Ensure Quality Assurance Research Articles

Planeación orientada a la implementación de un sistema integrado de gestión en una pyme

El término Sistemas Integrados de Gestión ha nacido para proporcionar una respuesta técnica y humana a la necesidad,cada vez más significativa, que poseen las organizaciones de concordar el cumplimiento de los distintos sistemas de gestiónque han implantado y orientar a proveer las pautas hacia donde debe ir enfocado el aseguramiento de la calidad, la gestiónambiental y la seguridad y salud ocupacional en la organización.En el perfeccionamiento de la investigación se ha utilizado una sistemática de tipo documental porque dependeprimordialmente de la información que se recoja o consulte en documentos, como material de índole intacto, y de diseñometodológico no experimental debido a que sólo se procederá a efectuar observaciones de circunstancias ya existentes.En el actual estudio se observó que las organizaciones encuestadas señalan a los empleados como el conjunto de interésque más se ha favorecido con la integración, y a la sociedad o comunidad en general como el que menos acoge beneficios.Además se halló que los principales beneficios alcanzados han sido la articulación de auditorías, y de planes y programas, ladisminución de documentación, y de riesgos, y la estandarización procesos.Con este documento se logran instaurar recomendaciones y conclusiones para que las pequeñas y medianas empresaspuedan lanzarse al desafío que involucra la ejecución de estos sistemas.

Starting the fight in the tumor: expert recommendations for the development of human intratumoral immunotherapy (HIT-IT)

A European Society for Medical Oncology (ESMO)-sponsored expert meeting was held in Paris on 8 March 2018 which comprised 11 experts from academia, 11 experts from the pharmaceutical industry and 2 clinicians who were representatives of ESMO. The focus of the meeting was exclusively on the intratumoral injection/delivery of immunostimulatory agents with the aim of harmonizing the standard terms and methodologies used in the reporting of human intratumoral immunotherapy (HIT-IT) clinical trials to ensure quality assurance and avoid a blurring of the data reported from different studies. The goal was to provide a reference document, endorsed by the panel members that could provide guidance to clinical investigators, pharmaceutical companies, ethics committees, independent review boards, patient advocates and the regulatory authorities and promote an increase in the number and quality of HIT-IT clinical trials in the future. Particular emphasis was placed not only on the development of precise definitions to facilitate a better understanding between investigators but also on the importance of systematic serial biopsies as a driver for translational research and the need for the recording and reporting of data, to facilitate a better understanding of the key processes involved.

Authentication of Balaa in selected traditional formulations using ITS2 and matK DNA barcoding markers

Balaa group of plant drugs is one of the important ingredients in many of the Ayurvedic formulations used for treating various neuro-muscular disorders. The accepted species as per Ayurvedic Pharmacopeia India is Sida cordifolia L. However in today’s practices, there are multiple species which go by the same trade name Balaa. This may be due to regional manifestations, context based usages, alternatives, substitutes thus leading to confusion and affecting quality of the medicine. In this context, advanced tools like application of signature sequence techniques, using defined DNA markers and decoding of DNA Sequence, would additionally help in identification of plant species from herbal formulations. The present paper shares the investigation on the detection of Balaa (Sida cordifolia L.) in the market formulations using Internal Transcribed Spacer 2 (ITS2) region and Maturase K (matK) barcoding markers using CTAB technique. The results show that for validating the presence of a particular species usage in the commercial formulation, complete gene sequencing of the claimed species/original species and accepted alternatives have to be made available for comparative studies. For the Balaa group of drugs, there is potential to develop the complete gene sequence for authentication purpose. This approach is now being used as a standard protocol in herbal pharmaco-vigilance research to verify labelled ingredients and detection of substitutes/alternatives in specific products. This process is meant to ensure Quality Assurance (QA) of raw drug materials used by herbal sector.

Under the lens: Dental expert witnesses in Brazil, Croatia, Indonesia, Italy, Saudi Arabia, and the United Kingdom.

