Regulatory Guide 4.15: Difference between revisions

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{{Adams
{{Adams
| number = ML13350A203
| number = ML071790506
| issue date = 12/31/1977
| issue date = 07/01/2007
| title = Quality Assurance for Radiological Monitoring Programs (Normal Operations)-Effluent Streams and the Environment
| title = Quality Assurance for Radiological Monitoring Programs (Inception Through Normal Operations to License Termination) - Effluent Streams and the Environment
| author name =  
| author name =  
| author affiliation = NRC/RES
| author affiliation = NRC/RES
Line 9: Line 9:
| docket =  
| docket =  
| license number =  
| license number =  
| contact person =  
| contact person = Ridgely JN RES 415-6555
| document report number = RG-4.015
| case reference number = DG-4010
| document report number = RG-4.015, Rev 2
| package number = ML071790495
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 10
| page count = 28
}}
}}
{{#Wiki_filter:U.S. NUCLEAR REGULATORY  
{{#Wiki_filter:1Special terms used in this guide are marked in SMALL CAPITALS the first time they are used, and are definedin the glossary provided in this regulatory guide.The U.S. Nuclear Regulatory Commission (NRC) issues regulatory guides to describe and make available to the public methodsthat the NRC staff considers acceptable for use in implementing specific parts of the agency's regulations, techniques that thestaff uses in evaluating specific problems or postulated accidents, and data that the staff need in reviewing applications forpermits and licenses.  Regulatory guides are not substitutes for regulations, and compliance with them is not required.  Method sand solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.This guide was issued after consideration of comments received from the public.
COMMISSION
 
December 1977 kREGULATORY
Regulatory guides are issued in 10 broad divisions:  1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and MaterialsFacilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products
GUIDE OFFICE OF STANDARDS
; 7, Transportation; 8, Occupational Hea lth;9, Antitrust and Financial Review; and 10, General.Electronic copies of this guide and other recently issued guides are available through the NRC's public Web site under theRegulatory Guides document collection of the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC's Agencywide Documents Access and ManagementSystem (ADAMS) at http://www.nrc.gov/reading-rm/adams.html , under Accession No. ML071790506.
DEVELOPMENT
 
REGULATORY  
U.S. NUCLEAR REGULATORY COMMISSION
GUIDE 4.15 QUALITY ASSURANCE  
July 2007 Revision 2 REGULATORY GUIDE
FOR RADIOLOGICAL  
OFFICE OF NUCLEAR REGULATORY RESEARCH
MONITORING  
REGULATORY GUIDE 4.15 (Draft was issued as DG-4010, dated November 2006)
PROGRAMS (NORMAL OPERATIONS)-EFFLUENT  
QUALITY ASSURANCE
STREAMS AND THE ENVIRONMENT
FOR RADIOLOGICAL MONITORING PROGRAMS (INCEPTION THROUGH NORMAL OPERATIONS
TO LICENSE TERMINATION) -
EFFLUENT STREAMS AND THE ENVIRONMENT


==A. INTRODUCTION==
==A. INTRODUCTION==
This guide describes a method acceptable to the NRC staff for designing a program to assure the qual-ity of the results of measurements of radioactive ma-terials in the effluents and the environment outside of nuclear facilities during normal operations.
This regulatory guide describes a method that the U.S. Nuclear Regulatory Commission (NRC)considers acceptable for use in designing and implementing programs to ensure the quality of the resultsof measurements of radioactive materials in the effluents from, and environment outside of, facilities that process, use, or store radioactive materials during all phases of the facility's life cycle.
 
QUALITY ASSURANCE
1 (QA) is a fundamental expectation of Title 10, "Energy," of the Code of Federal Regulations (10 CFR) for items and activities that are relied on to protect the health and safetyof the public and the environment.This guide specifically applies to facilities for which NRC regulations require routine monitoringof radioactive effluents to the environment, and particularly those facilities licensed under the following regulations:*10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities" (Ref. 1)*10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants" (Ref. 2)
Rev. 2 of RG 4.15, Page 2*10 CFR Part 61, "Licensing Requirements for Land Disposal of Radioactive Waste" (Ref. 3)*10 CFR Part 72, "Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-R
elated Greater Than Class C Waste" (Ref. 4)*10 CFR Part 76, "Certification of Gaseous Diffusion Plants" (Ref. 5)The guide also may apply to other facilities licensed by the NRC, for which the agencymay impose specific license conditions for effluent or environmental monitoring, as deemed necessaryto ensure the health and safety of the public and the environment, including those licensed under the following regulations:*10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material"(Ref. 6)*10 CFR Part 40, "Domestic Licensing of Source Material" (Ref. 7)
*10 CFR Part 70, "Domestic Licensing of Special Nuclear Material" (Ref. 8)Finally, radiological standards for occupational workers and members of the public are codified in 10 CFR Part 20, "Standards for Protection Against Radiation" (Ref. 9).Although the specific regulations provide the actual requirements, the following presents anoverview of applicable NRC regulations addressing limits on radioactive effluents, environmental levels ofradioactivity, requirements for effluent and environmental monitoring, and associated QA.In accordance with 10 CFR 20.1301, "Dose Limits for Individual Members of the Public," theTOTAL EFFECTIVE DOSE EQUIVALENT (TEDE) to individual members of the public from licensed operationmust not exceed 1 milli SIEVERT [1 mSv, or 100 milli REM (mrem)] per year.  Uranium fuel cycle facilities(excluding transportation and disposal) also must comply with the provisions that the U.S. EnvironmentalProtection Agency (EPA) established in 40 CFR Part 190, "Environmental Radiation Protection Standards for Nuclear Power Operations" (Ref. 10).  In a ddition, 10 CFR 20.1101(d) requires licensees (other than those subject to 10 CFR 50.34a, "Design Objectives for Equipment to Control Releases of Radioactive Material in Effluents - Nuclear Power Reactors,"
discussed below) to restrict releases of airborneradioactive materials so that the highest individual dose to the public will not exceed 0.1 mSv (10 mrem)per year.In addition, under 10 CFR 20.1101(b), licensees must apply AS LOW AS REASONABLY ACHIEVABLE (ALARA) concepts to doses to occupational workers and members of the general public.  In accordancewith 10 CFR 20.1302, "Compliance with Dose Limits for Individual Members of the Public," licensees must survey radiation levels to demonstrate compliance with the dose limits, and 10 CFR 20.1101,"Radiation Protection Programs," requires licensees to develop, document, and implement radiationprotection programs commensurate with the scope and ex tent of licensed activities and sufficient to ensurecompliance with the provisions of 10 CFR Part 20 (Ref. 9).In 10 CFR Part 20, Subpart E, "Radiological Criteria for License Termination," the NRC providesthe radiological criteria for license termination under unr estricted and restricted use scenario
 
====s. The NRC====
considers a site acceptable for unrestricted use if the residual radioactivity that is distinguishable frombackground radiation does not exceed 25 mrem/year (0.25mSv/year) TEDE to an average member of the critical group, including contributions from groundwater sources.  A site can be released under restricteduse if the residual radioactivity that is distinguishable from background dose not exceed a yearly dose of25 mrem (0.25mSv) TEDE with site use restrictions in place.
 
Rev. 2 of RG 4.15, Page 3 For nuclear power reactors, 10 CFR 50.34a and 10 CFR 50.36a, "Technical Specifications onEffluents from Nuclear Power Reactors," require ALARA concepts for operations to maintain releases ofradioactive materials in effluents consistent with the guidelines of Appendix I, "Numerical Guides forDesign Objectives and Limiting Conditions for Operati on to Meet the Criterion 'As Low As Is ReasonablyAchievable' for Radioactive Material in Light-W
ater-Cooled Nuclear Power Reactor Effluents," to10 CFR Part 50.  Licensees must also establish appropriate SURVEILLANCE and monitoring programs to provide QA with respect to (1) areas of equipment operation and (2) data on the quantities or concentrations of radionuclides released in liquid and gaseous effluents.  These programs will help to ensure accurate projection of the levels of radiation and radioactive materials found in the environment. Section III.B of Appendix I addresses requirements concerning estimates of radioactive iodine in water andfood pathways if land use changes occur after plant construction.The regulations in 10 CFR 30.34, "Byproduct Material," 10 CFR 40.41, "Source Material,"
10 CFR 50.50, "Production and Utilization Facilities," and 10 CFR 70.32, "Special Nuclear Material,"
provide that the NRC may incorporate in any governed license such terms and conditions as it deemsappropriate or necessary to protect health.For land disposal of radioactive waste, 10 CFR 61.53, "Environmental Monitoring," requiresmeasurements and observations to be made and recorded to provide data to evaluate potential health andenvironmental impacts, including long-term effects, as well as the need for mitigating measures.  Themonitoring system must be capable of providing early warning of releases of radionuclides from the disposal site.  A postclosure monitoring program is also required to detect the release of radionuclides.According to 10 CFR 70.59, "Effluent Monitoring Reporting Requirements," licensees authorizedto possess and use special nuclear materials for processing and fuel fabrication, scrap recovery, conversionof uranium hexafluoride, or in a uranium enrichment facility shall report to the NRC the quantity of each of the principal radionuclides released to unrestricted areas in liquid and gaseous effluents, and otherinformation as the Commission may require to estimate maximum potential annual radiation doses to the public resulting from effluent releases.
 
Appendix A, "General Design Criteria for Nuclear Power Plants," to 10 CFR Part 50 includes several applicable general design criteria (GDC) aff ecting nuclear power plant designs.  GDC 60, "Control of Releases of Radioactive Materials to the Environment," requires suitable means to control the release ofradioactive materials in gaseous and liquid effluents.  GDC 64, "Monitoring Radioactivity Releases,"requires means for monitoring effluent discharge paths and the plant environs for radioactivity that may bereleased from normal operations, including anticipated operational occurrences, and from postulatedaccidents.  GDC 1, "Quality Standards and Records," requires the establishment of a QA program for thosestructures, systems, and components that are important to safety to provide adequate assurance that theywill satisfactorily perform their safety functions.  Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part 50 establishes the QA requirements for power plants.The requirements in 10 CFR 72.104, "Criteria for Radioactive Material in Effluent and DirectRadiation from an ISFSI [Independent Spent Fuel Storage Installation] or MRS [Monitored RetrievableStorage]," mandate operational restrictions for main taining effluents and direct radiation levels in accordance with ALARA concepts, with limits so as not to exceed annual DOSE EQUIVALENTS of .25 mSv(25 mrem) to the whole body, 0.75 mSv (75 mrem) to the thyroid, and 0.25 mSv (25 mrem) to any other critical organ of any real individual beyond the controlled area.For gaseous diffusion uranium enrichment facilities, 10 CFR 76.87, "Technical SafetyRequirements," requires licensees to establish technical safety requirements with procedures and equipment
2While not specific to QA, other regulatory guides that address measurements of radioactive materials in effluents and the environment include the following:*Regulatory Guide 1.21, "Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Releases ofRadioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power Plants" (Ref. 13)*Regulatory Guide 4.1, "Programs for Monitoring Radioactivity in the Environs of Nuclear Power Plants"(Ref. 14)*Regulatory Guide 4.14, "Radiological Effluent and Environmental Monitoring at Uranium Mills" (Ref. 15)*Regulatory Guide 4.16, "Monitoring and Reporting Radioactivity in Releases of Radioactive Materials in Liquid and Gaseous Effluents from Nuclear Fuel Processing and Fabrication Plants and Uranium Hexafluoride Production Plants" (Ref. 16)
Rev. 2 of RG 4.15, Page 4to address (among other things) building and pro cess ventilation and off-gassing, radioactive wastemanagement, and environmental protection.  In addition, 10 CFR 76.93, "Quality Assurance," requires aQA program satisfying the applicable provisions of the American Society of Mechanical Engineers(ASME) standard  QA-1-1994, "Quality Assurance Program Requirements for Nuclear Facilities (with
 
Addenda)" (Ref. 11).Generic Letter 79065 (Ref. 12), regarding the NRC's Radiological Assessment Branch TechnicalPosition on Radiological Environmental Monitoring, provides guidance on the appropriate type of, andlocation for, sampling and monitoring the environment surrounding nuclear power plants.This regulatory guide presents more complete and extensive guidance on QA for facilities whereradiological effluent or environmental monitoring is required by NRC regulations.
 
2  However, thisguidance does not address all topics and elements that a facility's QA program may require (such as requirements of Appendix B to 10 CFR Part 50 for nuclear power plants or 10 CFR 76.93 for gaseousdiffusion uranium enrichment facilities).The NRC issues regulatory guides to describe to the public methods that the staff considersacceptable for use in implementing specific parts of the agency's regulations, to explain techniques that thestaff uses in evaluating specific problems or postulate d accidents, and to provide guidance to applicants. Regulatory guides are not substitutes for regulations, and compliance with regulatory guides is not required.
 
Rev. 2 of RG 4.15, Page 5
 
==B. DISCUSSION==
As used in the context of this guide, QA comprises all those planned and systematic actions that arenecessary to provide adequate confidence in the ASSESSMENT of monitoring results.  QUALITY CONTROL(QC) comprises those QA actions that provide a means to measure and control the characteristics ofmeasurement equipment and processes to meet established standards; QA includes QC.  This guide makesno further effort to distinguish those elements that may be considered QC from those composing QA.Quality assurance is necessary to ensure that all radiological and nonradiological measurementsthat support the radiological monitoring program are reasonably valid and of a defined quality.  Theseprograms are needed (1) to identify deficiencies in the sampling and measurement processes and reportthem to those responsible for these operations so that licensees may take CORRECTIVE ACTION
and (2) toobtain some measure of confidence in the results of the monitoring programs to assure the regulatory agencies and the public that the results are valid.  All steps of the monitoring process should involve QA(e.g., sampling, shipment of SAMPLES, receipt of samples in the laboratory, preparation of samples,radiological measurements, data reduction, data evaluation, and reporting of the measurement andmonitoring results) .An effective overall management system for quality must precede the design of a QA program.  Adocument by the International Organization for Sta ndardization (ISO/IEC 17025-2005, Ref. 17) is availablefor use by laboratories in developing their management system for quality, administrative, and technical operations.  Once a quality management system is in place, a DIRECTED PLANNING PROCESS
can be used todefine the data objectives for the specific monitoring program.  The DATA QUALITY OBJECTIVE (DQO)process (EPA QA/G-4-2006, Ref. 18) provides one exam ple of how to develop and define acceptance andperformance criteria for a sample collection, measurement, and data analysis program.  The QUALITY ASSURANCE PROJECT PLAN (QAPP), which documents how data will be collected, assessed, and analyzed,can form the basis of a QA program (EPA QA/G-5-2002, Ref. 19).  The QAPP provides a blueprint of where, when, why, and how a particular project will achieve data of the type and quality needed and expected.NUREG-1576, "Multi-Agency Radiological Laboratory Analytical Protocols Manual" (Ref. 20, hereafter referred to as MARLAP), contains guidance for developing DQOs for risk-informed decisions, and their consequent MEASUREMENT QUALITY OBJECTIVES (MQOs), in the context of radiochemicalanalyses of environmental samples.  The same methodology can be applied in other environmental monitoring contexts.  An example of a key MQO is the REQUIRED METHOD UNCERTAINTY
at a specified radiation dose or radionuclide concentration.  The specific dose may be a fractional amount of a radiationdose limit.  The specific concentration may be a fractional amount of an effluent release or environmentalradionuclide concentration.  For either case, the fractional amount of the limit should be sufficiently small so that a licensee may take reasonable operational actions before the limit is exceeded.  MARLAPrecommends a PERFORMANCE
-BASED APPROACH for selecting methods used to analyze samples or measuredose rates that meet the MQOs.  Under this approach, the licensee's QA program should incorporate the initial (project METHOD VALIDATION) and continued [internal and external PERFORMANCE EVALUATION (PE)PROGRAMS] assessment of a method's capability to meet the MQO specifications.  Process-radiationmonitoring equipment and instrumentation need to have the desired sensitivity to provide both real-time and data-trend values that can correlate to the actual measurements of process streams before release.  Theradiological environmental measurements program may be used to confirm the adequacy of the process-monitoring equipment.
 
Rev. 2 of RG 4.15, Page 6
 
==C. REGULATORY POSITION==
The QA program of each organization performing radiological effluent or environmentalmonitoring of nuclear facilities using, processing, or storing radioactive materials during all phases of the facility's life cycle should be documented by wr itten policies and procedures.  Licensees should have sufficient RECORDS of program conduct and performance to demonstrate program adherence.  In addition toits own program, a licensee should require any contractor or subcontractor performing support programactivities (e.g., sampling, analysis, evaluations, and r ecords) retain records su fficient for the licensee todevelop and maintain a QA program covering the applicable program elements.The following presents the QA program elements that should be developed and implemented toensure the quality of data/results for radiological effluent and environmental monitoring programs.1.Organizational Structure and Responsibilities of Managerial and Operational PersonnelThe structure of the organization as it relates to the management and operation of the monitoringprograms, including QA policy and functions, should be defined and documented.  The authorities, duties, and responsibilities of the positions within this organization, down to the first-line supervisory level, should be described.  This should include responsibilities fo r review and approval of written procedures and the preparation, review, and evaluation of monitoring data and reports.Persons and organizations performing QA functions should have sufficient authority andorganizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and toverify implementation of solutions.  Reporting should be at a management level that is independent ofactivity performance, costs, and schedule.
 
Section 2.1.1 of ANSI/ASQC E4-1994 (Ref. 21)
and Section 5.2.1 of ANSI N42.23-2003 (Ref. 22)provide additional guidance on management structur e and organizational responsibilities for radiologicaleffluent and environmental monitoring programs.2.Specification of Qualifications of Personnel The qualifications of individuals needed to carry out assigned radiological monitoring functionsshould be defined and documented (e.g., as in a job description).  Individuals with responsibility forperforming quality-related activities should be trained a nd qualified in the principles and techniques of theactivities to be performed.  These individuals should maintain proficiency by retraining, reexamining, andrecertifying or by periodic performance reviews, as a ppropriate.  Continual trai ning should be conducted asneeded to ensure that personnel maintain awareness of events and issues that could affect the quality ofprogram performance.
 
Section 2.3.1 of ANSI/ASQC E4-1994 (Ref. 21)
provides additional guidance and criteria for developing personnel training and qualification specifications for radiological effluent and environmentalmonitoring programs.
 
Rev. 2 of RG 4.15, Page 73.Operating Procedures and InstructionsMonitoring programs should have written procedures for all activities that generate data, such asdose calculations and measurements, sample collection, sample management and CHAIN OF CUSTODY
,sample preparation and analysis, data reduction and recording, data assessment and reporting, and finalsample disposal.  Procedures are also needed for addressing support functions, such as operation of processmonitors, training, preparation of QUALITY CONTROL SAMPLES, collection of meteorological data, corrective actions, AUDITS, and records.  Individuals satisfying the qua lifications described in Section C.2 of thisregulatory guide should write, review, and revise these procedures.


Section 30.34. ''Terms and Conditions of Licenses," of 10 CFR Part 30. "Rules of General Applicability to Licensing of Byproduct Material." provides that the Commission mayý.incorporate in any byproduct material license such'týrnis and conditions as it deems appropriate or neccssary.
Instructions, procedures, or schedules should be pr epared for the functions associated with the QAprogram, such as the following:*ancillary laboratory functions (including cleaning of glassware, contamination control, and storageof standards and chemicals)
*CALIBRATION and QC of instrumentation (including range of activity, range of energy,and frequency of calibration)*internal QC and external PE programs (including frequency, types, acceptance criteria for thelaboratory PERFORMANCE TESTING samples, and individual analyst qualifications)*timetable for VERIFICATION
and VALIDATION (V&V) of data Chapters 9, 11, and 12 of MARLAP (Ref. 20) provide guidance on the radioanalytical laboratory activities for which procedures are used. MARLAP Chapters 12 - 16 provide technical information that can be used to write or revise procedures.


in order to pro-ttr-t hn'ii,: ",T, The NRC regulations that require the control of re- Section 40.41. *.Terms".-nd Conditions of leases of radioactive materials from nuclear facilities, Licenscs,'
Section 5.4 of ISO/IEC 17025-2005 (Ref. 17) providesadditional guidance regarding the content and quality aspects of procedure and method technical content.
of I0.CFR'Part
402...Licensing ofSorc Licene -"Licesingof Source that require the measurements of radioactive mate- Material," provides that'tihe Commission may incor-rials in the effluents and environment outside of these porate in any source material license such terms and facilities, or that authorize license conditions not conditionsaasit d8ims appropriate or necessar)  
to otherwise authorized in the regulations are as protect heaih', follows:  flSeW1i0 ws: 50o '"-Issuance of Licenses and Con-Section 20.106, "Radioactivity in Effluents to Un- ý,vucttor,1Permits," of 10 CFR Part 50, "Licensing restricted Areas," of 10 CFR Part 20, "Standards for 'Iq production and Utilization Facilities." provides Protection Against Radiation." provides that a licen-r, t each operating license for a nuclear power plant see shall not release to an unrestricted area radioac- ssued by the Nuclear Regulatory Commission will tire materials in concentrations that exceed ,
such conditions and limitations as the Com-.~ý; .." "is * .specified in 10 CFR Part 20 or as other%ýRe aui t -Mission deems appropriate and necessary.


thorized in a license issued by the Comnssio Section 70.32, "Conditions of Licenses," of 10 tion 20.201, "Surveys." of 10 CFR Pflýt'' fORti CFR Part 70. "Special Nuclear Material." provides requires that a licensee conduct surv.ys, including meaurmetsofleel o raito or;' ... ..ton that the Commission may incorporate such terms and measurements of levels of radiation oroncentrations conditions as it deems appropriate or necessary to of radioactive materials, as necessary to i onstrate rotect health.compliance with the regulations in 10 CFR Part 20.Section IV.B. of Appendix i, "Numerical Guides Paragraph (c) of S4 n. /. "',Purpose," of 10 for Design Objectives and Limiting Conditions for CFR Part 20 states that r nable effort should Operation to Meet the Criterion
Section 2.5.2 of ANSI/ASQC E4-1994 (Ref. 21) identifies procedures that should be documented and may need control.4.Recordslicensees should maintain a system that produces unequivocal, accurate records that document allmonitoring activities. Licensees should maintain records of implementation or ongoing activities, such as the following:*procedure revision*personnel training and qualification records
'As Low As Is Rea-be made by N P- se o maintain radiation ex- sonably Achievable'
*analytical results
for Radioactive Material in posure, and f rdmoactive materials in Light-Water-Cooled Nuclear Power Reactor effluents t a ricted reas, as far below the limits Effluents," to 10 CFR Part 50, "Licensing of Pro.-is reasonably achievable, tak- duction and Utilization Facilities," requires that ing into " nt the state of technology and the eco- licensees establish an appropriate surveillance and nomics of " ' ovements in relation to public health monitoring program to provide data on quantities of and safety an to the utilization of atomic energy in radioactive material released in liquid and gaseous the public interest, effluents and to provide data on measurable levels of USNRC REGULATORY
*audits
GUIDES Comments should be sent to the Secretary at he Comn,$n,,,n.UOS.Nutlea, Regu Regulatory Guides are Issued to desctbe and make available to the public method0 1iotry Commission.
*corrective actions
*intermediate activities or calculations (as may be n eeded to validate or substantiate final results)*records of tracking and control (chain of custody) throughout all processes from sample collectionthrough analysis and reporting of results, in cluding unique identifiers, descriptions, sources,dates/times, packaging/preparation/shipping, and required analyses*field logs with sufficient information describing environmental conditions and recording relatedinformation and data documenting the nature of the sample and where and how it was taken*laboratory notebooks recording related information and data, observations of analysts, andlaboratory or other conditions potentially affecting the measurement process*electronic data collection and algorithms and QA documentation
*calculations (including data reduction, analysis, and verification)
Rev. 2 of RG 4.15, Page 8*QC records for radiation monitoring equipment, including the results of RADIOACTIVE SOURCE
checks, calibrations, INSTRUMEN


Washington.
==T. BACKGROUND==
determinations, and maintenance activitiesaffecting equipment performance*notifications to qualified staff that procedural changes affecting data quality have been made*QC records for laboratory counting systems and support instrumentation and equipment, includingcalibrations, maintenance or repair, QC sample results, and traceability of standards used forinstrument calibration Records should be legible and identifiable, retained in predetermined locations, and protectedagainst damage, deterioration, or loss.  Records should be maintained in a format that is easily retrievable. If the media for storage is electronic (as opposed to paper or microfilm/fiche), the licensee should maintainthe equipment necessary to read and present the data in an uncorrupted form.  The document retentionsystem should allow reconstruction of all activities associated with the generation of analytical results.  Thelicensee should establish a retention time for records c onsistent with licensing conditions and in accordancewith the licensee's overall QA program.Section 2.5 of ANSI/ASQC E4-1994 (Ref. 21) provides guidance on specific types of documentsthat should be maintained, while Basic Requirement 17 of ASME NQA-1-1994 (Ref. 11) details theadministrative criteria that should be considered for inclusion in a program for records and their retention.


