Use of video SOP at the pharmaceutical quality system management as alternative to reduce deviations ocurrence

Authors

DOI:

https://doi.org/10.33448/rsd-v9i12.10811

Keywords:

SOP video; Standard Operational Procedure; Deviations; Training; Pharmaceutical Quality System Management.

Abstract

In the presente article, it was performed the analyse of the obtained results with the implementation of Standard Operating Procedure with video, analternative called vídeo SOP, in a multinational company in the pharmaceutical industry. The company had a history of records of quality deviations related to procedures and training, such as lack of adherence by employees, lack of detailed instructions for operations, etc. After realizing that some implemented corrective actions were not effective in reducing the number of deviations, the proposed solution was to use explanatory videos as part of the standard operating procedure. With the adopted measure, it was expected that the audio visual resource would facilitate to fix the SOPs content during training, improving the adherence of employees in practice. The general objective of the article was to evaluate data on quality deviations of the company one year after the implementation of the vídeo SOP to check if there were improvements and if the action can be considered effective. The comparison between the number of deviations before and after the adopted measure demonstrates that the use of vídeo SOP has brought benefits to the company.

Author Biographies

Antonio Henriques de Araujo Junior, Universidade do Estado do Rio de Janeiro

In 2019, she developed a research project on economic aspects of wind power generation in partnership with the University of Porto (FEUP) and the Institute of Science and Innovation (INEGI), as well as with the Production and Systems Department (DPS) University of Minho, both institutions, based in Portugal. In September 2015, at the University of Minho, Portugal, she completed a post-doctoral research on relative efficiency between Brazilian and European ports with CAPES Grant support BEX-1445 / 14-6. Graduated in Transport Engineering (Ingenieurbauwesen) from Bergische Universitaet Wuppertal (Germany, 1976), Master in Controllership and Accounting from the University of São Paulo (1990) and PhD in Production Engineering from the Polytechnic School of the University of São Paulo (2004). Conducted postdoctoral research with CNPQ research grant, Grant CNPQ 154203/2006 - 8, at the Instituto Tecnológico de Aeronáutica (Aeronautical Mechanics division - Production Department, 2006-2007). He worked in the Economic and Strategic Management of the automotive industry (Daimler-Benz and Mercedes-Benz do Brasil) and aeronautics (Empresa Brasileira de Aeronáutica - EMBRAER). He is currently an Associate Professor at the State University of Rio de Janeiro (UERJ), in the Department of Production Engineering (Faculty of Technology), where he is responsible for the subjects Economic Engineering I and II, Industrial Costs and Research Methodology. The editorial board of the journals comprises: Journal of Aerospace Technology and Management, Publishing Management Systems (ISSN: 2175-9146), Science Journal of Business Management (ISSN: 2276-6316), Rio´s International Journal on Sciences of Industrial and Systems Engineering and Management (ISSN: 1982-6443), Revista Carioca de Produção (ISSN: 1984-4743) and Systems & Management (ISSN: 1980-5160). Reviewer of journals: Journal of Air Transport Management (ISBN: 0969-6997), Journal of Business Management (ISSN: 2276-6316), Metallurgy, Materials and Mining Technology (ISSN: 1807-300X), Accounting and Controllership Magazine, UFPR (ISSN: 1984-6266), and Systems & Management (ISSN: 1980-5160). He is also an evaluator of articles at the following symposia: National Meeting of Graduate Courses in Administration (ENANGRAD), National Meeting of Production Engineering (ENEGEP), Brazilian Congress of Costs (CBC) and Congress of the Brazilian Society for Operational Research ( SBPO). Operates in the research areas: Industrial Productivity, Air Transport Efficiency and Effectiveness, Transport Productivity, Air Transport Economics, Quality and Productivity Management and Environmental Economics. He is an appraiser of the Regional Accreditation System for MERCOSUR Undergraduate Courses, a national appraiser in the Institutional modality and of courses from the Ministry of Education and Culture (National Institute of Educational Studies and Research Anísio Teixeira - INEP), in addition to being part of the National Bank of Items of ENADE. He is a founding partner of Red Ibero Americana de Investigación en Transporte Aereo.

