ASTM F2717-2008 Standard Guide for Development of an Independent Third-Party Verification《发展第三方独立认证的标准指南》.pdf

1、Designation: F 2717 08Standard Guide forDevelopment of an Independent Third-Party Verification1This standard is issued under the fixed designation F 2717; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A

2、 number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 referenced in

3、 Test Method F 2343.1.2 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 di

4、scipline, 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 theresponsi

5、bility 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 ASTM Standards:2F 2343 Test Method for Livestock, Meat, and PoultryEvaluation Devices2.2 U.S. Department of Env

6、ironmental Protection:3EPA/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

7、 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

8、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 stakehold

9、er 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 incre

10、mental 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 inde

11、pendentthird 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

12、 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 tha

13、t 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 de

14、monstrate by documented education and experience,that they are competent to perform the requested verification.NOTE 1It is recommended that the independent third party is accred-ited from a number of organizations such as National Institute of1This guide is under the jurisdiction of ASTM Committee F

15、10 on Livestock,Meat, and Poultry Evaluation Systems and is the direct responsibility of Subcom-mittee F10.20 on Device Performance Criteria.Current edition approved April 1, 2008. Published May 2008.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Servic

16、e at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from United States Environmental Protection Agency (EPA), ArielRios Bldg., 1200 Pennsylvania Ave., NW, Washington, DC 20460, http:/www.epa.gov.1Copyri

17、ght ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Standards and Technology. Providing reasonable compensation to areviewer or reviewing organization does not affect the independence of thereviewer.4.5.2 The manufacturer or user of the electro

18、nic 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,records retention, confidentiality, dispute resolution, and otherrelated topics.4.6 Review Record:4.6.1 It is

19、 the formal record (file) of the proceedings anddecisions of the verification, the type of verification performed,and an explanation of how the results were addressed. TheITPV creates a separate, clearly marked verification record file,and once the verification is completed the manufacturer or userr

20、etains the file and stores it in a secure location.4.6.2 The ITPV record should include all materials consid-ered by the independent third parties, as well as their writtencomments and other input. Such materials include at a mini-mum:4.6.2.1 Reference material submitted for verification;4.6.2.2 Mat

21、erials and information (including the charge)given to the independent third party;4.6.2.3 Written comments, information, and materials re-ceived from the independent third party;4.6.2.4 Information about the independent third party (suchas independent third parties names, affiliations, resume ofeduc

22、ation and experience, statement of potential conflicts andtheir resolutions);4.6.2.5 Logistical information about conduct of the verifi-cation (such as times and locations of meetings);4.6.2.6 A written record, approved by the lead reviewer,specifying acceptance or where appropriate, non-acceptance;

23、and4.6.2.7 The final work product.5. Conducting an ITPV5.1 OverviewThe success and usefulness of any ITPVdepends on the quality of the reference material submitted forverification, the care given to the statement of issues or“charge,” and the scientific/technical expertise of the indepen-dent third

24、party.5.2 ITPV StandardThe manufacturer or user must informthe independent third party the specific tolerances for precisionand bias as set forth in Test Method F 2343. And to supply themanufacturers manual to the independent third party. Theessential elements of a standard operating procedure are a

25、sfollows:5.2.1 Brief overview or introduction (describe the referencematerial, how it was developed, and how it will be used or iscurrently being used);5.2.2 A description or listing of materials supplied to theindependent third party; and5.2.3 The issues to be addressed by the independent thirdpart

26、y, as follows:5.2.3.1 The due date of independent third party comments,5.2.3.2 The format of independent third party responses,and5.2.3.3 The manufacturers or users point of contact in casethe independent third parties have questions.6. Completing an ITPV6.1 OverviewThe ITPV process closes with thre

27、e majoractivities: evaluation of the end results, utilizing independentthird party comments for a recommendation, and submission ofan organized and comprehensive record.6.2 Final Work ProductThe independent third party mustappraise the manufacturer, user, and any regulatory agency ofthe results of t

28、he ITPV. Including but not limited to commentsand recommendations and how to address these comments andrecommendations.6.3 Completing the ITPV RecordOnce the ITPV is com-pleted and the final work product is approved by the ITPR, thereview record is brought up to date and then indexed andmaintained i

29、n a repository selected by the user or manufacturer.The location of the ITPR record needs to be readily identifiableand accessible so interested parties, with access rights, canlocate and review the file.7. Keywords7.1 evaluation systems; independent third-party verification;ITPV; livestock; meatAST

30、M International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are en

31、tirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsa

32、nd should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee

33、on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 2717 082