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{{#Wiki_filter:U.S. NUCLEAR REGULATORY | {{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION December 1977 kREGULATORY GUIDE | ||
OFFICE OF STANDARDS DEVELOPMENT | |||
REGULATORY GUIDE 4.15 QUALITY ASSURANCE FOR RADIOLOGICAL MONITORING PROGRAMS | |||
(NORMAL OPERATIONS)-EFFLUENT STREAMS AND THE ENVIRONMENT | |||
==A. INTRODUCTION== | ==A. INTRODUCTION== | ||
This guide describes a method acceptable to | Section 30.34. ''Terms and Conditions of This guide describes a method acceptable to the Licenses," of 10 CFR Part 30. "Rules of General NRC staff for designing a program to assure the qual- Applicability to Licensing of Byproduct Material." | ||
ity of the results of measurements of radioactive ma- provides that the Commission mayý.incorporate in any terials in the effluents and the environment outside of byproduct material license such'týrnis and conditions nuclear facilities during normal operations. as it deems appropriate or neccssary. in order to pro- ttr-t hn'ii,: h'*. ",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,' Licene of I0.CFR'Part | |||
- 402...Licensing | |||
"Licesingof ofSorcSource 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 production 'Iq 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- *A' ssued by the Nuclear Regulatory Commission will | |||
"is ,* ~'*;.coitain tire materials .~ý; in . concentrations | |||
." that exceed .*:, * . | |||
such conditions and limitations as the Com- 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*.ýec-,. Section 70.32, "Conditions of Licenses," of 10 | |||
tion 20.201, "Surveys." of 10 CFR Pflýt'' fORti CFR Part 70. "Special Nuclear Material." provides requiresmeaurmetsofleel that a licenseeo conduct raito surv.ys, or;' ... including | |||
. .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 'As Low As Is Rea- be made by N P- se o maintain radiation ex- sonably Achievable' for Radioactive Material in posure, and ease*. 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. | |||
specfi*ie P* -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 GUIDES Comments should be sent to the Secretary at he Comn,$n,,,n.UOS.Nutlea, Regu Regulatory Guides are Issued to desctbe and make available to the public method0 1iotry Commission. Washington. D.C. 20555. Attention Dorheting i,,d Service acceplable to the NRC staff of implementing specific parts of the Commiusion's Brfanct . | |||
regulations, to delineate techniques used by the talfl in evaluating specific problems The guides are issued .n the tollow tnqten broad d-%1.13 or poltulated accidents, or to provide guidance to applicants. Regulatory Guides are not tubssltult for regulations. and compliance with them is not required. 1. Power Reactors 6 Protuclts Met',dt end solutions different from those set out in the guides will be accept. 2. Research and Test Reactors 7. Tans4tjrlit.tn able if they provide a basis for Ithefindings requisite to the issuance or continuance 3. Fuels and Materials Faclittes 8. Occuluational Health of e permit or license by the Commli.son. 4. Enviros',,ental and Siting 9. Antitrust Rerty.v | |||
5. Materials and Plant Protection tO. General Comments and suggestions for improvements in thete guides ae encouraged at all times, and guides will be revisad. as apsrotortate. to accommodate comments and Requests Ifo singlecopies of issued g*i$es (which mavyb. ertsL'Acovll at gotelace to reflect new informatiots or eaperierrce. Howe*er, 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 div*s*ons should he mnde in writing to the US. Nuclear Regulatory Crmmoissot. | |||
evaluating the need lot an early revision, Washington. D.C. 20555. Attention. Directo,, Onvruon of DOcument Cunttol | |||
radiation and radioactive materials in the environ- ing, and this need has been widely recognized. Regu- ment. Section lll.B of Appendix I to 10 CFR Part 50 latory Guide 1.21, "Measuring, Evaluating, and Re- provides certain effluent and environmental monitor- porting Radioactivity in Solid Wastes and Releases of ing requirements. with respect to radioactive iodine if Radioactive Materials in Liquid and Gaseous estimates of exposure are made on the basis of exist- Effluents from Light-Water-Cooled Nuclear Power ing conditions and if potential changes in land and Plants," Regulatory Guide 4.1. "Programs for water usage and food pathways could result in expo- Monitoring Radioactivity in the Environs of Nuclear sures in excess of the guidelines of Appendix I to 10 Power Plants:" Regulatory Guide 4,8. "Environmen- CFR Part 50. tal Technical Specifications for Nuclear Power General Design Criterion 60. "'Control of releases Plants;" and Regulatory Guide 4.14, "Measuring, Evaluating, and Reporting Radioactivity in Releases of radioactive materials to the environment," of Ap- pendix A. "General Design Criteria for Nuclear of Radioactive Material in Liquid and Airborne Power Plants." to 10 CFR Part 50 requires that nu- Effluents from Uranium Mills," all give some guid- clear power plant designs provide means to control ance on means for assuring the quality of the meas- suitably the release of radioactive materials in gase- urements of radioactive materials in effluents and the ous a:nd liquid effluents. General Design Criterion environment outside of nuclear facilities. More com- | |||
64. "Monitoring radioactivity releases." of Appen- plete and extensive guidance on this subject is pro- vided in this document for nuclear power reactor dix A to 10 CFR Part 50 requires that nuclear power plant designs provide means for monitoring effluent facilities and for other facilities for which radiologi- discharge paths and the plant environs for radioactiv- cal monitoring is required by the NRC. This guidance ity that may be released from normal operations, in- applies both to monitoring that is safety-related and cluding anticipated operational occurrences, and from monitoring that is not. For safety-related monitoring of nuclear power plants and fuel reprocessing plants, postulated accidents. | |||
other regulatory guides on quality assurance (in the General Design Criterion 1. "'Quality standards Division I and the Division 3 series of regulatory and records." of Appendix A to 10 CFR Part 50 re- guides) should be consulted to determine their quires that a quality assurance program be established applicability, if any. to the radiological monitoring for those structures, systems. and components of a activities. | |||
nuclear power plant that are important to safety in | |||
==B. DISCUSSION== | ==B. DISCUSSION== | ||
*To assure that radiological monitoring meas-urements are reasonably valid, organizations per-forming these measurements have found it | * | ||
order to provide adequate assurance that they will satisfactorily perform their safety functions. To assure that radiological monitoring meas- Appendix B. "Quality Assurance Criteria for Nu- urements are reasonably valid, organizations per- clear Power Plants and Fuel Reprocessing Plants," to forming these measurements have found it necessary | |||
10 CFR Part 50 establishes quality assurance re- to establish quality assurance programs. These pro- quirements for the design, construction, and opera- grams are needed for the following reasons: (1) to tion of those structures, systems, and components of identify deficiencies in the sampling and measure- these facilities that prevent or mitigate the conse- ment processes to those responsible for these opera- quences of postulated accidents that could cause tions so that corrective action can be taken, (2) to uridue risk to the health and safety of the pitblic. The provide a means of relating the results of a particular monitoring program to the National Bureau of Stand- pertinent requirements of this Appendix apply to all safety-related functions of these structures. systems, ards and thereby to provide a common basis for com- and components. This guide describes a method ac- paring the results of various programs, and (3) to ob- ceptable to the NRC staff for the design and opera- tain some measure of confidence in the results of the tion of a program to meet the requirements of Ap- monitoring programs in order to assure the regulatory pendix B to 10 CFR Part 50, for the safety functions agencies and the public that the results are valid. | |||
of radiological monitoring of effluents and the Existing published guidance on specific quality as- environment. surance actions which are applicable to radiological As used in the context of this guide. quality assur- monitoring is limited and, in general, is restricted to ance comprises all those planned and systematic ac- quality control practices for radioanalytical labora. | |||
tions that are necessary to provide adequate confi- tories (Refs. 1-3). However, quality assurance should dence in the results of a monitoring program, and be applied to all steps of the monitoring process that quality control comprises those quality assurance ac- may include sampling, shipment of samples, receipt tions that provide a means to control and measure the of samples in the laboratory, preparation of samples, characteristics of measurement equipment and proc- measurement of radioactivity (counting), data reduc- esses to established requirements; therefore, quality tion, data evaluation, and reporting of the monitoring assurance includes quality cot,,arol. results. | |||
The need for quality assurance is implicit in all re- *Definitions of special terms used in this guide are given in a quirements for effluent and environmental monitor- glossary in Appendix A. | |||
4.15-2 | |||
The scope of this guide is limited to the elements 2. Specification of Qualifications of Personnel of a quality assurance program, which is a planned. | |||
systematic, and documented program that includes The qualification of. individuals performing quality control. Guidance on principles and good radiological monitoring to perform their assigned practice in the monitoring process itself and guidance functions should be specified and documented. Speci. | |||
on activities that can affect the quality of the monitor- fication of these qualifications in terms of previous ing results (e.g., design of facilities and equipment) training and performance on the job or satisfactory are outside the scope of this guide. However, some completion of proficiency testing is prclerred to spec- references are provided to documents that do provide ification of education and experience levels. | |||
