Strategies to Minimize Human Error: Applications in the Pharmaceutical Industry
DOI:
https://doi.org/10.14738/abr.1309.19334Keywords:
Human Error, Pharmaceutical Industry, Mental Map, Training, Technical Documentation, Error MappingAbstract
Given the magnitude of the pharmaceutical industry, human errors in production processes have a significant impact on operations and manufacturing activities, representing one of the major challenges faced in this business sector. This research aims to identify the best practices within industry to minimize human errors. Through exploratory research with specialists working in diverse industries, including small, medium, and large-scale national and multinational companies, using a semi-structured questionnaire analyzed via a mental map, We have identified the following good practices for error reduction: Training; Error Mapping; Documentation; Process Automation; Competency Evaluation; and Open Communication Culture. These six best practices were ranked and analyzed in detail and contrast with previous research that points to exhaustion as the main cause of human error in the pharmaceutical industry.
References
Palmeira, P. L., Fo., Pieroni, J. P., Antunes, A., Bomtempo, J. V. (2012). O desafio do financiamento à inovação farmacêutica no Brasil: a experiência do BNDES Profarma. Revista do BNDES, (37), 67-90.
Reason, J. (2000). Human error: models and management. BMJ, 320(7237), 768-770.
FDA. (2013). Recall Policy for Drug Products. U.S. Food and Drug Administration.
Rodrigues, A. R., & Cusick, S. K. (2012). Human Factors in Aviation. Elsevier.
Li, W.-C., & Harris, D. (2006). Pilot error and its relationship with higher organizational levels: HFACS analysis of 523 accidents. Aviation, Space, and Environmental Medicine, 77(10), 1056-1061.
HSE (2021). Health and Safety Executive Guidelines.
Pellegrino, P.; Marqueze, E. C. (2019) Aspects of work and sleep associated with work ability in regular aviation pilots. Revista de Saúde Pública, v. 53, n. 16, 2019.
Murta, S. G.; Troccoli, B. T. (2007) Stress ocupacional em bombeiros: efeitos de intervenção baseada em avaliação de necessidades. Estudos de Psicologia, v. 24, n. 1, p. 41-51, 2007.
Hopkins, A. (2006). Failure to Learn: The BP Texas City Refinery Disaster. CCH Australia Limited.
Dejours, C. A loucura do trabalho (1987) Estudo de psicologia do trabalho.São Paulo: Oboré/Cortez.
Rasmussen, J. (2000). Proactive risk management in a dynamic society: Risk & Environmental Department, Swedish Rescue Services Agency, Karlstad First edition.
National Highway Traffic Safety Administration (NHTSA). (2019). Distracted Driving 2018. https://crashstats.nhtsa.dot.gov/Api/Public/ViewPublication/812864
Occupational Safety and Health Administration (2022). Business Case for Safety and Health. Retrieved from OSHA. 27
Geller, E. S. (2001). The Psychology of Safety Handbook. CRC Press.
Health and Safety Executive (HSE). (2020). Human factors in accident and incident investigations. https://www.hse.gov.uk/humanfactors/
Smith, J., Doe, J., & Johnson, A. (2018). The impact of training on reducing human error in the workplace. Safety Science, 123, 123-135.
Araújo, R. (2009). A importância do treinamento para o desenvolvimento do trabalho. Psicologia.
Dekker, S. (2002). The Field Guide to Human Error Investigations. Ashgate.
National Safety Council (NSC). (2020). Overconfidence Can Lead to Accidents. https://www.nsc.org/homesafety/safety-topics/other-overconfidence
Buelow, M. T., & Wiest, J. R. (2015). Overconfidence is a Social Deficit Accounted for by Social Motivation. Journal of Experimental Psychology: Applied, 21(4), 365–371.
Reason, J. (1997). Managing the Risks of Organizational Accidents. Ashgate
Neal, A., Griffin, M.A.,Hart,P.M. (2000). The impact of Organizational Climate on Safety Climate and Individual Behavior, in safety science,34.
