Failure Reporting Analysis And Corrective Action System Research Articles

Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process.

Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, we would like to develop a sustainable, practical system for continuous total laboratory risk management. Materials and Methods: This study was composed of two phases: the development phase in 2019 and the application phase in 2020. A concept flow diagram for the computerized risk registry and management tool (RRMT) was designed using the failure mode and effects analysis (FMEA) and the failure reporting, analysis, and corrective action system (FRACAS) methods. The failure stage was divided into six according to the testing sequence. We applied laboratory errors to this system over one year in 2020. The risk priority number (RPN) score was calculated by multiplying the severity of the failure mode, frequency (or probability) of occurrence, and detection difficulty. Results: 103 cases were reported to RRMT during one year. Among them, 32 cases (31.1%) were summarized using the FMEA method, and the remaining 71 cases (68.9%) were evaluated using the FRACAS method. There was no failure in the patient registration phase. Chemistry units accounted for the highest proportion of failure with 18 cases (17.5%), while urine test units accounted for the lowest portion of failure with two cases (1.9%). Conclusion: We developed and applied a practical computerized risk-management tool based on FMEA and FRACAS methods for the entire testing process. RRMT was useful to detect, evaluate, and report failures. This system might be a great example of a risk management system optimized for clinical laboratories.

Errors of Clinical Laboratory and Its Impact on Patient Safety

The aim of this study is to analyse the potential risks of medical laboratory activities in all processes: Strategic, operational (pre-preanalytical, preanalytical, analytical, postanalytical and post-postanalytical) and support. Also, we value the impact of these risks in the patient safety. The methodology used in this study to identify and estimate the possible failure modes was the Failure Model and Effects Analysis (FMEA). The real failures then were registered in the same processes according to the methodology Failure Reporting Analysis and Corrective Action System (FRACAS). Moreover, it used the basis of available information of the laboratory quality system. The Risk Priority Number (RPN) with FMEA and FRACAS was calculated for every laboratory processes and it was made a comparative of the results obtained with both methodologies. Based on these results, we made the risk map in medical laboratory. These results allowed us identifying critical points in all laboratory processes and prioritize the control of these points. Furthermore, it helped to select preventive or corrective action that should be incorporated in the laboratory improvement planning and risk management.

Risk Management in Clinical Laboratory: from Theory to Practice

Abstract Clinical laboratory tests ensure approximately 70% of the medical decisions, so that the time until the release of the results and its accuracy are critical for the diagnosis and the efficiency of the treatment [1]. Risk management involves both the anticipation of what could happen erroneous and the assessment of errors’ frequency as well as the consequences or the severity of the effects caused by it, and finally to decide what can be done in order to reduce the risk to an acceptable clinical level. For this reason, organizations should not see the risk management as a compliance issue, but as an integral part of the decision-making process. EP23-A is a guideline of CLSI that introduces the risk management principles in the clinical laboratory and encourages the laboratories to develop plans of risk management which are addressed to the risks of each laboratory. EP18-A2 proposes 2 techniques for identifying and controlling the errors in the laboratory: FMEA (Failure Mode and Effects Analysis) and FRACAS (Failure Reporting, Analysis and Corrective Action System). The European Committee of Experts and Management of Safety and Quality in Health Care proposed to use the quality indicators to identify the critical stages of each process, thus being possible to assess continuously the medical processes with the aim of identifying the errors when they occur. This review summarizes the principles of the risk management in the clinical laboratory, thus it can achieve its aims to report valid, accurate and reliable test results

Process-Oriented Development of Failure Reporting, Analysis, and Corrective Action System

Although failure reporting, analysis, and corrective action system (FRACAS) has two management perspectives, its tasks and related information, the previous researches and applications mainly have focused on the data management. This study is to develop a process-oriented FRACAS which supports the operation of the failure-related activities. The development procedures are (1) to define the reporting and analysis tasks, (2) to define the information to be used at each task, and (3) to design a computerized business process model and set the attributes such as durations, rules, and document types. This computerized FRACAS process can be activated in a business process management system (BPMS) which employs the enactment functions, deliver tasks to the proper workers, provide the necessary information, and alarm the abnormal status of the tasks (delay, incorrect delivery, cancellation). Through implementing the prototype system, improvements are found for automation of the tasks, prevention of disoperation, and real-time activity monitoring.

Reliability Engineering Practice in the Light Duty Dodge Ram Truck Chassis Program

AbstractIn this paper, we demonstrate how we set up and executed an integrated reliability engineering process with the engineering team in the Light Duty (LD) Dodge Ram (DR) Truck chassis program. Organizationally, the LD DR chassis team consists of core engineering groups and supporting representatives from other related disciplines. The reliability engineer is a member of the team and he is the reliability advocate and leader. The integrated reliability engineering process was customized and implemented in the LD DR chassis program. Many of the tools developed by the company corporate quality office, such as design failure modes and effect analysis (DFMEA), design verification plan and reporting (DVP&R), and finite element analysis (FEA), were used in supporting the reliability engineering process. An array of technical enablers such as Test Matrix and ReliUp were also developed for supporting the implementation of the reliability engineering process. In the execution, the reliability engineer led the engineering team to set up reliability targets, develop reliability work plans, facilitate up‐front design analysis, review and integrate reliability test planning. The reliability engineer also set up the failure reporting, analysis and corrective action system (FRACAS) and managed reliability growth with the team. From the implementation, we have learned several things: (1) an integrated engineering team is crucial in order to develop a product better, quicker and cheaper; (2) a good team leader is the key to product reliability; (3) a capable reliability engineer is the catalyst to a reliability engineering process; (4) the best culture in which to achieve reliability is the delicate balance between ‘inside‐out’ and ‘outside‐in’; and (5) achieving reliability is far more important than measuring reliability. Copyright © 2004 John Wiley & Sons, Ltd.