Regulatory Guide 4.15

Quality Assurance for Radiological Monitoring Programs (Normal Operations)-Effluent Streams and the Environment

ML13350A203
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Issue date:	12/31/1977
From:	Office of Nuclear Regulatory Research
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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

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.

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.

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,'

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

'As Low As Is Rea-be made by N P- se o maintain radiation ex- sonably Achievable'

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

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 tnq ten 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 Ithe findings 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 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.

evaluating the need lot an early revision, Washington.

D.C. 20555. Attention.

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.

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 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.

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.

General Design Criterion 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.

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.

systems, and components.

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.

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;

therefore, quality assurance includes quality cot,,arol.

The need for quality assurance is implicit in all re-quirements for effluent and environmental monitor-ing, and this need has been widely recognized.

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.

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.

B. DISCUSSION

To assure that radiological monitoring meas-urements are reasonably valid, organizations per-forming these measurements have found it necessary to establish quality assurance programs.

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)

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;

and to verify implementation of solutions.

2. Specification of Qualifications of Personnel The qualification of. individuals performing radiological monitoring to perform their assigned functions should be specified and documented.

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.

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.

and recertifying.

as appropriate to the activity performed.

3. Operating Procedures and Instructions Written procedures should be prepared.

reviewed.and approved for activities involved in carrying out the monitoring program. including sample collection:

packaging.

shipment.

and receipt of samples for offsite analysis:

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)

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

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.

4.15-3 Records to accomplish this should cover the follow-* ing proce.sses:

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.

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;

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.

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.

Continuous sampling should be dem-onstrably representative of the material volumes sam-pled. The collection efficiencies of the samplers used should be documented.

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.

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

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.

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.

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.

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.

NBS notes that this condition can be achieved without using a single NBS standard.4.15-4 available.

Otherwise, standards should be obtained from other reputable suppliers.

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.

For example, potassium-40

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.

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.

Ad-justmients should be made as necessary.

Additional checks needed for spectrometry systems are the energy resolution of the system and the count rate (or counting efficiency)

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:

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.

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%, of the analytical load should consist of quality control samples.4.15-5

6.3.1 Intralaboratory Analyses Replicate samples, usually duplicates, should be analyzed routinely.

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;

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.

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)

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.

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.

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)

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.

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.

For com-puter calculations, the input data should be verified by a knowledgeable individual.

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

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.

Periodic inplant calibration should be performed using a secondary source or method that has been related to the initial calibration.

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.

These flow rate devices should be recalibrated periodically.

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.

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.

D. IMPLEMENTATION

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

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

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.

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.

16. "Specification and Performance of On-Site In-strumentation for Continuously Monitoring Radioac-tivity in Effluents," ANSI N13.10-1974.

17. Air Sampling Instruments for Evaluation of At-mospheric Contaminants, Fourth Edition, American Conference of Industrial Hygienists, 1972.18. Users' Guide for Radioactivity Standards.

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:

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

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-600/4.77-001, 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.

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.

a sample having all of the constituents of the unknown sample except those to be determined.

In radioanalytical practice.the term often refers it) the radiochemical processing of carrier(s)

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.

Thus. quality as-surance includes quality control.Spiketd Sample-a sample to which a known amount of radioactive material has been added. Generally.

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.

Standard (radioactive)

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