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The article discusses the minimum expectations for market authorization of continuous glucose monitoring devices in Europe, focusing on compliance status with eCGM standards. It emphasizes the importance of accurate glucose monitoring for individuals with diabetes and the shift towards continuous glucose monitoring systems. The article highlights concerns about the accuracy and safety of CGM systems, citing specific instances in Italy and the UK. It proposes minimum requirements for clinical investigation and device validation to ensure the safety and efficacy of CGM devices in the European healthcare marketplace. [Extracted from the article]

This perspective paper critically examines value-laden challenges that emerge when using standards to support regulation in the field of artificial intelligence, particularly within the context of the AI Act. It presents a dilemma arising from the inherent vagueness and contestable nature of the AI Act’s requirements. The effective implementation of these requirements necessitates addressing hard normative questions that involve complex value judgments. These questions, such as determining the acceptability of risks or the appropriateness of accuracy levels, need to be addressed in order to achieve compliance with the AI Act. However, this creates a dilemma: either the hard normative questions left open by the AI Act are addressed by the standards or they are addressed by the actors involved in the conformity assessment. This paper argues that the latter approach is more likely. Consequently, regulatory intermediaries such as notified bodies will be responsible for making critical value judgments while evaluating compliance with the AI Act’s value-laden requirements. This shift raises a series of concerns and implications that warrant further exploration. [ABSTRACT FROM AUTHOR]

Purpose: This paper deals with external audits, which are now commonly used in many industries (e.g. food, automotive and electrical). This study aims to assess whether a given organization meets the specific criteria. If the audit ends with a positive result, information about it is provided to selected interested parties, e.g. clients or contractors. Credibility is pivotal in adding value for all interested parties within the audit processes. This study seeks the factors which, in the opinion of the audited enterprises, have the most decisive impact on the credibility of external audits. Design/methodology/approach: In keeping with the extant literature, research questions were developed regarding the factors influencing the credibility assessment of external audits. Data collected from 100 companies in the Polish food sector were used to construct the model and carry out statistical analyses. Linear regression analyses were also applied to determine the key factors influencing the credibility of audits. Findings: This study is part of the research trend on the rationality of external audits and certification of quality management systems. This paper identifies nine main factors shaping the credibility of external audits. Two of them have the most decisive influence on credibility. The first one is the professional audit method (procedure). The second factor is the auditor's knowledge of the specificity of the audited area. Research limitations/implications: This study did not consider the impact that the image/credibility of the organization represented by the auditors may have on the reliability of audits. This is one of the fundamental limitations that should be considered when analyzing the obtained results. To recognize this type of dependence, additional research should be carried out. Another limitation is that the research covers the food industry only. It would be interesting to know the situation in other types of industries. Practical implications: This paper looks at the possibility of increasing the added value for audited enterprises. The proposed model can be used by managers of organizations conducting external audits and auditors to effectively use resources for process improvement, influencing the maximization of credibility of activities in the area of conformity assessment. Originality/value: The originality of this study lies in adopting the perspective of audited enterprises in assessing the credibility of audits. To the best of the authors' knowledge, this is the first study that adopts this approach. This paper contributes to the literature, particularly to better understand audited enterprises' behavior (trust in audit results, satisfaction with audits, etc.). [ABSTRACT FROM AUTHOR]

Coordinate measuring machines are widely used in the industrial field due to their ease of automation. However, estimating the measurement uncertainty is a delicate task, especially when controlling for deviation, given the large number of factors that influence the measurement. A precise estimate of the uncertainty is crucial to avoid incorrect conformity assessments. The purpose of this study is to control geometrical-form tolerance specifications, taking into consideration their associated uncertainty. A surface fitting model based on the least squares criterion is proposed, allowing one to obtain the variance–covariance matrix by iterative calculation according to the Levenberg–Marquard optimization method. The form deviation is then evaluated following the Geometrical Product Specifications (GPS) Standard, and its associated uncertainty is estimated using the guide to the expression of uncertainty in measurement (GUM) propagation of the uncertainty law. Finally, the conformity assessment is performed based on the measured deviation and its associated uncertainty. Different results for the measurement of straightness, flatness, circularity, roundness, and cylindricity are presented and detailed. This model is thereafter validated by a Monte Carlo simulation, and interlaboratory comparisons of the obtained results were performed, which showed satisfactory outcome. This contribution is of great use to manufacturing companies and metrology laboratories, allowing them to meet the normative guidelines, which stipulates that each measurement result must be accompanied by its associated uncertainty. [ABSTRACT FROM AUTHOR]

