Tuotantolaitteiden kvalifiointi ja prosessin validointi GMP-tuotantoa varten

GMP-säädösten mukaan aktiivisten lääkeaineiden, kriittisten lääkeaineintermediaattien ja lääkeapuaineiden valmistusprosessit pitää validoida. Validointityöhön kuuluu oleellisesti tuotantolaitteiden kvalifiointi ja prosessin validointi. Käytännössä tuotantolaitteiden kvalifiointi toteutetaan tekemällä laitteille suunnitelmien tarkastus (DQ), asennus- ja käyttöönottotarkastus (IQ), toiminnan testaus (OQ) sekä suorituskykytestit (PQ). Tuotantolaitteiden kvalifiointiin kuuluu myös laitteiden asianmukaisten kalibrointi-, kunnossapito- ja puhdistusohjeiden sekä työ- ja toimintaohjeiden (SOP:ien) laatiminen. Prosessin validoinnissa laaditaan dokumentoidut todisteet siitä, että prosessi toimii vakaasti ja tuotteelle asetetut vaatimukset täyttyvät johdonmukaisesti. GMP-tuotantolaitteiden kvalifiointiin ja lääkevalmistusprosessin validointiin on laadittu erilaisia GMP-säädöksiä noudattavia yleisiä validointiohjeita, kuten PIC/S:n ja FDA:n ohjeet kvalifioinnista ja validoinnista. IVT/SC on laatinut yksiselitteiset validointistandardit validointityön selventämiseksi. Validoinnin tilastolliseen tarkasteluun on käytettävissä GHTF:n laatimat tilastolliset validointimenetelmät. Yleensä tuotantolaitteiden kvalifiointi ja prosessin validointi tehdään ennen lääkevalmisteen kaupallisen tuotannon aloittamista. Kvalifiointi- ja validointityö voidaan tehdä kuitenkin myös tuotannon yhteydessä (konkurrentisti) tai retrospektiivisesti käyttäen hyväksi valmistettujen tuotantoerien prosessitietoja. Tässä työssä laadittiin Kemira Fine Chemicals Oy:n Kokkolan GMP-tuotantolinjan lääkeaineintermediaattiprosessin validoinnin yleissuunnitelma (VMP), joka sisältää sekä tuotantolaitteiden kvalifiointisuunnitelman että prosessin validointisuunnitelman. Suunnitelmissa huomioitiin tuotantolaitteiden aikaisempi käyttö muuhun hienokemikaalituotantoon ja tuotantolinjan muuttaminen GMP-vaatimusten mukaiseksi. Työhön kuului myös tuotantolaitteiden kvalifiointityön tekeminen laaditun suunnitelman mukaisesti.

Representations of work and worker in the three generations of knowledge management. Critical Discourse Analysis of selected texts.

The thesis studies the representations of different elements of contemporary work as present in Knowledge Management (KM). KM is approached as management discourse that is seen to affect and influence managerial practices in organizations. As representatives of KM discourse four journal articles are analyzed, using the methodology of Critical Discourse Analysis and the framework of Critical Management Studies, with a special emphasis on the question of structure and agency. The results of the analysis reveal that structural elements such as information technology and organizational structures are strongly present in the most influential KM representations, making their improvement also a desirable course of action for managers. In contrast agentic properties are not in a central role, they are subjugated to structural constraints of varying kind and degree. The thesis claims that one such constraint is KM discourse itself, influencing managerial and organizational choices and decision making. The thesis concludes that the way human beings are represented, studied and treated in management studies such as KM needs to be re-examined. Pro gradu-tutkielmassa analysoidaan työhön ja sen tekijään liittyviä representaatioita Tietojohtamisen kirjallisuudessa. Tietojohtamista tarkastellaan liikkeenjohdollisena diskurssina, jolla nähdään olevan vaikutus organisaatioiden päätöksentekoon ja toimintaan. Tutkielmassa analysoidaan neljä Tietojohtamisen tieteellistä artikkelia, käyttäen metodina kriittistä diskurssianalyysiä. Tutkielman viitekehyksenä on kriittinen liikkeenjohdon tutkimus. Lisäksi työssä pohditaan kysymystä rakenteen ja toimijan välisestä vuorovaikutuksesta. Tutkielman analyysi paljastaa, että tietojohtamisen vaikutusvaltaisimmat representaatiot painottavat rakenteellisia tekijöitä, kuten informaatioteknologiaa ja organisaatiorakenteita. Tämän seurauksena mm. panostukset em. tekijöihin nähdään organisaatioissa toivottavana toimintana. Vastaavasti representaatiot jotka painottavat yksilöitä ja toimintaa ovat em. tekijöille alisteisessa asemassa. Tapaa, jolla yksilöitä kuvataan ja käsitellään Tietojohtamisen diskurssissa, tulisikin laajentaa ja monipuolistaa.

