Integrating accreditation, good laboratory practice and good manufacturing practice in an industrial analytical laboratory

 The Analytical Laboratory of BASF is a central service unit for chemical analysis which can be used by all departments within the company. It carries out routine as well as non-routine work and has a high amount of R&D orders. A quality system conforming with GMP rules was installed in the 1970s, followed by a GLP system about 6 years later. In 1995 an EN 45001 certificate was granted, which also stated the conformity with ISO 9002. A "types of test" orientated system was chosen for accreditation. This was better suited to the needs of a testing laboratory with a high amount of non-routine work than a purely test-procedure orientated accreditation. An integrated quality system has now been developed from these activities. It has partly common elements and partly differing elements taking into account specific regulations. For example, instrument calibration, staff training, validation of test procedures and the use of computerized systems are covered by uniform rules. Other elements such as handling of samples and report generation are arranged according to the individual requirements of the various standards. Rules and regulations are laid down in a system of documents which comprise the quality manual, general standard operating procedures (SOPs), laboratory-specific SOPs and test procedures. The quality system has been accepted by other accreditiation bodies on application of special accreditations (workplace safety, biodegradable polymers). But it has had no advantageous influence on getting GLP certification. An integrated system is very complex and requires appreciable resources. Management of processes and documentation can only be handled by extensive use of computers. Frequent training of staff and internal audits are necessary to keep the system at an acceptable level. In order to reduce the complexity of quality management regulations a harmonization of the different quality systems would be desirable. Received: 1 October 1998 · Accepted: 10 January 1999     

The oxidative resistance of polymeric geosynthetic barriers (GBR-P) used for road and railway tunnels

The results of autoclave tests according to DIN EN ISO 13438 (method C) and conventional oven tests in line with DIN EN 14575 are presented for the evaluation of the resistance to oxidation of geosynthetic barriers GBR-P based on polyethylene. These GBR-P products are used as a barrier layer against water in road and railway tunnels. The residual mechanical stability of the exposed materials was determined by tensile testing. The remaining activity of the stabiliser was investigated using the OIT method. The results of both accelerating test methods are discussed and compared in detail. Based on autoclave tests at three temperatures (e.g. 60, 70 and 80 °C) and 50 bar oxygen pressure, and additionally two more measurements at 80 °C and 10 and 20 bar oxygen pressure, a modified Arrhenius extrapolation is used for an assessment of the expected service time of one of the GBR-P products.     

Practical experience of simultaneous accreditation and certification acquired in RIVM's official medicines control laboratories

 This article presents an overview of the practical experience acquired in two governmental medicines control laboratories in the Netherlands which combine the application of EN 45001 and ISO 9002 standards in the regulatory field of quality and risk assessment, and quality control of medicines and medical devices. This practical experience also includes simultaneous accreditation and certification. The EN 45001 standard was applied to laboratory testing activities and the ISO 9002 standard to non-laboratory file assessment activities as these activities are not covered by the scope of EN 45001. It appears that a combined application of these standards is practicable because they complement each other well. EN 45001 strongly emphasises technical competence. ISO 9002, on the contrary, emphasises more strongly the efficiency of the management processes and customer requirements. Received: 1 October 1998 · Accepted: 21 December 1998     

Method of preparing stable composites of a Cu-aluminosilicate microporous compound and cellulose material and their characterisation

A new aluminosilicate cellulose composite material was prepared by coating hydrogel on a cotton fabric. An aluminosilicate material zeolite Faujasite (FAU) was synthesised for a series of desired properties, observing the possibilities of the isomorphous replacement of Al or/and Si atoms, within the structure, with copper. Aluminosilicate microporous material was prepared by convection hydrothermal synthesis, applying microwave energy. The selection and modification of the zeolite deposition procedures on the cellulose material was also carried out. The stability of the obtained cellulose material to washing was determined. The crystalline structure of the aluminosilicate samples and their composites with cellulose materials were checked employing X-ray diffraction analysis. The following analysis methods were used for physicochemical characterisation: Fourier transform infrared spectroscopy and field emission scanning electron microscope with EDS. Structural properties of the newly created composite materials were investigated using the following standard methods: surface mass according to ISO 3801:1977, determination of thickness according to ISO 5084:1996, tensile strength according to DIN EN ISO 13934-1 and air permeability according to HRN EN ISO 9237:2003. Completely new constructional properties, compared to the unprocessed cellulose material, of the newly formed composite materials are mainly evident from the following experimental results: the air permeability values decrease for both samples (59.87 and 61.76 % for Cel-AlSi 1_K and Cel-AlSi 1_M, respectively), the areal density change values (1.45 % for Cel-AlSi 1_K, 4.61 % for Cel-AlSi 1_M), the sample thickness increased by 21.55 % for both composite materials while the tensile strengths decrease slightly for both samples (5.83 % for Cel- AlSi 1_K, 6.41 % for Cel-AlSi 1_M).     