The dentists’ main job is to restore health and function to the oral cavity. However, dental professionals can also be involved in medico legal activities as forensic odontologists or by being Expert Witnesses (EW) to testify in professional liability cases, car accidents and work-related injuries. When called to act as an expert witness by the Court, the appointed dentist has to combine both biological and technical knowledge with equivalent medico-legal and forensic knowledge. Spontaneous involvement in medico-legal matters without an adequate training and experience can lead to mistakes with irreversible consequences. As an expert witness, the dentist has precise responsibility with civil and/or penal consequences, depending on the national judicial system. Dental Expert Witness, working either privately or appointed by the Court, has defined responsibilities and is subjected to civil or criminal proceedings (depending on the judicial system) if found wanting. Keeping in mind that there are significant differences regarding the requirements of becoming eligible to be a Dental Expert Witness in different legal systems. In this work the authors investigated the Judicial Systems regarding the appointment of Dental Expert Witnesses in Brazil, Croatia, Indonesia, Italy, Saudi Arabia and the United Kingdom (Table 1), in order to marshal knowledge towards harmonization and the attainment of best practice. This premise acknowledges the fact that forensic odontology must encompass the necessity for robust systems of audit and accreditation for it to be accepted as an “evidence based” forensic discipline. Further steps to ensure quality assurance in legal dentistry and forensic odontology training should be considered to prevent the spontaneous involvement of inappropriately trained dentists to become involved in making decisions that are beyond their competence and expertise.

Major and trace elements in water from different sources in Jeddah City, KSA

We collected a total of 50 water samples comprising tap water, ground water, and bottled water, from various areas of Jeddah City. We collected tap water samples from 25 districts, groundwater samples from 10 wells, and 15 different brands of bottled water. The levels of 28 elements were determined by inductively coupled plasma mass spectrometry (ICP-MS). Water certified reference material (CWW-TM-B) was used to ensure quality assurance. Recoveries ranged from 92 to 104.8% for all measured elements. Levels of major and trace elements in groundwater samples were higher than those in both bottled and tap drinking water. Only four elements (Al, Cs, U, and Zn) were shown to be higher in tap water samples than other samples type. However, their values were far below the guideline values. All mean concentrations of Na, K, Mg, and Ca in well water samples were significantly (p < 0.05) higher than those in both bottled and tap drinking water. In addition, only Al and Zn in tap water samples were significantly (p < 0.05) higher than those in both bottled and well drinking water. Most of the other elements were higher in well water samples compared to other sources. The results from this study will be used to increase public awareness about the safety of drinking water. It will also be useful for increasing awareness of health issues related to drinking water and to water used for other purposes.

Rapid and accurate interpretation of dengue diagnostics in the context of dengue vaccination implementation: Viewpoints and guidelines issued from an experts group consultation.

This paper conclud that assess the overall benefits of vaccination in high burden countries for dengue, long-term surveillance will require a robust, affordable, and user-friendly diagnostic algorithm to detect suspected dengue cases. After that Since a large variability in the results of the diagnostics may occur between different kits and laboratories worldwide, future phase IV studies of CYD-TDV vaccine effectiveness should use the proposed combined diagnostic testing with the same validated and standardized kits/ protocols and international guidelines when designing sentinel sites to ensure quality assurance and to enhance data sharing and comparability across regions.

Buckling and Postbuckling Failure Analyses on a Rectangular Membrane for Touch Panel Applications

Thin conductive polymer membranes are the major sensing structure in resistive touch panels. However, device malfunctions such as early touching and false triggering have been reported during product development and reliability assessment. A surface profile examination has indicated that these membranes have considerable initial warpage, which could be a sign of membrane buckling, since the clamped design of the assembly may cause additional in-plane compression, in turn causing structural buckling. As a result, it is important to analyze the buckling and post-buckling behaviors of conductive polymer membranes due to initial imperfections, residual stress, or assembly issues in order to develop engineering solutions to ensure quality assurance. In this paper, both finite-element analyses and experimental characterizations are performed as the first step toward solving the observed problems. For the buckling analysis, we focus on the correlations between the calculated mode shapes and the observed surface warpage. Post-buckling analysis is also performed for exploring the performance of touch panels with initial warpage. In addition, several experimental investigations are conducted to validate the above mentioned mechanical analyses. The simulation results essentially agree with the observations. Both simulation and experimental investigations indicate that in-plane compression and shear can contribute to the observed failures. Engineering methods to increase buckling rigidity can be helpful for enhancing device reliability.

Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders.

Introduction: Key stakeholders’ involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. Method: We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. Results: 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients’ needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Conclusions: Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics.