Notified bodies (NBs), which perform conformity assessments, play a crucial role in protecting patient health and providing access to safety products on the market. The EU 2017/745 Medical Device Regulation (MDR) brings stricter rules and responsibilities for notified bodies. Designating authorities (DAs), who are also responsible for monitoring notified bodies, have not been provided with any guidance documents or written procedures. In this study, for the first time, we proposed a methodology aided by a digital system to monitor notified bodies effectively. We conducted a need analysis based on the MDR requirements and the relevant guidance documents, and we introduced a six-component technique for monitoring of the medical device notified bodies. Then, we identified the subcriteria of each component and created business activity diagrams for the main processes to monitor the notified bodies. There are now forty-nine notified bodies available under the MDR. Our monitoring approach consists of six steps that cover all NBrelated activities, such as review of technical documentation assessment, personnel authorization, and surveillance of the certified product on the market. The proposed system complies with the MDR requirements and handles all critical performance indicators of NBs. The new MDR requirements for NBs also require an advanced monitoring system for DAs. This study focused on the critical points for monitoring NBs. Member states should implement the proposed methodology and the activity diagrams to have an efficient monitoring system in accordance with MDR requirements. A similar system can be used for monitoring of the other conformity assessment bodies. [ABSTRACT FROM AUTHOR]

Copyright of Cyber Security & Data Governance is the property of Editorial Office of Information Technology & Network Security and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Traditionally, for indoor radon testing, predominantly passive measurements have been used, typically applying the solid-state alpha track-etch method for long-term and the charcoal method for short-term measurements. However, increasingly, affordable consumer-grade active monitors have become available in the last few years, which can generate a concentration time series of an almost arbitrary duration. Firstly, we argue that consumer-grade monitors can well be used for quality-assured indoor radon assessment and consequent reliable decisions. Secondly, we discuss the requirements of quality assurance, which actually allow for reliable decision-making. In particular, as part of a rational strategy, we discuss how to interpret measurement results from low-cost active monitors with high and low sensitivity with respect to deciding on conformity with reference levels that are the annual average concentration of indoor radon. Rigorous analysis shows that temporal variations in radon are a major component of the uncertainty in decision-making, the reliability of which is practically independent of monitor sensitivity. Manufacturers of low-cost radon monitors already provide sufficient reliability and quality of calibration for their devices, which can be used by both professional inspectors and the general public. Therefore, within the suggested measurement strategy and metrologically assured criteria, we only propose to clarify the set and values of the key metrological characteristics of radon monitors as well as to upgrade user-friendly online tools. By implementing clear metrological requirements as well as the rational measurement strategy for the reliable conformity assessment of a room (building) with radon safety requirements, we anticipate significant reductions in testing costs, increased accessibility, and enhanced quality assurance and control (QA/QC) in indoor radon measurements. [ABSTRACT FROM AUTHOR]

Copyright of Technisches Messen is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of GeSec: Revista de Gestao e Secretariado is the property of Sindicato das Secretarias e Secretarios do Estado de Sao Paulo (SINSESP) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The article addresses the ambiguity and diversity of requirements provided in regulatory documents and imposed on measurement and unit dissemination procedures comprising the chain of metrological traceability. A unified approach to the study of these procedures based on their classification is justified. Different types of procedures are analyzed: primary reference measurement procedures, reference measurement procedures, calibration procedures, verification procedures, end-user measurement procedures, and measurement procedures. Requirements for the development, study, and approval of the described procedures are considered. The article proposes a classification of procedures according to their place in the chain of metrological traceability, the type of metrological characteristics to be determined, and their application in the sphere of state control. The performed analysis of regulatory documents is summarized in a table describing the main requirements for the development and approval of measurement and unit dissemination procedures. The author considers requirements established for such conformity assessment of measurement and unit dissemination procedures as method certification, validation, and verification. The definitions and scope of application of conformity assessment procedures for measurement and unit dissemination procedures are presented. An analysis of requirements for the conformity assessment of procedures yielded a block diagram that can be used by laboratories to unambiguously select a conformity assessment procedure for approval of the required measurement or unit dissemination procedure, specifically when preparing for accreditation for compliance with ISO/IEC 17025-2017 General Requirements for the Competence of Testing and Calibration Laboratories. The proposed diagram for selecting a conformity assessment procedure for a particular procedure eliminates the ambiguity of requirements specified in regulatory documents. [ABSTRACT FROM AUTHOR]

