Asia Pacific Laboratory Accreditation Cooperation Research Articles

APMP-APLAC joint proficiency testing programs for elemental analysis in food with metrological reference values: Assessment of participants' performance considering measurement uncertainties

The Asia Pacific Metrology Program (APMP) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC) joint Proficiency Testing (PT) programs for toxic elements such as cadmium (Cd) and lead (Pb) or nutritional elements such as iron (Fe) and zinc (Zn) in food were organized by the Korea Research Institute of Standards and Science (KRISS) with the aim of enhancing the quality of measurement and metrological traceability in various economies of the Asia Pacific region by evaluating the performance with rigorous evaluation. Three APMP-APLAC joint PT programs for elemental analyses were carried out by KRISS sequentially, where candidate certified reference materials (CRMs) were used as the PT materials and metrologically traceable certified reference values (RVs) were used as the PT assigned values for the evaluation of participants' results, which allows reliable evaluation of participant performance. This article describes the operation of the PTs and the overall performance of the participating laboratories. The effectiveness of these joint PT programs and trends in PT performance assessment are also discussed. These PT programs confirm the significant importance of using the metrologically traceable RVs instead of the consensus values from participants as the PT assigned value for reliable assessment. The lack of understanding of the concept of coverage factor, degree of freedom, standard uncertainty, and expanded uncertainty was revealed by some participants in these PT programs. Interpreting the zeta-scores or En scores, which are derived by using measurement uncertainties, in conjunction with the z-scores is highly meaningful for assessing participants' ability in measurement capabilities and measurement uncertainty evaluation. Assessment of participants' performance considering measurement uncertainties helps the participants to check how reasonable their measurement uncertainty estimation was. The results of PTs also demonstrated that these PT programs are useful for improving the measurement capability of the laboratories, whereas more capability-building in uncertainty evaluation is required for further improvement.

An accuracy-based proficiency testing programme with metrological reference values for the mass fraction of acesulfame potassium and sucralose in cake mix flour

This paper describes a metrological approach to evaluate the measurement capability of laboratories participating in a then Asia Pacific Laboratory Accreditation Cooperation [APLAC, now Asia Pacific Accreditation Cooperation] proficiency testing (PT) programme on mass fraction of acesulfame potassium and sucralose in cake mix flour. The programme was jointly organised by the Chemical Metrology Laboratory of the Health Sciences Authority, Singapore, and the Singapore Accreditation Council. Through the extensive APLAC network of accreditation bodies, 41 nominated laboratories from 32 economies registered, of which 40 laboratories submitted their results. Reference values of artificial sweeteners in the programme for performance evaluation were obtained from a high-accuracy liquid chromatography isotope dilution mass spectrometry (LC-IDMS) method. One of the unique features of this PT programme was the provision of pure substance certified reference materials (CRMs) of acesulfame potassium and sucralose to the participating laboratories as calibration standards to ensure comparability and metrological traceability of results. The participating laboratories’ performance, based on z-scores, were evaluated using the assigned reference value determined from IDMS. Five and one of the laboratories’ results would be incorrectly evaluated using consensus value calculated from the laboratories’ results for performance evaluation and using commercial standard as calibrant, respectively. This PT programme demonstrates the importance of the use of metrologically traceable reference values as the assigned values for appropriate evaluation of accuracy and reliable assessment. The provision of CRMs also heightened the testing laboratories’ awareness on the importance of using CRMs as calibrants for accurate measurements.

RusAccreditation and International Recognition of the National Accreditation System

The activities of the Federal Accreditation Service including cooperation with international accreditation institutions, i.e., International Laboratory Accreditation Cooperation (ILAC) and the Asia-Pacific Laboratory Accreditation Cooperation (APLAC) are reviewed. Issues regarding implementation of the system of good laboratory practice in the context of cooperation between Russia, Organization for Economic Cooperation and Development (OECD), and Slovak National Accreditation Service are considered. Information about mutual recognition agreements and bilateral arrangements of the Federal Service for Accreditation and national accreditation bodies of the foreign countries are discussed along with the results of the activities of RusAccreditation during the 1st quarter of 2018 and goals for the near future.

