ASTM D8428-21

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: D8428 − 21
Standard Guide for
Establishing Analyst Competence to Perform a Test Method
This standard is issued under the fixed designation D8428; 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.
1. Scope 2. Referenced Documents
2.1 ASTM Standards:
1.1 This guide covers general guidance on assessing the
D6299 Practice for Applying Statistical Quality Assurance
competence of an analyst to perform a specific test method for
and Control Charting Techniques to Evaluate Analytical
a specific product or set of products (for example, light
Measurement System Performance
distillates). It also provides guidance on some of the possible
D6792 Practice for Quality Management Systems in Petro-
approaches that may be taken to perform the assessment.
leum Products, Liquid Fuels, and Lubricants Testing
1.2 This guide is intended for the establishment of compe-
Laboratories
tence for the entire performance of a test method (that is,
D7372 Guide for Analysis and Interpretation of Proficiency
sample preparation, instrument set up, preparation of standards
Test Program Results
and reagents, performance of the test method, calculations,
E456 Terminology Relating to Quality and Statistics
etc.) or the establishment of competence may be limited to a
2.2 ISO Standards:
specific aspect in the performance of a test method (for
ISO Guide 30 Reference materials - Selected terms and
example, sample preparation).
definitions
ISO/IEC 17025 General Requirements for the Competence
1.3 Theestablishmentofanalystcompetenceshouldonlybe
of Testing and Calibration Laboratories
performed if the laboratory itself is capable of performing the
ISO 17034 General Requirements for the Competence of
test in strict conformance with the test method (that is, has the
Reference Material Producers
equipment, standards and reagents, materials, etc. which meet
ANSI/ISO/ASQ Q9000 Quality Management System Stan-
test method requirements).
dards
1.4 This guide does not cover training of an analyst, other
2.3 Other Standards:
than a review of training records to indicate the analyst has
AASHTO R-18 Standard Recommended Practice for Estab-
been trained. lishing and Implementing a Quality Management System
for Construction Materials Testing Laboratories
1.5 This guide does not cover the establishment of general
technical competence of an analyst.
3. Terminology
1.6 This standard does not purport to address all of the
3.1 Definitions:
safety concerns, if any, associated with its use. It is the
3.1.1 accepted reference value, ARV, n—a value that serves
responsibility of the user of this standard to establish appro-
as an agreed upon reference for comparison, and which is
priate safety, health, and environmental practices and deter-
derived as: (1) a theoretical or established value, based on
mine the applicability of regulatory limitations prior to use.
scientific principles, (2) an assigned value, based on experi-
mental work of some national or international organization
1.7 This international standard was developed in accor-
such as the U.S. National Institute of Standards and Technol-
dance with internationally recognized principles on standard-
ogy (NIST), or (3) a consensus value, based on collaborative
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Barriers to Trade (TBT) Committee.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
Available from International Organization for Standardization (ISO), ISO
This guide is under the jurisdiction of ASTM Committee D02 on Petroleum Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Products, Liquid Fuels, and Lubricants and is the direct responsibility of Subcom- Switzerland, https://www.iso.org.
mittee D02.94 on Coordinating Subcommittee on Quality Assurance and Statistics. Available from American Association of State Highway and Transportation
Current edition approved Dec. 1, 2021. Published January 2022. DOI: 10.1520/ Officials (AASHTO), 444 N. Capitol St., NW, Suite 249, Washington, DC 20001,
D8428-21. http://www.transportation.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
D8428 − 21
experimental work under the auspices of a scientific or 4. Significance and Use
engineering group. E456
4.1 Analyst Competence is one of the largest influencing
3.1.2 calibration standard, n—a material with a certified
factors in whether a test method performed in a laboratory
value for a relevant property, issued by or traceable to a
yields accurate and precise test results and thus is an important
national organization such as NIST or whose production was
aspect in managing a laboratory.
ISO 17034 accredited, and whose properties are known with
4.2 Some Regulations, International Management System
sufficient accuracy to permit its use to evaluate the same
Standards, such as ISO 9001, ISO 17025,AASHTO R-18, etc.,
property of another sample.
and Quality Management Systems may require the establish-
3.1.3 certified reference material, CRM, n—a reference
ment of analyst competence. This guide aims to provide
material one or more of whose property values are certified by
general guidance in some of the possible approaches that may
a technically valid procedure, accompanied by a traceable
be taken to fulfill such requirements.
certificate or other documentation which is issued by a certi-
fying body. D6792 5. General Recommendations
3.1.4 proficiency testing, n—determination of a laboratory’s
5.1 It is recommended that the process for establishment of
testingcapabilitybyevaluatingitstestresultsininterlaboratory
analyst competence be documented within the organization’s
exchange testing or crosscheck programs. D6792
Quality Management System. Documentation may include, but
is not limited to, coverage of the following areas listed in Table
3.1.5 proficiency test program (PTP), n—statistical quality
1.
assurance activities that enable laboratories to assess their
performance in conducting test methods within their own
5.2 The assessment process should consider factors beyond
laboratory when their data are compared against other labora-
the actual performance of a test method such as knowledge of
toriesthatparticipateinthesameprogramcycleusingthesame
the significance and use of the test, knowledge of equipment
test method. D7372
operation and basic troubleshooting.
