Det finns en trend mot snabbare marknadsintroduktioner inom fordonsindustrin, vilket kräver tids- och kostnadseffektiva produktutvecklingsprocesser samtidigt som det sker ett kontinuerligt arbete för att förbättra kvaliteten på produkterna. Kvalitetsavvikelser på artiklar är kostsamma, leder till kassationer och miljöbelastningar, innebär säkerhetsrisker och försvårar planeringen inom tillverkningsorganisationer. För en hållbar tillväxt inom fordonsindustrin har den ideella organisationen Automotive Industry Action Group (AIAG) tagit fram den internationella kvalitetsstandarden IATF 16969. En del i att uppfylla IATF 16969 är att använda sig av Production Part Approval Process (PPAP), där riskhanteringsmetoden Failure Mode and Effects Analysis (FMEA) ingår. Process-FMEA (PFMEA) är en variant av FMEA som används vid kvalitetssäkring av tillverkningsprocessen. Studien syftade till att undersöka hur fordonstillverkare på ett framgångsrikt sätt kan tillämpa PFMEA vid artikelintroduktioner och produktionsförändringar. För att uppfylla syftet utfördes en fallstudie där styrkor och brister med nuvarande arbetssätt kartlades. Detta gjordes via 28 intervjuer vid två av Scanias bearbetande senheter, intervjuer med fem andra stora fordons- och komponenttillverkare samt en observationsstudie av tolv utförda PFMEA:or vid Scania. Resultatet från studien bekräftade gap mellan teoretisk framställning av PFMEA och praktisk tillämpning. De gap som identifierades gäller vilka avgränsningar som görs, användningen av risktalet, i vilka situationer PFMEA används som beslutsunderlag, processtödens uppbyggnad, avsaknaden av systemstöd, hur PFMEA ska itereras, brist på en standardiserad inlärningsprocess och sammankopplingen mellan relaterade verktyg. För respektive gap presenteras sedan framgångsfaktorer i rapporten. I avslutande rekommendationer framhölls vikten av att utgå från organisationens förutsättningar, strategi, mål och framtida vision vid tillämpning av PFMEA. Det behövs standardiserade inlärnings- och arbetsprocesser i enlighet med Lean samt tydliggöras hur informationsöverföringen mellan PFMEA, Design-FMEA, Design For Manufacturing-arbetet, styrplan, flödesschema och avvikelsesystem ska ske. Vidare rekommenderades framtagning av kravspecifikation för ett digitalt stödsystem i syfte att möjliggöra enklare och mer tidseffektiv informationsöverföring och erfarenhetsåterföring inom organisationen. Avslutningsvis antas kunskapsbidraget från studien vara av störst intresse för artikeltillverkare inom fordonsindustrin. Vid andra organisatoriska förutsättningar än vid Scanias tillverkande enheter, bör särskild uppmärksamhet ägnas åt rekommendationerna för arbetsprocesser, avvikelsesystem och organisationsstruktur. / There is a trend towards faster market introductions in the automotive industry, which requires time and cost effective product development processes at the same time as there is a continual effort to increase the quality of the products. Deviations in the quality of components are costly, lead to scrapping and environmental burdens, involve safety risks and complicate planning within manufacturing organizations. For sustainable growth in the automotive industry, the non-profit organization Automotive Industry Action Group (AIAG) has developed the international quality standard IATF 16969. A part of complying with IATF 16969 is the use of the Production Part Approval Process (PPAP), which includes the risk management method Failure Mode and Effects Analysis (FMEA). Process-FMEA (PFMEA) is a variant of FMEA used for quality assurance of the manufacturing process. The study aimed to investigate how vehicle manufacturers can successfully  apply PFMEA for introductions of components and changes in the production. To fulfill the purpose, a case study was conducted where strengths and shortcomings with current working methods were mapped. This was done by 28 interviews at two of Scania's manufacturing units and interviews with five other major vehicle and component manufacturers, as well as an observational study of twelve PFMEA:s performed at Scania. The results from the study confirmed gaps between existing research regarding PFMEA and the practitical application. The gaps identified concern the delimitations made, the use of the risk priority number, the situations in which PFMEA is used as a basis for decisions, the structure of process support, the lack of system support, how PFMEA should be iterated, lack of a standardized learning process and the connection between related tools to PFMEA. For each gap, success factors are presented in the report. In general, the importance of starting from the organisation's conditions, strategy, goals and future vision when applying PFMEA was emphasized. There is a need for standardized learning and work processes in accordance with Lean and clarification about how the information transfer between PFMEA, Design-FMEA, Design For Manufacturing, control plan, flowchart and deviation system should take place. Furthermore, the development of RFQ material for a digital support system was recommended in order to enable simpler and more time-efficient information transfer and lessons learned within the organization. In conclusion, the knowledge contribution from the study is assumed to be of greatest interest to part manufacturers in the automotive industry. In other organizational conditions than at Scania's manufacturing units, special attention should be paid to the recommendations for work processes, deviation systems and organizational structure.