Sähkösuunnittelun projektityön hallinta ja kehittäminen - Management and development of project work in electrical

Työssä on tutkittu sähkösuunnittelun projektityön hallintaa ja kehittämistä. Tavoitteena oli löytää ongelmia ja pyrkiä korjaamaan niitä, jotta suunnittelu olisi mahdollisimman toimivaa. Tutkimus perustuu kirjallisuuteen ja haastatteluihin. Työssä perehdytään kirjallisuuden avulla projektin peruskäsitteisiin ja hallintaan sekä sähkösuunnittelun projektin yleiseen toteutukseen. Haastattelujen avulla on selvitetty tämän hetkistä tilannetta sähkösuunnitteluprojektin hallinnasta ja siihen liittyvistä ongelmista Pöyryn Kouvolan konttorissa. Työn tuloksena on selvitetty merkittävimpiä ongelmia, jotka esiintyvät sähkösuunnitteluprojektissa. Työ keskittyy pääosin sähkösuunnitteluprojektin hallinnallisiin ongelmiin ja niiden toteutukseen. Kirjallisuuden ja haastattelujen pohjalta on koottu ohjeita sähkösuunnittelun projektinhallintaan

The effects of ICT on school: teachers’ and students’ perspectives

The purpose of this study was to investigate the effects of information and communication technology (ICT) on school from teachers’ and students’ perspectives. The focus was on three main subject matters: on ICT use and competence, on teacher and school community, and on learning environment and teaching practices. The study is closely connected to the national educational policy which has aimed strongly at supporting the implementation of ICT in pedagogical practices at all institutional levels. The phenomena were investigated using a mixed methods approach. The qualitative data from three cases studies and the quantitative data from three statistical studies were combined. In this study, mixed methods were used to investigate the complex phenomena from various stakeholders’ points of view, and to support validation by combining different perspectives in order to give a fuller and more complete picture of the phenomena. The data were used in a complementary manner. The results indicate that the technical resources for using ICT both at school and at homes are very good. In general, students are capable and motivated users of new technology; these skills and attitudes are mainly based on home resources and leisuretime use. Students have the skills to use new kinds of applications and new forms of technology, and their ICT skills are wide, although not necessarily adequate; the working habits might be ineffective and even wrong. Some students have a special kind of ICT-related adaptive expertise which develops in a beneficial interaction between school guidance and challenges, and individual interest and activity. Teachers’ skills are more heterogeneous. The large majority of teachers have sufficient skills for everyday and routine working practices, but many of them still have difficulties in finding a meaningful pedagogical use for technology. The intensive case study indicated that for the majority of teachers the intensive ICT projects offer a possibility for learning new skills and competences intertwined in the work, often also supported by external experts and a collaborative teacher community; a possibility that “ordinary” teachers usually do not have. Further, teachers’ good ICT competence help them to adopt new pedagogical practices and integrate ICT in a meaningful way. The genders differ in their use of and skills in ICT: males show better skills especially in purely technical issues also in schools and classrooms, whereas female students and younger female teachers use ICT in their ordinary practices quite naturally. With time, the technology has become less technical and its communication and creation affordances have become stronger, easier to use, more popular and motivating, all of which has increased female interest in the technology. There is a generation gap in ICT use and competence between teachers and students. This is apparent especially in the ICT-related pedagogical practices in the majority of schools. The new digital affordances not only replace some previous practices; the new functionalities change many of our existing conceptions, values, attitudes and practices. The very different conceptions that generations have about technology leads, in the worst case, to a digital gap in education; the technology used in school is boring and ineffective compared to the ICT use outside school, and it does not provide the competence needed for using advanced technology in learning. The results indicate that in schools which have special ICT projects (“ICT pilot schools”) for improving pedagogy, these have led to true changes in teaching practices. Many teachers adopted student-centred and collaborative, inquiry-oriented teaching practices as well as practices that supported students' authentic activities, independent work, knowledge building, and students' responsibility. This is, indeed, strongly dependent on the ICT-related pedagogical competence of the teacher. However, the daily practices of some teachers still reflected a rather traditional teacher-centred approach. As a matter of fact, very few teachers ever represented solely, e.g. the knowledge building approach; teachers used various approaches or mixed them, based on the situation, teaching and learning goals, and on their pedagogical and technical competence. In general, changes towards pedagogical improvements even in wellorganised developmental projects are slow. As a result, there are two kinds of ICT stories: successful “ICT pilot schools” with pedagogical innovations related to ICT and with school community level agreement about the visions and aims, and “ordinary schools”, which have no particular interest in or external support for using ICT for improvement, and in which ICT is used in a more routine way, and as a tool for individual teachers, not for the school community.

