliy V. Belyaev ◽  
A. P. Meshkovskii ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Document Management ◽  
Document Management System ◽  
Pharmaceutical Quality System ◽  
Four Blocks ◽  
Pharmaceutical Production

Drugs must be produced in compliance with good manufacturing practice rules approved by an authorized federal agency. Pharmaceutical Quality System is a global requirement for development and production processes for pharmaceutical products. The article describes a variant of automated document management system of pharmaceutical manufacturer’s quality management system in accordance with current requirements of GMP. The peculiarity of the proposed system is the focuses on pharmaceutical production taking into account the characteristics and requirements for the pharmaceutical products production. All documents which are supposed to be used within the system are grouped into the four blocks: normative legal acts, core manufacturer standards according to GMP, regulatory documents, and register documents.

Study of the Implementation of Continuous Improvement using Kaizen Philosophy in Indonesian Construction Projects

2021 ◽  
Vol 26 (2) ◽  
pp. 128-139
Author(s):  
Kartika Nur Rahma Putri
Keyword(s):  
Quality Management ◽  
Continuous Improvement ◽  
Management System ◽  
Construction Projects ◽  
Quality Management System ◽  
Descriptive Analysis ◽  
Project Planning ◽  
Road Projects ◽  
Questionnaire Method ◽  
Project Data

Kaizen as a quality management system offers a new approach to increase productivity by improving existing production processes without investing in new tools/procedures. This study aimed to determine the application of continuous improvement in construction projects according to kaizen philosophy. The research was conducted using descriptive analysis to describe the process of continuous improvement in a construction project. Data were collected using a questionnaire method on 24 building and road projects and interviews with two contractors. This study's results indicate that the application of the kaizen principle in construction projects is still limited. The research reveals that project planning has been carried out but not entirely following field conditions, standardization of work methods already exists but not detailed, all parties in the project have been involved in the construction process, but initiatives to make improvements have not been seen because it is still focused on corrective evaluation and work completion. The challenges in implementing continuous improvement are the lack of a quality management system, lack of working time, lack of consistency in the implementation of quality, and lack of worker’s skill in carrying out work. Some improvements required to support continuous improvement are to encourage top management's role in the application of quality management systems and internalization of the kaizen principle to all workers. The involvement of all production elements in maintaining product's quality in the internal system also needs to be improved.

scholarly journals QUALITY MANAGEMENT SYSTEM OF A PHARMACEUTICAL ORGANIZATION: CRITERIA AND IMPLEMENTATION

2019 ◽  
Vol 7 (3) ◽  
pp. 170-179
Author(s):  
A. A. Klimenkova ◽  
L. N. Geller ◽  
A. A. Skripko ◽  
L. A. Gravchenko ◽  
N. V. Fedorenko
Keyword(s):  
Quality Management ◽  
Business Processes ◽  
Quality Management System ◽  
Pharmaceutical Products ◽  
Retail Trade ◽  
Retail Sector ◽  
Normative Documents ◽  
Pharmaceutical Organization ◽  
First Results ◽  
Main Production

The aim of the study is a theoretical justification and development of a mechanism for the implementation of quality management systems (QMS) in the activities of retail trade in pharmaceutical products.Materials and methods. The study is based on the analysis of scientific literature data and Analytical Normative Documents regulating various aspects of QMS functioning in pharmaceutical organizations. Methods of documentary content analysis of international and national ISO standards, Series 9000, were used as the basis for the development and implementation of QMS organizations despite the type of their activities.Results. In the course of the study, the organization of the production process has been studied and the main production (business-) operations of seven structural subdivisions of “Apteka-Alex” LLC in Angarsk have been analyzed. The basic principles of QMS functioning are set forth and the author’s methodology for its development for retail trade in pharmaceutical products has been presented, taking into account the specifics of the organizational structure and production activities of pharmacy organizations. The mechanisms and successive stages of the QMS implementation have been specified and given grounds for. In accordance with the requirements of GOST R ISO 9000:2015, the definitions and classification of the main production operations (business processes) of the studied pharmacies have been made up. In addition, the list of mandatory (core) and basic standard operating procedures (SOPs), detailing the main production (business-) processes, has been made up, and an algorithm for developing and testing SOPs has been outlined.Conclusion. The results of the study allowed us to justify and propose a step-by-step methods of QMS implementation into the work of pharmaceutical organizations in the retail sector. The first results of the approbation and use of the developed methodology show that it contributes to the rational construction and functioning of the QMS, in accordance with the requirements of the existing standards, as well as the optimization of administrative management of all production (business-) processes. 

