Statistička kontrola parametara proizvodnog procesa i završne kvalitete dodataka prehrani

professional thesis

• Title (english): Statistical control of the production process parameters and final quality of dietary supplements
• Author: Ljubica Hodak
• Mentor: Nada Vahčić (mentor)
• Granter: University of Zagreb; Faculty of Food Technology and Biotechnology; Zagreb
• Defense date and country: 2012-10, Croatia
• Scientific / art field, discipline and subdiscipline: BIOTECHNICAL SCIENCES; Food Technology

Abstract

Dodaci prehrani su pripravci proizvedeni iz koncentriranih izvora hranjivih tvari ili drugih tvari s hranjivim ili fiziološkim učinkom koji imaju svrhu dodatno obogatiti uobičajenu prehranu u cilju održavanja zdravlja. Regulirani su zakonima i pravilnicima o hrani, ali se iz razloga što često sadrže istu djelatnu tvar kao i lijekovi postavlja pitanje trebaju li se regulirati kao hrana ili lijek. U skladu s dobrom proizvođačkom praksom, koju primjenjuju farmaceutske kompanije, vode se zapisi o gotovo svakom segmentu proizvodnog ciklusa čime se otvara mogućnost za primjenu one metodologije koja može unaprijediti procese obrađivanjem postojećih podataka. Uspješnost ili sposobnost procesa može se odrediti statističkom obradom postojećih podataka za određeni proizvod i na taj način procijeniti mogućnost za njegovim poboljšanjem. Statističkom kontrolom prikazuje se varijabilnost rezultata unutar raspona specifikacijskih zahtjeva te raspon procesa unutar ± 3 standardne devijacije (6σ) u odnosu na srednju vrijednost obrađenih rezultata. Na temelju navedenog može se izračunati indeks sposobnosti procesa koji predstavlja omjer zadanog raspona za određeni parametar u odnosu na stvarnu raspršenost rezultata. Ovakvim praćenjem se ostvaruje dobra podloga za implementaciju „šest sigma“ metodologije kojoj je svrha smanjiti proces varijacija, povećati razinu kvalitete proizvoda i istodobno povećati profitabilnost proizvoda. „Šest sigma“ označava mogućnost da će prilikom proizvodnje biti maksimalno 3.4 grešaka na milijun događaja. U ovom radu prikazana je statistička kontrola 15 serija jednog dodatka prehrani, proizvedenih u vremenskom periodu od tri godine. Obrađeni podaci podrazumijevaju rezultate iskorištenja u pojedinim fazama proizvodnje i pakiranja, rezultate procesnih parametara (poput mase, debljine, čvrstoće i raspadljivosti tabletnih jezgri i film-tableta) te rezultate kontrole kvalitete gotovog proizvoda (poput sadržaja djelatne tvari, sadržaja teških metala i raspadljivosti film-tableta). Na temelju tih rezultata procijenjena je uspješnost procesa i kvaliteta ispitivanog proizvoda.

Abstract (english)

Dietary supplements are preparations manufactured from concentrated sources of nutrients or other substances with nutritional or physiological effect with purpose to enrich usual diet and to maintain health as aim. They are regulated by food laws and regulations, but because they often contain the same active ingredients as drugs this raises the question whether they should be regulated as food or medicine. In accordance with good manufacturing practices, which pharmaceutical companies apply, almost every aspect of the production cycle is recorded which opens the possibility for the application of that methodology that can improve processes by the processing existing data. The success or the ability of the process can be determined by statistical analysis of existing data for a particular product and thus can estimate the possibility for its improvement. Statistical control shows the variability of results within the range of specification requirements and processes spread within the range of ± 3 standard deviations (6σ) in relation to the mean value of the processed results. Based on the above, the process capability index that represents the ratio of the given range for the parameter in relation to the actual dispersion of results can be calculated. By such monitoring a good foundation for the implementation of the "six sigma" methodology, which is designed to reduce process variation, increase the level of product quality and also increase the profitability of the product can be achieved. "Six Sigma" means a possibility that during production will be a maximum of 3.4 defects per million events. This paper presents statistical control of 15 batches of dietary supplement, produced in a period of three years. The processed data include the results of utilization in different stages of production and packaging, the results of process parameters (such as mass, thickness, hardness and disintegration of tablet cores and film-tablets) and the results of quality control of finished product (such as content of active substance, content of heavy metals and disintegration of film-tablets). Based on these results, effectiveness of the process and the quality of the tested product are estimated.

• Keywords: dodaci prehrani; dobra proizvođačka praksa; sposobnost procesa; šest sigma; procesni parametri; kontrola kvalitete
• Keywords (english): dietary supplements; good manufacturing practice; process capability; six sigma; process parameters; quality control
• Language: croatian
• URN:NBN: urn:nbn:hr:159:441106
• Study programme: Title: Food Management; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni/a specijalist/specijalistica upravljanja hranom (sveučilišni/a specijalist/specijalistica upravljanja hranom)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Access restricted to students and staff of home institution
• Created on: 2018-05-16 10:21:01