Medical Devices Regulation in United States of America, European Union and India: A Comparative Study

In order to market any medical device, marketing authorization from Regulatory authority is required. The process of gaining authorization is complex, multistep and requires review of information by competent authorities. Upon scrutinizing the information furnished by Manufacturer, marketing authorization is granted by the concerned Regulatory authority. In the USA, manufacturers are required to apply to United States Food and Drugs Application (USFDA) for Marketing Authorization. There are two types of applications in USA; 510 (k) and Pre-Market Application (PMA). In EU, National Authorities give approval for marketing medical devices. A system of third party compliance is followed, where Notified Bodies (Third Party) ensure Quality Assurance, pre and post approval. In India, Central Drugs Standard Control Organization (CDSCO) approves devices for sale and import. Medical Devices are regulated under CLAA scheme. The Drug Controller General of India (DCGI) is the central licensing authority for medical devices. This paper attempts to capture information on regulations of Medical Device in three regions namely; USA, EU and India and compare provisions of Market authorization in the respective regions, and further, for the readers, make this complex subject easier to grasp.

Accuracy and cost-effectiveness of dynamic contrast-enhanced CT in the characterisation of solitary pulmonary nodules—the SPUtNIk study

IntroductionSolitary pulmonary nodules (SPNs) are common on CT. The most cost-effective investigation algorithm is still to be determined. Dynamic contrast-enhanced CT (DCE-CT) is an established diagnostic test not widely available...

MOOCs as disruptive technologies: strategies for enhancing the learner experience and quality of MOOCs

This chapter considers the pedagogies associated with different types of Massive Open Online Courses (MOOCs). It argues that the current discourse around the concept of xMOOCs (primarily based around interaction with content and essentially adopting a behaviourist learning approach), and cMOOCs (which focus on harnessing the power of social media and interaction with peers, adopting a connectivist learning approach), is an inadequate way of describing the variety of MOOCs and the ways in which learners engage with them. It will provide a brief history of the emergence of MOOCs and the key stakeholders. It will introduce an alternative means of categorising MOOCs, based on their key characteristics. It will then describe the 7Cs of Learning Design framework, which can be used to design more pedagogically informed MOOCs, which enhances the learner experience and ensure quality assurance.

School-based evaluation to improve learner performance

The article focuses on the periods of program and school evaluation in particular. The article traces school evaluation through various periods. These periods are: Age of originality (1444-1700), Age of reform (Prior 1900), Efficiency and testing (1900-1930), Tylerian period (1930-1945), Age of innocence (1946-1957), Age of development (1958-1972), Age of professionalism (1973-1983) and Age of expansion and integration (1984-2000). From these ages, the article is able to identify as to how Whole-school Evaluation in South Africa has been able to draw important lessons towards ensuring quality assurance in education

IFixit Myself: User-Generated Content Strategy in “The Free Repair Guide for Everything”

Research problem: This study investigates the phenomenon of user-generated content strategy in an open-source, wiki-based content-management system (CMS) for the repair of technological devices ( http://ifixit.com ). By “user-generated content strategy,” we mean processes for developing systems for producing, moderating, and encouraging user-generated content. Research questions: (1) What strategies, or holistic means of organizing content, are used to manage repair manual content via an open-source, wiki-based content-management system that relies on content generated by a wide variety of users? (2) What content rules, or logical premises for how and where content is developed, emerge from a qualitative case study of such a CMS? Literature review: Though a wealth of empirical research has been conducted into user-generated content, few studies have focused on the explicit strategies employed by organizations to develop and encourage such content. At the same time, several recent calls by researchers in both academia and industry have indicated a need for such content models. Some of the challenges these thinkers have noted with creating user-generated content strategies include the difficulty of maintaining a consistent strategy across content generated by users who don’t necessarily understand what strategies are in place, as well as maintaining a modicum of quality assurance without squelching user participation. Methodology: We conducted a content audit of iFixit’s main educational initiative, the Technical Writing Project ( http://edu.ifixit.com ) to identify strategies iFixit uses to organize content in this initiative. iFixit is an open-source wiki to help users repair their own devices. We supplemented the audit with interviews with student participants in the project and iFixit technical writing staff to find out what technologies and other affordances affected users of the iFixit Technical Writing Project. Results and conclusions: The main user-generated content strategies used by iFixit include allowing users a wide range of means to participate (such as posting comments or developing their own repair guides), using a content moderation queue (or simple interface for seeing all updates to the wiki), ensuring quality assurance of all repair guide content through redundancy (such as making sure experienced users vetted every published guide), and staging (or arranging information in a linear sequence) information in a multimodal fashion (using multiple modes of communication to reinforce the same information). Such strategies represent a commitment by iFixit to opening up practices that are central to creating content, such as repair documentation, to any interested internet user. Lessons for organizations who wish to encourage user-generated content include developing strategies that protect users from the worst consequences of their actions, that encourage participation, and that allow for experienced users to vet new content.