In May, 2023, the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) published the international standard ISO/IEC 17043:2023 Conformity assessment—General requirements for the competence of proficiency testing providers. This article describes the 100 % online revision process from the perspective of the Working Group (WG) members, explains the latest changes, and explores the potential impact of these changes on interested parties. [ABSTRACT FROM AUTHOR]

Formulation of requirements for independent professional examination of legal circumstances and their consequences is associated with a number of issues, in particular, of a theoretical and methodological nature. One of the main issues is the development of a theory of competence of an independent professional expert institution, the starting point of which is to determine the requirements under which such an institution is able to perform certain actions (i. e., is competent), in particular, with regard to the organisation and conduct of an expert study to assess compliance with a material change in circumstances that the parties could not foresee when entering into an agreement (contract) and its legal consequences within the meaning of Article 652 of the Civil Code of Ukraine. Despite a certain number of scientific papers devoted to the study of various aspects of the possible implementation of the legal doctrine in practice, it should be noted that the legal literature has not yet formalised the requirements and established a full-fledged definition of the competence of an independent professional expert. The purpose of the publication is to substantiate the doctrinal basis for the requirements to such a category as the competence to assess compliance with a material change of circumstances which the parties could not foresee when entering into an agreement (contract) and its legal consequences within the meaning of Article 652 of the Civil Code of Ukraine; to analyse practical situations to which attempts have been made to apply the conclusions of chambers of commerce and industry in Ukraine and to find out the reasons for their judicial devaluation. The object is legal relations arising in the course of independent professional examinations, as well as the circumstances that significantly complicate the fulfilment of obligations under the agreement (contract) for reasons beyond the will, desires and actions of the parties; the subject is the current positive law, the practice of judicial activity and the activities of expert institutions. The author establishes that the opinions of chambers of commerce and industry in Ukraine on assessing a material change in circumstances which the parties could not foresee when concluding an agreement (contract) and its legal consequences within the meaning of Article 652 of the Civil Code of Ukraine are widely used. The author has clarified the legal conclusions of the court which state that chambers of commerce and industry in Ukraine do not have the authority to provide such conclusions. The optimal methodological basis for the competence of an independent professional expert to provide an assessment of compliance with a material change in circumstances that the parties could not foresee when concluding an agreement (contract) and its legal consequences within the meaning of Article 652 of the Civil Code of Ukraine may be legal requirements that: 1) are similar to the requirements of international standards, in particular, ISO 9001:2015 (Quality Management Systems), ISO 37001:2016 (Anti-Corruption Management Systems), ISO/IEC 27001:2013 (Information Security Management Systems), EN ISO/IEC 17020: 2012 (Management Systems for Inspection Bodies. Conformity Assessment), as they guarantee the adequacy and controllability of the processes of providing conformity assessment (independent professional expertise), and provide for: 2) the availability of statutory powers to carry out such activities; 3) confirmed professional qualifications and professional competence of experts; 4) voluntary insurance of professional liability risks for damage caused to third parties by the conformity assessment (expert opinion) provided. [ABSTRACT FROM AUTHOR]

This article examines the interplay between artificial intelligence (AI) and cybersecurity in light of future regulatory requirements on the security of AI systems, specifically focusing on the robustness of high-risk AI systems against cyberattacks in the context of the European Union’s AI Act. The paper identifies and analyses three challenges to achieve compliance of AI systems with the cybersecurity requirement: accounting for the diversity and the complexity of AI technologies, assessing AI-specific risks, and developing secure-by-design AI systems. The contribution of the article consists in providing an overview of AI cybersecurity practices and identifying gaps in current approaches to security conformity assessment for AI systems. Our analysis highlights the unique vulnerabilities present in AI systems and the absence of established cybersecurity practices tailored to these systems, and emphasises the need for continuous alignment between legal requirements and technological capabilities, acknowledging the necessity for further research and development to address the challenges. It concludes that comprehensive cybersecurity practices must evolve to accommodate the unique aspects of AI, with a collaborative effort from various sectors to ensure effective implementation and standardisation.

