Risk Priority Research Articles

Blue applicability grade index assessment and response surface modelling to synchronous determination of metformin hydrochloride, vildagliptin and dapagliflozin propanediol monohydrate by HPTLC method

Diabetes mellitus is major chronic disease found in human due to stressful lifestyle and bad food habit. Recently, the Central Drugs Standard Control Organization of India has approved combination of metformin hydrochloride, vildagliptin and dapagliflozin propanediol monohydrate for the management of diabetes mellitus. Numerous chromatographic methods have been published in the literature for estimation of these anti-diabetic drugs on individual basis and their combinations. But these chromatographic analyses promoted usage of toxic organic solvents which are harmful to the environment and aquatic animal lives. In addition, no chromatographic method was found in the literature for simultaneous estimation of these anti-diabetic drugs using green solvents. In recent days, white analytical chemistry approach has been introduced in the literature for development and assessment of green, accurate, precise, cost-effective and user-friendly chromatographic methods. Hence, white analytical chemistry-driven risk-based HPTLC method was developed for synchronous estimation of these anti-diabetic drugs using green solvents and response surface modelling. The analytical quality risk assessment was applied for identification of critical method variables and response variables using risk priority number ranking and filtering method. The critical method variables were linked with critical response variables using response surface modelling by Box–Behnken design. The analytical design space was navigated control strategy was framed for robust densitometric estimation of anti-diabetic drugs. The chromatographic method was validated as per ICH Q2 (R2) guideline. The developed method was applied for synchronous assay of multiple combinations of metformin, vildagliptin and dapagliflozin using single chromatographic condition to save time, cost and resources for analysis. The assay results of these anti-diabetic drug combinations were found to be complied with the respective labelled claim of the drugs. The developed and published chromatographic methods were assessed for their redness, greenness, blueness and whiteness profiles using green analytical metrics and RGB model scoring system. The proposed method was found to be green, cost-effective, robust and user-friendly for synchronous estimation of metformin, vildagliptin and dapagliflozin.

Fuzzy Analytic Hierarchy Process-Based Risk Priority Number Approach in FMEA for MRI-Guided HDR Brachytherapy in Gynecologic Cancer.

Fuzzy Analytic Hierarchy Process-Based Risk Priority Number Approach in FMEA for MRI-Guided HDR Brachytherapy in Gynecologic Cancer.

Using a Flexible Risk Priority Number Method to Reinforce Abilities of Imprecise Data Assessments of Risk Assessment Problems

Risk priority number (RPN) is the most commonly used failure risk ranking method among all risk assessment methods. However, the traditional RPN method not only cannot handle incomplete information and hesitation information (such as hesitation information between the s5=Low and s6=Moderate) provided by experts, but it also does not consider the objective weights of risk assessment factors. These reasons will lead to biased conclusions, causing decision makers to make wrong judgments. To address the limitations of the traditional RPN technique, the aim of this paper is to propose the flexible RPN assessment method under an uncertain environment. The flexible RPN assessment method is an extension of the traditional RPN technique. The flexible RPN method integrates the traditional RPN method and interval-valued 2-tuple weighted average method, and, simultaneously, considers subjective weights and objective weights. In the numerical verification, this study has adopted the example of stages of treatment planning for proton beam radiation therapy to verify the correctness and validity of the proposed flexible RPN technique. The numerical results show that the proposed flexible RPN technique not only handles the hesitation and incomplete information provided by experts but also considers the subjective and objective weights of risk assessment factors, providing more reasonable ranking results in the risk analysis.

Noise Level Measurement and Analysis in Safety Management in A Metal Work Fabrication Industry Using Six Sigma Methodology

This study was conducted in metal work fabrication industry. During the metal work fabrication, machineries and equipment are produces the noise. The excessive noise in the workplace causes the hearing disorder in workers, also annoys and disrupts the activities. Present study was to assess the magnitude of noise and remedial actions in controlling the industrial noise expose at an electrical equipment manufacturing plant. The noise level of 105dB was observed in coil winding machine. This noise level is highly unsafe as per the safety standards for noise level. This paper discusses about the Six Sigma methodology in reducing the noise level of the plant. The noise levels are smoothened by calculating Risk Priority Numbers (RPN) and implementing engineering control techniques in the machinery area. With the implementation of the Six Sigma Methodology, the noise level in the plant was reduced to less than 75db, which is an acceptable safe noise level as per the standard noise level of a manufacturing plant.

