Accreditation and Quality Assurance最新文献

The purpose of this study was to study the impact of ISO 9001 on the main factors of the sustained success of companies. A background theoretical study was conducted on sustained success factors and the impacts of ISO 9001 implementation on companies’ performance. Then, the impacts of ISO 9001 on industrial companies in Turkey were identified and validated through questionnaires and interviews. The study revealed that all the SSFs were positively influenced by ISO 9001. Despite the contradictions in the literature, the study shows ISO 9001 has a positive effect on the innovative ability of these companies and a clear positive effect on adopting spiritual values. But ISO 9001 does not support a shift toward a less bureaucratic culture. This study was limited by the difficulty of distinguishing the findings based on the sectors and sizes of the companies. Although the findings could cover all areas, this research was only conducted in industrial companies based in Turkey. At the time of undertaking the current study, there are no empirical studies on the effect of ISO 9001 on the SSFs; in this study, the effect of ISO 9001 implementation on these factors was practically validated.

L-lysine is an essential amino acid that contains a hydrophobic chain and fewer chromophore groups. Various L-lysine-based products are currently available in the market, and various analytical methods are reported in the literature; but their implementation to analyze L-lysine based products is highly cost-effective and requires considerable efforts to prepare the sample/derivatization. Currently, the developed method is being used to quantify L-lysine hydrochloride in the multivitamin oral suspension production in the pharmaceutical industry. Therefore, the aim of the work was to develop a novel, simple, sensitive, accurate, cost-effective, precise, and robust RP-HPLC-DAD method to quantify L-lysine hydrochloride in bulk drug substances and multivitamin oral suspension using C8 column, which may give more efficiency for amino acid analysis without any derivatization. Optimized mobile phase composition consists of solvent A (phosphate buffer: acetonitrile 95:5 v/v) and solvent B (Phosphate buffer: acetonitrile 5:95 v/v). Buffer pH was adjusted to 2.50 with 3 mol L⁻¹ Orthophosphoric acid. 1-Heptane sulphonic acid anhydrous sodium salt was used as an ion-pairing reagent in the buffer. The detector's wavelength was set at 208 nm with a mobile phase flow rate of 1 mL/minute. Limit of detection (({L}_{mathrm{D}})) and limit of quantification (({L}_{mathrm{Q}})) were found to be 17.80 g/mL and 53.94 g/mL, respectively. Excellent recovery was observed in the accuracy analysis of the sample L-lysine hydrochloride. The advantages of this newly developed method are very specific and cost-effective and do not require sample preparation and sample pretreatment. This analysis can be performed with an available C8 column and HPLC–UV detector that proves the cost-effectiveness of the developed method than the currently available analytical methods for the analysis of L-lysine based products.

Proficiency testing is the use of interlaboratory comparisons to assess the ability of a laboratory to perform a particular test or measurement competently and demonstrate the reliability of the results generated. To achieve this goal, the international standard ISO 13528:2022 presents four performance statistics and one of them is the z score. Some researchers have proposed an alternative approach for proficiency testing scheme interpretation based on an analysis of variance method. This short communication presents residual analysis to choose an appropriate analysis of variance model for proficiency testing interpretation when the assigned value is obtained by consensus value among participants. The analysis of variance approach was compared with z score to assess the performance of interlaboratory comparison for determining the amount of NO_x present in vehicle emissions. Preliminary results indicate that the conclusions obtained by both methodologies differ for one of the participating laboratories. This occurs due to violation of the homoscedasticity assumption which is not considered when using the z score. On the other hand, residual analysis can provide such information and feasible generalized least squares can deal with heteroscedasticity .

A study was made of the component of the error in measuring the resistance of an electrolytic cell with a solution, which is due to the shunting effect of the thermostat liquid. A physical model and equivalent circuits for a cell placed in a thermostat are proposed. The model is based on the example of a two-electrode cell of a common design, which is used for secondary standards of electrolytic conductivity (for solutions with low electrolytic conductivity). For research, computer simulation in the COMSOL Multiphysics software environment was used. The calculated values ​​of the immittance components of computer models of the cell were obtained in the software environment as a result of solving field tasks using the finite element method. The results of the work showed that the values of the investigated component of the relative error can exceed 0.1 % in real measurements of the electrolytic conductivity of solutions using cells of the considered type.

