Publicación: Propuesta metodológica para el análisis de causa raíz, en hallazgos de auditorías de calidad
| dc.contributor.advisor | Fernández Gualtero, Magda Liliana | |
| dc.contributor.author | Gómez Mayorga, Karen Dayhana | |
| dc.contributor.author | Reyes González, David Felipe | |
| dc.contributor.author | Sánchez Polanía, Cesar Augusto | |
| dc.creator.id | 1012449244 | |
| dc.creator.id | 1010197204 | |
| dc.creator.id | 10347786 | |
| dc.date.accessioned | 2026-04-04T10:26:02Z | |
| dc.date.issued | 2026-03-17 | |
| dc.description.abstract | La falta de estandarización en el análisis de causa raíz en Fresenius Medical Care Andina genera recurrencia de no conformidades y limita la eficacia de las acciones correctivas. El presente trabajo se desarrolla bajo la premisa de la necesidad de estandarizar la selección y aplicación del análisis de causa raíz (RCA) en los hallazgos de auditorías de calidad de Fresenius Medical Care Andina. Se adoptó un enfoque mixto convergente: análisis cuantitativo de 12 – 24 meses de registros (TMed de cierre de CAPA, recurrencia a 6 – 12 meses, % de CAPA con eficacia verificada y cumplimiento de plazos) y componente cualitativo con entrevistas y observación en gemba. Se espera reducir tiempos y recurrencias, fortalecer la trazabilidad y el cumplimiento regulatorio. | spa |
| dc.description.abstract | The lack of standardization in root cause analysis at Fresenius Medical Care Andina leads to recurring nonconformities and limits the effectiveness of corrective actions. This study is based on the premise of the need to standardize the selection and application of root cause analysis (RCA) in the findings of quality audits at Fresenius Medical Care Andina. A convergent mixed-methods approach was adopted: quantitative analysis of 12–24 months of records (average time to closure of CAPAs, recurrence at 6–12 months, percentage of CAPAs with verified effectiveness, and compliance with deadlines) and a qualitative component with interviews and on-site observation. The aim is to reduce response times and recurrences, strengthen traceability, and improve regulatory compliance. | eng |
| dc.description.degreelevel | Especialización | spa |
| dc.description.degreename | Especialista en Gerencia Procesos de Calidad e Innovación | spa |
| dc.format | ||
| dc.format.extent | 48 páginas | |
| dc.format.medium | Recurso electrónico | spa |
| dc.format.mimetype | application/pdf | |
| dc.identifier.instname | instname:Universidad Ean | spa |
| dc.identifier.local | BDM-PGPCI | |
| dc.identifier.reponame | reponame:Repositorio Institucional Biblioteca Digital Minerva | spa |
| dc.identifier.repourl | repourl:https://repository.ean.edu.co/ | |
| dc.identifier.uri | https://hdl.handle.net/10882/19174 | |
| dc.language.iso | spa | |
| dc.publisher | Universidad Ean | |
| dc.publisher.faculty | Facultad de Ingeniería | spa |
| dc.publisher.place | Bogotá, Colombia | |
| dc.publisher.program | Especialización en Gerencia Procesos de Calidad e Innovación Virtual | spa |
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| dc.relation.references | 11. International Organization for Standardization. (2015). ISO 9001:2015 – Quality management systems – Requirements . ISO. | |
| dc.relation.references | 12. International Organization for Standardization. (2016). ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes . ISO. | |
| dc.relation.references | 13. International Organization for Standardization. (2019). ISO 14971:2019 – Medical devices – Application of risk management to medical devices . ISO. | |
| dc.relation.references | 14. Ohno, T. (1988). Toyota production system: Beyond large - scale production . Productivity Press. | |