D.C. 20555. Attention Dorheting i,,d Service acceplable to the NRC staff of implementing specific parts of the Commiusion's Brfanct .regulations, to delineate techniques used by the talfl in evaluating specific problems The guides are issued .n the tollow tnq ten broad d-%1.13 or poltulated accidents, or to provide guidance to applicants.
Section 4.13 of ISO/IEC 17025-2005 (Ref. 17) also provides guidance on the control of record


Regulatory Guides are not tubssltult for regulations.
====s. Chapters====
4 and 11 of MARLAP (Ref. 20) discuss documents that should be retained as records.  Nuclear Informationand Records Management Association (NIRMA) TG11-1998 (Ref. 23), TG15-1998 (Ref. 24), TG16-1998 (Ref. 25), and TG21-1998 (Ref. 26) provide additional information addressing issues in developing andmaintaining electronic records programs.5.Quality Control in Environmental SamplingSampling of solids, liquids, and gases involves the measurement of sample masses, flow rates, orvolumes.  The ACCURACY of the instruments or containers used for this purpose should be determined andchecked regularly to ensure that sampling performance criteria remain within the limits specified by theMQOs.  The results of mass, flow rate, or volume calibrations and associated UNCERTAINTIES
should berecorded.  The frequency of these calibrations should be specified and should be consistent with the DQOsof the measurement program.  The collection efficiencies of the sampling equipment used should be documented; often such documentation is available from the manufacturer.  HPS/ANSI N13.1-1999(Ref. 27) provides guidance on QA and QC for air sampling instruments.  Chapter 19 of MARLAP
(Ref. 20) discusses measurement uncertainties in general and volume and mass measurements in particular.Sampling or measurements should be performed using equipment and methods that yield a resultthat is representative of the population in the particular environmental media.  F
IELD DUPLICATES
areco-located spatially or temporally and should be collected periodically to check REPRODUCIBILITY. Chapter 10 of MARLAP (Ref. 20) discusses the field and sampling issues that affect laboratory measurements, including packaging, shipping, and storage of samples.Some individual environmental samples are collected simply to confirm that radioactivity levels arebelow a specified (small) fraction of an established concentration limit.  In those cases, the MINIMUMDETECTABLE CONCENTRATION of the method used should be below that specified fraction of the limit.


and compliance with them is not required.
Chapter 20 of MARLAP (Ref. 20) discusses detection limits, while Appendix C to MARLAP covers therelationship between the desired fraction of the limit that is important to detect and the uncertainty of themeasurement method.  In some cases, a series of measurement results will be averaged for comparison with BACKGROUND LEVELS or a regulatory limit.  For such measurements, an appropriate MQO would be theMINIMUM QUANTIFIABLE CONCENTRATION (see Chapter 20 of MARLAP).
Rev. 2 of RG 4.15, Page 9For an isolated, well-mixed population, a single sample or measurement may be sufficient.  It ismore common, however, for spatial or temporal variations to exist.  In that case, the frequency of samplingand number of samples and locations will depend on the level of variability and amount of radioactivity(compared with an established risk-informed limit).  NUREG-1575, "Multi-Agency Radiation Survey and Site Investigation Manual" (Ref. 28, hereafter re ferred to as MARSSIM), discusses the effect that suchvariability has on the number of samples that may be appropriate for SURVEYS.  In general, the DQOprocess may be used together with specific statistical designs (EPA QA/G-9S-2006, Ref. 29) to optimizethe sampling.  Continuous sampling or integrated measurements may be used to mitigate temporalvariability.


1. Power Reactors 6 Protuclts Met',dt end solutions different from those set out in the guides will be accept. 2. Research and Test Reactors 7. Tans4tjrlit.tn able if they provide a basis for Ithe findings requisite to the issuance or continuance
Part 1, Sections II-11 and II-12, of ASME NQA-
3. Fuels and Materials Faclittes
1-1994 (Ref. 11) discuss test control and controlof measuring and test equipment.  Part II, Subpart 2.20, of ASME NQA-1-1994 discusses QA standards for
8. Occuluational Health of e permit or license by the Commli.son.


4. Enviros',,ental and Siting 9. Antitrust Rerty.v 5. Materials and Plant Protection tO. General Comments and suggestions for improvements in thete guides ae encouraged at all times, and guides will be revisad. as apsrotortate.
subsurface investigations for nuclear power plants.6.Quality Control in the Radioanalytical Laboratory The output of the directed planning process includes DQOs that encompass both sampling andanalysis activities for a project or program.  From the DQOs, a set of MQOs are developed for radioanalytical measurements (see Chapter 3 of MARLAP, Ref. 20).  In a performance-based approach,MQOs are critical criteria used for the selection and validation of analytical methods and protocols (see Regulatory Position 8, below) and subsequently form the basis for the ongoing and final evaluation of theanalytical data. The type, frequency of, and evaluation criteria for QC samples are developed during the directed planning process and are incorporated into ANALYTICAL PROTOCOL SPECIFICATIONS (APSs) for a project (see Chapter 3 of MARLAP, Ref. 20).Chapter 18 of MARLAP provides guidance on monitoring key laboratory PERFORMANCEINDICATORS to determine whether a laboratory's measureme nt processes are in control. The chapter alsoprovides information on likely causes of excursions for selected laboratory performance indicators, such aschemical yield, instrument background, and QC samples. Appendix C to MARLAP provides the rationale and guidance for developing MQOs for select method performance characteristics and gives guidance on developing criteria for QC samples.Performance criteria for radioanalytical measurements should be selected to provide a managementtool for tracking and trending performance and to identify precursors to nonconforming conditions. Laboratories should satisfy program-specific criteria for all measurement processes, including necessary


to accommodate comments and Requests Ifo single copies of issued (which mavy b. ertsL'Acovll at got elace to reflect new informatiots or eaperierrce. cOmmlnts on this guide,if ment on an automatic dctlic'butlon list tO tirngle Coli.es el luture quidtr &it 'tieleci-c taceived within about two months alter its jauance, will be partlcularly useful in should he mnde in writing to the US. Nuclear Regulatory Crmmoissot.
levels of PRECISION , acceptable BIAS , and applicable detection levels.6.1Calibration and Quality Control of Instru ments, Measuring Devices, and Test EquipmentInstruments, devices, and test equipment used for measuring radioactivity should be operated,calibrated, and maintained to ensure that analytical specifications are met.  All equipment should beoperated, calibrated, and maintained in adherence to any applicable standards and methods and as specifiedin the laboratory's quality manual and standard operating procedures.  Instrument configurations duringcalibration should match those used for subsequent analytical measurements of samples.Calibrations of instruments should be made using CERTIFIED REFERENCE MATERIALS
of known anddocumented value and stated uncertainty and should be traceable to a national standards body, such as the National Institute of Standards and Technology (NIST) in the United States. CALIBRATION SOURCESshould be prepared in a manner that provides comparability to TEST SOURCES
with respect to sourcegeometry, positioning relative to the detector, source composition, and distribution of the test-sourcematerial within a container or on a source mount (see Section 15.2 of MARLAP, Ref. 20).
Rev. 2 of RG 4.15, Page 10The frequency of calibrations should be consistent with the stability and performance of theinstrument. Complete system calibration should be performed before initial use or following systemmaintenance, repair, or any other changes in environment or operating conditions that could affectperformance (ASTM D7282-2006, Ref. 30).  In additi on, Sections 15.2 and 15.3 of MARLAP (Ref. 20)
present general guidance regarding calibrations of instruments.  Chapter 15 of MARLAP also presentsguidance specific to calibrations of different instrumentation types.The continuing validity of calibrations should be checked periodically as specified in a laboratory'squality manual (see Chapter 18 of MARLAP, Ref. 20).  Quality control checks of radioanalyticalinstrument calibration parameters, such as detector response or energy and resolution calibrations forspectrometers, should be performed by measuring the response of each radiation detection system to appropriate CHECK SOURCES.  Instrument QC frequencies are generally performed daily for systems usedcontinually or before use for those systems periodically employed, but frequencies may vary by instrumenttype.  Instrument QC checks should meet predefin ed acceptance criteria for the respective calibrationparameter and should ensure that conditions have not significantly ch anged since initial calibration (ASTM
D7282-2006, Ref. 30).Instrument-calibration QC check results should be tracked, trended, and compared withpredetermined ranges of acceptable performance. For example, if a monitor's response to a daily checksource showed a trend that may lead to a condition outside of established acceptance criteria, a calibrationmay be needed to reestablish acceptable operation.


evaluating the need lot an early revision, Washington.
Section 18.5 of MARLAP (Ref. 20) and ASTM D7282-2006 (Ref. 30) discuss radioanalytical instrument-calibration QC parameters.Additional method-specific quality controls (e.g., chemical yield, spectral quality, resolution) mayapply to certain methods and should be tracked and tr ended using control or tolerance charts to identifyconditions that could be adverse to quality.The laboratory quality manual and standard operating procedures should address the use,calibration, maintenance, and QC of all nonradiological instruments, measuring devices, and test equipmentused for measuring or quantifying other necessary data (e.g., sample masses or volumes, temperatures).  All measurement and test equipment should be calibrated be fore use and adjusted to maintain accuracy withinestablished limits.  Quality control checks should be performed at specified frequencies and should verifythat instruments are operating to specified performance levels.Nonradiological instruments, measurement, and test equipment should be operated according tomanufacturers' instructions, according to established standards, or as specified in the laboratory qualitymanual and procedures.  Section 18.6.7 of MARLAP (Ref. 20) provides guidance on control, calibration,and maintenance of calibration of apparatus used for mass and volume measurements.  ISO/IEC 17025-
2005 (Ref. 17) provides general guidance on establishing quality controls for nonradiological instruments. Items that do not conform to specified criteria should be controlled to prevent inadvertent use.  These itemsshould be tracked through the corrective action program.Careful control of contamination and routine monitoring of instrument background are integralparts of a measurement QC program.  Determinati on of the background counting rate should be performedon a regular, predefined frequency for systems in routine use and should ensure that analyticalspecifications for applicable programs can be met.  Instrument backgrounds used to determine a net countrate should replicate actual sample measurement conditions as closely as possible (i.e., using appropriatesample containers and geometries).
3Note that this list does not include field duplicate samples that are part of the QC requirement for sampling.


D.C. 20555. Attention.
Rev. 2 of RG 4.15, Page 11 Section 18.5.1 of MARLAP (Ref. 20) provides guidance on measurement and control of instrumentbackgrounds.  Section 18.3 and Attachment 18A of MA
RLAP contain guidance on the statistical evaluationof performance indicators and on using control and tolerance charts.


Directo,, Onvruon of DOcument Cunttol radiation and radioactive materials in the environ-ment. Section lll.B of Appendix I to 10 CFR Part 50 provides certain effluent and environmental monitor-ing requirements.
Sections 10-13 and 20-25 of ASTM D7282-2006 (R
ef. 30) and Section A.5.2 of ANSI N42.23-2003 (Ref. 22) provide additional guidance on instrume nt response source checks, background checks, and the use of control charts.  ASTM MNL 7A-2002 (Ref. 31) provides guidance on setting up and using control charts.6.2Internal Quality Control Samples and AnalysisThe use of QC samples should be an integral element of a laboratory QA program.  Chapter 18 ofMARLAP (Ref. 20) defines the different types of laboratory QC samples and provides guidance on evaluation techniques for QC samples.  The laboratory should have as part of the normal operationalsample load the following QC samples:
3*BLANK*MATRIX SPIKE
*LABORATORY CONTROL SAMPLE
*LABORATORY DUPLICATEAnalysis of QC samples should be performed as a part of the routine operation of a laboratory toverify that laboratory operations are consistent with applicable specifications.  The QC program shouldspecify the type of and minimum frequency for processing QC samples.  For example, this frequency may be defined as a minimum percentage of the total number of samples analyzed, a certain number peroperational time interval (e.g., once per shift) or per sample batch, or a licensee-specified frequency basedon laboratory-specific parameters. As part of its QC program, the laboratory may prepare and analyzeBLIND SAMPLES , provided the individuals responsible for preparing the samples are not directly responsiblefor conducting the laboratory analysis.  For example, the laboratory's assigned QC specialist may have theresponsibility for preparing and submitting blind samples (blank, duplicate, laboratory control sample, and matrix spike).  Blind samples are used primarily as a tool for evaluating the performance of individualsrather than as part of the laboratory QC load.Acceptability of QC sample results should be evaluated based on criteria from the QC program, which include specific equations based on METHOD UNCERTAINTY.  Chapters 7 and 18 of MARLAP(Ref. 20) provide guidance on the evaluation of QC samples.Quality control sample results should be tracked, trended, and compared with predetermined rangesof acceptable performance to identify conditions that are in, or may lead to, nonconformance with program specifications.  Such conditions should be tracked through the corrective action program.6.3 Performance Evaluation Program (Interlaboratory Comparison)Participation in an external PE program is an important independent check on the accuracy,possible bias, and precision of some radioanalytical or measurement methods used in a radiological monitoring program.  Internal and contract radioanalytical laboratories used in the monitoring programshould participate in one or more applicable PE programs that are administered by organizations that havean active measurement assurance (traceability) program with NIST (ANSI N42.22-1995, Ref. 32).  Chapter
4 Frequencies should be appropriate to the instrument under consideration and may be dictated by license conditions.


with respect to radioactive iodine if estimates of exposure are made on the basis of exist-ing conditions and if potential changes in land and water usage and food pathways could result in expo-sures in excess of the guidelines of Appendix I to 10 CFR Part 50.General Design Criterion
Rev. 2 of RG 4.15, Page 125 of MARLAP (Ref. 20) recommends incorporating the criteria for a radioanalytical laboratory toparticipate in a PE program into the statement of work for services.  Several external PE programsadministered by government agencies or commercia l radioactive-source suppliers are available forradionuclides and matrices germane to radiological monitoring programs.  The PE program should provide fundamental sample types (e.g., solid, liquid, gas) and radionuclides (e.g., alpha-, beta-, and gamma-emitting nuclides) of interest at the facility.  When available, laboratories should analyze samples as offeredby a PE program on a frequency stipulated by the monitoring program's QA criteria, with all types of samples and analyses repeated at least biennially.  Chapter 18 of MARLAP (Ref. 20) provides informationon organizations that administer PE programs.Acceptable performance criteria for results of performance-testing samples should be establishedthat are consistent with the MQOs for the radiological monitoring project or program.  For certain monitoring activities, the acceptance criteria of the PE program may be satisfactory.  The performance in aPE program should be tracked and trended as one of the performance indicators for the laboratory and evaluated as part of the corrective action program.7.Quality Control for Radioactive Effluent Monitoring Systems7.1Radioactive Effluent Process MonitorsAn initial, primary radiation monitor calibration that meets the specifications of ANSI N42.18-2004 (Ref. 33), should be performed with radioactive sources traceable to a national standards body (such as NIST).  Calibrations should be repeated periodically using (1) STANDARD REFERENCE MATERIALS
60. "'Control of releases of radioactive materials to the environment," of Ap-pendix A. "General Design Criteria for Nuclear Power Plants." to 10 CFR Part 50 requires that nu-clear power plant designs provide means to control suitably the release of radioactive materials in gase-ous a:nd liquid effluents.
or (2)certified reference materials that can be directly traced to the initial, primary calibration.  Complete system calibration - including electronics, detector, and any support functions (such as alarm, display, andrecording devices) - should be performed at a frequency that ensures system reliability and accuracy orafter repair or maintenance that may affect instrume nt calibration. Unless otherwise specified in licenserequirements, the licensee should verify and validate the complete effluent monitoring system every 12 months. This frequency may be extended to longer time periods coinciding with facility maintenance schedules, such as refueling for nuclear power plants, if the licensee has verified proper system operationthrough established system reliability and more frequent source checks and functional checks.


General Design Criterion 64. "Monitoring radioactivity releases." of Appen-dix A to 10 CFR Part 50 requires that nuclear power plant designs provide means for monitoring effluent discharge paths and the plant environs for radioactiv- ity that may be released from normal operations, in-cluding anticipated operational occurrences, and from postulated accidents.
Detectors should be response-checked periodically
4 for continuous effluent release points(e.g., ventilation systems and secondary water systems) and before release for batch discharges(e.g., primary boundary or containment purges and liquid waste tank releases). Licensees should ensure that check sources are of sufficient radiochemical purity so that the activity of the source may be correctedfor decay to the date of measurement.  These check sources need not be traceable to a national standardsbody (e.g., NIST).  Whenever practicable, check sources should be an integral part of the monitoringsystem and should be remotely actuated.  The functionality of isolation or alarm functions should beverified periodically, preferably by use of a radiation source.Trends of process radiation monitor readings ve rsus total radionuclide concentrations in themonitored release path should be performed routinely.  These trends should be based on the results ofanalyses for specific radionuclides in samples taken from the release path that will yield a monitorresponse.  Deviations in the trend may occur if concentrations or the mixture of radionuclides changedsignificantly (for example, during a fuel cycle in whic h significant fuel defects exist).  The licensee shoulddefine the monitor-response parameter for all radiation monitors.  The monitor-response constant should beadjusted to maintain this correlation between effluent radionuclide concentration and monitor response.


General Design Criterion
Rev. 2 of RG 4.15, Page 137.2Flow Monitoring InstrumentationContinuous sampling of liquids and gases involves the measurement of sample flow rates and/orsample volumes. The accuracy and associated uncertainty of the devices used for this purpose should bedetermined on a regularly scheduled basis, and adjustments should be made as needed to bring theperformance of the devices within specified limits.  Th e results of these calibrations should be recorded. The frequency of these calibrations should be specified and should be based on the necessary accuracy,purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.Any flow-rate measuring devices associated with the system should be calibrated to determineactual flow rates at the conditions of temperature and pressure under which the system will operate.  These flow rate devices should be recalibrated annually, but the frequency may be extended to that established forthe radiation detector system, provided suffici ent operating experience exists and an acceleratedmeasurement check frequency gives sufficient data to ensure reliable performance.Flow measuring devices should be checked periodically on an established frequency, consideringthe variability of the instrument, and recalibrated when established control limits are exceeded.  HPS/ANSIN13.1-1999 (Ref. 27) provides additional guidance on QA and QC measures for the use, maintenance, and calibration of airborne sampling instrumentati on.  ANSI N42.18-2004 (Ref. 33) provides additionalguidance on the calibration of liquid flow monitors.7.3Grab Sampling of Effluent Process Streams Whenever practicable, effluent releases should be batch-controlled and released when the volumeto be released has been mixed sufficiently to ensure uniform concentration.  Sampling and analysis for eachbatch should be performed, and release conditions set, before release.  A
1. "'Quality standards and records." of Appendix A to 10 CFR Part 50 re-quires that a quality assurance program be established for those structures, systems. and components of a nuclear power plant that are important to safety in order to provide adequate assurance that they will satisfactorily perform their safety functions.
certain percentage of all batch releases should have field duplicates taken either be fore or during the release to assess the reproducibilityof sampling and the effectiveness of the mixing process before release.  Where possible, samples that arespatially or temporally separated should be collected periodically to verify representativeness.For continuous-effluent discharges, composite samplers should be employed.  However, periodicgrab samples may be used when composite sampling of a continuous discharge point is not feasible.  Whengrab samples are collected instead of composite samples, licensees should design the sampling program tosample at the time, location, and frequency that ensures each sample is representative of the radioactivematerials released.7.4General Quality Control ConsiderationsThe QC plan should address the following items:*Sampling should be performed using calibrated instruments and equipment when taking acomposite sample.*Collection efficiencies based on the physical configuration of the sampling point and the type ofcollector should be documented.  Vendor-supplied data may be used where adequatedocumentation exists to ensure the reliability and accuracy of data.*Volumes of tanks and containers should be est ablished during initial in stallation and should beverified again following any physical changes that could alter the system configuration.


Appendix B. "Quality Assurance Criteria for Nu-clear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part 50 establishes quality assurance re-quirements for the design, construction, and opera-tion of those structures, systems, and components of these facilities that prevent or mitigate the conse-quences of postulated accidents that could cause uridue risk to the health and safety of the pitblic. The pertinent requirements of this Appendix apply to all safety-related functions of these structures.
5Replicate samples may be prepared by removing separate ALIQUANTS from the same grab sample.


systems, and components.
6 The Institute of Electrical and Electronics Engineers (IEEE) Standard 1063, "IEEE Standard for Software User Documentation" (Ref. 35); EPA Directive 2185, "Good Automated Laboratory Practices" (Ref. 36); Subpart 2.7of ASME NQA-1-1994 (Ref. 11); Regulatory Guide 1.168, "Verifi cation, Validation, Reviews, and Audits for DigitalComputer Software Used Safety Systems of Nuclear Power Plants" (Ref. 37); and Section 8 of ANSI N42.14-1999,"Calibration and Use of Germanium Spectrometers for the Measurement of Gamma-Ray Emission Rates


This guide describes a method ac-ceptable to the NRC staff for the design and opera-tion of a program to meet the requirements of Ap-pendix B to 10 CFR Part 50, for the safety functions of radiological monitoring of effluents and the environment.
of Radionuclides" (Ref. 38), also provide guidelines on software V&V.


