Accreditation and Quality Assurance最新文献

To analyze and statistically compare common errors in the evaluation of measurement uncertainty in medicine and health field, using literature research and comparison with national standards, in order to understand the current status of measurement uncertainty evaluation in the medicine and health field. Using Chinese National Knowledge Infrastructure (CNKI) as the sample population, Stratified Proportional Sampling (PPS) was used to extract journal articles related to measurement uncertainty in the field of medicine and health. The articles were compared with the Eurachem/CITAC Guide QUAM to analyze measurement uncertainty errors. Academic attention to measurement uncertainty in the field of medicine and health in the CNKI literature database has shown explosive growth since 2005. Seven common errors in measurement uncertainty evaluation were identified. None of the 30 journal articles analyzed were error-free, with a total error rate of 44 %. The error rate for ignorance of blank uncertainty was 87 %, improper evaluation of standard curve was 67 %, improper significant figures were 60 %, and insufficient information for Type B evaluation was 50 %. The error rate for provincial and higher-level institutions was 48 %, while the error rate for institutions below the provincial level was 43 %. The difference between the two error rates was not statistically significant (p = 0.523). There is an urgent need to improve the rationality of measurement uncertainty evaluation in medicine and health field, and to strengthen the education and academic communication through national and international cooperation.

Graphical abstract

The biotechnology policy encourages the creation of networks of institutions that carry out bioassays and preclinical studies and stimulate the implementation of principles of good laboratory practice (GLP). However, it becomes essential for trained and qualified professionals to understand, develop procedures and documents, and properly implement quality management requirements to implement a laboratory quality system. The use of tools such as multicriteria decision aid (MCDA) can assist in managing and implementing the quality system in institutions and laboratories. This research aimed to demonstrate the perception of the degree of difficulty in understanding GLP principles perceived by the respondents and analyzed through the MCDA model. According to the MCDA method, a survey was carried out with 27 professionals from laboratories who answered a questionnaire with a numerical scale of very difficult, difficult, regular, neutral, and easy for each GLP requirement. Results evidenced the GLP criteria that require a smaller and greater effort to be understood and allowed the identification of efforts level to increase each GLP criteria's level of understanding. The MCDA confirms to be a robust tool to identify and validate the participants' perception of GLP criteria, considering the diversity of professionals and their different qualifications, enabling the construction of training content that considers the difficulty levels of each criterion. This strategy helps in the management of the laboratory and the dissemination of knowledge of GLP principles to biotechnology professionals, academics, and students.

The assessment of homogeneity of liquids in storage tanks is crucial for quality control products, commercial relations and a salient technological challenge facing the petroleum industry. This study describes a method used in the Brazilian oil industry to estimate if there is significant (vertical) segregation in large storage tanks. Here, a method based on experimental design and classical ANOVA for analyzing the experimental data to arrive at a better method to estimate if there is statistically significant segregation within the storage tanks (lack of significance is called homogeneity in the paper) was used. Although ANOVA is a suitable tool for this purpose, the results were analyzed in more detail to propose a practical method that can be used routinely. Mechanical use of the ANOVA tests may easily lead to wrong conclusions.

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.