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| dc.relation.references | 16. Poveda Catalán, J., & Guardiola Aparisi, M. (2019). Análisis de causa raíz: técnicas y relación con los sistemas de gestión y las no conformidades. 3C Tecnología, 8 (2), 84 – 97. | |
| dc.relation.references | 17. PharmaNOW. (2022, July 19). Regulatory compliance in pharma manufacturing: Key challenges & CAPA . https:// www.pharmagmp.in/common - capa - mistakes - in - pharmaceutical - manufacturing - and - how - to - avoid - them | |
| dc.relation.references | 18. Rivera - Mendoza, F., Acevedo - Atala, C., Perea - Pérez, B., Labajo - González, E., & Fonseca, G. M. (2017). Análisis causa - raíz sobre evento adverso producido en la Clínica Odontológica Docente Asistencial, Facultad de Odontología, Universidad de La Frontera, Chile. International Journal of Odontostomatology, 11(2), 207 – 213. https://doi.org/10.4067/S0718 - 381X201700020001 . | |
| dc.relation.references | 19. U.S. Food and Drug Administration (FDA). (2011). Guidance for industry: Quality systems approach to pharmaceutical CGMP regulations . U.S. Department of Health and Human Services. | |
| dc.relation.references | 20. Jose David Castro Castro, & Edwin Darío Cendales Ladino. (2019). Casos aplicados del análisis de causa raíz: revisión. Ciencia e Ingeniería Neogranadina , 29 (1). | |
| dc.relation.references | 21. Creswell, J. W., & Creswell, J. D. (2018). Research design: Qualitative, quantitative, and mixed methods approaches (5th ed.). SAGE. | |
| dc.relation.references | 22. Crosby, P. B. (1979). Quality is free. McGraw – Hill. | |
| dc.relation.references | 23. Deming, W. E. (1986). Out of the crisis. MIT Press. | |
| dc.relation.references | 24. Evans, J. R., & Lindsay, W. M. (2015). Managing for quality and performance excellence (10th ed.). Cengage Learning. | |
| dc.relation.references | 25. Garvin, D. A. (1984). What does “product quality” really mean? Sloan Management Review, 26(1), 25 – 43. | |
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| dc.relation.references | 27. George, M., Rowlands, D., Price, M., & Maxey, J. (2005). The Lean Six Sigma pocket toolbook. McGraw – Hill. | |
| dc.relation.references | 28. Hernández Sampieri, R., Fernández Collado, C., & Baptista Lucio, P. (2018). Metodología de la investigación (6.ª ed.). McGraw – Hill. | |
| dc.relation.references | 29. IEC. (2015). IEC 62740: Root cause analysis (RCA). International Electrotechnical Commission. | |
| dc.relation.references | 30. Ishikawa, K. (1985). What is total quality control? The Japanese way. Prentice Hall. | |
| dc.relation.references | 31. ISO. (2015). ISO 9001:2015 Quality management systems — Requirements. International Organization for Standardization. | |
| dc.relation.references | 32. ISO. (2016). ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes. International Organization for Standardization. | |
| dc.relation.references | 33. ISO. (2018). ISO 31000:2018 Risk management — Guidelines. International Organization for Standardization. | |
| dc.relation.references | 34. ISO. (2019). ISO 14971:2019 Medical devices — Application of risk management to medical devices. International Organization for Standardization. | |
| dc.relation.references | 35. ISO. (2019). ISO 31010:2019 Risk management — Risk assessment techniques. International Organization for Standardization. | |
| dc.relation.references | 36. U.S. Food and Drug Administration. (2011). Quality systems approach to pharmaceutical CGMP regulations (21 CFR 820). U.S. Department of Health and Human Services. | |
| dc.relation.references | 37. Montgomery, D. C. (2009). Introduction to statistical quality control (6th ed.). Wiley. | |
| dc.relation.references | 38. Ohno, T. (1988). Toyota production system: Beyond large - scale production. Productivity Press. | |
| dc.relation.references | 39. Stamatis, D. H. (2003). Failure mode and effect analysis: FMEA from theory to execution (2nd ed.). ASQ Quality Press. | |