Use of solid extraction chromatography for determination of uranium in sea water and brine

AbstractBench scale field trials were initiated for the development of effective technology for recovery of uranium from sea water using acrylonitrile absorbents synthesized by radiation grafting. One of the important needs is to ensure quality assurance for the accurate measurement of heavy metal ion concentrations from lean solutions such as sea water and brine. Efforts have been made at Bioassay Laboratory of Radiation Safety Systems Division in India to improve the radiochemical separation and detection techniques for rapid, sensitive and accurate estimation of uranium in sea water samples. The earlier method using ion exchange had disadvantages of being lengthy and required use of sulphuric acid. Hence, a method was developed for estimation of uranium concentration in natural sea water and brine (desalination plant effluents) samples by solid extraction chromatography (SEC) using UTEVA resin (Uranium and TEtraValents Actinides). This resin consists of dipentyl pentylphosphonate sorbed onto an inert p...

Ensure Quality Assurance for Companies and Institutions

Ensure Quality Assurance for Companies and Institutions

English

This paper focused on the challenges in educating the visually impaired and modalities for ensuring quality assurance in tertiary institutions of learning in Nigeria. It examined the global challenges in the higher educational system and made it clear that the visually impaired are those with visual problems be it partial, low vision, or total blindness, as such need higher education to be liberated from the shackles of pity and sympathy. The paper found out that the educational needs of the visually impaired include computer application, optical aids, and Braille writing materials, issues of mobility, funding, library resources, personnel availability and physical infrastructural facilities. Recommendations were proffered to tackle the issues and challenges identified. Key words: Challenges, educating, visually impaired, quality assurance tertiary institutions, Nigeria.

Population-level scale-up of cervical cancer prevention services in a low-resource setting: development, implementation, and evaluation of the cervical cancer prevention program in Zambia.

BackgroundVery few efforts have been undertaken to scale-up low-cost approaches to cervical cancer prevention in low-resource countries.MethodsIn a public sector cervical cancer prevention program in Zambia, nurses provided visual-inspection with acetic acid (VIA) and cryotherapy in clinics co-housed with HIV/AIDS programs, and referred women with complex lesions for histopathologic evaluation. Low-cost technological adaptations were deployed for improving VIA detection, facilitating expert physician opinion, and ensuring quality assurance. Key process and outcome indicators were derived by analyzing electronic medical records to evaluate program expansion efforts.FindingsBetween 2006-2013, screening services were expanded from 2 to 12 clinics in Lusaka, the most-populous province in Zambia, through which 102,942 women were screened. The majority (71.7%) were in the target age-range of 25–49 years; 28% were HIV-positive. Out of 101,867 with evaluable data, 20,419 (20%) were VIA positive, of whom 11,508 (56.4%) were treated with cryotherapy, and 8,911 (43.6%) were referred for histopathologic evaluation. Most women (87%, 86,301 of 98,961 evaluable) received same-day services (including 5% undergoing same-visit cryotherapy and 82% screening VIA-negative). The proportion of women with cervical intraepithelial neoplasia grade 2 and worse (CIN2+) among those referred for histopathologic evaluation was 44.1% (1,735/3,938 with histopathology results). Detection rates for CIN2+ and invasive cervical cancer were 17 and 7 per 1,000 women screened, respectively. Women with HIV were more likely to screen positive, to be referred for histopathologic evaluation, and to have cervical precancer and cancer than HIV-negative women.InterpretationWe creatively disrupted the 'no screening' status quo prevailing in Zambia and addressed the heavy burden of cervical disease among previously unscreened women by establishing and scaling-up public-sector screening and treatment services at a population level. Key determinants for successful expansion included leveraging HIV/AIDS program investments, and context-specific information technology applications for quality assurance and filling human resource gaps.

What are the constraints and opportunities for HIVST scale-up in Africa? Evidence from Kenya, Malawi and South Africa.

