{"id":4334,"date":"2025-06-18T08:43:25","date_gmt":"2025-06-18T08:43:25","guid":{"rendered":"https:\/\/www.ub.edu\/creatio\/?post_type=actualitat&p=4334"},"modified":"2025-06-18T08:52:24","modified_gmt":"2025-06-18T08:52:24","slug":"claus-per-una-auditoria","status":"publish","type":"actualitat","link":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/","title":{"rendered":"Preparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3)"},"content":{"rendered":"\n

Per qu\u00e8 ens auditen?<\/strong><\/p>\n\n\n\n

La gesti\u00f3 de la qualitat a Creatio \u00e9s fonamental per garantir la confian\u00e7a i tra\u00e7abilitat dels resultats i activitats realitzades. En els nostres laboratoris, on treballem amb processos innovadors i complexos, la implementaci\u00f3 d\u2019un sistema de gesti\u00f3 de qualitat robust \u00e9s essencial per complir amb els est\u00e0ndards reguladors i assegurar que cada etapa del proc\u00e9s de recerca i desenvolupament es realitzi de forma \u00f2ptima.<\/p>\n\n\n\n

El nostre sistema de gesti\u00f3 de qualitat ens permet identificar i corregir possibles errors abans que afectin els resultats finals. A m\u00e9s a m\u00e9s, la gesti\u00f3 de la qualitat fomenta una cultura de millora cont\u00ednua, on es busca constantment optimitzar els processos i procediments per assolir nivells superiors d\u2019excel\u00b7l\u00e8ncia.<\/p>\n\n\n\n

No obstant aix\u00f2, no nom\u00e9s val una declaraci\u00f3 d\u2019intensions, \u00e9s indispensable demostrar davant les autoritats reguladores i certificadores el compliment de les normatives establertes. Per aix\u00f2, ens sotmetem a auditories que valoren l\u2019excussi\u00f3 reguladora i normativa, sent crucial que aquestes auditories es desenvolupin de forma satisfact\u00f2ria.<\/p>\n\n\n\n

A continuaci\u00f3, et presentem una s\u00e8rie de consells per assegurar que una auditoria es realitzi \u00f2ptimament.<\/p>\n\n\n\n

Qu\u00e8 he de tenir en compte abans d\u2019una auditoria?<\/strong><\/p>\n\n\n\n

Preparar amb antelaci\u00f3 l\u2019auditoria et permetr\u00e0 estar m\u00e9s preparat davant imprevistos que poden posar-te davant una situaci\u00f3 inc\u00f2moda. \u00c9s important valorar els seg\u00fcents punts:<\/p>\n\n\n\n

Realitzar una presentaci\u00f3 per a tots els auditors: <\/strong>si \u00e9s la primera vegada que es realitza l’auditoria, o els auditors no estan familiaritzats amb el centre, realitza una breu presentaci\u00f3 amb una visi\u00f3 global, els ajudar\u00e0 a situar-se, i si la realitza la direcci\u00f3, valoraran positivament la seva implicaci\u00f3 durant l\u2019auditoria.<\/p>\n\n\n\n

Comunicar el pla d\u2019auditoria<\/strong> a tot el personal: informar a tot el personal del programa, els ajudar\u00e0 a fer-se una impressi\u00f3 del que s\u2019auditar\u00e0 i de qui ser\u00e0 necessari estar accessible perqu\u00e8 l\u2019auditoria sigui fluida.<\/p>\n\n\n\n

Trobar espais adequats<\/strong> per l\u2019auditoria que garanteixin les necessitats de l’equip auditor: un bon entorn de treball far\u00e0 que l\u2019auditoria sigui menys pesada. \u00c9s important tenir en compte si \u00e9s necessari tenir acc\u00e9s a documents digitals, prou espai per entregar i revisar la documentaci\u00f3, incl\u00fas un espai reservat per tal que els auditors puguin reunir-se i discutir de forma m\u00e9s privada.<\/p>\n\n\n\n

Mantenir un espai de treball ordenat<\/strong>: \u00e9s important que durant l\u2019auditoria l’espai reflecteixi la professionalitat, l\u2019ordre i el control amb el qual treballem. Que tot tingui el seu lloc, i que aquest sigui de f\u00e0cil acc\u00e9s i senzill de trobar. Estalviar\u00e0 molt de temps en buscar tota la documentaci\u00f3 que sol\u00b7liciten.<\/p>\n\n\n\n

Com enfronto l\u2019auditoria?<\/strong><\/p>\n\n\n\n

\u00c9s comprensible que davant una auditoria se sentin nervis, at\u00e8s que es desitgi que tot transcorri de la millor manera possible. Per evitar que es produeixin contratemps, us oferim alguns consells:<\/p>\n\n\n\n

