ASTM E1301-95(2003)
(Guide)Standard Guide for Proficiency Testing by Interlaboratory Comparisons (Withdrawn 2003)
Standard Guide for Proficiency Testing by Interlaboratory Comparisons (Withdrawn 2003)
SCOPE
1.1 While there are a number of uses for interlaboratory tests, and variations in their design and implementation, it is still possible to specify the essential principles that need to be considered when organizing such tests. Part A of this guide defines those principles and describes the factors that should be taken into account in the organization and conduct of proficiency testing programs.
1.2 This guide also covers how laboratory accrediting bodies, which assess technical competence of testing laboratories, should select and use proficiency testing programs (refer to Part B).
1.3 Part A of the guide is intended for use by various parties, such as accrediting bodies, regulatory authorities and clients of laboratory services which have a need to assess the technical competence of laboratories. It is also useful for laboratories in self-evaluation, but recognizes that proficiency testing is only one mechanism that can contribute to establishing equivalent confidence among users of different testing laboratories.
1.4 It is currently a condition of some accreditation bodies that laboratories participate regularly in "approved" proficiency testing programs. Therefore, it is essential that program operators comply with principles for conduct of professionally managed proficiency programs, both in terms of technical requirements and quality management (see Annex A1 and Annex A2).
1.5 The methods of operation within different proficiency testing organizations are not expected to be identical and this guide does not give specific operational details for interlaboratory test comparisons. It does, however, cover both measurement comparison and testing programs in which large numbers of laboratories (over 20) or small groups of laboratories (1 to 20) are tested. Therefore, the contents of this guide are intended only as a framework to be modified appropriately for particular situations.
1.6 A list of some relevant references is given in Appendix X1.
WITHDRAWN RATIONALE
While there are a number of uses for interlaboratory tests, and variations in their design and implementation, it is still possible to specify the essential principles that need to be considered when organizing such tests.
Formerly under the jurisdiction of Committee E36 on Accreditation Certification, this guide was withdrawn in July 2012 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
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An American National Standard
Designation: E1301 – 95 (Reapproved 2003)
Standard Guide for
Proficiency Testing by Interlaboratory Comparisons
This standard is issued under the fixed designation E1301; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Proficiency testing is the use of interlaboratory test comparisons to determine the performance of
individual laboratories for specific tests and to monitor the consistency and comparability of a
laboratory’s 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 method—often known as interlaboratory studies (see Practice
E691), 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 of
assessing and demonstrating the reliability of the data they are producing.Although there are several
types of proficiency testing programs, they all share the common feature of the comparison of test
results obtained by two or more laboratories.
One of the main uses of proficiency testing programs is to assess laboratories’ ability to perform
tests competently. It thus supplements laboratories’ own internal quality control procedures by
providing an additional external evaluation of their testing capability. These activities also comple-
mentthetechniqueofon-sitelaboratoryassessmentbytechnicalspecialistsusuallyusedbylaboratory
accrediting bodies. Confidence that a testing or calibration laboratory consistently obtains reliable
results is of major importance to users of laboratory services. Users seeking such an assurance may
undertake their own evaluation or may use the evaluation of other bodies.
Bodies assessing the technical competence of testing laboratories normally require or expect
satisfactoryparticipationinproficiencytestingasevidenceofalaboratory’sabilitytoproducereliable
test results, except where proficiency testing is inappropriate. However, it is emphasized that a major
distinction exists between:
(1) Theevaluationofthecompetenceofalaboratorybytheassessmentofitstotaloperationagainst
pre-determined requirements, and
(2) The examination of the results of a laboratory’s participation in proficiency testing which may
only be considered as giving information about the technical competence of the testing laboratory at
a single point of time under the specific conditions of the test for tests involved in a particular
proficiency testing program.
1. Scope
1.1 While there are a number of uses for interlaboratory
tests, and variations in their design and implementation, it is
This guide is under the jurisdiction ofASTM Committee E36 onAccreditation
still possible to specify the essential principles that need to be
& Certification and is the direct responsibility of Subcommittee E36.60 on
Accreditation Bodies. considered when organizing such tests. Part A of this guide
Current edition approved June 10, 2003. Published June 2003. Originally
definesthoseprinciplesanddescribesthefactorsthatshouldbe
approved in 1989. Last previous edition approved in 1995 as E1301 – 05. DOI:
10.1520/E1301-95R03.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1301 – 95 (2003)
taken into account in the organization and conduct of profi- with Reference Materials
ciency testing programs.
