Quality assurance in analytical chemical laboratories: Towards harmonization and integration of current standards

This article presents the results of a comparative study of the main quality assurance (QA) and good laboratory practice (GLP) regulation systems and standards for analytical chemical laboratories currently being applied in Europe. A growing number of laboratories are being confronted with the need to cope with two or more of these systems, which involves separate audits and inspections for certification and accreditation. As these regulatory systems have essentially the same aims, there is an increasing interest in harmonization of QA and GLP guidelines. As a first step in exploring the possibilities of harmonization, similarities and differences of the current systems, compiled in the form of cross reference tables, have been analyzed (from a laboratory practice point of view) by a study group of EURACHEM, The Netherlands. The conclusions of this study have recently been endorsed by the Committee of EURACHEM Europe.     

Compliance with GLP standards and management in analytical laboratories: current status

 Analytical laboratories in Japan, operating more often as departments within a company than as independent contractors, have to contend with different good laboratory practice (GLP) standards. Problems also occur in the analytical laboratories which must comply with GLP, good manufacturing practice (GMP) and good clinical practice (GCP) regulations within the same facility. The status of these GLP-complied analytical laboratories is reviewed with regard to assurance program, validation method, laboratory information management, and security systems. The differences in the responsible authorities and scopes under the six GLPs are also briefly described. Analytical tests in GLP are not itemized as a test for accreditation. Therefore, the accreditation of analytical laboratories in Japan is currently granted as a part of ISO 9000 approvals. Received: 27 September 1996 Accepted: 11 November 1996     

Management of quality control in analytical laboratories

The sources of errors in the results of chemical analysis are classified. Methods for the on-line control of the precision and accuracy of analysis are briefly discussed and compared in order to reveal the types of sources of errors in the considered methods. Algorithms to estimate the quality of work of an analytical laboratory based on the statistical analysis of the summarized results of control obtained in a certain period of time are proposed.     

Robustness testing of control charts employed by analytical laboratories

 The robustness of Shewhart control charts for subgroup means and subgroup ranges was tested by using the Monte Carlo method using training data sets comprising various numbers of points, with two repetitions in each subgroup (as in routine laboratory practice). The following control chart designs were tested: conventional based on the arithmetic mean and standard deviation, robust based on the median and/or the trimmed mean and Winsorized standard deviation, and a two-step design. The methods were applied to the system in the state of statistical control (outliers excluded) and to the system without statistical control (outliers included). Satisfactory results for both cases were only obtained when using the two-stage control charts. The conventional charts led to underestimation of the effect of outliers in the system without statistical control, whereas the robust control charts led to overestimation of the effect of outliers (false alarm) in the system under statistical control. The tests also gave evidence that the training set should include 20 points as a minimum. Received: 13 January 1997 Accepted: 12 February 1997     

Establishment of a quality system for nuclear analytical laboratories

Comprehensive Quality Control (QC) and Quality Assurance (QA) Program is stated on the quality policy, organization, methods and records for nuclear analytical laboratories which are necessary for improvement of productivity, to upgrade the performance, credibility and reputation. The proper and complete identification of quality elements for management and technical requirements are being written in Quality Manual as well as analytical and organizational procedures and working instructions according to ISO 17025 standard. Technical ability of gamma, X-ray and a/b laboratories in the Center has been checked by participation in proficiency test, critical technical variables, and quality results. Performance of quality system has been controlled by external audit inspection, progress reports and service to clients. The present study is a framework of the model project of IAEA, coded RER/2/004, which has resulted self-sustainable accreditation from the national body, TURKAK. This revised version was published online in August 2006 with corrections to the Cover Date.     

Quality assurance systems in research and routine analytical laboratories

In our article we explain the connections between the implementation of quality assurance (QA) in research and routine analytical laboratories. J. K. Taylor claims that QA in an analytical laboratory consists of two independent but closely related terms, quality control and quality assessment. If we construct the QA system according to his ideas, problems concerning quality can be solved with only one concept regardless of the type of analytical laboratory. Therefore there is no need to introduce new QA standards for research laboratories as suggested in some papers. In the routine laboratory quality control is more important, while in the research laboratory quality assessment is dominant.     

Quality assurance systems in research and routine analytical laboratories

 In our article we explain the connections between the implementation of quality assurance (QA) in research and routine analytical laboratories. J. K. Taylor claims that QA in an analytical laboratory consists of two independent but closely related terms, quality control and quality assessment. If we construct the QA system according to his ideas, problems concerning quality can be solved with only one concept regardless of the type of analytical laboratory. Therefore there is no need to introduce new QA standards for research laboratories as suggested in some papers. In the routine laboratory quality control is more important, while in the research laboratory quality assessment is dominant.

