Implementation Of Quality System Research Articles

Food Safety and the Implementation of Quality System in Food

One of the goals the development of the food sector in Indonesia is food secured the release of which is characterized by the type of food that are harmful to health. In some way of avoiding the kind of food that is harmful to health, strengthen institutional food sector, and increase the number of food industry comply with regulations. Implementation of Good Handling Pratice (GHP) and Good Manufacturing Pratice (GMP) and Hazard Analysis Critical Control Point (HACCP) are a responsibility and awareness of manufacturers and distributors. Some of the food safety regulations have been issued by the government of Indonesia such as Law. 18 on Food in 2012 to provide protection to consumers and food producers will be healthy, safe and lawful. Development of quality systems and food safety and implementation quality system in the food industry are a shared responsibility between government, industry includes producers of raw materials, food industry and distributors, and consumers.

Impact analysis of the implemented quality management system on business performances in pharmaceutical-chemical industry in Serbia

International quality management standard (QMS) ISO 9001 became widely accepted as a framework for product and/or services quality improvement. There are recent research conducted in order to define relationships and effects between the applied QMS and financial and/or non-financial business parameters. The effects of the applied pharmaceutical quality system (PQS) on the business performances in Serbian pharmaceutical-chemical industry are analyzed in this paper using multivariate linear regression analysis. The empirical data were collected using a survey that was performed among experts from Serbian pharmaceutical-chemical industrial sector during 2010. An extensive questionnaire was used in the survey, grouping the questions in eight groups: Implementation of pharmaceutical quality system (AQ), Quality/strategy planning (QP), Human resource management (HR), Supply management (SM), Customer focus (CF), Process management (PM), Continuous improvement (CI), and Business results (BR). The primary goal of the research was to analyze the effects of the elements of first seven groups (AQ, QP, HR, SM, CF, PM, and CI) that present various aspects of the implementation of PQS, on the elements of business results (BR). Based on empirical data, regression relations were formed to present the effects of all considered elements of PQS implementation on the business performance parameters (BR). The positive effects of PQS implementation on the business performances such as the assessment of performance indicators, continual products and/or services quality improvement, and efficient problem solving, are confirmed in the presented research for the Serbian pharmaceutical-chemical industrial sector. The results of the presented research will create a room for the improvement of the existing models in application, and for attracting interested parties that aim to commence this business standardization process. Hence, implementation of PQS is not only the regulatory requirement or advertising movement, but very important issue for the development and improvement of business performances.

Organizational culture in public institutions and its impact in the process of implementation of total quality management (case of Kosovo)

Total Quality Management (TQM) is a management philosophy and approach, whose importance is growing evermore after the 90s. Kosovo's public institutions for a short time now organise activities as part of an independent state and as such they are facing ahead management challenges which are becoming more acute and in the framework of the EU integration processes.Total Quality Management in public institutions, is preceded by establishment and implementation phase ISO 9001 systems. In this paper we tried that through an empirical study in three public institutions of Kosovo, evidence the factors that facilitate or impede timely and successful implementation of quality systems and therefore of TQM. Moreover, we will concentrate on organizational culture. Analysis on the norms, beliefs, principles that characterize the organizational culture of Kosovo institutions and furthermore intertwined with the Law on Public Administration and the political context, will serve to shape the changes that need to be designed to proceed to successful implementation of TQM. In function of the analysis of impeding factors, elements of organizational culture as well as modeling the changes there will be used a number of interviews and questionnaires.

Safety of Structures–Control: An Integral Part of Design and Execution

This paper addresses the importance of achieving quality in new structures by first promoting implementation of adequate quality systems in design and execution standards, most prominently of them EN 1990 Basis of structural design. Secondly, by motivating the stakeholders in the industry to appreciate the added value that adequate quality procedures will provide and see this as a normal and natural part of their work. Naturally such procedures will also have a similar role in the increasing volume of assessment and retrofitting of existing structures.

