Browsing by Subject "quality assurance"

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  • Keto-Timonen, R; Tolvanen, R; Lunden, J; Korkeala, H (2007)
    Contamination routes of Listeria monocytogenes were examined in a chilled food processing plant that produced ready-to-eat and ready-to-reheat meals during an 8-year period by amplified fragment length polymorphism (AFLP) analysis. A total of 319 L. monocytogenes isolates were recovered from raw materials (n=18), the environment (n=77), equipment (n=193), and products (n=31), and 18 different AFLP types were identified, five of which were repeatedly found to be persistent types. The three compartments (I to III) of the plant showed markedly different contamination statuses. Compartment I, which produced cooked meals, was heavily contaminated with three persistent AFLP types. AFLP type A1 dominated, and it comprised 93% of the isolates of the compartment. Compartment II, which produced uncooked chilled food, was contaminated with four persistent and five nonpersistent AFLP types. The equipment of compartment III, which produced cooked ready-to-reheat meals, was free of contamination. In compartments that produced cooked meals, the cleaning routines, product types, and lack of compartmentalization seemed to predispose production lines to persistent contamination. The most contaminated lines harbored L. monocytogenes in coolers, conveyors, and packing machines. Good compartmentalization limited the flow of L. monocytogenes into the postheat -treatment area and prevented the undesired movement of equipment and personnel, thus protecting the production lines from contamination. In compartment II, grated cheese was shown to cause product contamination. Therefore, special attention should be paid to continuous quality control of raw ingredients when uncooked ready-to-eat foods are produced. In compartment II, reconstruction of the production line resulted in reduced prevalence rates of L. monocytogenes and elimination of two persistent AFLP types.
  • Vilhunen, Noora (Helsingin yliopisto, 2021)
    Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. The compounded preparations have many special features, such as the rapid/immediate need for the drug, the preparation of several pharmaceutical dosage forms, and the variation of batch sizes and manufacturing processes. Medicinal products prepared in hospital pharmacies may pose additional risks to patients compared to industrial products. These risks with limited evidence of quality, efficacy and microbiological purity can jeopardize patient safety. The aim of this study was to perform a product specific risk assessment of aseptically processed and terminally sterilized products belonging to the manufacturing range of the hospital pharmacy of Turku University Central Hospital. The study material contained 118 different products. The risk assessment was performed with the help of a risk matrix in which various quality and safety risks have been identified and assessed. The risk points obtained from the different areas of risks were multiplied together to obtain total risk points for each product. The products were qualitatively classified according to the total risk points into low-risk, medium-risk and high-risk products. All total parenteral nutrition (TPN) solutions of the study were classified as high-risk products. TPN solution prepared into a syringe without lipids and TPN solution prepared into an EVA bag without lipids had the highest risk points of the study (6561 points). Most of the eye drops (88 %) and patient controlled analgesia (PCA) pumps (68%) belonged to high-risk category. PCA pump containing morphine, clonidine, bupivacaine, ketamine and saline solution (1944 points) and autologous serum eye drops (1296 points) had the highest risk points of these product types. 60 percent of intraocular injections and half of pain products prepared into syringes were scored as high-risk products. Intravitreal bevacizumab had the highest risk points of intraocular injections (972 points). Medium-risk products were mainly different infusions. Infusions containing defibrotide, oxytocin and onasemnogene abeparvovec had the highest risk points in the medium-risk category. Liquid solutions and patient controlled analgesia (PCA) pumps were the second largest group in this category. All products used in allergy testing, all ointments and all inhalation solutions were in the low-risk category. The risk matrix used in the study can be used to identify high-risk compounded preparations in hospital pharmacies. Risk assessment enables targeting quality assurance more effectively to high-risk products. Risk assessment can be used to manage various risks in pharmaceutical compounding and reduce harm to patients. The results obtained in the study cannot be directly generalized to other hospital pharmacies because the products, manufacturing processes and the amounts of different products prepared vary among hospital pharmacies.
