计算机技术在水质检测实验室信息管理系统中的应用

介绍计算机技术在水质检测实验室信息管理系统中的应用,基于信息管理系统的总体设计思路,探讨计算机数据库技术和网络技术在排水监测站实验室信息管理系统中的应用。水质检测实验室信息管理系统是集分析检测、质量控制及实验室综合管理于一体的模块化、开放式信息平台,主要应用于水质检测流程控制、质量监测和实验室管理。对计算机技术在水质检测实验室信息管理系统建设中的应用进行分析,为水质检测实验室信息管理系统的建设应用提供解决方案。通过实验室信息管理系统建设,可以规范实验室的管理,调动实验室各种资源,提高工作效率,加大对污废水排放的监管力度。     

System for the generation of standard gas mixtures of volatile and semi-volatile organic compounds for calibrations of solid-phase microextraction and other sampling devices

Standard gases are used for quality control and quality assurance, development of analysis methods and novel air sampling devices. The use of solid-phase microextraction (SPME) and other novel technologies for research in the area of air sampling and analysis requires systems/devices for reliable standard gas generation and sampling. In this paper we describe a new gas standard generating system for volatile organic compounds (VOCs) and semi-VOCs that was designed, built, and tested to facilitate fundamental and applications research with SPME. The system provided for the generation of a wide range of VOC/semi-VOC concentrations and mixing various standard gases, estimation of detection limits, testing the effects of sampling time, air temperature and relative humidity, testing the effects of air velocity and ozone on sampling/extractions. The system can be also used for calibrations of analytical instrumentation, quality control and quality assurance checks, and cross-validations of SPME with/and other sampling techniques.     

水中易释放氰化物能力验证样品的研制及应用

根据国家地表水环境质量监测网监测任务要求和环境监测的实际需要,制备了水中易释放氰化物能力验证样品。通过均匀性、稳定性检验以及量值一致性评价,研制的样品均匀性良好,在3℃~6℃冷藏避光保存条件下1年内稳定,样品配制值与多家实验室协作测定结果一致。探讨了样品在能力验证活动中的应用,共有来自全国11个省的32家实验室参加了水中易释放氰化物的能力验证计划,实验室满意率在80%以上,实验室结果出现有问题或不满意主要是由于样品前处理以及检测过程质量控制不当导致的。经检测及实验室反馈的数据验证,该能力验证样品能够应用于能力验证活动。     

Why do food analysts need quality assurance?

 Most sophisticated products require testing for compliance with specifications and safety regulations before release into many markets, and trade in many simpler commodities and products also requires supporting technical information. Test documentation has become an essential element in this trade. Food intended for human consumption certainly falls into the "sophisticated products" category. Lack of acceptance of laboratory test data across national borders may be a significant barrier to trade. In order to avoid such barriers and unnecessary duplication of laboratory tests, mutual recognition of laboratory results should be regarded as an important means of facilitating international trade in food products. It is difficult to envisage recognition of test data across borders without internationally agreed criteria for assessing the competence of testing. These criteria should, as a minimum, require that a laboratory involved in the analysis of foods operates a suitable quality system. The laboratory must create a quality system appropriate to the type, range and volume of work performed. It is necessary for the elements of this system to be documented in a quality manual which is available for use by the laboratory personnel. The quality manual must be kept up-to-date by a person or persons having responsibility for quality assurance within the laboratory. This paper describes and discusses the elements of a quality system in a food laboratory, including suitable quality assurance measures, the use of validated analytical methods and participation in proficiency testing schemes. Received: 24 February 1996 Accepted: 13 March 1996     

The role of analytical testing in the quality system

Summary In view of the requirements to be fulfilled by chemical products for the purposes for which they are intended, it is essential to approach the planning, development and realisation of their quality in a systematic fashion. As the quality of a product cannot be created by testing, analytical testing takes on a central role within the quality system. It is an indispensable tool in every phase of product planning and product realisation, from the setting of specifications to procurement of raw materials and on to production, packaging, warehousing and transport.     

ISO 17025: practical benefits of implementing a quality system

As a laboratory certified to ISO 9001:2000 and accredited to ISO 17025, rtech laboratories has incorporated an overall system for technical and quality management, which results in benefits observed in daily laboratory practices. Technical requirements were updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program. In addition, a stronger definition of the sample preparation process was documented to maintain consistency in sampling, and a more rigorous quality control monitoring program was implemented for chemistry and microbiology. Management quality improvements focused on document control to maintain consistent analytical processes, improved monitoring of supplier performance, a contract review process for documenting customer requirements, and a system for handling customer comments and complaints, with continuous improvement through corrective and preventive action procedures and audits. Quarterly management review of corrective actions, nonconforming testing, and proficiency testing aid in determining long-term trending. The practical benefits of these technical and management quality improvements are seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.     