Quality Assurance in Testing Laboratories

General criteria for the operation of testing laboratories according to standards series EN 45000 and quality assurance under ISO series 9000 are discussed, and other quality management systems too are presented. The important elements of quality assurance as concerns measurements, tests and investigations are pointed out. This revised version was published online in August 2006 with corrections to the Cover Date.     

Quality management in analytical R&D in the pharmaceutical industry: Building quality from GLP

 The pharmaceutical industry is one of the most regulated activity sectors. The regulation includes specific quality systems such as good laboratory practice (GLP), good clinical practice (GCP) and good manufacture practice (GMP). The principles of GLP mainly cover the formal quality aspects of a procedure and do not evaluate the technical aspects in depth. On the other hand, EN 45001 accreditation covers technical performance and is not suitable for pharmaceutical research and development (R&D) as it is almost impossible to comply with the requirements of the European standard in the pharmaceutical environment. The challenge to the pharmaceutical industry is, therefore, to develop quality systems, compatible with GLP principles, that not only cover formal quality items but also ensure good scientific and technical performance. An implementation process focused on real quality improvement is the best way to achieve this objective, culminating in formal recognition of the quality system by third-party assessment. In the case of analytical R&D, the EURACHEM/CITAC Guide CG2 is a very good tool that can help in the definition, analysis and selection of the non GLP quality elements that will be useful. Received: 30 June 1999 / Accepted: 18 October 1999     

Implementation of a quality management system in university test laboratories: a brief review and new proposals

Quality management systems are difficult to implement in university laboratories involved in teaching activities, R&D and provision of testing services, because of their peculiar characteristics. Testing services are not a priority, the performance of professionals is measured based on their teaching activities and publications, and the laboratories are shared with research and teaching activities. Hard efforts were made all around the world to overcome some of these difficulties. This paper analyzes the process of implementing a quality management system according to the ISO/IEC 17025 standard at two laboratories of the Federal University of Rio Grande do Sul, in Brazil. Some new solutions to solve the main problems typically originated on this type of environment are presented and compared with reports from the literature. It was concluded that it is perfectly possible for university laboratories to have their tests accredited according to standard ISO/IEC 17025, respecting their peculiarities and adopting creative solutions that meet the characteristics and the needs of each institution.     

Quality system implementation in a Brazilian university laboratory

The introduction of quality systems in laboratories at universities is a difficult task. Test services for external customers are provided to generate additional budget, and there may be a clear awareness about the need for systematic QA/QC actions. However, offering services is not of the highest priority within most university environments. The staff performance is commonly evaluated on basis of published papers and teaching activities, giving little or no weight for the test services. Therefore, implementation of a quality system is often pushed back to a lower priority leading to postponement. The efforts for creating a quality system in a laboratory from a Brazilian university are described in this paper, along with the results produced.     

Implementing quality assurance in an R&D environment at the Belgian Nuclear Research Centre – SCK·CEN

If we agree that quality assurance (QA) in R&;D indeed provides added value, just how do we show the public that such a QA system is operating well? At the Belgian Nuclear Research Centre (SCKÖbullet CEN), where a QA system has been implemented by various laboratories in accordance with the EN 45001 standard within the general framework of ISO 9001 at the institutional level, several laboratories have already been accredited. At the request of one of our customers the Belgian Agency for Radioactive Waste Management (NIRAS/ONDRAF), we implemented a quality system for research projects related to the characterization, treatment and processing of radioactive wastes in view of disposal. We obtained accreditation for this research in 1999. In this paper, we discuss the implementation of our QS and important issues related to the overall management of the QA system, broken down into three parts: organizational, technical and project-specific quality elements such as the QA plan and internal communication.     

Step-by-step implementation of a quality system in the laboratory

In recent years laboratories have undergone huge transformations due to the technological development of inspection and testing equipment; the introduction of computerised and automated systems; keen competitiveness between companies/laboratories as a result of demand within Europe and on the international market; and greater consumer awareness of the quality of the products available. Laboratory accreditation, though a voluntary process, is formal recognition by an accreditation body of the laboratory's competence to carry out certain tests. This article presents those aspects which should be taken into account in the step-by-step implementation of a quality system and also makes reference to the requirements for the operation of accredited laboratories in accordance with European Standard EN 45001.     

