1、ANSI/ANS-41.5-2012verification and validation of radiologicaldata for use in waste managementand environmental remediationANSI/ANS-41.5-2012ANSI/ANS-41.5-2012American National StandardVerification and Validation of Radiological Data forUse in Waste Management and Environmental RemediationSecretariat
2、American Nuclear SocietyPrepared by theAmerican Nuclear SocietyStandards CommitteeWorking Group ANS-41.5Published by theAmerican Nuclear Society555 North Kensington AvenueLa Grange Park, Illinois 60526 USAApproved February 15, 2012by theAmerican National Standards Institute, Inc.AmericanNationalStan
3、dardDesignation of this document as an American National Standard attests thatthe principles of openness and due process have been followed in the approvalprocedure and that a consensus of those directly and materially affected bythe standard has been achieved.This standard was developed under the p
4、rocedures of the Standards Commit-tee of the American Nuclear Society; these procedures are accredited by theAmerican National Standards Institute, Inc., as meeting the criteria forAmer-ican National Standards. The consensus committee that approved the stan-dard was balanced to ensure that competent
5、, concerned, and varied interestshave had an opportunity to participate.An American National Standard is intended to aid industry, consumers, gov-ernmental agencies, and general interest groups. Its use is entirely voluntary.The existence of an American National Standard, in and of itself, does notp
6、reclude anyone from manufacturing, marketing, purchasing, or using prod-ucts, processes, or procedures not conforming to the standard.By publication of this standard, the American Nuclear Society does not insureanyone utilizing the standard against liability allegedly arising from or afterits use. T
7、he content of this standard reflects acceptable practice at the time ofits approval and publication. Changes, if any, occurring through developmentsin the state of the art, may be considered at the time that the standard issubjected to periodic review. It may be reaffirmed, revised, or withdrawn ata
8、ny time in accordance with established procedures. Users of this standardare cautioned to determine the validity of copies in their possession and toestablish that they are of the latest issue.The American Nuclear Society accepts no responsibility for interpretations ofthis standard made by any indi
9、vidual or by any ad hoc group of individuals.Responses to inquiries about requirements, recommendations, and0or permis-sive statements i.e., “shall,” “should,” and “may,” respectively! should be sentto the Standards Department at Society Headquarters. Action will be taken toprovide appropriate respo
10、nse in accordance with established procedures thatensure consensus.Comments on this standard are encouraged and should be sent to SocietyHeadquarters.Published byAmerican Nuclear Society555 North Kensington AvenueLa Grange Park, Illinois 60526 USACopyright 2012 by American Nuclear Society. All right
11、s reserved.Any part of this standard may be quoted. Credit lines should read “Extracted fromAmerican National Standard ANSI0ANS-41.5-2012 with permission of the publisher,the American Nuclear Society.” Reproduction prohibited under copyright conventionunless written permission is granted by the Amer
12、ican Nuclear Society.Printed in the United States of AmericaInquiryRequestsThe American Nuclear Society ANS! Standards Committee will provide re-sponses to inquiries about requirements, recommendations, and0or permissivestatementsi.e., “shall,” “should,” and “may,” respectively!in American NationalS
13、tandards that are developed and approved by ANS. Responses to inquiries willbe provided according to the Policy Manual for the ANS Standards Committee.Nonrelevant inquiries or those concerning unrelated subjects will be returnedwith appropriate explanation. ANS does not develop case interpretations
14、ofrequirements in a standard that are applicable to a specific design, operation,facility, or other unique situation only, and therefore is not intended for genericapplication.Responses to inquiries on standards are published in ANSs magazine, NuclearNews, and are available publicly on the ANS Web s
15、ite or by contacting the ANSStandards Administrator.InquiryFormatInquiry requests must include the following:1! the name, company name if applicable, mailing address, and telephonenumber of the inquirer;2! reference to the applicable standard edition, section, paragraph, figure,and0or table;3! the p
16、urposes of the inquiry;4! the inquiry stated in a clear concise manner;5! a proposed reply, if the inquirer is in a position to offer one.Inquiries should be addressed toAmerican Nuclear SocietyATTN: Standards Administrator555 N. Kensington AvenueLa Grange Park, IL 60526or standardsans.orgForewordTh
17、is Foreword is not part of American National Standard “Verification and Validation ofRadiological Data for Use in Waste Management and Environmental Remediation,”ANSI0ANS-41.5-2012.!The American Nuclear Society ANS! Nuclear Facilities Standards CommitteeNFSC!is responsible for development of America