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.     

Implementation of an integrated glucose POCT system

In response to a change of the Belgian National Directives whereby hospital laboratories became responsible for all point-of-care testing (POCT) performed within hospital walls a standardized and automated POC glucose-testing system was implemented in our hospital. The system consists of 50 AccuCheck Inform instruments (Roche Diagnostics, Vilvoorde, Belgium), 50 docking stations, a DataCare Server, and connections to the medical laboratory information system (MOLIS, Sysmex, Barchon, Belgium) and to the hospital information system. Implementation involved many parties and extensive preparation and communication. Key issues were bar-coded patient and user identification, training, and responsibilities. One year after the hospital wide implementation of this system the quality of POC glucose testing has significantly increased, thereby improving patient safety. This study describes a stepwise change over involving the medical laboratory and with a focus on hands-on quality.Presented at the ninth conference on Quality in the Spotlight, 18–19 March 2004, Antwerp, Belgium.     

Quality management in wastewater treatment plants

A quality management system has been designed for process analyses in wastewater plants. The quality management concept consists of a quality manual, quality control charts used together with certified reference materials, and proficiency testing. Certified reference materials have been used to eliminate basic analytical errors. Proficiency testing has been conducted by VKI, the Reference Laboratory for Environmental Chemistry, subcontracted by the Danish Environmental Protection Agency. In the first proficiency test the analytical quality was comparable in general to the quality of routine environmental laboratories. One of the simplified analytical systems resulted, however, in a low recovery of nitrate in wastewater. The COD results reported in the proficiency test were slightly higher than the theoretical values.     

Predicting coal ash fusion temperature based on its chemical composition using ACO-BP neural network

Coal ash fusion temperature is important to boiler designers and operators of power plants. Fusion temperature is determined by the chemical composition of coal ash, however, their relationships are not precisely known. A novel neural network, ACO-BP neural network, is used to model coal ash fusion temperature based on its chemical composition. Ant colony optimization (ACO) is an ecological system algorithm, which draws its inspiration from the foraging behavior of real ants. A three-layer network is designed with 10 hidden nodes. The oxide contents consist of the inputs of the network and the fusion temperature is the output. Data on 80 typical Chinese coal ash samples were used for training and testing. Results show that ACO-BP neural network can obtain better performance compared with empirical formulas and BP neural network. The well-trained neural network can be used as a useful tool to predict coal ash fusion temperature according to the oxide contents of the coal ash.     

Determination of Operating Conditions of Ethylene/1-Octene Copolymerization Using Artificial Neural Network (ANN)

An artificial neural network (ANN) is applied to determine appropriate parameters in copolymerization of ethylene and 1-octene via metallocene catalytic system for producing a copolymer with desired chain microstructures. The polymerization parameters of interests are polymerization temperature, ethylene pressure, and the amount of hydrogen used. The ANN used is a feed-forward network with a back propagation learning method and has a 5-6-6-3 architecture. When comparing with both training and testing experimental data sets, it was found that ANN can provide a good guesstimation of polymerization parameters.     

A quality systems approach for identifying and controlling sources of error with point of care testing devices

Historically, due to the size and nature of the instrumentation, highly skilled laboratory professionals performed clinical testing in centralized laboratories. Today’s clinicians demand realtime test data at the point of care. This has led to a new generation of compact, portable instruments permitting ”laboratory” testing to be performed at or near the patient’s bedside by nonlaboratory workers who are unfamiliar with testing practices. Poorly controlled testing processes leading to poor quality test results are an insidious problem facing point of care testing today. Manufacturers are addressing this issue through instrument design. Providers of clinical test results, regardless of location, working with manufacturers and regulators must create and manage complete test systems that eliminate or minimize sources of error. The National Committee for Clinical Laboratory Standards (NCCLS) in its EP18 guideline, ”Quality management for unit-use testing,” has developed a quality management system approach specifically for test devices used for point of care testing (POCT). Simply stated, EP18 utilizes a ”sources of error” matrix to identify and address potential errors that can impact the test result. The key is the quality systems approach where all stakeholders – professionals, manufacturers and regulators – collaboratively seek ways to manage errors and ensure quality. We illustrate the use of one quality systems approach, EP18, as a means to advance the quality of test results at point of care. Received: 26 June, 2002 Accepted: 17 July 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Abbreviations NCCLS National Committee for Clinical Laboratory Standards (formerly) · POCT point of care testing · QC quality control · HACCP hazard analysis critical control points · CLIA clinical laboratory improvement amendments (of 1988) Correspondence to S. S. Ehrmeyer     

Can the progress in quality management tools for POC tame the fiends from Pandora's box?

POCT provides the opportunity to significantly improve the overall quality of blood testing in an organization. The design of the product, the redesign of the testing process and the tools used to manage a completely distributed testing process, are key to the quality implementation of POCT. Both theoretical considerations and practical outcomes are discussed in this paper, using the i-STAT^® System as an example of a POCT system.     