some guidance in these areas. The citation of these references does not constitute an endorsement of all An introduction and orientation program, appro- of the guidance in these documents by the NRC staff. | |||
Rather, these references are provided as sources of priate to the size and complexity of the organization. | |||
information to aid the licensee and the licensee's con- should provide that (a) personnel performing tractors in developing and maintaining a monitoring quality-related activities are trained and qualified in program. the principles and techniques of the activities per- formed. and (b) proficiency of personnel who per- form activities affecting quality is maintained by re- Every organization actually performing effluent training, reexamining. and recertifying. as appropriate and environmental monitoring, whether an NRC | |||
licensee or the licensee's contractor, should include to the activity performed. | |||
the quality assurance program elements presented in this guide. | |||
3. Operating Procedures and Instructions Written procedures should be prepared. reviewed. | |||
==C. REGULATORY POSITION== | ==C. REGULATORY POSITION== | ||
The quality assurance program of each organiza-tion performing effluent or environmental | and approved for activities involved in carrying out the monitoring program. including sample collection: | ||
The quality assurance program of each organiza- packaging. shipment. and receipt of samples for offsite analysis: preparation and analysis of samples: | |||
tion performing effluent or environmental monitoring of nuclear facilities for normal operations should be maintenance, storage. and use of radioactive refer- documented by written policies and procedures and ence standards; calibration and checks of radiation records. These documents should include the ele- and radioactivity measurement systems: and reduc- ments given in this section. tion. evaluation, and reporting of data. Individuals who review and approve these procedures should be knowledgeable in the subjects of the procedures. | |||
In addition to its own program, a licensee should require any contractor or subcontractor performing monitoring activities for the licensee to provide a Guidance on principles and good practice in many quality assurance program consistent with the provi- of these activities is presented in NRC regulatory sions of this guide, as follows: guides (Refs.4-7) and other publications (Refs. 2.3. | |||
8-25). In addition to these publications, the American Public Health Association is preparing a book on | |||
1. Organizational Structure and Responsibilities quality assurance practices in health laboratories that of Managerial and Operational Personnel will include a chapter on radiochemistry. and Scien- tific Committee 18A of the NCRP is preparing a The structure of the organization as it relates to the manual of radioactivity measurement procedures that management and operation of the monitoring pro. will be a revision of NCRP Report 28, NBS Hand- gram(s), including quality assurance policy and func- book 80, "'A Manual of Radioactivity Procedures." | |||
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 4. Records written procedures and for preparation, review, and evaluation of monitoring data and reports. The records necessary to document the activities performed in the monitoring program should be spec- Persons and organizations performing quality as- ified in the quality assurance program. | |||
surance functions should have sufficient authority and organizational freedom to identify quality prob- One key aspect of quality control is maintaining lems; to initiate, recommend, or provide solutions; the ability to track and control a sample in its prog- and to verify implementation of solutions. ress through the sequence of monitoring processes. | |||
4.15-3 | |||
Records to accomplish this should cover the follow- Procedures for sampling, packaging, shipping, and | |||
* ing proce.sses: field and inplant sample collection and storage of samples should be designed to maintair (l;!: | |||
sample description; sample receipt and laboratory integrity of the sample from time of collection t, timc identification coding, sample preparation and of analysis. Aqueous samples may present a particu- | |||
* radiochcmical processing (e.g., laboratory note- lar problem in this regard, and one of the most severe books); radioactivity measurements (counting) of problems has been encountered with aqueous samples | |||
* samples, instrument backgrounds. and analytical of radioactive wastes from operating nuclear reactors blanks. and data reduction and verification. (Ref. 2 ). | |||
Quality control records for laboratory counting sys- Guidance on the principles and practice of sam- tems should include the results of measurements of pling in environmental monitoring is provided in sev- radioactive check sources, calibration sources, back- eral publications (Refs. 2,9.19). In addition, workers grounds. and blanks. at the National Bureau of Standards (NBS) have pub- lished the results of a survey of information on sam- Records relating to overall laboratory performance pling, sample handling, and long-term storage for should include the results of analysis of quality con- environmental materials (Ref. 13). Some guidance on trol samples such as analytical blanks, duplicates, the principles and practice of air sampling is provided interlaboratory cross-check samples and other quality in References 15, 17, and 22. Guidance on the prin- control analyses; use of standard (radioactive) refer- ciples and practice of water sampling is provided in ence materials to prepare working standards; prepara- numerous publications (Refs. II, 12, 23-25). | |||
tion and standardization of carrier solutions; and 6. Quality Control in the Radioanalytical Labora- calibration of analytical balances. tory Additional records that are needed should include 6.1 Radionuclide Reference Standards-Use for the calibration of inline radiation detection equip- Calibration of Radiation Measuretnenit ment. air samplers, and thermoluminescence Systemns dosimetry systems; verification and documentation of Reference standards are used to determine counting computer programs; qualifications of personnel; and efficiencies for specific radionuclides or, in the case results of. audits. of gamma-ray spectrometry systems, to determine counting efficiency as a function of gamma-ray The minimum period of retention of the records energy. A counting efficiency value is used to con- should be specified. Only the final results of the vert a sample counting rate to the disintegration rate monitoring programs need be retained for the life of of a radionuclide or to a radionuclide concentration. | |||
the facility. (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 | |||
5. Quality Control in Sampling (Including Packag- for publication as an ANSI Standard.) | |||
Ing, Shipping, and Storage of Samples) | |||
Radionuclide standards that have been certified by Continuous sampling of liquids and gases involves the NBS, or standards that have been standardized the measurement of sample flow rates and/or sample using a measurement system that is traceable to that volumcs. The accuracy of the devices used for this of the NBS,* should be used when such standards are purpose should be determined on a regularly sched- uled basis, and adjustments should be made as *For a discussion by NBS staff members of the concept of needed to bring the performance of the devices within traceability of radioactivity measurements to NBS, see Refer- specified limits. The results of these calibrations ence 27.A brief summary of this discussion is as follows: There should be recorded. The frequency of these calibra- are both direct and indirect traceability. Direct traceability to NBS exists when. any outside laboratory prepares a batch of tions should be specified and should be based on the calibrated radioactivity standards and submits several randomly required accuracy, purpose, degree of usage, stability selected samples to NBS for confirmation or verification. Indi. | |||
characteristics, and other conditions affecting the rect traceability to NBS exists when NBS provides "unknown" | |||
* measurement. Continuous sampling should be dem- calibrate radioactivity samples to one or more laboratories which in turn make measurements of activity that agree within certain onstrably representative of the material volumes sam- specified limits with those of NBS. Thus there can be 1%, etc., | |||
pled. The collection efficiencies of the samplers used traceability. Regular use of NBS radioactivity standards by an should be documented. outside laboratory to calibrate its measuring equipment does not, in the view of the NBS staff, constitute traceability. Only when Grab samples should be demonstrably representa- the outside laboratory can measure the activity of an unknown sample and send back values to NBS that agree with NBS values tive of the material sampled, and replicate samples within a certain specified range of error does NBS consider that should be taken periodically to demonstrate the re- traceability has been established. NBS notes that this condition producibility of sampling. can be achieved without using a single NBS standard. | |||
4.15-4 | |||
available. Otherwise, standards should be obtained with automatic sample changers, background mncas- from other reputable suppliers. An "International Di- urements should be included within each counting rectory of Certified Radioactive Materials" has been cycle. | |||
publi.;hcd by the International Atomic Energy Agency (Ref. 26). For alpha- and gamma-ray spectrometry systems, energy-calibration sources (i.e.. a source containing a Acceptable standards for certain natural radionuc- radionuclide. or mixture of radionuclides. emitting lides may be prepared from commercially available two or more alpha or gamma rays of known energies) | |||
high-purity chemicals. For example, potassium-40 arc counted to determine the relationship between standards for gross beta measurements or gamma-ray channel number and alpha- or gamma-ray energy. | |||
