ASTM_F_2717_-_14.pdf

Designation:F271714Standard Guide forDevelopment of an Independent Third-Party Verification ofReference Materials1This standard is issued under the fixed designation F2717;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide covers the significance and use,planning,conduct and completion of an independent third-party verifi-cation of reference materials.1.2 In this guide,independent third-party verification(ITPV)is defined as the evaluation of the conceptual andtechnical soundness a design or outcome being reviewed byone or more independent third party(ITPV)qualified by theireducation,training,and experience in the same discipline,orclosely related field of science,to judge the worthiness of thedesign or assess the designs likelihood of achieving theintended objectives and anticipated outcomes.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 U.S.Department of Environmental Protection:2EPA/100/B-06/002 EPA Peer Review Handbook3.Significance and Use3.1 In this guide,the planning,conduct,and completion ofthe independent verification,and other related details areaddressed.3.2 The ITPV is intended to assist manufacturers,users,andregulating authorities in ensuring the accuracy of a referencematerial with a high level of confidence.4.Standard Operating Procedures4.1 OverviewPlanning an ITPV is a critical first step toensure a successful verification of a reference material.Theindependent third party needs to create and document astandard operating procedure appropriate for verifying theaccuracy of the reference material.This includes identificationof needed resources(budget and personnel),schedule forcompletion,verification procedures,and verification of re-corded results.4.2 Identification of Needed Resources:4.3 SchedulingThe stakeholder decides on the timing andfrequency of the ITPV.At least one ITPV event must occur,beginning when the final draft work product becomes avail-able.However,a review performed earlier in the work productdevelopment stages is a superior approach for some workproducts.There may be substantial incremental benefit toconducting more than one peer review during the wholeprocess of work product development,particularly where itinvolves complex tasks or it could produce controversialfindings.4.4 Mechanism for VerificationAn ITPV provides thegreatest credibility when it involves well qualified independentthird parties.An ITPV requires at least one qualified person orentity with the expertise to adequately verify a referencematerial.In some instances it may require more than oneperson or entity to conduct an ITPV.Arrangements for the mostappropriate and feasible number of persons or entities formingan ITPV will involve good judgment and a willingness toconsider 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 aneffective verification of the accuracy of a reference material.Itis important that the independent third party be selected forindependence and technical expertise.Therefore,the manufac-turer or user will select a person or entity that does not haveany real or perceived bias or conflict of interest and that iscompletely independent.Independent third parties should beable to demonstrate by documented education and experience,that they are competent to perform the requested verification.NOTE1It is recommended that the independent third party isaccredited from a number of organizations such as National Institute ofStandards and Technology.Providing reasonable compensation to areviewer or reviewing organization does not affect the independence of thereviewer.1This guide is under the jurisdiction of ASTM Committee F10 on Livestock,Meat,and Poultry Evaluation Systems and is the direct responsibility of Subcom-mittee F10.20 on Device Performance Criteria.Current edition approved May 1,2014.Published June 2014.Originallyapproved in 2008.Last previous edition approved in 2008 as F2717 08.DOI:10.1520/F2717-14.2Available from United States Environmental Protection Agency(EPA),ArielRios 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 States1 4.5.2 The manufacturer or user of the electronic evaluationdevice must execute an appropriate agreement with the inde-pendent third party.The agreement statement of work shouldidentify responsible individuals,the work to be performed,re