Laboratory accreditation provides economic opportunities and medical laboratory excellence in resource limited countries

Many developing nations have limited resources, not only in funding, but also skilled laboratory workers partially due to lack of education/training facilities, and comparatively low wages to the international community. Accreditation of laboratories provides a clear pathway to ensure proper management, training and retention of laboratory personnel. Accreditation is a tool to demonstrate the competence of medical laboratories and ensure the delivery of timely, accurate and reliable results. Under ISO 15189:5.1 laboratories must include a substantial investment in their personnel, to ensure and maintain best practices. Approximately 28 nations are signatories of the Asia Pacific Laboratory Accreditation Cooperation.1 The WHO-AFRO Stepwise Accreditation Program provides an attainable framework for lab accreditation for all 55 nations of Africa.2 The establishment of ASLM and SADCAS are additional examples of the global effort to enhance laboratory accreditation programs. Throughout the world today, laboratory accreditation has been increasingly recognized as an effective tool to remove technical barriers to trade as well as to better quality of life. Accreditation by an objective, external body is an excellent way to incorporate accountability for laboratory services. Through the application of national and international standards, government, procurers and consumers can have confidence in laboratory systems. Many developing nations have limited resources, not only in funding, but also skilled laboratory workers partially due to lack of education/training facilities, and comparatively low wages to the international community. Accreditation of laboratories provides a clear pathway to ensure proper management, training and retention of laboratory personnel. Accreditation is a tool to demonstrate the competence of medical laboratories and ensure the delivery of timely, accurate and reliable results. Under ISO 15189:5.1 laboratories must include a substantial investment in their personnel, to ensure and maintain best practices. Approximately 28 nations are signatories of the Asia Pacific Laboratory Accreditation Cooperation.1 The WHO-AFRO Stepwise Accreditation Program provides an attainable framework for lab accreditation for all 55 nations of Africa.2 The establishment of ASLM and SADCAS are additional examples of the global effort to enhance laboratory accreditation programs. Throughout the world today, laboratory accreditation has been increasingly recognized as an effective tool to remove technical barriers to trade as well as to better quality of life. Accreditation by an objective, external body is an excellent way to incorporate accountability for laboratory services. Through the application of national and international standards, government, procurers and consumers can have confidence in laboratory systems.

Final report on APMP.QM-S5: Essential and toxic elements in seafood

The supplementary comparison APMP.QM-S5 was undertaken to demonstrate the capability of participating national metrology institutes (NMIs) and designated institutes (DIs) in measuring the contents of the incurred essential elements (iron and zinc) and toxic elements (total arsenic and cadmium) at µg/g levels in a test sample of dried shrimp by various analytical techniques.At the APMP TCQM Meeting held in Pattaya, Thailand in November 2010, Government Laboratory of the Government of the Hong Kong Special Administrative Region (GLHK) proposed this APMP supplementary comparison. The proposal was further discussed and agreed upon at the CCQM Inorganic Analysis Working Group Meeting held in Paris in April 2011. GLHK was the coordinating laboratory for the supplementary comparison. For enhancing the collaboration amongst specialized regional bodies in Asia-Pacific and to help build the laboratory capacity of NMIs/DIs from developing economies, the reference values of the supplementary comparison are used for evaluation of performance of participants of an APMP proficiency testing programme (APMP PT 11-01), an Asia-Pacific Laboratory Accreditation Cooperation proficiency testing programme (APLAC T082) and an Asia-Pacific Economic Co-operation proficiency testing programme (APEC PT), which were concurrently run using the same testing material as in APMP.QM-S5.The supplementary comparison serves to facilitate claims by participants on the Calibration and Measurement Capabilities (CMCs) as listed in Appendix C of the Key Comparison Database (KCDB) under the Mutual Recognition Arrangement of the International Committee for Weights and Measures (CIPM MRA).A total of 18 institutes registered for the supplementary comparison and all of them submitted their results. Most of the participants used microwave acid digestion methods for sample dissolution. For the instrumental determination, a variety of techniques like ICP-MS, ICP-OES, INAA and AAS were employed by the participants. For this supplementary comparison, inorganic core capabilities have been demonstrated by concerned participants with respect to methods including ICP-MS (without isotope dilution), ID-ICP-MS, ICP-OES, INAA and AAS on the determination of total arsenic, cadmium, iron and zinc in a matrix of seafood.Main text.To reach the main text of this paper, click on Final Report. Note that this text is that which appears in Appendix B of the BIPM key comparison database kcdb.bipm.org/.The final report has been peer-reviewed and approved for publication by the APMP, according to the provisions of the CIPM Mutual Recognition Arrangement (CIPM MRA).