Quality indicators for discarding blood in the National Blood Center, Kuala Lumpur

Background and Objective:The implementation of quality system and continuous evaluation of all activities of the Blood Transfusion Services (BTS) can help to achieve the maximum quantity and quality of safe blood. Optimizing blood collection and processing would reduce the rate of discard and improve the efficiency of the BTS. The objective of this study is to determine the rate of discard of blood and blood component and identify its reasons at the National Blood Centre (NBC), Kuala Lumpur, during the year of 2007 in order to introduce appropriate intervention.Study Designs and Methods:Data on the number of discarded whole blood units and its components, reasons for discard, and the number of blood components processed as well as the number of collected blood units were obtained from the Blood Bank Information System - NBC database. These were analyzed.Results:The total number of blood units collected in 2007 was 171169 from which 390636 units of components were prepared. The total number of discarded whole blood units and its components was 8968 (2.3%). Platelet concentrate recorded the highest of discard at 6% (3909) followed by whole blood at 3.7% (647), fresh frozen plasma (FFP) at 2.5% (2839), and cryoprecipitate at 2% (620). The rate of discarded packed red blood cells RBCs, plasma aphaeresis, and PLT aphaeresis was less than 1% at 0.6% (902), 0.6% (37), and 0.29% (14), respectively. RBC contamination of PLT and plasma were the major cause of discard at 40% (3558). Other causes include leakage (26% - 2306), lipemia (25% - 2208), and underweight (4% - 353).Conclusion:Good donor selection, training and evaluation of the staff, as well as implementation of automation will help to improve processes and output of BTS. This would reduce discard of blood components and wastage caused by non conformance.

CTM 4 model using Ishikawa diagram for quality management in design-and-build projects

In the demand for improved procurement methods, the design-and-build approach has become prevalent in the construction industry as a fast track strategy. However, the quality issues in design-and-build projects raise the alarm for attention. Competency of project managers in quality management of design-and-build projects may be questionable so that success is hard to achieve. This research intends to identify issues in implementing quality systems in design-and-build projects. A questionnaire survey was employed to collect data from 198 targeted project management consultant firms and construction management firms all over Malaysia. Finding shows that time constraint is the biggest obstacle in the implementation of quality system in design-and-build projects. Six root causes leading to success in design-and-build project have been identified, namely client, time, manpower, management, money, and material. The results of this study could be used as guidelines to successfully handle quality management in design-and-build construction projects in emerging economies in Asian, Africa and other developing regions. Key words: Design-and-build, CTM4 model, Ishikawa diagram, quality management, implementing quality system, critical success factors.

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Pathogen inactivation

Shedding more light on the impacts of quality certified systems in small service enterprises: A multidimensional analysis

The purpose of this paper is to describe the small enterprises within the service sector that have adopted certified quality systems, focusing on the motives that have encouraged these enterprises to do so and the organizational impacts such adoptions have had. The results highlight the importance that these enterprises grant to certified quality systems as a strategic tool that can be used in a proactive way to contend with market changes and adverse economic situations, providing them commercial benefits in particular. These results can help managers of small service enterprises analyse the advantage or disadvantage of the position in the market that they can achieve when they decide to implement certified quality systems. This paper provides evidence of how the motives behind small service enterprises’ implementation of quality systems differ from those found by research papers, focused on other types of service and industrial enterprises. Key words: Quality management, organizational performance, quality certificated systems, small business, service business, impacts of quality.

Quality system implementation process for business success

PurposeThe purpose of this paper is to examine the implementation activities involved in certifying a quality management system to the ISO 9000 quality management system standard. This includes developing the best business performance measures that will serve as indicators of an effective quality management system. This paper aims to establish a relationship between implementation activities involved in the quality system and specific business performance measures that can be used to assess the system's effectiveness.Design/methodology/approachData were collected using an online survey combined with publicly available financial reporting information. Regression and other statistical techniques along with text clustering and association of the survey comments were used to analyze the data.FindingsEmphasis on implementing a documentation system were found to be linked to business performance as measured by the return on assets financial measure.Research limitations/implicationsFuture research should explore various documentation system aspects such as knowledge management and information sharing in greater detail. A larger sample focused on a specific industry might provide useful information for industry appropriate performance indicators.Practical implicationsThe practical implications of this research focus on the design and implementation of an organization's quality management system in areas that will provide the most benefit to organizations seeking ISO 9000 certification. A baseline measurement can be used prior to implementing the system to strategically manage the implementation process. By understanding how best to implement the quality management system, fewer resources are wasted on ineffective quality management system certification projects and some of the skepticism around the implemention of an ISO 9000 certified quality management system is eliminated.Originality/valueFew quality system researchers target the implementation process for analysis. Combining survey data and publicly held financial represents is a new method for studying ISO 9000 implementation.