As used in the context of this guide. quality assur-ance comprises all those planned and systematic ac-tions that are necessary to provide adequate confi-dence in the results of a monitoring program, and quality control comprises those quality assurance ac-tions that provide a means to control and measure the characteristics of measurement equipment and proc-esses to established requirements;
Rev. 2 of RG 4.15, Page 14*The frequency of duplicates and REPLICATES
therefore, quality assurance includes quality cot,,arol.
5 should be established based on time (for continuousdischarges) or number of batches (for batch discharges).*Sample integrity should be maintained through chain of custody procedures.Procedures for continuous sampling should use methods that are designed to ensure that the sampleis representative of the volumes being discharged.8.Verification and ValidationThe V&V of certain aspects and support activities of the radiological measurement process ormonitoring program are essential to the QA program.  These aspects and activities include data andcomputer software V&V and project method validation.Project method validation is the demonstration that a method (radioanalytical or radiationmeasurement) using performance-based method selection is capable of providing analytical results to meet a project's MQOs and any other criteria in the analytical protocol specification (APS).  Acceptable method validation is necessary before the radiological analysis of samples or the taking of measurements in a monitoring program.  Chapter 6 of MARLAP (Ref. 20) presents detailed guidance on project methodvalidation for radioanalytical methods.  In additi on, Section 5.2.7 of ANSI N42.23-2003 (Ref. 22) and Section 5.4.5 of ISO/IEC 17025-2005 (Ref. 17) provide limited guidance for radioanalytical method validation.


The need for quality assurance is implicit in all re-quirements for effluent and environmental monitor-ing, and this need has been widely recognized.
Chapter 8 of MARLAP (Ref. 20) gives deta iled guidance and applicable tools for theradioanalytical data V&V evaluation process as well as information for developing a data V&V plan,determining acceptable criteria and tests, and applying da ta qualifiers for radioanaly tical data validation, as related to MQOs.  EPA QA/G-8-2002 (Ref. 34) provides guidance for nonradioanalytical data V&V.Computer programs used in the implementation of the radiological environmental monitoringprogram should be documented, verified, and va lidated before initial routine use and after eachmodification of the program.  As described in Section 5.4.3.2 of MARLAP (Ref. 20), the laboratory's quality manual should include the criteria for computer software V&V and documentation.  The software data reduction and reporting functions should be verified to perform as expected.


Regu-latory Guide 1.21, "Measuring, Evaluating, and Re-porting Radioactivity in Solid Wastes and Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power Plants," Regulatory Guide 4.1. "Programs for Monitoring Radioactivity in the Environs of Nuclear Power Plants:" Regulatory Guide 4,8. "Environmen- tal Technical Specifications for Nuclear Power Plants;" and Regulatory Guide 4.14, "Measuring, Evaluating, and Reporting Radioactivity in Releases of Radioactive Material in Liquid and Airborne Effluents from Uranium Mills," all give some guid-ance on means for assuring the quality of the meas-urements of radioactive materials in effluents and the environment outside of nuclear facilities.
69.Assessments and AuditsAssessments, audits, and surveillances are elemen ts used to evaluate the initial and ongoingeffectiveness of the QA program to monitor and control the quality of a radiological monitoring program.


More com-plete and extensive guidance on this subject is pro-vided in this document for nuclear power reactor facilities and for other facilities for which radiologi- cal monitoring is required by the NRC. This guidance applies both to monitoring that is safety-related and monitoring that is not. For safety-related monitoring of nuclear power plants and fuel reprocessing plants, other regulatory guides on quality assurance (in the Division I and the Division 3 series of regulatory guides) should be consulted to determine their applicability, if any. to the radiological monitoring activities.
Management having responsibility in the area being reviewed should document and review the results ofthese activities. Assessments that are independent of the day-to-day operations should be performedroutinely, including management surveillance, peer reviews, and READINESS REVIEWS
for new or revisedsystems and methods. Key performance indicators should be tracked and trended, with periodicmanagement reporting.  The QA program or project plan should outline the scope, frequency, and scheduleof assessments, audits, and surveillances.  A plan should be developed for each assessment audit or Rev. 2 of RG 4.15, Page 15surveillance for each area of the monitoring program be ing evaluated.  A report of these activities should begenerated according to the outline, format , and content established in the plan.Only qualified QA staff (see Regulatory Position 2, above), supported as needed by experts in the technical areas under evaluation, should conduct assessm ents, audits, and surveillances.  (See ASMENQA-1-1994, Supplement 2S, Ref. 11.)  Deficiencies, areas for improvement, and observations noted


==B. DISCUSSION==
should be incorporated into the corrective action program and tracked.  Section 18 of ASME NQA-1-1994 (Ref. 11) and Section 4.10 of ISO/IEC 17025-2005 (Ref. 17) provide guidance on establishing andconducting an audit program.When the monitoring program will depend upon the services of a radioanalytical laboratory, prioronsite audits of the laboratory may be conducted to ensure that the laboratory is capable of fulfilling the project criteria in accordance with the APS (including MQOs) outlined in a statement of work (MARLAPChapter 5 and Appendix E).  The ongoing evaluation of the laboratory's QUALITY SYSTEM
*
and operations isaccomplished through onsite audits and desk audits.  These audits are focused more on whether thelaboratory is meeting project or program specifications than whether the laboratory has the capability to meet monitoring program or project criteria.  Chapter 7 of MARLAP provides guidance and statistical tests to determine whether a laboratory is meeting the MQOs, especially the REQUIRED METHOD UNCERTAINTY. Section 5.2.10 of ANSI N42.23-2003 provides additional guidance for radioanalytical laboratoryassessments.Audits of the QA programs of contractors providing materials, supplies, or services affecting thequality of the laboratory's operations should be performed periodically (Section 4.6 of ISO/IEC 17025-
To assure that radiological monitoring meas-urements are reasonably valid, organizations per-forming these measurements have found it necessary to establish quality assurance programs.
2005, Ref. 17).10.Preventive and Corrective ActionsIntegral components of a QA program include identifying areas for improvement, definingperformance or programmatic deficiencies, and initiating appropriate corrective or preventive actions.  TheQA program for radiological effluent and environmental monitoring programs should contain both acontinuous-improvement program and a program for implementing corrective actions when conditionsadverse to quality have been identified.  In addition, needed improvements and potential sources ofnonconformance should be identified and reported as part of a preventive action initiative of thecontinuous-improvement program (ISO/IEC 17025-2005, Sections 4.10-4.12) - for example, a condition-reporting program.  Investigations should be initia ted for degrading conditions, and corrective actions should be taken when conditions fall outside quality or regulatory acceptance criteria.  For conditions thatare adverse to quality, the corrective action process includes the following basic elements:*identification and documentation*classification
*cause analysis
*corrections
*followup
*closure Findings and corrective actions should be documented, tracked, and reported to management. Followup reviews should be performed to verify the effectiveness and adequacy of the corrective actions.
 
Section 2.10 of ANSI/ASQC E4-1994 (Ref. 21) provid es specifications and guidelines for developing theprocess, programs, and procedures necessary to detect and correct items of nonconformance and for implementing continuous quality improvement.
 
Rev. 2 of RG 4.15, Page 16 When conducting an audit or surveillance of laboratory services, a prime area of review should bethe effectiveness of the laboratory's corrective action program (Section 7.4.2 of MARLAP, Ref. 20).
 
Section 4.11 of ISO/IEC 17025-2005 (Ref. 17) provid es general guidance on preventive and correctiveaction programs for laboratorie
 
====s. Annex C of ANS====
I N42.23-2003 (Ref. 22) provides additional guidance that should be considered in developing a corrective action program, including root cause analysis forradioanalytical services.
 
==D. IMPLEMENTATION==
The purpose of this section is to provide information to licensees regarding the NRC staff's plansfor using this regulatory guide.  No backfit is in tended or approved in connection with its issuance.
 
Non-nuclear power reactor applicants and licensees may continue to use Revision 1 of RegulatoryGuide 4.15, dated February 1979, or may adopt other procedures or practices that reflect generally acceptedstandards for ensuring quality in environmental data collected for effluent monitoring purposes.  Except in those cases in which a nuclear power reactor applicant or licensee proposes or has previously established anacceptable alternative method for complying with specified portions of the NRC's regulations, the methods and practices described in this guide will be used in evaluating QA practices for environmental radiologicalmonitoring programs.
 
7Certain terms included in this glossary are not used in the main body of this regulatory guide, but are includedbecause they are used w ithin other definitions.
 
Rev. 2 of RG 4.15, Page 17 GLOSSARY 7 accuracy-The closeness of a measured result to the true value of the quantity being measured.
 
Various recognized authorities have given the word "accuracy" different technical definitions,expressed in terms of bias and imprecision.  Following the Multi-Agency Radiological Laboratory Analytical Protocols (MARLAP) Manual (Ref. 20), the U.S. Nuclear Regulatory Commission (NRC) avoids all of these technical definitions and uses the term "accuracy" in its common, ordinary sense, which is consistent with the definition established by the International Organization for Standardization (ISO) in the "International Vocabulary of Basic and General Terms inMetrology" (Ref. 39).
aliquant-A representative portion of a homogeneous SAMPLE removed for the purpose of analysis orother chemical treatment.  The quantity removed is not an evenly divisible part of the whole sample.  An aliquot, by contrast, is an evenly divisible part of the whole.
 
analyte-See TARGET ANALYTE
.analytical protocol specification (APS)
-The output of a DIRECTED PLANNING PROCESS
that contains theproject's analytical data needs and criteria in an organized, concise form.  The level of specificityin the APS should be limited to those criteria that are considered essential to meeting the project'sanalytical data criteria to allow the laboratory the flexibility of selecting the protocols or methods that meet the analytical criteria.
 
as low as reasonably achievable (ALARA)-"As low as is reasonably achievable taking into account thestate of the technology and the economics of improvements in relation to benefits to the publichealth and safety and other societal and socioeconom ic considerations, and in relation to the use ofatomic energy in the public interest" [10 CFR 50.34a(a)].
assessment-A planned and documented activity performed to determine whether various elements withina quality management system are effective in achieving stated quality objectives (ANSI N42.23-
 
2003, Ref. 22).
audit-A planned and documented activity performed to determine by investigation, examination, orevaluation of objective evidence the adequacy of, and CONFORMANCE
with, established procedures, instructions, drawings, and other applicable documents as well as the effectiveness ofimplementation.  An audit should not be conf used with surveillance or inspection activitiesperformed for the sole purpose of process cont rol or product acceptance (after ANSI N42.23-2003, Ref. 22).background, instrument-Radiation detected by an instrument when no SOURCE is present.  Thebackground radiation that is detected may come from radionuclides in the materials of construction of the detector, its housing, its electronics, and the building as well as the environment and natural radiation.
 
background level-A term that usually refers to the presence of radioactivity or radiation in theenvironment.  From an analytical perspective, the presence of background radioactivity in samples Rev. 2 of RG 4.15, Page 18needs to be considered when clarifying the radioanalytical aspects of the decision or studyquestion.  Many radionuclides are present in measurable quantities in the environment.
 
bias (of a measurement process)-A persistent deviation of the mean measured result from the true oraccepted reference value of the quantity being measured, which does not vary if a measurement is repeated.blank (analytical or method)
-A SAMPLE that is assumed to be essentially free of the TARGET ANALYTE (the "unknown"), that is carried through the radiochemical preparation, analysis, mounting, andmeasurement process in the same manner as a routine sample of a given matrix.
 
blind sample
-A SAMPLE with a concentration not known to the analyst.  Blind samples are used to assessanalytical performance.  A double-blind sample is a sample whose concentration and identity as asample is known to the submitter, but not to the analyst.  The analyst should treat the double-blind sample as a routine sample, so it is important that the double-blind sample is identical inappearance to routine samples.
 
calibration
-The set of operations that establish, under specified conditions, the relationship betweenvalues indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known value of a parameter of interest.
 
calibration source
-A prepared SOURCE, made from a CERTIFIED REFERENCE MATERIAL OR STANDARDREFERENCE MATERIAL, that is used for calibrating instruments.
 
certified reference material-A reference material, accompanied by a certificate, with one or moreproperty values certified by a procedure that establishes its traceability to an accurate realization ofthe unit in which the property values are e xpressed, and for which each certified value isaccompanied by an UNCERTAINTY
at a stated level of confidence (ISO Guide 30, Ref. 40).  SeeSTANDARD REFERENCE MATERIAL
.chain of custody-Procedures that provide the means to trace the possession and handling of a samplefrom collection to data reporting.
 
check source-A material used to validate the operability of a radiation measurement device, sometimesused for instrument quality contro
 
====l. See TEST SOURCE====
and SOURCE , RADIOACTIVE
.condition adverse to quality- an all-inclusive term used in reference to any of the following:  failures,malfunctions, deficiencies, defective items, and nonconformances.  A significant condition adverseto quality is one which, if uncorrected, could have a serious effect on safety or operability.


These pro-grams are needed for the following reasons: (1) to identify deficiencies in the sampling and measure-ment processes to those responsible for these opera-tions so that corrective action can be taken, (2) to provide a means of relating the results of a particular monitoring program to the National Bureau of Stand-ards and thereby to provide a common basis for com-paring the results of various programs, and (3) to ob-tain some measure of confidence in the results of the monitoring programs in order to assure the regulatory agencies and the public that the results are valid.Existing published guidance on specific quality as-surance actions which are applicable to radiological monitoring is limited and, in general, is restricted to quality control practices for radioanalytical labora.tories (Refs. 1-3). However, quality assurance should be applied to all steps of the monitoring process that may include sampling, shipment of samples, receipt of samples in the laboratory, preparation of samples, measurement of radioactivity (counting), data reduc-tion, data evaluation, and reporting of the monitoring results.*Definitions of special terms used in this guide are given in a glossary in Appendix A.4.15-2 The scope of this guide is limited to the elements of a quality assurance program, which is a planned.systematic, and documented program that includes quality control. Guidance on principles and good practice in the monitoring process itself and guidance on activities that can affect the quality of the monitor-ing results (e.g., design of facilities and equipment)
conformance-An affirmative indication or judgment that a product or service has met the criteria of therelevant specifications, contract, or regulation; also the state of meeting the criteria (ANSI/ASQC
are outside the scope of this guide. However, some references are provided to documents that do provide some guidance in these areas. The citation of these references does not constitute an endorsement of all of the guidance in these documents by the NRC staff.Rather, these references are provided as sources of information to aid the licensee and the licensee's con-tractors in developing and maintaining a monitoring program.Every organization actually performing effluent and environmental monitoring, whether an NRC licensee or the licensee's contractor, should include the quality assurance program elements presented in this guide.C. REGULATORY
POSITION The quality assurance program of each organiza-tion performing effluent or environmental monitoring of nuclear facilities for normal operations should be documented by written policies and procedures and records. These documents should include the ele-ments given in this section.In addition to its own program, a licensee should require any contractor or subcontractor performing monitoring activities for the licensee to provide a quality assurance program consistent with the provi-sions of this guide, as follows: 1. Organizational Structure and Responsibilities of Managerial and Operational Personnel The structure of the organization as it relates to the management and operation of the monitoring pro.gram(s), including quality assurance policy and func-tions, should be presented.


The authorities, duties, and responsibilities of the persons holding specified positions within this organization should be stated, including responsibilities for review and approval of written procedures and for preparation, review, and evaluation of monitoring data and reports.Persons and organizations performing quality as-surance functions should have sufficient authority and organizational freedom to identify quality prob-lems; to initiate, recommend, or provide solutions;
E4-1994, Ref. 21).
and to verify implementation of solutions.
corrective actions-Those measures taken to prevent, rectify, or eliminate conditions adverse to quality ordetected nonconformities and - as necessary - to preclude repetition of those conditions.


2. Specification of Qualifications of Personnel The qualification of. individuals performing radiological monitoring to perform their assigned functions should be specified and documented.
data quality objective (DQO)-Qualitative and quantitative statements that clarify the study objectives,define the most appropriate type of data to collect, determine the most appropriate conditions fromwhich to collect the data, and specify tolerable limits on decision error rates. Because DQOs willbe used to establish the quality and quantity of data needed to support decisions, they should Rev. 2 of RG 4.15, Page 19encompass the total UNCERTAINTY resulting from all data collection activities, including analyticaland sampling activities.


Speci.fication of these qualifications in terms of previous training and performance on the job or satisfactory completion of proficiency testing is prclerred to spec-ification of education and experience levels.An introduction and orientation program, appro-priate to the size and complexity of the organization.
directed planning process-A systematic framework focused on defining the data needed to supportan informed decision for a specific project.  Di rected planning provides a logic for setting well- defined, achievable objectives and developing a cost-effective, technically sound sampling andanalysis design that balances the data user's tolerance for UNCERTAINTY
in the decision process and the available resources for obtaining data to support a decision.  Directed planning helps to eliminate unnecessary, poor, or inadequate sampling and analysis designs.


should provide that (a) personnel performing quality-related activities are trained and qualified in the principles and techniques of the activities per-formed. and (b) proficiency of personnel who per-form activities affecting quality is maintained by re-training, reexamining.
dose equivalent-Quantity that expresses all radiations on a common scale for calculating the effectiveabsorbed dose.  This quantity is the product of absorbed dose (GRAYS (Gy) or rads) multiplied by aquality factor and any other modifying factors (MARSSIM, Ref. 28).  The quality factor adjusts the absorbed dose because not all types of ionizing radiation create the same effect on human tissue. For example, a dose equivalent of one SIEVERT (Sv) requires 1 Gy of beta or gamma radiation, butonly 0.05 Gy of alpha radiation or 0.1 Gy of neut ron radiation.  Because the sievert is a large unit,radiation doses often are expressed in milli SIEVERTS (mSv).  See TOTAL EFFECTIVE DOSEEQUIVALENT
.duplicate, field-Two samples of the same material, collected at the same location at the same time andunder the same conditions, which are used to verify representativeness of the sampled material.


and recertifying.
duplicate, laboratory
-Two ALIQUANTS
of a SAMPLE, which are prepared and analyzed separately as partof the same batch, used in the laboratory to measure the overall PRECISION of the samplemeasurement process, beginning with laboratory subsampling of a field SAMPLE.field duplicate
-See DUPLICATE , FIELD.graded approach-A process of basing the level of management controls applied to an item or work on the intended use of the results and the degree of confidence needed in the quality of the results.


as appropriate to the activity performed.
The NRC follows a graded approach to project planning and QUALITY ASSURANCE
because of thediversity of environmental data collection activities.  This diversity in the type of project and thedata to be collected impacts the content and ex tent of the detail to be presented in the projectplanning documents.


3. Operating Procedures and Instructions Written procedures should be prepared.
gray (Gy)-The International System of Units (SI) unit for absorbed radiation dose. One Gy is 1 joule ofenergy absorbed per kilogram of matter, equal to 100
RAD.  See SIEVERT.laboratory control sample-A standard material of known composition or an artificial SAMPLE (createdby fortification of a clean material similar in nature to the sample), which is prepared and analyzedin the same manner as the sample.  In an ideal situation, the result of an analysis of the laboratorycontrol sample should be equivalent to (give 100 percent of) the TARGET ANALYTE
concentration oractivity known to be present in the fortified sample or standard material.  The result normally is expressed as percent recovery.  See also QUALITY CONTROL SAMPLE
.laboratory duplicate
-See DUPLICATE , LABORATORY
.matrix spike
-See SPIKE.


reviewed.and approved for activities involved in carrying out the monitoring program. including sample collection:
Rev. 2 of RG 4.15, Page 20
packaging.
measurement quality objective (MQO)-The analytical data criteria of the DATA QUALITY OBJECTIVES
,which are project- or program-specific and can be quantitative or qualitative.  These analytical data criteria serve as measurement performance criteria or objectives of the analytical process. MARLAP (Ref. 20) refers to these performance objectives as MQOs.  Examples of quantitativeMQOs include statements of required analyte detectability and the UNCERTAINTY of the analytical protocol at a specified radionuclide concentration, such as the action level.  Examples of qualitativeMQOs include statements of the required specificity of the analytical protocol (e.g., the ability toanalyze for the radionuclide of interest (or TARGET ANALYTE) given the presence of interferences).
method uncertainty
-Reference to the predicted UNCERTAINTY of the result that would be measured if themethod were applied to a hypothetical laboratory SAMPLE with a specified analyte concentration. Although individual measurement uncertainties will vary from one measured result to another, theREQUIRED METHOD UNCERTAINTY is a target value for the individual measurement uncertainties andis an estimate of uncertainty before the sample is actually measure


shipment.
====d. See also UNCERTAINTY====
andREQUIRED METHOD UNCERTAINTY
.method validation-The demonstration that the method selected for the analysis of a particular analyte ina given matrix is capable of providing analytical results to meet the project's MEASUREMENTQUALITY OBJECTIVES and any other criteria in the ANALYTICAL PROTOCOL SPECIFICATIONS. Compare with data and software VALIDATION
.minimum detectable concentration-The minimum detectable value of the analyte concentration in asample.  The smallest (true) value of the net state variable that gives a specified probability that the value of the response variable will exceed its critical value (i.e., that the material analyzed is not blank).minimum quantifiable concentration-Minimum quantifiable value of the analyte concentration, definedas the smallest concentration of analyte whose presence in a laboratory SAMPLE ensures that therelative standard deviation of the measurement does not exceed a specified value, usually 10
percent.nonconformance-a deficiency in characteristic, documentation, or procedure that renders the quality ofan item or activity unacceptable or indeterminate performance-based approach-Definition of the analytical data needs and criteria of a project in terms ofmeasurable goals during the planning phase of a project.  In a performance-based approach, theproject-specific data objectives that are determined during a DIRECTED PLANNING PROCESS
serve asmeasurement performance criteria for selections and decisions regarding the conduct of thelaboratory analyses.  The project-specific analyti cal data objectives are also used for the initial,ongoing, and final evaluation of the laboratory's performance and the laboratory data.  In methodselection, a performance-based approach is the process wherein a validated method is selectedbased on a demonstrated capability to meet defined quality and laboratory performance criteria.performance evaluation (PE) program-A laboratory's participation in an internal or external programof analyzing performance-testing samples appropriate for the analytes and matrices under consideration (i.e., PE program traceable to a national standards body, such as the NationalInstitute of Standards and Technology (NIST) in the United States).  Reference-material samplesused to evaluate the performance of the laboratory are called performance-evaluation orperformance-testing samples or materials.  See CERTIFIED REFERENCE MATERIAL
and STANDARDREFERENCE MATERIAL
.
Rev. 2 of RG 4.15, Page 21 performance indicator-Instrument- or protocol-related parameter routinely monitored to assess thelaboratory's estimate of controls such as chemical yield, instrument background, UNCERTAINTY
,PRECISION , and BIAS.  See BACKGROUND
, INSTRUMENT
.performance testing
-See PERFORMANCE EVALUATION PROGRAM
.precision-The closeness of agreement between independent test results obtained by applying theexperimental procedure under stipulated conditions.  Conversely, imprecision is the variation of the results in a set of REPLICATE measurements.  Precision may be expressed as the standard deviation (IUPAC, Ref. 41).
quality assurance (QA)-An integrated system of management activities involving planning,implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected.  Quality assurance includes QUALITY CONTROL.quality assurance project plan (QAPP)-A formal document describing in detail the necessary QUALITY ASSURANCE , QUALITY CONTROL, and other technical activities that must be implemented to ensurethat the results of the work performed will satisfy the stated performance criteria.  The QA projectplan describes policy, organization, and functional activities and the DATA QUALITY OBJECTIVESand measures necessary to achieve adequate data for use in selecting the appropriate remedy.


and receipt of samples for offsite analysis:
quality control (QC)-The overall system of technical activities that measures the attributes andperformance of a process, item, or service against defined standards to verify that they meet thestated objectives established by the project; opera tional techniques and activities that are used tofulfill objectives for quality.  This system of activities and checks is used to ensure thatmeasurement systems are maintained within prescribed limits, providing protection against out-of- control conditions and ensuring that the results are of acceptable quality.
preparation and analysis of samples: maintenance, storage. and use of radioactive refer-ence standards;  
calibration and checks of radiation and radioactivity measurement systems: and reduc-tion. evaluation, and reporting of data. Individuals who review and approve these procedures should be knowledgeable in the subjects of the procedures.