The German perspective of using the EFQM model in medical laboratories

The financial resources of health care services are only nominally growing in Germany. Therefore, the politicians have been forced to act. Up to now, a fixed limit of remuneration should not affect the quality of patient management. However, these primary economic issues have initiated positive and negative reactions from the laboratory medicine community. In hospital laboratories the challenge is to realise continuous improvement of service quality but at the same time reduce costs. This can only be achieved by introducing total quality management (TQM) and measuring the quality obtained by the European Foundation for Quality Management (EFQM) model. Predominantly formal attempts to improve quality at the level of ”enablers” such as certification (ISO 9000) or accreditation (EN 45000, ISO 15189) will not solve these problems. Two groups in Germany work on TQM and EFQM: the Working Group ”Laboratory Management” of the German, Austrian and Swiss Societies for Laboratory Medicine and for Clinical Chemistry, and the Institute for Quality Management in Medical Laboratories (INQUAM). Their work has resulted in several books on the subject, successful propagation of application of the EFQM model and a proposal for a formalized ”certification” procedure according to the model.     

A combination of accreditation and certification in an evolving process at EMPA: A management system to meet ISO 9001, ISO 14001 and EN 45001

 The Swiss Federal Laboratories for Materials Testing and Research (EMPA) have established a quality assurance system based on EN 45001 which meets the requirements for accreditation of all EMPA's testing activities. As testing is only a part of EMPA's range of activities, and is performed in decentralised departments, the system does not satisfy the management needs. The fundamental reorganisation of EMPA's St. Gallen site was used as an opportunity to implement an overall process-oriented management system which also included quality and the needs for accreditation. Later, an environmental management system was added and then certified for ISO 9001 and 14001. The system consists of a "Management Manual" for the St. Gallen site and a customised "Quality Manual" for each department. One of the key elements is a comprehensive review and planning procedure covering all business aspects.     

Accreditation of pathology laboratories in Finland

 The Finnish Accreditation Service (FINAS) accredits testing laboratories in all fields including medical laboratories according to European standard EN 45001 and ISO Guide 25. At the beginning of 1998, FINAS published a recommendation on how to apply general standards in histo- and cytopathology. Four pathology laboratories have been accredited to date. FINAS has not included autopsies in these accreditations. The International Academy of Pathology (IAP)-Finnish Division has recognized 21 pathology laboratories according to standards of their own. Although accreditation by FINAS is not connected to the system of the IAP-Finnish Division, the requirements are very similar in both. Less than half of the pathology laboratories in Finland participate in national quality improvement programme or have been accredited by FINAS.     

Strategies for multi-site GLP studies

 A GLP study can be performed at more than one site. This is called a multi-site study. Although, the study is performed at different sites, it is still one study and must completely comply with the GLP principles. The fact that different activities are conducted at different sites implies that the planning, the organization and the communication are crucial for the success of the study. This means that all the staff involved should know their responsibilities and should have the knowledge and skills to realize all the phases of the study according to the GLP principles. To achieve a well managed multi-site study, several strategies for setting up such a study can be followed. This paper focuses on the responsibilities, communication, and collaboration of the personnel, which are involved in a multi-site study. Several case studies are highlighted, and we concluded that the basic communication triangle in a single-site GLP study between test facility management, study director, and the quality assurance unit should be extended to the communication among test facility and test site management, study director, principle investigator(s), and the quality assurance units at the test sites. Introduction Received: 14 August 2002 Accepted: 26 November 2002     

A prelude of the 2004 Antwerp Quality Conference: Targets and target values—integrating quality management and costing

Questions about the value of services in the health care sector and the quality of them have been addressed frequently during the last decade, but as separate issues. In this article a method is proposed to combine these two issues. The starting point is the observation that competition will become fiercer among providers in the health care sector . Moreover, the patients opinion about quality in terms of convenience, emotional attention, etc., will be important in a competitive environment and will determine which health care service providers will be successful. These developments will have an impact on the engineering of the health care chain. Methods are discussed to integrate the determination of the value of innovations and new products, and the design of quality systems. The system of target costing is focused upon. It takes the outcome of care processes as desired by customers or the users as the starting point both for pricing the services as well as for designing the delivery system. This will not only improve cost control, but also quality improvements in two ways. First, the delivery system will be better adapted (and integrated if more health care providers are involved) to the needs of the patients, and second quality will improve as health care providers analyze, redesign, and monitor their processes more extensively.Presented at the 9th Conference on Quality in the Spotlight, 18–19 March 2004, Antwerp, Belgium     

Can the new ISO Guide 25/EN 45001 create better confidence in laboratory operations?