1.2 This guide also covers how laboratory accrediting bod-
3. Terminology
ies, which assess technical competence of testing laboratories,
3.1 Definitions—For formal definitions related to laboratory
should select and use proficiency testing programs (refer to
accreditation, Terminology E1187 applies. For formal defini-
Part B).
tions related to quality and statistics, Terminology E456
1.3 PartAoftheguideisintendedforusebyvariousparties,
applies. In addition, the following terms and their definitions
such as accrediting bodies, regulatory authorities and clients of
are provided for ease of reference.
laboratory services which have a need to assess the technical
3.1.1 accuracy—the closeness of agreement between a test
competence of laboratories. It is also useful for laboratories in
result and an accepted reference value (Terminology E456
self-evaluation, but recognizes that proficiency testing is only
without the note).
one mechanism that can contribute to establishing equivalent
3.1.2 bias—the difference between the population mean of
confidence among users of different testing laboratories.
the test results and an accepted reference value (Terminology
1.4 It is currently a condition of some accreditation bodies
E456 without the discussion).
that laboratories participate regularly in “approved” profi-
3.1.3 certified reference material (CRM)—a reference ma-
ciency testing programs. Therefore, it is essential that program
terial, accompanied by a certificate, one or more of whose
operators comply with principles for conduct of professionally
property values are certified by a procedure that establishes
managed proficiency programs, both in terms of technical
traceability to an accurate realization of the unit in which the
requirements and quality management (see Annex A1 and
property values are expressed, and for which each certified
Annex A2).
value is accompanied by an uncertainty at a stated level of
1.5 The methods of operation within different proficiency
confidence (ISO Guide 30 without the notes).
testing organizations are not expected to be identical and this
3.1.4 precision—the closeness of agreement between test
guide does not give specific operational details for interlabo-
results obtained under prescribed conditions (Terminology
ratory test comparisons. It does, however, cover both measure-
E456 without the three notes).
ment comparison and testing programs in which large numbers
3.1.5 proficiency testing (laboratory)—determination of
of laboratories (over 20) or small groups of laboratories (1 to
laboratory testing performance by means of interlaboratory
20) are tested. Therefore, the contents of this guide are
comparisons (ISO/IEC Guide 2).
intended only as a framework to be modified appropriately for
3.1.6 reference material—a material or substance, one or
particular situations.
more of whose property values are sufficiently homogeneous
1.6 A list of some relevant references is given in Appendix
and well established to be used for the calibration of an
X1.
apparatus, the assessment of a measurement method, or for
assigning values to materials (ISO Guide 30 without the note).
2. Referenced Documents
3.1.7 repeatability—the closeness of agreement between
2.1 ASTM Standards:
test results obtained under repeatability conditions (that is,
E178 Practice for Dealing With Outlying Observations
conditions under which test results are obtained with the same
E456 Terminology Relating to Quality and Statistics
test method in the same laboratory by the same operator with
E548 Guide for General Criteria Used for Evaluating Labo-
the same equipment in the shortest practical period of time
ratory Competence
usingtestunitsortestspecimenstakenatrandomfromasingle
E691 Practice for Conducting an Interlaboratory Study to
quantity of material that is as nearly homogeneous as possible
Determine the Precision of a Test Method
(Terminology E456 without the notes).
E1187 Terminology Relating to Conformity Assessment
3.1.8 reproducibility—the closeness of agreement between
2.2 ANSI Standard:
test results obtained under reproducibility conditions (that is,
ANSI/ISO/ASQC Q9000 Series: Quality Management and
conditions under which test results are obtained with the same
Quality Assurance Standards
test method on identical material in different laboratories
2.3 ISO Standards:
(Terminology E456 without the notes).
ISO/IEC Guide 2, General Terms and Their Definitions
3.1.9 test—technical operation that consists of determina-
Concerning Standardization and Related Activities
tion of one or more characteristics of a given product, process
ISO/IEC Guide 25, General Requirements for the Compe-
or service according to a specified procedure (ISO/IEC Guide
tence of Calibration and Testing Laboratories
2).
ISO Guide 30, Terms and Definitions Used in Connection
3.1.10 trueness—the closeness of agreement between the
population mean of the measurements or test results and an
acceptedreferencevalue(TerminologyE456withoutthenote).