This Thesis deals with creating system for controlling risks based on critical analysis for chosen company. The company is called Vinařství Kovář and it's owned by Mr Miroslav Kovář, who is a wine producer. The first part of the Thesis is focusing on theory of controlling risks. The second part analyses current state of the company, it's risks and evaluation of the risks. The assessment of the risk is done by doing an FMEA analysis. This helps to find the most severe risks which are then eliminated with set actions. The last part of the Thesis contains suggestions of controlling the risks for the company to prevent or minimalise potential risks.

The diploma thesis deals with the issue of risk management during the contract in Provident Financial company which focuses on short-term and mid-term loans. This thesis is divided into three parts. The first part provides theoretical basis based on professional literature. The analytical part is focused on introduction of the company, description of the course of the contract and risks associated with it and analysis of external environment. Last part shows proposals to minimize the risks mentioned in the analysis and a proposal for new information system, which is important for the company.

The diploma thesis deals with the issue of risk management in the company Bonita group Service s.r.o., which manufactures playgrounds, street workout and fitness machine. The thesis describes the current situation, an applicable legislation and methods for risk analysis and evaluation. It also describes the current state of the company and analyzes the causes and effects of risks. Based on the analyzes performed, it proposes a number of measures to mitigate these risks. The final part of the diploma thesis summarizes conclusions and presents recommendations.

This diploma thesis deals with risk management of a selected company. The described company is called PLASTIC BOX CZ, Ltd. and it is engaged in the manufacture of plastic products. The theoretical part contains the definition of components, which are mainly identification, analysis and methods to reduce individual risks. Appropriate analytical methods related to the risk management process are subsequently defined. In the analytical part, risks of the business entity are identified using selected methods. Risk analysis is performed by the FMEA analysis and elaborated in the specific process of running the company. The last part of this thesis includes the design of a risk management system of operating the company PLASTIC BOX CZ, Ltd., which is meant to ensure minimization and prevention of possible risks.

Embedded systems often involve safety critical applications, meaning that the malfunctioning of these systems would lead to catastrophic consequences. In this thesis project, a cross domain comparison of the industry specific standards for safety in embedded systems is be provided. After this, following the guidelines provided in ISO-26262/IEC-61508, a failure modes and effects analysis was performed on the implemented system, which consists of a STM32MP157F-DK2 board, on which two cores of the same SoC communicate through Remote Processor Messaging. One core runs OpenSTLinux, and the other the real-time operating system Zephyr. Based on the results of the failure modes and effects analysis, a combination of the addition of some headers to the message, and the implementation of cyclic redundant check, solved some of the issues pointed out. / Inbäddade system omfattar ofta säkerhetskritiska tillämpningar, vilket innebär att att fel i dessa system skulle leda till katastrofala konsekvenser. I detta avhandlingsprojekt görs en tvärdomänisk jämförelse av de branschspecifika standarder för säkerhet i inbyggda system. Därefter följer följande riktlinjerna i ISO-26262/IEC-61508, en analys av fel och effekter av fel och analys av fel och brister på det implementerade systemet, som består av följande ett STM32MP157F-DK2-kort, där två kärnor i samma SoC kommunicerar via Meddelandehantering för fjärrprocessor. Den ena kärnan kör OpenSTLinux och den andra realtidsoperativsystemet Zephyr. Baserat på resultaten av felet analysen av felkällor och effekter, en kombination av att lägga till vissa rubriker och till meddelandet och genomförandet av cyklisk redundant kontroll, löste problemet. några av de problem som påpekades.