A New Approach to Risk Assessment Model and Management for Jetty Fuel Terminal Industrywide Using Risk Priority Number

Jetty is an essential part of a fuel terminal and oil distribution process in terms of loading and unloading oil from and to tanker. Jetty has been widely used in fuel supply point facilities in archipelago countries like Indonesia. The increase in the importance given to maritime transportation has not only resulted in the development of the structure of safety issues but has also led to new investigations into the design of ships, the configuration of ports, and the operations conducted, all of which are essential components. However, it is not possible to ignore the risk inherent in jetty fuel terminal operations. Most of the reseach have pre-dominantly focused on the operation and impact of ship maneuvers and ship operations. But focusing on the jetty fuel risk itself is also very important as a whole part of reliability of a fuel receiving facility. FMEA is frequently used as a risk analysis method in determining risks arising from oil and gas sector. Each category of Severity, Occurance, and Detection from each risk factor can be rated to obtained the Risk Priority Number value. Mooring facilities assessment furthermore provides the implementation of assessment (grading) of operational suitability of jetties, based on the results of a visual assessment and special inspections. This paper aims to identify the risk associated with and to analyze these risk using Risk Priority Number ranking.

Application of failure model and effect analysis in nursing care for patients who have undergone endoscopic sub-mucosal dissection

ObjectiveThe objective of this study is to investigate the effect after the application of Failure Model and Effect Analysis (FMEA) in nursing care for patients who have undergone endoscopic submucosal dissection (ESD).MethodsA cohort of 40 patients who underwent ESD between July and September 2023 were selected as the control group, while 42 patients who underwent ESD between October 2023 and June 2024 after implementing FMEA were selected as the observation group. A multidisciplinary team was established based on the FMEA model to analyze and create a nursing flowchart. The 3 primary processes and 13 sub-processes were thoroughly analyzed and assessed to identify potential failure models, possible causes of failure, and consequences for each sub-process. Risk Priority Numbers (RPNs) were calculated to determine priority failure models, including medication and item preparation, specimen collection, equipment/instrument/accessory preparation, and nursing coordination. Corresponding improvement measures were formulated and implemented followed by a subsequent analysis of the effects.ResultsAfter implementing the improvement measures, there was a significant decrease in RPNs in the observation group when compared with the control group. A statistical significance was observed in context of medication and item preparation (P < 0.001), specimen collection (P < 0.001), equipment/instrument/accessory preparation (P < 0.001), and nursing coordination (P < 0.001).ConclusionThe application of the FMEA model can effectively facilitate early nursing interventions for identified risks in patient who have undergone ESD. By instituting suitable corrective measures for aspects deemed high-risk, this approach significantly diminishes surgical nursing hazards, enhances the quality of nursing care, and guarantees patient safety.

Investigating Communication Failures in AMR Meter at PT PLN UP3 Bali Selatan: A Failure Mode and Effect Analysis Approach

Automatic Meter Reading (AMR) is an automated system for reading electricity meter data that allows for remote monitoring and control of energy supply. The background of this research is based on the high level of communication failure in the AMR system, which significantly impacts the quality of electricity measurement and transactions. This study aims to identify the sources of communication failure in the Automatic Meter Reading (AMR) system at PT PLN UP3 Bali Selatan and estimate the highest potential risks using the Failure Mode and Effect Analysis (FMEA) method. Data was collected through direct observation and interviews with the AMR team over two months, as well as historical data held by the AMR team. The FMEA method identified and prioritized failure causes based on the value of the risk priority number (RPN). The Pareto diagram is used to help focus attention on the central issues that need to be addressed in improvement efforts. The analysis results indicate five critical communication failures in the Automatic Meter Reading (AMR) system. The most critical, “Can't connect to modem (1),” has an RPN of 225, followed by “Can't connect to modem (2)” (RPN 175) and “Modem no Answer” (RPN 125). The findings emphasize prioritizing the “Can't connect to modem (1)” failure due to its high risk.

