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.

Download Full-text

Evaluation of the Security Situation Abroad by the FMEA Method and Impact of Natural or Technical Threats on the Environment

Advanced Materials Research ◽

10.4028/www.scientific.net/amr.1001.469 ◽

2014 ◽

Vol 1001 ◽

pp. 469-474

Author(s):

Jarmila Stefankova ◽

Karol Balog ◽

Peter Raksany

Keyword(s):

Risk Management ◽

Failure Mode ◽

Information Quality ◽

Slovak Republic ◽

Electronic System ◽

Crisis Planning ◽

Regular Monitoring ◽

Everyday Activities ◽

Representative Office ◽

Fmea Method

The purpose of the project is the electronization of services provided to employees of the Ministry of Foreign and European Affairs of the Slovak Republic (MZVaEZ SR), as well as improvement of the information quality necessary for the operation of the situation centre (SITCEN) and the operating centre for the purpose of prevention (OPCEN) of the MZVaEZ with aim to prevent and solve crisis situations in the areas of residence of our citizens abroad. An electronic system supports the collection, evaluation, presentation and risk management. Regular monitoring of the security situation belongs to everyday activities of the Slovak representations [1]. The evaluated system in this process is the environment in which the specific representative office and its staff are located. Keywords: Threat, risk, crisis planning, Failure Mode and Effects Analysis (FMEA)

Download Full-text

Pre-Analytical Workstations as a Tool for Reducing Laboratory Errors

Journal of Medical Biochemistry ◽

10.2478/v10011-010-0031-x ◽

2010 ◽

Vol 29 (4) ◽

pp. 315-324 ◽

Cited By ~ 3

Author(s):

Giorgio Rin

Keyword(s):

Quality Improvement ◽

Clinical Laboratory ◽

Error Reduction ◽

Laboratory Errors ◽

Continuous Quality ◽

Complex Process ◽

Preanalytical Phase ◽

Analytical Phase ◽

Total Testing Process

Pre-Analytical Workstations as a Tool for Reducing Laboratory ErrorsReducing errors and improving quality are an integral part of Laboratory Medicine. Laboratory testing, a highly complex process commonly called the total testing process (TTP), is usually subdivided into three traditional (pre-, intra-, and post-) analytical phases. A series of papers published from 1989 drew the attention of laboratory professionals to the pre-analytical phase, which currently appears to be more vulnerable to errors than the other phases. Consequently, the preanalytical phase should be the main target for further quality improvement. Therefore, identifying the critical steps in the pre-analytical phase is a prerequisite for continuous quality improvement, further error reduction and thus for improving patient safety. Use of automated systems where feasible, and use of error reduction/improved quality as a factor when selecting instrumentation are the main tools we have to insure high quality and minimize errors in the pre-analytical phase. The reasons for automation of the pre-analytical phase have become so compelling that it is no longer simply a competitive advantage for laboratories, but rather a competitive necessity. These systems can impact on the clinical/laboratory interface and affect the efficiency, effectiveness and quality of care.

Download Full-text

Agricultural Risk Management Using Fuzzy TOPSIS Analytical Hierarchy Process (AHP) and Failure Mode and Effects Analysis (FMEA)

Agriculture ◽

10.3390/agriculture10110504 ◽

2020 ◽

Vol 10 (11) ◽

pp. 504

Author(s):

Peyman Zandi ◽

Mohammad Rahmani ◽

Mojtaba Khanian ◽

Amir Mosavi

Keyword(s):

Risk Assessment ◽

Risk Management ◽

Failure Mode ◽

Analytical Hierarchy Process ◽

Failure Modes ◽

Fuzzy Topsis ◽

Control Measures ◽

Management Tool ◽

Agricultural Risk ◽

Hierarchy Process

Failure mode and effects analysis (FMEA) is a popular technique in reliability analyses. In a typical FMEA, there are three risk factors for each failure modes: Severity (S), occurrence (O), and detectability (D). These will be included in calculating a risk priority number (RPN) multiplying the three aforementioned factors. The literature review reveals some noticeable efforts to overcome the shortcomings of the traditional FMEA. The objective of this paper is to extend the application of FMEA to risk management for agricultural projects. For this aim, the factor of severity in traditional FMEA is broken down into three sub-factors that include severity on cost, the severity on time, and severity on the quality of the project. Moreover, in this study, a fuzzy technique for order preference by similarity to ideal solution (TOPSIS) integrated with a fuzzy analytical hierarchy process (AHP) was used to address the limitations of the traditional FMEA. A sensitivity analysis was done by weighing the risk assessment factors. The results confirm the capability of this Hybrid-FMEA in addressing several drawbacks of the traditional FMEA application. The risk assessment factors changed the risk priority between the different projects by affecting the weights. The risk of water and energy supplies and climate fluctuations and pests were the most critical risk in agricultural projects. Risk control measures should be applied according to the severity of each risk. Some of this research’s contributions can be abstracted as identifying and classifying the risks of investment in agricultural projects and implementing the extended FMEA and multicriteria decision-making methods for analyzing the risks in the agriculture domain for the first time. As a management tool, the proposed model can be used in similar fields for risk management of various investment projects.

