Primjena korektivnih i preventivnih mjera kod nadzora odstupanja kao elementa sustava kvalitete

professional thesis

• Title (english): Application of corrective and preventive actions for nonconformances as quality system element
• Author: Karmen Kurek
• Mentor: Mara Banović (mentor)
• Granter: University of Zagreb; Faculty of Food Technology and Biotechnology; Zagreb
• Defense date and country: 2012, Croatia
• Scientific / art field, discipline and subdiscipline: BIOTECHNICAL SCIENCES; Food Technology

Abstract

Upravljanje korektivnim i preventivnim aktivnostima tzv. KAPA sustav (engl. Corrective i preventive action – CAPA management) jedan je od osnovnih elemenata suvremenog sustava kvalitete. Svrha upravljanja sustavom kvalitete je uskladenost s zahtjevima Dobre proizvodacke prakse kao i sa regulatornim zahtjevima, a s ciljem dobivanja proizvoda kojem nije narušen identitet, integritet, kvaliteta, efikasnost i cistoca i koji odgovara unaprijed postavljenim zahtjevima tijekom cijelog svog životnog cikusa. U ovom radu je prikazan i objašnjen sustav kvalitete u farmaceutskoj industriji kroz postupak primjene KAPA sustava za odstupanje uoceno tijekom proizvodnje jednog farmaceutskog proizvoda: od postupka uocavanja odstupanja, evidencije i tijeka rješavanja odstupanja, analiziranja, definiranja korektivnih i preventivnih aktivnosti i naknadnih zadataka do završetka svih propisanih korektivnih i preventivnih mjera, zatvaranja odstupanja te uvodenja promjena za poboljšanje na temelju provedenih aktivnosti.

Abstract (english)

Corrective and preventive actions management is one of the basic elements of modern quality system. The purpose of quality system management is the compliance with the requirements of Good Manufacturing Practice as well as regulatory requests and with a goal of producing a product which has no identity, integrity, quality, efficacy or purity issues and which conforms to the in advance set requirements during its entire lifecycle. In this paper quality system in pharmaceutical industry is presented and explained thought the application of CAPA system for nonconformance observed during production of one pharmaceutical product: from observation of nonconformance, thought the nonconformance evidence and problem solving, analyzing, defining corrective and preventive actions and follow up tasks, till the completion of all corrective and preventive measures, nonconformance closing and implementation of changes for improvement based on performed actions.

• Keywords: KAPA; korektivna mjera; kvaliteta; neuskladenost; preventivna mjera; sustav kvalitete
• Keywords (english): CAPA; corrective action; nonconformance; preventive action; quality; quality system
• Language: croatian
• URN:NBN: urn:nbn:hr:159:150782
• 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 10:09:48