Certification Approach Research Articles

Réussir une démarche de certification ISO 9001 v 2015 en investigation clinique

In order to evaluate the performance of this quality approach applied to all UHC investigations, the Investigation Department is committed to obtaining an ISO 9001:2015 certification. The quality division of the investigation department conducted the project according to a methodology, based on internal and external evaluations to determine an inventory and the retro-planning of the certification approach. The scope of the certification involved the investigation department of the University Hospital: 24 clinical investigation units, over 500 medical staff, 150 non-medical staff. In our certification approach, the client was the promoter of the clinical study. The process lasted 18 months and included phases of training and awareness-raising for all the staff involved. The quality management system of the investigation department has been revised and improved in accordance with current regulations. The Investigation Department obtained the ISO 9001:2015 certification for all clinical investigations at the Nantes University Hospital in June 2017 without any non-compliance. Our work shows that the investigation department has successfully adapted the ISO 9001:2015 standard to institutional clinical research. The certification for specific activities in clinical investigation is the guarantee of an optimized and relevant organization for the safety of volunteers, participating in clinical research as well as the scientific quality of the research and contributes to the satisfaction of sponsors.

Certification of Openness – Corner Stone of an Agile PLM Strategy

The change in products is taking place rapidly, from primarily electromechanical components to cyber physical systems. The associated digitalization in development, production and use is primarily based on data. In order to increase the potentials, a high quality, timeliness and availability of the data is necessary. Due to the increasing number of IT-based systems, interoperability between them is becoming more important. Without the appropriate interfaces and the openness of the systems, additional effort is required. If an appropriate PLM strategy is in current discussion, the principles of "agile strategy development" show high potential. With the further development of the Code of PLM Openness into a certification approach, it is possible to generate a base for an agile product life cycle management. In order to ensure the openness of systems, the developing company must also be in focus.

Closing Gaps for Aircraft Attitude Higher Order Sliding Mode Control Certification via Practical Stability Margins Identification

In this paper, the conventional aircraft control system certification approach based on phase margin (PM) and gain margin (GM) is extended to higher order sliding mode (HOSM) controllers. The proposed practical stability PM (PSPM) and the practical stability GM (PSGM) are used to quantify the HOSM control system robustness to unmodeled dynamics. The tools/algorithms for the identification of PSPM and PSGM are developed using describing function-harmonic balance method. A design algorithm of a cascade dynamic compensator for a dynamically perturbed HOSM control system is presented and can be used to satisfy required practical stability margins. The theoretical developments are illustrated and validated on controlling the attitude of an F-16 aircraft.

Solving QBF by Abstraction

Many verification and synthesis approaches rely on solving techniques for quantified Boolean formulas (QBF). Consequently, solution witnesses, in the form of Boolean functions, become more and more important as they represent implementations or counterexamples. We present a recursive counterexample guided abstraction and refinement algorithm (CEGAR) for solving and certifying QBFs that exploits structural reasoning on the formula level. The algorithm decomposes the given QBF into one propositional formula for every block of quantifiers that abstracts from assignments of variables not bound by this quantifier block. Further, we show how to derive an efficient certification extraction method on top of the algorithm. We report on experimental evaluation of this algorithm in the solver QuAbS (Quantified Abstraction Solver) which won the most recent QBF competition (QBFEVAL'18). Further, we show the effectiveness of the certification approach using synthesis benchmarks and a case study for synthesizing winning strategies in Petri Games.

Risk-based automated assessment and testing for the cybersecurity certification and labelling of IoT devices

Nowadays, security aspects represent one of the most significant barriers for the adoption of large-scale Internet of Things (IoT) deployments. In this sense, being able to certify and communicate the security level of a certain device is crucial for their acceptance. Towards this end, we propose a security certification methodology designed for IoT to empower different stakeholders with the ability to assess security solutions for large-scale IoT deployments in an automated way. It also supports transparency on the IoT security level to the consumers because the methodology provides a label as one of the main results of the certification process. The certification approach represents an instantiation of the Risk-based Security Assessment and Testing methodologies presented by ETSI based on the ISO 31000 and ISO 29119, and it is built on top of different technologies and approaches for security testing and risk assessment adapted to the IoT landscape. As a proof of concept, the proposed methodology is applied to one of the scenarios proposed in the scope of the Horizon 2020 ARMOUR project for assessing the fulfillment of several security properties of IoT devices.

