scholarly journals New Challenges for Biobanks: Accreditation to the New ISO 20387:2018 Standard Specific for Biobanks

BioTech ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 13
Author(s):  
Pasquale De Blasio ◽  
Ida Biunno
Keyword(s):  
Performance Monitoring ◽  
Quality Management System ◽  
Internal Audit ◽  
Accreditation Body ◽  
Accreditation Process ◽  
Testing Facility ◽  
Collection Data ◽  
Definition Of ◽  
First Time ◽  
Operational Aspects

Background: The emergence of “multi-omics” and “multi-parametric” types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality “Biological Materials and Associated Data” (BMaD). To meet the demands of biomedical research, several Biological Resource Centers (BRCs) or Biobanks world-wide have implemented a specific Quality Management System (QMS) certified ISO 9001:2015 or accredited by CAP9 ISO 20387:2018. For the first time, ISO, with the support of several Biobanking experts, issued the ISO 20387:2018 which is the first ISO norm specific for Biobanks. The fundamental difference with present certification/accreditation standards is that the ISO 20387:2018 focuses not only on the operational aspects of the Biobank, but also on the “competence of the Biobank to carry our specific Biobanking tasks”. Methods: The accreditation process for ISO 20387:2018 required the definition of: (1) objectives, goals and organizational structure of the Biobank, including procedures for governance, confidentiality and impartiality policies; (2) standard operating procedures (SOPs) of all activities performed, including acquisition, analysis, collection, data management, distribution, preparation, preservation, testing facility and equipment maintenance, calibration, and monitoring; (3) procedures for control of documents and records, the identification of risks and opportunities, improvements, corrective actions, nonconforming records and evaluation of external providers (4) an internal audit and management reviews, verification of QMS performance, monitoring of quality objectives and personnel qualification and competency in carrying out specific Biobanking tasks. Results: The accreditation process is performed by an independent authorized organization which certifies that all processes are performed according to the QMS, and that the infrastructure is engineered and managed according to the GDP and/or GMP guidelines. Conclusion: Accreditation is given by an accreditation body, which recognizes formally that the Biobank is “competent to carry out specific Biobanking tasks”.

What is the Relationship Between Quality, Quality Assurance and the Section III Design Specification

2014 ◽  
Author(s):  
Richard W. Barnes
Keyword(s):  
Quality Assurance ◽  
Management System ◽  
Quality Management System ◽  
Quality Assurance Program ◽  
System Quality ◽  
Design Specification ◽  
Quality Product ◽  
Definition Of ◽  
First Time ◽  
The Relationship

This paper explores the relationship between the Design Specification required for each Section III component and the terms Quality, Quality Assurance, Quality Product, and Management System (Quality Management System). The author’s experience indicates that the relationship between Quality and Quality Assurance is poorly understood and that the resistance experienced to the implementation of a Quality Assurance Program is often due to the person’s lack of understanding that a Quality Assurance Program really does help people do their work “right the first time”. This lack of understanding often results in poorly defined requirements in the purchasing documents, inadequate definition of scope and a product that does not meet requirements. Even more importantly it can lead to the development of poor relationships between the purchaser and the supplier and particularly in the nuclear field, poor relationships with Regulators. The economic impact is also significant, delays in schedule, delays in product acceptance and payment results in costs that are eventually passed on to the consumer. Once the above relationships are properly understood and appreciated resistance can turn into positive acceptance. The Section III concept of providing a Design Specification as a complete basis for construction also takes on new meaning.

scholarly journals KESESUAIAN DOKUMENTASI DI LP3I COLLEGE JAKARTA DENGAN STANDARD SISTEM MANAJEMEN MUTU ISO 9001:2008

2017 ◽  
Vol 6 (1) ◽  
pp. 131
Author(s):  
Nurdin Nurdin ◽  
Wiwiet Prihatmadji
Keyword(s):  
Quality Management ◽  
Management System ◽  
Evaluation System ◽  
Performance Monitoring ◽  
Quality Management System ◽  
Internal Audit ◽  
Monitoring And Evaluation ◽  
Iso 9001 ◽  
Audit Process ◽  
Documentation System

