1 Special terms used in this guide are marked in SMALL CAPITALS the first time they are used, and are defined

in the glossary provided in this regulatory guide.

The U.S. Nuclear Regulatory Commission (NRC) issues regulatory guides to describe and make available to the public methods

that the NRC staff considers acceptable for use in implementing specific parts of the agency’s regulations, techniques that the

staff uses in evaluating specific problems or postulated accidents, and data that the staff need in reviewing applications for

permits and licenses. Regulatory guides are not substitutes for regulations, and compliance with them is not required. Methods

and solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the

findings required for the issuance or continuance of a permit or license by the Commission.

This guide was issued after consideration of comments received from the public.

Regulatory guides are issued in 10 broad divisions: 1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials

Facilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Health;

9, Antitrust and Financial Review; and 10, General.

Electronic copies of this guide and other recently issued guides are available through the NRC’s public Web site under the

Regulatory Guides document collection of the NRC’s Electronic Reading Room

at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC’s Agencywide Documents Access and Management

System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML071790506.

U.S. NUCLEAR REGULATORY COMMISSION July 2007

Revision 2

REGULATORY GUIDE

OFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 4.15

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

QUALITY ASSURANCE

FOR RADIOLOGICAL MONITORING PROGRAMS

(INCEPTION THROUGH NORMAL OPERATIONS

TO LICENSE TERMINATION) —

EFFLUENT STREAMS AND THE ENVIRONMENT

A. INTRODUCTION

This regulatory guide describes a method that the U.S. Nuclear Regulatory Commission (NRC)

considers acceptable for use in designing and implementing programs to ensure the quality of the results

of measurements of radioactive materials in the effluents from, and environment outside of, facilities that

process, use, or store radioactive materials during all phases of the facility’s life cycle. 

QUALITY ASSURANCE1

 (QA) is a fundamental expectation of Title 10, “Energy,” of the Code of Federal

Regulations (10 CFR) for items and activities that are relied on to protect the health and safety

of the public and the environment.

This guide specifically applies to facilities for which NRC regulations require routine monitoring

of radioactive effluents to the environment, and particularly those facilities licensed under the following

regulations:

• 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities” (Ref. 1)

• 10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants” (Ref. 2)
Rev. 2 of RG 4.15, Page 2

• 10 CFR Part 61, “Licensing Requirements for Land Disposal of Radioactive Waste” (Ref. 3)

• 10 CFR Part 72, “Licensing Requirements for the Independent Storage of Spent Nuclear Fuel,

High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste” (Ref. 4)

• 10 CFR Part 76, “Certification of Gaseous Diffusion Plants” (Ref. 5)

The guide also may apply to other facilities licensed by the NRC, for which the agency

may impose specific license conditions for effluent or environmental monitoring, as deemed necessary

to ensure the health and safety of the public and the environment, including those licensed under

the following regulations:

• 10 CFR Part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material”

(Ref. 6)

• 10 CFR Part 40, “Domestic Licensing of Source Material” (Ref. 7)

• 10 CFR Part 70, “Domestic Licensing of Special Nuclear Material” (Ref. 8)

Finally, radiological standards for occupational workers and members of the public are codified

in 10 CFR Part 20, “Standards for Protection Against Radiation” (Ref. 9).

Although the specific regulations provide the actual requirements, the following presents an

overview of applicable NRC regulations addressing limits on radioactive effluents, environmental levels of

radioactivity, requirements for effluent and environmental monitoring, and associated QA.

In accordance with 10 CFR 20.1301, “Dose Limits for Individual Members of the Public,” the

TOTAL EFFECTIVE DOSE EQUIVALENT (TEDE) to individual members of the public from licensed operation

must not exceed 1 milliSIEVERT [1 mSv, or 100 milliREM (mrem)] per year. Uranium fuel cycle facilities

(excluding transportation and disposal) also must comply with the provisions that the U.S. Environmental

Protection Agency (EPA) established in 40 CFR Part 190, “Environmental Radiation Protection Standards

for Nuclear Power Operations” (Ref. 10). In addition, 10 CFR 20.1101(d) requires licensees (other than

those subject to 10 CFR 50.34a, “Design Objectives for Equipment to Control Releases of Radioactive

Material in Effluents — Nuclear Power Reactors,” discussed below) to restrict releases of airborne

radioactive materials so that the highest individual dose to the public will not exceed 0.1 mSv (10 mrem)

per year.

