Repository of colleges and higher education institutions

Show document
A+ | A- | Help | SLO | ENG

Title:Strategija validacije pri zagotavljanju kakovosti gama spektrometrijskih meritev : magistrska naloga
Authors:ID Žnideršič, Jasmina (Author)
ID Žurga, Gordana (Mentor) More about this mentor... New window
Files:.pdf RAZ_Znidersic_Jasmina_i2015.pdf (1,20 MB)
MD5: A5278DBD971A74DE3C20A78FC3D44D1F
 
Language:Slovenian
Work type:Master's thesis/paper
Typology:2.09 - Master's Thesis
Organization:FOŠ - Faculty of Organisation Studies Novo mesto
Abstract:Raziskovalno vprašanje (RV): Radiokemijski laboratorij v Nuklearni elektrarni Krško deluje v okviru kemijske službe, ki spada pod tehnično operativo. Naloge laboratorija so meritve radioaktivnosti v vzorcih različnih sistemov elektrarne in v vzorcih, ki se izpuščajo v reko Savo ter v ozračje. Prav na podlagi teh meritev ima laboratorij akreditirano metodo gama spektrometrije po standardu ISO/IEC 17025. Dokumentirani sistem politike kakovosti zavezuje najvišje vodstvo organizacije o ravni kakovosti storitev, kjer poleg ciljev in načinov vrednot enja učinkovitosti, odgovornosti, zahtevah in zavezanostjo k usposabljanju ter stalnim izboljšavam, opredeljuje tudi oceno negotovosti meritev . Slednje pa je potrebno dokazati s primerno strategijo validacije parametrov, ki vplivajo na merilno nego tovost merjenja z metodo gama spektrometrije. Namen: Cilj raziskave je razviti postopek validacije, ki bo potrje val , da analitična metoda gama spektrometrije daje točne, natančne in ponovljive rezultate, ki ustrezajo vnaprej postavljenim kriterijem. Gre z a pridobitev generičnega postopka, ki se bo v prihodnje uporabljal oz. izvajal v primeru sprememb v procesu gama spektrometrije. V sklopu strategije validacije so na vseh štirih gama detektorjih raziskane minimalna detekcijska aktivnost, točnost in ponovlj ivost ter obnovljivost in robustnost meritev. Metoda: Raziskavi minimalne detekcijske aktivnosti ter točnosti in ponovljivosti meritev sta ovrednoteni s t - testom, raziskava obnovljivosti meritev z metodo analize varianc in raziskava robustnosti s F - testom . Pri vseh štirih raziskavah so bili uporabljeni rezultati merjenja kontrolnih standardov, pripravljeni iz certificiranega referenčnega materiala. Rezultati: Statistični testi so dokazali, da metoda gama spektroskopije daje točne, ponovljive in robustne re zultate ter ustreza namenu uporabe. Z raziskavo obnovljivosti pa je bilo dokazano, da med štirimi detektorji ne obstajajo statistično značilne razlike. Organizacija: V organizaciji se prepleta več ključnih področjih: politika jedrske varnosti, stalne izbol jšave, upravljanje s človeškimi viri, varnostjo in zdravjem pri delu, upravljanje nadzora konfiguracije, radiološke zaščite in emisij, okoljske politike in politike kakovosti. Pri politiki emisij in okoljski politiki sodeluje tudi Radiokemijski laboratorij . Z nenehnim uvajanjem izboljšav ter vzdrževanjem sistema vodenja kakovosti zagotavlja uporabo ustrezno validiranih analitičnih metod ter točnost meritev emisij oz. izpustov v okolje. Družba: Rezultati raziskave, ki potrjujejo točnost, natančnost in ponovl jivost meritev izpustov v okolje, vsekakor predstavljajo družbi večje zaupanje v laboratorij, s tem pa tudi v samo organizacijo. Originalnost /nadaljnje raziskovanje : V raziskavi so bili upoštevani vsi pomembni parametri, ki vplivajo na točnost, natančnost in ponovljivost meritev in posledično tudi na oceno merilne negotovosti. V prihodnje pa je pomembno vsakršno spremembo v opremi ali postopku analize raziskati in po potrebi strategijo validacije nadgraditi. Sam načrt spremljanja učinkovitosti strategije va lidacije je definiran po principu Plan - Do - Check - Act kroga. Omejitve: Omejitev v raziskavi ni bilo.
Keywords:validacija, zagotavljanje kakovosti, nadzor kakovosti, merilna negotovost, ISO/IEC 17025, gama spektrometrija, radiokemijski laboratorij, jedrska elektrarna
Place of publishing:Novo mesto
Place of performance:Novo mesto
Publisher:[J. Žnideršič]
Year of publishing:2015
Year of performance:2015
Number of pages:V, 64 str., [2] str. pril.
PID:20.500.12556/ReVIS-8175 New window
COBISS.SI-ID:2048275458 New window
UDC:006
Note:Nasl. na ov.: Magistrska naloga študijski program druge stopnje;
Publication date in ReVIS:19.08.2021
Views:2803
Downloads:49
Metadata:XML DC-XML DC-RDF
:
Copy citation
  