Capability of laboratories to determine core nutrients in foods: results of an international proficiency test

A proficiency test (PT) to assess the capabilities of laboratories to determine nutrients in a biscuit sample was carried out in September 2009. The need for such interlaboratory comparison arose from an increasing nutrition labeling requirements of different countries around the world. Forty-eight laboratories worldwide participated in this PT program for the determination of total lipids, saturated fat, trans-fat, protein, sugars, total dietary fiber (TDF), ash and sodium in food. This program was organized under the auspices of the Asia-Pacific Laboratory Accreditation Cooperation (APLAC). APLAC considers PT programs as one of the objective means of assessing the performance of the accredited laboratories. The program is one of the APLAC PT series whose primary purposes are to establish mutual agreement on the equivalence of the operation of APLAC member laboratories and to provide an opportunity to identify testing deficiency so that corrective actions can be taken, if necessary. The results of this program indicated that the consensus mean values estimated by robust statistics were in good agreement with the corresponding values obtained in the homogeneity tests except for trans-fat and TDF. The relative standard deviations of participant results for trans-fat and TDF were also found to be higher (19 and 24%, respectively) than the other test parameters. The relative standard deviations for other test parameters were less than 10%. One-half of the laboratories obtained satisfactory z-scores \( (\left| z \right| < 3) \) for all their reported results. Although participants were instructed to provide the measurement uncertainties of their reported results, only 27.5% of them had done so. Albeit many of the measurement uncertainties appear to be reasonable, some of them were found to vary widely, indicating that some laboratories still have difficulties in estimating measurement uncertainties. Although the overall measurement capability can be considered to be satisfactory, there is still room for improvement of analytical procedures.

Performance assessment for determining malachite green and leucomalachite green in swamp eel (Monopterus albus) muscle using assigned reference values in a proficiency test

This paper presents the results of a proficiency test (APLAC T058) for malachite green (MG) and leucomalachite green (LMG) in swamp eel (Monopterus albus). The programme was organized by the Hong Kong Government Laboratory and Hong Kong Accreditation Service (HKAS), under the auspices of the Asia-Pacific Laboratory Accreditation Co-operation (APLAC) in 2007. Results submitted by participants were compared with the assigned reference values, which were determined by an accurate liquid chromatography-isotope dilution mass spectrometry (LC-IDMS) technique, and their performance was evaluated on the basis of z-score index. The distribution of data was very wide and discrepancy from the assigned reference values was found to be method dependent. Only 48% and 62% of participants achieved satisfactory z-scores (i.e. ) for MG and LMG, respectively. With the provision of reference values, the programme served to establish an external quality control mechanism for assessing the measurement capabilities of participating laboratories in the determination of MG and LMG in eel samples.

Proficiency Testing Program for the Determination of Total Arsenic, Cadmium, and Lead in Seawater Shrimp

The proficiency testing (PT) program for 97 worldwide laboratories for determining total arsenic, cadmium, and lead in seawater shrimp under the auspices of the Asia-Pacific Laboratory Accreditation Cooperation (APLAC) is discussed. The program is one of the APLAC PT series whose primary purposes are to establish mutual agreement on the equivalence of the operation of APLAC member laboratories and to take corrective actions if testing deficiencies are identified. Pooled data for Cd and Pb were normally distributed with interlaboratory variations of 21.9 and 34.8%, respectively. The corresponding consensus mean values estimated by robust statistics were in good agreement with those obtained in the homogeneity tests. However, a bimodal distribution was observed from the determination of total As, in which 14 out of 74 participants reported much smaller values (0.482-6.4 mg/kg) as compared with the mean values of 60.9 mg/kg in the homogeneity test. The use of consensus mean is known to have significant deviation from the true value in bi- or multimodal distribution. Therefore, the mode value, a better estimate of central tendency, was chosen to assess participants' performance for total As. Estimates of the overall uncertainty from participants varied in this program, and some were recommended to acquire more comprehensive exposure toward important criteria as stipulated in ISO/IEC 17025.

Interlaboratory Comparison for the Determination of Five Residual Organochlorine Pesticides in Ginseng Root Samples by Gas Chromatography

An interlaboratory comparison study for the determination of 5 residual organochlorine pesticides (hexachlorobenzene and 4 hexachlorocyclohexane isomers) in ginseng root was performed. This program [Asia Pacific Laboratory Accreditation Cooperation (APLAC) T049] was the first of its kind for an herbal matrix and involved the participation of 70 laboratories from 26 countries worldwide. Consensus mean values were computed statistically from the reported results, which were eventually used to assess the performance of individual laboratories in terms of the z-scores. The distribution of analytical data was found to be widespread, with standard deviation ranging from 43.9 to 55.9%, and the result patterns obtained were similar to those residue pesticide programs using other matrixes. Although the estimation of measurement uncertainty is a crucial requirement for all quantitative tests for laboratories that meet the requirements of International Organization for Standardization/International Electrotechnical Commisssion (ISO/IEC) 17025, some laboratories in this program had difficulties and showed unfamiliarity with respect to that quality criterion. It was recommended that laboratories review and rectify the situation promptly so that they would have a better understanding of measurement uncertainty or the test service provided.