Download Full-text

Enhancements to Failure Mode and Effects Analysis (FMEA) Method, Aiming to Improve Risk Management in the Knowledge-Based Organizations

International conference KNOWLEDGE-BASED ORGANIZATION ◽

10.2478/kbo-2019-0033 ◽

2019 ◽

Vol 25 (1) ◽

pp. 206-212

Author(s):

Vlad Ciprian Cupşan ◽

Mihail Aurel Țîţu ◽

Gheorghe Ioan Pop

Keyword(s):

Risk Management ◽

Failure Mode ◽

Value Added ◽

Knowledge Based ◽

Current State ◽

Defence Industry ◽

Preventive Approach ◽

Weak Points ◽

Fmea Method

Abstract This paper presents the current state of risk management in the knowledge-based organisations and the importance of a preventive approach, with emphasis on the aerospace and defence industry, as well as gives detailed information on the Failure Mode and Effects Analysis (FMEA) method, in its current known state. In order to generate enhancements to the Failure Mode and Effects Analysis (FMEA) method, the strong and weak points are analysed and specific solutions are proposed for the weak points, such as occurrence scoring, with the goal of enhancing the Failure Mode and Effects Analysis (FMEA) method and, in general, of improving risk management in the knowledge-based organizations. In conclusion, the paper evaluates the improvements generated by the proposed solutions, compared to the current known method, in order to establish the value added by the enhancements.

Download Full-text

Selecting a Risk-Based SQC Procedure for a HbA1c Total QC Plan

Journal of Diabetes Science and Technology ◽

10.1177/1932296817729488 ◽

2017 ◽

Vol 12 (4) ◽

pp. 780-785 ◽

Cited By ~ 2

Author(s):

Sten A. Westgard ◽

Hassan Bayat ◽

James O. Westgard

Keyword(s):

Risk Management ◽

Practice Guidelines ◽

Clinical Laboratory ◽

Method Performance ◽

Minimum Requirement ◽

Control Rules ◽

Graphical Tool ◽

The Us ◽

Practical Tool ◽

Total Testing Process

Background: Recent US practice guidelines and laboratory regulations for quality control (QC) emphasize the development of QC plans and the application of risk management principles. The US Clinical Laboratory Improvement Amendments (CLIA) now includes an option to comply with QC regulations by developing an individualized QC plan (IQCP) based on a risk assessment of the total testing process. The Clinical and Laboratory Standards Institute (CLSI) has provided new practice guidelines for application of risk management to QC plans and statistical QC (SQC). Methods: We describe an alternative approach for developing a total QC plan (TQCP) that includes a risk-based SQC procedure. CLIA compliance is maintained by analyzing at least 2 levels of controls per day. A Sigma-Metric SQC Run Size nomogram provides a graphical tool to simplify the selection of risk-based SQC procedures. Applications: Current HbA1c method performance, as demonstrated by published method validation studies, is estimated to be 4-Sigma quality at best. Optimal SQC strategies require more QC than the CLIA minimum requirement of 2 levels per day. More complex control algorithms, more control measurements, and a bracketed mode of operation are needed to assure the intended quality of results. Conclusions: A total QC plan with a risk-based SQC procedure provides a simpler alternative to an individualized QC plan. A Sigma-Metric SQC Run Size nomogram provides a practical tool for selecting appropriate control rules, numbers of control measurements, and run size (or frequency of SQC). Applications demonstrate the need for continued improvement of analytical performance of HbA1c laboratory methods.

Download Full-text

A Case Study of Risk Management of Automotive Industry Projects Using RFMEA Method

Mapta Journal of Mechanical and Industrial Engineering (MJMIE) ◽

10.33544/mjmie.v4i1.132 ◽

2020 ◽

Vol 4 (1) ◽

pp. 42-50

Author(s):

Leili Mirboroon ◽

Hamideh Razavi

Keyword(s):

Risk Management ◽

Failure Mode ◽

Automotive Industry ◽

Quality Management System ◽

Project Risk Management ◽

Project Risk ◽

Project Risks ◽

Fmea Method ◽

Definition Of

Considering the market need and customer attraction, automakers are always trying to define new projects and present products with new capabilities in the market. That is why a significant part of car companies’ development research is focused on the definition of new projects. Principally, project risk management in car companies is essential and thus given special attention. There are different theories and methods of project risk control. However, since there is complete awareness of FMEA-related issues (Failure Mode and Effects Analysis) in automotive companies due to the establishment of the quality management system, the project's risk analysis using FMEA method to control the risk of automotive industry projects is presented in this paper by a real example. For this purpose, FMEA indicators tables are designed and presented proportionally to project risk management. Results of this research show that using failure mode and effects analysis for project risk management ensures the detection of project's weaknesses and provides a practical model for identification and reduction of project risks.

Download Full-text

Automation of extra-analytical phase for clinical laboratory

Turkish Journal of Biochemistry ◽

10.1515/tjb-2020-0138 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Ebubekir Bakan ◽

Fatma Zuhal Umudum

Keyword(s):

Clinical Laboratory ◽

Diagnostic Errors ◽

Substantial Part ◽

Laboratory Diagnostics ◽

Total Quality ◽

Critical Importance ◽

Laboratory Errors ◽

Analytical Phase ◽

Total Testing Process

AbstractExtra-analytical automation is of critical importance in patient safety with respect to accurate, fast test result reporting. Through the previous decades, significant improvements in laboratory errors have been achieved by technological facilities, which have become a substantial part of the reduction of preventable diagnostic errors. In clinical laboratory practice, the total testing process (TTP) is under the effect of error sources: preanalytical, analytical, and post-analytical variables. Since many extra-analytical processes within and outside the clinical laboratory may be automated, management of the extra-analytical phase can prevent errors, resulting in the total quality of laboratory diagnostics and customer satisfaction. The automation technologies have added a serious impact on the proficiency of clinical laboratories. To improve standardization, organization, efficiency, and quality of TTP, many manual tasks have now been partially or entirely automated by labor-saving instrumentations. The implementation of extra-analytical automation in the laboratory processes has recently made them standardized and manageable. Depending on the workload and workflow of the clinical laboratory, it is of critical importance to implement adequate systems, providing standardization of the TTP and resulting in high-quality test results.

Download Full-text