Recorda que ning\u00fa millor que el personal de la mateixa \u00e0rea per explicar la manera de treballar en el dia a dia. Sigues part\u00edcip del sistema<\/strong> i amb la seguretat que ho pots fer molt b\u00e9.<\/p>\n\n\n\n

Quan l\u2019auditor\/a faci una pregunta, nom\u00e9s dona la informaci\u00f3 que et demana i mostra aquesta documentaci\u00f3 espec\u00edfica<\/strong>. No \u00e9s necessari entrar en temes relacionats, si no es requereix.<\/p>\n\n\n\n

Per sentir-te segur\/a \u00e9s molt aconsellable tenir la documentaci\u00f3 f\u00e0cilment localitzable<\/strong>, com s\u2019ha esmentat anteriorment. En cas que no trobis algun document en el moment que t\u2019ho demanen, no et preocupis. Simplement, pots demanar que continu\u00efn amb el punt seg\u00fcent i que et deixin un espai de temps per localitzar-lo, preguntant a la persona que saps que et pot ajudar a trobar-lo o el que necessitis. Per aix\u00f2, \u00e9s fonamental que les persones que treballen a l\u2019\u00e0rea s\u00e0piguen trobar la documentaci\u00f3 rellevant del laboratori, com PNTs, registres de dades, calibratges, manteniment, entre altres.<\/p>\n\n\n\n

En el cas que es detecti algun error, \u00e9s important tenir bona disposici\u00f3<\/strong> per solucionar-ho.<\/p>\n\n\n\n

\u00c9s possible que en alguna ocasi\u00f3 no estigueu d\u2019acord amb les deteccions de l\u2019equip auditor. Quan aquestes es mencionin durant l\u2019auditoria, o en finalitzar-la, podr\u00e0s dir la teva opini\u00f3<\/strong>, sempre mostrant la documentaci\u00f3 que la recolza. I, per descomptat, aclareix tots els teus dubtes<\/strong>, tant amb l\u2019equip auditor, com amb el personal de Garantia de Qualitat.<\/p>\n\n\n\n

No oblidis comentar els resultats de l\u2019auditoria amb els teus companys i companyes. Recorda que treball en equip<\/strong> \u00e9s fonamental per evolucionar amb Qualitat.<\/p>\n\n\n\n

Conclusi\u00f3<\/strong><\/p>\n\n\n\n

Les auditories no s\u2019han de veure com a obstacles, sin\u00f3 com a punts de control essencials en la millora cont\u00ednua dels processos de recerca biom\u00e8dica i desenvolupament de medicaments. Amb una preparaci\u00f3 rigorosa, una comunicaci\u00f3 clara i una s\u00f2lida cultura de qualitat, les auditories esdevenen una oportunitat per refor\u00e7ar l\u2019excel\u00b7l\u00e8ncia i garantir el compliment amb confian\u00e7a.<\/p>\n\n\n\n