The Effect of Quality on Hotel Risk

Analysis of the variation – increase or decrease – in the risk to a hotel chain's performance of the introduction of a new quality system is a crucial aspect of decision making. With this in mind, this paper detects changes in such risk deriving from the implementation of quality systems signalled by quality awards. The authors analyse this issue in the Spanish hotel market by employing autoregressive conditional heteroskedasticity models. The results show that, in the short term, the increase in fixed costs derived from quality systems is higher than the augmentation in sales; that is, there is an increment in the operating leverage and the firm's operational risk.

Organizational Change at a Local Center of Excellence—The Case of San Carlos University and the Office of Population Studies in the Philippines

th , 2011; revised April 15 th , 2011; accepted May 6 th , 2011. The Higher Education System in the Philippines is in a state of transition caused by global pressures at the one hand and local needs on the other hand. The transition is first of all visible in the implementation of quality systems and secondly in the need for sustainable research and education networks and centres of excellence. The transition not only asks for a policy agenda, but is also a matter of organizational change management at a local level. This paper presents an in-dept case-study of a local research and education network between the Office of Population Studies (OPS) and the Department of Sociology and Anthropology (SoAn) of the University of San Carlos (USC) in the region of the Central Visayas, Philippines. It shows that once loosely coupled local partners that worked successfully together in the past became de-coupled and non-sustainable. In order to overcome local constraints and to (re)build a stable, local centre of excellence, adequate change management based upon mutual understanding and trust is needed. It is only through this that the ambition to attain global research standards and, at the same time, to stay effectively engaged in addressing development needs of the region can be fully met.

The necessity and challenge of setting up a quality assurance system in the higher education system in Andalusia (Spain)

Spanish universities and particularly their Faculties are currently involved in implementing quality systems, a process many other European countries have already undertaken. This is raising a considerable number of doubts and worries in the teaching staff and student community. With this problem in mind, we have asked the teaching staff and students whether it is necessary or not to implement a quality assurance system, as the European Association for Quality Assurance (ENQA) is suggesting us. For this purpose, we have used a quantitative-qualitative methodology. At the beginning, a descriptive and correlation study was carried out together with an experimental analysis using variability analysis (ANVA) and Scheffé’s method to test any possible contrast, and concluding with a qualitative interpretation of the reflections offered by the participants.

Certification intensity level of the leading nations in ISO 9000 and ISO 14000 standards

PurposeAs the process of standardisation in all aspects of business management has accelerated in recent years in an environment characterised by economic globalisation and integration, two series of standards issued by the International Organisation for Standardisation (ISO) stand out: the ISO 9000 series, related to the implementation of quality systems; and the ISO 14000 series, related to the implementation of environmental management systems. The purpose of this paper is to analyse and compare the evolution of both standards in the leading countries in these certifications.Design/methodology/approachIt is noteworthy that the same few nations consistently occupy the highest rankings in both the number of ISO 9000 and ISO 14000 series certifications. These countries are also those with highest growth rates in certifications. The present study examines these phenomena in terms of: a proposed new index for measuring the “certification intensity”; and a proposed model to analyse how standards are disseminated in a given country.FindingsThe leading nations in ISO 9000 and ISO 14000 series certifications have a common spreading pattern. All of them are increasing in both standards, not only in absolute number of certifications, but also in its certification intensity. On the other hand, the logistic curve is a good pattern to forecast the trend of these intensities.Originality/valueThe paper concludes with some forecasts and trends for the immediate future in the most successful countries. Some suggestions are also made for future research.