Spatial Verification of Modulus for Pavement Foundation System

This paper presents the results of a field study recently completed on an Illinois Tollway construction project, in which intelligent compaction (IC) measurements were calibrated on site with in situ elastic modulus (E), resilient modulus (Mr), modulus of subgrade reaction ( k), and California bearing ratio (CBR) testing. The purpose of the field calibration was to generate geo-referenced spatial modulus maps that can be used for field verification of design input parameters. E values were obtained using light weight deflectometer (LWD), stress-dependent Mr values and static k values were obtained using automated plate load testing (APLT), and CBR values were obtained using a dynamic cone penetrometer (DCP). The IC measurements were obtained using a vibratory smooth drum roller outfitted with an index measurement value system, and a roller outfitted with a retrofit kit programmed to produce validated integrated compaction (VIC) measurements through a process of field calibration. Results showed that VIC based calibration can produce correlations with R2 > 0.9 with Mr and k values, and the VIC maps can be reliably used for quality assurance/verification testing. Although the index based IC measurement values showed statistically significant relationships, the R2 values were lower (<0.6). An implementation framework that emphasizes an independent certification approach for field calibration is being developed based on these test results for the Illinois Tollway, to aid in the effective implementation of the modulus-based mapping approach for pavement design field verification.

Composite-friendly approach to certification of advanced materials and fabrication methods used in aviation industry

An analysis of the applicability of metal-based certification methods to composite structures, as applied to materials and processes qualification, is presented. The major drawbacks of the above approach, such as the large amount of testing required and the impossibility of achieving the required weight efficiency of aircraft, are shown and the basic principles of a composite-friendly certification approach are formulated. The necessity to capture the impact of manufacturing factors on structural performance on all scales of the Building Block is stressed. A brief review of domestic studies on simulation of the influence of process parameters on the strength of structures as applied to processes currently used in the aviation industry is offered.

Experimental and numerical investigation of the influence of rivetless nut plate joints on fatigue crack growth in adhesively bonded composite joints

Current practice to design aircraft composite bonded joints only allows a non-growth certification approach for failure. However, an alternative damage tolerant approach would hold significant potential for weight and cost savings, but requires a thorough understanding of damage processes and methods to predict crack arrest in the adhesive bondline. In this paper application of a rivetless nut plate joint to arrest fatigue crack growth in hybrid adhesive-mechanical composite joints is studied experimentally and numerically. Results show that significant reduction of crack growth rate over a wide range of loading is possible. A material model for spatial fatigue crack growth in the adhesive bondline is developed and implemented in the commercial software ABAQUS using a user-defined material subroutine for cohesive zone elements. Numerical simulations closely match experimental results and identify peel load reduction and local reinforcement as the main mechanisms to arrest fatigue crack propagation.

Energizing agroforestry: Ilex guayusa as an additional commodity to diversify Amazonian agroforestry systems

ABSTRACTGuayusa (Ilex guayusa) is a native tree of the western Amazon region grown by indigenous farmers in traditional agroforestry systems. Its leaves are used as a drink similar to tea, which is now commercialized and marketed outside of the Amazon. To assess the impacts from the early stages of commercial guayusa production, we conducted interviews in four commercial guayusa-producing communities with indigenous guayusa farmers in the Ecuadorian Amazon. We focus on their experiences and critically discuss and speculate about the socio-ecological implications of the expanding commercialization of guayusa, particularly in relation to propositions of this special issue. Results reveal that revenues from guayusa have not overtaken those from other cash crops. Commercializing guayusa can have benefits for farmers and the environment, provided that rigorous criteria that measure social and environmental impacts are adhered to. Furthermore, guaysa production is characterized by vertical integration where many individual farmers supply one processing and wholesale company in a short value chain fostering a locally tailored certification approach that is able to exert the continuation of the traditional agroforestry practices. Yet, sustainability initiatives, standards and certification only provide partial solutions for protecting ecosystem services in the Ecuadorian Amazon.EDITED BY Beria Leimona