Guidance on principles and good practice in many of these activities is presented in NRC regulatory guides (Refs.4-7)  
quality control (QC) sample-An uncontaminated SAMPLE matrix spiked with known amounts of analytesfrom a source independent of the calibration standards.
and other publications (Refs. 2.3.8-25). In addition to these publications, the American Public Health Association is preparing a book on quality assurance practices in health laboratories that will include a chapter on radiochemistry.


and Scien-tific Committee
quality system-A structured and documented management system describing the policies, objectives,principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The qualitysystem provides the framework for planning, implementing, and assessing the work performed byan organization and for carrying out required QUALITY ASSURANCE
18A of the NCRP is preparing a manual of radioactivity measurement procedures that will be a revision of NCRP Report 28, NBS Hand-book 80, "'A Manual of Radioactivity Procedures." 4. Records The records necessary to document the activities performed in the monitoring program should be spec-ified in the quality assurance program.One key aspect of quality control is maintaining the ability to track and control a sample in its prog-ress through the sequence of monitoring processes.
and QUALITY CONTROL
activities (ANSI/ASQC E4-1994, Ref. 21).
readiness review-The formal process of performing a written or verbal assessment of key attributes of aprogram or project measured against defined minimum criteria, standards, or quality metrics beforeinitiation of activities under that project or program.


4.15-3 Records to accomplish this should cover the follow-* ing proce.sses:
record-A retrievable document that furnishes objective evidence of the quality of products, services, or activities and that has been verified and authenticated as technically complete and correct.
field and inplant sample collection and sample description;
sample receipt and laboratory identification coding, sample preparation and* radiochcmical processing (e.g., laboratory note-books); radioactivity measurements (counting)
of* samples, instrument backgrounds.


and analytical blanks. and data reduction and verification.
rem-The common unit for the effective or equivalent dose of radiation received by a living organism,equal to the actual dose (in rads) multiplied by a factor representing the danger of the radiation. Rem is an abbreviation for roentgen equivalent man, meaning that it measures the biological effectsof ionizing radiation in humans.  One rem is equal to 0.01 Sv.  See SIEVERT and DOSE EQUIVALENT
.
Rev. 2 of RG 4.15, Page 22 replicates-Two or more ALIQUANTS of a homogenous SAMPLE whose independent measurements are usedto determine the PRECISION of laboratory preparation and analytical procedures.


Quality control records for laboratory counting sys-tems should include the results of measurements of radioactive check sources, calibration sources, back-grounds. and blanks.Records relating to overall laboratory performance should include the results of analysis of quality con-trol samples such as analytical blanks, duplicates, interlaboratory cross-check samples and other quality control analyses;
reproducibility-The closeness of the agreement between the results of measurements of the sameparameter carried out under changed conditions of measurement. A valid statement ofreproducibility depends upon specification of the conditions changed. The changed conditionsmay include principle of measurement, method of measurement, observer (or analyst), measuring instrument, reference standard, location, conditions of use, and time.  Reproducibility may beexpressed quantitatively in terms of the dispersion ch aracteristics of the results. Results are usually understood to be corrected results.
use of standard (radioactive)
refer-ence materials to prepare working standards;
prepara-tion and standardization of carrier solutions;
and calibration of analytical balances.Additional records that are needed should include the calibration of inline radiation detection equip-ment. air samplers, and thermoluminescence dosimetry systems; verification and documentation of computer programs;
qualifications of personnel;
and results of. audits.The minimum period of retention of the records should be specified.


Only the final results of the monitoring programs need be retained for the life of the facility.5. Quality Control in Sampling (Including Packag-Ing, Shipping, and Storage of Samples)Continuous sampling of liquids and gases involves the measurement of sample flow rates and/or sample volumcs. The accuracy of the devices used for this purpose should be determined on a regularly sched-uled basis, and adjustments should be made as needed to bring the performance of the devices within specified limits. The results of these calibrations should be recorded.
required method uncertainty (u MR)-METHOD UNCERTAINTY
at a specified concentration. This is a keyMEASUREMENT QUALITY OBJECTIVE
.sample-(1) A portion of material selected from a larger quantity of material, or (2) a set of individualsamples or measurements drawn from a population whose properties are studied to gain information about the entire population.


The frequency of these calibra-tions should be specified and should be based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the* measurement.
sievert (Sv)-The Systme International (SI) unit for the effective dose of radiation received by a livingorganism.  This unit represents the actual dose received (GRAYS in SI or rads in traditional units)times a factor that is larger for more dangerous forms of radiation.  One Sv is 100
REM.  Radiationdoses are often measured in mSv.  An effective dose of 1 Sv requires 1 GRAY of beta or gammaradiation, but only 0.05 Gy of alpha radiation or 0.1 Gy of neutron radiation.


Continuous sampling should be dem-onstrably representative of the material volumes sam-pled. The collection efficiencies of the samplers used should be documented.
source, radioactive-A quantity of material configured for radiation measurement.


Grab samples should be demonstrably representa- tive of the material sampled, and replicate samples should be taken periodically to demonstrate the re-producibility of sampling.Procedures for sampling, packaging, shipping, and storage of samples should be designed to maintair (l;!: integrity of the sample from time of collection t, timc of analysis.
spike-A known amount of TARGET ANALYTE added to the environmental sample to establish whether themethod or procedure is appropriate for the analysis of the particular matrix and how the TARGET ANALYTE responds when the environmental sample is prepared and measured, thereby estimatingthe bias introduced by the sample matrix.  Also termed MATRIX SPIKE
.standard reference material
-A CERTIFIED REFERENCE MATERIAL issued by NIST in the United States. NIST certifies a standard reference material for specific chemical or physical properties and issues it with a certificate that reports the results of the characterization and indicates the intended use ofthe material.


Aqueous samples may present a particu-lar problem in this regard, and one of the most severe problems has been encountered with aqueous samples of radioactive wastes from operating nuclear reactors (Ref. 2 ).Guidance on the principles and practice of sam-pling in environmental monitoring is provided in sev-eral publications (Refs. 2,9.19). In addition, workers at the National Bureau of Standards (NBS) have pub-lished the results of a survey of information on sam-pling, sample handling, and long-term storage for environmental materials (Ref. 13). Some guidance on the principles and practice of air sampling is provided in References
surveillance-Continual or frequent monitoring and verification of the status of an activity and theanalysis of records to ensure that specified requirements are being fulfilled. A surveillance is lessextensive and more frequent than an AUDIT and concentrates on a single item or activity.
15, 17, and 22. Guidance on the prin-ciples and practice of water sampling is provided in numerous publications (Refs. II, 12, 23-25).6. Quality Control in the Radioanalytical Labora-tory 6.1 Radionuclide Reference Standards-Use for Calibration of Radiation Measuretnenit Systemns Reference standards are used to determine counting efficiencies for specific radionuclides or, in the case of gamma-ray spectrometry systems, to determine counting efficiency as a function of gamma-ray energy. A counting efficiency value is used to con-vert a sample counting rate to the disintegration rate of a radionuclide or to a radionuclide concentration.(Guidance on calibration and usage of germanium de-tectors for measurement of gamma-ray emission rates of radionuclides is being prepared by a writing group of the Health Physics Society Standards Committee for publication as an ANSI Standard.)
Radionuclide standards that have been certified by the NBS, or standards that have been standardized using a measurement system that is traceable to that of the NBS,* should be used when such standards are*For a discussion by NBS staff members of the concept of traceability of radioactivity measurements to NBS, see Refer-ence 27.A brief summary of this discussion is as follows: There are both direct and indirect traceability.


Direct traceability to NBS exists when. any outside laboratory prepares a batch of calibrated radioactivity standards and submits several randomly selected samples to NBS for confirmation or verification.
survey-A systematic evaluation and documentation of radiological measurements with a correctlycalibrated instrument or instruments that meet the sensitivity required by the objective of the evaluation.


Indi.rect traceability to NBS exists when NBS provides "unknown" calibrate radioactivity samples to one or more laboratories which in turn make measurements of activity that agree within certain specified limits with those of NBS. Thus there can be 1%, etc., traceability.
target analyte
-A radionuclide on the list of radionuclides of in terest or a radionuclide of concern for a project.test source-The final radioanalytical processing product or ma trix (e.g., precipitate, solution, filter) that isintroduced into a measurement instrument.  A test source is prepared from laboratory samplematerial for the purpose of determining its radioactive constituents.  See CALIBRATION SOURCE
, CHECK SOURCE , and SOURCE , RADIOACTIVE
.
Rev. 2 of RG 4.15, Page 23 total effective dose equivalent (TEDE)-The sum of the effective dose equivalent (for external exposure)and the committed effective dose equivalent (for inte rnal exposure), expressed in units of Sv or rem (MARSSIM, Ref. 28).  See DOSE EQUIVALENT
.uncertainty-A parameter, usually associated with the result of a measurement, that characterizes thedispersion of the values that could reasonably be attributed to the measurement of interest (Chapter 19 of MARLAP, Ref. 20).
validation
-(1) Data validation, the evaluation of data to determine the presence or absence of an analyte and to establish the UNCERTAINTY of the measurement process for contaminants of concern. Datavalidation qualifies the usability of each datum (after interpreting the impacts of exceptions identified during data VERIFICATION) by comparing the data produced with the MEASUREMENTQUALITY OBJECTIVES and any other analytical process criteria contained in the ANALYTICALPROTOCOL SPECIFICATIONS
developed in the planning process.  (2)
Software validation, theconfirmation by examination and provision of objective evidence that the particular criteria for a


Regular use of NBS radioactivity standards by an outside laboratory to calibrate its measuring equipment does not, in the view of the NBS staff, constitute traceability.
specific intended use are fulfilled.  Validation for a system is the set of activities ensuring andgaining confidence that the system is able to accomplish its intended use, goals, and objectives (ISO/IEC 15288-2002, Ref. 42).
verification
-(1) Data verification, a process that ensures that laboratory conditions and operations werecompliant with the statement of work, sampling and analysis plan, and QUALITY ASSURANCE
PROJECT PLAN and that identifies problems, if present, that should be investigated during datavalidation.  Data verification compares the material delivered by the laboratory to these criteria (compliance) and checks for consistency and comparability of the data throughout the data packageand for completeness of the results to ensure that all necessary documentation is available.  (2)
Software verification, the confirmation by examination and provision of objective evidence that specified criteria have been fulfilled.  A set of activities compares a system life cycle productagainst the necessary characteristics for that product.  The system life cycle products may include,but are not limited to, specified criteria, design description, and the system itself (ISO/IEC 15288-


Only when the outside laboratory can measure the activity of an unknown sample and send back values to NBS that agree with NBS values within a certain specified range of error does NBS consider that traceability has been established.
2002, Ref. 42).
8 All NRC regulations listed herein are available electronically through the Public Elect ronic Reading Room on theNRC's public Web site, at http://www.nrc.gov/reading-rm/doc-collections/cfr/.  Copies are also available forinspection or copying for a fee from the NRC's Public Document Room at 11555 Rockville Pike, Rockville, MD;
the PDR's mailing address is USNRC PDR, Washi ngton, DC 20555; telephone (301) 415-4737 or (800) 397-4209;
fax (301) 415-3548; email PDR@nrc.gov
.9This regulation is available electronically through the U.S. Environmental Protection Agency's public Web site, at http://www.epa.gov/epacfr40/chapt-I.info/
.10 Purchase information is available through the American Society of Mech anical Engineers (ASME) Web site at http://catalog.asme.org/Codes/PrintBook/NQA1_1994_Quality_Assurance.cfm
.Rev. 2 of RG 4.15, Page 24 REFERENCES1.10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities,"U.S. Nuclear Regulatory Commission, Washington, DC.


NBS notes that this condition can be achieved without using a single NBS standard.4.15-4 available.
82.10 CFR Part 52, "Licenses, Certifications, and A
pprovals for Nuclear Power Plants," U.S. NuclearRegulatory Commission, Washington, DC.


Otherwise, standards should be obtained from other reputable suppliers.
83.10 CFR Part 61, "Licensing Requirements for Land Disposal of Radioactive Waste," U.S. NuclearRegulatory Commission, Washington, DC.


An "International Di-rectory of Certified Radioactive Materials" has been publi.;hcd by the International Atomic Energy Agency (Ref. 26).Acceptable standards for certain natural radionuc-lides may be prepared from commercially available high-purity chemicals.
84.10 CFR Part 72, "Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reacto r-Related Greater Than Class C Waste,"U.S. Nuclear Regulatory Commission, Washington, DC.


For example, potassium-40
85.10 CFR Part 76, "Certification of Gaseous Diffusion Plants," U.S. Nuclear RegulatoryCommission, Washington, DC.
standards for gross beta measurements or gamma-ray spectrometry may be prepared from dried reagent-grade potassium chloride.The details of the preparation of working standards from certified standard solutions should be recorded.The working standard should be prepared in the same form as the unknown samples, or close approxima- tion thereto.Efficiency calibrations should he checked periodi-cally (typically monthly tc yearly) with standard sources. In addition, these checks should be made whenever the need is indicated, such as when a sig-nificant change in the measurement system is de-tected by routine measurements with a check source.6.2 Performance Checks of Radiation Measure-Inenit Systems Determination of the background counting rate and the response of each radiation detection system to ap-propriate check sources should be performed on a scheduled basis for systems in routine use. The re-sults of these measurements should be recorded in a log and/or plotted on a control chart. Appropriate in-vestigative and corrective action should be taken when the measurement value falls outside the pre-determined control value.A check source for determining changes in count-ing rate or counting efficiency should be of sufficient radiochemical purity to allow correction for decay but need not have an accurately known disintegration rate, i.e., need not be a standard source.For systems in which samples are changed manu-ally, check sources are usually measured daily. For systems with automatic sample changers, it may be more convenient to include the check source within each batch of samples and thus obtain a measurement of this source within each counting cycle. For propor-tional counter systems, the plateau(s)
should be checked after each gas change. Background meas-urements should be made frequently to ensure that levels arc within the expected range. For systems with automatic sample changers, background mncas-urements should be included within each counting cycle.For alpha- and gamma-ray spectrometry systems, energy-calibration sources (i.e.. a source containing a radionuclide.


or mixture of radionuclides.
86.10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material,"U.S. Nuclear Regulatory Commission, Washington, DC.


emitting two or more alpha or gamma rays of known energies)arc counted to determine the relationship between channel number and alpha- or gamma-ray energy.The frequency of these energy calibration checks de-pends on the stability of the system but usually is in the range of daily to weekly. The results of these should be recorded and compared to predetermined limits in order to determine whether or noi system gain and zero level need adjustment.
87.10 CFR Part 40, "Domestic Licensing of Source Material," U.S. Nuclear Regulatory Commission, Washington, DC.


Ad-justmients should be made as necessary.
88.10 CFR Part 70, "Domestic Licensing of Special Nuclear Material," U.S. Nuclear RegulatoryCommission, Washington, DC.


Additional checks needed for spectrometry systems are the energy resolution of the system and the count rate (or counting efficiency)
89.10 CFR Part 20, "Standards for Protection Against Radiation," U.S. Nuclear RegulatoryCommission, Washington, DC.
of a check source. These should be determined periodically (usually weekly to nmonthly for energy resolution and daily to weekly for count rate) and after system changes, such as power failures or repairs, to determine if there has been any significant change in the system. The results of these measurements should be recorded.6.3 Analysis of Quality' Control Samples The analysis of quality control samples provides a means to determine the precision and accuracy of the monitoring processes and include!, both intralabora- tory and interlaboratory measurements.


The analysis of replicate samples provides a means to determine precision:
810.40 CFR Part 190, "Environmental Radiation Prot ection Standards for Nuclear Power Operations,"U.S. Environmental Protection Agency, Washington, DC.
the analysis of samples con-taining known concentrations of radionuclides pro-vides a means to deter'mine accuracy.


The analysis of laboratory blanks provides a means to detect and measure radioactive contamination of analytical sam-ples, a common source of error in radiochemical analysis of low-level samples. The analysis of analyt-ical blanks also provides information on the adequacy of background subtraction, particularly for samples measured by gamma-ray spectrometry.
911.ASME NQA-1-1994, "Quality Assurance Program Requirements for Nuclear Facilities(with Addenda)," American Society of M
echanical Engineers, New York, NY, 1994.


The fraction of the analytical effort needed for the analysis of quality control samples depends to a large extent on (I) the mixture of sample types in a particu-lar laboratory in a particular time period and (2) the history of performance of that laboratory in the anal-ysis of quality control samples. H6wever, in general it is found that at least 5%, and typically
10
10%, of the analytical load should consist of quality control samples.4.15-5
11 Generic Letter 79065 is available electronically through the NRC's public Web site at http://www.nrc.gov/reading-rm/
6.3.1 Intralaboratory Analyses Replicate samples, usually duplicates, should be analyzed routinely.
doc-collections/gen-comm/
gen-letters/1979/gl79065.html
.12All regulatory guides listed herein were published by the U.S. Nuclear Regulatory Commission or its predecessor,the U.S. Atomic Energy Commission.  Most are available electronically through the Electronic Reading Room on the NRC's public Web site, at http://www.nrc.gov/reading-rm/
doc-collections/reg-guides/.  Active guides may bepurchased from the National Technical Information Service (NTIS).  Details may be obtained by contacting NTIS at5285 Port Royal Road, Springfield, Virginia 22161, online at http://www.ntis.gov, by telephone at (800) 553-NTIS(6847) or (703) 605-6000, or by fax to (703) 605-6900. Copies are also available for inspection or copying for a fee from the NRC's Public Document Room (PDR), which is located at 11555 Rockville Pike, Rockville, Maryland; thePDR's mailing address is USNRC PDR, Washington, DC 20555-0001. The PDR can also be reached by telephone at(301) 415-4737 or (800) 397-4209, by fax at (301) 415-3548, and by email to PDR@nrc.gov
.13 Copies of all ISO publications cited in this document may be purchased from ISO in Geneva, Switzerland.


These replicates should be pre-pared from samples that are as homogeneous as pos-sible, such as well-stirred or mixed liquids (water or milk) and solids (dried, ground, or screened soil, sed-iment, or vegetation;
Purchase information is availa ble through the ISO Web site at http://www.iso.org/iso/en/ISOOnlin
or the ash of these materials).
The size and other physical and chemical characteris- tics of the replicate samples should be similar to those of single samples analyzed routinely.


The analysis of the replicate samples as blind re-plicates is desirable but is not practicable for all lab-oratories or for all types of samples. For example, in small laboratories it may not be practicable to prevent the analysts from being aware that particular samples are replicates of one another.Obtaining true replicates of all types .of samples also is not practicable.
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.14Copies of all EPA quality system publications are available for download free of charge from the EPA public Web site at http://www.epa.gov/quality/qa_docs.html
.Rev. 2 of RG 4.15, Page 2512.Generic Letter 79065, "Radiological Assessment Branch Technical Position on RadiologicalEnvironmental Monitoring," Revision 1, U.S. Nuclear Regulatory Commission, Washington, DC,
November 27, 1979.


For example, obtaining repli-cate samples of airborne materials usually is not prac-ticable on a routine basis because it requires either a separate sampling system or splitting a single sample (e.g., cutting a filter in half). Use of replicate samplers usually is not economically feasible and splitting of samples results in replicates that do not represent the usual sample size or measurement con-figuration (counting geometry)
1113.Regulatory Guide 1.21, "Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-CooledNuclear Power Plants," U.S. Nuclear Regulatory Commission, Washington, DC.
for direct measure-ment. However, simulated samples of airborne mate-rials may be prepared in replicate and submitted for analysis as unknowns.Analysis of intralaboratory blank and spiked sam-ples is an important part of each laboratory's quality control program. A known analytical blank sample should be analyzed with each group of unknown samples that is processed radiochemically to deter-mine a specific radionuclide or radionuclides.


Spiked and blank samples should be submitted for analysis as unknowns to provide an intralaboratory basis for estimating the accuracy of the analytical results.These blanks and spikes may include blind replicates.
1214.Regulatory Guide 4.1, "Programs for Monitoring Radioactivity in the Environs of Nuclear PowerPlants," U.S. Nuclear Regulatory Commission, Washington, DC.


6.3.2 Interlaboratvry Analyses Analysis of effluent and environmental samples split with one or more independent laboratories is an important part of the quality assurance program be-cause it provides a means to detect errors that might not be detected by intralaboratory measurements alone. When possible, these independent laboratories should be those whose measurements are traceable to NBS (Ref. 27).Analysis of split field samples, such as samples of milk, water, soil or sediment, and vegetation, is par-ticularly important in environmental monitoring pro-grams to provide an independent test of the ability to measure radionuclides at the very low concentrations present in most environmental samples.The NRC Office of Inspection and Enforcement conducts a Ccnfirmatory Measurements Program for laboratories of licensees that measure nuclear reactor effluents.
1215.Regulatory Guide 4.14, "Radiological Effluent and Environmental Monitoring at Uranium Mills,"U.S. Nuclear Regulatory Commission, Washington, DC.


The analyses of liquid waste holdup tank samples, gas samples, charcoal cartridges, and stack particulate filters are included in this program. The results of the licensee's measurements of samples split with the NRC are compared to those of an NRC reference laboratory whose measurements are trace-able to the National Bureau of Standards (Ref. 27).Thus the results of this comparison provide to the NRC an objective measure of the accuracy of the licensee's analyses.Laboratories of licensees or their contractors that perform environmental measurements should partici-pate in the EPA's Environmental Radioactivity Lab-oratory Intercomparison Studies (Cross-check)
1216.Regulatory Guide 4.16, "Monitoring and Reporting Radioactivity in Releases of RadioactiveMaterials in Liquid and Gaseous Effluents from Nuclear Fuel Processing and Fabrication Plantsand Uranium Hexafluoride Production Plants," U.S. Nuclear Regulatory Commission, Washington, DC.1217.ISO/IEC 17025-2005, "General Requirements for the Competence of Testing and Calibration Laboratories," International Standards Organization/International Electrotechnical Commission,Geneva, Switzerland, May 2005, Correction 1, August 2006.
Pro-gram, or an equivalent program. This participation should include all of the determinations (sample medium/radionuclide combinations)
that are both of-fered by EPA and included in the licensee's environ-mental monitoring program. Participation in the EPA program provides an objective measure of the accu-racy of the analyses because the EPA measurements are traceable to the National Bureau of Standards.


