Forgot your password?
New user?
New Window Opens on the Secret Life of Microbes: Scientists Develop First Microbial Profiles of Ecosystems
CAS announces the release of SciFinder Scholar for Mac OS X
Press Releases
Press Releases
| Check out our New Publishers' Select for Free Articles |
Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.2, #3)
The Japan Accreditation Board for Conformity Assessment – Introduction to the Japanese accreditation system by T. Ohtsubo (pp. 111-114).
The background to the establishment of the Japan Accreditation Board for Conformity Assessment (JAB) is reviewed in relation to the latest global developments in conformity assessment activities. JAB (known as the Japan Accreditation Board for Quality System Registration at the time of its establishment) was established in 1993 as the accreditation body for quality system registration, the focal point for conformity assessment in the private sector in Japan. The extension of the area of accreditation was made in June 1996, covering all conformity assessment activities including laboratory accreditation, which resulted in the amendment of the name of the body to the current one. Various elements of the laboratory accreditation program are introduced to give the overview of this new program.
Keywords: Key words Japan; Accreditation; Laboratories; Traceability; Quality
The present situation of Japanese certified reference materials registered in the COMAR database by H. Imai; S. Tago; Y. Yamauchi (pp. 115-119).
In the field of reference materials, COMAR (Code d'Indexation des Matériaux de Référence) is now internationally known as a reliable directory. In order to improve the quality of COMAR, a document which covers general requirements for the registration of reference material has recently been adopted by the Japanese coding centre, NITE. This paper describes the general requirements for reference materials and the current status of the COMAR database coded by the National Institute of Technology and Evaluation (NITE), Japan. The concept of the requirements is fundamentally based on the ISO Guides 30, 31, 33, 34 and 35. Certifications of reference materials are divided into the following three categories in the newly adopted document.1. Certifications based on the results of interlaboratory comparisons2. Certifications in accordance with the Measurement Law3. Certifications in accordance with the measurement results of national institutionsAn example of an uncertainty evaluation is also presented in the paper.
Keywords: Key words Certified reference material; Database; ISO/Guide; Interlaboratory comparison; Uncertainty estimation
Accreditation system for reference material producers and certified reference materials for iron and steel in Japan by N. Sagara; T. Kondo; M. Saeki; I. Inamoto; K. Kakita (pp. 120-129).
ISO 9000 series strictly requires traceability to national or international measurement standards. It is becoming more necessary to make clear the concept of traceability of measurement standards with respect to chemical composition and to accredit the reference material producers. In Japan, the accreditation system for reference material producers is considered to satisfy the requirement of ISO Guide 34, ISO 9000 series and ISO/IEC Guide 25, while the producer fulfills the concept of traceability of measurement standards. This paper describes the production of iron and steel reference materials in Japan relating to the international standardization of methods (written standards) and accreditation of reference material producers.
Keywords: Key words Accreditation; Chemical analysis; Reference material; Standard; Traceability
Development and supply system of reference materials based on the Measurement Law in Japan by M. Kubota; K. Kato; A. Hioki; H. Iijima; Y. Matsumoto (pp. 130-136).
Analytical instruments used for measurements of air and water pollution are calibrated by using reference materials such as standard gases and standard solutions. In Japan, since the middle of the 1970s, those reference materials which are traceable to the national standards maintained at national research institutes have been supplied to users by reference material producers. In order to establish the primary standards and to secure the traceability from the working standards to the national ones, various analytical methods such as coulometric, titrimetric and gravimetric analyses for purity determination and highly sensitive atomic spectrometry for trace analysis have been developed as the primary methods and reference methods. The Japanese Measurement Law, revised in 1992, has introduced a new traceability system in which a public organization, a "designated calibration body", can also prepare and maintain the national standards under the advice and instruction of national research institutes. The designated calibration body can provide calibration services to reference material producers (accredited calibration bodies) by using the national standards. The reference materials supplied in conformity with the traceability system include standard gases, pH standard solutions, metal standard solutions and non-metal ion standard solutions.
Keywords: Key words Reference material; Standard gas; Standard solution; Traceability; Measurement Law
Uniform oligomers as reference materials for molecular weight determination of polymers by S. Kinugasa; H. Nakahara; S. Hattori (pp. 137-139).