A intensa competição no mercado global e as constantes mudanças nas exigências dos clientes têm feito com que muitas empresas repensem seus processos de negócios não somente para sobreviver, mas também para se manterem competitivas no mercado atual. O processo de desenvolvimento de produtos é um fator importante para qualquer empresa se manter competitiva neste cenário. A falta de um bom processo de desenvolvimento de produtos é sem dúvida uma grande desvantagem para uma empresa. Somente um bom processo de desenvolvimento não garante a vantagem competitiva das empresas, é necessário também que seus produtos sejam confiáveis e para que isto aconteça torna-se essencial desenvolver produtos com qualidade, através do uso disciplinado e constante de ferramentas de qualidade. Para ser competitivo um produto precisa ser desenvolvido com o mínimo de tempo, recursos e custo, para atender às necessidades de mercado. Algumas metodologias foram desenvolvidas e estas focam no desenvolvimento de um produto sempre pensando nas necessidades da manufatura, montagem, qualidade, confiabilidade e ciclo de vida do produto, evitando mudanças tardias no produto. Muitos estudos acadêmicos e industriais têm sido propostos nesta área. Cada empresa deve encontrar e se adaptar ao processo ou modelo mais adequado para ela dentro das suas necessidades técnicas e culturais. Este estudo apresenta uma metodologia a ser usada para melhorar a qualidade do produto e deve ser usada quando da fase conceitual onde se escolhem os melhores sistemas e/ou componentes para formar um novo produto final. / The intense competition in global market along with constant changes in customers demands have forced companies to re-think some of their business processes, not only to survive, but also to stay competitive on this market. The product development process is one of the key business processes for any company to stay competitive and global on this scenario. The lack of a good development process is with no doubt a big disadvantage for any company. Only a good development process does not guarantee a competitive advantage for anyone, it becomes necessary to have reliable products in the field and to make this happens it is vital to develop products with quality through the use of quality tools in a constant and disciplined way. To be competitive, a product needs to be designed in a minimum amount of time, with minimum resources and cost. To meet market needs some methodologies were developed thinking on manufacturing, assembly, quality, reliability and life cycle avoiding late product changes. Many studies academic and industrial have been proposed in this area. Each company has to find and adapt the most appropriate model that fits its technical and cultural needs. This research presents a methodology to be used to improve product quality during the early phases of development when systems and/or components are chosen for a new product.