spectrometry may be prepared from dried reagent- The frequency of these energy calibration checks de- grade potassium chloride. pends on the stability of the system but usually is in the range of daily to weekly. The results of these The details of the preparation of working standards *l.ci,,uienlents should be recorded and compared to from certified standard solutions should be recorded. predetermined limits in order to determine whether or The working standard should be prepared in the same noi system gain and zero level need adjustment. Ad- form as the unknown samples, or close approxima- justmients should be made as necessary. | |||
tion thereto. | |||
Additional checks needed for spectrometry systems Efficiency calibrations should he checked periodi- are the energy resolution of the system and the count cally (typically monthly tc yearly) with standard rate (or counting efficiency) of a check source. These sources. In addition, these checks should be made should be determined periodically (usually weekly to whenever the need is indicated, such as when a sig- nmonthly for energy resolution and daily to weekly for nificant change in the measurement system is de- count rate) and after system changes, such as power tected by routine measurements with a check source. failures or repairs, to determine if there has been any significant change in the system. The results of these measurements should be recorded. | |||
6.2 Performance Checks of Radiation Measure- Inenit Systems 6.3 Analysis of Quality' Control Samples Determination of the background counting rate and The analysis of quality control samples provides a the response of each radiation detection system to ap- means to determine the precision and accuracy of the propriate check sources should be performed on a monitoring processes and include!, both intralabora- scheduled basis for systems in routine use. The re- tory and interlaboratory measurements. | |||
sults of these measurements should be recorded in a log and/or plotted on a control chart. Appropriate in- The analysis of replicate samples provides a means vestigative and corrective action should be taken to determine precision: the analysis of samples con- when the measurement value falls outside the pre- taining known concentrations of radionuclides pro- determined control value. vides a means to deter'mine accuracy. The analysis of laboratory blanks provides a means to detect and A check source for determining changes in count- measure radioactive contamination of analytical sam- ing rate or counting efficiency should be of sufficient ples, a common source of error in radiochemical radiochemical purity to allow correction for decay but analysis of low-level samples. The analysis of analyt- need not have an accurately known disintegration ical blanks also provides information on the adequacy rate, i.e., need not be a standard source. of background subtraction, particularly for samples measured by gamma-ray spectrometry. | |||
For systems in which samples are changed manu- ally, check sources are usually measured daily. For The fraction of the analytical effort needed for the systems with automatic sample changers, it may be analysis of quality control samples depends to a large more convenient to include the check source within extent on (I) the mixture of sample types in a particu- each batch of samples and thus obtain a measurement lar laboratory in a particular time period and (2) the of this source within each counting cycle. For propor- history of performance of that laboratory in the anal- tional counter systems, the plateau(s) should be ysis of quality control samples. H6wever, in general checked after each gas change. Background meas- it is found that at least 5%, and typically 10%, of the urements should be made frequently to ensure that analytical load should consist of quality control levels arc within the expected range. For systems samples. | |||
4.15-5 | |||
6.3.1 IntralaboratoryAnalyses grams to provide an independent test of the ability to measure radionuclides at the very low concentrations Replicate samples, usually duplicates, should be present in most environmental samples. | |||
analyzed routinely. These replicates should be pre- pared from samples that are as homogeneous as pos- The NRC Office of Inspection and Enforcement sible, such as well-stirred or mixed liquids (water or conducts a Ccnfirmatory Measurements Program for milk) and solids (dried, ground, or screened soil, sed- laboratories of licensees that measure nuclear reactor iment, or vegetation; or the ash of these materials). | |||
effluents. The analyses of liquid waste holdup tank The size and other physical and chemical characteris- samples, gas samples, charcoal cartridges, and stack tics of the replicate samples should be similar to particulate filters are included in this program. The those of single samples analyzed routinely. | |||
results of the licensee's measurements of samples split with the NRC are compared to those of an NRC | |||
The analysis of the replicate samples as blind re- reference laboratory whose measurements are trace- plicates is desirable but is not practicable for all lab- able to the National Bureau of Standards (Ref. 27). | |||
oratories or for all types of samples. For example, in Thus the results of this comparison provide to the small laboratories it may not be practicable to prevent NRC an objective measure of the accuracy of the the analysts from being aware that particular samples licensee's analyses. | |||
are replicates of one another. | |||
Laboratories of licensees or their contractors that Obtaining true replicates of all types .of samples perform environmental measurements should partici- also is not practicable. For example, obtaining repli- pate in the EPA's Environmental Radioactivity Lab- cate samples of airborne materials usually is not prac- oratory Intercomparison Studies (Cross-check) Pro- ticable on a routine basis because it requires either a gram, or an equivalent program. This participation separate sampling system or splitting a single sample should include all of the determinations (sample (e.g., cutting a filter in half). Use of replicate medium/radionuclide combinations) that are both of- samplers usually is not economically feasible and fered by EPA and included in the licensee's environ- splitting of samples results in replicates that do not mental monitoring program. Participation in the EPA | |||
represent the usual sample size or measurement con- program provides an objective measure of the accu- figuration (counting geometry) for direct measure- racy of the analyses because the EPA measurements ment. However, simulated samples of airborne mate- are traceable to the National Bureau of Standards. If rials may be prepared in replicate and submitted for the mean result of a cross-check analysis exceeds the analysis as unknowns. control limit as defined by EPA (Ref. 28), an investi- gation should be made to determine the reason for Analysis of intralaboratory blank and spiked sam- this deviation and corrective action should be taken ples is an important part of each laboratory's quality as necessary. Similarly, an investigation and any control program. A known analytical blank sample necessary corrective action should take place if the should be analyzed with each group of unknown "normalized range." as calculated by EPA, exceeds samples that is processed radiochemically to deter- the control limit, as defined by EPA. A series of re- mine a specific radionuclide or radionuclides. Spiked sults that is within the control limits but that exhibits and blank samples should be submitted for analysis a trend toward these limits may indicate a need for an as unknowns to provide an intralaboratory basis for investigation to determine the reason for the trend. | |||
estimating the accuracy of the analytical results. | |||
These blanks and spikes may include blind replicates. | |||
6.4 Compuitational Checks | |||
6.3.2 InterlaboratvryAnalyses Procedures for the computation of the concentra- tion of radioactive materials should include the inde- Analysis of effluent and environmental samples pendent verification of a substantial fraction of the split with one or more independent laboratories is an results of the computation by a person other than the important part of the quality assurance program be- one performing the original computat'on. For com- cause it provides a means to detect errors that might puter calculations, the input data should be verified not be detected by intralaboratory measurements by a knowledgeable individual. All computer pro- alone. When possible, these independent laboratories grams should be documented and verified before ini- should be those whose measurements are traceable to tial routine use and after each modification of the NBS (Ref. 27). program. The verification process should include ver- ification, by a knowledgeable individual, of the al- Analysis of split field samples, such as samples of gorithm used and test runs in which the output of the milk, water, soil or sediment, and vegetation, is par- computer computation for given input can be com- ticularly important in environmental monitoring pro- pared to "true" values that are known or determined | |||
4.15-6 | |||
independently of the computer calculation. Documen- under which the system will be optrated. These flow tation of the program should include a description of rate devices should be recalibrated periodically. | |||
the algorithm and a current listing of the program. | |||
Guidelines for the documentation of digital computer Whenever practicable, a check source that is ac- programs are given in ANSI N413-1974 (Ref. 29). tuated remotely should be installed for integrity cheeks of the detector and the associated electrical | |||
7. Quality Control for Continuous Effluent system. | |||
Monitoring Systems 8. Review, Analysis, and Reporting Data The specified frequency of calibration for a par- Procedures for review, analysis, and reporting of ticular system should he based on considerations of the data should include examinatiuns for reasonableness nature and stability of that system. For nuclear power and consistency of the data and investigative and plants, specific requirements for calibrations and corrective actions to be taken under specified checks of particular effluent monitoring systems usu- circumstances. | |||
ally are included in the technical specifications for the plant. 9. Audits Initial calibration of each measuring system should Planned and periodic audits should be made to ver- be performed using one or more of the reference ify implementation of the quality assurance program. | |||
