Abstract
Risk management is systematic identification, analysis, and mitigation of potential failures and threats. Risk management should be a proactive process incorporated into the quality management system of the laboratory. This chapter provides an overview of the principles and methodologies of risk management related to clinical laboratories set up. Risk identification and analysis assesses potential hazards, their likelihood, and potential impact. Specific methodologies such as failure mode effect analysis (FMEA) and failure reporting analysis and corrective action system (FRACAS) give an approach to identify possible failures in a process and assess the consequences and help in the formulation of a corrective action plan.
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Suggested Reading
International Organization for Standardization. ISO 22367:2020(en). Medical laboratories—Application of risk management to medical laboratories; https://www.iso.org/obp/ui/#iso:std:iso:22367:ed-1:v1:en.
International Organization for Standardization. ISO 35001:2019(en). Biorisk management for laboratories and other related organizations; https://www.iso.org/obp/ui/#iso:std:iso:35001:ed-1:v1:en.
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Verma, A., Singh, S. (2023). Risk Management. In: Yadav, S.K., Gupta, R., Singh, S. (eds) Clinical Laboratory Management . Springer, Cham. https://doi.org/10.1007/978-3-031-46420-1_48
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DOI: https://doi.org/10.1007/978-3-031-46420-1_48
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Publisher Name: Springer, Cham
Print ISBN: 978-3-031-46419-5
Online ISBN: 978-3-031-46420-1
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