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Title:UPORABA METODE FMEA PRI OBVLADOVANJU STROŠKOV KAKOVOSTI V POGODBENI PROIZVODNJI FARMACEVTSKE INDUSTRIJE
Authors:ID Ilić, Žaklina (Author)
ID Gomišček, Boštjan (Mentor) More about this mentor... New window
Files:.pdf UNI_Ilic_Zaklina_2012.pdf (1,62 MB)
MD5: 981051FCA6E36C29C3122CAE75B4E2BE
PID: 20.500.12556/dkum/4073d032-b01a-4aee-ba18-1ab9a2b45774
 
Language:Slovenian
Work type:Undergraduate thesis
Organization:FOV - Faculty of Organizational Sciences in Kranj
Abstract:Nenehne izboljšave, ki jih narekujejo smernice in standardi, so gonilna sila napredka na vseh področjih delovanja Krke. V svetu se danes pojavlja pozitiven trend pogodbene proizvodnje v farmacevtski industriji z namenom zniževanja stroškov in povečevanja tržnega deleža. Proizvodnjo pri pogodbenem partnerju je potrebno pravilno določiti, se dogovoriti in izvajati nadzor, da bi preprečili nesporazume, ki bi lahko povzročili neustrezno kakovost izvajanja ali izdelka. Skleniti je treba pisno pogodbo o zagotavljanju kakovosti. Obvladovanje kakovosti, kot so ocenjevanje dobaviteljev, obvladovanje prenosa tehnologij, sproščanje izdelkov na trg, obvladovanje sprememb in obvladovanje napak, s tem tudi stroškov kakovosti, so ena od izhodišč zagotavljanja kakovosti med proizvodnima partnerjema. V nalogi je predstavljena uporaba metode FMEA s stroški nekakovosti v procesu Prejema izdelka pogodbenikov. Zagotavlja nam sprotno odkrivanje napak, vrednotenja le teh, ustrezno podlago za ukrepanje in zagotavlja, da neustrezni izdelki ne pridejo do kupca ali končnega uporabnika. Napake, predstavljene v nalogi, so ovrednotene v denarnih vrednostih in prikazane kot stroški nekakovosti. Manjše napake so povzročile največ stroškov nekakovosti, kar 43 %, delež stroškov kritičnih napak je znašal 41, večjih napak pa le 16 %. Največji delež stroškov nekakovosti so predstavljali stroški dodatnega dela (34 %), sledili so stroški prepakiranja in reklamacij (po 30 %) ter stroški zastoja procesa sproščanja (6 %). Z uporabo metode FMEA smo obravnavali napake in stroške kakovosti ter določili stopnje tveganja napak na podlagi faktorja RPN v procesu pogodbene proizvodnje. Tako bi lahko zaključili, da je ustrezno vrednotenje nastalih in potencialnih napak, s pomočjo metode FMEA, pomembno orodje sistema managementa kakovosti.
Keywords:Kakovost, TQM - Management celovite kakovosti, Farmacevtska industrija, Pogodbena proizvodnja, Stroški kakovosti, Metoda FMEA – Analiza možnih napak in njihovih posledic
Place of publishing:Maribor
Year of publishing:2012
PID:20.500.12556/DKUM-22224 New window
COBISS.SI-ID:7040531 New window
NUK URN:URN:SI:UM:DK:JSPJSF9N
Publication date in DKUM:09.08.2012
Views:3903
Downloads:956
Metadata:XML DC-XML DC-RDF
Categories:FOV
:
ILIĆ, Žaklina, 2012, UPORABA METODE FMEA PRI OBVLADOVANJU STROŠKOV KAKOVOSTI V POGODBENI PROIZVODNJI FARMACEVTSKE INDUSTRIJE [online]. Bachelor’s thesis. Maribor. [Accessed 23 April 2025]. Retrieved from: https://dk.um.si/IzpisGradiva.php?lang=eng&id=22224
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Secondary language

Language:English
Title:USE OF THE FMEA IN MANAGING QUALITY COSTS IN THE PHARMACEUTICAL CONTRACT MANUFACTURING INDUSTRY
Abstract:Continuous improvements dictated by relevant guidelines and standards are the driving force of the progress in all fields of Krka's operation. We can note a positive trend of contract manufacture in the pharmaceutical industry in the world today. Its purpose is to reduce costs and to increase the market share. However, the contract manufacture should be properly defined, agreements should be made and relevant control should be carried out to prevent any misunderstandings which might lead to the non-quality of processes or products. A quality assurance contract should therefore be concluded in writing. Proper quality management, including supplier assessment, technology transfer management, product release to market, change control and management of faults or failures and, consequently, the cost of quality, is one of the starting points for quality assurance between the manufacturing partners. In this thesis, the use of the Failure Mode and Effects Analysis (FMEA) method is presented in relation to the costs of non-quality in the process of product receipt from contract manufacturers. It enables detection of faults and failures as they occur and their evaluation, and provides a proper basis for taking actions. It also ensures that products of inadequate quality do not reach consumers or end users. The failures presented in the thesis have been evaluated and shown as the value of the costs of non-quality. Minor failures accounted for the biggest proportion of these costs, i.e. 43%, critical failures for 41%, while the number of major failures was lower and represent only 16% of these costs. The largest share of the non-quality costs referred to the costs of additional work (34%), which were followed by the costs of re-packaging and complaints (by 30% each) and the costs of the delay in the release process (6%). By use of the FMEA method we have dealt with the failures and the costs of quality, and defined the failure risk level on the basis of the RPN factor in the contract manufcaturing process. It can therefore be concluded that proper evaluation of the actual and potential failures by use of the FMEA method is an important tool of the quality managment system.
Keywords:Quality, TQM - Totaly quality management, Pharmaceutical industry, Contract manufacturing, Quality costs, FMEA metode - Failure Mode and Effects Analysis


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