Bazı Risk Analizi Teknikleri, Hata Türleri ve Etkileri Analizi
Özet
Referanslar
International Organization for Standardization. ISO 31010:2019: Risk management - Risk assessment techniques, 2nd Edition. Geneva, Switzerland: International Organization for Standardization; 2019.
International Organization for Standardization. ISO 22367:2020: Medical laboratories - Application of the risk management to medical laboratories. Geneva, Switzerland: International Organization for Standardization;2020.
International Council For Harmonisation. ICH Harmonised Guideline: Quality Risk Management Q9(R1). European Medicines Agency, 2023. Erişim adresi: https://www.ema.europa.eu/en/ich-q9-quality-risk-management-scientific-guideline
Clinical and Laboratory Standards Institute. CLSI document EP18-A2: Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline, 2nd Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
Institute for Safe Medication Practices. The systems approach to quality assurance for pharmacy practice: a frame work formitigating risk. Canada: Institute for Safe Medication Practices; 2012.
Jeon J, Hyland S, Burns CM, et al. Challenges with applying FMEA to the process for reading labels on injectable drug containers. Proceedings of the human factors and ergonomics society 51st annual meeting, 2007; 735–9.
Agarwal R. Measurement of Errors in Clinical Laboratories. Ind J Clin Biochem 2013;28:227-34.
International Organization for Standardization. ISO 14971:2019 Medical devices -Application of risk management to medical devices. Geneva, Switzerland: International Organization for Standardization;2019.
Clinical and Laboratory Standards Institute. CLSI document EP23: Laboratory Quality Control Based on Risk Management, 2nd Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2023.
Anjalee JAL, Rutter V, Samaranayake NR. Application of Failure Mode and Effect Analysis (FMEA) to improve medication safety: a systematic review. Postgraduate Medical Journal 2021;97:168-74.
Karadağ C, Demirel NN. Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management. Clin Chem Lab Med 2019;57:1530-8.
Xia Y, Wang X, Yan C, Wu J, Xue H, Li M, vd. Risk assessment of the total testing process based on quality indicators with the Sigma metrics. Clin Chem Lab Med 2020;58:1223-31.
Liu H, Zhang L, Ping Y, Wang L. Failure mode and effects analysis for proactive healthcare risk evaluation: A systematic literature review. J Eval Clin Pract 2020;26:1320- 37.
Nieva VF. Safety culture assessment: a tool for improving patient safety in healthcare organizations Qual Saf Health Care 2003;12: 17ii-23.
Ashley L, Armitage G. Failure Mode and Effects Analysis: An Empirical Comparison of Failure Mode Scoring Procedures. J Patient Saf 2010;6:210-5.
Jain K. Use of failure mode effect analysis (FMEA) to improve medication management process. IJHCQA 2017;30:175-86.
Referanslar
International Organization for Standardization. ISO 31010:2019: Risk management - Risk assessment techniques, 2nd Edition. Geneva, Switzerland: International Organization for Standardization; 2019.
International Organization for Standardization. ISO 22367:2020: Medical laboratories - Application of the risk management to medical laboratories. Geneva, Switzerland: International Organization for Standardization;2020.
International Council For Harmonisation. ICH Harmonised Guideline: Quality Risk Management Q9(R1). European Medicines Agency, 2023. Erişim adresi: https://www.ema.europa.eu/en/ich-q9-quality-risk-management-scientific-guideline
Clinical and Laboratory Standards Institute. CLSI document EP18-A2: Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline, 2nd Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
Institute for Safe Medication Practices. The systems approach to quality assurance for pharmacy practice: a frame work formitigating risk. Canada: Institute for Safe Medication Practices; 2012.
Jeon J, Hyland S, Burns CM, et al. Challenges with applying FMEA to the process for reading labels on injectable drug containers. Proceedings of the human factors and ergonomics society 51st annual meeting, 2007; 735–9.
Agarwal R. Measurement of Errors in Clinical Laboratories. Ind J Clin Biochem 2013;28:227-34.
International Organization for Standardization. ISO 14971:2019 Medical devices -Application of risk management to medical devices. Geneva, Switzerland: International Organization for Standardization;2019.
Clinical and Laboratory Standards Institute. CLSI document EP23: Laboratory Quality Control Based on Risk Management, 2nd Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2023.
Anjalee JAL, Rutter V, Samaranayake NR. Application of Failure Mode and Effect Analysis (FMEA) to improve medication safety: a systematic review. Postgraduate Medical Journal 2021;97:168-74.
Karadağ C, Demirel NN. Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management. Clin Chem Lab Med 2019;57:1530-8.
Xia Y, Wang X, Yan C, Wu J, Xue H, Li M, vd. Risk assessment of the total testing process based on quality indicators with the Sigma metrics. Clin Chem Lab Med 2020;58:1223-31.
Liu H, Zhang L, Ping Y, Wang L. Failure mode and effects analysis for proactive healthcare risk evaluation: A systematic literature review. J Eval Clin Pract 2020;26:1320- 37.
Nieva VF. Safety culture assessment: a tool for improving patient safety in healthcare organizations Qual Saf Health Care 2003;12: 17ii-23.
Ashley L, Armitage G. Failure Mode and Effects Analysis: An Empirical Comparison of Failure Mode Scoring Procedures. J Patient Saf 2010;6:210-5.
Jain K. Use of failure mode effect analysis (FMEA) to improve medication management process. IJHCQA 2017;30:175-86.
