{"id":18932,"date":"2026-11-11T22:48:02","date_gmt":"2026-11-11T21:48:02","guid":{"rendered":"https:\/\/www.s-vt.net\/oq-calificarea-operationala-operational-qualification\/"},"modified":"2026-11-11T23:18:30","modified_gmt":"2026-11-11T22:18:30","slug":"operational-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/ro\/operational-qualification\/","title":{"rendered":"OQ \u2013 calificarea opera\u021bional\u0103 (Operational Qualification)"},"content":{"rendered":"<div style='' class=''><section class='page-content' style=''  ><section class='container'><div style='' class=''><div class='row' style=''><div style='' class=''><div class='col-md-12 ' style=''><div style='' class=''><div class='cma-wysiwyg-editor'><p class=\"svt-lead2\">Calificarea opera\u021bional\u0103 (OQ) este dovada documentat\u0103 c\u0103 facilit\u0103\u021bile, sistemele \u0219i instala\u021biile, \u00een varianta montat\u0103 sau modificat\u0103, func\u021bioneaz\u0103 conform cerin\u021belor \u00een \u00eentregul domeniu de operare prev\u0103zut.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><strong>Verificarea func\u021biilor<\/strong><span>Conformitatea cu func\u021biile cerute \u00een caietul de sarcini.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-tachometer\" aria-hidden=\"true\"><\/i><strong>Calibrare<\/strong><span>Calibrarea punctelor de m\u0103surare \u0219i stabilirea intervalelor.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>Procese-verbale \u0219i raport<\/strong><span>Procese-verbale de testare, jurnal \u0219i raport OQ.<\/span><\/div><\/div><h2>Defini\u021bii ale calific\u0103rii opera\u021bionale<\/h2><div class=\"svt-kgrid svt-kgrid-2\"><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Aide Memoire GMP<\/h3><p>\u201eDovada documentat\u0103 c\u0103 facilit\u0103\u021bile, sistemele \u0219i instala\u021biile, \u00een varianta montat\u0103, respectiv modificat\u0103, func\u021bioneaz\u0103 conform cerin\u021belor \u00een \u00eentregul domeniu de operare prev\u0103zut.\u201d<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Ghidul GMP al UE, Anexa 15<\/h3><p>\u201eVerificarea documentat\u0103 a faptului c\u0103 facilit\u0103\u021bile, sistemele \u0219i echipamentele, a\u0219a cum au fost instalate sau modificate, func\u021bioneaz\u0103 conform a\u0219tept\u0103rilor \u00een cadrul domeniilor de operare prev\u0103zute.\u201d<\/p><\/div><\/div><h2>Con\u021binutul OQ<\/h2><p class=\"svt-knote\"><strong>Condi\u021bie prealabil\u0103:<\/strong> Calificarea <a href=\"https:\/\/www.s-vt.net\/ro\/installation-qualification\/\">IQ<\/a> a fost \u00eencheiat\u0103 cu succes. Ulterior, OQ verific\u0103 dac\u0103 func\u021bionarea sistemului tehnic corespunde cu <a href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#lastenheft\">caietul de sarcini<\/a> \u00een privin\u021ba func\u021bionalit\u0103\u021bilor cerute.<\/p><div class=\"svt-kgrid svt-kgrid-3\"><div class=\"svt-kcard\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><h3>Planificare \u0219i documenta\u021bie<\/h3><ul class=\"svt-klist\"><li>Planul de efectuare a OQ<\/li><li>Procese-verbale de testare pentru fiecare test func\u021bional<\/li><li>\u00centocmirea unui jurnal<\/li><li>Verificarea documenta\u021biei tehnice a furnizorului<\/li><li>Verificarea completitudinii<\/li><li>Raport privind efectuarea OQ<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><h3>Teste func\u021bionale<\/h3><ul class=\"svt-klist\"><li>Verificarea func\u021biilor individuale<\/li><li>Identificarea \u0219i verificarea func\u021biilor care influen\u021beaz\u0103 calitatea<\/li><li>Verificarea parametrilor de performan\u021b\u0103<\/li><li>Verificarea condi\u021biilor de mediu<\/li><li>Verificarea compatibilit\u0103\u021bii electromagnetice<\/li><li>Revizuirea analizei riscurilor<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-wrench\" aria-hidden=\"true\"><\/i><h3>Calibrare \u0219i exploatare<\/h3><ul class=\"svt-klist\"><li>Calibrarea punctelor de m\u0103surare \u0219i stabilirea intervalelor de calibrare<\/li><li>Instruc\u021biuni de lucru \u00een completarea manualelor de utilizare<\/li><li>Adaptarea instruc\u021biunilor de lucru pentru calibrare \u0219i \u00eentre\u021binere<\/li><\/ul><\/div><\/div><h2>Procesul de calificare pe scurt<\/h2><ol class=\"svt-steps\"><li><span class=\"svt-step-n\">1<\/span><strong>RA \u2013 analiza riscurilor<\/strong><span class=\"svt-step-tx\">Identificarea \u0219i evaluarea riscurilor \u00eenainte de stabilirea designului.<\/span><\/li><li><span class=\"svt-step-n\">2<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ro\/design-qualification\/\">DQ \u2013 calificarea designului<\/a><\/strong><span class=\"svt-step-tx\">Dovada c\u0103 designul este adecvat utiliz\u0103rii prev\u0103zute.