standards that are certified by the National Bureau of The audits should be performed by qualified indi- Standards or that are calibrated by a measurement viduals who do not have direct responsibilities in the system that is traceable to that of the National Bureau areas being audited. | |||
of Standards (Ref. 27). For nuclear power plants, Audit results should be documented and reviewed these calibrations are usually repeated at least annu- by management having responsibility in the area au- ally. The radionuclide standards should permit calib- dited. Followup action, including reaudit of deficient rating the system over its intended range of energy areas, should be taken where indicated. | |||
and rate capabilities. Periodic inplant calibration should be performed using a secondary source or | |||
==D. IMPLEMENTATION== | ==D. IMPLEMENTATION== | ||
The purpose of this section is to provide informa-tion to applicants and licensees regarding the | method that has been related to the initial calibration. | ||
For nuclear power plants, these calibrations are usu- The purpose of this section is to provide informa- ally performed at least monthly. tion to applicants and licensees regarding the NRC | |||
staff's plans for using this regulatory guide. | |||
Periodic correlations should be made during opera- This guide reflects current NRC staff practice. | |||
tion to relate monitor readings to the concentrations Therefore, except in those cases in which the appli- and/or release rates of radioactive material in the monitored release path. These correlations should be cant or licensee proposes an acceptable alternative method, the staff will use the method described based on the results of analyses for specific radionuc- herein in evaluating an applicant's or licensee's ca- lides in grab samples from the release path. | |||
pability for and performance in complying with spec- Flow-rate measuring devices associated with the ified portions of the Commission's regulations until system should be calibrated to determine actual flow this guide is revised as a result of suggestions from rates at the conditions of temperature and pressure the public or additional staff review. | |||
4.15-7 | |||
REFERENCES | |||
I. Section 6.2, "Validation of Analyses," Chapter Interface 5 (#4), 49-62 (1976). Also available from | |||
6, "Validity of Results," Methods of Radiochewnical the Superintendent of Documents, U.S. Government Analysis, World l-ealth Organization, Geneva, 1966. Printing Office, Washington, D.C. 20402, as NBS | |||
Technical Note #929, October 1976, C 13.46:929, | |||
2. "Analytical Quality Control Methods," Environ- S/N 003.003-01694-2. | |||
mental Radioactivity Surveillance Guide, U.S. En- 14. Tritium Measure.'ent Techniques, Report of vironniental Protection Agency Report, ORP/SID | |||
72-2, June 1972. NCRP SC-36, NCRP Report No. 47, 1976. | |||
3. Environmental Ra,.'iation Measurements, Report 15. "Guide to Sampling Airborne Radioactive Mate- of NCRP SC.35, NCRP Report No. 50, 1976. rials in Nuclear Facilities," ANSI N 13.1-1969. | |||
4. Regulatory Guide 1.21, "Measuring, Evaluating, 16. "Specification and Performance of On-Site In- and Reporting Radioactivity in Solid Wastes and Re- strumentation for Continuously Monitoring Radioac- leases of Radioactive Materials in Liquid and Gase- tivity in Effluents," ANSI N13.10-1974. | |||
ous Effluents from Light-Water-Cooled Nuclear 17. Air Sampling Instruments for Evaluation of At- Power Plants." mospheric Contaminants, Fourth Edition, American | |||
5. Regulatory Guide 4.5, "Measurements of Conference of Industrial Hygienists, 1972. | |||
Radionuclides in the Environment-Sampling and | |||
18. Users' Guide for Radioactivity Standards. Sub- Analyses of Plutonium in Soil." | |||
committee on Radiochemistry and Subcommittee on | |||
6. Regulatory Guide 4.6, "Measurements of the Use of Radioactivity Standards, Committee on Radionuclides in the Environment-Strontium-89 and Nuclear Science, National Academy of Sciences- Strontium-90 Analyses." National Research Council Report, NAS-NS-3115, February 1974. | |||
7. Regulatory Cuide 4.13, "Performance, Testing, and Procedural Specifications for Thermolumines- 19. Environmental Impact Monitoring for Nuclear cence Dosimetry: Environmental Applications." Power Plants, Source Book of Monitoring Methods, Vol. I, Atomic Industrial Forum Report, AIF/ | |||
8. HASL Procedures Manual, U.S. Energy Research NESP-004, February 1975. | |||
and Development Administration Report, HASL-300, | |||
1972 (updated annually). 20. Instrumentation for Environmental Monitoring: | |||
Radiation, Lawrence Berkeley Laboratory Report, | |||
9. A Guide for Environmental Radiological Surveil- LBL-l, Vol. 3, First Ed., May 1972; First update, lance at ERDA Installations, Energy Research and February 1973; Second update, October 1973. | |||
Development Administration Report, ERDA 77-24, March 1977. 21. C. W. Sill, "Problems in Sample Treatment in Trace Analysis." National Bureau of Standards Spe- | |||
10. Handbook of Radiochemical Analytical Methods, cial Publication 4-22, Accuracy in Trace Analysis: | |||
U.S. Environmental Protection Agency Report, Sampling, Sample Handling. and Analysis, pp. 463- EPA-680/4-75-001, February 1975. 490, August 1976. | |||
I1. Standard Methods for the Examination of Water 22. "General Principles for Sampling Airborne and Wastewater, Thirteenth Edition, American Pub- Radioactive Materials," International Standard, lic Health Association, 1975. ISO-2889, 1975. | |||
12. Handbookfor Sampling and Sample Preservation 23. Manual of Methods for Chemical Analysis of of Water and Wastewater, U.S. Environmental Pro- Water and Wastes, EPA-625/6-74-003, U.S. En- tection Agency Report, Office of Research and De- vironmental Protection Agency, Office of Technol- velopment, Environmental Monitoring Support Lab- ogy Transfer, Washington, D.C. 20460, 1974. | |||
oratory, EPA-200/4-76-049. September 1976i | |||
24. Annual Book of ASTM Standards (Part31), Wa- | |||
13. E. J. Maienthal and D. A. Becker, "A Survey on ter, American Society for Testing and Materials, Current Literature on Sampling, Sample Handling, Method D, 3370, pp. 71-82, Philadelphia, PA, July and Long-Term Storage for Environmental Materials," 1975. | |||
4.15-8 | |||
25. Biological Field and Laboratory, Methods for Standards and Measurements in Different Fields," | |||
Measuring the Quality of Surface Waters and Nuclear Instruments and Methods, Vol. 112, pp. | |||
Effluents, EPA-670/4-73-001, Office of Research and 5-18, 1973. | |||
Development, U.S. Environmental Protection Agency, Cincinnati, Ohio, July 1973. 28. Environmental Radioactivity Laboratory Inter- comparison Studies Program, FY 1977, EPA-600/4. | |||
26. International Directory of Certified Radioactive 77-001, January 1977. | |||
Materials, International Atomic Energy Agency Re- port, STI/PUB/398, 1975. 29. "Guidelines for the Documentation of Digital | |||
27. L. M. Cavallo et al.. "Needs for Radioactivity Computer Programs," ANSI N413- 1974. | |||
4.15-9 | |||
APPENDIX A | |||
GLOSSARY | |||
A-ccurac'yv-normally refers to the difference (error or electronic components of the system are operating bias) between tile mean, K. of the set of results and correctly. | |||
the value *. which is accepted as the true or correct Instrument Batckground--the response of the instru- value for the quantity measured. It is also used as the ment in the absence of a radioactive sample or other difference between an individual value X, and X. | |||
radioactive source. | |||
Absolhte acciuracy of the mean is given by "-,* | |||
Precision-relates to the reproducibility (f meas- and of an individual value by XrT. | |||
urements within a set, that is. to the scatter or disper- Relative accrwvr of the mean is given by t.-,)/:. son of a set about its central value. | |||
Pr'rcentageaccurac*y is given by 100 (X-0)/*. Quality Assurance (QA )-(the planned and systematic actions that are necessary to provide adequate confi- | |||
,Imd Vtic*'l Blank (Sample)-ideally. a sample having dence in the results of a monitoring program. | |||
all of the constituents of the unknown sample except those to be determined. In radioanalytical practice. Quaitiy Control (QC)-those quality assurance ac- the term often refers it) the radiochemical processing tions that provide a means to control and measure the of carrier(s) or tracers without the sample matrix ma- characteristics of measurement equipment and proc- terial. esses to established requirements. Thus. quality as- surance includes quality control. | |||
"Blind" Replivcat (Sample)-replicate samples that are not identified as replicates to the persons pcrform- Spiketd Sample-a sample to which a known amount ing the analysis. of radioactive material has been added. Generally. | |||
spiked samples are submitted as unknowns to the Calibrainon-the process of determining the numeri- analysts. | |||
cal relationship between the observed output of a measurement system and the value, based on refer- Split Sample-a sample that is divided into parts. | |||
ence standards, of the characteristics being measured. each of which is analyzed independently by separate Calibration Source-any radioactive source that is laboratory organizations. | |||
used for calibration of a measurement system. | |||
Standard (radioactive) Source-a radioactive source Check Source (or instrumnent check source, perform- having an accurately known radionuclide content and anlce check source, or referJence source)-a radioac- radioactive disintegration rate or particle or photon tive source used to determine if the detector and all emission rate. | |||
4.15-10}} | |||
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Latest revision as of 01:28, 20 March 2020
ML13350A203 | |
Person / Time | |
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Issue date: | 12/31/1977 |
From: | Office of Nuclear Regulatory Research |
To: | |
References | |
RG-4.015 | |
Download: ML13350A203 (10) | |
U.S. NUCLEAR REGULATORY COMMISSION December 1977 kREGULATORY GUIDE
OFFICE OF STANDARDS DEVELOPMENT
REGULATORY GUIDE 4.15 QUALITY ASSURANCE FOR RADIOLOGICAL MONITORING PROGRAMS
(NORMAL OPERATIONS)-EFFLUENT STREAMS AND THE ENVIRONMENT
A. INTRODUCTION
Section 30.34. Terms and Conditions of This guide describes a method acceptable to the Licenses," of 10 CFR Part 30. "Rules of General NRC staff for designing a program to assure the qual- Applicability to Licensing of Byproduct Material."
