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EnglishThe authors have experimented the application of the Failure Mode and Effect Analysis (FMEA) technique in a clinical laboratory. FMEA technique allows: a) to evaluate and measure the hazards of a process malfunction, b) to decide where to execute improvement actions, and c) to measure the outcome of those actions. A small sample of analytes has been studied: there have been determined the causes of the possible malfunctions of the analytical process, calculating the risk probability index (RPI), with a value between 1 and 1,000. Only for the cases of RPI > 400, improvement actions have been implemented that allowed a reduction of IPR values between 25% to 70% with a costs increment of <1%. FMEA technique can be applied to the processes of a clinical laboratory, even if of small dimensions, and offers a high potential of improvement. Nevertheless, such activity needs a thorough planning because it is complex, even if the laboratory already operates an ISO 9000 Quality Management System.
| Titolo: | A FMEA clinical laboratory case study: how to make problems and improvements measurable |
| Autori: | |
| Data di pubblicazione: | 2004 |
| Rivista: | |
| Abstract: | The authors have experimented the application of the Failure Mode and Effect Analysis (FMEA) technique in a clinical laboratory. FMEA technique allows: a) to evaluate and measure the hazards of a process malfunction, b) to decide where to execute improvement actions, and c) to measure the outcome of those actions. A small sample of analytes has been studied: there have been determined the causes of the possible malfunctions of the analytical process, calculating the risk probability index (RPI), with a value between 1 and 1,000. Only for the cases of RPI > 400, improvement actions have been implemented that allowed a reduction of IPR values between 25% to 70% with a costs increment of <1%. FMEA technique can be applied to the processes of a clinical laboratory, even if of small dimensions, and offers a high potential of improvement. Nevertheless, such activity needs a thorough planning because it is complex, even if the laboratory already operates an ISO 9000 Quality Management System. |
| Handle: | http://hdl.handle.net/11386/1002587 |
| Appare nelle tipologie: | 1.1.2 Articolo su rivista con ISSN |
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