In addition, under 10 CFR 20.1101(b), licensees must apply AS LOW AS REASONABLY ACHIEVABLE

(ALARA) concepts to doses to occupational workers and members of the general public. In accordance

with 10 CFR 20.1302, “Compliance with Dose Limits for Individual Members of the Public,” licensees

must survey radiation levels to demonstrate compliance with the dose limits, and 10 CFR 20.1101,

“Radiation Protection Programs,” requires licensees to develop, document, and implement radiation

protection programs commensurate with the scope and extent of licensed activities and sufficient to ensure

compliance with the provisions of 10 CFR Part 20 (Ref. 9).

In 10 CFR Part 20, Subpart E, “Radiological Criteria for License Termination,” the NRC provides

the radiological criteria for license termination under unrestricted and restricted use scenarios. The NRC

considers a site acceptable for unrestricted use if the residual radioactivity that is distinguishable from

background radiation does not exceed 25 mrem/year (0.25mSv/year) TEDE to an average member of the

critical group, including contributions from groundwater sources. A site can be released under restricted

use if the residual radioactivity that is distinguishable from background dose not exceed a yearly dose of

25 mrem (0.25mSv) TEDE with site use restrictions in place.
Rev. 2 of RG 4.15, Page 3

For nuclear power reactors, 10 CFR 50.34a and 10 CFR 50.36a, “Technical Specifications on

Effluents from Nuclear Power Reactors,” require ALARA concepts for operations to maintain releases of

radioactive materials in effluents consistent with the guidelines of Appendix I, “Numerical Guides for

Design Objectives and Limiting Conditions for Operation to Meet the Criterion ‘As Low As Is Reasonably

Achievable’ for Radioactive Material in Light-Water-Cooled Nuclear Power Reactor Effluents,” to

10 CFR Part 50. Licensees must also establish appropriate SURVEILLANCE and monitoring programs to

provide QA with respect to (1) areas of equipment operation and (2) data on the quantities or

concentrations of radionuclides released in liquid and gaseous effluents. These programs will help to

ensure accurate projection of the levels of radiation and radioactive materials found in the environment. 

Section III.B of Appendix I addresses requirements concerning estimates of radioactive iodine in water and

food pathways if land use changes occur after plant construction.

The regulations in 10 CFR 30.34, “Byproduct Material,” 10 CFR 40.41, “Source Material,”

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

provide that the NRC may incorporate in any governed license such terms and conditions as it deems

appropriate or necessary to protect health.

For land disposal of radioactive waste, 10 CFR 61.53, “Environmental Monitoring,” requires

measurements and observations to be made and recorded to provide data to evaluate potential health and

environmental impacts, including long-term effects, as well as the need for mitigating measures. The

monitoring system must be capable of providing early warning of releases of radionuclides from the

disposal site. A postclosure monitoring program is also required to detect the release of radionuclides.

According to 10 CFR 70.59, “Effluent Monitoring Reporting Requirements,” licensees authorized

to possess and use special nuclear materials for processing and fuel fabrication, scrap recovery, conversion

of uranium hexafluoride, or in a uranium enrichment facility shall report to the NRC the quantity of each of

the principal radionuclides released to unrestricted areas in liquid and gaseous effluents, and other

information as the Commission may require to estimate maximum potential annual radiation doses to the

public resulting from effluent releases.

Appendix A, “General Design Criteria for Nuclear Power Plants,” to 10 CFR Part 50 includes

several applicable general design criteria (GDC) affecting nuclear power plant designs. GDC 60, “Control

of Releases of Radioactive Materials to the Environment,” requires suitable means to control the release of

radioactive materials in gaseous and liquid effluents. GDC 64, “Monitoring Radioactivity Releases,”

requires means for monitoring effluent discharge paths and the plant environs for radioactivity that may be

released from normal operations, including anticipated operational occurrences, and from postulated

accidents. GDC 1, “Quality Standards and Records,” requires the establishment of a QA program for those

structures, systems, and components that are important to safety to provide adequate assurance that they

will satisfactorily perform their safety functions. Appendix B, “Quality Assurance Criteria for Nuclear

Power Plants and Fuel Reprocessing Plants,” to 10 CFR Part 50 establishes the QA requirements for power

plants.