If the mean result of a cross-check analysis exceeds the control limit as defined by EPA (Ref. 28), an investi-gation should be made to determine the reason for this deviation and corrective action should be taken as necessary.
1318.EPA QA/G-4-2006, "Guidance on Systematic Planning Using the Data Quality ObjectivesProcess," U.S. Environmental Protection Agency, Washington, DC, EPA 240/B-06/001, February 2006.


Similarly, an investigation and any necessary corrective action should take place if the"normalized range." as calculated by EPA, exceeds the control limit, as defined by EPA. A series of re-sults that is within the control limits but that exhibits a trend toward these limits may indicate a need for an investigation to determine the reason for the trend.6.4 Compuitational Checks Procedures for the computation of the concentra- tion of radioactive materials should include the inde-pendent verification of a substantial fraction of the results of the computation by a person other than the one performing the original computat'on.
1419.EPA QA/G-5-2002, "Guidance for Quality Assurance Project Plans," U.S. EnvironmentalProtection Agency, Washington, DC, EPA/240/R-02/009, December 2002.


For com-puter calculations, the input data should be verified by a knowledgeable individual.
1420.NUREG-1576 (MARLAP), "Multi-Agency Radiological Laboratory Analytical ProtocolsManual," Volumes 1-3, U.S. Nuclear Regulatory Commission, Environmental Protection Agency, Department of Energy, Department of Defense, Department of Homeland Security, National
15Copies are available electronically through NRC's public Web site at http://www.nrc.gov/reading-rm/doc-collections/
nuregs/staff/sr1576/
and from EPA's public Web site at http://www.epa.gov/radiation/marlap/links.htm
.16 Copies of all ANSI publications cited in this document may be purchased from the American National Standards Institute, 1819 L Street, NW, 6 th floor, Washington, DC 20036.  Purchase information is available through the ANSIWeb site at http://webstore.ansi.org/ansidocstore/default.asp
.17Copies of all NIRMA Technical Guidance documents cited herein may be purchased from the Nuclear Information and Records Management Association, Inc., 10 Almas Road, Windham, NH; telephone (603) 432-6476;
fax (603) 432-3024; see the NIRMA Web site at http://www.nirma.org/member/publications.htm
.18Copies of this standard are available for purchase from the HPS Web site at http://hps.org/hpssc/n13standards.html
.Rev. 2 of RG 4.15, Page 26Institute of Standards and Technology, U.S. Geological Survey, and Food and DrugAdministration, Washington, DC, July 2004.


All computer pro-grams should be documented and verified before ini-tial routine use and after each modification of the program. The verification process should include ver-ification, by a knowledgeable individual, of the al-gorithm used and test runs in which the output of the computer computation for given input can be com-pared to "true" values that are known or determined
1521.ANSI/ASQC E4-1994, "Specifications and Guidelines for Quality Systems for Environmental DataCollection and Environmental Technology Programs," American National Standards Institute/American Society for Quality Control, New York, NY, 1994.
4.15-6 independently of the computer calculation.


Documen-tation of the program should include a description of the algorithm and a current listing of the program.Guidelines for the documentation of digital computer programs are given in ANSI N413-1974 (Ref. 29).7. Quality Control for Continuous Effluent Monitoring Systems The specified frequency of calibration for a par-ticular system should he based on considerations of the nature and stability of that system. For nuclear power plants, specific requirements for calibrations and checks of particular effluent monitoring systems usu-ally are included in the technical specifications for the plant.Initial calibration of each measuring system should be performed using one or more of the reference standards that are certified by the National Bureau of Standards or that are calibrated by a measurement system that is traceable to that of the National Bureau of Standards (Ref. 27). For nuclear power plants, these calibrations are usually repeated at least annu-ally. The radionuclide standards should permit calib-rating the system over its intended range of energy and rate capabilities.
1622.ANSI N42.23-2003, "Measurement and Associated Instrumentation Quality Assurance forRadioassay Laboratories," American National Standards Institute, New York, NY, 2003.


Periodic inplant calibration should be performed using a secondary source or method that has been related to the initial calibration.
1623.NIRMA TG11, "Authentication of Records and Media," Nuclear Information and RecordsManagement Association, Inc., Windham, NH, 1998.


For nuclear power plants, these calibrations are usu-ally performed at least monthly.Periodic correlations should be made during opera-tion to relate monitor readings to the concentrations and/or release rates of radioactive material in the monitored release path. These correlations should be based on the results of analyses for specific radionuc-lides in grab samples from the release path.Flow-rate measuring devices associated with the system should be calibrated to determine actual flow rates at the conditions of temperature and pressure under which the system will be optrated.
1724.NIRMA TG15, "Management of Electronic Records," Nuclear Information and RecordsManagement Association, Inc., Windham, NH, 1998.


These flow rate devices should be recalibrated periodically.
1725.NIRMA TG16, "Software Configuration Management and Quality Assurance," NuclearInformation and Records Management Association, Inc., Windham, NH, 1998.


Whenever practicable, a check source that is ac-tuated remotely should be installed for integrity cheeks of the detector and the associated electrical system.8. Review, Analysis, and Reporting Data Procedures for review, analysis, and reporting of data should include examinatiuns for reasonableness and consistency of the data and investigative and corrective actions to be taken under specified circumstances.
1726.NIRMA TG21, "Electronic Records Protection and Restoration," Nuclear Information and RecordsManagement Association, Inc., Windham, NH, 1998.


9. Audits Planned and periodic audits should be made to ver-ify implementation of the quality assurance program.The audits should be performed by qualified indi-viduals who do not have direct responsibilities in the areas being audited.Audit results should be documented and reviewed by management having responsibility in the area au-dited. Followup action, including reaudit of deficient areas, should be taken where indicated.
1727.HPS/ANSI N13.1-1999, "Sampling and Monitoring Releases of Airborne Radioactive Substancesfrom the Stacks and Ducts of Nuclear Facilities," Health Physics Society (HPS), McLean, VA, 1999.1828.NUREG-1575 (MARSSIM), "Multi-Agency Radiation Survey and Site Investigation Manual,"
Revision 1 (EPA 402-R-97-016 Revision 1, DOE/E
H-0624 Revision 1), U.S. Nuclear RegulatoryCommission, Environmental Protection Agency, Department of Energy, Washington, DC,
August 2000.


==D. IMPLEMENTATION==
1529.EPA QA/G-9S-2006, "Data Quality Assessment:  Statistical Tools for Practitioners," U.S.Environmental Protection Agency, Washington, DC, EPA/240/B-06/003, February 2006.
The purpose of this section is to provide informa-tion to applicants and licensees regarding the NRC staff's plans for using this regulatory guide.This guide reflects current NRC staff practice.Therefore, except in those cases in which the appli-cant or licensee proposes an acceptable alternative method, the staff will use the method described herein in evaluating an applicant's or licensee's ca-pability for and performance in complying with spec-ified portions of the Commission's regulations until this guide is revised as a result of suggestions from the public or additional staff review.4.15-7 REFERENCES
I. Section 6.2, "Validation of Analyses," Chapter 6, "Validity of Results," Methods of Radiochewnical Analysis, World l-ealth Organization, Geneva, 1966.2. "Analytical Quality Control Methods," Environ-mental Radioactivity Surveillance Guide, U.S. En-vironniental Protection Agency Report, ORP/SID 72-2, June 1972.3. Environmental Ra,.'iation Measurements, Report of NCRP SC.35, NCRP Report No. 50, 1976.4. Regulatory Guide 1.21, "Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Re-leases of Radioactive Materials in Liquid and Gase-ous Effluents from Light-Water-Cooled Nuclear Power Plants." 5. Regulatory Guide 4.5, "Measurements of Radionuclides in the Environment-Sampling and Analyses of Plutonium in Soil." 6. Regulatory Guide 4.6, "Measurements of Radionuclides in the Environment-Strontium-89 and Strontium-90
Analyses." 7. Regulatory Cuide 4.13, "Performance, Testing, and Procedural Specifications for Thermolumines- cence Dosimetry:
Environmental Applications." 8. HASL Procedures Manual, U.S. Energy Research and Development Administration Report, HASL-300, 1972 (updated annually).
9. A Guide for Environmental Radiological Surveil-lance at ERDA Installations, Energy Research and Development Administration Report, ERDA 77-24, March 1977.10. Handbook of Radiochemical Analytical Methods, U.S. Environmental Protection Agency Report, EPA-680/4-75-001, February 1975.I1. Standard Methods for the Examination of Water and Wastewater, Thirteenth Edition, American Pub-lic Health Association, 1975.12. Handbook for Sampling and Sample Preservation of Water and Wastewater, U.S. Environmental Pro-tection Agency Report, Office of Research and De-velopment, Environmental Monitoring Support Lab-oratory, EPA-200/4-76-049.


September
14
1976i 13. E. J. Maienthal and D. A. Becker, "A Survey on Current Literature on Sampling, Sample Handling, and Long-Term Storage for Environmental Materials," Interface
19Copies of all ASTM standards cited herein may be pur chased from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA
5 (#4), 49-62 (1976). Also available from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402, as NBS Technical Note #929, October 1976, C 13.46:929, S/N 003.003-01694-2.
19428-2959; see the ASTM International Web-based standards search tool at http://www.astm.org/cgi-bin/SoftCart.exe/NEWS
ITE_JAVASCRIPT/index.shtml?L+mystore+qkyo3147+117461063
.20 Copies of this standard are available for purchase from the IEEE Web site athttp://standards.ieee.org/db/status/inde


14. Tritium Measure.'ent Techniques, Report of NCRP SC-36, NCRP Report No. 47, 1976.15. "Guide to Sampling Airborne Radioactive Mate-rials in Nuclear Facilities," ANSI N 13.1-1969.
====x. shtml====
.21Copies of this directive are available electronically from the EPA's public Web site


16. "Specification and Performance of On-Site In-strumentation for Continuously Monitoring Radioac-tivity in Effluents," ANSI N13.10-1974.
at http://www.epa.gov/irmpoli8/archived/irm_galp/
.Rev. 2 of RG 4.15, Page 2730.ASTM D7282-2006, "New Standard Practice for Setup, Calibration, and Quality Control ofInstruments Used for Radioactivity Measurements," American Society for Testing and Materials, West Conshohocken, PA, 2006.


17. Air Sampling Instruments for Evaluation of At-mospheric Contaminants, Fourth Edition, American Conference of Industrial Hygienists, 1972.18. Users' Guide for Radioactivity Standards.
1931.ASTM MNL 7A-2002, "Manual on Presentation of Data and Control Chart Analysis," 7 th Edition,American Society for Testing and Materials, West Conshohocken, PA, 2002.


Sub-committee on Radiochemistry and Subcommittee on the Use of Radioactivity Standards, Committee on Nuclear Science, National Academy of Sciences-National Research Council Report, NAS-NS-3115, February 1974.19. Environmental Impact Monitoring for Nuclear Power Plants, Source Book of Monitoring Methods, Vol. I, Atomic Industrial Forum Report, AIF/NESP-004, February 1975.20. Instrumentation for Environmental Monitoring:
1932.ANSI N42.22-1995, "Traceability of Radioactive Sour ces to the National Institute of Standards andTechnology (NIST) and Associated Instrument Quality Control," American National Standards
Radiation, Lawrence Berkeley Laboratory Report, LBL-l, Vol. 3, First Ed., May 1972; First update, February 1973; Second update, October 1973.21. C. W. Sill, "Problems in Sample Treatment in Trace Analysis." National Bureau of Standards Spe-cial Publication
4-22, Accuracy in Trace Analysis: Sampling, Sample Handling.


and Analysis, pp. 463-490, August 1976.22. "General Principles for Sampling Airborne Radioactive Materials," International Standard, ISO-2889, 1975.23. Manual of Methods for Chemical Analysis of Water and Wastes, EPA-625/6-74-003, U.S. En-vironmental Protection Agency, Office of Technol-ogy Transfer, Washington, D.C. 20460, 1974.24. Annual Book of ASTM Standards (Part 31), Wa-ter, American Society for Testing and Materials, Method D, 3370, pp. 71-82, Philadelphia, PA, July 1975.4.15-8
Institute, New York, NY, 1995 (R2002).
25. Biological Field and Laboratory, Methods for Measuring the Quality of Surface Waters and Effluents, EPA-670/4-73-001, Office of Research and Development, U.S. Environmental Protection Agency, Cincinnati, Ohio, July 1973.26. International Directory of Certified Radioactive Materials, International Atomic Energy Agency Re-port, STI/PUB/398, 1975.27. L. M. Cavallo et al.. "Needs for Radioactivity Standards and Measurements in Different Fields," Nuclear Instruments and Methods, Vol. 112, pp.5-18, 1973.28. Environmental Radioactivity Laboratory Inter-comparison Studies Program, FY 1977, EPA-600/4.
1633.ANSI N42.18-2004, "American National Standard Specification and Performance of On-SiteInstrumentation for Continuously Monitoring Radioactivity in Effluents," Institute of Electrical and Electronics Engineers, Inc., New York, NY, 1980 (R2004).
1634.EPA QA/G-8-2002, "Guidance on Environmental Da ta Verification and Data Validation," U.S.Environmental Protection Agency, Washington, DC, EPA/240/R-02/004, November 2002.


77-001, January 1977.29. "Guidelines for the Documentation of Digital Computer Programs," ANSI N413- 1974.4.15-9 APPENDIX A GLOSSARY A-ccurac'yv-normally refers to the difference (error or bias) between tile mean, K. of the set of results and the value *. which is accepted as the true or correct value for the quantity measured.
1435.IEEE 1063, "IEEE Standard for Software User Documentation," Institute of Electrical andElectronics Engineers, Inc. (IEEE), Piscataway, New Jersey, December 2001.


It is also used as the difference between an individual value X, and X.Absolhte acciuracy of the mean is given by and of an individual value by XrT.Relative accrwvr of the mean is given by t.-,)/:.Pr'rcentage is given by 100 ,Imd Blank (Sample) -ideally.
2036.EPA Directive 2185, "Good Automated Laboratory Practices," U.S. Environmental ProtectionAgency (EPA), Office of Information Resources Management, 1995.


a sample having all of the constituents of the unknown sample except those to be determined.
2137.Regulatory Guide 1.168, "Verification, Validation, Reviews, and Audits for Digital ComputerSoftware Used in Safety Systems of Nuclear Power Plants," U.S. Nuclear Regulatory Commission, Washington, DC.


In radioanalytical practice.the term often refers it) the radiochemical processing of carrier(s)
1238.ANSI N42.14-1999, "Calibration and Use of Germanium Spectrometers for the Measurement ofGamma-Ray Emission Rates of Radionuclides," Amer ican National Standards Institute, New York, NY, 1999.1639.International Organization for Standardization (ISO), "International Vocabulary of Basic andGeneral Terms in Metrology," 2 nd Edition, Geneva, Switzerland, 1993.
or tracers without the sample matrix ma-terial."Blind" Replivcat (Sample)-replicate samples that are not identified as replicates to the persons pcrform-ing the analysis.Calibrainon-the process of determining the numeri-cal relationship between the observed output of a measurement system and the value, based on refer-ence standards, of the characteristics being measured.Calibration Source-any radioactive source that is used for calibration of a measurement system.Check Source (or instrumnent check source, perform-anlce check source, or referJence source)-a radioac-tive source used to determine if the detector and all electronic components of the system are operating correctly.


Instrument Batckground--the response of the instru-ment in the absence of a radioactive sample or other radioactive source.Precision-relates to the reproducibility (f meas-urements within a set, that is. to the scatter or disper-son of a set about its central value.Quality Assurance (QA )-(the planned and systematic actions that are necessary to provide adequate confi-dence in the results of a monitoring program.Quaitiy Control (QC)-those quality assurance ac-tions that provide a means to control and measure the characteristics of measurement equipment and proc-esses to established requirements.
1340.ISO Guide 30, "Terms and Definitions Used in C
onnection with Reference Materials
,"International Organization for Standa rdization, Geneva, Switzerland, 1992.


Thus. quality as-surance includes quality control.Spiketd Sample-a sample to which a known amount of radioactive material has been added. Generally.
13
22Copies are available electronically through the IUPAC public Web site at http://www.iupac.org/publica tions/pac/1994/6612/index.html
.Rev. 2 of RG 4.15, Page 2841.International Union of Pure and Applied Chemistry (IUPAC), "Nomenclature for RadioanalyticalChemistry,"
Pure and Applied Chemistry , 66:12, pp. 2513-2526, 1994.


spiked samples are submitted as unknowns to the analysts.Split Sample-a sample that is divided into parts.each of which is analyzed independently by separate laboratory organizations.
2242.ISO/IEC 15288-2002, "System Engineering - System Life Cycle Processes," International Organization for Standardiza tion, Geneva, Switzerland, 2002.


Standard (radioactive)
13}}
Source-a radioactive source having an accurately known radionuclide content and radioactive disintegration rate or particle or photon emission rate.4.15-10}}


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Revision as of 22:30, 12 July 2019

Quality Assurance for Radiological Monitoring Programs (Inception Through Normal Operations to License Termination) - Effluent Streams and the Environment
ML071790506
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Issue date: 07/01/2007
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Office of Nuclear Regulatory Research
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Ridgely JN RES 415-6555
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References
DG-4010 RG-4.015, Rev 2
Download: ML071790506 (28)
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1Special terms used in this guide are marked in SMALL CAPITALS the first time they are used, and are definedin the glossary provided in this regulatory guide.The U.S. Nuclear Regulatory Commission (NRC) issues regulatory guides to describe and make available to the public methodsthat the NRC staff considers acceptable for use in implementing specific parts of the agency's regulations, techniques that thestaff uses in evaluating specific problems or postulated accidents, and data that the staff need in reviewing applications forpermits and licenses. Regulatory guides are not substitutes for regulations, and compliance with them is not required. Method sand solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.This guide was issued after consideration of comments received from the public.

Regulatory guides are issued in 10 broad divisions: 1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and MaterialsFacilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products

7, Transportation; 8, Occupational Hea lth;9, Antitrust and Financial Review; and 10, General.Electronic copies of this guide and other recently issued guides are available through the NRC's public Web site under theRegulatory Guides document collection of the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC's Agencywide Documents Access and ManagementSystem (ADAMS) at http://www.nrc.gov/reading-rm/adams.html , under Accession No. ML071790506.

U.S. NUCLEAR REGULATORY COMMISSION

July 2007 Revision 2 REGULATORY GUIDE

OFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 4.15 (Draft was issued as DG-4010, dated November 2006)

QUALITY ASSURANCE

FOR RADIOLOGICAL MONITORING PROGRAMS (INCEPTION THROUGH NORMAL OPERATIONS

TO LICENSE TERMINATION) -

EFFLUENT STREAMS AND THE ENVIRONMENT

A. INTRODUCTION

This regulatory guide describes a method that the U.S. Nuclear Regulatory Commission (NRC)considers acceptable for use in designing and implementing programs to ensure the quality of the resultsof measurements of radioactive materials in the effluents from, and environment outside of, facilities that process, use, or store radioactive materials during all phases of the facility's life cycle.

QUALITY ASSURANCE

1 (QA) is a fundamental expectation of Title 10, "Energy," of the Code of Federal Regulations (10 CFR) for items and activities that are relied on to protect the health and safetyof the public and the environment.This guide specifically applies to facilities for which NRC regulations require routine monitoringof radioactive effluents to the environment, and particularly those facilities licensed under the following regulations:*10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities" (Ref. 1)*10 CFR Part 52, "Licenses, Certifications, and Approvals for Nuclear Power Plants" (Ref. 2)

Rev. 2 of RG 4.15, Page 2*10 CFR Part 61, "Licensing Requirements for Land Disposal of Radioactive Waste" (Ref. 3)*10 CFR Part 72, "Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-R

elated Greater Than Class C Waste" (Ref. 4)*10 CFR Part 76, "Certification of Gaseous Diffusion Plants" (Ref. 5)The guide also may apply to other facilities licensed by the NRC, for which the agencymay impose specific license conditions for effluent or environmental monitoring, as deemed necessaryto ensure the health and safety of the public and the environment, including those licensed under the following regulations:*10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material"(Ref. 6)*10 CFR Part 40, "Domestic Licensing of Source Material" (Ref. 7)

  • 10 CFR Part 70, "Domestic Licensing of Special Nuclear Material" (Ref. 8)Finally, radiological standards for occupational workers and members of the public are codified in 10 CFR Part 20, "Standards for Protection Against Radiation" (Ref. 9).Although the specific regulations provide the actual requirements, the following presents anoverview of applicable NRC regulations addressing limits on radioactive effluents, environmental levels ofradioactivity, requirements for effluent and environmental monitoring, and associated QA.In accordance with 10 CFR 20.1301, "Dose Limits for Individual Members of the Public," theTOTAL EFFECTIVE DOSE EQUIVALENT (TEDE) to individual members of the public from licensed operationmust not exceed 1 milli SIEVERT [1 mSv, or 100 milli REM (mrem)] per year. Uranium fuel cycle facilities(excluding transportation and disposal) also must comply with the provisions that the U.S. EnvironmentalProtection Agency (EPA) established in 40 CFR Part 190, "Environmental Radiation Protection Standards for Nuclear Power Operations" (Ref. 10). In a ddition, 10 CFR 20.1101(d) requires licensees (other than those subject to 10 CFR 50.34a, "Design Objectives for Equipment to Control Releases of Radioactive Material in Effluents - Nuclear Power Reactors,"

discussed below) to restrict releases of airborneradioactive materials so that the highest individual dose to the public will not exceed 0.1 mSv (10 mrem)per year.In addition, under 10 CFR 20.1101(b), licensees must apply AS LOW AS REASONABLY ACHIEVABLE (ALARA) concepts to doses to occupational workers and members of the general public. In accordancewith 10 CFR 20.1302, "Compliance with Dose Limits for Individual Members of the Public," licensees must survey radiation levels to demonstrate compliance with the dose limits, and 10 CFR 20.1101,"Radiation Protection Programs," requires licensees to develop, document, and implement radiationprotection programs commensurate with the scope and ex tent of licensed activities and sufficient to ensurecompliance with the provisions of 10 CFR Part 20 (Ref. 9).In 10 CFR Part 20, Subpart E, "Radiological Criteria for License Termination," the NRC providesthe radiological criteria for license termination under unr estricted and restricted use scenario

s. The NRC

considers a site acceptable for unrestricted use if the residual radioactivity that is distinguishable frombackground radiation does not exceed 25 mrem/year (0.25mSv/year) TEDE to an average member of the critical group, including contributions from groundwater sources. A site can be released under restricteduse if the residual radioactivity that is distinguishable from background dose not exceed a yearly dose of25 mrem (0.25mSv) TEDE with site use restrictions in place.