José Glenio Medeiros de Barros, Universidade do Estado do Rio de Janeiro

With a PhD in Production Engineering from the Federal University of Rio de Janeiro (1999), he is an Associate Professor at the State University of Rio de Janeiro having already been an Assistant Professor at the University of Taubaté for over 13 years. He has been working for more than 20 years in the area of Production Engineering, especially in the areas of Manufacturing Management, Statistical Process Control, Quality Management, Productivity and Production Administration. With research and work developed in various companies and institutions, he worked, in particular, in the following sectors: automobile industry, metal-mechanical industry, chemical industry, shipbuilding, aeronautical industry and universities. He is also an evaluator of undergraduate courses and higher education institutions at INEP / MEC.

Nilo Antonio Souza Sampaio, Universidade do Estado do Rio de Janeiro

PhD in Mechanical Engineering from Universidade Estadual Paulista (UNESP-FEG), Master in Mechanical Engineering from Universidade de Taubaté (UNITAU), Chemical Engineer from Universidade de São Paulo (EEL / USP). He is currently an Adjunct Professor at the State University of Rio de Janeiro teaching undergraduate courses in Production Engineering, Mechanical Engineering and Chemical Engineering. He works with Mathematics and Statistics, with an emphasis on Applications of Statistics and Mathematics in Sciences, Experiment Planning, Multivariate Statistics and Process Monitoring. He has several articles published in journals and annals of national and international scientific events.https: //orcid.org/0000-0002-6168-785X https://publons.com/researcher/1768265/nilo-as-sampaio/

José Wilson de Jesus Silva, Centro Universitário Teresa D'Ávila

Pós-Doutorado em Engenharia de Materiais pela Universidade Estadual Paulista Júlio de Mesquita Filho, Campus de Guaratinguetá - UNESP-FEG (2015), Doutorado em Engenharia Mecânica pela Universidade Estadual Paulista Júlio de Mesquita Filho, UNESP-FEG (2011), Mestrado em Engenharia Mecânica pela Universidade Estadual Paulista Júlio de Mesquita Filho UNESP-FEG (2003) e Graduação em Engenharia Civil pela Universidade Estadual Paulista Júlio de Mesquita Filho, UNESP-FEG (2000). Atualmente é Professor Titular I e Coordenador do Laboratório de Design de Joias do Centro Universitário Teresa DÁvila - UNIFATEA, membro do Instituto Superior de Pesquisa e Iniciação Científica - ISPIC/UNIFATEA, membro do Comitê de Ética em Pesquisa do UNIFATEA, Professor do Programa de Pós-Graduação Stricto Sensu, UNIFATEA - Mestrado Profissional em Design, Tecnologia e Inovação, Professor do curso de Arquitetura e Urbanismo - UNIFATEA, Professor na Associação Educacional Dom Bosco, AEDB, para o curso de Engenharia Civil e Professor colaborador no departamento de química da UNESP, Campus de Guaratinguetá. Possui experiência em ensino, pesquisa e extensão nas áreas de Desenho Industrial, Design de Joias de Nióbio, Línguas Estrangeiras, Engenharia Civil, Mecânica e Produção, com ênfase em Novos Materiais, Planejamento de Experimentos, Corrosão, Caracterização Microestrutural e Gerenciamento da Cadeia de Suprimentos.

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Published

16/12/2020

How to Cite

SILVA, C. B. da .; ARAUJO JUNIOR, A. H. de .; BARROS, J. G. M. de . .; SAMPAIO, N. A. S. .; SILVA, J. W. de J. Use of video SOP at the pharmaceutical quality system management as alternative to reduce deviations ocurrence. Research, Society and Development, [S. l.], v. 9, n. 12, p. e16091210811, 2020. DOI: 10.33448/rsd-v9i12.10811. Disponível em: https://rsdjournal.org/index.php/rsd/article/view/10811. Acesso em: 19 apr. 2024.

Issue

Vol. 9 No. 12

Section

Health Sciences

License

Copyright (c) 2020 Catilene Barboza da Silva; Antonio Henriques de Araujo Junior; José Glenio Medeiros de Barros; Nilo Antonio Souza Sampaio; José Wilson de Jesus Silva

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