3.1.6 quality control sample (QC sample), n—for use in
5.3 Records should be clear as to what the analyst is being
quality assurance program to determine and monitor the
deemed competent to perform. If the establishment of compe-
precision and stability of a measurement system; a stable and
tence is limited to only a particular aspect of the performance
homogenous material having physical or chemical properties,
ofatestmethodsuchassamplepreparation,itisrecommended
or both, similar to those of typical samples tested by the
analytical measurement system; the material is properly stored
to ensure sample integrity and is available in sufficient quantity TABLE 1 Documentation Elements
for repeated long-term testing. D6299
Element Description
Approaches for the Establishment of Explanation of the approaches taken
3.1.7 reference material (RM), n—a material with accepted
Competence for the establishment of competence,
reference value(s), accompanied by an uncertainty at a stated
which may vary dependent on several
factors including whether the test is
level of confidence for desired properties, which may be used
regulated, accredited or has a high
for calibration or quality control purposes in the laboratory.
level of commercial importance.
D6792 Assessor Qualifications In cases where the establishment of
competence involves an assessor, the
3.1.7.1 Discussion—Sometimes these may be prepared “in-
qualifications of the assessor should
house” provided the reference values are established using
be defined, even if the qualifications
accepted standard procedures. are general (e.g., a specific level of
education, certain number of years of
3.1.8 site expected value (SEV), n—for a QC sample this is
relevant experience, etc.).
an estimate of the theoretical limiting value towards which the Timing and Frequency The timing and frequency for
establishing competence, including
average of results collected from a single in-statistical-control
re-establishment of competence
measurement system under site precision conditions tends as
should be defined (e.g., at what point
should the competence be
the number of results approaches infinity. D6299
established and for how long is it
3.1.9 site precision conditions, n—conditions under which
valid).
Handling of Deficiencies Actions to be taken to correct analyst
test results are obtained by one or more operators in a single
and laboratory deficiencies which are
site location practicing the same test method on a single
detected during the establishment of
measurement system which may comprise multiple competence and next steps once the
deficiencies have been corrected.
instruments, using test specimens taken at random from the
Declaration of Competence and In cases where a laboratory wishes to
same sample of material over an extended period of time
Levels of Competence declare or establish various levels of
spanning at least a 15-day interval. D6299 competence, these should be defined.
An example is provided in Appendix
3.2 Definitions of Terms Specific to This Standard:
X1.
Record Keeping How records generated through the
3.2.1 analyst competence, n—verified demonstration of ap-
process of establishing competence
propriate knowledge and skills to perform a test according to
are managed including retention. An
test method requirements without direct oversight.
example of a record to document the
establishment of competence is
3.3 Acronyms:
provided in Appendix X2.
3.3.1 NIST—NationalInstituteofStandardsandTechnology
D8428 − 21
that this be evident in any records of competence. If the analyst 6.1.5 To assure the integrity of the written examination,
is competent to perform a test method, then the test method randomized selection of questions from a question “bank”
designation and version should be recorded not just the should also be considered.
technique, that is, D2622 – 16 instead of Sulfur by WDXRF.
6.2 Analyst Interview:
Also, if a test method is comprised of more than one procedure
6.2.1 Questions and answers asked of the analyst should be
or has multiple options, then records should be clear as to
documented.
which of these procedures or options was assessed.
6.2.2 The assessor should be technically competent to
5.4 Assessment of competence should include a review to
perform such an assessment and there should be a record to
establish that an analyst has received training. In cases where
support the assessor’s competence.
training records are not accessible, this review may not be
6.2.3 Cautions should be taken so that the assessor does not
possible.
“lead” the analyst to the desired answers.
5.5 A lack of documented evidence in support of an ana-
6.3 Analysis of Reference Material:
lyst’s competency to perform a test method should initiate the
6.3.1 This approach involves having an analyst perform
establishment of competence.
testing on a material with anARV or SEV. There may be cases
where the ARV or SEV is not yet known at the time of the
5.6 In cases where a test method has been revised, an
assessment (for example, Exchange Sample) and thus may be
evaluation should be performed to determine if re-assessment
obtained later so that the assessment may be concluded.
for analyst competence is necessary. In cases where revisions
6.3.1.1 Exchange samples circulated as part of an interlabo-
to test methods are not technical in nature and do not impact
ratory exchange program, or round robin, may be used as
the outcome of the result, then a re-assessment of analyst
reference mat
...