Performance and Methodological Aspects in Positron Emission Tomography

Performance standards for Positron emission tomography (PET) were developed to be able to compare systems from different generations and manufacturers. This resulted in the NEMA methodology in North America and the IEC in Europe. In practices, the NEMA NU 2- 2001 is the method of choice today. These standardized methods allow assessment of the physical performance of new commercial dedicated PET/CT tomographs. The point spread in image formation is one of the factors that blur the image. The phenomenon is often called the partial volume effect. Several methods for correcting for partial volume are under research but no real agreement exists on how to solve it. The influence of the effect varies in different clinical settings and it is likely that new methods are needed to solve this problem. Most of the clinical PET work is done in the field of oncology. The whole body PET combined with a CT is the standard investigation today in oncology. Despite the progress in PET imaging technique visualization, especially quantification of small lesions is a challenge. In addition to partial volume, the movement of the object is a significant source of error. The main causes of movement are respiratory and cardiac motions. Most of the new commercial scanners are in addition to cardiac gating, also capable of respiratory gating and this technique has been used in patients with cancer of the thoracic region and patients being studied for the planning of radiation therapy. For routine cardiac applications such as assessment of viability and perfusion only cardiac gating has been used. However, the new targets such as plaque or molecular imaging of new therapies require better control of the cardiac motion also caused by respiratory motion. To overcome these problems in cardiac work, a dual gating approach has been proposed. In this study we investigated the physical performance of a new whole body PET/CT scanner with NEMA standard, compared methods for partial volume correction in PET studies of the brain and developed and tested a new robust method for dual cardiac-respiratory gated PET with phantom, animal and human data. Results from performance measurements showed the feasibility of the new scanner design in 2D and 3D whole body studies. Partial volume was corrected, but there is no best method among those tested as the correction also depends on the radiotracer and its distribution. New methods need to be developed for proper correction. The dual gating algorithm generated is shown to handle dual-gated data, preserving quantification and clearly eliminating the majority of contraction and respiration movement

Improving the effectiveness of supply chain development work – an expert role perspective