scholarly journals PENERAPAN SISTEM MANAJEMEN MUTU ISO 9001 PADA KONTRAKTOR PT. X

2020 ◽  
Vol 2 (3) ◽  
pp. 201-211
Author(s):  
Arief Darmawan ◽  
Sidiq Wacono ◽  
Jonathan Saputra
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Iso 9001 ◽  
Quality Data ◽  
Documented Information ◽  
Information And Communication ◽  
Testing Techniques ◽  
Questionnaire Method ◽  
Service Businesses

ABSTRACTInfrastructures development in Indonesia is experiencing a high increase. However, many construction failures were due to construction that was not following the predetermined quality. Data obtained from the Investigation of the PNK Technical Team in 2013 contained 5 cases of construction project failure handled by the authorities with a total loss of more than 5 billion to the state. The reality shows that many construction service businesses have names but do not have the supporting facilities. Therefore, data collection aims to analyze the application of the ISO 9001: 2015 application quality management system and its application constraints. Processing data use descriptive statistical analysis and using SPSS version 25 software. The data testing techniques used include validity, reliability, and descriptive hypothesis. The data was collected using a questionnaire method for construction employees in the Design Project for the Tanjung Barat Station Flats. This analysis indicates that the application of the ISO 9001: 2015 quality management system by taking into account all the points from clause 4 to clause 10 is 85.19% and is in the excellent category (80-100%). Factors that become obstacles in implementing ISO 9001: 2015 are due to the lack of socialization regarding the application of ISO 9001, documented information, and communication between project teams.Keywords : ISO 9001; ISO 9001:2015; Quality Management System.ABSTRAKPerkembangan infrastruktur di Indonesia sedang mengalami peningkatan yang tinggi. Tetapi, banyak ditemui kegagalan konstruksi yang disebabkan oleh pelaksanaan konstruksi yang tidak sesuai dengan kualitas yang sudah ditetapkan. Data yang diperoleh dari Investigasi Tim Teknis PNK pada tahun 2013 menunjukkan 5 kasus kegagalan proyek konstruksi yang ditangani pihak berwajib dengan nilai kerugian negara mencapai lebih dari 5 milyar. Kenyataan menunjukkan banyak usaha jasa konstruksi yang memiliki nama tetapi tidak memiliki fasilitas yang mendukung. Oleh karena itu, dilakukan pengambilan data yang bertujuan untuk menganalisis penerapan sistem manajemen mutu ISO 9001:2015 dan faktor kendala dalam penerapannya. Pengolahan data menggunakan uji hipotesis deskriptif dan menggunakan bantuan software SPSS versi 25. Teknik pengujian data yang digunakan meliputi uji validitas, uji reliabilitas dan hipotesis deskriptif. Pengumpulan data dilakukan menggunakan metode kuesioner terhadap karyawan konstruksi yang terlibat dalam Proyek Rancang Bangun Rumah Susun Stasiun Tanjung Barat. Hasil analisis ini menunjukkan bahwa penerapan sistem manajemen mutu ISO 9001:2015 dengan memperhatikan seluruh butir dari klausul 4 sampai klausul 10 adalah sebesar 85,19% dan masuk kategori sangat baik (80-100%). Faktor yang menjadi kendala dalam penerapan ISO 9001:2015 adalah akibat kurangnya sosialisasi mengenai penerapan ISO 9001, informasi terdokumentasi, dan komunikasi antar tim proyek.Kata kunci : ISO 9001; ISO 9001:2015; Sistem Manajemen Mutu.

scholarly journals DEVELOPMENT OF THE INTEGRATED QUALITY MANAGEMENT SYSTEM OF AIR TRANSPORT ENTERPRISES

2021 ◽  
Author(s):  
Tetiana Simkova ◽  
Tetiana Panchoshna
Keyword(s):  
Quality Management ◽  
Financial Management ◽  
Management System ◽  
Production Management ◽  
Quality Management System ◽  
Negative Impact ◽  
Great Influence ◽  
Air Transport ◽  
Corporate Management ◽  
Normative Documents