| dc.relation.references | 40. International Organization for Standardization. (2016). ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes. | |
| dc.relation.references | 41. International Organization for Standardization. (2019). ISO 14971:2019 — Medical devices — Application of risk management to medical devices. | |
| dc.relation.references | 42. U.S. Food and Drug Administration. (2011). Quality systems approach to pharmaceutical CGMP regulations (21 CFR 820). | |
| dc.relation.references | 43. Fresenius Medical Care. (s. f.). Fresenius Medical Care en Colombia. https://freseniusmedicalcare.com/es - co | |
| dc.relation.references | 44. Fresenius Medical Care Colombia S.A. (s. f.). Contacto. https://freseniusmedicalcare.com/es - co/contacto/ | |
| dc.relation.references | 45. Dun & Bradstreet. (s. f.). Fresenius Medical Care Andina S.A.S. Perfil de compañía. https:// www.dnb.com/. | |
| dc.relation.references | 46. EMIS. (2025). Fresenius Medical Care Andina S.A.S. (Colombia). https:// www.emis.com/. | |
| dc.relation.references | 47. INVIMA. (s. f.). Dispositivos médicos y equipos biomédicos. https:// www.invima.gov.co/productos - vigilados/dispositivos - medicos/dispositivos - medicos - y - equipos - biomedicos. | |
| dc.rights.accessrights | info:eu-repo/semantics/openAccess | |
| dc.rights.coar | http://purl.org/coar/access_right/c_abf2 | |
| dc.rights.creativecommons | Atribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0) | |
| dc.rights.license | Atribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0) | |
| dc.rights.local | Abierto (Texto Completo) | spa |
| dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
| dc.subject.armarc | Garantía de calidad | spa |
| dc.subject.armarc | Auditoría | spa |
| dc.subject.armarc | Control de procesos industriales | spa |
| dc.subject.lemb | Aseguramiento de la calidad | spa |
| dc.subject.lemb | Control de Calidad | spa |
| dc.subject.lemb | Mejoramiento de procesos | spa |
| dc.subject.ods | ODS 8: Trabajo decente y crecimiento económico. Promover el crecimiento económico sostenido, inclusivo y sostenible, el empleo pleno y productivo y el trabajo decente para todos | |
| dc.subject.ods | ODS 9: Industria, innovación e infraestructura. Construir infraestructuras resilientes, promover la industrialización inclusiva y sostenible y fomentar la innovación | |
| dc.subject.ods | ODS 16: Paz, justicia e instituciones sólidas. Promover sociedades pacíficas e inclusivas para el desarrollo sostenible, facilitar el acceso a la justicia para todos y construir a todos los niveles instituciones eficaces e inclusivas que rindan cuentas | |
| dc.subject.proposal | Auditorías de calidad | spa |
| dc.subject.proposal | Causa raíz | spa |
| dc.subject.proposal | Metodología | spa |
| dc.subject.proposal | Recurrencias | spa |
| dc.subject.proposal | Seguridad del paciente | spa |
| dc.subject.proposal | Gestión de procesos | spa |
| dc.title | Propuesta metodológica para el análisis de causa raíz, en hallazgos de auditorías de calidad | spa |
| dc.title | Methodological proposal for root cause analysis in quality audit findings | eng |
| dc.type | Trabajo de grado - Especialización | spa |
| dc.type.coar | http://purl.org/coar/resource_type/c_7a1f | |
| dc.type.coarversion | http://purl.org/coar/version/c_ab4af688f83e57aa | |
| dc.type.content | Text | |
| dc.type.driver | info:eu-repo/semantics/bachelorThesis | |
| dc.type.other | Trabajo de grado - Especialización | |
| dc.type.redcol | http://purl.org/redcol/resource_type/TP | |
| dc.type.version | info:eu-repo/semantics/acceptedVersion | |
| dspace.entity.type | Publication | |
| person.affiliation.name | Especialización en Gerencia de Procesos de Calidad e Innovación - Virtual |
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