U.S. Food and Drug Administration (FDA) recalls of medical devices are at historically high levels despite efforts by manufacturers to meet stringent agency requirements to ensure quality and patient safety. A factor in the release of potentially dangerous devices might be the interpretations of nonnormal test data by statistically unsophisticated engineers. The purpose of this study was to test the hypothesis that testing by lot provides a better indicator of true process behavior than process capability indices (PCIs) calculated from the mixed lots that often occur in a typical production situation. The foundations of this research were in the prior work of Bertalanffy, Kane, Shewhart, and Taylor. The research questions examined whether lot traceability allows the decomposition of the combination distribution to allow more accurate calculations of PCIs used to monitor medical device production. The study was semiexperimental, using simulated data. While the simulated data were random, the study was a quasiexperimental design because of the control of the simulated data through parameter selection. The results of this study indicate that decomposition does not increase the accuracy of the PCI. The conclusion is that a systems approach using the PCI, additional statistical tools, and expert knowledge could yield more accurate results than could decomposition alone. More accurate results could ensure the production of safer medical devices by correctly identifying noncapable processes (i.e., processes that may not produce required results), while also preventing needless waste of resources and delays in potentially life-savings technology, reaching patients in cases where processes evaluate as noncapable when they are actually capable.

Covid-19 brought various challenges that the world that was not fully prepared to face since 2019. The pandemic came with both health and economic repercussions, and various organizations had to adapt their Organization Design to confront these new challenges posed by this Black Swan event. Since the pandemic is still recent, most of the research related to Organization Design and Covid-19 has focused on the changes during the pandemic. What has been missing in the research is a perspective on the evolution of Organization Design over time. Two research questions were addressed. The first question explored how individuals from different positions perceived changes in Organization Design during the pandemic using Jay Galbraith's Star Model. The findings revealed variations in perceptions across positions, particularly regarding hiring growth, structure, communication, rewards, and the hiring process. The second research question uses a combination of Path Dependence Theory and Jay Galbraith's Star Model to compare the short-term and long-term effects of contingencies on Organization Design within a Medical Manufacturing Company. Some changes, like temporary Covid-19 protocols and rewards, were phased out, while others, including remote work, digital transformation, hybrid work models, and certain structural changes, became permanent. The thesis contributes to the understanding of how Black Swan events impact Organization Design in the Medical Manufacturing Industry, providing practical recommendations for decision-making during crises and emphasizing the significance of organizational resilience and change management. The study's theoretical contributions include exploring path dependence in crisis-induced transformations, highlighting the dynamic nature of organizational responses, and suggesting future research avenues. Overall, this research enhances knowledge of Organization Design dynamics and offers guidance for organizations in crisis response and resilience-building. / Covid-19 förde med sig olika utmaningar och konsevenser såväl ekonomiskt som hälsomässigt. Pandemin kan ses som ett exempel på en svart svan-händelse, dvs. en osannolik händelse med omfattande konsekvenser. Organisationer var tvungna att anpassa sig för att möta utmaningarna som denna svarta svan-händelse medförde, i synnerhet när det gäller organisationsdesign. Eftersom pandemin fortfarande ligger relativt nära i tiden, har en stor del av forskningen kring organisationsdesign och Covid-19 fokuserat på förändringarna under pandemin. Det som har saknats i forskningen är ett perspektiv på utvecklingen av organisationsdesign över tid. Denna uppsats bidrar till att fylla detta kunskapsgap genom en fallstudie av ett medicinskt tillverkningsföretag. Två forskningsfrågor behandlas, den första frågan fokuserar på hur individer på olika positioner i företaget uppfattade förändringar i organisationsdesign under pandemin. Med utgångspunkt i Jay Galbraiths Star Model visar uppsatsen att uppfattningar om förändringar skiljer sig åt mellan olika positioner, särskilt med avseende på personaltillväxt, struktur, kommunikation, belöningar och rekryteringsprocesser. Den andra forskningsfrågan behandlar hur organisationsdesignen utvecklats i ett stigberoende perspektiv.Vissa förändringar, som rutiner för hantering av Covid-19 och specifika belöningsmodeller, fasades ut, medan andra, som distansarbete, digitalisering, hybridarbetsmodeller och vissa strukturella förändringar, förblev permanenta. Uppsatsen bidrar till en ny förståelse för hur en svarta svan-händelse kan påverka organisationsdesign inom ett företag och ger rekommendationer för beslutsfattande under kriser samt betonar betydelsen av organisationsresiliens och förändringshantering. Studiens teoretiska bidrag ligger i kombinationen av stigberoendeteori och omvandling under en extern kris av svart svan-typ.