Uniform oligomers are special oligomers having no molecular weight distribution. They have been used as reference materials for polymer characterization, especially for accurate molecular weight determination in lower molecular weight ranges. These oligomers are used for different purposes. First, they are used in the calibration for chromatographic or spectroscopic data. Second, they are applied to identifying peaks appearing in chromatographies such as supercritical fluid chromatography (SFC) of oligomeric mixtures. Finally, they could give accurate instrumental or physicochemical constants used in polymer characterizations. The uniform oligomers have been prepared by using preparative chromatographies as separation methods. In some cases, step-wise syntheses have been applied together with the chromatographic methods. Recently, we prepared uniform oligostyrenes and oligo(oxyethylene)s whose molecular weights are greater than 1000 by using preparative size exclusion chromatography. More recently, using preparative SFC, some Japanese researchers have prepared high molecular weight and uniform oligomers such as oligo(methylmethacrylate)s. In this article, we briefly review recent progress mainly made by Japanese researchers in the field of preparation, analysis and applications of these pure oligomers.
Keywords: Key words Uniform oligomer; Reference materials; Supercritical fluid chromatography; Size exclusion chromatography
Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry by S. Seno; S. Ohtake; H. Kohno (pp. 140-145).
Analytical validation is required as the basis for any evaluation activities during manufacturing process validation, cleaning validation and validation of the testing method itself in the pharmaceutical industry according to good manufacturing practice (GMP) rules and guidelines. Validation of analytical methods and procedures in a quality control (QC) laboratory is implemented mainly at the time of transfer or introduction of the methods developed by the analytical development laboratory within group companies or elsewhere. However, it is sometimes necessary to develop a new or improved method of analysis for the QC laboratory's own use. In the first part of this report, a general description of analytical validation of the high performance liquid chromatography (HPLC) method including preparation of documents is presented based on the experience in our QC laboratory. A typical example of method validation of robotic analysis system is then cited. Finally the merits and demerits of these analytical validations for QC laboratories are summarized. The authors emphasize the importance of analytical validation and the responsibility of QC laboratory management for the effective design and implementation of validation activities.
Keywords: Key words Analytical method and procedure; Validation; Quality control laboratory; Documentation; Robotic analysis
Compliance with GLP standards and management in analytical laboratories: current status by T. Iwaoka (pp. 146-149).
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.
Keywords: Key words Analytical laboratories; Good laboratory practice (GLP); Validation; Good manufacturing practice (GMP); Accreditation
The Japanese traceability system and the role of uncertainty evaluation in measurement by H. Imai; H. Ijima (pp. 150-153).
The new traceability system of measurement standards based on the Japanese Measurement Law has been established since November 1993. Some reference materials such as metal standard solutions, pH standard solutions and standard gas mixtures are included in the system together with relevant physical quantities. In this system, primary measurement standard instruments or primary reference materials are designated by the regulation for each quantity. For the practical dissemination of each quantity, accreditation of calibration bodies is recognized by the steering committee under the supervision of the government. In the course of assessment of a candidate calibration body, the concepts of ISO/IEC Guide 25 and ISO/IEC Guide 58 are effectively introduced. For the estimation of reliability, the concept of how to introduce the statistical approach is effectively considered. The method of uncertainty evaluation described in the ISO document entitled "Guide to the expression of uncertainty in measurement" is adopted.
Keywords: Key words Traceability of measurement; Calibration; Certified reference materials; National metrology institute; Measurement uncertainty
NIES certified reference materials for arsenic speciation by J. Yoshinaga; Y. Shibata; T. Horiguchi; M. Morita (pp. 154-156).
The National Institute for Environmental Studies (NIES) recently prepared two candidate certified reference materials (CRMs) for arsenicals to meet the growing demand for the quality assurance of arsenic speciation analysis. The NIES candidate CRM No. 14 Brown Alga was prepared from Hijiki seaweed for the certification of inorganic arsenic content, and No. 15 Scallop was prepared from adductor muscle of scallop for the certification of arsenobetaine content. The preparation of the candidate CRMs is briefly described. Cooperative analyses for total arsenic content of the candidate CRMs have been underway. The preliminary speciation analysis at NIES revealed difficulty in establishing suitable conditions for extracting arsenic species from the materials. Chromatograms of arsenic species by a high performance liquid chromatography-inductively coupled plasma mass spectrometric detection system are presented to provide information about arsenic species present in these candidate CRMs.
Keywords: Key words Inorganic arsenic; Arsenobetaine; Speciation; Certified reference material; Marine organism
Preparation and certification of JAC river water reference material for trace element analysis by K. Okamoto (pp. 157-158).
The Japan Society for Analytical Chemistry has recently issued a river water-certified reference material (CRM) for use in the ultratrace analysis of elements in fresh water. The river water CRM consists of a set of two (natural and spiked) 500-ml samples. The natural water is certified for Pb, Cr, As, Cu, Fe, Mn, Zn, B and Al at their sub-μg/l levels, while the spiked water is intended for use in the regulatory analysis of tap water and fresh water. Key words River water · Trace element analysis · Regulatory analysis · Reference materials