<\/span><\/li><li><span class=\"svt-step-n\">3<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ro\/installation-qualification\/\">IQ \u2013 calificarea instal\u0103rii<\/a><\/strong><span class=\"svt-step-tx\">Verificarea instal\u0103rii \u00een raport cu documentele de comand\u0103.<\/span><\/li><li><span class=\"svt-step-n\">4<\/span><strong>OQ \u2013 calificarea opera\u021bional\u0103 (aceast\u0103 pagin\u0103)<\/strong><span class=\"svt-step-tx\">Verificarea func\u021bion\u0103rii prev\u0103zute.<\/span><\/li><li><span class=\"svt-step-n\">5<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ro\/process-qualification\/\">PQ \u2013 calificarea performan\u021bei<\/a><\/strong><span class=\"svt-step-tx\">Dovada performan\u021bei cerute \u00een exploatare.<\/span><\/li><\/ol><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-ghost\" style=\"flex:0 0 auto\" href=\"https:\/\/www.s-vt.net\/ro\/process-qualification\/\">Mai departe: PQ \u2013 calificarea performan\u021bei <i class=\"fa fa-arrow-right\" aria-hidden=\"true\"><\/i><\/a><\/div><p>Calificarea <strong>SEEFRIED Verfahrenstechnik GmbH<\/strong> v\u0103 sprijin\u0103 la \u00eentocmirea documenta\u021biei \u0219i la verificarea calific\u0103rii opera\u021bionale.<\/p><h2>\u00centreb\u0103ri frecvente despre calificarea opera\u021bional\u0103 (OQ)<\/h2><h3>Ce este calificarea opera\u021bional\u0103 (OQ)?<\/h3><p>OQ este dovada documentat\u0103 c\u0103 facilit\u0103\u021bile, sistemele \u0219i instala\u021biile, \u00een varianta montat\u0103, func\u021bioneaz\u0103 conform a\u0219tept\u0103rilor \u00een \u00eentregul domeniu de operare prev\u0103zut (Ghidul GMP al UE, Anexa 15).<\/p><h3>Care este condi\u021bia prealabil\u0103 pentru OQ?<\/h3><p>Calificarea instal\u0103rii (IQ) trebuie s\u0103 fie \u00eencheiat\u0103 cu succes.<\/p><h3>Ce se verific\u0103 \u00een cadrul OQ?<\/h3><p>Dac\u0103 func\u021biile instala\u021biei corespund func\u021bionalit\u0103\u021bilor cerute \u00een caietul de sarcini \u2013 printre altele func\u021biile individuale, func\u021biile care influen\u021beaz\u0103 calitatea, parametrii de performan\u021b\u0103, condi\u021biile de mediu, calibrarea punctelor de m\u0103surare \u0219i compatibilitatea electromagnetic\u0103.<\/p><h3>Ce documente rezult\u0103 \u00een cadrul OQ?<\/h3><p>Planul OQ, procesele-verbale de testare, intervalele de calibrare, instruc\u021biunile de lucru pentru exploatare, calibrare \u0219i \u00eentre\u021binere, jurnalul \u0219i un raport OQ final.<\/p><h2 class=\"svt-pcta-h\">Contacta\u021bi-ne<\/h2><div class=\"svt-pcta svt-pcta-m\"><div class=\"svt-pcta-tx\">V\u0103 oferim cu pl\u0103cere consultan\u021b\u0103 privind calificarea opera\u021bional\u0103 \u2013 telefonic la <a href=\"tel:+494203789492\">+49 4203 789492<\/a> sau prin e-mail la <a href=\"mailto:inf&#111;&#64;s-&#118;t&#46;&#110;e&#116;\">in&#102;&#111;&#64;s-vt&#46;&#110;&#101;&#116;<\/a>.<\/div><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-primary\" href=\"https:\/\/www.s-vt.net\/ro\/contact\/?produkt=Verfahrenstechnische%20Beratung\">Trimite\u021bi solicitarea<\/a><a class=\"svt-btn svt-btn-ghost\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#planung\">Toate serviciile<\/a><\/div><\/div><h2>Alte servicii<\/h2><div class=\"svt-sgrid\"><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#planung\"><span>Proiectare<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#basic-engineering\"><span>Basic engineering<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#konstruktion\"><span>Asisten\u021b\u0103 la proiectarea constructiv\u0103<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#beschaffung\"><span>Asisten\u021b\u0103 la achizi\u021bii<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#lastenheft\"><span>Caiet de sarcini pentru instala\u021bii de proces<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#terminplanung\"><span>Planificarea \u0219i controlul termenelor<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#bauueberwachung\"><span>Supravegherea execu\u021biei<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/design-qualification\/\"><span>DQ \u2013 calificarea designului<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/installation-qualification\/\"><span>IQ \u2013 calificarea instal\u0103rii<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/process-qualification\/\"><span>PQ \u2013 calificarea performan\u021bei<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/process-optimisation\/\"><span>Optimizarea proceselor<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><\/div><script 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