This study focuses to the intersection of three sets of activities in a company: expert work, development work and supply chain management, SCM. Experts and expert work represent a set of individuals whose efficiency and impact this study is intended to improve, while development work defines the set of organizational activities to focus on. SCM as an expertise area acts as the platform on which this study is built. The study has two aims. Firstly, it aims to derive a model helping an SCM expert to increase the effectiveness of expert work in development tasks by understanding the encountered organizational situations and processes better, reflecting his/her past and future actions to organizational processes and selecting and adjusting the processes and contents of his/her work accordingly. Secondly, it aims to develop applicable approaches and methods to understand, evaluate and manage the organizational processes and situations in development work. The integrative model on approaches and methods to improve the effectiveness of development processes is split to two aggregate dimensions: technical performance of the developed solution and consumption of resources of the development process. Six potential approaches and methods aiming at helping in the management of organizational dimensions are presented in enclosed publications. The approaches focus on three subtasks of development work: decision making, implementation and change, and knowledge accumulation. The approaches and methods have been tested in case studies representing typical development processes in the area of supply chain management. As a result, four suggestions are presented. Firstly, SCM experts are advised to consider the SCM development work to be consisting of development processes. Secondly, inside these processes they should identify and evaluate the risk of difficult decision-making related to organizational factors. Thirdly, they are prompted for an active role in implementation and change, supporting the implementation through whole process. Finally, the development should be seen in a holistic view, taking into account the stage of knowledge and organizational issues related to it, and adopt a knowledge development strategy.

Cumulative Costs of Caries Prevention and Treatment in Children - with Special Reference to Work Division and Cohort Effect

Lapsen karieshoidon kustannuskertymän muutokset ja karieshoidon toimintakäytäntöjen yhteys kustannuksiin Tutkimuksen tavoitteena oli mitata terveyskeskuksessa hoidettavien lasten karieshoidon kumulatiivisia kustannuksia ja verrata niitä kahden erilaisen toimintatavan välillä. Lisäksi tarkasteltiin lasten hampaiden terveyttä. Tutkimus tehtiin julkisen palvelutuottajan näkökulmasta. Tutkimusaineisto kerättiin Kemin ja Tornion terveyskeskusten suun terveydenhuollon potilaskertomuksista. Kemin kohortit 1980, 1983 ja 1986 (n = 600) ja Tornion kohortit 1980 ja 1992 (n = 400) edustivat perinteistä ja Kemin kohortit 1989, 1992 ja 1995 (n = 600) uutta toimintatapaa työnjaon ja ehkäisyn ajoituksen suhteen. Kohortteja ja kaupunkeja verrattiin hampaiden terveyden (dmft/DMFT = 0 ja dmft ja DMFT keskiarvot 5 ja 12 vuoden iässä) ja voimavarojen käytön suhteen. Panoskäyttö johdettiin käyntimäärien avulla laskennallisen työajan kautta. Kustannuskertymät muodostettiin käyttämällä henkilöstömenoista laskettuja suorittajakohtaisia yksikkökustannuksia. Panoskäytön ja yksikkökustannusten kautta muodostettiin kustannuskertymät. Kustannusten ja terveysvaikutusten suhteita arvioitiin kustannus-vaikuttavuusanalyysissä. Suuhygienistien työpanosta hyödyntävällä varhaisen ehkäisyn toimintamallilla saavutettiin vähäisemmin kustannuksin alle kouluiässä parempi ja kouluiässä yhtä hyvä hammasterveys kuin perinteisellä, enemmän hammaslääkärien työpanokseen perustuvalla tavalla. Karieksen hoitoon liittyvien käyntien määrä oli nuorimmissa syntymävuosikohorteissa pienempi kuin vanhimmissa kohorteissa. Käynnit hammaslääkärissä vähenivät eniten. Toimintatavalla oli merkittävä vaikutus lapsen karieshoidon kokonaiskustannuksiin. Herkkyysanalyysin mukaan karieshoidon kustannukset olivat työnjakoa hyödyntämällä kolmanneksen pienemmät, kuin jos hoidon suorittajana olisi ollut ainoastaan hammaslääkäri-hoitaja työpari. Lasten karieshoidon kustannusvaikuttavuus kohentui molemmissa terveyskeskuksissa nuoremmissa kohorteissa vanhempiin verrattuna. Suun terveydenhuollon potilaskertomuksia olisi hyödynnettävä toiminnan kehittämisessä. Varhaisen ehkäisyn avulla voitaisiin kaikkien suun terveydenhuollon ammattihenkilöiden työpanos kohdentaa kustannustehokkaasti.