<p><em>The main steps in order to obtain international certification of ISO 9001 Quality Management System is to prepare the mentality and habits of employees, that is to prepare quality culture as a culture of employees. The next step is the technical preparation, preparing of documents and records, preparations for work process control systems, preparing the performance monitoring and evaluation system, which is summarized in the documentation system of LP3I College. Challenges to the process of implementation of ISO 9001 is overcome by socialization the culture of quality as a work culture in every meeting of the BOD till to the technical meeting daily in the employees or  operators, using the authority of the President Director for any activity in the socialization, training, and implementation of the Quality Management System, making each Head of Department in charge of ISO 9001, arrange the efffectiveness of  internal audit process and making corrective action of any findings of non-conformance and prepared oppotunity for improvement for any observasion findings. The entire process of implementation of ISO 9001 in LP3I College was documented, and controlled accordance to ISO 9001 requirements.</em></p><p><em> </em></p><p><em>Keyword : Quality Management System, ISO 9001:2008</em></p>

Pedagang Kaki Lima, Profil Entrepreneurship Sejati, Pelaku Ekonomi Kerakyatan, Ciptakan Jiwa Kewirausahaan Mandiri

2019 ◽  
Vol 20 (1) ◽  
pp. 30-35
Author(s):  
Agus Prasetya
Keyword(s):  
Qualitative Research ◽  
Data Analysis ◽  
Data Display ◽  
Job Seekers ◽  
Street Vendor ◽  
Street Vendors ◽  
The Social ◽  
Collection Data ◽  
Definition Of ◽  
Depth Interviews

This article is motivated by the fact that the existence of the Street Vendor (PKL) profession is a manifestation of the difficulty of work and the lack of jobs. The scarcity of employment due to the consideration of the number of jobs with unbalanced workforce, economically this has an impact on the number of street vendors (PKL) exploding ... The purpose of being a street vendor is, as a livelihood, making a living, looking for a bite of rice for family, because of the lack of employment, this caused the number of traders to increase. The scarcity of jobs, causes informal sector migration job seekers to create an independent spirit, entrepreneurship, entrepreneurship, with capital, managed by traders who are true populist economic actors. The problems in street vendors are: (1) how to organize, regulate, empower street vendors in the cities (2) how to foster, educate street vendors, and (3) how to help, find capital for street vendors (4) ) how to describe grief as a Five-Foot Trader. This paper aims to find a solution to the problem of street vendors, so that cases of conflict, cases of disputes, clashes of street vendors with Satpol PP can be avoided. For this reason, the following solutions must be sought: (1) understanding the causes of the explosions of street vendors (2) understanding the problems of street vendors. (3) what is the solution to solving street vendors in big cities. (4) describe Street Vendors as actors of the people's economy. This article is qualitative research, the social paradigm is the definition of social, the method of retrieving observational data, in-depth interviews, documentation. Data analysis uses Interactive Miles and Huberman theory, with stages, Collection Data, Display Data, Data Reduction and Vervying or conclusions.

CHAETOCNEMA CONCINNA (MARSHAM, 1802), A EUROPEAN FLEA BEETLE INTRODUCED IN NORTH AMERICA (COLEOPTERA: CHRYSOMELIDAE: ALTICINAE)

1990 ◽  
Vol 122 (4) ◽  
pp. 647-650
Author(s):  
Laurent Lesage
Keyword(s):  
Nova Scotia ◽  
North America ◽  
Prince Edward Island ◽  
Host Plants ◽  
Flea Beetle ◽  
Collection Data ◽  
First Time

AbstractChaetocnema concinna (Marsham, 1802), a European flea beetle, is reported for the first time from Canada. Preliminary collection data indicate that it may feed on the same host plants as in Europe. It has been collected to date in Prince Edward Island, Nova Scotia, and Maine.