The requirements in 10 CFR 72.104, “Criteria for Radioactive Material in Effluent and Direct

Radiation from an ISFSI [Independent Spent Fuel Storage Installation] or MRS [Monitored Retrievable

Storage],” mandate operational restrictions for maintaining effluents and direct radiation levels in

accordance with ALARA concepts, with limits so as not to exceed annual DOSE EQUIVALENTS of .25 mSv

(25 mrem) to the whole body, 0.75 mSv (75 mrem) to the thyroid, and 0.25 mSv (25 mrem) to any other

critical organ of any real individual beyond the controlled area.

For gaseous diffusion uranium enrichment facilities, 10 CFR 76.87, “Technical Safety

Requirements,” requires licensees to establish technical safety requirements with procedures and equipment
2 While not specific to QA, other regulatory guides that address measurements of radioactive materials in effluents

and the environment include the following:

• Regulatory Guide 1.21, “Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Releases of

Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power Plants” (Ref. 13)

• Regulatory Guide 4.1, “Programs for Monitoring Radioactivity in the Environs of Nuclear Power Plants”

(Ref. 14)

• Regulatory Guide 4.14, “Radiological Effluent and Environmental Monitoring at Uranium Mills” (Ref. 15)

• Regulatory Guide 4.16, “Monitoring and Reporting Radioactivity in Releases of Radioactive Materials in Liquid

and Gaseous Effluents from Nuclear Fuel Processing and Fabrication Plants and Uranium Hexafluoride

Production Plants” (Ref. 16)

Rev. 2 of RG 4.15, Page 4

to address (among other things) building and process ventilation and off-gassing, radioactive waste

management, and environmental protection. In addition, 10 CFR 76.93, “Quality Assurance,” requires a

QA program satisfying the applicable provisions of the American Society of Mechanical Engineers

(ASME) standard QA-1-1994, “Quality Assurance Program Requirements for Nuclear Facilities (with

Addenda)” (Ref. 11).

Generic Letter 79065 (Ref. 12), regarding the NRC’s Radiological Assessment Branch Technical

Position on Radiological Environmental Monitoring, provides guidance on the appropriate type of, and

location for, sampling and monitoring the environment surrounding nuclear power plants.

This regulatory guide presents more complete and extensive guidance on QA for facilities where

radiological effluent or environmental monitoring is required by NRC regulations.2

 However, this

guidance does not address all topics and elements that a facility’s QA program may require (such as

requirements of Appendix B to 10 CFR Part 50 for nuclear power plants or 10 CFR 76.93 for gaseous

diffusion uranium enrichment facilities).

The NRC issues regulatory guides to describe to the public methods that the staff considers

acceptable for use in implementing specific parts of the agency’s regulations, to explain techniques that the

staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants. 

Regulatory guides are not substitutes for regulations, and compliance with regulatory guides is not

required. 
Rev. 2 of RG 4.15, Page 5

B. DISCUSSION

As used in the context of this guide, QA comprises all those planned and systematic actions that are

necessary to provide adequate confidence in the ASSESSMENT of monitoring results. QUALITY CONTROL

(QC) comprises those QA actions that provide a means to measure and control the characteristics of

measurement equipment and processes to meet established standards; QA includes QC. This guide makes

no further effort to distinguish those elements that may be considered QC from those composing QA.

Quality assurance is necessary to ensure that all radiological and nonradiological measurements

that support the radiological monitoring program are reasonably valid and of a defined quality. These

programs are needed (1) to identify deficiencies in the sampling and measurement processes and report

them to those responsible for these operations so that licensees may take CORRECTIVE ACTION and (2) to

obtain some measure of confidence in the results of the monitoring programs to assure the regulatory

agencies and the public that the results are valid. All steps of the monitoring process should involve QA

(e.g., sampling, shipment of SAMPLES, receipt of samples in the laboratory, preparation of samples,

radiological measurements, data reduction, data evaluation, and reporting of the measurement and

monitoring results) .