Aquest article ha estat redactat per M\u00aa Jos\u00e9 Garc\u00eda i Felipe Chiappe, del Departament d\u2019Assegurament de la Qualitat de Creatio.<\/p>\n","protected":false},"author":1,"featured_media":4345,"template":"","acf":[],"yoast_head":"\nPreparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3) - Creatio<\/title>\n<meta name=\"description\" content=\"Consells per dur a terme una auditoria amb \u00e8xit en el desenvolupament de medicaments, ter\u00e0pies avan\u00e7ades\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Preparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3) - Creatio\" \/>\n<meta property=\"og:description\" content=\"Consells per dur a terme una auditoria amb \u00e8xit en el desenvolupament de medicaments, ter\u00e0pies avan\u00e7ades\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/\" \/>\n<meta property=\"og:site_name\" content=\"Creatio\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-18T08:52:24+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2025\/06\/BL7A9527-1-1-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2048\" \/>\n\t<meta property=\"og:image:height\" content=\"1365\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@Creatio_UB\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/\",\"url\":\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/\",\"name\":\"Preparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3) - Creatio\",\"isPartOf\":{\"@id\":\"https:\/\/www.ub.edu\/creatio\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2025\/06\/BL7A9527-1-1-scaled.jpg\",\"datePublished\":\"2025-06-18T08:43:25+00:00\",\"dateModified\":\"2025-06-18T08:52:24+00:00\",\"description\":\"Consells per dur a terme una auditoria amb \u00e8xit en el desenvolupament de medicaments, ter\u00e0pies avan\u00e7ades\",\"breadcrumb\":{\"@id\":\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#primaryimage\",\"url\":\"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2025\/06\/BL7A9527-1-1-scaled.jpg\",\"contentUrl\":\"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2025\/06\/BL7A9527-1-1-scaled.jpg\",\"width\":2048,\"height\":1365},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\/\/www.ub.edu\/creatio\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Preparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.ub.edu\/creatio\/#website\",\"url\":\"https:\/\/www.ub.edu\/creatio\/\",\"name\":\"Creatio\",\"description\":\"Production and validation center of advanced therapies\",\"publisher\":{\"@id\":\"https:\/\/www.ub.edu\/creatio\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.ub.edu\/creatio\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.ub.edu\/creatio\/#organization\",\"name\":\"Creatio\",\"url\":\"https:\/\/www.ub.edu\/creatio\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/www.ub.edu\/creatio\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2021\/12\/creatio-logo.png\",\"contentUrl\":\"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2021\/12\/creatio-logo.png\",\"width\":698,\"height\":110,\"caption\":\"Creatio\"},\"image\":{\"@id\":\"https:\/\/www.ub.edu\/creatio\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/x.com\/Creatio_UB\",\"https:\/\/www.linkedin.com\/company\/creatio-ub\",\"https:\/\/www.instagram.com\/creatio.ub\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Preparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3) - Creatio","description":"Consells per dur a terme una auditoria amb \u00e8xit en el desenvolupament de medicaments, ter\u00e0pies avan\u00e7ades","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/","og_locale":"es_ES","og_type":"article","og_title":"Preparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3) - Creatio","og_description":"Consells per dur a terme una auditoria amb \u00e8xit en el desenvolupament de medicaments, ter\u00e0pies avan\u00e7ades","og_url":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/","og_site_name":"Creatio","article_modified_time":"2025-06-18T08:52:24+00:00","og_image":[{"width":2048,"height":1365,"url":"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2025\/06\/BL7A9527-1-1-scaled.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_site":"@Creatio_UB","twitter_misc":{"Tiempo de lectura":"4 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/","url":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/","name":"Preparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3) - Creatio","isPartOf":{"@id":"https:\/\/www.ub.edu\/creatio\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#primaryimage"},"image":{"@id":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#primaryimage"},"thumbnailUrl":"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2025\/06\/BL7A9527-1-1-scaled.jpg","datePublished":"2025-06-18T08:43:25+00:00","dateModified":"2025-06-18T08:52:24+00:00","description":"Consells per dur a terme una auditoria amb \u00e8xit en el desenvolupament de medicaments, ter\u00e0pies avan\u00e7ades","breadcrumb":{"@id":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#primaryimage","url":"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2025\/06\/BL7A9527-1-1-scaled.jpg","contentUrl":"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2025\/06\/BL7A9527-1-1-scaled.jpg","width":2048,"height":1365},{"@type":"BreadcrumbList","@id":"https:\/\/www.ub.edu\/creatio\/actualitat\/claus-per-una-auditoria\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/www.ub.edu\/creatio\/"},{"@type":"ListItem","position":2,"name":"Preparats per a les Auditories (Direcci\u00f3 i Gesti\u00f3)"}]},{"@type":"WebSite","@id":"https:\/\/www.ub.edu\/creatio\/#website","url":"https:\/\/www.ub.edu\/creatio\/","name":"Creatio","description":"Production and validation center of advanced therapies","publisher":{"@id":"https:\/\/www.ub.edu\/creatio\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.ub.edu\/creatio\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/www.ub.edu\/creatio\/#organization","name":"Creatio","url":"https:\/\/www.ub.edu\/creatio\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.ub.edu\/creatio\/#\/schema\/logo\/image\/","url":"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2021\/12\/creatio-logo.png","contentUrl":"https:\/\/www.ub.edu\/creatio\/wp-content\/uploads\/2021\/12\/creatio-logo.png","width":698,"height":110,"caption":"Creatio"},"image":{"@id":"https:\/\/www.ub.edu\/creatio\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/x.com\/Creatio_UB","https:\/\/www.linkedin.com\/company\/creatio-ub","https:\/\/www.instagram.com\/creatio.ub\/"]}]}},"lang":"ca","translations":{"ca":4334,"es":4336,"en":4338},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/www.ub.edu\/creatio\/wp-json\/wp\/v2\/actualitat\/4334"}],"collection":[{"href":"https:\/\/www.ub.edu\/creatio\/wp-json\/wp\/v2\/actualitat"}],"about":[{"href":"https:\/\/www.ub.edu\/creatio\/wp-json\/wp\/v2\/types\/actualitat"}],"author":[{"embeddable":true,"href":"https:\/\/www.ub.edu\/creatio\/wp-json\/wp\/v2\/users\/1"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.ub.edu\/creatio\/wp-json\/wp\/v2\/media\/4345"}],"wp:attachment":[{"href":"https:\/\/www.ub.edu\/creatio\/wp-json\/wp\/v2\/media?parent=4334"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}