ity of the results of measurements of radioactive ma- provides that the Commission mayý.incorporate in any terials in the effluents and the environment outside of byproduct material license such'týrnis and conditions nuclear facilities during normal operations. as it deems appropriate or neccssary. in order to pro- ttr-t hn'ii,: h'*. ",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,' Licene of I0.CFR'Part
- 402...Licensing
"Licesingof ofSorcSource 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 production 'Iq 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- *A' ssued by the Nuclear Regulatory Commission will
"is ,* ~'*;.coitain tire materials .~ý; in . concentrations
." that exceed .*:, * .
such conditions and limitations as the Com- 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*.ýec-,. Section 70.32, "Conditions of Licenses," of 10
tion 20.201, "Surveys." of 10 CFR Pflýt fORti CFR Part 70. "Special Nuclear Material." provides requiresmeaurmetsofleel that a licenseeo conduct raito surv.ys, or;' ... including
. .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 'As Low As Is Rea- be made by N P- se o maintain radiation ex- sonably Achievable' for Radioactive Material in posure, and ease*. 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.
specfi*ie P* -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 GUIDES Comments should be sent to the Secretary at he Comn,$n,,,n.UOS.Nutlea, Regu Regulatory Guides are Issued to desctbe and make available to the public method0 1iotry Commission. Washington. D.C. 20555. Attention Dorheting i,,d Service acceplable to the NRC staff of implementing specific parts of the Commiusion's Brfanct .
regulations, to delineate techniques used by the talfl in evaluating specific problems The guides are issued .n the tollow tnqten broad d-%1.13 or poltulated accidents, or to provide guidance to applicants. Regulatory Guides are not tubssltult for regulations. and compliance with them is not required. 1. Power Reactors 6 Protuclts Met',dt end solutions different from those set out in the guides will be accept. 2. Research and Test Reactors 7. Tans4tjrlit.tn able if they provide a basis for Ithefindings requisite to the issuance or continuance 3. Fuels and Materials Faclittes 8. Occuluational Health of e permit or license by the Commli.son. 4. Enviros',,ental and Siting 9. Antitrust Rerty.v
5. Materials and Plant Protection tO. General Comments and suggestions for improvements in thete guides ae encouraged at all times, and guides will be revisad. as apsrotortate. to accommodate comments and Requests Ifo singlecopies of issued g*i$es (which mavyb. ertsL'Acovll at gotelace to reflect new informatiots or eaperierrce. Howe*er, 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 div*s*ons should he mnde in writing to the US. Nuclear Regulatory Crmmoissot.
evaluating the need lot an early revision, Washington. D.C. 20555. Attention. Directo,, Onvruon of DOcument Cunttol
radiation and radioactive materials in the environ- ing, and this need has been widely recognized. Regu- ment. Section lll.B of Appendix I to 10 CFR Part 50 latory Guide 1.21, "Measuring, Evaluating, and Re- provides certain effluent and environmental monitor- porting Radioactivity in Solid Wastes and Releases of ing requirements. with respect to radioactive iodine if Radioactive Materials in Liquid and Gaseous estimates of exposure are made on the basis of exist- Effluents from Light-Water-Cooled Nuclear Power ing conditions and if potential changes in land and Plants," Regulatory Guide 4.1. "Programs for water usage and food pathways could result in expo- Monitoring Radioactivity in the Environs of Nuclear sures in excess of the guidelines of Appendix I to 10 Power Plants:" Regulatory Guide 4,8. "Environmen- CFR Part 50. tal Technical Specifications for Nuclear Power General Design Criterion 60. "'Control of releases Plants;" and Regulatory Guide 4.14, "Measuring, Evaluating, and Reporting Radioactivity in Releases of radioactive materials to the environment," of Ap- pendix A. "General Design Criteria for Nuclear of Radioactive Material in Liquid and Airborne Power Plants." to 10 CFR Part 50 requires that nu- Effluents from Uranium Mills," all give some guid- clear power plant designs provide means to control ance on means for assuring the quality of the meas- suitably the release of radioactive materials in gase- urements of radioactive materials in effluents and the ous a:nd liquid effluents. General Design Criterion environment outside of nuclear facilities. More com-
64. "Monitoring radioactivity releases." of Appen- plete and extensive guidance on this subject is pro- vided in this document for nuclear power reactor dix A to 10 CFR Part 50 requires that nuclear power plant designs provide means for monitoring effluent facilities and for other facilities for which radiologi- discharge paths and the plant environs for radioactiv- cal monitoring is required by the NRC. This guidance ity that may be released from normal operations, in- applies both to monitoring that is safety-related and cluding anticipated operational occurrences, and from monitoring that is not. For safety-related monitoring of nuclear power plants and fuel reprocessing plants, postulated accidents.
other regulatory guides on quality assurance (in the General Design Criterion 1. "'Quality standards Division I and the Division 3 series of regulatory and records." of Appendix A to 10 CFR Part 50 re- guides) should be consulted to determine their quires that a quality assurance program be established applicability, if any. to the radiological monitoring for those structures, systems. and components of a activities.
nuclear power plant that are important to safety in
B. DISCUSSION
order to provide adequate assurance that they will satisfactorily perform their safety functions. To assure that radiological monitoring meas- Appendix B. "Quality Assurance Criteria for Nu- urements are reasonably valid, organizations per- clear Power Plants and Fuel Reprocessing Plants," to forming these measurements have found it necessary
10 CFR Part 50 establishes quality assurance re- to establish quality assurance programs. These pro- quirements for the design, construction, and opera- grams are needed for the following reasons: (1) to tion of those structures, systems, and components of identify deficiencies in the sampling and measure- these facilities that prevent or mitigate the conse- ment processes to those responsible for these opera- quences of postulated accidents that could cause tions so that corrective action can be taken, (2) to uridue risk to the health and safety of the pitblic. The provide a means of relating the results of a particular monitoring program to the National Bureau of Stand- pertinent requirements of this Appendix apply to all safety-related functions of these structures. systems, ards and thereby to provide a common basis for com- and components. This guide describes a method ac- paring the results of various programs, and (3) to ob- ceptable to the NRC staff for the design and opera- tain some measure of confidence in the results of the tion of a program to meet the requirements of Ap- monitoring programs in order to assure the regulatory pendix B to 10 CFR Part 50, for the safety functions agencies and the public that the results are valid.
of radiological monitoring of effluents and the Existing published guidance on specific quality as- environment. surance actions which are applicable to radiological As used in the context of this guide. quality assur- monitoring is limited and, in general, is restricted to ance comprises all those planned and systematic ac- quality control practices for radioanalytical labora.
tions that are necessary to provide adequate confi- tories (Refs. 1-3). However, quality assurance should dence in the results of a monitoring program, and be applied to all steps of the monitoring process that quality control comprises those quality assurance ac- may include sampling, shipment of samples, receipt tions that provide a means to control and measure the of samples in the laboratory, preparation of samples, characteristics of measurement equipment and proc- measurement of radioactivity (counting), data reduc- esses to established requirements; therefore, quality tion, data evaluation, and reporting of the monitoring assurance includes quality cot,,arol. results.
