ASTM F2717-14
(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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F2717 −14
Standard Guide for
Development of an Independent Third-Party Verification of
1
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 independent third party needs to create and document a
standard operating procedure appropriate for verifying the
1.1 This guide covers the significance and use, planning,
accuracy of the reference material. This includes identification
conduct and completion of an independent third-party verifi-
of needed resources (budget and personnel), schedule for
cation of reference materials.
completion, verification procedures, and verification of re-
1.2 In this guide, independent third-party verification
corded results.
(ITPV) is defined as the evaluation of the conceptual and
4.2 Identification of Needed Resources:
technical soundness a design or outcome being reviewed by
one or more independent third party (ITPV) qualified by their
4.3 Scheduling—The stakeholder decides on the timing and
education, training, and experience in the same discipline, or
frequency of the ITPV. At least one ITPV event must occur,
closely related field of science, to judge the worthiness of the
beginning when the final draft work product becomes avail-
design or assess the design’s likelihood of achieving the
able. However, a review performed earlier in the work product
intended objectives and anticipated outcomes.
development stages is a superior approach for some work
1.3 This standard does not purport to address all of the products. There may be substantial incremental benefit to
safety concerns, if any, associated with its use. It is the conducting more than one peer review during the whole
responsibility of the user of this standard to establish appro- process of work product development, particularly where it
priate safety and health practices and determine the applica- involves complex tasks or it could produce controversial
bility of regulatory limitations prior to use. findings.
4.4 Mechanism for Verification—An ITPV provides the
2. Referenced Documents
greatest credibility when it involves well qualified independent
2
2.1 U.S. Department of Environmental Protection:
third parties.An ITPV requires at least one qualified person or
EPA/100/B-06/002 EPA Peer Review Handbook
entity with the expertise to adequately verify a reference
material. In some instances it may require more than one
3. Significance and Use
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.
3.2 The ITPVis intended to assist manufacturers, users, and
4.5 Selection of an Independent Third Party:
regulating authorities in ensuring the accuracy of a reference
4.5.1 Selection of an independent third party is crucial to an
material with a high level of confidence.
effective verification of the accuracy of a reference material. It
4. Standard Operating Procedures is important that the independent third party be selected for
independence and technical expertise. Therefore, the manufac-
4.1 Overview—Planning an ITPV is a critical first step to
turer or user will select a person or entity that does not have
ensure a successful verification of a reference material. The
any real or perceived bias or conflict of interest and that is
completely independent. Independent third parties should be
1
This guide is under the jurisdiction of ASTM Committee F10 on Livestock,
able to demonstrate by documented education and experience,
Meat, and Poultry Evaluation Systems and is the direct responsibility of Subcom-
that they are competent to perform the requested verification.
mittee F10.20 on Device Performance Criteria.
Current edition approved May 1, 2014. Published June 2014. Originally
NOTE 1—It is recommended that the independent third party is
approved in 2008. Last previous edition approved in 2008 as F2717 – 08. DOI:
accredited from a number of organizations such as National Institute of
10.1520/F2717-14.
2
Standards and Technology. Providing reasonable compensation to a
Available from United States Environmental Protection Agency (EPA), Ariel
Rios Bldg., 1200 Pennsylvania Ave., NW, Washington, DC 20460, http:// reviewerorreviewingorganizationdoesnotaffecttheindependenceofthe
www.epa.gov. reviewer.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C7
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2717 − 08 F2717 − 14
Standard Guide for
Development of an Independent Third-Party Verification of
1
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
1.1 This guide covers the significance and use, planning, conduct and completion of an independent third-party verification
referenced in Test Method of reference materials.F2343.
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F2343 Test Method for Livestock, Meat, and Poultry Evaluation Devices
2
2.1 U.S. Department of Environmental Protection:
EPA/100/B-06/002 EPA Peer Review Handbook
3. 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.
4. Standard Operating Procedures
4.1 Overview—Planning an ITPV is a critical first step to ensure a successful verification of a reference material. The
independent third party needs to create and document a standard operating procedure appropriate for verifying the accuracy of the
reference material. This includes identification of needed resources (budget and personnel), schedule for completion, verification
procedures, and verification of recorded results.
4.2 Identification of Needed Resources:
4.3 Scheduling—The stakeholder decides on the timing and frequency of the ITPV. At least one ITPV event must occur,
beginning when the final draft work product becomes available. However, a review performed earlier in the work product
development stages is a superior approach for some work products. There may be substantial incremental benefit to conducting
more than one peer review during the whole process of work product development, particularly where it involves complex tasks
or it could produce controversial findings.
4.4 Mechanism for Verification—An ITPV provides the greatest credibility when it involves well qualified independent third
parties. An ITPV requires at least one qualified person or entity with the expertise to adequately verify a reference material. In some
1
This guide is under the jurisdiction of ASTM Committee F10 on Livestock, Meat, and Poultry Evaluation Systems and is the direct responsibility of Subcommittee F10.20
on Device Performance Criteria.
Current edition approved April 1, 2008May 1, 2014. Published May 2008June 2014. Originally approved in 2008. Last previous edition approved in 2008 as F2717 – 08.
DOI: 10.1520/F2717-08.10.1520/F2717-14.
2
Available from United States Environmental Protection Agency (EPA), Ariel Rios Bldg., 1200 Pennsylvania Ave., NW, Washington, DC 20460, http://www.epa.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2717 − 14
instances it may require more than one person or entity to conduct an ITPV. Arrangements for the most appropriate and feasible
number of persons or entities forming an ITPV will involve good judgment and a willingness to consider substance, time, and
resource tradeoffs.
4.5 Selection of an Independent Third Party:
4.5.1 Selection of an independent third party is crucial to an effective verification of the accuracy of a reference material. It is
important that the independent third party be selected for independence and technical expertise. Therefore, the manufacturer o
...
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