{"id":5090,"date":"2025-05-05T07:46:30","date_gmt":"2025-05-05T07:46:30","guid":{"rendered":"https:\/\/www.centogene.com\/?page_id=5090"},"modified":"2025-06-03T14:31:16","modified_gmt":"2025-06-03T14:31:16","slug":"procedimento-de-reclamacao-do-cliente","status":"publish","type":"page","link":"https:\/\/www.centogene.com\/pt\/customer-complaint-procedure\/","title":{"rendered":"Procedimento de Reclama\u00e7\u00e3o do Cliente"},"content":{"rendered":"
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Procedimento de Reclama\u00e7\u00e3o do Cliente<\/h1>\n\n\n\n

Reclama\u00e7\u00f5es de clientes<\/strong> S\u00e3o comunica\u00e7\u00f5es escritas, eletr\u00f4nicas ou orais referentes a supostas defici\u00eancias na identidade, qualidade, durabilidade, confiabilidade, usabilidade, seguran\u00e7a ou desempenho de um produto oferecido pela CENTOGENE. Essas reclama\u00e7\u00f5es podem se referir a produtos que j\u00e1 foram liberados do controle da CENTOGENE ou a servi\u00e7os que impactam o desempenho desses produtos.<\/p>\n\n\n\n

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Procedimento<\/strong><\/h6>\n\n\n\n

Cada funcion\u00e1rio da CENTOGENE pode receber uma reclama\u00e7\u00e3o de um cliente por meio de comunica\u00e7\u00e3o pessoal, telefone, fax, correio ou e-mail. \u00c9 responsabilidade de cada funcion\u00e1rio encaminhar imediatamente (em at\u00e9 24 horas) essas reclama\u00e7\u00f5es ao departamento de Suporte ao Cliente (customer.support@centogene.com), fornecendo uma descri\u00e7\u00e3o detalhada do problema.<\/p>\n\n\n\n

O Suporte ao Cliente coleta e monitora todas as informa\u00e7\u00f5es relacionadas \u00e0 seguran\u00e7a do paciente e \u00e0 satisfa\u00e7\u00e3o do cliente, incluindo feedbacks ou reclama\u00e7\u00f5es sobre os produtos e servi\u00e7os da CENTOGENE. O Suporte ao Cliente ou o funcion\u00e1rio em contato com o cliente informa que a reclama\u00e7\u00e3o foi recebida e est\u00e1 sendo processada. Internamente, um Evento de Qualidade \u00e9 iniciado para documentar as informa\u00e7\u00f5es e a descri\u00e7\u00e3o iniciais.<\/p>\n\n\n\n

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Avalia\u00e7\u00e3o inicial<\/strong><\/h6>\n\n\n\n

Todos os detalhes relevantes s\u00e3o inseridos no evento. As informa\u00e7\u00f5es s\u00e3o avaliadas para determinar se s\u00e3o coment\u00e1rios ou reclama\u00e7\u00f5es.<\/p>\n\n\n\n

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Investiga\u00e7\u00e3o e Avalia\u00e7\u00e3o de Riscos<\/h2>\n\n\n\n

Em caso de reclama\u00e7\u00f5es v\u00e1lidas, o problema ser\u00e1 investigado e resolvido, com a equipe de Suporte ao Cliente tomando as medidas necess\u00e1rias para solucion\u00e1-lo. Durante a investiga\u00e7\u00e3o, s\u00e3o realizadas uma an\u00e1lise da causa raiz (por exemplo, 5 Porqu\u00eas, Ishikawa) e uma an\u00e1lise de risco, a fim de determinar se o problema \u00e9 grave. in vitro<\/em> O dispositivo m\u00e9dico de diagn\u00f3stico (IVD*) reclamado foi a causa da reclama\u00e7\u00e3o. Al\u00e9m disso, verifica-se se outros IVDs, processos, equipamentos, amostras de pacientes, etc., s\u00e3o afetados pelo problema e se j\u00e1 houve reclama\u00e7\u00f5es anteriores com o mesmo problema.<\/p>\n\n\n\n