Factors Affecting Consumer’s Illicit Purchase of Copyrighted Digital Work

Peer-to-Peer (P2P) technology has revolutionized file exchange activities besides enhancing processing power distribution. As such, this technology which is nowadays made freely available to all internet users also imposes a threat as it enables the illegal distribution of copyrighted digital work. P2P technology continuously evolves in a greater pace than copyright legislation, leading to compatibility gaps between the applicability of copyright law and the illicit file sharing and downloading. Such issues give high incentives to consumers to practise piracy using P2P systems with a low perception of risk towards prosecution, leading to substantial losses for copyright owners. This study focuses on developing insights for content owners on consumer behaviour towards piracy in Finland, where quantitative analyses are assessed using a data set based on a survey conducted by the Helsinki Institute for IT. The research approach investigates the significance of three fundamental areas in relation to evaluate consumer behaviour as: environmental-related factors, innovation-related factors and consumer-related. each of these are integrates concepts derived in previous theoretical models such as the technology acceptance model, theory of reasoned action, theory of planned behaviour, the issue-risk-judgement model and the Hunt & Vitell’s model.

Determining risk potential through accidents and near-accidents: an empirical study in a steel factory

Fatal and permanently disabling accidents form only one per I cent of all occupational accidents but in many branches of industry they account for more than half the accident costs. Furthermore the human suffering of the victim and his family is greater in severe accidents than in slight ones. For both human and economic reasons the severe accident risks should be identified befor injuries occur. It is for this purpose that different safety analysis methods have been developed . This study shows two new possible approaches to the problem.. The first is the hypothesis that it is possible to estimate the potential severity of accidents independent of the actual severity. The second is the hypothesis that when workers are also asked to report near accidents, they are particularly prone to report potentially severe near accidents on the basis of their own subjective risk assessment. A field study was carried out in a steel factory. The results supported both the hypotheses. The reliability and the validity of post incident estimates of an accident's potential severity were reasonable. About 10 % of accidents were estimated to be potentially critical; they could have led to death or very severe permanent disability. Reported near accidents were significantly more severe, about 60 $ of them were estimated to be critical. Furthermore the validity of workers subjective risk assessment, manifested in the near accident reports, proved to be reasonable. The studied new methods require further development and testing. They could be used both in routine usage in work places and in research for identifying and setting the priorities of accident risks.

The effects of social networks on work-team effectiveness

This is a study of team social networks, their antecedents and outcomes. In focusing attention on the structural configuration of the team this research contributes to a new wave of thinking concerning group social capital. The research site was a random sample of Finnish work organisations. The data consisted of 499 employees in 76 teams representing 48 different organisations. A systematic literature review and quantitative methods were used in conducting the research: the former primarily to establish the current theoretical position on the relationships among the variables and the latter to test these relationships. Social network analysis was the primary method used in identifying the social-network relations among the work-team members. The first and key contribution of this study is that it relates the structuralnetwork properties of work teams to behavioural outcomes, attitudinal outcomes and, ultimately, team performance. Moreover, it shows that addressing attitudinal outcomes is also important in terms of team performance; attitudinal outcomes (team identity) mediated the relationship between the team’s performance and its social network. The second contribution is that it examines the possible antecedents of the social structure. It is thus one response to Salancik’s (1995) call for a network theory in that it explains why certain network characteristics exist. Itdemonstrates that irrespective of whether or not a team is heterogeneous in terms of age or gender, educational diversity may protect it from centralisation. However, heterogeneity in terms of gender turned out to have a negative impact on density. Thirdly, given the observation that the benefits of (team) networks are typically theorised and modelled without reference to the nature of the relationships comprising the structure, the study directly tested whether team knowledge mediated the effects of instrumental and expressive network relationships on team performance. Furthermore, with its focus on expressive networks that link the workplace to a more informal world, which have been rather neglected in previous research, it enhances knowledge of teams andnetworks. The results indicate that knowledge sharing fully mediates the influence of complementarities between dense and fragmented instrumental network relationships, thus providing empirical validation of the implicit understanding that networks transfer knowledge. Fourthly, the study findings suggest that an optimal configuration of the work-team social-network structure combines both bridging and bonding social relationships.