The need for quality assurance is implicit in all re- *Definitions of special terms used in this guide are given in a quirements for effluent and environmental monitor- glossary in Appendix A.
4.15-2
The scope of this guide is limited to the elements 2. Specification of Qualifications of Personnel of a quality assurance program, which is a planned.
systematic, and documented program that includes The qualification of. individuals performing quality control. Guidance on principles and good radiological monitoring to perform their assigned practice in the monitoring process itself and guidance functions should be specified and documented. Speci.
on activities that can affect the quality of the monitor- fication of these qualifications in terms of previous ing results (e.g., design of facilities and equipment) training and performance on the job or satisfactory are outside the scope of this guide. However, some completion of proficiency testing is prclerred to spec- references are provided to documents that do provide ification of education and experience levels.
some guidance in these areas. The citation of these references does not constitute an endorsement of all An introduction and orientation program, appro- of the guidance in these documents by the NRC staff.
Rather, these references are provided as sources of priate to the size and complexity of the organization.
information to aid the licensee and the licensee's con- should provide that (a) personnel performing tractors in developing and maintaining a monitoring quality-related activities are trained and qualified in program. the principles and techniques of the activities per- formed. and (b) proficiency of personnel who per- form activities affecting quality is maintained by re- Every organization actually performing effluent training, reexamining. and recertifying. as appropriate and environmental monitoring, whether an NRC
licensee or the licensee's contractor, should include to the activity performed.
the quality assurance program elements presented in this guide.
3. Operating Procedures and Instructions Written procedures should be prepared. reviewed.
C. REGULATORY POSITION
and approved for activities involved in carrying out the monitoring program. including sample collection:
The quality assurance program of each organiza- packaging. shipment. and receipt of samples for offsite analysis: preparation and analysis of samples:
tion performing effluent or environmental monitoring of nuclear facilities for normal operations should be maintenance, storage. and use of radioactive refer- documented by written policies and procedures and ence standards; calibration and checks of radiation records. These documents should include the ele- and radioactivity measurement systems: and reduc- ments given in this section. tion. evaluation, and reporting of data. Individuals who review and approve these procedures should be knowledgeable in the subjects of the procedures.
In addition to its own program, a licensee should require any contractor or subcontractor performing monitoring activities for the licensee to provide a Guidance on principles and good practice in many quality assurance program consistent with the provi- of these activities is presented in NRC regulatory sions of this guide, as follows: guides (Refs.4-7) and other publications (Refs. 2.3.
8-25). In addition to these publications, the American Public Health Association is preparing a book on
1. Organizational Structure and Responsibilities quality assurance practices in health laboratories that of Managerial and Operational Personnel will include a chapter on radiochemistry. and Scien- tific Committee 18A of the NCRP is preparing a The structure of the organization as it relates to the manual of radioactivity measurement procedures that management and operation of the monitoring pro. will be a revision of NCRP Report 28, NBS Hand- gram(s), including quality assurance policy and func- book 80, "'A Manual of Radioactivity Procedures."
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 4. Records written procedures and for preparation, review, and evaluation of monitoring data and reports. The records necessary to document the activities performed in the monitoring program should be spec- Persons and organizations performing quality as- ified in the quality assurance program.
surance functions should have sufficient authority and organizational freedom to identify quality prob- One key aspect of quality control is maintaining lems; to initiate, recommend, or provide solutions; the ability to track and control a sample in its prog- and to verify implementation of solutions. ress through the sequence of monitoring processes.
4.15-3
Records to accomplish this should cover the follow- Procedures for sampling, packaging, shipping, and
- ing proce.sses: field and inplant sample collection and storage of samples should be designed to maintair (l;!:
sample description; sample receipt and laboratory integrity of the sample from time of collection t, timc identification coding, sample preparation and of analysis. Aqueous samples may present a particu-
- radiochcmical processing (e.g., laboratory note- lar problem in this regard, and one of the most severe books); radioactivity measurements (counting) of problems has been encountered with aqueous samples
- samples, instrument backgrounds. and analytical of radioactive wastes from operating nuclear reactors blanks. and data reduction and verification. (Ref. 2 ).
Quality control records for laboratory counting sys- Guidance on the principles and practice of sam- tems should include the results of measurements of pling in environmental monitoring is provided in sev- radioactive check sources, calibration sources, back- eral publications (Refs. 2,9.19). In addition, workers grounds. and blanks. at the National Bureau of Standards (NBS) have pub- lished the results of a survey of information on sam- Records relating to overall laboratory performance pling, sample handling, and long-term storage for should include the results of analysis of quality con- environmental materials (Ref. 13). Some guidance on trol samples such as analytical blanks, duplicates, the principles and practice of air sampling is provided interlaboratory cross-check samples and other quality in References 15, 17, and 22. Guidance on the prin- control analyses; use of standard (radioactive) refer- ciples and practice of water sampling is provided in ence materials to prepare working standards; prepara- numerous publications (Refs. II, 12, 23-25).
tion and standardization of carrier solutions; and 6. Quality Control in the Radioanalytical Labora- calibration of analytical balances. tory Additional records that are needed should include 6.1 Radionuclide Reference Standards-Use for the calibration of inline radiation detection equip- Calibration of Radiation Measuretnenit ment. air samplers, and thermoluminescence Systemns dosimetry systems; verification and documentation of Reference standards are used to determine counting computer programs; qualifications of personnel; and efficiencies for specific radionuclides or, in the case results of. audits. of gamma-ray spectrometry systems, to determine counting efficiency as a function of gamma-ray The minimum period of retention of the records energy. A counting efficiency value is used to con- should be specified. Only the final results of the vert a sample counting rate to the disintegration rate monitoring programs need be retained for the life of of a radionuclide or to a radionuclide concentration.
the facility. (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
5. Quality Control in Sampling (Including Packag- for publication as an ANSI Standard.)
Ing, Shipping, and Storage of Samples)
Radionuclide standards that have been certified by Continuous sampling of liquids and gases involves the NBS, or standards that have been standardized the measurement of sample flow rates and/or sample using a measurement system that is traceable to that volumcs. The accuracy of the devices used for this of the NBS,* should be used when such standards are purpose should be determined on a regularly sched- uled basis, and adjustments should be made as *For a discussion by NBS staff members of the concept of needed to bring the performance of the devices within traceability of radioactivity measurements to NBS, see Refer- specified limits. The results of these calibrations ence 27.A brief summary of this discussion is as follows: There should be recorded. The frequency of these calibra- are both direct and indirect traceability. Direct traceability to NBS exists when. any outside laboratory prepares a batch of tions should be specified and should be based on the calibrated radioactivity standards and submits several randomly required accuracy, purpose, degree of usage, stability selected samples to NBS for confirmation or verification. Indi.
characteristics, and other conditions affecting the rect traceability to NBS exists when NBS provides "unknown"
- measurement. Continuous sampling should be dem- calibrate radioactivity samples to one or more laboratories which in turn make measurements of activity that agree within certain onstrably representative of the material volumes sam- specified limits with those of NBS. Thus there can be 1%, etc.,
pled. The collection efficiencies of the samplers used traceability. Regular use of NBS radioactivity standards by an should be documented. outside laboratory to calibrate its measuring equipment does not, in the view of the NBS staff, constitute traceability. Only when Grab samples should be demonstrably representa- the outside laboratory can measure the activity of an unknown sample and send back values to NBS that agree with NBS values tive of the material sampled, and replicate samples within a certain specified range of error does NBS consider that should be taken periodically to demonstrate the re- traceability has been established. NBS notes that this condition producibility of sampling. can be achieved without using a single NBS standard.
