<p>Safety assessment is a rational and systematic process for assessing the risk associated with the usage of a product. While the safety assessment process is important even when making a simple product, the true importance of this process comes into light when designing for example an aircraft, where a failure could possibly lead to the loss of human lives. However,even though this process is vital for certain industries, it is plagued by a lack of tools. The existing tools are focused on specific parts of the process and do not make use of work done in earlier steps of the process which often means that the safety engineer needs to manually do work that could have been calculated automatically from information that is already present from an earlier step in the process.</p><p>This thesis shows that by creating a model of the product that can be present and augmented throughout every step in the process, many calculations that are currently done by hand can be automated or semi-automated by examining this shared model. The thesis proposes a specification for a modeling formalism that is simple enough to be used as early as the requirements phase of a project, but powerful enough to provide important information all the way throughout the safety assessment process.</p><p>The thesis also specifically shows how this model can be used to help in the creation and updating process of Failure Mode and Effects Analysis (FMEA) documents as a proof-of concept implementation based on Sörman Information AB’s product “Uptime BPC Standard”.Algorithms for synchronizing between the model and the FMEA representation, as well as algorithms for automatically calculating the next level effect and global level effect of failure modes based on the hierarchy and connections made in the model are also presented.</p><p>The prototype implementation shows that even though the entire safety assessment process cannot be automated it is possible to extract information from the model by analyzing its hierarchy and connections. While more work still needs to be done before the entire safety assessment process can be encompassed, the initial results shows that the proposed modeling formalism allows us to create models from which relevant information that can be used to support the safety assessment process can be calculated.</p>

Sammanfattning Detta examensarbete inom produkt- och processutveckling har genomförts på uppdrag av SMS Smart Media Solutions AB i Stockholm. Syftet med arbetet har varit att ta fram och utveckla ett stativ som ska kunna hålla upp till 4 stycken datorskärmar och som tillåter ergonomisk anpassning och användning. Under projektets gång har antalet skärmar utökats från 4 till 8 för att tillmötesgå uppkomna kund- och marknadskrav. Målet med examensarbetet har varit att ta fram en färdig prototyp som ska kunna ligga till grund för tillverkning av stativet. Under utvecklingsarbetet har verktyg som QFD, funktionsanalys, Ishikawa-diagram, Pugh’s jämförelsematris och FMEA använts för att säkerställa att kund-, marknads-, kvalitets och funktionskrav uppfylls. Arbetet inleddes med en idégeneringsfas som utmynnade i ett antal olika koncept. Koncepten utvärderades utifrån kravspecifikation, funktion, antal standardkomponenter och pris. Konceptet som ansågs starkast utvecklades till en prototyp vilken i sin tur testades och utvärderades. Resultatet av examensarbetet är att det utvecklade stativet är infört i SMS Smart Media Solutions’ produktportfolio och kommer att finnas med i SMS’ produktkatalog för 2010. Stativet motsvarar alla krav som satts upp i kravspecifikationen och alla problemen som definierats i problemformuleringen har lösts. / Abstract This thesis in product and process development has been made in cooperation with SMS Smart Media Solutions AB in Stockholm. The aim of the thesis has been to develop a new display bracket that can carry up to 4 monitors and that allows ergonomically adjustments and usage. During the project the amount of maximum monitors has been changed from 4 to 8 to meet the demand of the customers and the market. The goal of the thesis has been to develop a prototype that would be the ground of the future bracket that will be offered in SMS Smart Media Solutions’ product portfolio. To make sure that the developed bracket meets all the demands and criteria, tools like QFD, analysis of function, Ishikawa diagram, Pugh’s matrix and FMEA have been used. The process of the product development started with brainstorming and concept generation. The developed concepts were evaluated using analysis of requirements, costs, functions and the amount of used standard components. The winning concept was carried on into a prototype that was tested, evaluated and improved. The result of the thesis is that the developed bracket has been integrated to SMS Smart Media Solutions’ product portfolio and will be added to SMS’ product catalogue for 2010. The final bracket met all the criterions that were set in the specification of requirements and all the problems form the problem statement were solved.