The effects of nationality of origin on satisfaction: An application for the public service of social housing

The public administrations are implementing quality systems that require analysing citizen satisfaction. The demand for services is increasing from a growing segment of the population: immigrants. This work seeks to fulfill two objectives: determine the elements that have an impact on citizen satisfaction with a public service and analyse if there are differences in these elements depending on the nationality of the citizen demanding the service. The results show that citizen satisfaction is determined by the personnel and by the tangible elements. Moreover, the personnel element has a greater effect on satisfaction when the citizen is a foreigner.

Survey on minor and trace elements in Antarctic and Arctic biota as indicators of local and global-scale pollution

Trace and minor elements in biota in the extreme regions of the planet (Antarctic, Arctic and related areas) play a pivotal role to assess global pollution and climate changes. The relevant scientific literature was scanned over the period 1978–2008 and the most recent trends in polar research in this field were outlined. In this context, two aspects were found to be of paramount importance, i.e., the role of sentinel organisms in monitoring ongoing processes of environmental pollution caused by chemical elements and the implementation of quality systems to attach credibility to experimental information.

Testing strategies looking forward

The early days of the AIDS epidemic brought tragic conse-quences for blood recipients. However, the attention, reflec-tion, resources and research triggered by the epidemic ledto the development of highly effective approaches for theprevention of transmission of infectious agents by transfu-sion of blood-, components- and plasma-derived therapeu-tic proteins. Before the availability of screening assays,prevention focused exclusively on the deferral of individu-als thought to be at higher risk of transmitting the infectionfrom donating blood components or plasma for furthermanufacture. Undoubtedly, the most significant currentcontributors to recipient safety are the testing of blooddonations for the most relevant diseases transmissible bytransfusion in the area where the blood was collected, andthe implementation of quality systems that guarantee theadoption of appropriate screening assays and their useaccording to good laboratory practices.This summary follows two in-depth reviews about assaysavailable for the screening of blood donors in this session;one, by M. Busch, addresses serological assays and theother, by M. Schmidt, looks at molecular assays. This sum-mary is purposely focused on thoughts about choices ofassays, current testing strategies and future technologicaladvances in the context of different countries with differentepidemiology of transfusion transmitted infectious diseases(TTID) and variable resources available for transfusionsafety.

INFLUÊNCIA DOS TRAÇOS CULTURAIS NACIONAIS NA FORMAÇÃO DE APL´S – O CASO DAS EMPRESAS DE ESQUADRIAS DO APL DA MADEIRA

O setor florestal tem, historicamente, no Sul do Brasil, importância estratégica. O presente estudo buscou identificar o grau de presença das chamadas características culturais nacionais na região do Arranjo Produtivo Local (APL) da madeira de União da Vitória – Porto União. Dentre as características analisadas – personalismo, protecionismo, aversão à incerteza, formalismo, “jeitinho”, receptividade ao estrangeiro e orientação ao curto prazo –, apenas duas representaram diferentes níveis de presença entre as empresas participantes e não participantes do APL: formalismo e receptividade ao estrangeiro. As características mais marcantes foram a orientação ao curto prazo e o protecionismo. Com base nessa realidade, para potencializar o processo de formação e implementação do APL, recomenda-se: i) profissionalização do setor; ii) realização de estudos de mercado e de competitividade do segmento; iii) implementação de sistemas de qualidade; iv) adoção de soluções com base na realidade local; v) trabalhar a importância da gerência local e a participação de todos os interessados; e, por fim, vi) elaboração de um planejamento regional com horizonte temporal, com respectivo acompanhamento da execução. Palavras-chave: Características culturais nacionais; APL; planejamento. Abstract Influence of the Brazilian national cultural traits in the formation of the APL´S – The case of the enterprises of the wood’s local productive arrangement. Historically, the Forest sector in South Brazilian is strategic importance. This study aimed to identify the level of presence of the main Brazilian national cultural traits in the Wood’s Local Productive Arrangement (APL) of União da Vitória – Porto União, southern Brazil. Among the analyzed characteristics: personal relations, protectionist, formalism, local and informal procedures of finding ways to solve problems, aversion to uncertainty, receptivity and short-term orientation only of them, two showed difference level of presence among participants of APL and non-participants enterprises – formalism and receptivity. The most outs tan ding national cultural traits found were short-term orientation and protectionism. To help the formation and implementation of the APL, taking into account the scenarios identified, some actions are suggested: I) sector’s professionalization, II) development of market and sector’s competition studies, III) implementation of quality systems, IV) solutions based in the local reality, V) development of local management and stakeholders participation, and, VI) preparation of a long-term regional planning, with implementation of monitoring and evaluation system. Keywords: Brazilian national cultural traits; APL; planning.