 Confidence in laboratory operations is discussed based on the ongoing revision of the ISO/IEC Guide 25. Confidence is a subjective attribute, which also depends on whose interest is considered. New and better-defined quality systems and technical elements will be included, and these are beneficial to the transparency of laboratory operations, as well as to the accreditation process. The ultimate aim is, of course, to satisfy customers. The testing laboratories' industrial customers are, however, generally unfamiliar with the ISO/IEC Guide 25 and accreditation. The main reason for improved confidence in testing and calibration laboratories is foreseen to come from closer interaction between laboratories and their customers.     

Assessing toxicological data quality: basic principles,existing schemes and current limitations

Existing toxicological data may be used for a variety of purposes such as hazard and risk assessment or toxicity prediction. The potential use of such data is, in part, dependent upon their quality. Consideration of data quality is of key importance with respect to the application of chemicals legislation such as REACH. Whether data are being used to make regulatory decisions or build computational models, the quality of the output is reflected by the quality of the data employed. Therefore, the need to assess data quality is an important requirement for making a decision or prediction with an appropriate level of confidence. This study considers the biological and chemical factors that may impact upon toxicological data quality and discusses the assessment of data quality. Four general quality criteria are introduced and existing data quality assessment schemes are discussed. Two case study datasets of skin sensitization data are assessed for quality providing a comparison of existing assessment methods. This study also discusses the limitations and difficulties encountered during quality assessment, including the use of differing quality schemes and the global versus chemical-specific assessments of quality. Finally, a number of recommendations are made to aid future data quality assessments.     

Accreditation: a challenge

 This paper describes a real accreditation case from VTT Chemical Technology in Finland. The laboratory has acquired accreditation according to ISO/IEC Guide 25 and EN 45001 for a variety of organic and inorganic environmental tests. The present paper summarizes the reasons for applying for accreditation and selecting the test methods, gives the costs involved, and describes some future developments and views. Also, some details of laboratory intercomparisons and quality system structures are briefly reported.     

Comparison of ED-XRF and LA-ICP-MS with the European reference method of acid digestion-ICP-MS for the measurement of metals in ambient particulate matter

A comparison study of the measurement of metals in ambient particulate matter collected on air filters, using energy-dispersive X-ray fluorescence (ED-XRF), laser ablation inductively coupled plasma-mass spectrometry (LA-ICP-MS) and wet chemical digestion followed by ICP-MS analysis according to the European ‘reference method’ EN14902, is presented. Whilst it is shown that the methods have a low systematic bias with respect to each other, overall they do show a high random variability, and when considered individually using regression methods, some analytes have shown bias with respect to the EN14902 method. The low systematic bias observed is not unexpected since both the ED-XRF and LA-ICP-MS methods have been calibrated using results from the EN14902 technique. The uncertainty of each analysis has been estimated and compared with the data quality objectives for uncertainty specified in the relevant European air quality legislation. This has tentatively shown that approximately 75% of the analyses using ED-XRF and LA-ICP-MS meet the requirements of the legislation. However, improvements in repeatability and calibration methods for both ED-XRF and LA-ICP-MS would be needed before these methods were truly applicable for routine use in air quality measurements of this type.     

Development of an element-selective monitoring system for adsorbable organic halogens (AOX) with plasma emission spectrometric detection for quasi-continuous waste-water analysis

An automated quasi-continuously-operating monitor has been developed for element-selective analysis of adsorbable organic halogens (AOX) in water. After extensive optimization the automatic method was applied to the analysis of standard solutions and real waste water samples to prove its analytical applicability. The new instrument is based on the element-selective analysis of halogens by means of a spectroscopic detection system consisting of a microwave-induced helium plasma excitation source (TM010-type; developed in this laboratory) and the plasma emission detector (PED) which operates with oscillating narrow-band interference filters. After enriching the organic components on activated charcoal and pyrolysis in an oxygen stream at 950 degrees C, in accordance with DIN/EN 38409,H14/1485, interfering CO2 and H2O gas generated during combustion is removed from the analytes in the so-called ELSA-system (element-selective AOX-analyzer). For focused injection into the plasma excitation source the analytes (hydrogen halides) are trapped in a deactivated fused silica capillary at -180 degrees C; this is followed by identification and quantification on the basis of element-specific emission of radiation in the VIS and NIR-region (chlorine 837.6 nm, fluorine 685.6 nm). Bromine and iodine could not be detected with satisfactory inter-element selectivity, because of spectral interferences caused by matrix elements, and so results from the respective single-element investigations for determination of AOBr and AOI are not presented. The procedure has been validated and the analytical performance has been examined by calibration with p-chlorophenol and p-fluorophenol. The limit of detection was 1.1 microg (absolute) for chlorine and 6.6 microg (absolute) for fluorine.