20.500.12556/DKUM-10515 IZBOLJŠAVA SISTEMA PROCESNE KONTROLE POLNJENJA INJEKCIJ IMPROVEMENT OF IN-PROCESS CONTROL SYSTEM FOR FILLING OF AMPOULES V Krki, tovarni zdravil, d.d., v obratu za proizvodnjo injekcij na fazi polnjenja injekcij, odgovorne osebe proizvodnje ali službe za zagotavljanje kakovosti rezultate procesnih kontrol ročno beležijo v Zapisnike o proizvodnji, ki jih tiskamo za vsako serijo posebej. Pri ročnem izpolnjevanju obrazcev lahko prihaja do napak. Odločili smo se, da je potrebno podatke sproti zapisati v računalniško aplikacijo, ki bo beležila, kdo in kdaj je meritev izvajal in vse rezultate. Hkrati smo želeli čim bolj izključiti vpliv izvajalca kontrole oz. meritve na rezultat in smo se odločili, da preverimo možnost merjena polnilnega volumna s pomočjo tehtanja. Na osnovi primerljivih rezultatov volumetričnega in gravimetričnega določanja polnilnega volumna smo prišli do sklepa, da pripravimo zahteve za pripravo računalniškega programa za podporo procesni kontroli, ki bo za merjenje polnilnega volumna imel tehtalno aplikacijo. Podpora procesne kontrole naj bi bil računalniški sistem, oblikovan z namenom, da zagotovimo optimalno obdelavo podatkov procesne kontrole. In Krka d. d., pharmaceutical company, in injection production plant on the basis of injection filling, the responsibles of production or the department for quality assurance record the results of process controls manually. This is done into the minutes about production which are printed for each production series separately. Errors can occur during manual completion of formulations. It has been decided that data must be recorded into a computer device regularly. This device will make notes about who carried out the measuring, when it was done and it will also note the results. We wanted to exclude the influence of the controlling or measuring person on the results. We have decided to check the possibility of measuring the filling volume by means of weighing. On the basis of comparable results of volumetric and gravimetric determining we concluded that we would prepare requirements for preparation of computer programme that will help the process control and will have a weighing application for measuring the filling volume. The computer system should help process control. It will be designed in order to provide an optimal procession of process control data. Procesna kontrola Proizvodnja injekcij Statistična obdelava rezultatov Kontrola kakovosti Process control Injection production Statistical data processing Quality control true true false Slovenski jezik Angleški jezik Diplomsko delo 2009-05-20 12:53:16 2009-06-04 12:17:27 2022-04-11 16:20:34 2022-04-16 03:30:40 2009 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 6449939 URN:SI:UM:DK:IFHMSTMC VS_Klobcar_Slavica_2009.pdf VS_Klobcar_Slavica_2009.pdf 1 F58B60B9E39921360191E8FED2C25B5E 0e554c50faec752ca2a2d38f7f5e0e874b8a81b772c9298c9dc5002f2007dfa6 d99fa687-7c02-11eb-bb7a-00155d0001ca 20.500.12556/dkum/fe74afef-e4fd-4caf-a3d3-a74ed87554ad https://dk.um.si/Dokument.php?lang=slv&id=8967 Fakulteta za organizacijske vede 0 0 0