实验室质量体系和体系文件的策划

简述了实验室质量体系所含的要素和建立质量体系的一般过程,以及质量体系文件的组成和编写、编辑文件的要点。     

用质量检测管理信息系统统计质量目标

阐述了综合性检测机构的质量目标在报告准确性、及时性和客户满意度方面的体现,详细介绍了分解及统计质量目标的方法、质量管理信息系统在统计质量目标方面的功能及其在统计质量目标方面的应用.     

Thermomechanical properties of liquid‐crystalline epoxy networks arranged by a magnetic field

During the curing process of a liquid‐crystalline epoxy resin, a relatively strong magnetic field was applied, and the thermomechanical properties of the cured resin were investigated. The network orientation and mechanical properties of the cured system were evaluated with wide‐angle X‐ray diffraction, dynamic mechanical analysis, and fracture toughness testing. The cured system was found to have an anisotropic network structure, which arranged along the applied field, and the anisotropy was reflected in the thermomechanical properties. In particular, the fracture toughness of the system dramatically increased when the network chains were arranged across the direction of the crack propagation. © 2004 Wiley Periodicals, Inc. J Polym Sci Part B: Polym Phys 42: 758–765, 2004     

The study for optimization of chromatographic condition by means of artificial neural networks

In this paper, the optimization of gas chromatographic experimental parameters is investigated using a three layer feed-forward neural network with the back-propagating. The design, development, and testing of the neural network are described in detail. The chosen structure is 4-6-2 system with a learning rate eta of 0.6 and a momentum constant mu of 0.4. The results of several simulations are very satisfactory. Network results are compared with the results obtained by the orthogonal method.     

Quality control in residual solvent analysis: the static headspace gas chromatographic method

 Residual solvent testing of raw materials and drug products constitutes part of a quality control programme. Static headspace gas chromatography (HS/GC) is suggested in current pharmacopoeias as a general tool for residual solvent testing. But the main obstacles to using HS/GC procedures are the absence of performance tests, suitable reference solvents and matrix standards, and reference methods. Harmonized regulations for residual solvent testing allow the use of a cumulative approach to estimate the residual solvent content in drug products. The supplier data may be appropriate. Therefore, in a quality control programme the main accent is put on the definition of specification limits (in accordance with toxicological data, and the influence of residual solvents on the physical properties and stability of the product) and supplier qualification. This paper focuses on two main problems linked to supplier qualification: system performance and matrix effect. HS/GC of a mixture containing solvents of different volatility and polarity is proposed as a performance test. The test can be done in three ways in accordance with the residual solvents characteristics, the test sample solubility and the specification levels required. The use of the test as a diagnostic tool is demonstrated and sources of uncertainty of the recovery determination are discussed. Received: 12 December 1998 · Accepted: 25 January 1999     

Evaluation of proficiency testing results taking into account their uncertainties

A new composite score for the evaluation of performance of proficiency testing participants is proposed. The score is based on a combination of the z-score, uncertainty of a participant’s measurement result and uncertainty of the proficiency testing scheme’s assigned value. The use of such a composite score will allow evaluation not only of the participant’s ability to determine an analyte in corresponding matrix, but also their understanding of the uncertainty in the obtained analytical result. The score may be helpful for the laboratory’s quality system and for laboratory accreditation according to ISO 17025.     

Validating automated analytical instruments to meet regulatory and quality standard requirements

Analytical laboratories are more and more faced to meet official regulatory requirements as described in FDA and EPA good laboratory practice, good automated laboratory practice and good manufacturing practice regulations or to officially establish quality systems, such as specified in the ISO 9000 Series quality standards, in the ISO Guide 25 or in the EN 45001 guidelines. The impact on analytical instrumentation will be the requirement for stringent validation of analytical equipment and methods which increase the overall analysis costs. An overview is presented on the validation requirements using e.g. gas chromatography, high performance liquid chromatography, capillary electrophoresis and UV-visible spectroscopy and on the strategy to meet such needs at minimal extra costs with the help of an instrument vendor. It is recommended to use instrument hardware that has already built-in tools for self-verification and which is to be validated at the vendor's site. Performance testing in the user's laboratory is done using standard operating procedures as supplied with the instrument. If resources in the user's laboratory are limited, the performance verification is done by the vendor. Software and the entire computer system is validated prior to shipment at the vendor's site. Acceptance testing is done in the user's environment following the vendor recommendations. Analytical methods are validated automatically at the end of method development using a dedicated software. The software can be customized such that it can also be used for daily automated system suitability testing. Security and integrity of analytical data are ensured by saving the raw data together with instrument conditions and instrument log-books in check-sum protected binary register files for long-term archiving.