IntroductionHIV self-testing (HIVST) has the potential to increase uptake of HIV testing among untested populations in sub-Saharan Africa and is on the brink of scale-up. However, it is unclear to what extent HIVST would be supported by stakeholders, what policy frameworks are in place and how variations between contexts might influence country-preparedness for scale-up. This qualitative study assessed the perceptions of HIVST among stakeholders in three sub-Saharan countries.MethodsFifty-four key informant interviews were conducted in Kenya (n=16), Malawi (n=26) and South Africa (n=12) with government policy makers, academics, activists, donors, procurement specialists, laboratory practitioners and health providers. A thematic analysis was conducted in each country and a common coding framework allowed for inter-country analysis to identify common and divergent themes across contexts.ResultsRespondents welcomed the idea of an accurate, easy-to-use, rapid HIV self-test which could increase testing across all populations. High-risk groups, such as men, Men who have sex with men (MSM), couples and young people in particular, could be targeted through a range of health facility and community-based distribution points. HIVST is already endorsed in Kenya, and political support for scale-up exists in South Africa and Malawi. However, several caveats remain. Further research, policy and ensuing guidelines should consider how to regulate, market and distribute HIVST, ensure quality assurance of tests and human rights, and critically, link testing to appropriate support and treatment services. Low literacy levels in some target groups would also need context-specific consideration before scale up. World Health Organization (WHO) policy and regulatory frameworks are needed to guide the process in those areas which are new or specific to self-testing.ConclusionsStakeholders in three HIV endemic sub-Saharan countries felt that HIVST will be an important complement to existing community and facility-based testing approaches if accompanied by the same essential components of any HIV testing service, including access to accurate information and linkages to care. While there is an increasingly positive global policy environment regarding HIVST, several implementation and social challenges limit scale-up. There is a need for further research to provide contextual and operational evidence that addresses concerns and contributes to normative WHO guidance.

Efficacy of Innovative Technological Approach Ensuring Quality Assurance in Teaching Learning Process in Open and Distance Learning

The present study discusses innovative approach ensuring quality assurance taking into account two important aspects namely: pedagogy and evaluation strategies integrating the effective use of technology. Open and distance learning system plays a key role in enhancing the enrollment ratio in higher education. Therefore, sustaining quality assurance is essentially pivotal in the current digital era. Considering these issues, the paper work illustrates one of the effective ways of evaluation strategies. The study is focused on the undergraduate teacher education program (B. Ed) offered mostly through open and distance education in India. As this course attracts students from urban, rural, with or without technology acquaintance, it should be assessed with transparency by the effective use of technology. The teaching and evaluation procedure used for the students enrolled for the B. Ed degree course includes group discussions integrating brain storming sessions followed by on line tests during their contact classes conducted in the university affiliated institutions. During the evaluation the student’s identification should be made authentic by installing software program which detects malpractice. For e.g. if a student logs in to take up online test his/her identification could be detected by the verification of pre-installed photograph. This strategy works out effectively by having proper co-ordination between the Host University and affiliated institution. Maintaining student’s authenticity strategy suggested in the present study prevents malpractices during evaluation and enhances student’s involvement as it provides transparency without any bias developing faith amongst students enrolled in distance learning.

Usability of iStudyGuides: A confirmatory factor analysis model

With the advances of technology, technological learning tools are becoming more important in enabling learners to study more effectively. The pre-requisite for the success of any technological learning tool hinges on its usability or technical ease of use. A tool that is not usable has the undesired effect of disrupting the user’s learning as more time is expended on learning the tool than the contents (Wong, Nguyen, Chang &amp; Jayaratna, 2003). Therefore, the aim of this research is to explore and uncover the dimensions of the usability of the interactive e-study guide known as the iStudyGuide used as one of the main learning resources in the context of SIM University (UniSIM). Therefore, the research question in this study is “What are the dimensions that determine the usability of iStudyGuides?”. It employs a survey research methodology, utilising the statistical methods of exploratory and confirmation factor analysis. Data are collected from 278 students who used iStudyGuides in their learning at UniSIM. In the confirmatory factor analysis process, Bollen-Stine bootstrap p = 0.688. CFI = 0.996, RMSEA = 0.026 and PCLOSE= 0.918. The confirmatory factor analysis shows that the final model of usability of the iStudyGuides that comprises of the dimension of reliability, utility, learnability, accessibility and control has a good fit on the data. The emergence of the model of usability of iStudyGuides sets as the basis that iStudyGuides can be evaluated to ensure quality assurance in terms of usability.