Does forest certification enhance livelihood conditions? Empirical evidence from forest management in Kilwa District, Tanzania

The Forest Stewardship Council (FSC) forest management certification standards have been promoted to contribute to community livelihood conditions. However, little has been done to evaluate it quantitatively. Employing theory of change, this study assesses and compares empirical evidence of the influence of the FSC forest management certification approach to enhance livelihood conditions in Kilwa, Tanzania, by using economic valuation methods and governance indicators. This is achieved through a comparative study of villages with certified community forests (FSC) under community based forest management and those without (non-FSC). Results show that annual average household forest income from FSC-certified forests is significantly higher than that of households in non-FSC-certified forests. With reference to rule compliance as an indicator of good governance, implementation of forest bylaws in villages managing FSC-certified forests is significantly more effective than villages in non-FSC-certified forests. These findings provide an insight into the influence of forest certification in enhancing livelihood conditions and that the incorporation of FSC standards into forest policies may lead to more enhancement of livelihood conditions. These findings serve as a baseline for further research on the effects of forest certification at both spatial and temporal scales.

A FRAMEWORK FOR AN OPEN SOURCE GEOSPATIAL CERTIFICATION MODEL

Abstract. The geospatial industry is forecasted to have an enormous growth in the forthcoming years and an extended need for well-educated workforce. Hence ongoing education and training play an important role in the professional life. Parallel, in the geospatial and IT arena as well in the political discussion and legislation Open Source solutions, open data proliferation, and the use of open standards have an increasing significance. Based on the Memorandum of Understanding between International Cartographic Association, OSGeo Foundation, and ISPRS this development led to the implementation of the ICA-OSGeo-Lab imitative with its mission “Making geospatial education and opportunities accessible to all”. Discussions in this initiative and the growth and maturity of geospatial Open Source software initiated the idea to develop a framework for a worldwide applicable Open Source certification approach. Generic and geospatial certification approaches are already offered by numerous organisations, i.e., GIS Certification Institute, GeoAcademy, ASPRS, and software vendors, i. e., Esri, Oracle, and RedHat. They focus different fields of expertise and have different levels and ways of examination which are offered for a wide range of fees. The development of the certification framework presented here is based on the analysis of diverse bodies of knowledge concepts, i.e., NCGIA Core Curriculum, URISA Body Of Knowledge, USGIF Essential Body Of Knowledge, the “Geographic Information: Need to Know", currently under development, and the Geospatial Technology Competency Model (GTCM). The latter provides a US American oriented list of the knowledge, skills, and abilities required of workers in the geospatial technology industry and influenced essentially the framework of certification. In addition to the theoretical analysis of existing resources the geospatial community was integrated twofold. An online survey about the relevance of Open Source was performed and evaluated with 105 respondents worldwide. 15 interviews (face-to-face or by telephone) with experts in different countries provided additional insights into Open Source usage and certification. The findings led to the development of a certification framework of three main categories with in total eleven sub-categories, i.e., “Certified Open Source Geospatial Data Associate / Professional”, “Certified Open Source Geospatial Analyst Remote Sensing & GIS”, “Certified Open Source Geospatial Cartographer”, “Certified Open Source Geospatial Expert”, “Certified Open Source Geospatial Associate Developer / Professional Developer”, “Certified Open Source Geospatial Architect”. Each certification is described by pre-conditions, scope and objectives, course content, recommended software packages, target group, expected benefits, and the methods of examination. Examinations can be flanked by proofs of professional career paths and achievements which need a peer qualification evaluation. After a couple of years a recertification is required. The concept seeks the accreditation by the OSGeo Foundation (and other bodies) and international support by a group of geospatial scientific institutions to achieve wide and international acceptance for this Open Source geospatial certification model. A business case for Open Source certification and a corresponding SWOT model is examined to support the goals of the Geo-For-All initiative of the ICA-OSGeo pact.