18、n National Standards InstituteANSI! standards for nuclear facilities, including criteria and operations re-quired for environmental remediation of nuclear facility sites that have becomecontaminated. The ANS Subcommittee on Decommissioning and Site Remedia-tion Standards manages the development and
19、maintenance of standards thataddress the cleanup of radioactive materials and radioactivity mixed with haz-ardous substances This subcommittee has authorized a working group to developa new ANSI0ANS standard, ANSI0ANS-41.5-2012, for verification and validationof data from radiological analysis suppo
20、rtive of waste management and environ-mental remediation. The verification process will be called compliance verifica-tion in this standard. Compliance verification may involve compliance to writtenanalytical specifications e.g., statement of work, contract, project plans! butmay also involve compli
21、ance to programmatic or project-specific requirements.Therefore, this standard does not assume or require that the laboratory work beperformed under contract.This standard provides requirements and recommended practices for determin-ing the validity of radioanalytical data for waste management and e
22、nvironmen-tal remediation. These applications will include site characterization, wasteacceptance, waste certification, waste treatment design, process control, litiga-tion, and other applications as deemed necessary. This standard will provide aminimum set of checks and tests that will ensure a con
23、sistent approach forcompliance verification and validation of data produced by any radioanalyticallaboratory. This standard should eliminate many of the inconsistencies in theapproaches, evaluation algorithms, parameters evaluated, and qualifiers used inexisting site-specific data compliance verific
24、ation and validation programs.The requirements of this standard apply only to independent compliance verifi-cation and validation processes and should not be construed to apply to anyactions taken by laboratories to internally generate or review data, includingaudits and performance evaluation studi
25、es. Other standards are available thatprovide quality and performance requirements for radioanalytical laboratoriese.g.,ANSI N42.23-1996R2003!, “Measurement andAssociated InstrumentationQualityAssurance for Radioassay Laboratories”#. However, this standard expectsthat certain laboratory quality cont
26、rolQC!and programmatic quality assuranceQA! measures have taken place that feed data for review by the data verifiersand validators. The interface of these QA0QC measures with the complianceverification and validation process will be discussed in Sec. 3 of this standard.Since this standard does not
27、place requirements on laboratories or on wastemanagement and environmental remediation programs, the points of interface inSec. 3 are necessarily listed as only recommendations, and all requirements arecontained in Secs. 4 through 7 of this standard.While this standard will provide a minimum set of
28、checks and tests for compli-ance verification and validation of data, the acceptance criteria for the test andchecks are intentionally not provided in most cases. This is because each wastemanagement or environmental remediation program or project may have uniquemeasurement quality objectives MQOs!
29、based on the intended use of the data.This standard has been developed with the assumption that a proper dataquality objectiveDQO!process has been used by the project to define the qualityof data needed for the decision process and to develop corresponding MQOs ofiaccuracy, precision, sensitivity, s
30、electivity, and representativeness to be met.Therefore, set limits for QC parameters and many other acceptance criteria willnot be recommended in the standard, but rather the user will be referred to thelimits established by the DQO process. This approach will allow data qualifica-tion to be based o
31、n how factors such as error, bias, lack of precision, lack ofsensitivity, or lack of selectivity affect the decision process. The DQO processshould also provide guidance for the frequency, percentage, and extent of datavalidation. This standard will incorporate an evaluation of data end use andactio
32、n levels throughout the qualification process. This approach will preventunnecessary rejection of data for minor quality problems.This standard contains four appendices, which are informative and containadditional description of the relationship of the programmatic and laboratoryQA0QC measures with
33、the compliance verification and validation processes. Thisforeword is not part of the standard.This standard might reference documents and other standards that have beensuperseded or withdrawn at the time the standard is applied. A statement hasbeen included in Sec. 8, “References,” that provides gu