Replacement, reduction and refinement alternatives to animal use in vaccine potency measurement

Models to measure potency in vaccine research and development and preclinical testing are frequently based on an immunization–challenge procedure in laboratory animals. These models have proven to be very instrumental in scientifically underpinning the correlation of protection of selected vaccine antigens and their efficacy. In vivo models in vaccine research and development are, for the time being, irreplaceable, although significant progress has been made in using in vitro prescreening tests to evaluate particular immunological parameters. For a long time, in vivo potency tests have been similarly relevant for routine vaccine lot-release testing. The design of a potency test, defined in most pharmacopeias, relied on a direct or indirect-challenge procedure in laboratory animals. For various reasons, there now is an increased interest in the development of alternatives to the current in vivo potency tests. Animal models have their limitations, with respect to their relevance, reliability, costs and moral acceptability. All alternative approaches have in common that they ultimately result in a refinement, reduction or replacement in the use of animals. The new models range from modifications of the existing in vivo test procedure (e.g., use of humane end points or serology instead of challenge) to in vitro antigen-quantification tests. A new paradigm in quality control of vaccines is the consistency approach. This approach is state-of-the-art in quality control of the new-generation vaccines and it is now finding its way into the quality control of traditional vaccines. The consistency approach implies the use of a set of parameters to constitute a product profile, which is monitored throughout production, and which guarantees that each lot released is similar to a manufacturer-specific vaccine of proven clinical efficacy and safety. Consistency relies heavily on the implementation of quality systems, such as good manufacturing practice and quality assurance, and on the use of in vitro analytical tools, such as immunochemical and physicochemical tests.

Cost analysis in the implementation of ISO quality system in a petroleum refinery

The substantial amounts of financial and non-financial resources invested annually on petroleum refinery operations justify the need for documentation on the cost of implementing ISO quality systems in refineries. The experience of ISO quality system implementation cost analysis in a petroleum refinery in a developing country is reported with a combination of mathematical model and application. The concept of strain as a function of growth in the physical sciences is adopted to conceptualise the growth phenomenon in the ISO organisation. Practically, developing a quantitative approach in evaluating cost of ISO implementation would help the manager in relying on scientific fact instead of intuition. The approach is new and has the potential for helping the top management in planning the strategy and allocating necessary funds for effective implementation of ISO quality systems.

Current challenges for FDA‐regulated bioanalytical laboratories performing human BA/BE studies; Part III: selected discussion topics in bioanalytical LC/MS/MS method validation

AbstractThis article is the third of a three‐part series that deals with current compliance issues/challenges for bioanalytical laboratories performing analysis for bioavailability (BA)/bioequivalence (BE) studies. Part 1 of this series discusses the application of key elements from the FDA Good Laboratory Practices (GLP) and the current Good Manufacturing Practices (cGMP) regulations as the framework for the implementation of sound Quality Systems in a bioanalytical laboratory to be in compliance with current regulatory expectations. Part 2 discusses recent Food and Drug Administration (FDA) inspection trends for bioanalytical laboratories and provides an overview of the recent FDA 483 observations related to LC/MS/MS method validation issued to bioanalytical laboratories. This current article provides a more in‐depth analysis of the scientific and compliance aspects of different approaches for selected validation parameters of LC/MS/MS bioanalytical methods. Copyright © 2009 John Wiley & Sons, Ltd.