4.15-4
available. Otherwise, standards should be obtained with automatic sample changers, background mncas- from other reputable suppliers. An "International Di- urements should be included within each counting rectory of Certified Radioactive Materials" has been cycle.
publi.;hcd by the International Atomic Energy Agency (Ref. 26). For alpha- and gamma-ray spectrometry systems, energy-calibration sources (i.e.. a source containing a Acceptable standards for certain natural radionuc- radionuclide. or mixture of radionuclides. emitting lides may be prepared from commercially available two or more alpha or gamma rays of known energies)
high-purity chemicals. For example, potassium-40 arc counted to determine the relationship between standards for gross beta measurements or gamma-ray channel number and alpha- or gamma-ray energy.
spectrometry may be prepared from dried reagent- The frequency of these energy calibration checks de- grade potassium chloride. pends on the stability of the system but usually is in the range of daily to weekly. The results of these The details of the preparation of working standards *l.ci,,uienlents should be recorded and compared to from certified standard solutions should be recorded. predetermined limits in order to determine whether or The working standard should be prepared in the same noi system gain and zero level need adjustment. Ad- form as the unknown samples, or close approxima- justmients should be made as necessary.
tion thereto.
Additional checks needed for spectrometry systems Efficiency calibrations should he checked periodi- are the energy resolution of the system and the count cally (typically monthly tc yearly) with standard rate (or counting efficiency) of a check source. These sources. In addition, these checks should be made should be determined periodically (usually weekly to whenever the need is indicated, such as when a sig- nmonthly for energy resolution and daily to weekly for nificant change in the measurement system is de- count rate) and after system changes, such as power tected by routine measurements with a check source. failures or repairs, to determine if there has been any significant change in the system. The results of these measurements should be recorded.
6.2 Performance Checks of Radiation Measure- Inenit Systems 6.3 Analysis of Quality' Control Samples Determination of the background counting rate and The analysis of quality control samples provides a the response of each radiation detection system to ap- means to determine the precision and accuracy of the propriate check sources should be performed on a monitoring processes and include!, both intralabora- scheduled basis for systems in routine use. The re- tory and interlaboratory measurements.
sults of these measurements should be recorded in a log and/or plotted on a control chart. Appropriate in- The analysis of replicate samples provides a means vestigative and corrective action should be taken to determine precision: the analysis of samples con- when the measurement value falls outside the pre- taining known concentrations of radionuclides pro- determined control value. vides a means to deter'mine accuracy. The analysis of laboratory blanks provides a means to detect and A check source for determining changes in count- measure radioactive contamination of analytical sam- ing rate or counting efficiency should be of sufficient ples, a common source of error in radiochemical radiochemical purity to allow correction for decay but analysis of low-level samples. The analysis of analyt- need not have an accurately known disintegration ical blanks also provides information on the adequacy rate, i.e., need not be a standard source. of background subtraction, particularly for samples measured by gamma-ray spectrometry.
For systems in which samples are changed manu- ally, check sources are usually measured daily. For The fraction of the analytical effort needed for the systems with automatic sample changers, it may be analysis of quality control samples depends to a large more convenient to include the check source within extent on (I) the mixture of sample types in a particu- each batch of samples and thus obtain a measurement lar laboratory in a particular time period and (2) the of this source within each counting cycle. For propor- history of performance of that laboratory in the anal- tional counter systems, the plateau(s) should be ysis of quality control samples. H6wever, in general checked after each gas change. Background meas- it is found that at least 5%, and typically 10%, of the urements should be made frequently to ensure that analytical load should consist of quality control levels arc within the expected range. For systems samples.
4.15-5
6.3.1 IntralaboratoryAnalyses grams to provide an independent test of the ability to measure radionuclides at the very low concentrations Replicate samples, usually duplicates, should be present in most environmental samples.
analyzed routinely. These replicates should be pre- pared from samples that are as homogeneous as pos- The NRC Office of Inspection and Enforcement sible, such as well-stirred or mixed liquids (water or conducts a Ccnfirmatory Measurements Program for milk) and solids (dried, ground, or screened soil, sed- laboratories of licensees that measure nuclear reactor iment, or vegetation; or the ash of these materials).
effluents. The analyses of liquid waste holdup tank The size and other physical and chemical characteris- samples, gas samples, charcoal cartridges, and stack tics of the replicate samples should be similar to particulate filters are included in this program. The those of single samples analyzed routinely.
results of the licensee's measurements of samples split with the NRC are compared to those of an NRC
The analysis of the replicate samples as blind re- reference laboratory whose measurements are trace- plicates is desirable but is not practicable for all lab- able to the National Bureau of Standards (Ref. 27).
oratories or for all types of samples. For example, in Thus the results of this comparison provide to the small laboratories it may not be practicable to prevent NRC an objective measure of the accuracy of the the analysts from being aware that particular samples licensee's analyses.
are replicates of one another.
Laboratories of licensees or their contractors that Obtaining true replicates of all types .of samples perform environmental measurements should partici- also is not practicable. For example, obtaining repli- pate in the EPA's Environmental Radioactivity Lab- cate samples of airborne materials usually is not prac- oratory Intercomparison Studies (Cross-check) Pro- ticable on a routine basis because it requires either a gram, or an equivalent program. This participation separate sampling system or splitting a single sample should include all of the determinations (sample (e.g., cutting a filter in half). Use of replicate medium/radionuclide combinations) that are both of- samplers usually is not economically feasible and fered by EPA and included in the licensee's environ- splitting of samples results in replicates that do not mental monitoring program. Participation in the EPA
represent the usual sample size or measurement con- program provides an objective measure of the accu- figuration (counting geometry) for direct measure- racy of the analyses because the EPA measurements ment. However, simulated samples of airborne mate- are traceable to the National Bureau of Standards. If rials may be prepared in replicate and submitted for the mean result of a cross-check analysis exceeds the analysis as unknowns. control limit as defined by EPA (Ref. 28), an investi- gation should be made to determine the reason for Analysis of intralaboratory blank and spiked sam- this deviation and corrective action should be taken ples is an important part of each laboratory's quality as necessary. Similarly, an investigation and any control program. A known analytical blank sample necessary corrective action should take place if the should be analyzed with each group of unknown "normalized range." as calculated by EPA, exceeds samples that is processed radiochemically to deter- the control limit, as defined by EPA. A series of re- mine a specific radionuclide or radionuclides. Spiked sults that is within the control limits but that exhibits and blank samples should be submitted for analysis a trend toward these limits may indicate a need for an as unknowns to provide an intralaboratory basis for investigation to determine the reason for the trend.
estimating the accuracy of the analytical results.
These blanks and spikes may include blind replicates.
6.4 Compuitational Checks
6.3.2 InterlaboratvryAnalyses Procedures for the computation of the concentra- tion of radioactive materials should include the inde- Analysis of effluent and environmental samples pendent verification of a substantial fraction of the split with one or more independent laboratories is an results of the computation by a person other than the important part of the quality assurance program be- one performing the original computat'on. For com- cause it provides a means to detect errors that might puter calculations, the input data should be verified not be detected by intralaboratory measurements by a knowledgeable individual. All computer pro- alone. When possible, these independent laboratories grams should be documented and verified before ini- should be those whose measurements are traceable to tial routine use and after each modification of the NBS (Ref. 27). program. The verification process should include ver- ification, by a knowledgeable individual, of the al- Analysis of split field samples, such as samples of gorithm used and test runs in which the output of the milk, water, soil or sediment, and vegetation, is par- computer computation for given input can be com- ticularly important in environmental monitoring pro- pared to "true" values that are known or determined
4.15-6
independently of the computer calculation. Documen- under which the system will be optrated. These flow tation of the program should include a description of rate devices should be recalibrated periodically.
the algorithm and a current listing of the program.
Guidelines for the documentation of digital computer Whenever practicable, a check source that is ac- programs are given in ANSI N413-1974 (Ref. 29). tuated remotely should be installed for integrity cheeks of the detector and the associated electrical
7. Quality Control for Continuous Effluent system.
Monitoring Systems 8. Review, Analysis, and Reporting Data The specified frequency of calibration for a par- Procedures for review, analysis, and reporting of ticular system should he based on considerations of the data should include examinatiuns for reasonableness nature and stability of that system. For nuclear power and consistency of the data and investigative and plants, specific requirements for calibrations and corrective actions to be taken under specified checks of particular effluent monitoring systems usu- circumstances.
ally are included in the technical specifications for the plant. 9. Audits Initial calibration of each measuring system should Planned and periodic audits should be made to ver- be performed using one or more of the reference ify implementation of the quality assurance program.
standards that are certified by the National Bureau of The audits should be performed by qualified indi- Standards or that are calibrated by a measurement viduals who do not have direct responsibilities in the system that is traceable to that of the National Bureau areas being audited.
of Standards (Ref. 27). For nuclear power plants, Audit results should be documented and reviewed these calibrations are usually repeated at least annu- by management having responsibility in the area au- ally. The radionuclide standards should permit calib- dited. Followup action, including reaudit of deficient rating the system over its intended range of energy areas, should be taken where indicated.
and rate capabilities. Periodic inplant calibration should be performed using a secondary source or
D. IMPLEMENTATION
method that has been related to the initial calibration.