  • Sundell, Veli-Matti; Mäkelä, Teemu; Meaney, Alexander; Kaasalainen, Touko; Savolainen, Sauli (2019)
    Background: The high requirements for mammography image quality necessitate a systematic quality assurance process. Digital imaging allows automation of the image quality analysis, which can potentially improve repeatability and objectivity compared to a visual evaluation made by the users. Purpose: To develop an automatic image quality analysis software for daily mammography quality control in a multi-unit imaging center. Material and Methods: An automated image quality analysis software using the discrete wavelet transform and multi-resolution analysis was developed for the American College of Radiology accreditation phantom. The software was validated by analyzing 60 randomly selected phantom images from six mammography systems and 20 phantom images with different dose levels from one mammography system. The results were compared to a visual analysis made by four reviewers. Additionally, long-term image quality trends of a full-field digital mammography system and a computed radiography mammography system were investigated. Results: The automated software produced feature detection levels comparable to visual analysis. The agreement was good in the case of fibers, while the software detected somewhat more microcalcifications and characteristic masses. Long-term follow-up via a quality assurance web portal demonstrated the feasibility of using the software for monitoring the performance of mammography systems in a multi-unit imaging center. Conclusion: Automated image quality analysis enables monitoring the performance of digital mammography systems in an efficient, centralized manner.
  • Akmal, Jan Sher; Salmi, Mika; Hemming, Björn; Teir, Linus; Suomalainen, Anni; Kortesniemi, Mika; Partanen, Jouni; Lassila, Antti (2020)
    Featured Application Accuracy of additively manufactured implants for clinical surgery. Abstract In craniomaxillofacial surgical procedures, an emerging practice adopts the preoperative virtual planning that uses medical imaging (computed tomography), 3D thresholding (segmentation), 3D modeling (digital design), and additive manufacturing (3D printing) for the procurement of an end-use implant. The objective of this case study was to evaluate the cumulative spatial inaccuracies arising from each step of the process chain when various computed tomography protocols and thresholding values were independently changed. A custom-made quality assurance instrument (Phantom) was used to evaluate the medical imaging error. A sus domesticus (domestic pig) head was analyzed to determine the 3D thresholding error. The 3D modeling error was estimated from the computer-aided design software. Finally, the end-use implant was used to evaluate the additive manufacturing error. The results were verified using accurate measurement instruments and techniques. A worst-case cumulative error of 1.7 mm (3.0%) was estimated for one boundary condition and 2.3 mm (4.1%) for two boundary conditions considering the maximum length (56.9 mm) of the end-use implant. Uncertainty from the clinical imaging to the end-use implant was 0.8 mm (1.4%). This study helps practitioners establish and corroborate surgical practices that are within the bounds of an appropriate accuracy for clinical treatment and restoration.
  • Eklund, Max Julius (Helsingfors universitet, 2013)
    The importance of universities providing quality-assurance schemes has increased during the last two decades due to, among other things, an increased tendency in public administration to use evaluations as a tool to enhance efficiency and the changed nature of the state-university relationship. Moreover, we can witness an increased integration of European higher education. Also Finnish higher education has been exposed to these trends and external evaluation and quality assurance systems has become a recurring phenomenon. The objective of this research was to analyse organizational responses at universities to the demand of showing a QA-scheme, and to increase understanding on the role of audits in relation to national and supranational developments, from a perspective of organizational intuitionalism. In so doing, attention is put on what kinds of effects and practices a national form of evaluation has, if compared at the organizational level of two universities. The methodological approach builds on insights from qualitative methods, new-institutional theory and organizational institutionalism. The empirical materials used consisted of documents and half-structured interviews. The interviews were transcribed and analysed through the creation of reference codes in the program ATLAS TI. The reference codes were created according to logics of analytic coding. In the research, four core themes were witnessed. First, in implementing processes or reforms that might be perceived critically in universities, the role of commitment and semantics become of high importance, as does a degree of hierarchy. Second, responding to the demand of showing a quality assurance-scheme and succeeding in audits are not seen to be of high importance by university leadership in that only scarce resources were allocated to the exercise. Third, developing the QA-system was clearly accepted to be a response to European developments but this is hardly an instrument for governance that the Ministry of Education would value in comparison to other instruments. Finally, the recommendations made by the audit teams are not as neutral as they seem, in that they do define what the Universities should accomplish. However, the loosely coupled structure has in many ways lessened many of the impacts and recommendation gained from the audits.
  • Kauko, Jaakko (2012)
    The article posits that the institutionalisation of quality assurance within European higher education is largely attributable to the reshaping of power relations by means of practices that are very similar to the open method of coordination. All the major parties involved in this process – universities, governments, the European Commission and quality-assurance agencies – have been able to gain from it. The whole process is open to scrutiny in the central documents of the Bologna process: following the formation of a common ‘truth’ about the European situation, it has been possible to move forward and reshape power through normative procedures.