An effective overall management system for quality must precede the design of a QA program. A

document by the International Organization for Standardization (ISO/IEC 17025-2005, Ref. 17) is available

for use by laboratories in developing their management system for quality, administrative, and technical

operations. Once a quality management system is in place, a DIRECTED PLANNING PROCESS can be used to

define the data objectives for the specific monitoring program. The DATA QUALITY OBJECTIVE (DQO)

process (EPA QA/G-4-2006, Ref. 18) provides one example of how to develop and define acceptance and

performance criteria for a sample collection, measurement, and data analysis program. The QUALITY

ASSURANCE PROJECT PLAN (QAPP), which documents how data will be collected, assessed, and analyzed,

can form the basis of a QA program (EPA QA/G-5-2002, Ref. 19). The QAPP provides a blueprint of

where, when, why, and how a particular project will achieve data of the type and quality needed and

expected.

NUREG-1576, “Multi-Agency Radiological Laboratory Analytical Protocols Manual” (Ref. 20,

hereafter referred to as MARLAP), contains guidance for developing DQOs for risk-informed decisions,

and their consequent MEASUREMENT QUALITY OBJECTIVES (MQOs), in the context of radiochemical

analyses of environmental samples. The same methodology can be applied in other environmental

monitoring contexts. An example of a key MQO is the REQUIRED METHOD UNCERTAINTY at a specified

radiation dose or radionuclide concentration. The specific dose may be a fractional amount of a radiation

dose limit. The specific concentration may be a fractional amount of an effluent release or environmental

radionuclide concentration. For either case, the fractional amount of the limit should be sufficiently small

so that a licensee may take reasonable operational actions before the limit is exceeded. MARLAP

recommends a PERFORMANCE-BASED APPROACH for selecting methods used to analyze samples or measure

dose rates that meet the MQOs. Under this approach, the licensee’s QA program should incorporate the

initial (project METHOD VALIDATION) and continued [internal and external PERFORMANCE EVALUATION (PE)

PROGRAMS] assessment of a method’s capability to meet the MQO specifications. Process-radiation

monitoring equipment and instrumentation need to have the desired sensitivity to provide both real-time

and data-trend values that can correlate to the actual measurements of process streams before release. The

radiological environmental measurements program may be used to confirm the adequacy of the processmonitoring equipment.
Rev. 2 of RG 4.15, Page 6

C. REGULATORY POSITION

The QA program of each organization performing radiological effluent or environmental

monitoring of nuclear facilities using, processing, or storing radioactive materials during all phases of the

facility’s life cycle should be documented by written policies and procedures. Licensees should have

sufficient RECORDS of program conduct and performance to demonstrate program adherence. In addition to

its own program, a licensee should require any contractor or subcontractor performing support program

activities (e.g., sampling, analysis, evaluations, and records) retain records sufficient for the licensee to

develop and maintain a QA program covering the applicable program elements.

The following presents the QA program elements that should be developed and implemented to

ensure the quality of data/results for radiological effluent and environmental monitoring programs.

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

programs, including QA policy and functions, should be defined and documented. The authorities, duties,

and responsibilities of the positions within this organization, down to the first-line supervisory level, should

be described. This should include responsibilities for review and approval of written procedures and the

preparation, review, and evaluation of monitoring data and reports.

Persons and organizations performing QA functions should have sufficient authority and

organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to

verify implementation of solutions. Reporting should be at a management level that is independent of

activity performance, costs, and schedule.

Section 2.1.1 of ANSI/ASQC E4-1994 (Ref. 21) and Section 5.2.1 of ANSI N42.23-2003 (Ref. 22)

provide additional guidance on management structure and organizational responsibilities for radiological

effluent and environmental monitoring programs.

