scholarly journals Analytical performance assessment and improvement by means of the Failure mode and effect analysis (FMEA)

2020 ◽  
Vol 30 (2) ◽  
pp. 250-256
Author(s):  
Leonor Guiñón ◽  
Anna Soler ◽  
Luisa Alvarez ◽  
Aurea Mira ◽  
Josep Lluís Bedini ◽  
...  

Introduction: Laboratories minimize risks through quality control but analytical errors still occur. Risk management can improve the quality of processes and increase patient safety. This study aims to use the failure mode and effect analysis (FMEA) to assess the analytical performance and measure the effectiveness of the risk mitigation actions implemented. Materials and methods: The measurands to be included in the study were selected based on the measurement errors obtained by participating in an External Quality Assessment (EQA) Scheme. These EQA results were used to perform an FMEA of the year 2017, providing a risk priority number that was converted into a Sigma value (σFMEA). A root-cause analysis was done when σFMEA was lower than 3. Once the causes were determined, corrective measures were implemented. An FMEA of 2018 was carried out to verify the effectiveness of the actions taken. Results: The FMEA of 2017 showed that alkaline phosphatase (ALP) and sodium (Na) presented a σFMEA of less than 3. The FMEA of 2018 revealed that none of the measurands presented a σFMEA below 3 and that σFMEA for ALP and Na had increased. Conclusions: Failure mode and effect analysis is a useful tool to assess the analytical performance, solve problems and evaluate the effectiveness of the actions taken. Moreover, the proposed methodology allows to standardize the scoring of the scales, as well as the evaluation and prioritization of risks.

Author(s):  
Candrianto Candrianto ◽  
Rizaldi Sardani ◽  
Rizki Fadhillah Lubis ◽  
M. Zakaria

PT. X is an industry that produces green tea and black tea. In this study, there are often problems with the wrapping machine due to the age of use and the tight schedule of usage in the wrapping machine. If the machine operates in an unstable condition, it will greatly affect the results of the production. Damaged components such as cutting blades, heating heaters, thermo control and bearings. By using the Failure Mode and Effect Analysis (FMEA) method and also calculating the Risk Priority Number (RPN) value, the highest RPN value to the lowest is obtained, namely Cutting Knife (RPN = 100), Heater (RPN = 90), Thermo Control (RPN = 72) and Bearings (RPN = 36). It can be seen that the cause of damage to the wrapping machine and also the highest RPN calculation is found in the damage to the cutting knife whose RPN value is 100. From the analysis of the damage to the cutting knife, the author provides a suggested repair plan for the company so that it can be implemented in the company which can later improve the quality of the machine to be operated. for the future which cannot be separated from the supervisory role of the operators in charge of their cooperation to improve quality and the quality control team that always monitors quality.


2012 ◽  
Vol 32 (3) ◽  
pp. 505-514 ◽  
Author(s):  
Sibel Ozilgen

The Failure Mode and Effect Analysis (FMEA) was applied for risk assessment of confectionary manufacturing, in whichthe traditional methods and equipment were intensively used in the production. Potential failure modes and effects as well as their possible causes were identified in the process flow. Processing stages that involve intensive handling of food by workers had the highest risk priority numbers (RPN = 216 and 189), followed by chemical contamination risks in different stages of the process. The application of corrective actions substantially reduced the RPN (risk priority number) values. Therefore, the implementation of FMEA (The Failure Mode and Effect Analysis) model in confectionary manufacturing improved the safety and quality of the final products.


2021 ◽  
Vol 10 (2) ◽  
pp. 106-114
Author(s):  
Yuli Wibowo ◽  
Andrew S Rusdianto ◽  
Septy T Wahyuni

