Critical factors for the implementation of ISO45001 in the view of managers of pharmaceutical companies
DOI:
https://doi.org/10.33448/rsd-v12i2.40359Keywords:
Occupational health; Certification; Drug industry; Safety management; Health management.Abstract
Occupational accidents and occupational diseases stand out in society because of their deleterious effect on the physical integrity of the human being, in addition to the direct and indirect costs that fall on the government and organizations. The implementation of ISO 45001 acts as a management tool with the potential to improve the organization's performance for occupational health and safety outcomes, as it reduces the risks of occupational accidents and diseases. The objective of this research was to identify the main critical factors related to the implementation of the ISO 45001 Standard in the view of its managers, in companies in the pharmaceutical sector, located in the Southeast region of Brazil. The methodological approach used was qualitative research with a multiple case study, based on semi-structured interviews. As a result, it was evidenced that the main critical factors for the implementation of ISO 45001 are directly related to the level of commitment of the company's senior management to occupational health and safety issues. Thus, the propositions resulting from the study suggest that the greater and more effective the commitment of leadership to occupational health and safety, the less complex the implementation of iso 45001 and the greater the adherence of managers and employees involved.
References
Abad, J., Dalmau, I., & Vilajosana, J. (2014). Taxonomic proposal for integration levels of management systems based on empirical evidence and derived corporate benefits. Journal of Cleaner Production, 78, 164–173. https://doi.org/10.1016/j.jclepro.2014.04.084
Badri, A., Boudreau-Trudel, B., & Souissi, A. S. (2018). Occupational health and safety in the industry 4.0 era: A cause for major concern? Safety Science, 109, 403–411. https://doi.org/10.1016/j.ssci.2018.06.012
BNDES – Banco Nacional do Desenvolvimento Econômico e Social (2005). Inovação farmacêutica: padrão setorial e perspectivas para o caso brasileiro.
BNDES – Banco Nacional do Desenvolvimento Econômico e Social (2006). A indústria farmacêutica brasileira e a atuação do BNDES.
Brito, A. C. F., Pontes, D. L. (2016). A indústria farmacêutica. Universidade Federal do Rio Grande do Norte.
Camargo, D., & Sartori, R. V. (2016). Análise do Sistema de Gestão Integrado: estudo de caso em uma indústria farmacêutica. Engenharia Ambiental – Espírito Santo do Pinhal, 13(1), 95-106.
Campailla, C., Martini, A., Minini, F., & Sartori, F. (2019). Quality Management: Tools, Methods and Standards. Emerald Publishing Limited, 217-243.
Cordeiro, R. A inadequação da classificação geral dos acidentes do trabalho no Brasil (2018). Cadernos de Saúde Pública, 34(2), 1-7. http://cadernos.ensp.fiocruz.br/csp/artigo/356/a-inadequacao-da-classificacao-oficial-dos-acidentes-de-trabalho-no-brasil
Creswell, J. W. (2010). Projeto de pesquisa: métodos qualitativo, quantitativo e misto (3a ed.). Artmed.
Darabont, D. C., Antonov, A.E., & Bejinariu, C (2017). Key elements on implementing an occupational health and safety management system using ISO 45001 standard. MATEC Web of Conferences, 121, 11007. https://doi.org/10.1051/matecconf/201712111007
Drucker, P.F. (2002). Prática da Administração de Empresas. Pioneira Thompson.
Fernández, F. B., & Pérez, M. N. S. (2015). Analysis and Modeling of New and Emerging Occupational Risks in the Context of Advanced Manufacturing Processes. Procedia Engineering, 100, 1150–1159. https://doi.org/10.1016/j.proeng.2015.01.478
Flanagan, R. J. (2006). Globalization and labor conditions: workers conditions and worker rights in a global economy. Oxford University Press.
Forster, N. S., & Rockart, J. F. Critical Success Factors: an annotated bibliography. (1989). Massachusetts Institute of Technology.
FUNDACENTRO – Fundação Jorge Duprat Figueiredo de Segurança e Medicina do Trabalho. (2020). Brasil registra 17 mil mortes e 4 milhões de acidentes do trabalho. http://www.fundacentro.gov.br/noticias/detalhe-da-noticia/2019/4/
Gil, A.C. (2016). Métodos e Técnicas de Pesquisa Social. Atlas.
Górny, A. (2015). Occupational Health and Safety Management In The International Condition (Consistent With Objectives The ISO45001 Standard). Research Journal, 4, 73-88.
ILO – International Labour Organization. (2020). Safety and health at work. https://www.ilo.org/global/topics/safety-and-health-at-work/lang--en/index.htm.