2. Specification of Qualifications of Personnel

The qualifications of individuals needed to carry out assigned radiological monitoring functions

should be defined and documented (e.g., as in a job description). Individuals with responsibility for

performing quality-related activities should be trained and qualified in the principles and techniques of the

activities to be performed. These individuals should maintain proficiency by retraining, reexamining, and

recertifying or by periodic performance reviews, as appropriate. Continual training should be conducted as

needed to ensure that personnel maintain awareness of events and issues that could affect the quality of

program performance.

Section 2.3.1 of ANSI/ASQC E4-1994 (Ref. 21) provides additional guidance and criteria for

developing personnel training and qualification specifications for radiological effluent and environmental

monitoring programs.
Rev. 2 of RG 4.15, Page 7

3. Operating Procedures and Instructions

Monitoring programs should have written procedures for all activities that generate data, such as

dose calculations and measurements, sample collection, sample management and CHAIN OF CUSTODY,

sample preparation and analysis, data reduction and recording, data assessment and reporting, and final

sample disposal. Procedures are also needed for addressing support functions, such as operation of process

monitors, training, preparation of QUALITY CONTROL SAMPLES, collection of meteorological data, corrective

actions, AUDITS, and records. Individuals satisfying the qualifications described in Section C.2 of this

regulatory guide should write, review, and revise these procedures.

Instructions, procedures, or schedules should be prepared for the functions associated with the QA

program, such as the following:

• ancillary laboratory functions (including cleaning of glassware, contamination control, and storage

of standards and chemicals)

• CALIBRATION and QC of instrumentation (including range of activity, range of energy,

and frequency of calibration)

• internal QC and external PE programs (including frequency, types, acceptance criteria for the

laboratory PERFORMANCE TESTING samples, and individual analyst qualifications)

• timetable for VERIFICATION and VALIDATION (V&V) of data

Chapters 9, 11, and 12 of MARLAP (Ref. 20) provide guidance on the radioanalytical laboratory

activities for which procedures are used. MARLAP Chapters 12 – 16 provide technical information that

can be used to write or revise procedures. Section 5.4 of ISO/IEC 17025-2005 (Ref. 17) provides

additional guidance regarding the content and quality aspects of procedure and method technical content. 

Section 2.5.2 of ANSI/ASQC E4-1994 (Ref. 21) identifies procedures that should be documented and may

need control.

4. Records

licensees should maintain a system that produces unequivocal, accurate records that document all

monitoring activities. Licensees should maintain records of implementation or ongoing activities, such as

the following:

• procedure revision

• personnel training and qualification records

• analytical results

• audits

• corrective actions

• intermediate activities or calculations (as may be needed to validate or substantiate final results)

• records of tracking and control (chain of custody) throughout all processes from sample collection

through analysis and reporting of results, including unique identifiers, descriptions, sources,

dates/times, packaging/preparation/shipping, and required analyses

• field logs with sufficient information describing environmental conditions and recording related

information and data documenting the nature of the sample and where and how it was taken

• laboratory notebooks recording related information and data, observations of analysts, and

laboratory or other conditions potentially affecting the measurement process

• electronic data collection and algorithms and QA documentation

• calculations (including data reduction, analysis, and verification)
Rev. 2 of RG 4.15, Page 8

• QC records for radiation monitoring equipment, including the results of RADIOACTIVE SOURCE

checks, calibrations, INSTRUMENT BACKGROUND determinations, and maintenance activities

affecting equipment performance

• notifications to qualified staff that procedural changes affecting data quality have been made

• QC records for laboratory counting systems and support instrumentation and equipment, including

calibrations, maintenance or repair, QC sample results, and traceability of standards used for

instrument calibration

Records should be legible and identifiable, retained in predetermined locations, and protected

against damage, deterioration, or loss. Records should be maintained in a format that is easily retrievable. 

If the media for storage is electronic (as opposed to paper or microfilm/fiche), the licensee should maintain

the equipment necessary to read and present the data in an uncorrupted form. The document retention

system should allow reconstruction of all activities associated with the generation of analytical results. The

licensee should establish a retention time for records consistent with licensing conditions and in accordance

with the licensee’s overall QA program.

Section 2.5 of ANSI/ASQC E4-1994 (Ref. 21) provides guidance on specific types of documents

that should be maintained, while Basic Requirement 17 of ASME NQA-1-1994 (Ref. 11) details the

administrative criteria that should be considered for inclusion in a program for records and their retention. 