Laboratory accreditation-procedural guidelines

Accreditation is the formal recognition, authorizationand registration of a laboratory that has demonstratedits capability, competence and credibility to carry outthe tasks it is claiming to be able to do. It providesfeedback to laboratories as to whether they areperforming their work in accordance with internationalcriteria for technical competence.The concept of laboratory accreditation was developedto provide third-party certification that a laboratory iscompetent to perform the specific test or type of tests.Laboratory accreditation is a means to improvecustomer confidence in the test reports issued by thelaboratory so that the clinicians and through them thepatients shall accept the reports with confidence.The National Accreditation Board for Testing andCalibration Laboratories (NABL) is an autonomousbody under the aegis of the Dept. of Science &Technology, Govt. of India, and is registered under theSocieties Act. NABL, which was initially establishedwith the objective to provide accreditation to testing &calibration laboratories, later on extended its servicesto the clinical laboratories in our country.Govt. of India has authorized NABL as the soleaccreditation body for testing and calibrationlaboratories. The objective of NABL is to provide thirdparty assessment of quality and technical competence.Four years ago NABL established links withinternational bodies - Asia Pacific LaboratoryAccreditation Cooperation and InternationalLaboratory Accreditation Cooperation. This hasimparted international recognition to NABL accreditedlaboratories. The international standard currentlyfollowed by NABL is ISO 15189, specific for medicallaboratories.

APLAC Interpretation and Guidance on the Estimation of Uncertainty of Measurement in Testing

The Asia Pacific Laboratory Accreditation Cooperation (APLAC) is the organization representing the community of bodies that accredit testing and calibration laboratories throughout the Asia Pacific region, including China and North America. APLAC members assess the competence of laboratories and grant them accreditation. They also provide mutual recognition of the equivalence of their accreditations, which facilitates international trade and acceptance by regulators. Harmonization of accreditation requirements is therefore vital to maintaining Mutual Recognition Arrangements. APLAC establishes management and technical criteria for accreditation and publishes guidance documents for accreditation bodies and laboratories.

The Operational System of National Accreditation of Laboratories in China

This document gives a brief introduction to CNACL (China National Accreditation Committee for Laboratories). Laboratory accreditation in China is integrally administrated by the China State Bureau of Quality and Technical Supervision, a government administrative department of China State Council, which authorizes CNACL to implement Chinese laboratory accreditation activities. CNACL was established on September 20, 1994. It is a full member of both ILAC (International Laboratory Accreditation Cooperation), and APLAC (Asia Pacific laboratory Accreditation Cooperation), and signed the APLAC MRA (Mutual Recognition Arrangement) in New Delhi, India on December 3, 1999. CNACL carries out laboratory accreditation activities in full compliance with international general criteria. Its operation complies with ISO/IEC Guide 58 (1993), ISO/IEC 17025 (1999), ISO/IEC Guide 43 (1997) and other international standards.

Imperatives of Metrology and Standardization for Global Trade

International buyers look for quality products from all over the world. Global trade demands adherence to stringent quality standards. World class quality is required at competitive prices. Metrology and standardization are two integral determinants of quality in the international trade. India is having a sound infrastructure of metrology laboratories. Most of these laboratories are established by the Government of India and are accredited with the National Accreditation Board of Laboratories. There is an urgent need that India should be a signatory to the Asia Pacific Laboratory Accreditation Cooperation and the calibration certificates from Indian metrology laboratories should be recognized internationally through the mechanism of Mutual Recognition Agreements. A national policy and commitment for the promotion of metrological infrastructure is required. New metrology laboratories should be encouraged in the private sector. Appropriate fiscal incentives and institutional support are required for private enterpreneurs to establish metrology institutes with state-of-the-art test and calibration equipment. Further a planned effort is required to maintain and upgrade the existing test and calibration equipment in government funded laboratories. Corporatization of government metrology laboratories will improve their productivity, make them more efficient and ensure optimum utilization of existing facilities. The work ethos in government laboratories require attitudinal transformation so that services can be delivered to the customers efficiently. The emergence of ISO 9000, QS 9000 and ISO 14000 standards have brought tremendous pressure on metrology laboratories for calibration and testing. The multi-lateral government agreements and global trade will depend upon the quality of metrology institutes in India.