Risk management approach for testing and calibration laboratories

Santana, Michelly Karoline Alves; Loureiro, Geilson

doi:10.1007/s00769-022-01521-y

Cited by 3 publications

(3 citation statements)

References 7 publications

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“…In this paper, we develop the information system using the waterfall software development method, which is a systematic approach, starting from the system requirements stage and moving on to the analysis, design, coding, testing/verification, and maintenance stages [4]. To construct the information system, we implement the waterfall model as a compound of activities into linear sequential phases, meaning they are passed down onto each other, where each stage depends on the deliverables of the previous one and corresponds to a specialization of tasks.…”

Section: Proposed Methodsmentioning

confidence: 99%

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SIMANTUL: Model of Internal Quality Audit Management System in Higher Education

Mulyani

Nugroho²,

Nurain³

2022

ijicom

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Many organizations carry out the quality assurance system through the Internal Quality Assurance System (SPMI) and the External Quality Assurance System (SPME). The SPMI framework uses the stages of a continuous quality assurance cycle with the PPEPP method (Application, Implementation, Evaluation, Control, and Improvement), which is carried out periodically to achieve University's Vision, Mission, Goals, and Targets. This paper discusses the implementation stages of the internal quality audit management system at Universitas Respati Yogyakarta, Indonesia. Using an information system, the university audit body, BPM, regularly and consistently carries out an Internal Quality Audit (AMI) every year to audit the implementation of academic and non-academic activities at the University. In this research, we construct an audit system, namely the E-Audit application, with the Waterfall software development method. This study can produce an efficient system called SIMANTUL, which refers to the Higher Education Accreditation assessment instrument version 3.0 and can store documents digitally.

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Section: Proposed Methodsmentioning

confidence: 99%

“…Although the new version introduces the idea, procedures to be adopted for implementing risk management in testing and calibration laboratories are not addressed. The article is conceptual and summarizes information from the literature to assess the application of reputable risk management models and implement them in laboratories [4].…”

Section: Introductionmentioning

confidence: 99%

SIMANTUL: Model of Internal Quality Audit Management System in Higher Education

Mulyani

Nugroho²,

Nurain³

2022

ijicom

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“…Однако в стандарте отсутствуют какие-либо требования к использованию формальных методов управления рисками или документированного процесса управления рисками. Лаборатории могут сами решить, следует ли им разрабатывать более обширную ме-тодологию управления рисками, например, путем применения другого стандарта [1].…”

Section: Introductionunclassified

Application of the Failure Mode and Effects Analysis Tool in Testing Laboratory for a Risk Analysis

Makaeva,

Denisova

et al. 2024

Vestnik IzhGTU imeni M.T. Kalashnikova

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The new version of the GOST ISO/IEC 17025-2019 standard requires the laboratories to plan and carry out actions to eliminate risks and opportunities. Several management tools can be used to identify risks, such as Failure Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), Ishikawa diagram, risk matrix, brainstorming, and etc. The result of risk identification in the laboratory is a risk register containing all potential risks that may arise during laboratory activities. FMEA is one of the such registries. The purpose of this study was to demonstrate the possibility of using the FMEA tool for risk assessment in a testing laboratory, taking into account the requirements of GOST ISO/IEC 17025-2019. Two processes were selected and used for FMEA analysis - review of requests, applications and internal laboratory control. As part of the analysis, point estimates (on a ten-point scale) of the Severity of Effect S, the Probability of Occurrence O, and the Likelihood of Detection D. Based on the scores, the risk priority number RPN is calculated. For nonconformities with the RPN value exceeded 100, corrective measures were developed that made it possible to reduce the RPN values to an acceptable laboratory level. It is recommended to analyze the processes using the FMEA method in order to identify the causes of nonconformities and prevent their recurrence periodically. Risk analysis and management are necessary to achieve the intended results in the activities of testing laboratories, maintain and improve the quality management system.

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On the issue of resolving disputes about the compliance of the research object with regulatory requirements

Rahmanin,

Rozental

2024

Hygiene and Sanitation

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Conclusions on the fulfillment or violation of regulatory requirements ensuring the hygienic safety of the research object of the supervised object are carried out by state sanitary and epidemiological supervision bodies based on the results of laboratory studies of controlled indicators. These are, in particular, conclusions on the safety of drinking water sources for the population. The composition and properties of this water, on the instructions of sanitary and epidemiological supervision bodies and water supply institutions, can be examined equally by accredited laboratories that comply with the accreditation criteria in carrying out their activities. At the same time, unfortunately, it is impossible to guarantee the same results of laboratory testing of controlled microbiological, chemical, and other indicators, due to their variability and measurement errors. As a result, the conclusions about the quality and safety of water obtained by the supervisory authority and the supplier (user), primarily in cases concerning the boundary values of hygiene standards, may differ. For constructive resolution of controversial situations arising in this case, this paper proposes a method of tolerance control, the result of which is a logical judgment on the compliance or non-compliance of controlled quantities with established standards. It is shown how this reduces the risk of erroneous recognition of non-compliance of the composition or properties of water with hygienic requirements and guarantees safe water supply to the population. Authors suggested equations of admission control to assess compliance with the requirements of sanitary, epidemiological, and hygienic safety of controlled facilities. A method convenient for practical use is proposed, and using a specific example of monitoring the water quality of wells in the Talitsky district of the Sverdlovsk region, it is shown how it is possible to establish the water safety of almost half of the initially rejected water sources. The use of tolerance control is recommended if it is necessary to increase the reliability of hygienic conclusions on the safety of a wide range of supervised facilities, for which convenient mathematical expressions are given.

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Risk management approach for testing and calibration laboratories

Cited by 3 publications

References 7 publications

SIMANTUL: Model of Internal Quality Audit Management System in Higher Education

SIMANTUL: Model of Internal Quality Audit Management System in Higher Education

Application of the Failure Mode and Effects Analysis Tool in Testing Laboratory for a Risk Analysis

On the issue of resolving disputes about the compliance of the research object with regulatory requirements

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