The article considers how the development of the quality management system affects the market position of air transport enterprises. The development of an integrated management system will ensure a stable level of quality of airport services, its full compliance with the established requirements, taking into account the needs of consumers, mostly airlines, to achieve maximum satisfaction, and reduce the negative impact of airports on the environment. Improving the quality management system will take into account the requirements and needs of service consumers, control the level of customer satisfaction, avoid possible mistakes in planning and performing work at each stage, regularly monitor the effectiveness of actions taken to ensure quality, and generally improve the entire enterprise , ensure coordination of requirements of buyers of services and normative documents, find and make efforts to eliminate discrepancies as soon as possible, and promptly prescribe methods to eliminate their cause and do everything possible to avoid their recurrence; manage important aspects of ecological activity of the enterprise, plan measures for environmental protection. However, quality management has a great influence on the following processes of the enterprise: production management, project management, corporate management, investment management, personnel management, financial management. But in practice to achieve the desired quality is much more difficult than it seems. Because the appropriate managers must control all processes in production. And their work can be facilitated only by subordinates. That is, a fully covered quality improvement can be achieved only through the interest and motivation of workers at all levels. This is confirmed by the activities of the world's leading companies, which in recent years have begun to pay more attention to corporate policy, feedback from their customers and improving production technology. Modern production technologies are increasingly confirming that the concept of quality must be embedded in the product from the very beginning of its creation and continue its implementation at all stages of its development. That is, a comprehensive quality assurance system at the enterprise can be considered as a set of all organizational structures, processes, measures and techniques for its improvement, as well as stakeholders. Therefore, this article will also consider how global international quality standards have changed, in particular the ISO 9001 series over the past few years, and what they have changed in approaches to quality management.

ANALYSIS THE IMPACT OF THE IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM (QMS) AND SAFETY AND HEALTHY AT WORK MANAGEMENT SYSTEM (SHWMS / SMK3) ON THE JOB PERFORMANCE OF EMPLOYEES

2018 ◽  
Vol 3 (01) ◽  
pp. 45
Author(s):  
Nur Hidayat ◽  
Indah Kusuma Hayati
Keyword(s):  
Quality Management ◽  
Job Performance ◽  
Latent Variables ◽  
Management System ◽  
Quality Management System ◽  
Partial Least Square ◽  
Least Square ◽  
Global Challenges ◽  
The Impact ◽  
Work Management

Recently, the evolvement of globalization era has been the global challenges that cannot be avoided either by private or government sectors, and they are requested to be survived encountering such the condition. The implementation of Quality Management System (QMS) in the operational company is the way how to guarantee the quality of products or services offered to the people. One of the purposes of QMS implementation is to provide a prime satisfaction to the customers. The impact of QMS implementation is expected to increase job performance of the employees. Besides the implementation of Quality Management System (QMS), the impact of global challenges has been increasing the competitive efforts to execute more effective production process. However, it has required manpower protection accordingly. This research aims to find out whether the implementation of quality management system and safety and healthy at work management system have impacted on the job performance of employees. Objects of this research are the employees in the production department at PT Guna Senaputra Sejahtera Plant 1 Bogor. Data analysis technique of this research has applied software Smart PLS (Partial Least Square). PLS has estimated a model of correlation among the latent variables and correlation between latent variables and its indicators. Result of data processing has indicated that the implementation of Quality Management System (QMS) and system of safety and healthy at work have positively and significantly impacted job performance of employees.Keywords : Quality Management System (QMS), Safety and Healthy at Work System ( SHWS / SMK3), and Job Performance of Employees

Development of a Quality Management System for Electric Power applied to Small Wind Turbines

2012 ◽  
pp. 1083-1088
Author(s):  
O.H. Ando Junior ◽  
M.O. Oliveira ◽  
J.M. Neto ◽  
A.D. Spacek ◽  
R.C.B. Leborgne ◽  
...  
Keyword(s):  
Quality Management ◽  
Electric Power ◽  
Wind Turbines ◽  
Management System ◽  
Quality Management System ◽  
Small Wind Turbines

ROLE OF RESPONSIBILITY IN THE QUALITY MANAGEMENT SYSTEM

2020 ◽  
Vol 14 (3) ◽  
pp. 805-816
Author(s):  
Zdravko Krivokapić ◽  
◽  
Miladin Stefanović
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System
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