Emergency Departments (ED) are highly dynamic environments comprising complex multi-dimensional patient-care processes. In recent decades, there has been increased pressure to improve ED services, while taking into account various aspects such as clinical quality, operational efficiency, and cost performance. Overcrowding has become a major barrier to receiving a proper and timely emergency care in many acute hospitals throughout the world. Patients often face long waiting times to be seen and treated. Those who require admission may even wait longer. The scope of this research is to focus on ED factors that lead to overcrowding and their management. Technology is being cited as one of the management tools, specifically the utilization of Radio Frequency Identification (RFID) for tracking patients as their journey progresses through an ED. Like any technology, RFID has potential and pitfalls. The author chose to use Failure Mode and Effect Analysis (FMEA) as a tool to explore the possible failures of RFID technology as it is utilized in one of the ED in Riyadh Military Hospital (RMH). This particular ED has been used as a case study to explore those failures and, with the use of FMEA, propose a set of recommendations to address those failures and improve the design and implementation of RFID. The experience of RMH-ED was explored through interviews and a survey in which 100 participants took part. The survey touched upon various aspects of this experience. This was due to the various roles of the surveyed staff who were involved with this technology. These roles ranged from front line clinical staff to administrative staff, management staff and technical support staff. Data analysis showed convincing evidence of the positive impact RFID had on managing ED overcrowding. However, and as expected, there are some pitfalls and failures that FMEA helped identifying and suggested potential solutions to them. RFID is a small link in the chain of other technological innovations and solutions. It is by no means capable of solving the problems associated with ED overcrowding by itself. Most of the search carried out by the author identified large variation in approaches to dealing with the issue of ED overcrowding. Those ranged from applying more human resources to altering the pathways of managing patients journey through healthcare system to applying more intermediate layers of management to ease the pressure of the Emergency departments. Other approaches included some aspects of technology such as development of early warning systems that have not been widely adopted and remained as isolated efforts.

The goal of every program or project manager is to have a safe reliable product and to have an understanding of the residual risk of operating that product. Two very important systems engineering analysis tools to achieve those objectives are Hazard Analysis and Failure Modes and Effects Analysis. Sometimes seen strictly as Safety and Reliability tasks, these analyses are key to a successful program or project and require input from all stakeholders. When viewed in the Systems Engineering process, Safety and Reliability are truly specialty disciplines within Systems Engineering. Hazard Analysis is used to improve system safety while Failure Modes and Effects Analysis is used to identify ways to increase product reliability; both analyses are required to improve systems design and fully capture the risk for a system or program. Depending on how the analyses are scoped, there could be a perception of overlap and duplication of effort. This paper will present a systems engineering approach to show the need and benefits for performing both types of analyses. Both analysis processes are required to ensure that all possible hazardous conditions and failure modes have been identified and addressed to minimize overall risk to the program/project and to ensure a safe and reliable system. / text

I denna rapport behandlas verktyget FMEA (Failure Mode Effect Analysis), dess användning och genomförande på identifierade komponenter som ingår i elmotorer tillverkade hos ABB LV Motors i Västerås. Målet med detta arbete har varit att ge lärdom om metoden FMEA på företaget för att möjliggöra användandet av verktyget bland medlemmarna på företaget och att vi implementerar verktyget på befintlig motor för att analysera de felsätt som kan uppstå. Eftersom ABB just nu har ett pågående projekt med en ny motor kan våra slutgiltiga felanalyser även ge dem information om vilka ändringar och åtgärder som kan vara till nytta vid utformningen av den nya motorn. Efter två veckors praktik i verkstan och en grundlig genomgång av företagets reklamationer kunde vi avgränsa arbetet genom att identifiera de komponenter som analyserna skulle genomföras på. Efter en genomgång tillsammans med våra handledare på företaget kom vi fram till att utföra våra analyser på fem komponenter, två av dem framstod som mycket kritiska som upptäcktes redan vid genomgång av reklamationerna. Komponenterna som vi har analyserat är: 1. Lager 2. Lindning 3. Tätning av uttagslåda och uttagslock 4. Fötter 5. Sköldar Lager som är den näst största kritiska komponent som vi tittat på är en del i motorn som är väldigt känslig, det är viktigt att följa instruktioner för underhåll och smörjning för att undvika för tidiga lagerskador. Lindningen är klart den mest kritiska komponenten i våra analyser, detta är för att det är så mycket som spelar in lindningens funktion, koppartrådar, isoleringar, impregnering samt under själva processen kan det uppstå felsätt som påverkar lindningen negativt både direkt men även i ett senare skede då motorn är i drift. Tätning av uttagslåda och lock beskriver de felsätt som kan uppstå då tätningen inte är effektiv och tät, vad som kan hända då det kommer in smuts och fukt och hur det eventuellt kan påverka plint eller andra elektriska applikationer. Felanalysen på fötter och sköldar behandlar mycket designfel, toleransfel och hur det påverkar komponenterna. I rapporten beskrivs utförligt komponenternas funktioner, processer, underhåll samt det är i princip vad vi har kommit fram till i våra felanalyser fast vi i rapporten beskriver det mer utförligt. Efter beskrivning av varje komponent följer ett FMEA för respektive komponent och de FMEA:n är våra resultat av arbetet, där visas åtskilliga felsätt som är möjliga att uppstå hos varje komponent och även vilka felsätt som är mest kritiska att ta itu med. / In this report we discuss the tool, FMEA (Failure Mode Effect Analysis), we look at its usage and realization on identified components that are included in electrical motors made at ABB LV Motors in Västerås. Our goals with this work have been to give knowledge about the method FMEA to the company so they can learn to use this tool and for us to implement the tool on an existing application to analyze the failures that can occur. Since ABB have a project ongoing with a new motor our analyses can also give them input on what changes and actions to take on the new motor. After two weeks training in the workshop and a thorough survey of the companys warranty claims we could define our work by identifying which components we would survey our analyses on. After a run through with our instructors at the company we draw the conclusion to survey our work on five components, which there are two components that are very critical that we discovered during our information collection with the warranty claims. The analyzed components are: 1. Bearing 2. Winding 3. Sealing of terminal box and terminal cap. 4. Motor feet’s 5. Shields Bearing which is after the winding the most critical component, it is a sensitive part and it is very important to follow instructions for maintenance and lubrication to avoid early bearing damages. Winding is the clearest most critical component in our analyzes, this is because there is many parts that plays role in the windings function, copper wires, isolations, impregnation and during the process you can have failures that affect the winding in a negative way immediately but also in a later phase when the motor is running. Sealing of the terminal box and cap describes those failures that can occur when the sealing is not effective and compact, and what happens is that you get dirt and damp in to the box and how it possibly can affect the connection box and other electrical applications. The failure analyze on feets and shields deals with design faults, tolerance faults and how it affects the components. In the report we describe the functions of the components, processes, maintenance and that is in general what we have in our FMEA analyses, however in the report we describe it more thoroughly. After the description of every component we have the FMEA of respective component attached. The FMEA analyses are our results in this work, in the analyses we show many possible failures at each component and also which failures are most critical to deal with.