Share:Bookmark and Share


Hover the mouse pointer over a document title to show the abstract or click on the title to get all document metadata.

Secondary language

Language:English
Abstract:Research Question ( RQ ) : Radiochemistry Laboratory operates within the chemical department , which is one of departments in the technical operative in Nuclear Power Plant Krško . The main tasks of the laboratory are measurements of radioactivity in various plant systems and samples, which are discharged into the River Sava and into atmosphere. Based on these measurements the laboratory has ac credited the gamma spectrometry method in accordance with ISO/IEC 17025 standard. Its documented system of quality commits the top management of the organization on the quality of service, where in addition to goals and ways of evaluating effectiveness, re sponsibilities, requirements and commitment to training and continuous improvement, also defines the estimation of measurement uncertainty. This requires providing proof of suitable validation strategy of parameters witch affect the uncertainty of measurem ent by gamma spectrometry method. Purpose: The aim of the research is to develop a validation process , which will confirm that the analytical method of gamma spectrometry provides accurate , precise and reproducible results which corresponds in advance appr oved criteria. The obtained generic procedure will be applied or implemented in the future in case of changes in the process of gamma spectrometry. Within the validation strategy there are studies made regarding the minimal detectable activity, accuracy, r epeatability and reproducibility on all four gamma detectors. Method: The studies of minimal detectable activities and accuracy of measurements were evaluated with t - test, the study of reproducibility of measurements with analysis of variance and the robustness study with F - test. In all four studies the data was obtained by measurements of control standards prepared from certified reference material. Results: Statistical tests have proofed that gamma spectrometry provides accurate, repeatable and robus t results and corresponds to the intended use. The study of reproducibility proofed that there are no significant differences between four detectors. Organization: In the organization there are several key areas intertwined, these are the policies of nucle ar safety , continuous improvement, human resources management, health and safety at work, control configuration, radiation protection and emissions, environmental policy and quality . Emission and environmental policies also involve Radiochemistry laborator y. By constantly introducing improvements and maintaining the quality management system ensures the use of appropriate validated analytical methods and the accuracy of measurements of emissions or discharges into the environment. Society: Results of the s tudy that confirm the accuracy, precision and reproducibility of measurements of discharges into the environment, certainly represent greater confidence in the Radiochemistry laboratory, as well as in the organization itself. Originality /further research : The study took into account all relevant parameters influencing the accuracy , precision and reproducibility of the measurements and consequently also on the evaluation of measurement uncertainty . In the future, it is important to investigate any change in equipment or analyze process and if it%s necessary upgrade the validation strategy. A plan for monitoring the effectiveness of the validation strategy is defined by the principle of Plan - Do - Check - Act circle. Limitations: There were no limitations in the study.
Keywords:validation, quality assurance, quality control, measurement uncertainty, ISO/IEC 17025, gamma spectrometry, radiochemistry laboratory, nuclear power plant


Back