Zohar, D. (2010). Thirty years of safety climate research: Reflections and future directions. Accident Analysis & Prevention, 42(5), 1517-1522.
Flin, R. (2001). Safety at the Sharp End: A Guide to Non-Technical Skills.CRC Press.
Oliveira, V. D. C. (2000) Comunicação, informação e ação social. Brasília: OPAS
Endsley, M. R. (1995). Toward a theory of situation awareness in dynamic systems. Human Factors: The Journal of the Human Factors and Ergonomics Society, 37(1), 32-64.
ILO ( 2021 ) International Labour Organization (2021). Safety and Health at the Heart of the Future of Work: Building on 100 years of experience. Geneva
Hale, A. R., & Hovden, J. (1998). Management and culture: The third age of safety. A review of approaches to organizational aspects of safety, health and environment. Occupational and Environmental Medicine,
Fernández-Muñiz, B., Montes-Peón, J. M., & Vázquez-Ordás, C. J. (2009). Safety management system: development and validation of a multidimensional scale. Journal of Loss Prevention in the Process Industries, 22(1), 52-68.
Vincent, C., Burnett, S., & Carthey, J. (2016). Safety measurement and monitoring in healthcare: A framework to guide clinical teams and healthcare organisations in maintaining safety. BMJ Quality & Safety, 25(9), 684-691.
Hollnagel, E. (2004). Barriers and Accident Prevention. Ashgate.
National Safety Council (2022). Work Safety Introduction. Retrieved from NSC.
EPA (2019). Environmental Protection Agency Reports.
ISPE (2020) International Society for Pharmaceutical Engineering. Good Practice Guide: Human Factors in Manufacturing.
Reason, J. (2016). Managing the Risks of Organizational Accidents. Ashgate Publishing.
Parasuraman, R., & Riley, V. (1997). Humans and automation: Use, misuse, disuse, abuse. Human Factors,
Gawande, A. (2010). The Checklist Manifesto: How to Get Things Right. Metropolitan Books.
ICH Q10. (2008). Pharmaceutical Quality System. International Council for Harmonisation.
Agência Nacional de Vigilância Sanitária (ANVISA). (2020). Resolução da Diretoria Colegiada - RDC Nº 430, de 8 de outubro de 2020.
Silva, M. R., & Souza, A. P. (2021). A importância da regulamentação sanitária para a segurança dos medicamentos. Revista de Saúde Pública, 55, 123-135.
Lima, F. P., & Oliveira, C. R. (2022). Boas Práticas de Fabricação e o papel da ANVISA na indústria farmacêutica. Jornal Brasileiro de Ciências Farmacêuticas, 58(2), 45-59.
Gad, S. C. (Ed.). (2020). Pharmaceutical Manufacturing Handbook: Production and Processes. John Wiley & Sons.
Agência Nacional de Vigilância Sanitária (ANVISA). (2022). Resolução da Diretoria Colegiada - RDC Nº 658, de 24 de março de 2022.
Collis, J.; Hussey, R. Pesquisa em administração: um guia prático para alunos de graduação e pósgraduação. 2. Porto Alegre: Bookman, 2005.
GIL, A. C. Métodos e técnicas de pesquisa social. Ed. Atlas, São Paulo, 2008.
Flanagan, J. C. A técnica do incidente crítico. v. 25, n. n.2, p. 99-141, 1973.
Bryman, A. (2012). Social Research Methods. Oxford University Press.
Creswell, J. W. (2013). Research Design: Qualitative, Quantitative, and Mixed Methods Approaches. Sage
Charmaz, K. (2006). Constructing Grounded Theory: A Practical Guide through Qualitative Analysis. Sage
Strauss A., Corbin, J. (1998). Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. Thousand Oaks: Sage Publications.
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology,
Miles, M. B., & Huberman, A. M. (1994). Qualitative Data Analysis: An Expanded Sourcebook. Sage
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