Neonatal Intensive Care Unit (NICU) patients present unique patient identification challenges. Prospective hazard analysis (PHA) assesses safety by identifying hazards before an adverse event occurs. This project analyzes a barcoded feeding process in one NICU, and conducts a preliminary evaluation of PHA methods. Observations were conducted to quantify patient identification methods used in one NICU; the unit’s barcoded feeding process was examined for potential failures. The process underwent PHA with two methods, Global Hazard Ratings (GHR), a simplified method developed for this project, and Failure Modes and Effects Analysis (FMEA). FMEA showed greater interrater reliability; there was poor agreement between methods. A list of 21 hazards was developed for the clinical team from the FMEA results. Recommendations are for the unit to formulate and implement mitigation strategies for the identified hazards. Future work involves a more in depth look at FMEA interrater reliability and reliability comparison with other PHA methods.

Estágio realizado na Sakthi Portugal, SA, e orientado pela Eng. Helena Coimbra / Tese de mestrado integrado. Engenharia Metalúrgica e de Materiais. Universidade do Porto. Faculdade de Engenharia. 2010

A biological assay is designed to set up a rapid and robust drug-screening system on a small scale. An assay is considered as a single unit of a platform to screen various compounds for aiding in drug discovery. Each assay is carried out in a 96-well plate, each of whose wells consists of the biological component called the Spheroids. The value of each assay lies in it facilitating for versatile screening applications. The spheroid is considered as a micro-structural product. And the addition of various compounds for testing is performed in each well (consisting of the spheroids). The focus has been to put forth the production principles and validation strategies to run the biological assay and test its efficacy to be used for screening in high volumes. The assay development illustrates processing and validation techniques. The goal is to develop optimized standards to process the assay, addressing various quality control issues, from the raw material to the end-product stage. Such an approach also brings interesting analogies of biological process in a manufacturing scenario. The developed system incorporates a value stream approach, by pulling the product from the customer end. The process involves simply encapsulating HUVECs (Human Umbelical Vein Endothelial cells) from the raw material stage, culturing to form the spheroid and transferring the component to assemblage in a 96-well format undergoing stages of heat treatments. The small scale screening system allows the use of small amounts of drug, which is especially essential for new drug synthesis or in rapid decision making to find out any unknown potent compounds. The design of optimal processes in product development of the spheroid assay is illustrated. Thus in light of the value of this assay, developing the production system has been pivotal so as to produce quality spheroids in the 96-well plate formats. The quantification of the stimulatory and inhibitory effects of the different agents is required to help understand the complex biological behavior involved. The goal is to validate the data using image analysis software. The image analysis helps determine the quantification to be accurate, objective, and consistent. The quality of the product is tested by the reproducibility and robustness of the assay.