Mundialmente, eventos relatados constituídos por incidentes e acidentes em radioterapia, tem aumentado ao longo dos últimos 25 anos e a maioria destes eventos são resultados de falha humana, além de terem ocorrido com maior frequência em centros sofisticados que utilizam alta tecnologia. Em radioterapia a Gestão da Qualidade necessita de uma abordagem prospectiva através de análise de risco. Esta abordagem é defendida por recentes publicações por ser atualmente uma urgência em virtude do expressivo número de acidentes ocorridos. Dada a complexidade do processo em radioterapia, a busca pela qualidade do tratamento de forma a garantir a segurança do paciente é um dos assuntos mais discutidos mundialmente. Embora apenas 14% dos centros de radioterapia no Brasil ofereçam tratamentos com a técnica de radiocirurgia intracranial (SRS), estudos relativos a qualidade do tratamento relacionada a segurança do paciente submetido à esta técnica, é de relevante importância, pois qualquer desvio da dose prescrita é considerado muito mais crítico que em outras modalidades de tratamento radioterápico, já que são utilizadas altas doses de radiação que em geral variam de 10 Gy a 40 Gy para lesões até 50 mm de diâmetro, que são aplicadas em uma única fração ou até cinco frações. Tendo em vista tais conhecimentos, o objetivo deste trabalho foi atender um novo paradigma de Gestão da Qualidade, através do desenvolvimento de um modelo de análise de risco e de um Índice de Qualidade para a SRS no Brasil, a partir da técnica de Mapa do Processo e FMEA utilizadas pelo TG 100/AAPM. O trabalho foi desenvolvido em três centros de radioterapia de referência em alta tecnologia, dois localizados no Rio de Janeiro e um em São Paulo. Um Mapa do Processo de SRS foi identificado em cada centro de radioterapia e em seguida foi aplicada a técnica FMEA para todos os subprocessos identificados no mapa. A partir dos valores de NPR obtidos pela FMEA foi realizado um ranqueamento dos modos de falha. Modos de falha com NPR ≥ 100 e S ≥ 7 foram escolhidos como prioridade para implementação de estratégias de segurança. A partir das pontuações do parâmetro S atribuídas na aplicação da FMEA foi criado o Índice de Severidade (IS) e um Índice de Qualidade (IQ) foi criado a partir de uma relação entre o NPR e o IS. O resultado deste estudo, indica que as estratégias de segurança sejam implementadas para os 10 primeiros modos de falha do ranking e uma reavaliação do processo deve ocorrer a cada 1 ano. É também indicado que o IQ obtenha uma melhora mínima de 9% após a reavaliação do processo. De forma geral, o estudo mostrou que a adoção da ferramenta FMEA juntamente com o IQ são de fato justificadas, por minimizar os riscos para o paciente, melhorando a qualidade do tratamento aprimorando a segurança, criando mecanismos que permitam a garantia de que a dose será entregue de forma precisa e exata, e consequentemente, aumentando as chances de cura ou do controle local com uma desejada qualidade de vida para estes pacientes. / The reported events in radiotherapy that constitute accidents or incidents have increased worldwide in the last 25 years. Most of these events resulted from human failure and have happened in radiotherapy centers that use high technologies. The radiotherapy Quality Management needs a prospective approach through risk analysis. This approach is supported by recent publications as this actually extremely needed due the large number of accidents. Because of the complexity of the process in radiotherapy, the search for quality of care in order to ensure patient safety is one of the most discussed topics worldwide. Although only 14% of radiotherapy centers in Brazil offer treatments with intracranial radiosurgery technique (SRS), studies about the quality of care related to the safety of patients undergoing this technique is of great importance. Any deviations from the prescribed dose using SRS technique is considered more critical than in other methods of radiation treatment, as the delivered doses in SRS are higher, in the range of 10 Gy to 40 Gy, to lesions up to 50 mm in diameter, which are delivered in a single fraction or in five fractions. In view of those information, this work aims to satisfy the new Quality Management paradigm by developing a risk analysis model, and a Quality Index for SRS in Brazil, through the techniques of Process Map and FMEA used in the TG100/AAPM. The study was performed in three high technology reference radiotherapy centers, two located in Rio de Janeiro city and one in Sao Paulo city. A SRS Process Map was identified for each radiotherapy center, and then FMEA technique was applied in every subprocesses identified on the map. From NPR values obtained by the FMEA a ranking of failure modes was held. Failure modes with NPR ≥ 100 and S ≥ 7 were chosen as priority to implement safety strategies. From the scores assigned to the S parameter in the implementation of FMEA a Severity Index (SI) and a Quality Index (QI) were created from an association between the NPR and the SI. The result of this study indicates that safety strategies should be implemented for the first 10 failure modes of the ranking, and a new evaluation of the process should occur every year. In addition, it is also indicated that the QI shows a minimum improvement of 9 % after the re-evaluation of the process. Overall, the study showed that the adoption of the FMEA tool together with the QI are justified as they minimize the risks to the patient, improving the quality of care and enhancing the safety Taken together the FMEA and the QI create mechanisms for ensuring that the dose will be delivered more precisely and accurately, and consequently, this increases the chances of cure or local control of the tumor, improving quality of life of the patients.