Rev. 2 of RG 4.15, Page 3 For nuclear power reactors, 10 CFR 50.34a and 10 CFR 50.36a, "Technical Specifications onEffluents from Nuclear Power Reactors," require ALARA concepts for operations to maintain releases ofradioactive materials in effluents consistent with the guidelines of Appendix I, "Numerical Guides forDesign Objectives and Limiting Conditions for Operati on to Meet the Criterion 'As Low As Is ReasonablyAchievable' for Radioactive Material in Light-W

ater-Cooled Nuclear Power Reactor Effluents," to10 CFR Part 50. Licensees must also establish appropriate SURVEILLANCE and monitoring programs to provide QA with respect to (1) areas of equipment operation and (2) data on the quantities or concentrations of radionuclides released in liquid and gaseous effluents. These programs will help to ensure accurate projection of the levels of radiation and radioactive materials found in the environment.Section III.B of Appendix I addresses requirements concerning estimates of radioactive iodine in water andfood pathways if land use changes occur after plant construction.The regulations in 10 CFR 30.34, "Byproduct Material," 10 CFR 40.41, "Source Material,"

10 CFR 50.50, "Production and Utilization Facilities," and 10 CFR 70.32, "Special Nuclear Material,"

provide that the NRC may incorporate in any governed license such terms and conditions as it deemsappropriate or necessary to protect health.For land disposal of radioactive waste, 10 CFR 61.53, "Environmental Monitoring," requiresmeasurements and observations to be made and recorded to provide data to evaluate potential health andenvironmental impacts, including long-term effects, as well as the need for mitigating measures. Themonitoring system must be capable of providing early warning of releases of radionuclides from the disposal site. A postclosure monitoring program is also required to detect the release of radionuclides.According to 10 CFR 70.59, "Effluent Monitoring Reporting Requirements," licensees authorizedto possess and use special nuclear materials for processing and fuel fabrication, scrap recovery, conversionof uranium hexafluoride, or in a uranium enrichment facility shall report to the NRC the quantity of each of the principal radionuclides released to unrestricted areas in liquid and gaseous effluents, and otherinformation as the Commission may require to estimate maximum potential annual radiation doses to the public resulting from effluent releases.

Appendix A, "General Design Criteria for Nuclear Power Plants," to 10 CFR Part 50 includes several applicable general design criteria (GDC) aff ecting nuclear power plant designs. GDC 60, "Control of Releases of Radioactive Materials to the Environment," requires suitable means to control the release ofradioactive materials in gaseous and liquid effluents. GDC 64, "Monitoring Radioactivity Releases,"requires means for monitoring effluent discharge paths and the plant environs for radioactivity that may bereleased from normal operations, including anticipated operational occurrences, and from postulatedaccidents. GDC 1, "Quality Standards and Records," requires the establishment of a QA program for thosestructures, systems, and components that are important to safety to provide adequate assurance that theywill satisfactorily perform their safety functions. Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part 50 establishes the QA requirements for power plants.The requirements in 10 CFR 72.104, "Criteria for Radioactive Material in Effluent and DirectRadiation from an ISFSI [Independent Spent Fuel Storage Installation] or MRS [Monitored RetrievableStorage]," mandate operational restrictions for main taining effluents and direct radiation levels in accordance with ALARA concepts, with limits so as not to exceed annual DOSE EQUIVALENTS of .25 mSv(25 mrem) to the whole body, 0.75 mSv (75 mrem) to the thyroid, and 0.25 mSv (25 mrem) to any other critical organ of any real individual beyond the controlled area.For gaseous diffusion uranium enrichment facilities, 10 CFR 76.87, "Technical SafetyRequirements," requires licensees to establish technical safety requirements with procedures and equipment

2While not specific to QA, other regulatory guides that address measurements of radioactive materials in effluents and the environment include the following:*Regulatory Guide 1.21, "Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Releases ofRadioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power Plants" (Ref. 13)*Regulatory Guide 4.1, "Programs for Monitoring Radioactivity in the Environs of Nuclear Power Plants"(Ref. 14)*Regulatory Guide 4.14, "Radiological Effluent and Environmental Monitoring at Uranium Mills" (Ref. 15)*Regulatory Guide 4.16, "Monitoring and Reporting Radioactivity in Releases of Radioactive Materials in Liquid and Gaseous Effluents from Nuclear Fuel Processing and Fabrication Plants and Uranium Hexafluoride Production Plants" (Ref. 16)

Rev. 2 of RG 4.15, Page 4to address (among other things) building and pro cess ventilation and off-gassing, radioactive wastemanagement, and environmental protection. In addition, 10 CFR 76.93, "Quality Assurance," requires aQA program satisfying the applicable provisions of the American Society of Mechanical Engineers(ASME) standard QA-1-1994, "Quality Assurance Program Requirements for Nuclear Facilities (with

Addenda)" (Ref. 11).Generic Letter 79065 (Ref. 12), regarding the NRC's Radiological Assessment Branch TechnicalPosition on Radiological Environmental Monitoring, provides guidance on the appropriate type of, andlocation for, sampling and monitoring the environment surrounding nuclear power plants.This regulatory guide presents more complete and extensive guidance on QA for facilities whereradiological effluent or environmental monitoring is required by NRC regulations.

2 However, thisguidance does not address all topics and elements that a facility's QA program may require (such as requirements of Appendix B to 10 CFR Part 50 for nuclear power plants or 10 CFR 76.93 for gaseousdiffusion uranium enrichment facilities).The NRC issues regulatory guides to describe to the public methods that the staff considersacceptable for use in implementing specific parts of the agency's regulations, to explain techniques that thestaff uses in evaluating specific problems or postulate d accidents, and to provide guidance to applicants. Regulatory guides are not substitutes for regulations, and compliance with regulatory guides is not required.

Rev. 2 of RG 4.15, Page 5

B. DISCUSSION

As used in the context of this guide, QA comprises all those planned and systematic actions that arenecessary to provide adequate confidence in the ASSESSMENT of monitoring results. QUALITY CONTROL(QC) comprises those QA actions that provide a means to measure and control the characteristics ofmeasurement equipment and processes to meet established standards; QA includes QC. This guide makesno further effort to distinguish those elements that may be considered QC from those composing QA.Quality assurance is necessary to ensure that all radiological and nonradiological measurementsthat support the radiological monitoring program are reasonably valid and of a defined quality. Theseprograms are needed (1) to identify deficiencies in the sampling and measurement processes and reportthem to those responsible for these operations so that licensees may take CORRECTIVE ACTION

and (2) toobtain some measure of confidence in the results of the monitoring programs to assure the regulatory agencies and the public that the results are valid. All steps of the monitoring process should involve QA(e.g., sampling, shipment of SAMPLES, receipt of samples in the laboratory, preparation of samples,radiological measurements, data reduction, data evaluation, and reporting of the measurement andmonitoring results) .An effective overall management system for quality must precede the design of a QA program. Adocument by the International Organization for Sta ndardization (ISO/IEC 17025-2005, Ref. 17) is availablefor use by laboratories in developing their management system for quality, administrative, and technical operations. Once a quality management system is in place, a DIRECTED PLANNING PROCESS

can be used todefine the data objectives for the specific monitoring program. The DATA QUALITY OBJECTIVE (DQO)process (EPA QA/G-4-2006, Ref. 18) provides one exam ple of how to develop and define acceptance andperformance criteria for a sample collection, measurement, and data analysis program. The QUALITY ASSURANCE PROJECT PLAN (QAPP), which documents how data will be collected, assessed, and analyzed,can form the basis of a QA program (EPA QA/G-5-2002, Ref. 19). The QAPP provides a blueprint of where, when, why, and how a particular project will achieve data of the type and quality needed and expected.NUREG-1576, "Multi-Agency Radiological Laboratory Analytical Protocols Manual" (Ref. 20, hereafter referred to as MARLAP), contains guidance for developing DQOs for risk-informed decisions, and their consequent MEASUREMENT QUALITY OBJECTIVES (MQOs), in the context of radiochemicalanalyses of environmental samples. The same methodology can be applied in other environmental monitoring contexts. An example of a key MQO is the REQUIRED METHOD UNCERTAINTY

at a specified radiation dose or radionuclide concentration. The specific dose may be a fractional amount of a radiationdose limit. The specific concentration may be a fractional amount of an effluent release or environmentalradionuclide concentration. For either case, the fractional amount of the limit should be sufficiently small so that a licensee may take reasonable operational actions before the limit is exceeded. MARLAPrecommends a PERFORMANCE

-BASED APPROACH for selecting methods used to analyze samples or measuredose rates that meet the MQOs. Under this approach, the licensee's QA program should incorporate the initial (project METHOD VALIDATION) and continued [internal and external PERFORMANCE EVALUATION (PE)PROGRAMS] assessment of a method's capability to meet the MQO specifications. Process-radiationmonitoring equipment and instrumentation need to have the desired sensitivity to provide both real-time and data-trend values that can correlate to the actual measurements of process streams before release. Theradiological environmental measurements program may be used to confirm the adequacy of the process-monitoring equipment.

Rev. 2 of RG 4.15, Page 6

C. REGULATORY POSITION

The QA program of each organization performing radiological effluent or environmentalmonitoring of nuclear facilities using, processing, or storing radioactive materials during all phases of the facility's life cycle should be documented by wr itten policies and procedures. Licensees should have sufficient RECORDS of program conduct and performance to demonstrate program adherence. In addition toits own program, a licensee should require any contractor or subcontractor performing support programactivities (e.g., sampling, analysis, evaluations, and r ecords) retain records su fficient for the licensee todevelop and maintain a QA program covering the applicable program elements.The following presents the QA program elements that should be developed and implemented toensure the quality of data/results for radiological effluent and environmental monitoring programs.1.Organizational Structure and Responsibilities of Managerial and Operational PersonnelThe structure of the organization as it relates to the management and operation of the monitoringprograms, including QA policy and functions, should be defined and documented. The authorities, duties, and responsibilities of the positions within this organization, down to the first-line supervisory level, should be described. This should include responsibilities fo r review and approval of written procedures and the preparation, review, and evaluation of monitoring data and reports.Persons and organizations performing QA functions should have sufficient authority andorganizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and toverify implementation of solutions. Reporting should be at a management level that is independent ofactivity performance, costs, and schedule.

Section 2.1.1 of ANSI/ASQC E4-1994 (Ref. 21)

and Section 5.2.1 of ANSI N42.23-2003 (Ref. 22)provide additional guidance on management structur e and organizational responsibilities for radiologicaleffluent and environmental monitoring programs.2.Specification of Qualifications of Personnel The qualifications of individuals needed to carry out assigned radiological monitoring functionsshould be defined and documented (e.g., as in a job description). Individuals with responsibility forperforming quality-related activities should be trained a nd qualified in the principles and techniques of theactivities to be performed. These individuals should maintain proficiency by retraining, reexamining, andrecertifying or by periodic performance reviews, as a ppropriate. Continual trai ning should be conducted asneeded to ensure that personnel maintain awareness of events and issues that could affect the quality ofprogram performance.

Section 2.3.1 of ANSI/ASQC E4-1994 (Ref. 21)

provides additional guidance and criteria for developing personnel training and qualification specifications for radiological effluent and environmentalmonitoring programs.

Rev. 2 of RG 4.15, Page 73.Operating Procedures and InstructionsMonitoring programs should have written procedures for all activities that generate data, such asdose calculations and measurements, sample collection, sample management and CHAIN OF CUSTODY

,sample preparation and analysis, data reduction and recording, data assessment and reporting, and finalsample disposal. Procedures are also needed for addressing support functions, such as operation of processmonitors, training, preparation of QUALITY CONTROL SAMPLES, collection of meteorological data, corrective actions, AUDITS, and records. Individuals satisfying the qua lifications described in Section C.2 of thisregulatory guide should write, review, and revise these procedures.

Instructions, procedures, or schedules should be pr epared for the functions associated with the QAprogram, such as the following:*ancillary laboratory functions (including cleaning of glassware, contamination control, and storageof standards and chemicals)

  • CALIBRATION and QC of instrumentation (including range of activity, range of energy,and frequency of calibration)*internal QC and external PE programs (including frequency, types, acceptance criteria for thelaboratory PERFORMANCE TESTING samples, and individual analyst qualifications)*timetable for VERIFICATION

and VALIDATION (V&V) of data Chapters 9, 11, and 12 of MARLAP (Ref. 20) provide guidance on the radioanalytical laboratory activities for which procedures are used. MARLAP Chapters 12 - 16 provide technical information that can be used to write or revise procedures.

Section 5.4 of ISO/IEC 17025-2005 (Ref. 17) providesadditional guidance regarding the content and quality aspects of procedure and method technical content.

Section 2.5.2 of ANSI/ASQC E4-1994 (Ref. 21) identifies procedures that should be documented and may need control.4.Recordslicensees should maintain a system that produces unequivocal, accurate records that document allmonitoring activities. Licensees should maintain records of implementation or ongoing activities, such as the following:*procedure revision*personnel training and qualification records

  • analytical results
  • audits
  • corrective actions
  • intermediate activities or calculations (as may be n eeded to validate or substantiate final results)*records of tracking and control (chain of custody) throughout all processes from sample collectionthrough analysis and reporting of results, in cluding unique identifiers, descriptions, sources,dates/times, packaging/preparation/shipping, and required analyses*field logs with sufficient information describing environmental conditions and recording relatedinformation and data documenting the nature of the sample and where and how it was taken*laboratory notebooks recording related information and data, observations of analysts, andlaboratory or other conditions potentially affecting the measurement process*electronic data collection and algorithms and QA documentation
  • calculations (including data reduction, analysis, and verification)

Rev. 2 of RG 4.15, Page 8*QC records for radiation monitoring equipment, including the results of RADIOACTIVE SOURCE

checks, calibrations, INSTRUMEN

T. BACKGROUND

determinations, and maintenance activitiesaffecting equipment performance*notifications to qualified staff that procedural changes affecting data quality have been made*QC records for laboratory counting systems and support instrumentation and equipment, includingcalibrations, maintenance or repair, QC sample results, and traceability of standards used forinstrument calibration Records should be legible and identifiable, retained in predetermined locations, and protectedagainst damage, deterioration, or loss. Records should be maintained in a format that is easily retrievable. If the media for storage is electronic (as opposed to paper or microfilm/fiche), the licensee should maintainthe equipment necessary to read and present the data in an uncorrupted form. The document retentionsystem should allow reconstruction of all activities associated with the generation of analytical results. Thelicensee should establish a retention time for records c onsistent with licensing conditions and in accordancewith the licensee's overall QA program.Section 2.5 of ANSI/ASQC E4-1994 (Ref. 21) provides guidance on specific types of documentsthat should be maintained, while Basic Requirement 17 of ASME NQA-1-1994 (Ref. 11) details theadministrative criteria that should be considered for inclusion in a program for records and their retention.

Section 4.13 of ISO/IEC 17025-2005 (Ref. 17) also provides guidance on the control of record

s. Chapters

4 and 11 of MARLAP (Ref. 20) discuss documents that should be retained as records. Nuclear Informationand Records Management Association (NIRMA) TG11-1998 (Ref. 23), TG15-1998 (Ref. 24), TG16-1998 (Ref. 25), and TG21-1998 (Ref. 26) provide additional information addressing issues in developing andmaintaining electronic records programs.5.Quality Control in Environmental SamplingSampling of solids, liquids, and gases involves the measurement of sample masses, flow rates, orvolumes. The ACCURACY of the instruments or containers used for this purpose should be determined andchecked regularly to ensure that sampling performance criteria remain within the limits specified by theMQOs. The results of mass, flow rate, or volume calibrations and associated UNCERTAINTIES

should berecorded. The frequency of these calibrations should be specified and should be consistent with the DQOsof the measurement program. The collection efficiencies of the sampling equipment used should be documented; often such documentation is available from the manufacturer. HPS/ANSI N13.1-1999(Ref. 27) provides guidance on QA and QC for air sampling instruments. Chapter 19 of MARLAP

(Ref. 20) discusses measurement uncertainties in general and volume and mass measurements in particular.Sampling or measurements should be performed using equipment and methods that yield a resultthat is representative of the population in the particular environmental media. F

IELD DUPLICATES

areco-located spatially or temporally and should be collected periodically to check REPRODUCIBILITY. Chapter 10 of MARLAP (Ref. 20) discusses the field and sampling issues that affect laboratory measurements, including packaging, shipping, and storage of samples.Some individual environmental samples are collected simply to confirm that radioactivity levels arebelow a specified (small) fraction of an established concentration limit. In those cases, the MINIMUMDETECTABLE CONCENTRATION of the method used should be below that specified fraction of the limit.

Chapter 20 of MARLAP (Ref. 20) discusses detection limits, while Appendix C to MARLAP covers therelationship between the desired fraction of the limit that is important to detect and the uncertainty of themeasurement method. In some cases, a series of measurement results will be averaged for comparison with BACKGROUND LEVELS or a regulatory limit. For such measurements, an appropriate MQO would be theMINIMUM QUANTIFIABLE CONCENTRATION (see Chapter 20 of MARLAP).

Rev. 2 of RG 4.15, Page 9For an isolated, well-mixed population, a single sample or measurement may be sufficient. It ismore common, however, for spatial or temporal variations to exist. In that case, the frequency of samplingand number of samples and locations will depend on the level of variability and amount of radioactivity(compared with an established risk-informed limit). NUREG-1575, "Multi-Agency Radiation Survey and Site Investigation Manual" (Ref. 28, hereafter re ferred to as MARSSIM), discusses the effect that suchvariability has on the number of samples that may be appropriate for SURVEYS. In general, the DQOprocess may be used together with specific statistical designs (EPA QA/G-9S-2006, Ref. 29) to optimizethe sampling. Continuous sampling or integrated measurements may be used to mitigate temporalvariability.

Part 1, Sections II-11 and II-12, of ASME NQA-

1-1994 (Ref. 11) discuss test control and controlof measuring and test equipment. Part II, Subpart 2.20, of ASME NQA-1-1994 discusses QA standards for

subsurface investigations for nuclear power plants.6.Quality Control in the Radioanalytical Laboratory The output of the directed planning process includes DQOs that encompass both sampling andanalysis activities for a project or program. From the DQOs, a set of MQOs are developed for radioanalytical measurements (see Chapter 3 of MARLAP, Ref. 20). In a performance-based approach,MQOs are critical criteria used for the selection and validation of analytical methods and protocols (see Regulatory Position 8, below) and subsequently form the basis for the ongoing and final evaluation of theanalytical data. The type, frequency of, and evaluation criteria for QC samples are developed during the directed planning process and are incorporated into ANALYTICAL PROTOCOL SPECIFICATIONS (APSs) for a project (see Chapter 3 of MARLAP, Ref. 20).Chapter 18 of MARLAP provides guidance on monitoring key laboratory PERFORMANCEINDICATORS to determine whether a laboratory's measureme nt processes are in control. The chapter alsoprovides information on likely causes of excursions for selected laboratory performance indicators, such aschemical yield, instrument background, and QC samples. Appendix C to MARLAP provides the rationale and guidance for developing MQOs for select method performance characteristics and gives guidance on developing criteria for QC samples.Performance criteria for radioanalytical measurements should be selected to provide a managementtool for tracking and trending performance and to identify precursors to nonconforming conditions. Laboratories should satisfy program-specific criteria for all measurement processes, including necessary

levels of PRECISION , acceptable BIAS , and applicable detection levels.6.1Calibration and Quality Control of Instru ments, Measuring Devices, and Test EquipmentInstruments, devices, and test equipment used for measuring radioactivity should be operated,calibrated, and maintained to ensure that analytical specifications are met. All equipment should beoperated, calibrated, and maintained in adherence to any applicable standards and methods and as specifiedin the laboratory's quality manual and standard operating procedures. Instrument configurations duringcalibration should match those used for subsequent analytical measurements of samples.Calibrations of instruments should be made using CERTIFIED REFERENCE MATERIALS

of known anddocumented value and stated uncertainty and should be traceable to a national standards body, such as the National Institute of Standards and Technology (NIST) in the United States. CALIBRATION SOURCESshould be prepared in a manner that provides comparability to TEST SOURCES

with respect to sourcegeometry, positioning relative to the detector, source composition, and distribution of the test-sourcematerial within a container or on a source mount (see Section 15.2 of MARLAP, Ref. 20).

Rev. 2 of RG 4.15, Page 10The frequency of calibrations should be consistent with the stability and performance of theinstrument. Complete system calibration should be performed before initial use or following systemmaintenance, repair, or any other changes in environment or operating conditions that could affectperformance (ASTM D7282-2006, Ref. 30). In additi on, Sections 15.2 and 15.3 of MARLAP (Ref. 20)

present general guidance regarding calibrations of instruments. Chapter 15 of MARLAP also presentsguidance specific to calibrations of different instrumentation types.The continuing validity of calibrations should be checked periodically as specified in a laboratory'squality manual (see Chapter 18 of MARLAP, Ref. 20). Quality control checks of radioanalyticalinstrument calibration parameters, such as detector response or energy and resolution calibrations forspectrometers, should be performed by measuring the response of each radiation detection system to appropriate CHECK SOURCES. Instrument QC frequencies are generally performed daily for systems usedcontinually or before use for those systems periodically employed, but frequencies may vary by instrumenttype. Instrument QC checks should meet predefin ed acceptance criteria for the respective calibrationparameter and should ensure that conditions have not significantly ch anged since initial calibration (ASTM

D7282-2006, Ref. 30).Instrument-calibration QC check results should be tracked, trended, and compared withpredetermined ranges of acceptable performance. For example, if a monitor's response to a daily checksource showed a trend that may lead to a condition outside of established acceptance criteria, a calibrationmay be needed to reestablish acceptable operation.

Section 18.5 of MARLAP (Ref. 20) and ASTM D7282-2006 (Ref. 30) discuss radioanalytical instrument-calibration QC parameters.Additional method-specific quality controls (e.g., chemical yield, spectral quality, resolution) mayapply to certain methods and should be tracked and tr ended using control or tolerance charts to identifyconditions that could be adverse to quality.The laboratory quality manual and standard operating procedures should address the use,calibration, maintenance, and QC of all nonradiological instruments, measuring devices, and test equipmentused for measuring or quantifying other necessary data (e.g., sample masses or volumes, temperatures). All measurement and test equipment should be calibrated be fore use and adjusted to maintain accuracy withinestablished limits. Quality control checks should be performed at specified frequencies and should verifythat instruments are operating to specified performance levels.Nonradiological instruments, measurement, and test equipment should be operated according tomanufacturers' instructions, according to established standards, or as specified in the laboratory qualitymanual and procedures. Section 18.6.7 of MARLAP (Ref. 20) provides guidance on control, calibration,and maintenance of calibration of apparatus used for mass and volume measurements. ISO/IEC 17025-

2005 (Ref. 17) provides general guidance on establishing quality controls for nonradiological instruments. Items that do not conform to specified criteria should be controlled to prevent inadvertent use. These itemsshould be tracked through the corrective action program.Careful control of contamination and routine monitoring of instrument background are integralparts of a measurement QC program. Determinati on of the background counting rate should be performedon a regular, predefined frequency for systems in routine use and should ensure that analyticalspecifications for applicable programs can be met. Instrument backgrounds used to determine a net countrate should replicate actual sample measurement conditions as closely as possible (i.e., using appropriatesample containers and geometries).