Significant temporal variations in radon are observed in any buildings, including unoccupied buildings with limited ventilation. This fact causes serious difficulties in radiation monitoring to assess the compliance of premises with the requirements of the normative, which limits the annual average level of radon in buildings. Therefore, neither at the national nor at the international level has yet been solved the problem of standardizing the indoor radon measurement if the test duration is less than a year. An analysis of approaches to radon measurement, including an assessment of the effectiveness of regulation, shows very significant differences between practices established in different countries. For example, in Russia, rapid (no more than 20 min) measurements are mainly used and mitigation measures to protect existing buildings from radon are practically not carried out. In European countries, mainly long-term (at least two months) measurements are used, while mitigation measures are still relatively rare, with the exception of the UK and Sweden. In the USA, short-term (2–7 days) measurements are widely used, which are not only carried out, but also paid for by residents themselves, including mitigation measures. However, despite the established approaches to indoor radon monitoring in Russia and the USA, there is a persistent distrust among specialists in the results of shortterm and, especially, rapid measurements. In this regard, a compromise approach is proposed to standardize radon measurements based on a rational criterion by applying fundamental ISO/IEC concepts such as “measurement uncertainty” and “conformity assessment”. The rational criterion for conformity assessment allows using measurements of different durations, providing a given reliability when making a decision. It also proposes a rationale for optimizing indoor radon monitoring through the participation of not only professional inspectors, but also the population itself due to the possibility of introducing simple methods and inexpensive radon devices within the rational criterion.

Coordinate measuring machines are widely used in the industrial field due to their ease of automation. However, estimating the measurement uncertainty is a delicate task, especially when controlling for deviation, given the large number of factors that influence the measurement. A precise estimate of the uncertainty is crucial to avoid incorrect conformity assessments. The purpose of this study is to control geometrical-form tolerance specifications, taking into consideration their associated uncertainty. A surface fitting model based on the least squares criterion is proposed, allowing one to obtain the variance–covariance matrix by iterative calculation according to the Levenberg–Marquard optimization method. The form deviation is then evaluated following the Geometrical Product Specifications (GPS) Standard, and its associated uncertainty is estimated using the guide to the expression of uncertainty in measurement (GUM) propagation of the uncertainty law. Finally, the conformity assessment is performed based on the measured deviation and its associated uncertainty. Different results for the measurement of straightness, flatness, circularity, roundness, and cylindricity are presented and detailed. This model is thereafter validated by a Monte Carlo simulation, and interlaboratory comparisons of the obtained results were performed, which showed satisfactory outcome. This contribution is of great use to manufacturing companies and metrology laboratories, allowing them to meet the normative guidelines, which stipulates that each measurement result must be accompanied by its associated uncertainty.

Abstract Medicines must be subject to physical, chemical, and biological analysis to guarantee their quality, safety, and effectiveness. Despite the efforts to ensure the reliability of analytical results, some uncertainty will always be associated with the measured value, which can lead to false decisions regarding conformity/non-conformity assessment. This work aims to calculate the specific risk of false decisions regarding conformity/non-conformity of acetaminophen oral solution dosage form. The acetaminophen samples from five different manufacturers (A, B, C, D, and E) were subject to an active pharmaceutical ingredient assay, density test, and dose per drop test according to the official compendia. Based on measured values and their respective uncertainties, the risk values were calculated using the Monte Carlo method implemented in an MS Excel spreadsheet. The results for two acetaminophen oral solution samples (C and D) provided an increased total risk value of false acceptance (33.1% and 9.6% for C and D, respectively). On the other hand, the results for the other three acetaminophen samples (A, B, and E) provided a negligible risk of false acceptance (0.004%, 0.025%, and 0.045% for A, B, and E, respectively). This indicates that measurement uncertainty is very relevant when a conformity assessment is carried out, and information on the risks of false decisions is essential to ensure proper decisions.

