125 resultados para Medicinal Product Liability


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Työn teoriaosuudessa tutkittiin prosessien uudelleen suunnittelua, prosessien mallintamista sekä prosessimittariston rakentamista. Työn tavoitteena oli uudelleen suunnitella organisaation sertifiointiprosessi. Tämän tavoitteen saavuttamiseksi piti mallintaa nykyinen ja uusi prosessi sekä rakentaa mittaristo, joka antaisi organisaatiolle arvokasta tietoa siitä, kuinka tehokkaasti uusi prosessi toimii. Työ suoritettiin osallistuvana toimintatutkimuksena. Diplomityön tekijä oli toiminut kohdeorganisaatiossa työntekijänä jo useita vuosia ja pystyi näinollen hyödyntämään omaa tietämystään sekä nykyisen prosessin mallintamisessa, että uuden prosessin suunnittelussa. Työn tuloksena syntyi uusi sertifiointiprosessi, joka on karsitumpi ja tehokkaampi kuin edeltäjänsä. Uusi mittaristojärjestelmä rakennettiin, jota organisaation johto kykenisi seuraamaan prosessin sidosryhmien tehokkuutta sekä tuotteiden laadun kehitystä. Sivutuotteena organisaatio sai käyttöönsä yksityiskohtaiset prosessikuvaukset, joita voidaan hyödyntää koulutusmateriaalina uutta henkilöstöä rekrytoitaessa sekä informatiivisena työkaluna esiteltäessä prosessia virallisille sertifiointitahoille.

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Product assurance is an essential part of product development process if developers want to ensure that final product is safe and reliable. Product assurance can be supported withrisk management and with different failure analysis methods. Product assurance is emphasized in system development process of mission critical systems. The product assurance process in systems of this kind requires extra attention. Inthis thesis, mission critical systems are space systems and the product assurance processof these systems is presented with help of space standards. The product assurance process can be supported with agile development because agile emphasizes transparency of the process and fast response to changes. Even if the development process of space systems is highly standardized and reminds waterfall model, it is still possible to adapt agile development in space systems development. This thesisaims to support the product assurance process of space systems with agile developmentso that the final product would be as safe and reliable as possible. The main purpose of this thesis is to examine how well product assurance is performed in Finnish space organizations and how product assurance tasks and activities can besupported with agile development. The research part of this thesis is performed in survey form.

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Product assurance is an essential part of product development process if developers want to ensure that final product is safe and reliable. Product assurance can be supported with risk management and with different failure analysis methods. Product assurance is emphasized in system development process of mission critical systems. The product assurance process in systems of this kind requires extra attention. In this thesis, mission critical systems are space systems and the product assurance process of these systems is presented with help of space standards. The product assurance process can be supported with agile development because agile emphasizes transparency of the process and fast response to changes. Even if the development process of space systems is highly standardized and reminds waterfall model, it is still possible to adapt agile development in space systems development. This thesis aims to support the product assurance process of space systems with agile development so that the final product would be as safe and reliable as possible. The main purpose of this thesis is to examine how well product assurance is performed in Finnish space organizations and how product assurance tasks and activities can be supported with agile development. The research part of this thesis is performed in survey form.

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The purpose of this master’s thesis was to study the opportunity to apply Lean practices to product management function which happens in an office environment. Since product management plays an important role in the company’s success story, it’s important to have it functioning as effectively as possible. The goal was to find those Lean tools and methods that fit the best to the needs of product management. The research was conducted as a qualitative action research which comprises a comprehensive literature review and a single case study. Theoretical information about Lean Thinking and product management was collected from articles, literature and Internet sources. Moreover, empirical data was collected by conducting interviews in the Case Company’s product management department in order to gain an in-depth understanding of product management’s problematics. The results indicate that most of the product management challenges could be overcome by applying Lean practises. Based on the usability rate, which has been discussed in the empirical part of this study, the most suitable Lean practises for product management function are: value stream mapping, Kanban and KPIs.

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The thesis presents the study relative to the collaboration between suppliers and buyers in packaging industry with the impact of product features. The main purpose of this study is to examine the importance of product characteristics on collaboration to develop better packaging and to figure out how buyer-supplier collaboration in the supply chain perspectives is conducted and managed in packaging industry. The theoretical part reviewed some basic frameworks of collaboration including the scopes and levels of collaboration, risks as well as powers of collaboration, relationship and some key factors for successful collaboration. Followed by the overviews of packaging industry with the main issues related to product characteristics in packaging. By using the qualitative method, secondary data consisting of articles, reports, websites and primary data through interviewing some well-known packaging companies and case companies are collected in the thesis. The empirical result emphasized the importance of product features’ analysis in packaging industry since it plays a central role in the materials, design process, production and innovation with the role of collaboration. Collaboration in packaging is vital for packaging companies to survive and grow in the competitive environment. Finally, some key factors for effective collaboration were summarized based on the perspectives of packaging companies. It is highly recommend building a long-run collaboration with their customers due to undeniable benefits With increasingly importance of collaboration in packaging industry, further studies may be conducted.