Over the years, risk management gains significant importance in laboratories of every kind. The safety of workers, the accuracy and reliability of laboratory results, issues of financial sustainability as well as the protection of the environment play an important role in decision-making in both industry and services. In order a laboratory to be considered as reliable, safe, and therefore competitive, it is recommended to comply with the requirements of international standards and other regulatory documents as well as to use tools and risk management procedures. In this paper, information is summarized concerning the terms “risk” and “risk management” which are then approached through the latest ISO 9001, ISO/IEC 17025, and ISO 14001 standards. The process of risk management based on the ISO 31000 standard is described, the options for treatment and the techniques that can be applied in the risk management process based on the latest ISO 31010 standard are grouped and indicated. Additionally, information from the literature is referred to the reasons that led the laboratories to integrate in their quality system risk management techniques, the most common mistakes that occur in the various phases of laboratory tests, their causes, their consequences as well as the proposed treatments. The aim of this work is to highlight significant challenges concerning the need to implement management procedures in the daily routine, to warn, raise awareness and inform about existing ways of risk management that can be implemented, methodologically and technically, to laboratories, under internationally recognized and updated standards.

This work presents research focused on obtaining and maintaining the ISO/IEC 17025 recognition in a Brazilian environmental analysis laboratory that acts as an environmental consultancy, providing services for the biological treatment of effluents. Three research cycles were conducted, covering the recognition preparation, surveillance period, and first reassessment preparation. The importance of considering both the technical and managerial aspects of this process is highlighted. In addition, it is fundamental to involve all employees in the process and reinforce the value of audits as an instrument for evaluating and improving the entire system. Despite the importance of the consultancy contracted to assist in the design of the management system, only with its effective use was it possible to improve the laboratory’s needs. Thus, the contribution of all collaborators to this process is fundamental. Despite the importance of “metrological networks” for encouraging a quality culture and accreditation in Brazil, greater rigor may be needed regarding the demand for systematic evidence of sustainable compliance and maturity of the management system. The recognition and accreditation challenges are the first, as the need to review and improve the Quality Management System is recurrent, whether due to the greater maturity of the laboratory or the identification of new opportunities.

The International Vocabulary of Metrology (VIM) is presently at its third Edition (2012) (VIM3). VIM3 was a major achievement done with an important contribution of Paul De Bièvre. Numerous comments can be found in the literature concerning the evaluation of VIM3 that will be taken here as a reference for the future developments. The present paper is based mainly on the concept that such a vocabulary is assumed to be of great help for the practitioners of metrology, i.e., in general of people that must correctly apply the idiom of metrology according to the current meaning of its terms. The core of VIM3, i.e., its few basic terms, which are those currently used in metrology (defined according to paper’s Glossary), is identified, and their current meaning recalled together with the rationale for their choice. The above illustration is compared with recently proposed changes of several of them, and with some terms newly proposed.

Reference material (RM) documents are indispensable for proper use of reference materials, playing an important role in guiding users to store and use reference materials correctly. However, limitations have been found in paper documents of reference materials, such as waiting long for their preparation, high risk of loss, and lack of security measures. This paper describes the design and implementation of an information system for electronic reference material documents. Based on the varieties and batches of reference materials, the coding rules for two-dimensional codes of reference materials are formulated and employed to uniquely manage each unit of reference materials. A complete process of document template making, review and release has been designed as part of the manufacturing process for reference materials. Using the interface development function of major social media platforms, the method of generating and previewing documents by scanning the QR code on the label of a reference material with a mobile phone is designed. Users may view and download all electronic documents generated by their scanning through the special document management website page. The system has been implemented and is currently in use. Compared with paper documents, electronic documents have obvious advantages in uniqueness, security and convenience.