Abstract The quality, efficacy, and safety of medicines are usually verified by analytical results. Measurement uncertainty is a critical aspect for the reliability of these analytical results. The pharmacopeial compendia usually adopt a simple acceptance rule that does not consider information from measurement uncertainty. In this work, we compared decision-making using simple acceptance and decision rules with the use of guard-band for multiparameter evaluation of ofloxacin ophthalmic solution and acyclovir topical cream. Ciprofloxacin ophthalmic solution and acyclovir topical cream samples were subject to pharmacopeial tests and assays. Multivariate guard-band widths were calculated by multiplying the standard uncertainty (u) by an appropriate multivariate coverage factor (k’). The multivariate coverage factor (k’) was obtained by the Monte Carlo method. According to the simple acceptance rule, all the results obtained for ciprofloxacin ophthalmic solution and acyclovir topical cream are within the specification limits. However, the risk of false conformity decisions increases for ciprofloxacin tests. Decisions made using the simple acceptance rule and decision rules with the use of guard-band may differ. The simple acceptance rule may increase the risk of false conformity decisions when the measured value is close to the regulatory specification limits and/or when the measurement uncertainty value is inappropriately high. Nevertheless, the guard-band decision rule will always reduce the risk of false conformity decisions. Therefore, using information on measurement uncertainty in conformity assessment is highly recommended to ensure the proper efficacy, safety, and quality of medicines.

Indoor radon measurements have been conducted in many countries worldwide for several decades. However, to date, there is a lack of a globally harmonized measurement standard. Furthermore, measurement protocols in the US (short-term tests for 2–7 days) and European Union countries (long-term tests for at least 2 months) differ significantly, and their metrological support is underdeveloped, as clear mathematical algorithms (criteria) and QA/QC procedures considering fundamental ISO/IEC concepts such as "measurement uncertainty" and "conformity assessment" are still absent. In this context, for many years, the authors have been advancing and refining the theory of metrological support for standardizing indoor radon measurements based on a rational criterion for conformity assessment within the ISO/IEC concepts. The rational criterion takes into account the main uncertainties arising from temporal variations in indoor radon and instrumental errors, enabling the utilization of both short- and long-term measurements while ensuring specified reliability in decision making (typically no less than 95%). The paper presents improved mathematical algorithms for determining both temporal and instrumental uncertainties. Additionally, within the framework of the rational criterion, unified metrological requirements are formulated for various methods and devices employed in indoor radon measurements. [ABSTRACT FROM AUTHOR]

A Bayesian multivariate approach to the evaluation of risks of false decisions on conformity of chemical composition of a substance or material due to measurement uncertainty is adapted to cases for which the composition is subject to a mass balance constraint. The constraint means that sum of the actual ("true") values of the composition component contents under conformity assessment is equal to 1 (or 100 %) or another positive value less than 1 (less than 100 %). As a consequence, the actual values of the component contents are intrinsically correlated. Corresponding measured values of the component contents are correlated also. Any correlation can influence evaluation of risks of false decisions in conformity assessment of the substance or material chemical composition. A technique for appropriate evaluation of the relevant risks, including evaluation of the conformance probability of a subject or material composition, is discussed for different scenarios of the data modeling, taking into account all observed correlations. A Monte Carlo method is applied in the R programming language for the necessary calculations. Examples of evaluation of the risks are provided for conformity assessment of chemical composition of a platinum-rhodium alloy, pure potassium trioxidoiodate, a sausage, and synthetic air. [ABSTRACT FROM AUTHOR]

