{"id":702,"date":"2026-06-24T05:59:59","date_gmt":"2026-06-24T03:59:59","guid":{"rendered":"https:\/\/www.mjm-automation.sk\/?p=702"},"modified":"2026-06-24T05:59:59","modified_gmt":"2026-06-24T03:59:59","slug":"zapisnik-montaznika-vi-papier-znesie-vsetko-farmacia-nie-vitajte-v-byrokratickom-pekle-validacii","status":"publish","type":"post","link":"https:\/\/www.mjm-automation.sk\/en\/nezaradene\/zapisnik-montaznika-vi-papier-znesie-vsetko-farmacia-nie-vitajte-v-byrokratickom-pekle-validacii\/","title":{"rendered":"Z\u00e1pisn\u00edk mont\u00e1\u017enika VI: Papier znesie v\u0161etko, farm\u00e1cia nie. Vitajte v byrokratickom pekle valid\u00e1ci\u00ed"},"content":{"rendered":"

V predch\u00e1dzaj\u00facom diele sme prebrali, ako vyzer\u00e1 \u00fadr\u017eba magnetick\u00e9ho levituj\u00faceho prepravn\u00edka (LEV) v ostrej prev\u00e1dzke a ako sa rie\u0161ia softv\u00e9rov\u00e9 anom\u00e1lie cez gumen\u00e9 rukavice izol\u00e1tora. Ma\u0161ina stoj\u00ed, dr\u00e1ha je vyrovnan\u00e1 na stotiny milimetra, movery lietaj\u00fa bez jedin\u00e9ho oteru a v\u0161etko svieti na zeleno. Chlap z klasickej mont\u00e1\u017ee by si v tomto momente zbalil kufr\u00edk s n\u00e1rad\u00edm, potriasol by si rukou so \u0161\u00e9fom prev\u00e1dzky a i\u0161iel na zasl\u00fa\u017een\u00e9 pivo.<\/p>\n\n\n\n

Len\u017ee vy ste vo farmaceutickej fabrike. A tu sa pr\u00e1ve teraz za\u010d\u00edna t\u00e1 najv\u00e4\u010d\u0161ia psychologick\u00e1 vojna celej stavby. Vojna s papierom.<\/p>\n\n\n\n

Vo farm\u00e1cii toti\u017e plat\u00ed jedno krut\u00e9, absol\u00fatne nepriestreln\u00e9 pravidlo: \u201e\u010co nie je na papieri, to neexistuje.\u201c<\/strong> Va\u0161a ma\u0161ina m\u00f4\u017ee by\u0165 mechanicky a elektronicky t\u00fdm najdokonalej\u0161\u00edm dielom na plan\u00e9te, ale k\u00fdm neprejde byrokratick\u00fdm sitom valid\u00e1ci\u00ed a kvalifik\u00e1ci\u00ed, investor z nej leg\u00e1lne nem\u00f4\u017ee pou\u017ei\u0165 ani jednu jedin\u00fa injek\u010dn\u00fa strieka\u010dku. Pre legislat\u00edvu je to len drah\u00e1 kopa nerezov\u00e9ho \u0161rotu.<\/p>\n\n\n\n

V tejto \u0161iestej \u010dasti sa pozrieme na to, \u010do to znamen\u00e1, ke\u010f mont\u00e1\u017enik vymen\u00ed imbus\u00e1k za modr\u00e9 gu\u013e\u00f4\u010dkov\u00e9 pero a pre\u010do pri testoch LEV syst\u00e9mov simulujeme stavy, z ktor\u00fdch by be\u017en\u00e9mu \u00fadr\u017eb\u00e1rovi nasko\u010dili \u0161ediny.<\/p>\n\n\n\n

FAT (Factory Acceptance Test): Gener\u00e1lka na dom\u00e1cej p\u00f4de<\/h2>\n\n\n\n

Cel\u00e9 toto byrokratick\u00e9 dobrodru\u017estvo sa za\u010d\u00edna d\u00e1vno predt\u00fdm, ne\u017e sa \u010dist\u00e9 priestory v\u00f4bec postavia. Prv\u00e1 ve\u013ek\u00e1 sk\u00fa\u0161ka je FAT \u2013 Factory Acceptance Test<\/strong> (Preberac\u00ed test u v\u00fdrobcu).<\/p>\n\n\n\n