HIRF Transfer Function Observations: Notes on Results Versus Requirements and Certification Approach

HIRF transfer functions results are rarely available to the public. Generally, the data provided in applicable guidance material are used for estimation of internal HIRF environment in an air vehicle. An exemplary set of HIRF transfer functions for a small aircraft is presented here. Results for the aircraft (10.4-m wingspan and 8.3 m of length) are compared with regard to state of the art approaches applied for aircraft HIRF certification campaigns. This is done in appropriate frequency ranges and by the use of applicable test methods with regard to requirements in place. For all major types of contemporary test methods, results are generated by measurement and numerical computer modeling. Principles of outcomes are discussed and compared to current practice in place. This concerns the shapes of the transfer functions on one hand and the order of magnitudes of obtained levels on the other hand. The obtained results show significant deviations from generic transfer functions currently applied in aircraft industry. The coupling to the interior of the aircraft observed here was higher than indicated by the applicable generic transfer functions. Numerical computer modeling is used here to verify the obtained outcomes by principle.

Assessing quality standards for ChIP-seq and related massive parallel sequencing-generated datasets: When rating goes beyond avoiding the crisis.

Massive parallel DNA sequencing combined with chromatin immunoprecipitation and a large variety of DNA/RNA-enrichment methodologies is at the origin of data resources of major importance. Indeed these resources, available for multiple genomes, represent the most comprehensive catalogue of (i) cell, development and signal transduction-specified patterns of binding sites for transcription factors (‘cistromes’) and for transcription and chromatin modifying machineries and (ii) the patterns of specific local post-translational modifications of histones and DNA (‘epigenome’) or of regulatory chromatin binding factors. In addition, (iii) the resources specifying chromatin structure alterations are emerging. Importantly, these types of “omics” datasets populate increasingly public repositories and provide highly valuable resources for the exploration of general principles of cell function in a multi-dimensional genome–transcriptome–epigenome–chromatin structure context. However, data mining is critically dependent on the data quality, an issue that, surprisingly, is still largely ignored by scientists and well-financed consortia, data repositories and scientific journals. So what determines the quality of ChIP-seq experiments and the datasets generated therefrom and what refrains scientists from associating quality criteria to their data? In this ‘opinion’ we trace the various parameters that influence the quality of this type of datasets, as well as the computational efforts that were made until now to qualify them. Moreover, we describe a universal quality control (QC) certification approach that provides a quality rating for ChIP-seq and enrichment-related assays. The corresponding QC tool and a regularly updated database, from which at present the quality parameters of more than 8000 datasets can be retrieved, are freely accessible at www.ngs-qc.org.

RESOURCE UTILIZATION EFFECTS OF FADAMA III UNDER RAINY SEASON AND DRY SEASON WATER MELON (Citrullus lanatus) PRODUCTION IN GOMBE STATE, NIGERIA

The study was conducted in Gombe State, Nigeria to examine the impact of Fadama III project on resource utilization under rainy season and dry season water melon production. A combination of stratified and simple random sampling was used to draw up the 308 respondents. Both descriptive and inferential statistics (difference-in-difference and efficiency ratios) were used to analyze the data. The results reveal that estimated marginal value product(MVP) of land (NGN 20.60), seeds (NGN 29.62), organic chemicals (NGN33.00) and fuel (NGN13.33) were higher than their respective marginal input cost (MIC) for beneficiaries of Fadama III project meaning that their r > 1 (underutilization) because of the limited access to farm resource faced by farmers. For the non-beneficiaries group, the MVP of land (NGN28.28), seeds (NGN26.30), organic chemicals (NGN30.46) and fuel (NGN20.41) were higher than their corresponding MIC implying that a 1% increase in either variable will lead to an increase of the corresponding total value product. It was further disclosed that the average mean total area contribution to output by Fadama III beneficiaries was 41.7 tons/ha valued at NGN10,121.0 per ton compared with the non-beneficiaries water melon farmers in rainy season with average mean total area contribution to output of 27.1tons/ha valued at NGN1,733.0 per ton. In dry season, it was 100.7 tons/ha valued at NGN 1,812.0 per ton for beneficiaries compared with total area contribution to output of 70.8tons/ha valued at NGN425.0 per ton for non-beneficiaries. This signifies that the beneficiaries were better off than the non-beneficiaries in both rainy and dry season farming in terms of total plot area cultivation. The findings, even though, shows a moderate substitution existed between family and hired labour, in the study area, family labour was more economical to use by Fadama III beneficiaries rainy season.In terms of non-crop activities, the demand for hired labour was elastic. A 45% increase in value addition was also reported with expected increase in the respondent’s income through reduction of post-harvest losses. The study recommends that farmers in the study area should be allowed to have increased access to farm land through community-driven land certification approach and more processing technologies through community-driven development approach.