Volvo Cars Corporation (VCC) is devoted to Lean and Six Sigma, and has lately considered an imple-mentation of Design for Manufacturing and Assembly (DFMA) with the purpose of improving their product design process and production. The goal for this project work is therefore to investigate if DFMA is a beneficial method for VCC to use, how DFMA can be used and suggest a DFMA method. A literature study is performed as a starting point to understand DFMA methods and its possibilities. Scientific articles, technical books and online sources is used during the study in order to gather in-formation regarding DFMA implementations, application areas, approaches and potential risks that need to be eliminated for a successful implementation. In order to map the product development and manufacturing processes of VCC interviews are per-formed. The interviews also gathered information regarding what VCC employees thinks of DFMA and how they wish to use it. This information is compiled into a demand specification where the de-mands are weighted after importance by the interviewees. After the pre-study, three idea generation sessions is performed with three different focus groups. The generated ideas are then evaluated and classified. The remaining ideas are classified with the purpose of enabling the possibility to use a morphological chart to build whole concepts from the single ideas. Three concepts are chosen amongst the generated concepts. These concepts are then evaluated against the weighted demand specification. The concept considered most suitable is further devel-oped which resulted in a proposed DFMA method for VCC. A case study on a product is performed in order to communicate, test and evaluate the final DFMA method. The project is rounded off with discussions regarding DFMA and the suggested method from sustain-ability point of view and how to motivate usage. All results and discussions from the project are handed over to the company, enabling further research on a possible implementation of DFMA in the organization. / Volvo Cars Corporation arbetar hängivet efter metoderna Lean och Sex Sigma och har avsikt att im-plementera Design for Manufacturing and Assembly (DFMA) i syfte att förbättra deras produkt- och produktutvecklingsprocess. Målet med detta arbete är att undersöka om DFMA är en värdefull me-tod för VCC att använda och hur metoden kan tänkas användas och implementeras inom organisat-ionen. Som utgångspunkt för att förstå DFMA metoden och dess möjligheter genomförs en litteraturstudie. Under studien granskades aktuella vetenskapliga artiklar, tekniska böcker och webbkällor i syfte att samla information om DFMA-implementeringar, användningsområden, tillvägagångsätt och potenti-ella risker som behövs elimineras för en lyckad implementation av metoden. Vidare utförs intervjuer i syfte att kartlägga produktutvecklings- och tillverkningsprocessen samt samla information om hur anställda ställer sig till, och önskar använda DFMA. Denna information sammanställs sedan till en kravspecifikation där kraven i sin tur viktas av intervjuobjekten efter hur viktiga de anses vara. Tre idégenereringssessioner utförs därefter med tre olika fokusgrupper. Dessa idéer gallras sedan ut och klassificeras för att sedan kombineras med hjälp av en morfologisk tabell i syfte att bygga kon-cept av de enskilda idéerna. Tre koncept väljs ut bland de genererade koncepten. Dessa koncept utvärderas sedan mot varandra med kravspecifikationen som bedömningsskala. Det koncept som bedöms som mest lämpligt vidare-utvecklas och en föreslagen metod för VCC tas fram. För att testa och illustrera den slutgiltiga meto-den genomförs en fallstudie på en produkt. Arbetet rundas av med diskussioner kring DFMA och den föreslagna metoden ur både hållbarhets-synpunkt och motivationssynpunkt. Samtliga resultat och diskussioner överlämnas sedan till företa-get för att möjliggöra vidare undersökningar kring en eventuell implementation av DFMA. / DFMA FMEA DFM DFA Lean Produktdesign Metodutveckling

Kriminalvården är den myndighet i Sverige som ansvarar för fängelser, häkten och frivård. Myndigheten har länge känt ett behov att inom flera verksamheter kunna få tillgång till delmängder av deras klientsystem i ett mobilt och uppkopplat format. Det största hindret i deras fall med mobilitet och applikationsteknik var säkerheten. Därför genomfördes en riskanalys med hänsyn till frivården och mobilapplikationsteknik. För att välja en lämplig och passande riskanalysmetod jämförde vi ett antal metoder. Det visade sig att metoden CORAS passade bäst. När vi väl genomfört riskanalysen med CORAS försökte vi sedan matcha åtgärderna mot de olika mobilplattformarnas egenskaper för att se hur de kan fullfölja åtgärderna. Mobilplattformarna vi undersökte var Android, Windows Phone 8 och iOS. Resultatet av riskanalysen och jämförelsen av plattformar kan ligga som grund till beslut hos Kriminalvården. / Kriminalvården is the government agency in Sweden which is responsible for prisons, jails and probation. The agency has realized a need of access to a several features of their inmate register systems from mobiles and handsets within different areas in their organization. The safety with the mobility and application technology is a comprehensive issue in this case. Therefore, a risk analysis about mobile application technology was initiated. We took the probation services into account as a concrete scenario where mobile application technology could be used. In order to select an appropriate and adequate risk analysis method, we compared a number of methods. It turned out that the method CORAS was the most suitable method. When we completed the risk analysis with CORAS, we tried to match the treatments against different mobile platforms properties to see how they can pursue the treatments. Mobile platforms we examined were Android, Windows Phone 8 and iOS. The result of the risk analysis and the comparison of mobile platforms can the agency use as a basis for further decisions.