ASTM_E_1301_-_95_2003.pdf

Designation:E 1301 95(Reapproved 2003)An American National StandardStandard Guide forProficiency Testing by Interlaboratory Comparisons1This standard is issued under the fixed designation E 1301;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.INTRODUCTIONProficiency testing is the use of interlaboratory test comparisons to determine the performance ofindividual laboratories for specific tests and to monitor the consistency and comparability of alaboratorys test data.Interlaboratory test comparisons are conducted for a number of other purposes including:(1)Check the consistency and comparability of data for individual testing personnel;(2)Assist in maintaining the calibration of instrumentation;(3)Establish the effectiveness and comparability of new test methods;(4)Achieve commercial improvement;(5)Assist in determining reasons for interlaboratory differences;(6)Determine the precision of a test methodoften known as interlaboratory studies(see PracticeE 691),collaborative trials,or round-robins;and(7)Assign values to certified reference materials(CRMs).Participation in proficiency testing programs provides laboratories with an objective means ofassessing and demonstrating the reliability of the data they are producing.Although there are severaltypes of proficiency testing programs,they all share the common feature of the comparison of testresults obtained by two or more laboratories.One of the main uses of proficiency testing programs is to assess laboratories ability to performtests competently.It thus supplements laboratories own internal quality control procedures byproviding an additional external evaluation of their testing capability.These activities also comple-ment the technique of on-site laboratory assessment by technical specialists usually used by laboratoryaccrediting bodies.Confidence that a testing or calibration laboratory consistently obtains reliableresults is of major importance to users of laboratory services.Users seeking such an assurance mayundertake their own evaluation or may use the evaluation of other bodies.Bodies assessing the technical competence of testing laboratories normally require or expectsatisfactory participation in proficiency testing as evidence of a laboratorys ability to produce reliabletest results,except where proficiency testing is inappropriate.However,it is emphasized that a majordistinction exists between:(1)The evaluation of the competence of a laboratory by the assessment of its total operation againstpre-determined requirements,and(2)The examination of the results of a laboratorys participation in proficiency testing which mayonly be considered as giving information about the technical competence of the testing laboratory ata single point of time under the specific conditions of the test for tests involved in a particularproficiency testing program.1.Scope1.1 While there are a number of uses for interlaboratorytests,and variations in their design and implementation,it isstill possible to specify the essential principles that need to beconsidered when organizing such tests.Part A of this guidedefines those principles and describes the factors that should betaken into account in the organization and conduct of profi-ciency testing programs.1.2 This guide also covers how laboratory accrediting bod-ies,which assess technical competence of testing laboratories,should select and use proficiency testing programs(refer toPart B).1This guide is under the jurisdiction of ASTM Committee e36 on LaboratoryAccreditation and is the direct responsibility of Subcommittee E36.60 on Accredi-tation Systems.Current edition approved October,10,1995.Published January 1996.Originallypublished as E 1301 89.Last previous edition E 1301 89.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.1.3 PartAof the guide is intended for use by various parties,such as accrediting bodies,regulatory authorities and clients oflaboratory services which have a need to assess the technicalcompetence of laboratories.It is also useful for laboratories inself-evaluation,but recognizes that proficiency testing is onlyone mechanism that can contribute to establishing equivalentconfidence among users of different testing laboratories.1.4 It is currently a condition of some accreditation bodiesthat laboratories participate regularly in“approved”profi-ciency testing programs.Therefore,it is essential that programoperators comply with principles for conduct of professionallymanaged proficiency programs,both in terms of technicalrequirements and quality management(see Annex A1 andAnnex A2).1.5 The methods of operation within different proficiencytesting organizations are not expected to be identical and thisgui