34、idance on the use ofreferences.This standard does not incorporate the concepts of generating risk-informedinsights, performance-based requirements, or a graded approach to QA. The useris advised that one or more of these techniques could enhance the application ofthis standard.The working group woul
35、d like to gratefully acknowledge the contributions byJason C. Jang, who died prior to the completion of this standard.This standard was submitted for approval by the ANS-41.5 Working Group. TheANS-41.5 Working Group had the following members:S. R. Salaymeh Chair!, Savannah River National Laboratory
36、(Retired)T. L. Rucker Co-Chair!, Science Applications International CorporationA. E. Rosecrance, Oilfield Environmental ComplianceD. E. McCurdy, Independent Technical ConsultantJ. E. Chambers, Fluor-B itis not calculated from the sampling data.!analyte: The particular radionuclides! to bedetermined
37、in a sample of interest.As a matterof clarity when interpreting various clauses ofthis standard, a gamma-ray spectral analysisis considered one analysis category but mayinclude multiple target analytes.analytical protocol specification (APS): Theoutput of a project planning process that con-tains th
38、e projects analytical data needs andrequirements in an organized, concise form.audit: A planned and documented activity per-formed to determine by investigation, examina-tion, or evaluation of objective evidence theadequacy of and compliance with establishedprocedures, instructions, drawings, and ot
39、herapplicable documents and the effectiveness ofimplementation. An audit should not be con-fused with surveillance or inspection activitiesperformed for the sole purpose of process con-trol or product acceptance.Also see “desk audit.”background: Ambient signal response due tospurious electronic nois
40、e or incidental radia-tion in the vicinity of the detector system asrecorded by measuring instruments that is in-dependent of radioactivity contributed by theradionuclides being measured in the sample.batch:Agroup of samples prepared at the sametime, in the same location, using the samemethod, and b
41、y the same analyst.bias: A fixed deviation from the true valuethat remains constant over replicated measure-ments within the statistical precision of themeasurement. Synonyms are deterministic er-ror, fixed error, and systematic error.calibration: The set of operations or processesconducted under sp
42、ecified conditions that es-tablish the relationship between values indi-cated by a measuring instrument or systemand the corresponding known values. The term“calibration” refers to both the first calibrationafter the instrument is placed in use and toany recalibrations subsequently performed.certifi
43、ed reference material:Areference ma-terial, one or more of whose property valuesare certified by a technically valid procedure,accompanied by or traceable to a certificate orother documentation that is issued by a certi-fying body e.g., National Institute of Stan-dards and Technology NIST!, Internat
44、ionalAtomic Energy Agency#.combined standard uncertainty (CSU): Thestandard 1s! uncertainty of a calculated re-sult obtained by propagating the standard un-certainties of a number of input values of theAmerican National Standard ANSI0ANS-41.5-20122measurement process. The value is sometimesreferred
45、to as total propagated uncertaintyTPU!.compliance verification: Compliance verifi-cation is the process of determining whetherthe data are complete, correct, consistent, andin compliance with established standards orwritten analytical specifications e.g., state-ment of work SOW!, contract, project p
46、lans#.The process of compliance verification is inde-pendent of validation. The compliance verifica-tion is conducted at various levels both internaland external to the data generator. The outputof verification is a data set ready for datavalidation.concentration: The quantity of radioactive ma-teri
47、al stated in terms of activity or mass! perunit of volume or mass of a medium.critical level Lc): See “decision level.”data quality assessment (DQA): The lastphase of the data collection process, which con-sists of a scientific and statistical evaluation ofthe data set to assess its validity and usa
48、bility.The focus of DQA is the evaluation of the datarelative to their intended use.data quality objective (DQO): The qualita-tive and quantitative statements that specifythe type and quality of data required to sup-port decisions for any process requiring radio-chemical analysis radioassay!.decisio
49、n level (DL) (also Lc): The minimummeasured analyte quantity or concentration aposteriori result! required to give a stated con-fidence that a positive amount of the analyte ispresent. For this standard, the stated confi-dence level will be assumed to be 95%. Corre-spondingly, the probability of a Type I errorprobability of erroneously concluding a radio-nuclide is detected in a sample that is blank!isset at 0.05. However, other confidence levelsmay be established by the MQOs.desk audit: An off-site or remote review oflaboratory-submitted documents.dupli