3Note that this list does not include field duplicate samples that are part of the QC requirement for sampling.

Rev. 2 of RG 4.15, Page 11 Section 18.5.1 of MARLAP (Ref. 20) provides guidance on measurement and control of instrumentbackgrounds. Section 18.3 and Attachment 18A of MA

RLAP contain guidance on the statistical evaluationof performance indicators and on using control and tolerance charts.

Sections 10-13 and 20-25 of ASTM D7282-2006 (R

ef. 30) and Section A.5.2 of ANSI N42.23-2003 (Ref. 22) provide additional guidance on instrume nt response source checks, background checks, and the use of control charts. ASTM MNL 7A-2002 (Ref. 31) provides guidance on setting up and using control charts.6.2Internal Quality Control Samples and AnalysisThe use of QC samples should be an integral element of a laboratory QA program. Chapter 18 ofMARLAP (Ref. 20) defines the different types of laboratory QC samples and provides guidance on evaluation techniques for QC samples. The laboratory should have as part of the normal operationalsample load the following QC samples:

3*BLANK*MATRIX SPIKE

  • LABORATORY CONTROL SAMPLE
  • LABORATORY DUPLICATEAnalysis of QC samples should be performed as a part of the routine operation of a laboratory toverify that laboratory operations are consistent with applicable specifications. The QC program shouldspecify the type of and minimum frequency for processing QC samples. For example, this frequency may be defined as a minimum percentage of the total number of samples analyzed, a certain number peroperational time interval (e.g., once per shift) or per sample batch, or a licensee-specified frequency basedon laboratory-specific parameters. As part of its QC program, the laboratory may prepare and analyzeBLIND SAMPLES , provided the individuals responsible for preparing the samples are not directly responsiblefor conducting the laboratory analysis. For example, the laboratory's assigned QC specialist may have theresponsibility for preparing and submitting blind samples (blank, duplicate, laboratory control sample, and matrix spike). Blind samples are used primarily as a tool for evaluating the performance of individualsrather than as part of the laboratory QC load.Acceptability of QC sample results should be evaluated based on criteria from the QC program, which include specific equations based on METHOD UNCERTAINTY. Chapters 7 and 18 of MARLAP(Ref. 20) provide guidance on the evaluation of QC samples.Quality control sample results should be tracked, trended, and compared with predetermined rangesof acceptable performance to identify conditions that are in, or may lead to, nonconformance with program specifications. Such conditions should be tracked through the corrective action program.6.3 Performance Evaluation Program (Interlaboratory Comparison)Participation in an external PE program is an important independent check on the accuracy,possible bias, and precision of some radioanalytical or measurement methods used in a radiological monitoring program. Internal and contract radioanalytical laboratories used in the monitoring programshould participate in one or more applicable PE programs that are administered by organizations that havean active measurement assurance (traceability) program with NIST (ANSI N42.22-1995, Ref. 32). Chapter

4 Frequencies should be appropriate to the instrument under consideration and may be dictated by license conditions.

Rev. 2 of RG 4.15, Page 125 of MARLAP (Ref. 20) recommends incorporating the criteria for a radioanalytical laboratory toparticipate in a PE program into the statement of work for services. Several external PE programsadministered by government agencies or commercia l radioactive-source suppliers are available forradionuclides and matrices germane to radiological monitoring programs. The PE program should provide fundamental sample types (e.g., solid, liquid, gas) and radionuclides (e.g., alpha-, beta-, and gamma-emitting nuclides) of interest at the facility. When available, laboratories should analyze samples as offeredby a PE program on a frequency stipulated by the monitoring program's QA criteria, with all types of samples and analyses repeated at least biennially. Chapter 18 of MARLAP (Ref. 20) provides informationon organizations that administer PE programs.Acceptable performance criteria for results of performance-testing samples should be establishedthat are consistent with the MQOs for the radiological monitoring project or program. For certain monitoring activities, the acceptance criteria of the PE program may be satisfactory. The performance in aPE program should be tracked and trended as one of the performance indicators for the laboratory and evaluated as part of the corrective action program.7.Quality Control for Radioactive Effluent Monitoring Systems7.1Radioactive Effluent Process MonitorsAn initial, primary radiation monitor calibration that meets the specifications of ANSI N42.18-2004 (Ref. 33), should be performed with radioactive sources traceable to a national standards body (such as NIST). Calibrations should be repeated periodically using (1) STANDARD REFERENCE MATERIALS

or (2)certified reference materials that can be directly traced to the initial, primary calibration. Complete system calibration - including electronics, detector, and any support functions (such as alarm, display, andrecording devices) - should be performed at a frequency that ensures system reliability and accuracy orafter repair or maintenance that may affect instrume nt calibration. Unless otherwise specified in licenserequirements, the licensee should verify and validate the complete effluent monitoring system every 12 months. This frequency may be extended to longer time periods coinciding with facility maintenance schedules, such as refueling for nuclear power plants, if the licensee has verified proper system operationthrough established system reliability and more frequent source checks and functional checks.

Detectors should be response-checked periodically

4 for continuous effluent release points(e.g., ventilation systems and secondary water systems) and before release for batch discharges(e.g., primary boundary or containment purges and liquid waste tank releases). Licensees should ensure that check sources are of sufficient radiochemical purity so that the activity of the source may be correctedfor decay to the date of measurement. These check sources need not be traceable to a national standardsbody (e.g., NIST). Whenever practicable, check sources should be an integral part of the monitoringsystem and should be remotely actuated. The functionality of isolation or alarm functions should beverified periodically, preferably by use of a radiation source.Trends of process radiation monitor readings ve rsus total radionuclide concentrations in themonitored release path should be performed routinely. These trends should be based on the results ofanalyses for specific radionuclides in samples taken from the release path that will yield a monitorresponse. Deviations in the trend may occur if concentrations or the mixture of radionuclides changedsignificantly (for example, during a fuel cycle in whic h significant fuel defects exist). The licensee shoulddefine the monitor-response parameter for all radiation monitors. The monitor-response constant should beadjusted to maintain this correlation between effluent radionuclide concentration and monitor response.

Rev. 2 of RG 4.15, Page 137.2Flow Monitoring InstrumentationContinuous sampling of liquids and gases involves the measurement of sample flow rates and/orsample volumes. The accuracy and associated uncertainty of the devices used for this purpose should bedetermined on a regularly scheduled basis, and adjustments should be made as needed to bring theperformance of the devices within specified limits. Th e results of these calibrations should be recorded. The frequency of these calibrations should be specified and should be based on the necessary accuracy,purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.Any flow-rate measuring devices associated with the system should be calibrated to determineactual flow rates at the conditions of temperature and pressure under which the system will operate. These flow rate devices should be recalibrated annually, but the frequency may be extended to that established forthe radiation detector system, provided suffici ent operating experience exists and an acceleratedmeasurement check frequency gives sufficient data to ensure reliable performance.Flow measuring devices should be checked periodically on an established frequency, consideringthe variability of the instrument, and recalibrated when established control limits are exceeded. HPS/ANSIN13.1-1999 (Ref. 27) provides additional guidance on QA and QC measures for the use, maintenance, and calibration of airborne sampling instrumentati on. ANSI N42.18-2004 (Ref. 33) provides additionalguidance on the calibration of liquid flow monitors.7.3Grab Sampling of Effluent Process Streams Whenever practicable, effluent releases should be batch-controlled and released when the volumeto be released has been mixed sufficiently to ensure uniform concentration. Sampling and analysis for eachbatch should be performed, and release conditions set, before release. A

certain percentage of all batch releases should have field duplicates taken either be fore or during the release to assess the reproducibilityof sampling and the effectiveness of the mixing process before release. Where possible, samples that arespatially or temporally separated should be collected periodically to verify representativeness.For continuous-effluent discharges, composite samplers should be employed. However, periodicgrab samples may be used when composite sampling of a continuous discharge point is not feasible. Whengrab samples are collected instead of composite samples, licensees should design the sampling program tosample at the time, location, and frequency that ensures each sample is representative of the radioactivematerials released.7.4General Quality Control ConsiderationsThe QC plan should address the following items:*Sampling should be performed using calibrated instruments and equipment when taking acomposite sample.*Collection efficiencies based on the physical configuration of the sampling point and the type ofcollector should be documented. Vendor-supplied data may be used where adequatedocumentation exists to ensure the reliability and accuracy of data.*Volumes of tanks and containers should be est ablished during initial in stallation and should beverified again following any physical changes that could alter the system configuration.

5Replicate samples may be prepared by removing separate ALIQUANTS from the same grab sample.

6 The Institute of Electrical and Electronics Engineers (IEEE) Standard 1063, "IEEE Standard for Software User Documentation" (Ref. 35); EPA Directive 2185, "Good Automated Laboratory Practices" (Ref. 36); Subpart 2.7of ASME NQA-1-1994 (Ref. 11); Regulatory Guide 1.168, "Verifi cation, Validation, Reviews, and Audits for DigitalComputer Software Used Safety Systems of Nuclear Power Plants" (Ref. 37); and Section 8 of ANSI N42.14-1999,"Calibration and Use of Germanium Spectrometers for the Measurement of Gamma-Ray Emission Rates

of Radionuclides" (Ref. 38), also provide guidelines on software V&V.

Rev. 2 of RG 4.15, Page 14*The frequency of duplicates and REPLICATES

5 should be established based on time (for continuousdischarges) or number of batches (for batch discharges).*Sample integrity should be maintained through chain of custody procedures.Procedures for continuous sampling should use methods that are designed to ensure that the sampleis representative of the volumes being discharged.8.Verification and ValidationThe V&V of certain aspects and support activities of the radiological measurement process ormonitoring program are essential to the QA program. These aspects and activities include data andcomputer software V&V and project method validation.Project method validation is the demonstration that a method (radioanalytical or radiationmeasurement) using performance-based method selection is capable of providing analytical results to meet a project's MQOs and any other criteria in the analytical protocol specification (APS). Acceptable method validation is necessary before the radiological analysis of samples or the taking of measurements in a monitoring program. Chapter 6 of MARLAP (Ref. 20) presents detailed guidance on project methodvalidation for radioanalytical methods. In additi on, Section 5.2.7 of ANSI N42.23-2003 (Ref. 22) and Section 5.4.5 of ISO/IEC 17025-2005 (Ref. 17) provide limited guidance for radioanalytical method validation.

Chapter 8 of MARLAP (Ref. 20) gives deta iled guidance and applicable tools for theradioanalytical data V&V evaluation process as well as information for developing a data V&V plan,determining acceptable criteria and tests, and applying da ta qualifiers for radioanaly tical data validation, as related to MQOs. EPA QA/G-8-2002 (Ref. 34) provides guidance for nonradioanalytical data V&V.Computer programs used in the implementation of the radiological environmental monitoringprogram should be documented, verified, and va lidated before initial routine use and after eachmodification of the program. As described in Section 5.4.3.2 of MARLAP (Ref. 20), the laboratory's quality manual should include the criteria for computer software V&V and documentation. The software data reduction and reporting functions should be verified to perform as expected.

69.Assessments and AuditsAssessments, audits, and surveillances are elemen ts used to evaluate the initial and ongoingeffectiveness of the QA program to monitor and control the quality of a radiological monitoring program.

Management having responsibility in the area being reviewed should document and review the results ofthese activities. Assessments that are independent of the day-to-day operations should be performedroutinely, including management surveillance, peer reviews, and READINESS REVIEWS

for new or revisedsystems and methods. Key performance indicators should be tracked and trended, with periodicmanagement reporting. The QA program or project plan should outline the scope, frequency, and scheduleof assessments, audits, and surveillances. A plan should be developed for each assessment audit or Rev. 2 of RG 4.15, Page 15surveillance for each area of the monitoring program be ing evaluated. A report of these activities should begenerated according to the outline, format , and content established in the plan.Only qualified QA staff (see Regulatory Position 2, above), supported as needed by experts in the technical areas under evaluation, should conduct assessm ents, audits, and surveillances. (See ASMENQA-1-1994, Supplement 2S, Ref. 11.) Deficiencies, areas for improvement, and observations noted

should be incorporated into the corrective action program and tracked. Section 18 of ASME NQA-1-1994 (Ref. 11) and Section 4.10 of ISO/IEC 17025-2005 (Ref. 17) provide guidance on establishing andconducting an audit program.When the monitoring program will depend upon the services of a radioanalytical laboratory, prioronsite audits of the laboratory may be conducted to ensure that the laboratory is capable of fulfilling the project criteria in accordance with the APS (including MQOs) outlined in a statement of work (MARLAPChapter 5 and Appendix E). The ongoing evaluation of the laboratory's QUALITY SYSTEM

and operations isaccomplished through onsite audits and desk audits. These audits are focused more on whether thelaboratory is meeting project or program specifications than whether the laboratory has the capability to meet monitoring program or project criteria. Chapter 7 of MARLAP provides guidance and statistical tests to determine whether a laboratory is meeting the MQOs, especially the REQUIRED METHOD UNCERTAINTY. Section 5.2.10 of ANSI N42.23-2003 provides additional guidance for radioanalytical laboratoryassessments.Audits of the QA programs of contractors providing materials, supplies, or services affecting thequality of the laboratory's operations should be performed periodically (Section 4.6 of ISO/IEC 17025-

2005, Ref. 17).10.Preventive and Corrective ActionsIntegral components of a QA program include identifying areas for improvement, definingperformance or programmatic deficiencies, and initiating appropriate corrective or preventive actions. TheQA program for radiological effluent and environmental monitoring programs should contain both acontinuous-improvement program and a program for implementing corrective actions when conditionsadverse to quality have been identified. In addition, needed improvements and potential sources ofnonconformance should be identified and reported as part of a preventive action initiative of thecontinuous-improvement program (ISO/IEC 17025-2005, Sections 4.10-4.12) - for example, a condition-reporting program. Investigations should be initia ted for degrading conditions, and corrective actions should be taken when conditions fall outside quality or regulatory acceptance criteria. For conditions thatare adverse to quality, the corrective action process includes the following basic elements:*identification and documentation*classification

  • cause analysis
  • corrections
  • followup
  • closure Findings and corrective actions should be documented, tracked, and reported to management. Followup reviews should be performed to verify the effectiveness and adequacy of the corrective actions.

Section 2.10 of ANSI/ASQC E4-1994 (Ref. 21) provid es specifications and guidelines for developing theprocess, programs, and procedures necessary to detect and correct items of nonconformance and for implementing continuous quality improvement.

Rev. 2 of RG 4.15, Page 16 When conducting an audit or surveillance of laboratory services, a prime area of review should bethe effectiveness of the laboratory's corrective action program (Section 7.4.2 of MARLAP, Ref. 20).

Section 4.11 of ISO/IEC 17025-2005 (Ref. 17) provid es general guidance on preventive and correctiveaction programs for laboratorie

s. Annex C of ANS

I N42.23-2003 (Ref. 22) provides additional guidance that should be considered in developing a corrective action program, including root cause analysis forradioanalytical services.

D. IMPLEMENTATION

The purpose of this section is to provide information to licensees regarding the NRC staff's plansfor using this regulatory guide. No backfit is in tended or approved in connection with its issuance.

Non-nuclear power reactor applicants and licensees may continue to use Revision 1 of RegulatoryGuide 4.15, dated February 1979, or may adopt other procedures or practices that reflect generally acceptedstandards for ensuring quality in environmental data collected for effluent monitoring purposes. Except in those cases in which a nuclear power reactor applicant or licensee proposes or has previously established anacceptable alternative method for complying with specified portions of the NRC's regulations, the methods and practices described in this guide will be used in evaluating QA practices for environmental radiologicalmonitoring programs.

7Certain terms included in this glossary are not used in the main body of this regulatory guide, but are includedbecause they are used w ithin other definitions.

Rev. 2 of RG 4.15, Page 17 GLOSSARY 7 accuracy-The closeness of a measured result to the true value of the quantity being measured.

Various recognized authorities have given the word "accuracy" different technical definitions,expressed in terms of bias and imprecision. Following the Multi-Agency Radiological Laboratory Analytical Protocols (MARLAP) Manual (Ref. 20), the U.S. Nuclear Regulatory Commission (NRC) avoids all of these technical definitions and uses the term "accuracy" in its common, ordinary sense, which is consistent with the definition established by the International Organization for Standardization (ISO) in the "International Vocabulary of Basic and General Terms inMetrology" (Ref. 39).

aliquant-A representative portion of a homogeneous SAMPLE removed for the purpose of analysis orother chemical treatment. The quantity removed is not an evenly divisible part of the whole sample. An aliquot, by contrast, is an evenly divisible part of the whole.

analyte-See TARGET ANALYTE

.analytical protocol specification (APS)

-The output of a DIRECTED PLANNING PROCESS

that contains theproject's analytical data needs and criteria in an organized, concise form. The level of specificityin the APS should be limited to those criteria that are considered essential to meeting the project'sanalytical data criteria to allow the laboratory the flexibility of selecting the protocols or methods that meet the analytical criteria.

as low as reasonably achievable (ALARA)-"As low as is reasonably achievable taking into account thestate of the technology and the economics of improvements in relation to benefits to the publichealth and safety and other societal and socioeconom ic considerations, and in relation to the use ofatomic energy in the public interest" [10 CFR 50.34a(a)].

assessment-A planned and documented activity performed to determine whether various elements withina quality management system are effective in achieving stated quality objectives (ANSI N42.23-

2003, Ref. 22).

audit-A planned and documented activity performed to determine by investigation, examination, orevaluation of objective evidence the adequacy of, and CONFORMANCE

with, established procedures, instructions, drawings, and other applicable documents as well as the effectiveness ofimplementation. An audit should not be conf used with surveillance or inspection activitiesperformed for the sole purpose of process cont rol or product acceptance (after ANSI N42.23-2003, Ref. 22).background, instrument-Radiation detected by an instrument when no SOURCE is present. Thebackground radiation that is detected may come from radionuclides in the materials of construction of the detector, its housing, its electronics, and the building as well as the environment and natural radiation.

background level-A term that usually refers to the presence of radioactivity or radiation in theenvironment. From an analytical perspective, the presence of background radioactivity in samples Rev. 2 of RG 4.15, Page 18needs to be considered when clarifying the radioanalytical aspects of the decision or studyquestion. Many radionuclides are present in measurable quantities in the environment.

bias (of a measurement process)-A persistent deviation of the mean measured result from the true oraccepted reference value of the quantity being measured, which does not vary if a measurement is repeated.blank (analytical or method)

-A SAMPLE that is assumed to be essentially free of the TARGET ANALYTE (the "unknown"), that is carried through the radiochemical preparation, analysis, mounting, andmeasurement process in the same manner as a routine sample of a given matrix.

blind sample

-A SAMPLE with a concentration not known to the analyst. Blind samples are used to assessanalytical performance. A double-blind sample is a sample whose concentration and identity as asample is known to the submitter, but not to the analyst. The analyst should treat the double-blind sample as a routine sample, so it is important that the double-blind sample is identical inappearance to routine samples.

calibration

-The set of operations that establish, under specified conditions, the relationship betweenvalues indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known value of a parameter of interest.

calibration source

-A prepared SOURCE, made from a CERTIFIED REFERENCE MATERIAL OR STANDARDREFERENCE MATERIAL, that is used for calibrating instruments.

certified reference material-A reference material, accompanied by a certificate, with one or moreproperty values certified by a procedure that establishes its traceability to an accurate realization ofthe unit in which the property values are e xpressed, and for which each certified value isaccompanied by an UNCERTAINTY

at a stated level of confidence (ISO Guide 30, Ref. 40). SeeSTANDARD REFERENCE MATERIAL

.chain of custody-Procedures that provide the means to trace the possession and handling of a samplefrom collection to data reporting.

check source-A material used to validate the operability of a radiation measurement device, sometimesused for instrument quality contro

l. See TEST SOURCE

and SOURCE , RADIOACTIVE

.condition adverse to quality- an all-inclusive term used in reference to any of the following: failures,malfunctions, deficiencies, defective items, and nonconformances. A significant condition adverseto quality is one which, if uncorrected, could have a serious effect on safety or operability.

conformance-An affirmative indication or judgment that a product or service has met the criteria of therelevant specifications, contract, or regulation; also the state of meeting the criteria (ANSI/ASQC

E4-1994, Ref. 21).

corrective actions-Those measures taken to prevent, rectify, or eliminate conditions adverse to quality ordetected nonconformities and - as necessary - to preclude repetition of those conditions.

data quality objective (DQO)-Qualitative and quantitative statements that clarify the study objectives,define the most appropriate type of data to collect, determine the most appropriate conditions fromwhich to collect the data, and specify tolerable limits on decision error rates. Because DQOs willbe used to establish the quality and quantity of data needed to support decisions, they should Rev. 2 of RG 4.15, Page 19encompass the total UNCERTAINTY resulting from all data collection activities, including analyticaland sampling activities.

directed planning process-A systematic framework focused on defining the data needed to supportan informed decision for a specific project. Di rected planning provides a logic for setting well- defined, achievable objectives and developing a cost-effective, technically sound sampling andanalysis design that balances the data user's tolerance for UNCERTAINTY

in the decision process and the available resources for obtaining data to support a decision. Directed planning helps to eliminate unnecessary, poor, or inadequate sampling and analysis designs.

dose equivalent-Quantity that expresses all radiations on a common scale for calculating the effectiveabsorbed dose. This quantity is the product of absorbed dose (GRAYS (Gy) or rads) multiplied by aquality factor and any other modifying factors (MARSSIM, Ref. 28). The quality factor adjusts the absorbed dose because not all types of ionizing radiation create the same effect on human tissue. For example, a dose equivalent of one SIEVERT (Sv) requires 1 Gy of beta or gamma radiation, butonly 0.05 Gy of alpha radiation or 0.1 Gy of neut ron radiation. Because the sievert is a large unit,radiation doses often are expressed in milli SIEVERTS (mSv). See TOTAL EFFECTIVE DOSEEQUIVALENT

.duplicate, field-Two samples of the same material, collected at the same location at the same time andunder the same conditions, which are used to verify representativeness of the sampled material.

duplicate, laboratory

-Two ALIQUANTS

of a SAMPLE, which are prepared and analyzed separately as partof the same batch, used in the laboratory to measure the overall PRECISION of the samplemeasurement process, beginning with laboratory subsampling of a field SAMPLE.field duplicate

-See DUPLICATE , FIELD.graded approach-A process of basing the level of management controls applied to an item or work on the intended use of the results and the degree of confidence needed in the quality of the results.