Risk assessment of design faults

This paper focuses on the risk assessment of design faults which can be made in design documentation thus leading to significant damage and reduced construction efficiency. The data on statistics of the remarks made at the stage of design expertise are given. The steps of risk management at different stages of design, as well as types of risks are described. A method is proposed to analyze the risks of design faults involving the analysis of the types, consequences, and criticality of failures. In this method, the frequency of faults, their significance, and the probability of their detection are scored. Additionally, the probability of a fault can be pre-determined by a sample of specific types of objects or accepted by expert judgment. By multiplying the scores, the value of the complex (priority) risk of design fault is found and the risk level is assigned. For this purpose, the complex risk is compared with the boundary value of the priority risk number (PRN) and then classified as high, medium, or low. The risk level is determined by estimates of the frequency and significance of design faults. According to the risk level the measures significant for design quality management can be assigned. Criteria for assigning scores as well as management measures for each level of complex risk are proposed. Risk assessment for the main high-risk design faults has been performed. As a result, the method can be used to form a list of critical design faults, to justify control and preventive measures, as well as optimize the design process for increasing the quality of projects.

Risk assessment and quality management in AIO based on CT-linac for nasopharyngeal carcinoma: An improved FMEA and FTA approach.

All-in-one radiotherapy workflow (AIO) is a novel one-stop solution that integrates the multiple conventional radiotherapy steps from simulation, contouring, planning, image guidance, beam delivery, and in vivo dosimetry into a single device (integrated computed tomography linac, the uRT-linac 506c), making the treatment process more efficient and convenient while reducing errors for cancer patients' initial radiotherapy. Despite its numerous advantages, the implementation of AIO faces challenges such as interdisciplinary coordination, software and hardware complexity, and reliance on artificial intelligence. To ensure its safety and effectiveness, it is necessary to conduct a risk assessment and identify appropriate quality management measures. To perform risk assessment on the AIO for nasopharyngeal carcinoma using failure mode and effects analysis (FMEA) and fault tree analysis (FTA), and to validate the effectiveness of the quality management measures. A flowchart was established for the AIO of nasopharyngeal carcinoma. FMEA analysis was conducted based on the flowchart, and quantitative assessments of each failure mode (FM) were performed to obtain (occurrence), (severity), and (Detectability). Weighted , , and were obtained using the similarity aggregation method (SAM), and the final risk priority number (RPN) was calculated by multiplying these values. The FMs were then evaluated into two groups based on whether quality management (QM) measures were implemented, and sorted by the RPN. Finally, FTA analysis was conducted on the highest-risk FMs identified through ranking. A flowchart of AIO for nasopharyngeal carcinoma was established, consisting of 5 main steps and 28 sub-steps. After FMEA analysis, 86 FMs were identified. In the group without implementing QM measures (QM-free group), the RPN of FMs ranged from 13.5 to 186.2, with a threshold of 94.6 for the top 20% RPN scores, resulting in 17 high-risk FMs. Additionally, 21 FMs had , with a cumulative total of 25 high-risk FMs after removing duplicates. In the group that implemented QM measures (QM group), the RPN of FMs ranged from 3.0 to 46.7, showing an overall decrease compared to the QM-free group. There was a statistically significant difference in RPN between the QM-free (55.80±38.40) and QM (16.17±10.99) groups (p<0.001), validating the effectiveness of the QM measures. Finally, FTA analysis was performed on the highest-risk step identified in the QM-free group with the highest RPN. The improved FMEA and FTA analysis methods are practical and operational, allowing for a comprehensive analysis of potential failures and risks in the AIO for nasopharyngeal carcinoma. They can effectively assist in establishing and evaluating QM standards for AIO of nasopharyngeal carcinoma. Moreover, the analytical methods and QM measures of this study can be effectively applied to AIO for tumors in other sites.

Perancangan Jaminan Kualitas Kehalalan Produk Makanan Berdasarkan Metode Failure Mode Effect Analysis (FMEA) (Studi Kasus: UMKM Cilok ABC)

Cilok is a type of traditional snack from West Java made from tapioca flour. Based on observations, the cilok production process includes activities that have the risk of reducing the halal assurance of the product. Therefore, this study aims to identify any reduction in halal assurance using the Failure Mode and Effect Analysis (FMEA) method to ensure halal compliance by business operators. Based on the results of identification by identifying halal assurance by determining the Risk Priority Number (RPN) based on a scale on severity (severity), level of occurrence (occurrence) and level of occurrence (detection), revealed eleven risks of reduced halal assurance. The next step is to propose improvements to implement halal assurance measures, following the given recommendations to maintain the product’s halal status.