Learning Robot Motions from Visual Sensing

Learning from demonstration becomes increasingly popular as an efficient way of robot programming. Not only a scientific interest acts as an inspiration in this case but also the possibility of producing the machines that would find application in different areas of life: robots helping with daily routine at home, high performance automata in industries or friendly toys for children. One way to teach a robot to fulfill complex tasks is to start with simple training exercises, combining them to form more difficult behavior. The objective of the Master’s thesis work was to study robot programming with visual input. Dynamic movement primitives (DMPs) were chosen as a tool for motion learning and generation. Assuming a movement to be a spring system influenced by an external force, making this system move, DMPs represent the motion as a set of non-linear differential equations. During the experiments the properties of DMP, such as temporal and spacial invariance, were examined. The effect of the DMP parameters, including spring coefficient, damping factor, temporal scaling, on the trajectory generated were studied.

Mission and development : Finnish Pentecostal, Lutheran and Orthodox mission agencies in development work in Kenya 1948 - 1989

År 1974 började den finska regeringen kanalisera pengar för utvecklingssamarbete genom medborgarorganisationer. Tre år senare och fram till år 1988 beviljade regeringen ett speciellt anslag specifikt för missionsorganisationers utvecklingsprojekt. De finska pingstvännerna, lutheranerna och de ortodoxa utvidgade samtliga sitt sociala arbete i Kenya med statens stöd. Deras projekt var likadana: alla byggde läroanstalter, utvecklade Kenyas hälsoservice och sysselsatte kenyaner. Olikheterna mellan pingstvännerna, lutheranerna och de ortodoxa blev tydliga genom diverse problem som de mötte inom ramen för utvecklingssamarbetet. Den finska pingströrelsen bestod av självständiga församlingar, och pingstvännerna måste omvandla sin takorganisation, Suomen Vapaa Ulkolähetys, så att utvecklingsprojekt blev en viktig gren av dess verksamhet. Lutheranerna som till en början hade sänt missionärer för att arbeta i den kenyanska kyrkans tjänst började i medlet av 1970-talet i ökande grad bygga sociala anstalter med statens pengar. Ett problem var att statens stöd varade endast för en begränsad tid och att den lutherska kyrkan i Kenya inte hade råd att överta dessa anstalter och täcka deras löpande kostnader i framtiden. De finska ortodoxa, för sin del, igångsatte sociala projekt i samarbete med de ortodoxa i Kenya. Under några år fick de dock lära sig att de inte kunde driva självständiga utvecklingsprojekt i Patriarkens i Alexandria maktsfär. Den finska ortodoxa missionen blev tvungen att underkasta sig ärkebiskopen i Nairobi. År för år beviljade den finska regeringen större anslag för missionsorganisationernas utvecklingsprojekt och statens ansvar för kostnaderna ökade från 50% till 60% år 1984. Intressant nog mottog både lutheranerna och de ortodoxa mindre statliga pengar för utvecklingssamarbete år 1989 än 1984. Däremot växte pingstvännernas utvecklingssamarbete i Kenya under hela 1980-talet. Eftersom pingstvännerna inte ville använda sina medlemmarnas pengar (som var avsedda för missionsverksamhet) till sociala projekt täckte de sin andel i utvecklingskostnaderna med pengar från utanförstående. Pingstvännerna utvecklade en omfatttande komersiell och även industriell verksamhet för att samla in pengar för sina utvecklingsprojekt.