Predstavte si to tak, \u017ee dod\u00e1vate\u013e linky (napr\u00edklad v Rak\u00fasku alebo Nemecku) posklad\u00e1 cel\u00fd LEV syst\u00e9m na svojej mont\u00e1\u017enej hale. E\u0161te to nie je cleanroom, chod\u00ed sa tam v mont\u00e9rkach, ale dr\u00e1ha u\u017e mus\u00ed fungova\u0165. Na t\u00fd\u017ede\u0148 sa tam nas\u0165ahuje t\u00edm auditorov, in\u017einierov a mana\u017e\u00e9rov kvality od koncov\u00e9ho z\u00e1kazn\u00edka (farmaceutickej firmy).<\/p>\n\n\n\n

\n

Poh\u013ead z haly:<\/strong> FAT je v podstate divadlo, kde mus\u00edte dok\u00e1za\u0165, \u017ee ma\u0161ina rob\u00ed to, \u010do m\u00e1 v zmluve. Ako mont\u00e1\u017enik tam stoj\u00edte ako technick\u00e1 podpora. Auditor uk\u00e1\u017ee prstom do tabu\u013eky a povie: \u201eDok\u00e1\u017ete mi, \u017ee tento mover vie c\u00favnu\u0165 r\u00fdchlos\u0165ou 1 m\/s na poz\u00edciu v\u00e1hy.\u201c Program\u00e1tor klikne, vy meriate, auditor zap\u00ed\u0161e. Ak v\u0161etko prejde, ma\u0161ina sa podp\u00ed\u0161e, kompletne rozoberie, zabal\u00ed do obrovsk\u00fdch dreven\u00fdch debien a po\u0161le k n\u00e1m na skuto\u010dn\u00fa stavbu.<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

SAT (Site Acceptance Test): Druh\u00e9 kolo, tentoraz naostro<\/h2>\n\n\n\n

Ke\u010f tie bedne dorazia k n\u00e1m, cel\u00fa dr\u00e1hu posklad\u00e1me znova, ale tentoraz u\u017e v skuto\u010dnom cleanroome triedy ISO 5. A tu prich\u00e1dza SAT \u2013 Site Acceptance Test<\/strong> (Preberac\u00ed test na mieste).<\/p>\n\n\n\n

Tu u\u017e kon\u010d\u00ed sranda. Ak na FAT nie\u010do nesedelo, dalo sa to r\u00fdchlo upravi\u0165 v dielni. Na SAT pracujete v sterilnom obleku a ka\u017ed\u00e1 zmena znamen\u00e1 schva\u013eovac\u00ed proces. Pri SAT sa v podstate opakuje to ist\u00e9 \u010do na FAT, ale overuje sa, \u010di ma\u0161ina neutrpela \u0161ok pri preprave a \u010di nov\u00e1 infra\u0161trukt\u00fara fabriky (nap\u00e1janie, chladenie, \u010dist\u00fd stla\u010den\u00fd vzduch) st\u00edha k\u0155mi\u0165 hladn\u00e9 elektromagnetick\u00e9 segmenty dr\u00e1hy.<\/p>\n\n\n\n

\"\"<\/figure>\n<\/blockquote>\n\n\n\n

IQ a OQ: Ke\u010f sa overuje ka\u017ed\u00e1 skrutka a h\u013eadaj\u00fa sa katastrofy<\/h2>\n\n\n\n

Po \u00faspe\u0161nom SAT nastupuje skuto\u010dn\u00e9 papierov\u00e9 peklo rozdelen\u00e9 na dve hlavn\u00e9 f\u00e1zy: IQ<\/strong> and OQ<\/strong><\/a>. Pre mont\u00e1\u017enika to znamen\u00e1 stovky str\u00e1n protokolov, kde mus\u00edte urobi\u0165 kr\u00ed\u017eik a da\u0165 svoj vlastn\u00fd podpis ku ka\u017ed\u00e9mu jedn\u00e9mu \u00fakonu.<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

1. IQ (Installation Qualification) \u2013 In\u0161tala\u010dn\u00e1 kvalifik\u00e1cia<\/h3>\n\n\n\n

V tejto f\u00e1ze sa kontroluje, \u010di je ma\u0161ina postaven\u00e1 presne pod\u013ea v\u00fdkresov. A pod pojmom \u201epresne\u201c mysl\u00ed farm\u00e1cia tot\u00e1lny extr\u00e9m.<\/p>\n\n\n\n