INTERFARMA – Associação da Indústria Farmaacêutica de Pesquisa. (2021). Interfarma divulga guia com ranking das maiores indústrias farmacêuticas. https://revistadafarmacia.com.br/industria/interfarma-divulga-guia-com-ranking-das-maiores-industrias-farmaceuticas/
Jain, A., Leka, S., & Zwetsloot, G. I. J. M. (2018). Work, Health, Safety and Well-Being: Current State of the Art. Aligning Perspectives on Health, Safety and Well-Being, 1–31. https://doi.org/10.1007/978-94-024-1261-1_1
Jones, R. (2017). ISO 45001 and the evolution of occupational health and safety management systems. Institution of Occupational Safety and Health Paper. https://iosh.com/media/4413/iso_45001_and_the_evolution_of_ohsms.pdf.
Kretchy, I.A., Asiedu-Danso, M., & Kretchy, J-P. (2020). Medication management and adherence during the COVID-19 pandemic:Perspectives and experiences from low-and middle-income countries. Research in Social and Administrative Pharmacy, 17(1), 2023-2026.
Malerba, F., & Orsenigo, L. (2015). The evolution of the pharmaceutical industry. Business History, 57(5), 664–687. https://doi.org/10.1080/00076791.2014.975119
Martins, G. A., & Theóphilo, C. R. (2016). Metodologia da investigação científica para ciências sociais aplicadas. Atlas.
Morgado, L., Silva, F., & Fonseca, L. (2019). Mapping Occupational Health and Safety Management Systems in Portugal: outlook for ISO 45001:2018 adoption. Procedia Manufacturing, 38, 755–764. https://doi.org/10.1016/j.promfg.2020.01.103
Neag, P. N., Ivascu, L., & Draghici, A. (2020). A debate on issues regarding the new ISO 45001:2018 standard adoption. MATEC Web of Conferences, 305, 00002. https://doi.org/10.1051/matecconf/202030500002
OIT – Organización Internacional del Trabajo. (2003). La Seguridad en Cifras: sugerencias para uma cultura general em matéria de seguridad em el trabajo. https://www.ilo.org/legacy/english/protection/safework/worldday/report_esp.pdf
Podgórski, D., Majchrzycka, K., Dąbrowska, A., Gralewicz, G., & Okrasa, M. (2016). Towards a conceptual framework of OSH risk management in smart working environments based on smart PPE, ambient intelligence and the Internet of Things technologies. International Journal of Occupational Safety and Ergonomics, 23(1), 1–20. https://doi.org/10.1080/10803548.2016.1214431
Purwanto, A., Putri, R. S., Ahmad, A. H., Asbari, M., Bernarto, I., Santoso, P. B., & Sihite, O. B. (2020). The Effect of Implementation Integrated Management System ISO 9001, ISO 14001, ISO 22000 and ISO 45001 on Indonesian Food Industries Performance. Test Engineering & Management, 82, 14054-14069.
Rocha, C. S., & Souza, B. J. Compreendendo a nova Norma ISO 45001 e sua relação com a OHSAS 18001. In Anais Encontro Nacional de Engenharia de Produção. São Paulo, Brasil: ENEGEP.
Seker, S. (2019). Analyzing occupational risks of pharmaceutical industry under uncertainty using a Bow-Tie analysis. An International Journal of Optimization and Control: Theories & Applications, 9(2), 113-124.
Simon, A., Yaya, L. H. P., Karapetrovic, S., & Casadesús, M. (2014). An empirical analysis of the integration of internal and external management system audits. Journal of Cleaner Production, 66, 499–506. https://doi.org/10.1016/j.jclepro.2013.11.020
Takala, J., Hämäläinen, P., Saarela, K. L., Yun, L. Y., Manickam, K., Jin, T. W., Heng, P., Tjong, C., Kheng, L. G., Lim, S., & Lin, G. S. (2014). Global Estimates of the Burden of Injury and Illness at Work in 2012. Journal of Occupational and Environmental Hygiene, 11(5), 326–337. https://doi.org/10.1080/15459624.2013.863131
Vergara, S. H. C. (n.d.). Projetos e Relatórios de Pesquisa em Administração. ATLAS.
Yin, R. K. (2022). Estudo de Caso. Planejamento e Métodos. Bookman.
Yin, R. K. (2016). Pesquisa qualitativa do início ao fim. Penso.
Zivikovic, S., & Petrovic, D. (2015). Integrated Protection Model – ISO 45001 as a Future of Safety and Health Standards. Megatrend Review, 12(3), 165-182.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2023 Eliana Sgarbi de Carvalho Potascheff; Antônio Augusto Gonçalves; José Geraldo Pereira Barbosa
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
1) Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
2) Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
3) Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.