Improving the Volumetric Efficiency of the Axial Piston Pump

2012 ◽  
Vol 134 (11) ◽  
Author(s):  
Shu Wang
Keyword(s):  
Operating Conditions ◽  
Volumetric Efficiency ◽  
Valve Plate ◽  
Piston Pump ◽  
Efficient Design ◽  
Axial Piston Pumps ◽  
Definition Of ◽  
Engineering Practices ◽  
First Time ◽  
Axial Piston

The volumetric efficiency is one of the most important aspects of system performance in the design of axial piston pumps. From the standpoint of engineering practices, the geometric complexities of the valve plate (VP) and its multiple interactions with pump dynamics pose difficult obstacles for optimization of the design. This research uses the significant concept of pressure carryover to develop the mathematical relationship between the geometry of the valve plate and the volumetric efficiency of the piston pump. For the first time, the resulting expression presents the theoretical considerations of the fluid operating conditions, the efficiency of axial piston pumps, and the valve plate designs. New terminology, such as discrepancy of pressure carryover (DPC) and carryover cross-porting (CoCp), is introduced to explain the fundamental principles. The important results derived from this study can provide clear recommendations for the definition of the geometries required to achieve an efficient design, especially for the valve plate timings. The theoretical results are validated by simulations and experiments conducted by testing multiple valve plates under various operating conditions.

Updating the knowledge of the flower flies (Diptera: Syrphidae) from Chile: Illustrated catalog, extinction risk and biological notes

Zootaxa ◽  
2021 ◽  
Vol 4959 (1) ◽  
pp. 1-178
Author(s):  
RODRIGO M. BARAHONA-SEGOVIA ◽  
PAMELA RIERA ◽  
LAURA PAÑINAO-MONSÁLVEZ ◽  
VICENTE VALDÉS GUZMÁN ◽  
PATRICIA HENRÍQUEZ-PISKULICH
Keyword(s):  
Extinction Risk ◽  
Critical Role ◽  
Floral Biology ◽  
Iucn Red List ◽  
Decomposition Of Organic Matter ◽  
Management Plans ◽  
Flower Flies ◽  
Iucn Red List Criteria ◽  
Definition Of ◽  
First Time

Syrphidae, more commonly known as flower flies, are considered one of the most important Diptera families worldwide because of their critical role in pollination, biological control and decomposition of organic matter. The study of these flies in Chile has stagnated due to a lack of local experts as well as the absence of an updated catalog of species. This study is an attempt to remedy the latter of these issues by providing an illustrated and updated catalog to the Syrphidae of Chile. Species are presented under currently accepted names, with synonyms and previous combinations listed and original references. Type localities, world and Chilean distribution by geopolitical Chilean regions, taxonomic and biological notes, a complete record of bibliographic references and extinction risk under IUCN Red List criteria are provided. This catalog recognizes 132 species of Syrphidae, belonging to four subfamilies (Eristalinae, Microdontinae, Pipizinae and Syrphinae), 13 tribes and 47 genera. A total of 46 species (34.84 %) is restricted to the geopolitical territory of Chile. Eight species are considered exotic, one is considered incertae sedis and three are based on doubtful records. Seventeen species of 10 different genera (Copestylum Macquart, 1846; Dolichogyna Macquart, 1842; Eosalpingogaster Hull, 1949b; Eupeodes Osten Sacken, 1877; Meromacrus Rondani, 1848; Palpada Macquart, 1834; Paragus Latreille, 1804; Sphiximorpha Rondani, 1850; Sterphus Philippi, 1865 and Toxomerus Macquart, 1855) are reported from Chile for the first time. A total of 44 species (33.33 %) reported from Chile are directly threatened by human activities such as agriculture, forestry, mining and/or urbanization and indirectly by climate change. The gaps found in the geographic distribution of Chilean flower fly species and what it means for its use by disciplines such as ecology, floral biology and agronomy, are discussed. In addition, the use of this illustrated catalog for biological conservation, the potential definition of priority areas and ecosystem management plans based on this group of Diptera are also discussed. 

