ASTM F2717-14(2019)
(Guide)Standard Guide for Development of an Independent Third-Party Verification of Reference Materials
Standard Guide for Development of an Independent Third-Party Verification of Reference Materials
SIGNIFICANCE AND USE
3.1 In this guide, the planning, conduct, and completion of the independent verification, and other related details are addressed.
3.2 The ITPV is intended to assist manufacturers, users, and regulating authorities in ensuring the accuracy of a reference material with a high level of confidence.
SCOPE
1.1 This guide covers the significance and use, planning, conduct and completion of an independent third-party verification of reference materials.
1.2 In this guide, independent third-party verification (ITPV) is defined as the evaluation of the conceptual and technical soundness a design or outcome being reviewed by one or more independent third party (ITPV) qualified by their education, training, and experience in the same discipline, or closely related field of science, to judge the worthiness of the design or assess the design’s likelihood of achieving the intended objectives and anticipated outcomes.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 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.
General Information
Relations
Standards Content (Sample)
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: F2717 −14 (Reapproved 2019)
Standard Guide for
Development of an Independent Third-Party Verification of
Reference Materials
This standard is issued under the fixed designation F2717; 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 3.2 The ITPVis intended to assist manufacturers, users, and
regulating authorities in ensuring the accuracy of a reference
1.1 This guide covers the significance and use, planning,
material with a high level of confidence.
conduct and completion of an independent third-party verifi-
cation of reference materials.
4. Standard Operating Procedures
1.2 In this guide, independent third-party verification
4.1 Overview—Planning an ITPV is a critical first step to
(ITPV) is defined as the evaluation of the conceptual and
ensure a successful verification of a reference material. The
technical soundness a design or outcome being reviewed by
independent third party needs to create and document a
one or more independent third party (ITPV) qualified by their
standard operating procedure appropriate for verifying the
education, training, and experience in the same discipline, or
accuracy of the reference material. This includes identification
closely related field of science, to judge the worthiness of the
of needed resources (budget and personnel), schedule for
design or assess the design’s likelihood of achieving the
completion, verification procedures, and verification of re-
intended objectives and anticipated outcomes.
corded results.
1.3 This standard does not purport to address all of the
4.2 Identification of Needed Resources:
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4.3 Scheduling—The stakeholder decides on the timing and
priate safety, health, and environmental practices and deter-
frequency of the ITPV. At least one ITPV event must occur,
mine the applicability of regulatory limitations prior to use.
beginning when the final draft work product becomes avail-
1.4 This international standard was developed in accor-
able. However, a review performed earlier in the work product
dance with internationally recognized principles on standard-
development stages is a superior approach for some work
ization established in the Decision on Principles for the
products. There may be substantial incremental benefit to
Development of International Standards, Guides and Recom-
conducting more than one peer review during the whole
mendations issued by the World Trade Organization Technical
process of work product development, particularly where it
Barriers to Trade (TBT) Committee.
involves complex tasks or it could produce controversial
findings.
2. Referenced Documents
4.4 Mechanism for Verification—An ITPV provides the
2.1 U.S. Department of Environmental Protection:
greatest credibility when it involves well qualified independent
EPA/100/B-06/002 EPA Peer Review Handbook
third parties.An ITPV requires at least one qualified person or
entity with the expertise to adequately verify a reference
3. Significance and Use
material. In some instances it may require more than one
personorentitytoconductanITPV.Arrangementsforthemost
3.1 In this guide, the planning, conduct, and completion of
appropriate and feasible number of persons or entities forming
the independent verification, and other related details are
an ITPV will involve good judgment and a willingness to
addressed.
consider substance, time, and resource tradeoffs.
4.5 Selection of an Independent Third Party:
This guide is under the jurisdiction of ASTM Committee F10 on Livestock,
4.5.1 Selection of an independent third party is crucial to an
Meat, and Poultry Evaluation Systems and is the direct responsibility of Subcom-
effective verification of the accuracy of a reference material. It
mittee F10.20 on Device Performance Criteria.
is important that the independent third party be selected for
Current edition approved July 1, 2019. Published July 2019. Originally approved
in 2008. Last previous edition approved in 2014 as F2717 – 14. DOI: 10.1520/
independence and technical expertise. Therefore, the manufac-
F2717-14R19.
turer or user will select a person or entity that does not have
Available from United States Environmental Protection Agency (EPA), Ariel
any real or perceived bias or conflict of interest and that is
Rios Bldg., 1200 Pennsylvania Ave., NW, Washington, DC 20460, http://
www.epa.gov. completely independent. Independent third parties should be
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2717 − 14 (2019)
able to demonstrate by documented education and experience, verification, the care given to the statement of issues or
that they are competent to perform the requested
...
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