A intensa competição no mercado global e as constantes mudanças nas exigências dos clientes têm feito com que muitas empresas repensem seus processos de negócios não somente para sobreviver, mas também para se manterem competitivas no mercado atual. O processo de desenvolvimento de produtos é um fator importante para qualquer empresa se manter competitiva neste cenário. A falta de um bom processo de desenvolvimento de produtos é sem dúvida uma grande desvantagem para uma empresa. Somente um bom processo de desenvolvimento não garante a vantagem competitiva das empresas, é necessário também que seus produtos sejam confiáveis e para que isto aconteça torna-se essencial desenvolver produtos com qualidade, através do uso disciplinado e constante de ferramentas de qualidade. Para ser competitivo um produto precisa ser desenvolvido com o mínimo de tempo, recursos e custo, para atender às necessidades de mercado. Algumas metodologias foram desenvolvidas e estas focam no desenvolvimento de um produto sempre pensando nas necessidades da manufatura, montagem, qualidade, confiabilidade e ciclo de vida do produto, evitando mudanças tardias no produto. Muitos estudos acadêmicos e industriais têm sido propostos nesta área. Cada empresa deve encontrar e se adaptar ao processo ou modelo mais adequado para ela dentro das suas necessidades técnicas e culturais. Este estudo apresenta uma metodologia a ser usada para melhorar a qualidade do produto e deve ser usada quando da fase conceitual onde se escolhem os melhores sistemas e/ou componentes para formar um novo produto final. / The intense competition in global market along with constant changes in customers demands have forced companies to re-think some of their business processes, not only to survive, but also to stay competitive on this market. The product development process is one of the key business processes for any company to stay competitive and global on this scenario. The lack of a good development process is with no doubt a big disadvantage for any company. Only a good development process does not guarantee a competitive advantage for anyone, it becomes necessary to have reliable products in the field and to make this happens it is vital to develop products with quality through the use of quality tools in a constant and disciplined way. To be competitive, a product needs to be designed in a minimum amount of time, with minimum resources and cost. To meet market needs some methodologies were developed thinking on manufacturing, assembly, quality, reliability and life cycle avoiding late product changes. Many studies academic and industrial have been proposed in this area. Each company has to find and adapt the most appropriate model that fits its technical and cultural needs. This research presents a methodology to be used to improve product quality during the early phases of development when systems and/or components are chosen for a new product.

Ett undersöknings- och utvecklingsarbete för att lösa ett problem med att dränkbara pumpar i ett vattenavrinningssystem gick sönder med perioder på två år i genomsnitt, utfördes i samarbete med Cementa AB i Skövde. Orsak till pumpars haveri söktes och fanns vara bristande rutiner och kunskap om det underhåll pumparna krävde. För att lösa detta problem utvecklades riktlinjer för nyinköp av torruppställda pumpar för att möjliggöra kontinuerligt underhåll. Då möjligheter för placering av torruppställd pump saknades utvecklades ett pumpfundament för placering av torruppställd pump. Krav för utvecklingsarbetet togs fram i samarbete med Cementas underhållsavdelning och teoretisk dimensionering av dränkbara länspumpars dåvarande volymflödeskapacitet utfördes. Krav utvärderades och viktades med hjälp av parvis jämförelse. Dimensionering och kontroll av hållfasthet för utvecklat pumpfundamentet utfördes med hjälp av Finita Element Analyser i programvaran Pro/Engineer Creo 1.0 Mechanica. Kontroll av hållfasthet i infästning av pumpfundamentet samt svetsfogar utfördes analytiskt. Arbetet resulterade i en rekommendation till Cementa AB i Skövde att ta in offerter på nya torruppställda pumpar med hjälp av utvecklade riktlinjer och att tillverka det pumpfundament som tagits fram inom ramen för examensarbetet, för att placera nya pumpar på. Att noggrant följa de underhållsinstruktioner som pumpar har och att underlätta för personal att utföra detta underhåll ansågs kunna bidra till att pumpar skulle få en längre och mer ekonomisk livslängd. / A development project to solve problems with why submersible pumps in a run-off system broke down with periods of two years, on average, was performed in collaboration with Cementa AB in Skövde. Reason for the pumps breakdowns was searched and found to be inadequate procedures and missing knowledge of the maintenance required on the pumps. To solve this problem, guidelines for the purchase of new dry pit pumps were developed to allow for continuous maintenance. As the possibilities of placing a dry well pump did not exist at Cementa, a pump foundation was developed. Requirements for the development work were produced in cooperation with Cementas maintenance department and theoretical dimensioning of the submersible bilge pumps volume flow capacity was performed. Requirements were evaluated and weighted using Pairwise comparison. The design and control of the strength of the developed pump foundation was performed using finite element analysis in the software Pro/Engineer Creo 1.0 Mechanica. Controls of the strength of the attachment of the pump foundation and welds were performed analytically. The work resulted in a recommendation to Cementa AB in Skövde to bring in quotes on the new dry-pit pumps using the developed guidelines and to manufacture the pump foundation developed within the framework of the thesis. Cementa was also recommended to carefully follow the maintenance instructions for pumps and make it easier for staff to perform this maintenance. This was recommended to ensure that new pumps would have a longer and more economical lifetime.