Ap\u00f3s a identifica\u00e7\u00e3o da causa raiz, s\u00e3o tomadas medidas\/corre\u00e7\u00f5es imediatas e desenvolvidas estrat\u00e9gias e a\u00e7\u00f5es destinadas a prevenir ocorr\u00eancias futuras ou a reduzir a frequ\u00eancia dos problemas.<\/p>\n\n\n\n

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Decis\u00e3o de Notifica\u00e7\u00e3o de IVD<\/h2>\n\n\n\n

Se a reclama\u00e7\u00e3o afetar ou puder afetar IVDs (dispositivos de diagn\u00f3stico in vitro) e constituir um evento de notifica\u00e7\u00e3o obrigat\u00f3ria, o Respons\u00e1vel pela Conformidade Regulat\u00f3ria (PRRC) e o Representante da Gest\u00e3o da Qualidade (QMR) devem ser informados imediatamente \u2013 no m\u00e1ximo em 1 dia \u00fatil ap\u00f3s tomarem conhecimento da reclama\u00e7\u00e3o. <\/p>\n\n\n\n

Para determinar se o evento pode ser notific\u00e1vel, considera-se o seguinte:<\/p>\n\n\n\n

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  • Seguran\u00e7a do Paciente: A reclama\u00e7\u00e3o sugere um risco real ou potencial para a seguran\u00e7a do paciente?<\/li>\n\n\n\n
  • Desempenho do produto: O problema est\u00e1 relacionado a uma falha ou deteriora\u00e7\u00e3o nas caracter\u00edsticas ou no desempenho do produto IVD?<\/li>\n<\/ul>\n\n\n\n
    <\/div>\n\n\n\n

    Resolu\u00e7\u00e3o de reclama\u00e7\u00f5es<\/h2>\n\n\n\n

    Ap\u00f3s receber a resolu\u00e7\u00e3o adequada, o Suporte ao Cliente comunica isso ao cliente e conclui a documenta\u00e7\u00e3o do evento.<\/p>\n\n\n\n

    Um relat\u00f3rio 8D pode ser emitido mediante solicita\u00e7\u00e3o.<\/p>\n\n\n\n

    <\/div>\n\n\n\n

    Decis\u00e3o e Encerramento Final da CAPA<\/h2>\n\n\n\n

    Como etapa final, decide-se se uma A\u00e7\u00e3o Corretiva e Preventiva (CAPA) \u00e9 necess\u00e1ria de acordo com crit\u00e9rios definidos, e o evento \u00e9 encerrado.<\/p>\n\n\n\n

    <\/div>\n\n\n\n

    *IVD: Inclui IVDs com marca\u00e7\u00e3o CE e IVDs desenvolvidos internamente (LDTs)<\/p>\n\n\n\n

    <\/div>\n\n\n\n

    Procedimento resumido<\/h2>\n\n\n\n

    Reclama\u00e7\u00e3o recebida \u2192<\/strong> Resposta ao cliente e evento aberto \u2192<\/strong> avalia\u00e7\u00e3o inicial (feedback\/reclama\u00e7\u00e3o) \u2192<\/strong> Investiga\u00e7\u00e3o e avalia\u00e7\u00e3o de riscos, incluindo an\u00e1lise da causa raiz, an\u00e1lise de riscos e a\u00e7\u00f5es imediatas. \u2192<\/strong> decis\u00e3o de notifica\u00e7\u00e3o de IVD \u2192<\/strong> Resolu\u00e7\u00e3o de reclama\u00e7\u00f5es \u2192<\/strong> Decis\u00e3o e evento CAPA encerrados<\/p>\n\n<\/div>\r\n \r\n <\/div>\r\n <\/div> \r\n <\/div>\r\n <\/div>\r\n<\/section>","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-5090","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nCustomer Complaint Procedure | 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