The AI Act provides a risk-based framework for the regulation of Artificial Intelligence, delegating the implementation of essential requirements to harmonised standards. This regulatory approach raises several issues concerning the alignment of standards with regulation’s requirements, the legitimacy of the European standardisation system, and the ability of harmonised standards to ensure fundamental rights protection. This paper discusses and analyses the regulatory approach underlying the AI Act, the main issues surrounding the proposed regulation, and the implications for the AI Act's ability to achieve its goals. L'AI Act propone un quadro legislativo basato sul rischio per la regolamentazione dell’IA, che delega l'attuazione dei requisiti essenziali alle norme armonizzate. Questo approccio solleva diverse questioni riguardanti l'allineamento degli standard ai requisiti del regolamento, la legittimità del sistema della standardizzazione europea e la capacità degli standard armonizzati di garantire la protezione dei diritti fondamentali. Il presente articolo discute e analizza l'approccio normativo alla base dell'AI Act, le principali questioni relative alla regolamentazione proposta e le implicazioni per la capacità dell'AI Act di raggiungere gli obiettivi prefissati.

In the era of the Fourth Industrial Revolution, the establishment of a TBT system that utilizes the knowledge-based view as a means of overcoming the problems of scarcity of human resources and lack of technological capabilities faced by export companies that produce and supply products and services is being emphasized. The WTO TBT Agreement, which is based on the multilateral agreement of the GATT 7th Tokyo Round, consists of 15 articles and 3 annexes to ensure that technical regulations, standards, and conformity assessment systems do not act as technical barriers to trade. The transition to the digital economy (EDT) has been accelerating, and currently the EDT presents both a challenge and an opportunity. The US, which is at the center of the international standards competition, has accelerated standards competition by invoking supply chain executive order decoupling, and as China looks to implement the policy set out in the China Standards 2035 Plan, the relationship between the US and China is worsening in relation to the preoccupation with standards. Dreaming of a Chinese version of this US strategy, China, which is connected from 12.5 to 14.5 units, is accelerating its standardization strategy through the Made in China 2035 program. The “double cycle development strategy” and “technological innovation” are key mid- to long-term policy directions. Korea should develop a Korean-style conformity assessment development model based on the TBT system, which is a major element of non-tariff barriers, under the WTO/FTA system that promotes the flow of the KBV along with the establishment of a digital transformation system.

Global supply chains rely on the compliance and safety of their products, processes, and facilities. These vital services (often referred to as 'quality assurance' or 'conformity assessment' services) are provided by Conformity Assessment Bodies (CABs). This empirical study explores the impact of the COVID-19 pandemic on CABs as well as their response to the resulting challenges. Data was gathered through an online survey among all accredited CABs in Germany, which resulted in 555 valid responses. Taking a resilience perspective, we reveal that CABs were hit hard by the disruptions caused by the pandemic, albeit to different degrees, in part due to their type of services, size, and sectors served. Furthermore, we find that contingency plans do not directly cushion order declines (as the main indicator of the economic impact of the pandemic) but rather indirectly through helping CABs respond more quickly, which in turn mitigates their order declines. However, our results show that contingency plans can also have adverse effects if they hinder flexible reaction to the crisis. The findings of our study help managers and policymakers learn from the COVID-19 pandemic and improve the resilience of the conformity assessment sector and quality assurance in the event of future crises. [ABSTRACT FROM AUTHOR]

This research evaluates the perceptions from the conformity assessment community regarding the auditability of ISO 9001:2015 and the perception of its ease of use by the audited organisations. The study is supported on a survey promoted by the Strategic, Planning and Operations Task Group (SPOTG) of Subcommittee 2 of ISO TC 176 (TC 176/SC2) aiming at collect insights on using the standard and identify any need for future revisions. As an overall conclusion, in the view of certification bodies' auditors, programme managers and certification decision-makers, ISO 9001:2015 attained its main objectives. Nevertheless, it is suggested in the forthcoming ISO 9001 review cycle to adopt a more simplified language and to improve the ease of understanding and consistency of interpretations of the ISO 9001:2015 requirements. Additionally, suggestions for making clauses (e.g. 4.1. Understanding the organisation and its context, 6.1 Actions to address risks and opportunities, 7.1.6 Organisational Knowledge, and 4.2 Understanding the needs and expectations of interested parties) easier to apply and improving its auditability have also been identified. [ABSTRACT FROM AUTHOR]