     

Reference materials in the Russian system of accreditation of analytical laboratories

 This article is devoted to the role of reference materials (RMs) in chemical analysis and their main applications in analytical laboratories. The principal requirements of the RMs used in accredited laboratories in the Russian Analytical Laboratories Accreditation System (SAAL) are presented. These include the basic regulatory and metrological requirements of RMs. Finally, a review of the provision of RMs used for the analytical control of various test objects is presented. Received: 9 August 1998 / Accepted: 9 November 1998     

The accreditation system for Russian analytical laboratories and its development

The analytical laboratories accreditation system (SAAL) began its work in 1992. At first, SAAL was created for laboratories performing quantitative chemical analysis, but its activities have constantly expanded. SAAL presently covers laboratories determining oil and petroleum properties, properties of construction materials, parameters of dangerous and harmful industrial goods, precious stones, rubber, plastic, metals etc. Today, SAAL comprises over 3,000 accredited laboratories, 34 accreditation bodies and over 200 assessors united under the Federal Agency on Technical Regulating and Metrology. Within the Russian Federation, SAAL is recognized by various bodies and organizations as a reliable tool in the demonstration of technical competence of laboratories. This report is devoted to the history of SAAL, describing the separate stages of its development, evolution of its requirements for laboratories and accreditation procedures, the principles on which SAAL was based, and conformity of these principles to the legal requirements of the Russian Federation. Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel.     

Education: a microfluidic platform for university-level analytical chemistry laboratories

We demonstrate continuous flow acid-base titration reactions as an educational microfluidic platform for undergraduate and graduate analytical chemistry courses. A series of equations were developed for controlling and predicting the results of acid-base neutralisation reactions conducted in a microfluidic format, including the combinations of (i) a strong base and a strong acid, (ii) a strong base and a weak acid, and (iii) a strong base and a multiprotic acid. Microfluidic titrations yielded excellent repeatability. The small experimental footprint is advantageous in crowded teaching laboratories, and it offers limited waste and exposure to potentially hazardous acids and bases. This platform will help promote the utilisation of microfluidics at an earlier stage of students' careers.     

Towards some ultimates in luminogenic analytical methods

Luminogenic methods have a demonstrated potential for assays of great sensitivity, selectivity and simplicity in the analytical procedures concerned. This paper reviews in particular the potential of such methods for the ultimate sensitivities now needed, for instance, in the detection of infections agents and genetic variants in biological cells. The indications are that the sensitivities, specificities and speed with which such assays can be performed are strongly interactive factors.     

The Russian system for accreditation of analytical laboratories (centers)

 The history and the present state of the national system for accreditation of analytical laboratories in Russia are described. Received: 1 September 1998 / Accepted: 1 September 1998     

Proficiency testing in analytical laboratories: how to make it work

 This paper covers the role of proficiency testing schemes in providing an occasional but objective means of assessing and documenting the reliability of the data produced by a laboratory, and in encouraging the production of data that are "fit-for-purpose". A number of aspects of proficiency testing are examined in order to highlight features critical for their successful implementation. Aspects that are considered are: accreditation, the economics and scope of proficiency testing schemes, methods of scoring, assigned values, the target value of standard deviation σ_p, the homogeneity of the distributed material, proficiency testing in relation to other quality assurance measures and whether proficiency testing is effective. Stress is placed on the importance of any proficiency testing scheme adhering to a protocol that is recognised, preferably internationally. It is also important that the results from the scheme are transparent to both participating laboratory and its "customer". Received: 03 November 1995 Accepted: 20 November 1995     

Quality assurance in analytical laboratories engaged in research and development activities

 Research and development activities are carried out by various types of laboratories that are not the typical testing and calibration laboratories for which the ISO/IEC 17025 is the quality assurance implementation reference. In this paper, such laboratories engaged in R&D activities are classified and different approaches they can adopt with a view to implementing a quality system that are suited to their characteristics and the type of work they conduct are proposed. These approaches take account of existing standards for the certification/accreditation of laboratories and of guides on quality assurance for non-routine analytical laboratories. Received: 11 July 2002 Accepted: 29 November 2002 Presented at Analytica Conference, 23–26 April 2002, Munich, Germany Correspondence to M. Valcárcel     

Some considerations on batch arrival and batch analysis in analytical laboratories

The mean delay of analytical results is an important parameter in the performance of analytical laboratories. The modes of sample arrival and processing influence that delay. By the application of queueing theory and digital simulation, the effects of batch arrival and batch processing on the delay are estimated.