ANFIS method to enhance FMEA water operation model of Indonesia drinking water distribution system

Many problems are found in water treatment and distribution in water operations. Those problems range from low to critical risk. All critical risks must be addressed immediately. The Failure Mode and Effects Analysis (FMEA) prioritizes problems based on Occurrence, Severity, and Detection values to identify critical risks. However, this method is also having problems. With the same risk priority number (RPN) calculation, FMEA would be a ranking problem with the same RPN value; hence, we have a priority problem that is not critical but based on the highest value. To solve this problem, we propose additional methods, such as the ANFIS, to give weight based on risk level classification. From the results of data processing carried out by the ANFIS method, it is proven that it can perform re-ranking, for example, in the L2, R5, S8, and U3 code, which has an FMEA RPN value of 12. However, in FMEA-ANFIS, the RPN value becomes L2 2.05, R5 1.52, S8 1.32, and U3 2.52. Furthermore, with these results, it can be concluded that the ANFIS method can enhance the FMEA model in water operations.

A case study on risk analysis of machine breakdown using the FMEA method

This study addresses the frequent disruptions in PT X, the first cement factory in Indonesia, which affect its productivity and quality. The main problem involves the frequent stoppages of key machinery such as raw mills, kilns, cement mills, and especially coal mills, which are crucial for combustion processes. In 2021, the 6K1 coal mill experienced 384 hours and 38 minutes of downtime, with the Rotary 6K1A03 component being the most problematic, causing 205 out of 359 total disruptions. The Failure Mode and Effect Analysis (FMEA) method was employed to analyze these disturbances. The analysis revealed a critical Risk Priority Number (RPN) value of 5.148, with eight factors exceeding this threshold, including the high current in Rotary 6K1A03, with RPN values of 90, 35, 25, 24, 9, 8, and 6. These critical factors are prioritized for intervention. Consequently, it is imperative to implement management and risk mitigation strategies to address these issues and enhance the operational efficiency of the factory.

Supply Chain Risk Management of Aftermarket Products in Automotive Spare Parts Manufacturing Companies Using the House of Risk (HoR) Method

This study was conducted at an automotive component manufacturing company that produces aftermarket products. This study aims to identify risk events and agents that occur in the supply chain and develop strategies to control existing risks so as to minimize losses. The method used is the House of Risk (HoR). In HoR phase 1, 19 risk events were identified, with 38 risk agents as risk causes. From HoR phase 1, eight priority risks were selected. HoR phase 2 was carried out by determining a mitigation strategy plan with 16 mitigation actions, and then 7 priority mitigation actions were selected based on the effectiveness ratio obtained from the level of difficulty in realizing the mitigation action. Priority mitigation actions that will be carried out include conducting technology evaluations, providing supporting tools such as barcode scanners, creating clear work instructions, reviewing and updating SOPs, conducting three-point checks, conducting systematic quality control, and setting quality limits.

Risk Mitigation in the Sacrificial Cattle Supply Chain in Indonesia: A Supply Chain Management (SCRM) Approach

Paskas Farm is one of the cattle farms located in the Tangerang City area. This Paskas farm has a supply chain business process, namely small-sized cattle imported from the island of Java, namely Yogyakarta, Banyuwangi and Kediri. Then the cows are bred at the farm until they are large and have enough weight to be distributed for the benefit of Eid al-Adha. One of the supply chain risks at Paskas Farms related to animal welfare is during transportation and distribution. The transportation of this sacrificial cow takes a long time, namely for 16 hours, causing this sacrificial cow to experience stress during the distribution trip. The tight capacity in the truck also makes the sacrificial cattle experience stress because they do not implement animal welfare. Mitigation plans really need to be done to prevent or reduce the emergence of causes of risk. This study aims to determine the supply chain business process flow for qurban cattle from Paskas Farms, find out what risk events and the causes of priority risks that can arise in the supply chain business processes for sacrificial cattle at Paskas Farms, find out the appropriate handling strategy for priority risk causes in the process supply chain business for sacrificial cattle at Paskas Farm. Therefore, risk identification is carried out using the House of Risk phase 1 method which is grouped based on 5 main processes plan, source, make, deliver, return. From this process it was identified that there were 38 risk events and 24 risk agents. The recommended mitigation action or treatment strategy for the cause of the risk with the highest ranking is by using the House of Risk phase 2 method and get the result that there are 9 recommendations for mitigation actions that can be implemented by Paskas Farms.

