Quality assurance. EN aerospace products. Approval of the quality system of manufacturers

2015 ◽  
Author(s):  
A J Singer ◽  
G F Churchill ◽  
B G Dale

This paper reports the results of a study which investigated the impact of quality assurance on 13 suppliers to the nuclear industry. The purpose of the study was to determine the benefits and problems of applying quality assurance in the supply of high risk plant items and material for nuclear installations. The paper discusses the problems facing the industry including: multiple audits and inspections, the irritation with having to contend with two quality system standards (namely BS 5750 and BS 5882) and the cost effectiveness of the more stringent quality system and quality control surveillance requirements imposed by the nuclear industry. It is also pointed out that companies supplying non-nuclear industrial customers were dissatisfied with the qualifications, experience and professional competence of some auditors and many inspectors.


2005 ◽  
Vol 117 (1-3) ◽  
pp. 291-297 ◽  
Author(s):  
E. P. Efstathopoulos ◽  
O. Benekos ◽  
M. Molfetas ◽  
E. Charou ◽  
S. Kottou ◽  
...  

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.


2021 ◽  
Vol 1 (47) ◽  
pp. 108-118
Author(s):  
O. Lytvynenko

The analysis and generalization of theoretical approaches to the formation of the construction quality system, the generalization of the legislative and regulatory framework for quality control in construction. Analysis of the theoretical prerequisites for the formation of quality control of construction revealed that the digital transformation of construction is an integral part of the development of modern society, a prerequisite for changing the system of construction, including control, quality assurance and evaluation of construction processes, works, materials, products and structures. It was found that the quality in construction is directly affected by the following factors: quality and completeness of design documentation; the possibility and obligation to comply with legal requirements; quality of construction processes and works, strict compliance with the requirements of technology and construction organization; quality of construction products and structures; technical ability to provide a given level of quality with the help of machines, mechanisms, means of small mechanization, etc .; the level of qualification of management staff, workers and line ITP. The quality system itself can be presented in the format of a "black box", where the factor will be named at the entrance, and at the exit - buildings and structures that meet a given level of quality throughout the life cycle of the object. It is proposed to consider the construction quality management system in the form of a multicomponent formation and at the same time a dynamic environment, which is constantly changing under the influence of external and internal factors and has a high degree of scholasticism and uncertainty. With the introduction of digital technologies in the organization of construction, including VIM modeling, use of artificial intelligence, cloud services for information storage, quality control tools that can be performed without human intervention, such as drones, robotic elements, surveillance cameras and others, the construction quality assurance system has to change, taking into account the realities of time. Therefore, the system of quality formation in the article is proposed to be considered throughout the life cycle of the object - from pre-project research to liquidation. This will, in contrast to existing approaches, not only combine into a single system all the components of assurance, evaluation and quality control, which are used at the level of all participants in the construction, but also to ensure integrated process management.


2020 ◽  
Vol 66 (1) ◽  
pp. 91-101
Author(s):  
Mirela Ilikj ◽  
Irena Brchina ◽  
Liljana Ugrinova ◽  
Vasil Karcev ◽  
Aleksandra Grozdanova

In 2015, in Republic of North Macedonia, a new law for narcotics has been adopted, where the changes include legal cultivation of cannabis for medicinal use as well as legal production of cannabis extracts for medicinal use. In order to gain high quality of cannabis and cannabis products for medicinal use and to meet some quality standards that will guarantee consistency, traceability and continuous quality of the product, it is necessary to implement Quality Systems. Good quality system is ISO standard system but for cannabis for medicinal use, GACP, GMP and GLC standards are used more often. Production of cannabis for medicinal use consists of: process of cultivation where GACP standards are applicable, primary processing where GMP standards are the most important and quality control of final product regulated with GLP standard. In this review, explanation of these standards as well as overview of modes of their implementation has been made. Keywords: GxP, GMP, GACP, GLP


Author(s):  
Muhamed Ali Hashim Mohamed

Some companies seek ISO 9000 registration for competitive reasons or because customers require it. PETRONAS Gas Bhd, pipeline division company TOD or Transmission Operations Division, seek ISO 9000 registrations purely for the benefits since the management believes that a well designed and well implemented quality system has a process which tends to be lean, sensitive to customers needs, highly reactive and efficient. This paper informs how TOD sets out to put ISO 9002 international quality system to work in its operations. A Quality Steering Council was formed in Feb. 1994 and the HSE and Quality Management Manager was appointed as management representative. The current working system was first assessed. Next, an implementation plan was prepared. Training was provided and the quality manual prepared followed by all the necessary work procedures and instructions. Finally there was trial implementation and actual “live” implementation. In January 1995 TOD ISO 9002 registration was approved.


2021 ◽  
Vol 93 (3) ◽  
pp. 5-13
Author(s):  
E. L. Alexandrova

The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.


2019 ◽  
Vol 11 (1) ◽  
pp. 14
Author(s):  
Princy Agarwal ◽  
Amul Mishra

Auditing is a vital function within a pharmaceutical company nowadays. Quality audit is a review and evaluation of all or part of a quality system with the specific purpose of improving it. It is one of the means to examine pharmacy programs and ensures that the procedures and reimbursement mechanisms comply with the contractual and regulatory requirements. A quality audit is usually conducted by external or independent experts or by a team designated by management for this purpose. These audits can be extended to suppliers and contractors as well. An audit will assess the strengths and weaknesses of quality assurance and quality assurance processes, the results of which assists in improving processes and building a better system for company benefits. This article focuses on various aspects of quality auditing in the pharmaceutical industry including its principles, objectives, importance and benefits and planning along with the deficiencies that are likely to occur during the process. This review comprises a well-organized summary of various guidelines available till date using the Google Scholar search engine and the keywords listed below.


2014 ◽  
Vol 22 (2) ◽  
pp. 125-144 ◽  
Author(s):  
Zakarya A. Alzamil

Purpose – In Saudi Arabia, technical education is managed by Technical and Vocational Training Corporation. However, there is no independent accrediting body to accredit the technical institutes and assure its quality, which causes the lack of unified quality assurance standards and manageable quality improvement processes. The purpose of this paper is to propose self-evaluation standards to help the technical institutes to evaluate their performance. Design/methodology/approach – The author has used a brainstorming technique of local practitioners in quality assurance. Such technique was performed by adopting DACUM that stands for “Developing A CurriculUM”. The author has used a heuristic educational and training process as the foundation of the standards and processes development, namely; curriculum, environment, training managements, and instructors. A team has been established that has been trained locally and abroad on the quality assurance standards and processes. The team studied several quality frameworks of the different countries to come up with guidelines for quality self-evaluation and standards. Findings – The author has found that such an approach is a very effective tool for improving the institutes' performance and gives them the flexibility to decide about their missions. Most of institutes' staff is reluctant to participate in the self-evaluation process because of the fear it may reveal their weaknesses, but with encouragement and motivation especially from the top management they tend to participate in such a process. Self-evaluation helps the educational institutes to be benchmarked with other international institutions, in which good practices may be adopted by the institutes' managements to achieve their vision. Research limitations/implications – The proposed approach can help the technical education institutes to manage their quality system. In addition, the implementation of such an approach might be the starting point to develop a quality system framework for the technical education in Saudi Arabia. However, further investigation is needed to measure whether applying such standards may help the technical education institutes to meet the required quality standards to attain an accreditation from the international quality agencies. Originality/value – The proposed guidelines for quality standards and processes is a contribution in the accreditation and quality assurance processes for many public and private institutions in Saudi Arabia. In addition, it is an important step to standardize the quality processes.


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