The future regulation of suborbital flight in Europe

The EU 7th Framework Project FAST20XX [1] aimed to enlarge the foundations of suborbital high-speed transportation in a wide variety of fields. One of the key issues of this project was to outline a desirable regulatory framework that would best serve the interests of all European stakeholders in this new activity.The US Federal Aviation Administration (FAA) has issued a series of requirements for operators of commercial suborbital flights under the 2004 Commercial Space Launch Amendments Act (CSLAA), enabling the corresponding market to develop. These regulations were initially valid until 2012 but have now been extended until 2015.In Europe, practical and successful attempts to fly experimental vehicles of this kind do not yet exist. However, several developments indicate that it is becoming urgent to pay attention to this potential new industry and find ways to regulate it in a safe yet flexible manner. Although the European Aviation Safety Agency (EASA) explored the possibility in 2008 to prepare for a certification approach under the concept of “Suborbital Aeroplanes” (SoA), this initiative was put on hold in 2011, and a final decision by the European Commission is still pending.This paper highlights some of the research performed by the authors towards the establishment of a roadmap for future regulation of suborbital flight in Europe. In particular, it will present results of a survey carried out among stakeholders, including operators and manufacturers of vehicles, spaceports, national and European regulators, insurers and brokers, consultants, users and lobbyists. The paper also presents results from the workshop on the future regulatory framework for suborbital flights in Europe, which was co-organised by the present authors and held in Brussels in October 2012.

Protecting Endangered Cultures from Harms of Globalization: A New Product Certification Approach Using Business Incentives

A recent article by this author borrowed a strategy used by environmentalists to promote rights of species— that of the "Red Book," used to protect biodiversity—and outlined how applied anthropologists could combine with rights advocates to promote systematic monitoring and legal protections for endangered cultures, to highlight the endangerment of and to protect cultural diversity (Lempert 2010). That was one of a series of potential approaches to cultural protections suggested by this author (Lempert 1997; 2008; 2009; 2012; Lempert and Nguyen 2008) and by others to try to use governance, law, and "rights" as a means of enforcing existing international and domestic laws and obligations. Most such strategies, however, are major initiatives requiring investment of resources and risk-taking by individual anthropologists and our profession. Accountability and law enforcement are also confrontational.

Toward applied Islamic business ethics: responsible halal business

PurposeThe purpose of this paper is to explore the opportunities of using halal regulation and certification as a mechanism for applying Islamic business ethics in contemporary world.Design/methodology/approachThe current practices of halal regulation and certification and literature on Islamic ethics were reviewed, to identify a practical approach for Islamic business ethics.FindingsIslam allows and accepts different levels of ethical commitment. A multi‐level Islamic ethics framework and a multi‐level halal certification approach are proposed to facilitate the implementation of Islamic business ethics in a relative context. Two major developments can enrich halal business practices: harmonization of global standards and governance structure, and integrating responsibility and ethical issues in halal standards.Practical implicationsThe proposed framework and developments can enrich halal regulation and certification practice.Originality/valueThe paper emphasizes the importance of flexibility and adaptability in Islamic business ethics implementation, and proposes a new framework and approach to apply Islamic business ethics.