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Product Data Management (PDM) systems have been utilized within companies since the 1980s. Mainly the PDM systems have been used by large companies. This thesis presents the premise that small and medium-sized companies can also benefit from utilizing the Product Data Management systems. Furthermore, the starting point for the thesis is that the existing PDM systems are either too expensive or do not properly respond to the requirements SMEs have. The aim of this study is to investigate what kinds of requirements and special features SMEs, operating in Finnish manufacturing industry, have towards Product Data Management. Additionally, the target is to create a conceptual model that could fulfill the specified requirements. The research has been carried out as a qualitative case study, in which the research data was collected from ten Finnish companies operating in manufacturing industry. The research data is formed by interviewing key personnel from the case companies. After this, the data formed from the interviews has been processed to comprise a generic set of information system requirements and the information system concept supporting it. The commercialization of the concept is studied in the thesis from the perspective of system development. The aim was to create a conceptual model, which would be economically feasible for both, a company utilizing the system and for a company developing it. For this reason, the thesis has sought ways to scale the system development effort for multiple simultaneous cases. The main methods found were to utilize platform-based thinking and a way to generalize the system requirements, or in other words abstracting the requirements of an information system. The results of the research highlight the special features Finnish manufacturing SMEs have towards PDM. The most significant of the special features is the usage of project model to manage the order-to-delivery –process. This differs significantly from the traditional concepts of Product Data Management presented in the literature. Furthermore, as a research result, this thesis presents a conceptual model of a PDM system, which would be viable for the case companies interviewed during the research. As a by-product, this research presents a synthesized model, found from the literature, to abstract information system requirements. In addition to this, the strategic importance and categorization of information systems within companies has been discussed from the perspective of information system customizations.

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This thesis focuses on consolidation the recommendations on the integration of consumer in new product development (NPD) given in the academic literature, and on the example of the three NPD projects in the case company. The empirical findings advocate that the case company fulfills the principles of consumer-led NPD, and it is only one-step away of the full consumer empowerment strategy. Therefore, its NPD can be seen as an example of consumer-led NPD implementation. The findings also suggest that the product can be developed in consumer-led way regardless of the source of an idea (product- or need-driven), the target audience and resources assigned, in case when consumer mindset is integrated on all levels of organisation: strategic, cultural, operational and process. It is possible with top-management commitment, internal consumer research group, and the sophisticated consumer research methods. The specific managerial recommendations are given on developing consumer-led culture, strategy, NPD process and the appropriate consumer research methods and techniques.

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The purpose of conducting this thesis is to gather around information about additive manufacturing and to design a product to be additively manufactured. The specific manufacturing method dealt with in this thesis, is powder bed fusion of metals. Therefore when mentioning additive manufacturing in this thesis, it is referred to powder bed fusion of metals. The literature review focuses on the principle of powder bed fusion, the general process chain in additive manufacturing, design rules for additive manufacturing. Examples of success stories in additive manufacturing and reasons for selecting parts to be manufactured with additive manufacturing are also explained in literature review. This knowledge is demanded to understand the experimental part of the thesis. The experimental part of the thesis is divided into two parts. Part A concentrates on finding proper geometry for building self-supporting pipes and proper parameters for support structures of them. Part B of the experimental part concentrates on a case study of designing a product for additive manufacturing. As a result of experimental part A, the design process of self-supporting pipes, results of visual analysis and results of 3D scanning are presented. As a result of experimental part B the design process of the product is presented and compared to the original model.

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Under EU competition law, parent companies may be held jointly and severally liable for the competition law infringements committed by their subsidiaries. The possibility of holding parent companies liable demonstrates a significant exception from the idea of separate legal entities. However, it is not the only deviation developed under EU competition law. In cases, where the legal entity responsible for the anti-competitive conduct has changed its form, liability can be attributed to the new operator, in particular, to its successor. The principles of legal certainty and legitimate expectations are issues that surround the doctrines of parental and successor liability. The aim of this thesis is to present a comprehensive comparative analysis of the parental and successor liability doctrines and to clarify the conditions under which it is possible to attribute liability for the infringements of EU competition law. The main purpose is therefore to demonstrate the problems related to the allocation of liability and to discuss whether these liability principles, established to assure the effective enforcement of the EU competition rules, are good solutions. The research methods used in this thesis are the legal dogmatic approach and the comparative law approach. The former enables the possibility of using the case law and legislation as a framework in which the difficulties concerning the application of parental and successor liability can be discussed while the latter ensures the comparison of the characteristics and judgments. The doctrines of parental and successor liability are both well established, but the application practice has caused several difficulties. These problems derive from, inter alia, the broadness and disjointed developed of the doctrines. There has been much recent case law dealing with these issues and having the potential to open up a considerable risk and to allocate strict liability for parent and successor companies.