The NRC follows a graded approach to project planning and QUALITY ASSURANCE

because of thediversity of environmental data collection activities. This diversity in the type of project and thedata to be collected impacts the content and ex tent of the detail to be presented in the projectplanning documents.

gray (Gy)-The International System of Units (SI) unit for absorbed radiation dose. One Gy is 1 joule ofenergy absorbed per kilogram of matter, equal to 100

RAD. See SIEVERT.laboratory control sample-A standard material of known composition or an artificial SAMPLE (createdby fortification of a clean material similar in nature to the sample), which is prepared and analyzedin the same manner as the sample. In an ideal situation, the result of an analysis of the laboratorycontrol sample should be equivalent to (give 100 percent of) the TARGET ANALYTE

concentration oractivity known to be present in the fortified sample or standard material. The result normally is expressed as percent recovery. See also QUALITY CONTROL SAMPLE

.laboratory duplicate

-See DUPLICATE , LABORATORY

.matrix spike

-See SPIKE.

Rev. 2 of RG 4.15, Page 20

measurement quality objective (MQO)-The analytical data criteria of the DATA QUALITY OBJECTIVES

,which are project- or program-specific and can be quantitative or qualitative. These analytical data criteria serve as measurement performance criteria or objectives of the analytical process. MARLAP (Ref. 20) refers to these performance objectives as MQOs. Examples of quantitativeMQOs include statements of required analyte detectability and the UNCERTAINTY of the analytical protocol at a specified radionuclide concentration, such as the action level. Examples of qualitativeMQOs include statements of the required specificity of the analytical protocol (e.g., the ability toanalyze for the radionuclide of interest (or TARGET ANALYTE) given the presence of interferences).

method uncertainty

-Reference to the predicted UNCERTAINTY of the result that would be measured if themethod were applied to a hypothetical laboratory SAMPLE with a specified analyte concentration. Although individual measurement uncertainties will vary from one measured result to another, theREQUIRED METHOD UNCERTAINTY is a target value for the individual measurement uncertainties andis an estimate of uncertainty before the sample is actually measure

d. See also UNCERTAINTY

andREQUIRED METHOD UNCERTAINTY

.method validation-The demonstration that the method selected for the analysis of a particular analyte ina given matrix is capable of providing analytical results to meet the project's MEASUREMENTQUALITY OBJECTIVES and any other criteria in the ANALYTICAL PROTOCOL SPECIFICATIONS. Compare with data and software VALIDATION

.minimum detectable concentration-The minimum detectable value of the analyte concentration in asample. The smallest (true) value of the net state variable that gives a specified probability that the value of the response variable will exceed its critical value (i.e., that the material analyzed is not blank).minimum quantifiable concentration-Minimum quantifiable value of the analyte concentration, definedas the smallest concentration of analyte whose presence in a laboratory SAMPLE ensures that therelative standard deviation of the measurement does not exceed a specified value, usually 10

percent.nonconformance-a deficiency in characteristic, documentation, or procedure that renders the quality ofan item or activity unacceptable or indeterminate performance-based approach-Definition of the analytical data needs and criteria of a project in terms ofmeasurable goals during the planning phase of a project. In a performance-based approach, theproject-specific data objectives that are determined during a DIRECTED PLANNING PROCESS

serve asmeasurement performance criteria for selections and decisions regarding the conduct of thelaboratory analyses. The project-specific analyti cal data objectives are also used for the initial,ongoing, and final evaluation of the laboratory's performance and the laboratory data. In methodselection, a performance-based approach is the process wherein a validated method is selectedbased on a demonstrated capability to meet defined quality and laboratory performance criteria.performance evaluation (PE) program-A laboratory's participation in an internal or external programof analyzing performance-testing samples appropriate for the analytes and matrices under consideration (i.e., PE program traceable to a national standards body, such as the NationalInstitute of Standards and Technology (NIST) in the United States). Reference-material samplesused to evaluate the performance of the laboratory are called performance-evaluation orperformance-testing samples or materials. See CERTIFIED REFERENCE MATERIAL

and STANDARDREFERENCE MATERIAL

.

Rev. 2 of RG 4.15, Page 21 performance indicator-Instrument- or protocol-related parameter routinely monitored to assess thelaboratory's estimate of controls such as chemical yield, instrument background, UNCERTAINTY

,PRECISION , and BIAS. See BACKGROUND

, INSTRUMENT

.performance testing

-See PERFORMANCE EVALUATION PROGRAM

.precision-The closeness of agreement between independent test results obtained by applying theexperimental procedure under stipulated conditions. Conversely, imprecision is the variation of the results in a set of REPLICATE measurements. Precision may be expressed as the standard deviation (IUPAC, Ref. 41).

quality assurance (QA)-An integrated system of management activities involving planning,implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected. Quality assurance includes QUALITY CONTROL.quality assurance project plan (QAPP)-A formal document describing in detail the necessary QUALITY ASSURANCE , QUALITY CONTROL, and other technical activities that must be implemented to ensurethat the results of the work performed will satisfy the stated performance criteria. The QA projectplan describes policy, organization, and functional activities and the DATA QUALITY OBJECTIVESand measures necessary to achieve adequate data for use in selecting the appropriate remedy.

quality control (QC)-The overall system of technical activities that measures the attributes andperformance of a process, item, or service against defined standards to verify that they meet thestated objectives established by the project; opera tional techniques and activities that are used tofulfill objectives for quality. This system of activities and checks is used to ensure thatmeasurement systems are maintained within prescribed limits, providing protection against out-of- control conditions and ensuring that the results are of acceptable quality.

quality control (QC) sample-An uncontaminated SAMPLE matrix spiked with known amounts of analytesfrom a source independent of the calibration standards.

quality system-A structured and documented management system describing the policies, objectives,principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The qualitysystem provides the framework for planning, implementing, and assessing the work performed byan organization and for carrying out required QUALITY ASSURANCE

and QUALITY CONTROL

activities (ANSI/ASQC E4-1994, Ref. 21).

readiness review-The formal process of performing a written or verbal assessment of key attributes of aprogram or project measured against defined minimum criteria, standards, or quality metrics beforeinitiation of activities under that project or program.

record-A retrievable document that furnishes objective evidence of the quality of products, services, or activities and that has been verified and authenticated as technically complete and correct.

rem-The common unit for the effective or equivalent dose of radiation received by a living organism,equal to the actual dose (in rads) multiplied by a factor representing the danger of the radiation. Rem is an abbreviation for roentgen equivalent man, meaning that it measures the biological effectsof ionizing radiation in humans. One rem is equal to 0.01 Sv. See SIEVERT and DOSE EQUIVALENT

.

Rev. 2 of RG 4.15, Page 22 replicates-Two or more ALIQUANTS of a homogenous SAMPLE whose independent measurements are usedto determine the PRECISION of laboratory preparation and analytical procedures.

reproducibility-The closeness of the agreement between the results of measurements of the sameparameter carried out under changed conditions of measurement. A valid statement ofreproducibility depends upon specification of the conditions changed. The changed conditionsmay include principle of measurement, method of measurement, observer (or analyst), measuring instrument, reference standard, location, conditions of use, and time. Reproducibility may beexpressed quantitatively in terms of the dispersion ch aracteristics of the results. Results are usually understood to be corrected results.

required method uncertainty (u MR)-METHOD UNCERTAINTY

at a specified concentration. This is a keyMEASUREMENT QUALITY OBJECTIVE

.sample-(1) A portion of material selected from a larger quantity of material, or (2) a set of individualsamples or measurements drawn from a population whose properties are studied to gain information about the entire population.

sievert (Sv)-The Systme International (SI) unit for the effective dose of radiation received by a livingorganism. This unit represents the actual dose received (GRAYS in SI or rads in traditional units)times a factor that is larger for more dangerous forms of radiation. One Sv is 100

REM. Radiationdoses are often measured in mSv. An effective dose of 1 Sv requires 1 GRAY of beta or gammaradiation, but only 0.05 Gy of alpha radiation or 0.1 Gy of neutron radiation.

source, radioactive-A quantity of material configured for radiation measurement.

spike-A known amount of TARGET ANALYTE added to the environmental sample to establish whether themethod or procedure is appropriate for the analysis of the particular matrix and how the TARGET ANALYTE responds when the environmental sample is prepared and measured, thereby estimatingthe bias introduced by the sample matrix. Also termed MATRIX SPIKE

.standard reference material

-A CERTIFIED REFERENCE MATERIAL issued by NIST in the United States. NIST certifies a standard reference material for specific chemical or physical properties and issues it with a certificate that reports the results of the characterization and indicates the intended use ofthe material.

surveillance-Continual or frequent monitoring and verification of the status of an activity and theanalysis of records to ensure that specified requirements are being fulfilled. A surveillance is lessextensive and more frequent than an AUDIT and concentrates on a single item or activity.

survey-A systematic evaluation and documentation of radiological measurements with a correctlycalibrated instrument or instruments that meet the sensitivity required by the objective of the evaluation.

target analyte

-A radionuclide on the list of radionuclides of in terest or a radionuclide of concern for a project.test source-The final radioanalytical processing product or ma trix (e.g., precipitate, solution, filter) that isintroduced into a measurement instrument. A test source is prepared from laboratory samplematerial for the purpose of determining its radioactive constituents. See CALIBRATION SOURCE

, CHECK SOURCE , and SOURCE , RADIOACTIVE

.

Rev. 2 of RG 4.15, Page 23 total effective dose equivalent (TEDE)-The sum of the effective dose equivalent (for external exposure)and the committed effective dose equivalent (for inte rnal exposure), expressed in units of Sv or rem (MARSSIM, Ref. 28). See DOSE EQUIVALENT

.uncertainty-A parameter, usually associated with the result of a measurement, that characterizes thedispersion of the values that could reasonably be attributed to the measurement of interest (Chapter 19 of MARLAP, Ref. 20).

validation

-(1) Data validation, the evaluation of data to determine the presence or absence of an analyte and to establish the UNCERTAINTY of the measurement process for contaminants of concern. Datavalidation qualifies the usability of each datum (after interpreting the impacts of exceptions identified during data VERIFICATION) by comparing the data produced with the MEASUREMENTQUALITY OBJECTIVES and any other analytical process criteria contained in the ANALYTICALPROTOCOL SPECIFICATIONS

developed in the planning process. (2)

Software validation, theconfirmation by examination and provision of objective evidence that the particular criteria for a

specific intended use are fulfilled. Validation for a system is the set of activities ensuring andgaining confidence that the system is able to accomplish its intended use, goals, and objectives (ISO/IEC 15288-2002, Ref. 42).

verification

-(1) Data verification, a process that ensures that laboratory conditions and operations werecompliant with the statement of work, sampling and analysis plan, and QUALITY ASSURANCE

PROJECT PLAN and that identifies problems, if present, that should be investigated during datavalidation. Data verification compares the material delivered by the laboratory to these criteria (compliance) and checks for consistency and comparability of the data throughout the data packageand for completeness of the results to ensure that all necessary documentation is available. (2)

Software verification, the confirmation by examination and provision of objective evidence that specified criteria have been fulfilled. A set of activities compares a system life cycle productagainst the necessary characteristics for that product. The system life cycle products may include,but are not limited to, specified criteria, design description, and the system itself (ISO/IEC 15288-

2002, Ref. 42).

8 All NRC regulations listed herein are available electronically through the Public Elect ronic Reading Room on theNRC's public Web site, at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Copies are also available forinspection or copying for a fee from the NRC's Public Document Room at 11555 Rockville Pike, Rockville, MD;

the PDR's mailing address is USNRC PDR, Washi ngton, DC 20555; telephone (301) 415-4737 or (800) 397-4209;

fax (301) 415-3548; email PDR@nrc.gov

.9This regulation is available electronically through the U.S. Environmental Protection Agency's public Web site, at http://www.epa.gov/epacfr40/chapt-I.info/

.10 Purchase information is available through the American Society of Mech anical Engineers (ASME) Web site at http://catalog.asme.org/Codes/PrintBook/NQA1_1994_Quality_Assurance.cfm

.Rev. 2 of RG 4.15, Page 24 REFERENCES1.10 CFR Part 50, "Domestic Licensing of Production and Utilization Facilities,"U.S. Nuclear Regulatory Commission, Washington, DC.

82.10 CFR Part 52, "Licenses, Certifications, and A

pprovals for Nuclear Power Plants," U.S. NuclearRegulatory Commission, Washington, DC.

83.10 CFR Part 61, "Licensing Requirements for Land Disposal of Radioactive Waste," U.S. NuclearRegulatory Commission, Washington, DC.

84.10 CFR Part 72, "Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reacto r-Related Greater Than Class C Waste,"U.S. Nuclear Regulatory Commission, Washington, DC.

85.10 CFR Part 76, "Certification of Gaseous Diffusion Plants," U.S. Nuclear RegulatoryCommission, Washington, DC.

86.10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material,"U.S. Nuclear Regulatory Commission, Washington, DC.

87.10 CFR Part 40, "Domestic Licensing of Source Material," U.S. Nuclear Regulatory Commission, Washington, DC.

88.10 CFR Part 70, "Domestic Licensing of Special Nuclear Material," U.S. Nuclear RegulatoryCommission, Washington, DC.

89.10 CFR Part 20, "Standards for Protection Against Radiation," U.S. Nuclear RegulatoryCommission, Washington, DC.

810.40 CFR Part 190, "Environmental Radiation Prot ection Standards for Nuclear Power Operations,"U.S. Environmental Protection Agency, Washington, DC.

911.ASME NQA-1-1994, "Quality Assurance Program Requirements for Nuclear Facilities(with Addenda)," American Society of M

echanical Engineers, New York, NY, 1994.

10

11 Generic Letter 79065 is available electronically through the NRC's public Web site at http://www.nrc.gov/reading-rm/

doc-collections/gen-comm/

gen-letters/1979/gl79065.html

.12All regulatory guides listed herein were published by the U.S. Nuclear Regulatory Commission or its predecessor,the U.S. Atomic Energy Commission. Most are available electronically through the Electronic Reading Room on the NRC's public Web site, at http://www.nrc.gov/reading-rm/

doc-collections/reg-guides/. Active guides may bepurchased from the National Technical Information Service (NTIS). Details may be obtained by contacting NTIS at5285 Port Royal Road, Springfield, Virginia 22161, online at http://www.ntis.gov, by telephone at (800) 553-NTIS(6847) or (703) 605-6000, or by fax to (703) 605-6900. Copies are also available for inspection or copying for a fee from the NRC's Public Document Room (PDR), which is located at 11555 Rockville Pike, Rockville, Maryland; thePDR's mailing address is USNRC PDR, Washington, DC 20555-0001. The PDR can also be reached by telephone at(301) 415-4737 or (800) 397-4209, by fax at (301) 415-3548, and by email to PDR@nrc.gov

.13 Copies of all ISO publications cited in this document may be purchased from ISO in Geneva, Switzerland.

Purchase information is availa ble through the ISO Web site at http://www.iso.org/iso/en/ISOOnlin

e. frontpage

.14Copies of all EPA quality system publications are available for download free of charge from the EPA public Web site at http://www.epa.gov/quality/qa_docs.html

.Rev. 2 of RG 4.15, Page 2512.Generic Letter 79065, "Radiological Assessment Branch Technical Position on RadiologicalEnvironmental Monitoring," Revision 1, U.S. Nuclear Regulatory Commission, Washington, DC,

November 27, 1979.

1113.Regulatory Guide 1.21, "Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-CooledNuclear Power Plants," U.S. Nuclear Regulatory Commission, Washington, DC.

1214.Regulatory Guide 4.1, "Programs for Monitoring Radioactivity in the Environs of Nuclear PowerPlants," U.S. Nuclear Regulatory Commission, Washington, DC.

1215.Regulatory Guide 4.14, "Radiological Effluent and Environmental Monitoring at Uranium Mills,"U.S. Nuclear Regulatory Commission, Washington, DC.

1216.Regulatory Guide 4.16, "Monitoring and Reporting Radioactivity in Releases of RadioactiveMaterials in Liquid and Gaseous Effluents from Nuclear Fuel Processing and Fabrication Plantsand Uranium Hexafluoride Production Plants," U.S. Nuclear Regulatory Commission, Washington, DC.1217.ISO/IEC 17025-2005, "General Requirements for the Competence of Testing and Calibration Laboratories," International Standards Organization/International Electrotechnical Commission,Geneva, Switzerland, May 2005, Correction 1, August 2006.

1318.EPA QA/G-4-2006, "Guidance on Systematic Planning Using the Data Quality ObjectivesProcess," U.S. Environmental Protection Agency, Washington, DC, EPA 240/B-06/001, February 2006.

1419.EPA QA/G-5-2002, "Guidance for Quality Assurance Project Plans," U.S. EnvironmentalProtection Agency, Washington, DC, EPA/240/R-02/009, December 2002.

1420.NUREG-1576 (MARLAP), "Multi-Agency Radiological Laboratory Analytical ProtocolsManual," Volumes 1-3, U.S. Nuclear Regulatory Commission, Environmental Protection Agency, Department of Energy, Department of Defense, Department of Homeland Security, National

15Copies are available electronically through NRC's public Web site at http://www.nrc.gov/reading-rm/doc-collections/

nuregs/staff/sr1576/

and from EPA's public Web site at http://www.epa.gov/radiation/marlap/links.htm

.16 Copies of all ANSI publications cited in this document may be purchased from the American National Standards Institute, 1819 L Street, NW, 6 th floor, Washington, DC 20036. Purchase information is available through the ANSIWeb site at http://webstore.ansi.org/ansidocstore/default.asp

.17Copies of all NIRMA Technical Guidance documents cited herein may be purchased from the Nuclear Information and Records Management Association, Inc., 10 Almas Road, Windham, NH; telephone (603) 432-6476;

fax (603) 432-3024; see the NIRMA Web site at http://www.nirma.org/member/publications.htm

.18Copies of this standard are available for purchase from the HPS Web site at http://hps.org/hpssc/n13standards.html

.Rev. 2 of RG 4.15, Page 26Institute of Standards and Technology, U.S. Geological Survey, and Food and DrugAdministration, Washington, DC, July 2004.

1521.ANSI/ASQC E4-1994, "Specifications and Guidelines for Quality Systems for Environmental DataCollection and Environmental Technology Programs," American National Standards Institute/American Society for Quality Control, New York, NY, 1994.

1622.ANSI N42.23-2003, "Measurement and Associated Instrumentation Quality Assurance forRadioassay Laboratories," American National Standards Institute, New York, NY, 2003.

1623.NIRMA TG11, "Authentication of Records and Media," Nuclear Information and RecordsManagement Association, Inc., Windham, NH, 1998.

1724.NIRMA TG15, "Management of Electronic Records," Nuclear Information and RecordsManagement Association, Inc., Windham, NH, 1998.

1725.NIRMA TG16, "Software Configuration Management and Quality Assurance," NuclearInformation and Records Management Association, Inc., Windham, NH, 1998.

1726.NIRMA TG21, "Electronic Records Protection and Restoration," Nuclear Information and RecordsManagement Association, Inc., Windham, NH, 1998.

1727.HPS/ANSI N13.1-1999, "Sampling and Monitoring Releases of Airborne Radioactive Substancesfrom the Stacks and Ducts of Nuclear Facilities," Health Physics Society (HPS), McLean, VA, 1999.1828.NUREG-1575 (MARSSIM), "Multi-Agency Radiation Survey and Site Investigation Manual,"

Revision 1 (EPA 402-R-97-016 Revision 1, DOE/E

H-0624 Revision 1), U.S. Nuclear RegulatoryCommission, Environmental Protection Agency, Department of Energy, Washington, DC,

August 2000.

1529.EPA QA/G-9S-2006, "Data Quality Assessment: Statistical Tools for Practitioners," U.S.Environmental Protection Agency, Washington, DC, EPA/240/B-06/003, February 2006.

14

19Copies of all ASTM standards cited herein may be pur chased from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA

19428-2959; see the ASTM International Web-based standards search tool at http://www.astm.org/cgi-bin/SoftCart.exe/NEWS

ITE_JAVASCRIPT/index.shtml?L+mystore+qkyo3147+117461063

.20 Copies of this standard are available for purchase from the IEEE Web site athttp://standards.ieee.org/db/status/inde

x. shtml

.21Copies of this directive are available electronically from the EPA's public Web site

at http://www.epa.gov/irmpoli8/archived/irm_galp/

.Rev. 2 of RG 4.15, Page 2730.ASTM D7282-2006, "New Standard Practice for Setup, Calibration, and Quality Control ofInstruments Used for Radioactivity Measurements," American Society for Testing and Materials, West Conshohocken, PA, 2006.

1931.ASTM MNL 7A-2002, "Manual on Presentation of Data and Control Chart Analysis," 7 th Edition,American Society for Testing and Materials, West Conshohocken, PA, 2002.

1932.ANSI N42.22-1995, "Traceability of Radioactive Sour ces to the National Institute of Standards andTechnology (NIST) and Associated Instrument Quality Control," American National Standards

Institute, New York, NY, 1995 (R2002).

1633.ANSI N42.18-2004, "American National Standard Specification and Performance of On-SiteInstrumentation for Continuously Monitoring Radioactivity in Effluents," Institute of Electrical and Electronics Engineers, Inc., New York, NY, 1980 (R2004).

1634.EPA QA/G-8-2002, "Guidance on Environmental Da ta Verification and Data Validation," U.S.Environmental Protection Agency, Washington, DC, EPA/240/R-02/004, November 2002.

1435.IEEE 1063, "IEEE Standard for Software User Documentation," Institute of Electrical andElectronics Engineers, Inc. (IEEE), Piscataway, New Jersey, December 2001.

2036.EPA Directive 2185, "Good Automated Laboratory Practices," U.S. Environmental ProtectionAgency (EPA), Office of Information Resources Management, 1995.

2137.Regulatory Guide 1.168, "Verification, Validation, Reviews, and Audits for Digital ComputerSoftware Used in Safety Systems of Nuclear Power Plants," U.S. Nuclear Regulatory Commission, Washington, DC.

1238.ANSI N42.14-1999, "Calibration and Use of Germanium Spectrometers for the Measurement ofGamma-Ray Emission Rates of Radionuclides," Amer ican National Standards Institute, New York, NY, 1999.1639.International Organization for Standardization (ISO), "International Vocabulary of Basic andGeneral Terms in Metrology," 2 nd Edition, Geneva, Switzerland, 1993.

1340.ISO Guide 30, "Terms and Definitions Used in C

onnection with Reference Materials

,"International Organization for Standa rdization, Geneva, Switzerland, 1992.

13

22Copies are available electronically through the IUPAC public Web site at http://www.iupac.org/publica tions/pac/1994/6612/index.html

.Rev. 2 of RG 4.15, Page 2841.International Union of Pure and Applied Chemistry (IUPAC), "Nomenclature for RadioanalyticalChemistry,"

Pure and Applied Chemistry , 66:12, pp. 2513-2526, 1994.

2242.ISO/IEC 15288-2002, "System Engineering - System Life Cycle Processes," International Organization for Standardiza tion, Geneva, Switzerland, 2002.

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