It is well-known that the error of a measurement result can increase at each step of a laboratory procedure, as well as because of the sample character of partial measurements. To overcome these difficulties, close cooperation between hydrologists and analytical chemists is required in order to obtain reliable information about the composition and properties of natural waters, which are extremely unstable. The study focuses on details that are of importance for both the client-hydrologist and the performer—chemist-analyst. The article gives different variants of conclusions regarding the compliance or non-compliance with the established requirements. The cost of reliable measurements is calculated, and variants of optimization of enterprise's payments for discharges are proposed. Recommendations are given to customers regarding the choice of a competent analytical laboratory. [ABSTRACT FROM AUTHOR]

The dissolution test is a critical quality control method in the pharmaceutical industry, primarily used to assess drug bioavailability and ensure the consistency of manufactured batches. This test simulates the release of the active ingredient in the body and verifies compliance with specifications through multiple stages (e.g., S1, S2, S3). However, measurement uncertainty can undermine the reliability of test results, potentially leading to erroneous conformity decisions. This study aims to quantify the uncertainties arising from the dissolution, sampling, and quantification steps, as well as to estimate the risk of false conformity decisions in the dissolution test results for tablets. A comprehensive uncertainty evaluation was conducted for the dissolution, sampling, and quantification stages. The Monte Carlo method (MCM) was applied to assess the overall measurement uncertainty, which was determined to be approximately 5.2 %. The study revealed that sampling was the predominant contributor, accounting for 92 % of the total uncertainty, compared to 7 % from quantification and 1 % from dissolution steps. An MS Excel spreadsheet was developed to calculate the total risk value and classify it as either producer or consumer risk. This tool enables the evaluation of uncertainty in both individual tested units and mean values, depending on the stage criteria (e.g., S1, S2, S3). The proposed improved criteria were tested across various scenarios where the risk of false decisions due to measurement uncertainty was considered. These tests demonstrated the effectiveness of the criteria in managing consumer risk, highlighting the critical impact of sampling uncertainty on the decision-making process. This study introduces novel, improved criteria for the dissolution test that account for the risk of false decisions due to measurement uncertainty. The proposed criteria significantly enhance the reliability of drug quality assessments. The study provides a robust framework for minimizing false conformity decisions. The development of a practical MS Excel tool further supports the reliable assessment of dissolution test results, ensuring higher standards of drug safety and efficacy in pharmaceutical quality control. [Display omitted] • Uncertainty arising from dissolution, sampling and quantification steps were quantified. • Measurement uncertainty evaluation was performed using Monte Carlo methods. • A novel MS Excel tool to evaluate risk in pharmaceutical quality control was developed. • A risk-based improved criteria for dissolution tests was proposed. [ABSTRACT FROM AUTHOR]

This paper presents the conformity assessment process of the epoxy coating thickness applied on water pipes made of gray cast iron with the specifications given for this kind of coating appliance. An epoxy coating was applied to prevent a special form of corrosion called the graphitization of cast iron. In order for the pipe to withstand its designed service life, it is necessary to ensure the required thickness of the applied coating. In accordance with the EN 877 norm, the thickness of the epoxy coating on the pipes for the projected corrosiveness of the environment C4 and the durability of 20 years is at least 70 μm and this indicates the required accuracy of the product. To achieve the desired product quality, statistical control of the coating application process was carried out and the impact of uncertainty associated with the measurement result was analyzed. Considering the quality of the coating application process and the quality of the measuring system, and to ensure the quality of products and to reduce consumer risk, the optimal thickness of the coating was determined. [ABSTRACT FROM AUTHOR]

Analytical results are often used in scientific research, industrial and clinical applications to support decision making. Despite all efforts to ensure the reliability of analytical results (including method validation, internal quality control, use of certified reference materials, proficiency tests, and ISO 17025 accreditation), there will always be an uncertainty associated with the measured value. The measurement uncertainty expresses the quality of the analytical result and allows the comparability between analytical results or between the measured value and the specification limit(s). This work discusses the importance of measurement uncertainty, including the steps involved in the measurement uncertainty evaluation, the bottom-up and top-down approaches used in measurement uncertainty calculation, the measurement uncertainty evaluation in drug and medicine analyses, and the application of measurement uncertainty in conformity assessment for quality control, stability studies, and pharmaceutical equivalence. [ABSTRACT FROM AUTHOR]