Verification of automated review, release and reporting of results with assessment of the risk of harm for patients: the procedure algorithm proposal for clinical laboratories.

Autoverification increases the efficiency of laboratories. Laboratories accredited according to ISO 15189:2022 need to validate their processes, including autoverification, and assess the associated risks to patient safety. The aim of this study was to propose a systematic verification algorithm for autoverification and to assess its potential risks. The study was conducted using retrospective data from the Laboratory Information System (LIS). Seven laboratory medicine specialists participated. Autoverification rules were defined for analytes in serum, stool, urine and whole blood determined on Alinity ci (Abbott), Atellica 1500 (Siemens) and ABL90 FLEX (Radiometer). Criteria included internal quality control results, instrument flags, hemolysis/icteria/lipemia indices, median patient values, critical values, measurement ranges, delta checks, and reference values. Verification was performed step by step. Risk analysis was performed using Failure Modes and Effects Analysis and the Risk Priority Number (RPN) was calculated. During the study, 23,633 laboratory reports were generated, containing 246,579 test results for 167 biochemical tests. Of these, 198,879 (80.66 %) met the criteria for autoverification. For 2,057 results (0.83 %), the experts disagreed with the autoverification criteria (false negatives). Discrepancies were mainly associated to median and delta check values. Only 45 false positives (0.02 %) were identified, resulting in an RPN of 0 for all cases. The autoverified and non-autoverified results showed high agreement with the expert opinions, with minimal disagreement (0.02 % and 0.83 %, respectively). The risk analysis showed that autoverification did not pose a significant risk to patient safety. This study, the first of its kind, provides step-by-step recommendations for implementing autoverification in laboratories.

Identifying risks for effective maintenance of renewable energy plants in the new green Capital City of Indonesia

This study explores the use of Failure Mode and Effects Analysis (FMEA) to identify and mitigate risks in Solar Power Plants (PLTS) in Indonesia’s new National Capital City (IKN). As renewable energy is vital to Indonesia’s sustainability goals, managing risks in PLTS is essential for ensuring reliable and efficient energy production. The research identifies key challenges such as PV Array module failures, shading effects, and control system disruptions, which significantly impact electricity generation. Using the Risk Priority Number (RPN) methodology, the study ranks PV Array modules as the highest risk component (RPN 192), followed by Control and Management Systems (RPN 140) and PV Circuit Breakers and Video Monitoring Systems (RPN 120). These findings underline the need for targeted mitigation strategies. Recommendations include regular PV module inspections, hotspot monitoring technology, firmware updates, and enhanced fire protection systems. Preventive measures like grounding current maintenance and fire sensor upgrades further minimize operational disruptions, ensuring component durability and system efficiency. By leveraging the FMEA framework, this study systematically identifies and prioritizes risks while providing actionable solutions to enhance operational resilience. The results align with Indonesia’s vision of achieving 80 % renewable energy utilization in IKN by 2045. This research offers broader applicability for renewable energy systems in similar contexts, contributing to clean energy initiatives, reducing fossil fuel dependency, and supporting sustainable urban planning. It serves as a critical resource for integrating renewable energy into Indonesia’s green and resilient capital city vision

PENGUKURAN RISIKO OPERASIONAL AGROINDUSTRI MINYAK KAYU PUTIH KUPANG MOJOKERTO DENGAN METODE FMEA

Kupang Mojokerto Eucalyptus Oil Agroindustry is a modern industry engaged in distilling eucalyptus leaves into eucalyptus oil products. This study aims to describe the level of operational risk measures that have the potential to occur in the Kupang Mojokerto Eucalyptus Oil Agroindustry. The method used in measuring the level of potential operational risk is Failure Mode and Effect Analysis (FMEA) which serves to identify and analyze the occurrence of potential operational risks so that companies can carry out appropriate risk control based on the risk priority number (RPN) value with a high criticality category. The results showed that the types of operational risks in the high criticality category include not maximizing evaporation with RPN 360, receiving raw materials in the rainy season in wet and budding conditions with RPN 348, dependence on certain technologies with RPN 346, and weather conditions with high rainfall intensity with RPN 336. Measurement of the level of operational risk is carried out so that the company can control and anticipate the occurrence of risks in operational activities.