Analisis Pembiayaan Dana Talangan Haji untuk  Biaya Perjalan Ibadah Haji

2018 ◽  
Vol 1 (2) ◽  
pp. 228-244
Author(s):  
Asmawarna Sinaga ◽  
Anjur Perkasa Alam ◽  
Fariz Arkan ◽  
Sri Wahyuni Hasibuan
Keyword(s):  
Islamic Law ◽  
Field Research ◽  
Interactive Methods ◽  
Islamic Banks ◽  
Data Presentation ◽  
Analysis Techniques ◽  
Collection Data ◽  
Definition Of ◽  
The Cost

  Analysis of the amount of financing the hajj bailout for the cost of the pilgrimage (Case Study of Bank Sumut Syariah Sub-Branch Stabat).Asmawarna Sinaga and Anjur Perkasa Alam. Hajj financing is a loan from a sharia bank to customers to cover the shortage of funds to obtain a seat (seat) Hajj at the time of repayment BPIH (Hajj Travel Expenses). This financing product uses the Qardh Wal Ijarah principle. The purpose of this research is to know the view of Islamic law against financing of Hajj bailout fund and to know the view of Islamic law about ujrah fee on akad of bailout fund of Hajj. This research is field research. The definition of the Hajj bailout is a bailout fund from a bank to a special customer to cover kekurangandana to cover the lack of funds to obtain a portion number at the time to pay the cost of organizing the pilgrimage. The research design uses a qualitative approach with non-statistical analysis While the data analysis techniques use content analysis and interactive methods consisting of data reduction, data collection, data presentation and conclusion. The results of this study note that the akad bailout funds in Islamic banks contain multi-akad, where the contract used qardh and ijarah is allowed. While the view of Islamic law regarding the taking of ujrah fee on hajj bailout fund is not in accordance with sharia due to the percentage of ujrah fee based on qardh fund.

Perforation mechanics of UHMWPE soft ballistic sub-laminate and soft ballistic armor pack: A finite element study

2021 ◽  
pp. 089270572110420
Author(s):  
Bazle Z (Gama) Haque ◽  
John W Gillespie
Keyword(s):  
Finite Element ◽  
Single Layer ◽  
Areal Density ◽  
Element Model ◽  
Transverse Impact ◽  
Free Standing ◽  
Uhmwpe Fibers ◽  
Ballistic Limit Velocity ◽  
Definition Of ◽  
First Time

Soft-ballistic sub-laminate (SBSL) made from ultra-high molecular weight polyethylene (UHMWPE) fibers in [0/90] stacking sequence are the building block of a multi-layer soft-ballistic armor pack (SBAP, aka Soft Armor). A systematic study of the perforation dynamics of a single layer SBSL and several multi-layer SBAPs (2, 3, 4, 8, 16, 24, 32 layers) is presented for the first time in the literature. A previously validated finite element model of transverse impact on a single layer is used to study the perforation mechanics of multi-layer SBAPs with friction between individual layers. Following the classical definition of ballistic limit velocity, a minimum perforation velocity has been determined for free-standing single layer SBSL and multi-layer SBAPs. For the multi-layer SBAPs, complete perforations have been identified as progressive perforation of individual layers through the thickness. The minimum perforation velocities of multi-layer SBAPS is linear with the areal density for the eight (8) layer target and thicker. Large deformation behavior and perforation mechanics of the SBAPs is discussed in detail.

scholarly journals CULTURE-BASED STUDIES’ TOPOGRAPHY IN THE MODERN FRENCH SOCIAL SCIENCE

2019 ◽  
pp. 14-17
Author(s):  
B. E. Nosenok
Keyword(s):  
Social Sciences ◽  
Cultural Studies ◽  
Cultural History ◽  
Interdisciplinary Approach ◽  
The Body ◽  
Social Knowledge ◽  
History Of Culture ◽  
Critical Turn ◽  
Definition Of ◽  
First Time