For nuclear power plants, these calibrations are usu- The purpose of this section is to provide informa- ally performed at least monthly. tion to applicants and licensees regarding the NRC
staff's plans for using this regulatory guide.
Periodic correlations should be made during opera- This guide reflects current NRC staff practice.
tion to relate monitor readings to the concentrations Therefore, except in those cases in which the appli- and/or release rates of radioactive material in the monitored release path. These correlations should be cant or licensee proposes an acceptable alternative method, the staff will use the method described based on the results of analyses for specific radionuc- herein in evaluating an applicant's or licensee's ca- lides in grab samples from the release path.
pability for and performance in complying with spec- Flow-rate measuring devices associated with the ified portions of the Commission's regulations until system should be calibrated to determine actual flow this guide is revised as a result of suggestions from rates at the conditions of temperature and pressure the public or additional staff review.
4.15-7
REFERENCES
I. Section 6.2, "Validation of Analyses," Chapter Interface 5 (#4), 49-62 (1976). Also available from
6, "Validity of Results," Methods of Radiochewnical the Superintendent of Documents, U.S. Government Analysis, World l-ealth Organization, Geneva, 1966. Printing Office, Washington, D.C. 20402, as NBS
Technical Note #929, October 1976, C 13.46:929,
2. "Analytical Quality Control Methods," Environ- S/N 003.003-01694-2.
mental Radioactivity Surveillance Guide, U.S. En- 14. Tritium Measure.'ent Techniques, Report of vironniental Protection Agency Report, ORP/SID
72-2, June 1972. NCRP SC-36, NCRP Report No. 47, 1976.
3. Environmental Ra,.'iation Measurements, Report 15. "Guide to Sampling Airborne Radioactive Mate- of NCRP SC.35, NCRP Report No. 50, 1976. rials in Nuclear Facilities," ANSI N 13.1-1969.
4. Regulatory Guide 1.21, "Measuring, Evaluating, 16. "Specification and Performance of On-Site In- and Reporting Radioactivity in Solid Wastes and Re- strumentation for Continuously Monitoring Radioac- leases of Radioactive Materials in Liquid and Gase- tivity in Effluents," ANSI N13.10-1974.
ous Effluents from Light-Water-Cooled Nuclear 17. Air Sampling Instruments for Evaluation of At- Power Plants." mospheric Contaminants, Fourth Edition, American
5. Regulatory Guide 4.5, "Measurements of Conference of Industrial Hygienists, 1972.
Radionuclides in the Environment-Sampling and
18. Users' Guide for Radioactivity Standards. Sub- Analyses of Plutonium in Soil."
committee on Radiochemistry and Subcommittee on
6. Regulatory Guide 4.6, "Measurements of the Use of Radioactivity Standards, Committee on Radionuclides in the Environment-Strontium-89 and Nuclear Science, National Academy of Sciences- Strontium-90 Analyses." National Research Council Report, NAS-NS-3115, February 1974.
7. Regulatory Cuide 4.13, "Performance, Testing, and Procedural Specifications for Thermolumines- 19. Environmental Impact Monitoring for Nuclear cence Dosimetry: Environmental Applications." Power Plants, Source Book of Monitoring Methods, Vol. I, Atomic Industrial Forum Report, AIF/
8. HASL Procedures Manual, U.S. Energy Research NESP-004, February 1975.
and Development Administration Report, HASL-300,
1972 (updated annually). 20. Instrumentation for Environmental Monitoring:
Radiation, Lawrence Berkeley Laboratory Report,
9. A Guide for Environmental Radiological Surveil- LBL-l, Vol. 3, First Ed., May 1972; First update, lance at ERDA Installations, Energy Research and February 1973; Second update, October 1973.
Development Administration Report, ERDA 77-24, March 1977. 21. C. W. Sill, "Problems in Sample Treatment in Trace Analysis." National Bureau of Standards Spe-
10. Handbook of Radiochemical Analytical Methods, cial Publication 4-22, Accuracy in Trace Analysis:
U.S. Environmental Protection Agency Report, Sampling, Sample Handling. and Analysis, pp. 463- EPA-680/4-75-001, February 1975. 490, August 1976.
I1. Standard Methods for the Examination of Water 22. "General Principles for Sampling Airborne and Wastewater, Thirteenth Edition, American Pub- Radioactive Materials," International Standard, lic Health Association, 1975. ISO-2889, 1975.
12. Handbookfor Sampling and Sample Preservation 23. Manual of Methods for Chemical Analysis of of Water and Wastewater, U.S. Environmental Pro- Water and Wastes, EPA-625/6-74-003, U.S. En- tection Agency Report, Office of Research and De- vironmental Protection Agency, Office of Technol- velopment, Environmental Monitoring Support Lab- ogy Transfer, Washington, D.C. 20460, 1974.
oratory, EPA-200/4-76-049. September 1976i
24. Annual Book of ASTM Standards (Part31), Wa-
13. E. J. Maienthal and D. A. Becker, "A Survey on ter, American Society for Testing and Materials, Current Literature on Sampling, Sample Handling, Method D, 3370, pp. 71-82, Philadelphia, PA, July and Long-Term Storage for Environmental Materials," 1975.
4.15-8
25. Biological Field and Laboratory, Methods for Standards and Measurements in Different Fields,"
Measuring the Quality of Surface Waters and Nuclear Instruments and Methods, Vol. 112, pp.
Effluents, EPA-670/4-73-001, Office of Research and 5-18, 1973.
Development, U.S. Environmental Protection Agency, Cincinnati, Ohio, July 1973. 28. Environmental Radioactivity Laboratory Inter- comparison Studies Program, FY 1977, EPA-600/4.
26. International Directory of Certified Radioactive 77-001, January 1977.
Materials, International Atomic Energy Agency Re- port, STI/PUB/398, 1975. 29. "Guidelines for the Documentation of Digital
27. L. M. Cavallo et al.. "Needs for Radioactivity Computer Programs," ANSI N413- 1974.
4.15-9
APPENDIX A
GLOSSARY
A-ccurac'yv-normally refers to the difference (error or electronic components of the system are operating bias) between tile mean, K. of the set of results and correctly.
the value *. which is accepted as the true or correct Instrument Batckground--the response of the instru- value for the quantity measured. It is also used as the ment in the absence of a radioactive sample or other difference between an individual value X, and X.
radioactive source.
Absolhte acciuracy of the mean is given by "-,*
Precision-relates to the reproducibility (f meas- and of an individual value by XrT.
urements within a set, that is. to the scatter or disper- Relative accrwvr of the mean is given by t.-,)/:. son of a set about its central value.
Pr'rcentageaccurac*y is given by 100 (X-0)/*. Quality Assurance (QA )-(the planned and systematic actions that are necessary to provide adequate confi-
,Imd Vtic*'l Blank (Sample)-ideally. a sample having dence in the results of a monitoring program.
all of the constituents of the unknown sample except those to be determined. In radioanalytical practice. Quaitiy Control (QC)-those quality assurance ac- the term often refers it) the radiochemical processing tions that provide a means to control and measure the of carrier(s) or tracers without the sample matrix ma- characteristics of measurement equipment and proc- terial. esses to established requirements. Thus. quality as- surance includes quality control.
"Blind" Replivcat (Sample)-replicate samples that are not identified as replicates to the persons pcrform- Spiketd Sample-a sample to which a known amount ing the analysis. of radioactive material has been added. Generally.
spiked samples are submitted as unknowns to the Calibrainon-the process of determining the numeri- analysts.
cal relationship between the observed output of a measurement system and the value, based on refer- Split Sample-a sample that is divided into parts.
ence standards, of the characteristics being measured. each of which is analyzed independently by separate Calibration Source-any radioactive source that is laboratory organizations.
used for calibration of a measurement system.
Standard (radioactive) Source-a radioactive source Check Source (or instrumnent check source, perform- having an accurately known radionuclide content and anlce check source, or referJence source)-a radioac- radioactive disintegration rate or particle or photon tive source used to determine if the detector and all emission rate.
4.15-10