Besuki Na-Oogst tobacco is a type of plantation commodity that requires special handling. Improper post-harvest handling increases the risks of being damaged. This study aimed to identify the types of damage to Besuki Na‑Oogst tobacco leaves, analyze the risk level of damage to Besuki Na-Oogst tobacco leaves, and provide recommendations for risk control of tobacco leaves damage. The Failure Mode and Effect Analysis method was applied to Identify the Besuki Na-Oogst tobacco leaves risk damages. This method can determine the value of severity, occurrence, and detection to obtain a critical Risk Priority Number (RPN) that indicates the most critical level of risk. The results showed that the types of damage to Besuki Na-Oogst tobacco leaf classified as having a high-risk impact were perforated leaves, oily leaves, white spots, blue spots, and moldy leaves indicated by RPN values greater than the critical value. If these risks are not appropriately handled, it can decrease the quality of the tobacco leaves, resulting in losses. The risk control of leaf damage is based on risk-causing factors in suggestions for improvements that the management can follow up. Keywords: Besuki Na-Oogst tobacco leaves; critical value; FMEA; risk; RPN   ABSTRAK Tembakau Besuki Na-Oogst merupakan jenis komoditas perkebunan yang memerlukan penanganan khusus. Penanganan pasca panen yang tidak tepat menimbulkan risiko yang tidak diinginkan yaitu daun tembakau menjadi rusak. Penelitian ini bertujuan untuk mengidentifikasi jenis kerusakan daun tembakau Besuki Na-Oogst, menganalisis tingkat risiko kerusakan daun tembakau Besuki Na-Oogst, dan memberikan rekomendasi pengendalian risiko kerusakan daun tembakau. Identifikasi risiko kerusakan daun tembakau Besuki Na-Oogst menggunakan metode Failure Mode and Effect Analysis. Metode ini dapat digunakan untuk menentukan nilai keparahan, kejadian, dan deteksi untuk mendapatkan risk priority number kritis yang menunjukkan tingkat risiko paling kritis. Hasil penelitian menunjukkan bahwa jenis kerusakan pada daun tembakau Besuki Na-Oogst yang tergolong berisiko tinggi adalah daun berlubang, daun berminyak, bercak putih, bercak biru, dan daun berjamur yang ditunjukkan dengan nilai RPN lebih besar dari nilai kritis. Jika risiko tersebut tidak ditangani dengan baik, maka daun tembakau akan mengalami penurunan kualitas yang dapat mengakibatkan kerugian. Pengendalian risiko kerusakan daun tembakau didasarkan pada faktor penyebab risiko berupa saran perbaikan yang dapat ditindaklanjuti oleh pihak perusahaan. Kata kunci: Daun tembakau Besuki Na-Oogst; FMEA; nilai kritis; risiko; RPN


2021 ◽  
Vol 74 (6) ◽  
Author(s):  
Luciana Andrade de Lima ◽  
Louise Constancia de Melo Alves Silva ◽  
Joyce Karolayne dos Santos Dantas ◽  
Maria Solange Moreira de Lima ◽  
Daniele Vieira Dantas ◽  
...  

ABSTRACT Objectives: to analyze the applicability of Root Cause Analysis and Failure Mode and Effect Analysis tools, aiming to improve care in pediatric units. Methods: this is a scoping review carried out according to the Joanna Briggs Institute guidelines, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes extension for Scoping Reviews. Search took place in May 2018 on 15 data sources. Results: search totaled 8,254 studies. After using the relevant inclusion and exclusion criteria, 15 articles were included in the review. Of these, nine were published between 2013 and 2018, 12 used Failure Mode and Effect Analysis and 11 carried out interventions to improve the quality of the processes addressed, showing good post-intervention results. Final Considerations: the application of the tools indicated significant changes and improvements in the services that implemented them, proving to be satisfactory for detecting opportunities for improvement, employing specific methodologies for harm reduction in pediatrics.


2013 ◽  
Vol 748 ◽  
pp. 1203-1207 ◽  
Author(s):  
Siew Hong Ding ◽  
Nur Amalina Muhammad ◽  
Nur Hanisah Zulkurnaini ◽  
Amanina Nadia Khaider ◽  
Shahru Kamaruddin

With the rapid growth of semiconductor industry, manufacturers are always seeking for improvement to produce better product quality with lower cost in order to survive under competitive marketing environment. However, these matters are easily affected by the failures occurred on the machines. Thus, this paper proposes framework using failure mode and effect analysis (FMEA) with 5-Whys analysis to discover the root cause of the failure furthermore to identify the effective solutions. Drilling machine has been used to justify the practicability of the proposed framework.


2017 ◽  
Vol 15 (2) ◽  
pp. 210
Author(s):  
Viki Hestiarini ◽  
Lia Amalia ◽  
Eni Margayani

Medication error can occur at all stages, starting from prescribing, dispensing and administration of drugs. This study aims to assess the medication errors that occur in the pharmaceutical care process and analyze the cause of failure using the root cause analysis method, to improvement action and decrease the incidence of medication errors. The data were completeness prescription, frequency of dispensing error and completeness of drug information. The number of sample was 1100 prescriptions Prescribing errors were found the potential injury 15.69±11.51% and near missed error 0.5±0.55%. At dispensing stage, occur 427 incidences (9.71%), consist of two incidences (0.04%) for validation assessment regulations, 224 incidences (5.09%) of data entry, 113 incidences (2.57%) of retrieval of drugs, 19 incidences (0.43%) of fi ll in drugs, 69 incidences (1.57%) of fi nal check. At dispensing stage, near missed 330 incidences (7.51%) of near missed and 97 incidences (2.21%) of potential injury. Failure mode and effect analysis calculate of risk priority number, the drug retrieval (RPN 210) and data entry (RPN 126) were analyzed root cause of the analysis for man, material, method, facility and environment.


