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
- Status
- Published
- Publication Date
- 30-Jun-2019
- Technical Committee
- F10 - Livestock, Meat, and Poultry Evaluation Systems
- Drafting Committee
- F10.20 - Device Performance Criteria
Relations
- Effective Date
- 01-Jul-2019
- Referred By
ASTM F2463-15(2021) - Standard Terminology for Livestock, Meat, and Poultry Evaluation Systems - Effective Date
- 01-Jul-2019
Overview
ASTM F2717-14(2019): Standard Guide for Development of an Independent Third-Party Verification of Reference Materials provides a comprehensive framework for planning, conducting, and completing independent third-party verifications (ITPV) of reference materials. Developed by ASTM International, this standard is designed to help manufacturers, users, and regulatory authorities ensure the accuracy and reliability of reference materials with a high level of confidence. The guide emphasizes impartiality and technical soundness by defining criteria for selecting qualified independent experts to conduct verifications.
Key Topics
Independent Third-Party Verification (ITPV):
- Involves evaluation by individuals or entities with relevant expertise, education, and experience in the specific or closely related scientific discipline.
- ITPVs assess the design and expected outcomes of reference materials to judge their suitability and effectiveness.
Planning the ITPV Process:
- Requires detailed documentation, including standard operating procedures tailored for verification.
- Involves identification of resources (such as budget, personnel), establishing a verification schedule, and defining verification procedures.
- Early-stage and iterative reviews may provide greater value, especially for complex or high-stakes materials.
Selection of Independent Experts:
- Independence and technical expertise are critical.
- The selected third party must have no actual or perceived conflict of interest.
- Accreditation from recognized organizations (for example, NIST) is recommended but not mandatory.
Conducting and Documenting Verification:
- All proceedings, decisions, written comments, and reference materials involved in the ITPV must be formally recorded.
- The verification record should include the scope of work, responsible individuals, and logistical details.
Completion and Reporting:
- Final results, including third-party comments and recommendations, must be communicated to all stakeholders.
- The comprehensive review record is indexed and securely maintained for future access.
Applications
- Reference Material Production:
- Used by manufacturers to verify the accuracy and traceability of reference materials in fields such as laboratory calibration, food safety, and device performance.
- Regulatory Compliance:
- Supports regulatory authorities in independently reviewing and approving reference materials to meet industry and legal requirements.
- Quality Assurance Programs:
- Assists laboratories and organizations in implementing robust quality management systems by providing a reliable process for independent verification.
- Stakeholder Assurance:
- Offers all stakeholders, including users and auditors, confidence in the technical soundness and impartial validation of reference materials.
Related Standards
- EPA Peer Review Handbook: Cited as a referenced document for guidance on peer review processes.
- ISO/IEC 17025: Relates to general requirements for the competence of testing and calibration laboratories, which may use reference materials.
- ASTM Standards for Livestock, Meat, and Poultry Evaluation Systems: Developed under the jurisdiction of ASTM Committee F10, relevant for reference materials in agricultural and food sectors.
- World Trade Organization Principles: Developed in accordance with WTO’s internationally recognized principles on standardization, supporting global acceptance and trade harmonization.
Keywords: independent third-party verification, ITPV, reference materials, ASTM F2717, laboratory standard, quality assurance, regulatory compliance, impartial evaluation, standard operating procedures, technical verification.
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Frequently Asked Questions
ASTM F2717-14(2019) is a guide published by ASTM International. Its full title is "Standard Guide for Development of an Independent Third-Party Verification of Reference Materials". This standard covers: 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.
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.
ASTM F2717-14(2019) is classified under the following ICS (International Classification for Standards) categories: 19.020 - Test conditions and procedures in general. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F2717-14(2019) has the following relationships with other standards: It is inter standard links to ASTM F2717-14, ASTM F2463-15(2021). Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F2717-14(2019) is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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