ОЦЕНКА РИСКА ВОЗНИКНОВЕНИЯ АВАРИИ ГРУЗОПОДЪЕМНЫХ СООРУЖЕНИЙ ПРИ СТРОИТЕЛЬСТВЕ МОСТА

This work is devoted to assessing the risk of an accident of lifting structures during the construction of the bridge. The object of research in this work is a SENEBOGEN 7700 jib type crawler crane, the subject of the study is an accident risk assessment. After analyzing the accident statistics when using lifting structures, the main types of defects leading to an accident were identified. With the help of the «Tree of failures» method, the probabilities of the accident occurrence were found on the SENEBOGEN 7770 boom type crawler crane when moving the pile. Then, using the method of analysis of the types, consequences and criticality of failures (FMECA), the risk priority was assessed by conducting an expert survey to identify the most dangerous of the selected types of failures and to rank these defects according to the degree of criticality for the construction object and the person. After the ranking, measures were proposed in the work that will reduce the risk of an accident at the construction site.

Sentinel testing, analytical sigma metrics and a risk management approach as part of a simplified method verification/validation process

Introduction Verification and validation of analytical methods are crucial aspects of quality assurance in a laboratory. This study aimed to develop a risk analysis and assessment tool to streamline the process of identifying so-called ‘sentinel’ tests. Materials and methods The Roche Cobas 8000 systems were evaluated to analyze 83 serum analytes, including routine chemistry, immunoassays, and therapeutic drugs. A failure mode and effects analysis were conducted to produce an analytic risk rating. This was achieved by multiplying the scores for Sigma metrics, the score for potential damage extent, and the score for environmental factors. Each test was assigned a typical risk priority number (RPN). Tests with an RPN of ≤9 were rated as low risk and ranked as ‘B’. Tests with an RPN of >10 were considered high risk and graded as ‘A’. Results Regarding the Cobas C701/ISE, 17 of 54 methods were rated as ‘A’ and subject to a systematic method review process. A total of 37 methods were assigned a rank of ‘B’ and hence were eligible for a selective verification process. Concerning the Cobas E801, 10 out of 29 methods were classified as ‘A’ and, therefore, require a systematic verification process. A further nineteen methods were assigned a rank of ‘B’ and hence eligible for a select verification. Conclusions This study demonstrated the high effectiveness of the risk analysis and assessment model developed to identify sentinel tests in the lean management of the verification/validation process.

The Heads Up Checkup Digital Mental Health &amp; Behavioral Risk Screening System: Clinical Inter‐Rater Reliability for Identifying Youth in Crisis

ABSTRACTThe present study evaluated the inter‐rater reliability of the Heads Up Checkup (HCU), a brief digital mental health and behavioral adaptive screening system designed for use in primary care and diverse school settings. Two independent licensed clinical psychologists reviewed a random sample of 30 (N = 30) HCU clinical screening reports of 13−14 year old adolescents drawn from a larger sample (N = 846) enrolled in a public middle school in California. Results showed strong inter‐rater agreement (Fleiss kappa = 0.93) between clinician ratings and the screener's priority risk index (HPI) in identifying students “in crisis.” In addition, clinicians' ratings of confidence in their priority judgments were found to be significantly higher for the “in crisis” cases. Reasonable evidence of convergent validity emerged due to a strong relationship between clinician ratings of psychological distress and the HPI. Overall findings suggest that as an online universal school‐based screener, the HCU has valid utility for identifying young adolescents “in crisis” which can translate into timely interventions and pragmatic real‐world therapeutic solutions. Future research directions with respect to the refinement of the HCU's measurement characteristics and its feasibility as an online screener at the population‐level in schools are discussed.