Effectiveness and legitimacy of forest carbon standards in the OTC voluntary carbon market

BackgroundIn recent years, the voluntary over-the-counter (OTC) carbon market has reached a significant market volume. It is particularly interesting for forest mitigation projects which are either ineligible in compliance markets or confronted with a plethora of technical and financial hurdles and lacking market demand. As the OTC market is not regulated, voluntary standards have been created to secure the social and environmental integrity of the traded mitigation projects and thus to ensure the quality of the resulting carbon credits. Building on a theoretical efficiency-legitimacy framework, this study aims to identify and analyse the characteristics and indicators that determine the efficiency and organisational legitimacy of standards for afforestation/reforestation carbon projects.ResultsAll interviewed market actors consider third-party certification and standards as a crucial component of market functionality, which provide quality assurance mechanisms that reduce information asymmetries and moral hazard between the actors regarding the quality of carbon credits, and thus reduce transaction costs. Despite this development, the recent evolution of many new and differing standards is seen as a major obstacle that renders it difficult for project developers and buyers to select an appropriate standard. According to the interviewed experts the most important legitimating factors of standards are assurance of a sufficient level of quality of carbon credits, scientifically substantiated methodological accounting and independent third-party verification, independence of standard bodies, transparency, wide market acceptance, back-up of the wider community including experts and NGOs, rigorous procedures, and the resemblance to the Afforestation/Reforestation (A/R) CDM due to its international policy endorsements. In addition, standards must provide evidence that projects contribute to a positive social and environmental development, do no harm as a minimum requirement and build a strong track record of successful projects. Project developers require clear, easily and practically applicable standards at lowest possible costs with a high potential in order to achieve good carbon prices, while buyers require that standards are legitimate, credible and that no public criticism arises when carbon credits are purchased from projects certified by a certain standard.ConclusionsDespite the fragmented and immature state of the OTC market, standards act as 'market-making' intermediaries and contribute to the quality and transparency of the OTC market. However, the variety of different standards imposes new hurdles for their efficiency and often creates confusion instead of confidence among potential buyers. Despite the lacking legitimacy of the standards, pressures from the institutional environment on standards ensure a minimum quality of carbon credits (including positive social and environmental impacts of carbon credits) that serves as an insurance mechanism for the integrity of standards. Its unregulated nature and the pressure from an increasingly competitive environment provides innovative space to deliver efficient certification procedures without imposing unreasonably high transaction costs on market actors. Furthermore, voluntary standards imply a more innovative certification approach, as one legal authority could do, because standards have to compete for adopters backed by civil society organisations. Thereby, the forest sector in OTC voluntary market bears great opportunities to provide the forest sector with crucial lessons for international climate policy and governmental institutions when designing regulation for forest regulation such as international and national REDDplus schemes.

Leading Inclusive ELL

Purpose: This article attempts to build a better understanding of the leadership necessary to create socially just schools for English language learners (ELLs) by addressing these questions: In what ways do principals create asset-based, collaborative, and inclusive learning opportunities and services for ELLs? What do varying approaches of these services and the leadership necessary look like in practice? Research Design: This article reports on the instrumental case studies of two urban elementary schools and the principals involved in school reform that resulted in inclusive ELL services. Findings: The first principal led her school to adopt a dual certification approach, where the staff engaged in professional development around ELL. They combined federal, state, and local resources to eliminate pullout ELL programs and reduce class size so elementary teachers would take sole responsibility for building community and instructing ELL and all students. The second principal led his school to adopt a coteaching approach where teams of general education and English as a second language (ESL) teachers planned as a team and cotaught all students. They eliminated pullout ELL services and focused on community building, professional development, and collaboration. Student achievement at both schools, and in particular the achievement of ELL students, greatly improved, as did the connection with ELL families. The cross-case analysis provides a comparison between the cases of inclusive ESL reform. Conclusions: The authors propose implications for school leaders that build on the literature, social justice leadership, and the work of the principals, staffs, and communities at the schools from the case studies described here.

Testing as a Certification Approach

For years, one of the main reasons to buy commercial software instead of adopting open-source applications was the, supposed, guarantee of quality. Unfortunately that was rarely true and, fortunately, open-source projects soon adopted some good practices in their code development that lead to better tested software and therefore higher quality products. In this article we provide a guided tour of some of the best practices that have been implemented in the Perl community in the recent years, as the pathway to a better community oriented repository of modules, with automatic distributed testing in different platforms and architectures, and with automatic quality measures calculation.