Author(s):  
Ю.І. Сеник

У роботі розглянуто застосування модифікованого до системи ощадливого виробництва методу оцінки ризиків FMEA для виробничих лабораторій молокопереробних підприємств. Описано алгоритм реалізації failure mode and effect analysis та вказано основні принципи розрахунку S (значимість потенційних збоїв у роботі), O (ймовірність виникнення збою у роботі), D (ймовірність виявлення збою) та RPN (risk priority number). Розглянуто два основні недоліки класичного підходу методики FMEA та для їх усунення використано модифікацію, запропоновану Rapinder Sawhney та ін., яка полягає у використанні інтегрального показника «значення оцінки ризиків». Для аналізу ризиків виробничої лабораторії згідно з модифікованою методикою FMEA вибрано окремий шаблон таблиці, представлений у тексті статті. Він містить як елементи FMEA, так і спосіб вирішення критичних показників згідно з принципами LEAN. Такий підхід до роботи лабораторії є вкрай важливим, адже саме від оперативності та точності проведених досліджень залежатиме можливість уникнення прямих утрат для підприємства та випуску безпечної та якісної продукції.


2020 ◽  
Vol 319 ◽  
pp. 01004
Author(s):  
Voraya Wattanajitsiri ◽  
Rapee Kanchana ◽  
Surat Triwanapong ◽  
Kittipong Kimapong

The objective of this research was to study a risk assessment of the rice combine harvester using FMEA technique implementation and suggested the procedures to maintain the parts of the rice combine harvester by analyzing the causes of risk assessment of FMEA. The FMEA was also applied to specify failure causes and effects that occurred in the rice harvester. The obtained data were calculated for a risk priority number (RPN) and then sorted to be a descending order. The high RPN part was analyzed for the causes and effects and then suggested a preventive maintenance in near future. The results revealed that the highest RPN of 576 was found when a chain surface was considered and also showed the maximum risk among the considered parts in the rice combine harvester. While, the lowest RPN of 144 was found when a rice sieve part was considered but this RPN was still higher than that of 100 RPN which was required to specify the preventive maintenance.


2014 ◽  
Vol 627 ◽  
pp. 365-371 ◽  
Author(s):  
Em Ardchaya Rungsa ◽  
Somkiat Tangjitsitcharoen

In order to realize the intelligent maintenance management system, this paper presents a development of computerized preventive maintenance management system (CPMMS) to manage and record the maintenance information in the database for the CNC machines. The failure mode and effect analysis (FMEA) has been utilized to deal with the computerized preventive maintenance management system in this research. The FMEA is analyzed to determine the risk priority number (RPN) of the CNC machines in order to set the preventive maintenance plan as a standard maintenance. The developed program can generate the next schedule of the preventive maintenance plan automatically, which increases the efficiency and decreases the breakdown. It has been proved that the proposed and developed CPMMS with FMEA program can improve the overall equipment effectiveness (OEE). The RPN has been reduced due to a decrease in the severity and the occurrence.


2012 ◽  
Vol 18 (1) ◽  
pp. 103-113 ◽  
Author(s):  
Parinaz Salati ◽  
Seyed Jozi

The ninth olefin plan of Arya Sasol Petrochemical Company (A.S.P.C.) is regarded the largest gas Olefin Unit located on Pars Special Economic Energy Zone (P.S.E.E.Z). Considering the importance of the petrochemical unit, its environmental assessment seems necessary to identify and reduce potential hazards. For this purpose, after determining the scope of the study area, identification and measurement of the environmental parameters, environmental risk assessment of the unit was carried out using Environment Failure Mode and Effect Analysis (EFMEA). Using the noted method, sources causing environmental risks were identified, rated and prioritized. Beside, the impacts of the environmental aspects derived from the unit activities as well as their consequences were also analyzed. Furthermore, the identified impacts were prioritized based on Risk Priority Number (RPN) and severity level of the consequences imposed on the affected environment. After performing statistical calculations, it was found that the environmental aspects owing the risk priority number higher than 15 have a high level of risk. Results obtained from Low Density Polyethylene Unit revealed that the highest risk belongs to the emergency vent system with risk priority number equal to 48. It is occurred due to imperfect performance of the reactor safety system leading to the emissions of ethylene gas, particles, and radioactive steam as well as air and noise pollutions. Results derived from secondary assessment of the environmental aspects, through difference in calculated RPN and activities risk levels showed that employing modern methods and risk assessment are have remarkably reduced the severity of risk and consequently detracted the damages and losses incurred on the environment.


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