Cultural studies as a humanities researcher takes the place of an expert. The relevance of this topic is due to the lack of development of the issues of “culture-based studies” in Ukrainian culturology. There is a lack of translated into French or Ukrainian languages of French sources published since 1975. French culturological science, which developed after 1975, is almost not represented in Ukrainian culturology. The present stage of the development of French historiography, which lies at the heart of cultural history, and cultural studies, is associated with increased attention to social knowledge. This stage is characterized by the deployment of a “critical turn”, which proceeds from the following principles: the interdisciplinary approach, the significance of cultural expertise, the severity of publications and the multiplicity of their forms, multidisciplinarity. The “critical turn” affects the following spheres of knowledge: la Culturologie, les Études culturelles, les Sciences de la Culture. The article substantiates the relevance of the use of the concept of “culture-based studies” to the definition of processes that are unfolding within the framework of French humanities and are associated exclusively with the theoretical formations in the context of the social sciences. The purpose of the article is to outline a map of culture-based studies in the field of French humanitaristics. The methodology of the article is based on the application of interdisciplinary and multidisciplinary approaches to research in the field of culturology. Also, methodological developments in the field of “critical turn” and the achievements of the sociological circle and the interdisciplinary discussion club “Eranos” were applied. The scientific novelty of the article is to substantiate the appropriateness of the use of the concept of “culture-based studies” on the definition of processes that are unfolding within the framework of French humanitaristics and relate exclusively to theoretical formations in the context of social sciences. This concept to the field of Ukrainian culturology is introduced for the first time. Also, for the first time, the place and forms of culturology in French humanities were clarified. Conclusions. Working with a source base and methodology is one of the points that are compulsory on the way to the solution of the tasks, the main of which is the formation of the body of fundamental works for French history (including the history of culture) and historiography of the period since 1975 year to the present day. On the basis of this building, there is the prospect of building an alternative national cultural history project addressed to the vector of the French historiographical, historical-anthropological and cultural-related issues in the field of social knowledge. The article presents the arguments why it is appropriate to use the concept of “culture-based studies” in the context of conducting research in relation to French humanitaristics, in particular, the modern period of its development.

scholarly journals The influence of quality management systems for improvement of logistics supply in Poland

2017 ◽  
Vol 8 (4) ◽  
pp. 643-655 ◽  
Author(s):  
Dominik Zimon
Keyword(s):  
Quality Management ◽  
Quality Management System ◽  
Empirical Studies ◽  
Iso 9001 ◽  
Management Systems ◽  
Quality Management Systems ◽  
Supply Logistics ◽  
Definition Of ◽  
The Impact ◽  
A Company

Research background: ISO 9001 with its requirements gives a company a guidance on the definition of the quality management system architecture, based on the process approach and the indications for its continuous improvement. Despite the general emphasis to the benefits of implementation of ISO 9001 in the literature, there is a still lack of research concerning the actual impact of quality management systems for improving specific logistics processes. The research is focused on the Polish market because there is no research in the subject literature which concerns the impact of the implementation of quality management systems on the improvement of logistic processes in Polish enterprises. Purpose of the article: The focus of this publication was to examine the impact of the implementation of the requirements of ISO 9001 for process improvement supply logistics. Methods: Empirical studies were carried out in September and October 2014 on a group of 17 companies with implemented and certified quality management systems according to ISO 9001. The research tool was a questionnaire survey sent to management representatives (25 respondents) and workers (140 respondents). The surveys were supplemented with direct interviews with employees of the companies. Findings: Based on the survey it can be stated that the quality management systems, accord-ing to ISO 9001, had a fairly large impact on improving procurement processes. This is particularly evident in areas including relationships with suppliers, quality control, workflow and communication, both internal and external. The positive aspects achieved through the implementation of quality management systems due to the fact that the ISO 9001 standard in its commitments puts great emphasis on the organization of the procurement process.

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