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3.2 Definitions of Terms Specific to This Standard:
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3.2.1 accepted reference value—a value that serves as an
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
agreed-upon reference for comparison and which is derived as:
Withdrawn. The last approved version of this historical standard is referenced
(1) a theoretical or established value, based on scientific
on www.astm.org.
principles, (2) an assigned value, based on experimental work
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. of some national or international organization, and (3)a
E1301 – 95 (2003)
consensus value, based on collaborative experimental work also use proficiency testing programs or other forms of
under the auspices of a scientific or engineering group. interlaboratory tests operated by other bodies. The purpose of
3.2.2 Discussion—When the accepted reference value is the Part B of this guide is to provide harmonized principles for
theoreticalvalue,itissometimesreferredtoasthe“true”value. selection of suitable interlaboratory test programs for use as
(This is a small variation from the definition in Terminology proficiency testing programs by laboratory accreditation bod-
E456.) ies.
3.2.3 assigned value—estimate of the true value used in the
4.6 Part B of this guide is intended:
assessment of proficiency (also referred to as assigned refer-
4.6.1 To establish principles for the selection of proficiency
ence value).
testing programs for use in laboratory accreditation programs;
3.2.4 coordinator—person or body that coordinates all the
and
activities associated with a proficiency program.
4.6.2 To assist in harmonizing the use of results of profi-
3.2.5 internal quality control (IQC)—the set of procedures
ciency testing programs by laboratory accreditation bodies.
undertaken by a laboratory for continuous monitoring of
4.7 As results from proficiency testing programs may be
operationsandresultsinordertodecidewhethertheresultsare
used in accreditation decisions, it is important that both the
reliable enough to be released; IQC primarily monitors the
accrediting bodies and participating laboratories have confi-
batch-to-batch accuracy of results on quality control materials,
dence in the design and operation of the programs.
and precision on independent replicate analyses of test mate-
4.8 It is also important for participating laboratories and
rials.
laboratoryaccreditationassessorstohaveaclearunderstanding
3.2.6 outlier—an observation that appears to deviate mark-
of the accrediting bodies’ policies for participation in such
edlyfromtheotherobservationsofthesample(alsoreferredto
programs; the criteria they use for judging successful perfor-
as extreme result, outlying or doubtful observation, or aberrant
mance in proficiency testing programs; and their policies and
value) (see Practice E178).
procedures for following up any unsatisfactory results from a
3.2.7 quality assurance system—the sum total of a labora-
proficiency test.
tory’s activities aimed at achieving the required standard of
4.9 It should be recognized that laboratory accrediting
analysis.
bodies and their assessors may take into account the suitability
3.2.8 reference laboratory—laboratory that establishes the
of test data produced from other activities apart from profi-
accepted reference value or assigned value.
ciency testing programs. This includes results of laboratories’
3.2.9 test item—material(s) or artifact(s) presented to the
own internal quality control procedures with control samples,
participating laboratory for the purpose of proficiency testing.
comparison with split-sample data from other laboratories,
3.2.10 testing laboratory—laboratory that performs tests
performance of one-time audit tests with certified reference
(including calibration) (also referred to as “participating labo-
materials, and so on. The use of data from these sources by
ratory” or just “laboratory”).
laboratory accrediting bodies is not covered by this guide.
However, the principles set out in this guide, regarding
4. Significance and Use
follow-up of unsatisfactory performance, could also apply to
4.1 The previous edition of this guide (E1301 – 89) covered
these activities.
the development and operation of laboratory proficiency test-
ing programs with limited, if any, emphasis on the use of the
Part A: DEVELOPMENT AND OPERATION OF
outcomes of proficiency testing by accreditation bodies.
PROFICIENCY TESTING PROGRAMS
4.2 This revised version is now intended to provide guid-
ance in three areas:
5. Types of Proficiency Testing
4.2.1 The introduction to this guide distinguishes between
5.1 Proficiency testing techniques vary depending on the
use of interlaboratory tests for proficiency testing and for other
nature of the item or material under test, the test method in use
purposes.
and the number of testing laboratories participating. They
4.2.2 Part A of this guide provides guidance on the devel-
possess the common feature of comparison of test results
opment and operation of interlaboratory tests for use in
obtained by one testing laboratory with those obtained by one
proficiency testing programs.
or more other testing laboratories. In some programs, one of
4.2.3 PartBofthisguideprovidesguidanceontheselection
the participating laboratories may have a controlling, coordi-
and use of proficiency testing programs by laboratory accredi-
nating, or reference function. Paragraphs 5.2-5.4 describe the
tation bodies.
major types of proficienc
...
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