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

4 and 11 of MARLAP (Ref. 20) discuss documents that should be retained as records. Nuclear Information

and Records Management Association (NIRMA) TG11-1998 (Ref. 23), TG15-1998 (Ref. 24), TG16-1998

(Ref. 25), and TG21-1998 (Ref. 26) provide additional information addressing issues in developing and

maintaining electronic records programs.

5. Quality Control in Environmental Sampling

Sampling of solids, liquids, and gases involves the measurement of sample masses, flow rates, or

volumes. The ACCURACY of the instruments or containers used for this purpose should be determined and

checked regularly to ensure that sampling performance criteria remain within the limits specified by the

MQOs. The results of mass, flow rate, or volume calibrations and associated UNCERTAINTIES should be

recorded. The frequency of these calibrations should be specified and should be consistent with the DQOs

of the measurement program. The collection efficiencies of the sampling equipment used should be

documented; often such documentation is available from the manufacturer. HPS/ANSI N13.1-1999

(Ref. 27) provides guidance on QA and QC for air sampling instruments. Chapter 19 of MARLAP

(Ref. 20) discusses measurement uncertainties in general and volume and mass measurements in particular.

Sampling or measurements should be performed using equipment and methods that yield a result

that is representative of the population in the particular environmental media. FIELD DUPLICATES are

co-located spatially or temporally and should be collected periodically to check REPRODUCIBILITY. 

Chapter 10 of MARLAP (Ref. 20) discusses the field and sampling issues that affect laboratory

measurements, including packaging, shipping, and storage of samples.

Some individual environmental samples are collected simply to confirm that radioactivity levels are

below a specified (small) fraction of an established concentration limit. In those cases, the MINIMUM

DETECTABLE CONCENTRATION of the method used should be below that specified fraction of the limit. 

Chapter 20 of MARLAP (Ref. 20) discusses detection limits, while Appendix C to MARLAP covers the

relationship between the desired fraction of the limit that is important to detect and the uncertainty of the

measurement method. In some cases, a series of measurement results will be averaged for comparison with

BACKGROUND LEVELS or a regulatory limit. For such measurements, an appropriate MQO would be the

MINIMUM QUANTIFIABLE CONCENTRATION (see Chapter 20 of MARLAP).
Rev. 2 of RG 4.15, Page 9

For an isolated, well-mixed population, a single sample or measurement may be sufficient. It is

more common, however, for spatial or temporal variations to exist. In that case, the frequency of sampling

and number of samples and locations will depend on the level of variability and amount of radioactivity

(compared with an established risk-informed limit). NUREG-1575, “Multi-Agency Radiation Survey and

Site Investigation Manual” (Ref. 28, hereafter referred to as MARSSIM), discusses the effect that such

variability has on the number of samples that may be appropriate for SURVEYS. In general, the DQO

process may be used together with specific statistical designs (EPA QA/G-9S-2006, Ref. 29) to optimize

the sampling. Continuous sampling or integrated measurements may be used to mitigate temporal

variability.

Part 1, Sections II-11 and II-12, of ASME NQA-1-1994 (Ref. 11) discuss test control and control

of measuring and test equipment. Part II, Subpart 2.20, of ASME NQA-1-1994 discusses QA standards for

subsurface investigations for nuclear power plants.

6. Quality Control in the Radioanalytical Laboratory

The output of the directed planning process includes DQOs that encompass both sampling and

analysis activities for a project or program. From the DQOs, a set of MQOs are developed for

radioanalytical measurements (see Chapter 3 of MARLAP, Ref. 20). In a performance-based approach,

MQOs are critical criteria used for the selection and validation of analytical methods and protocols (see

Regulatory Position 8, below) and subsequently form the basis for the ongoing and final evaluation of the

analytical data. The type, frequency of, and evaluation criteria for QC samples are developed during the

directed planning process and are incorporated into ANALYTICAL PROTOCOL SPECIFICATIONS (APSs) for a

project (see Chapter 3 of MARLAP, Ref. 20).

Chapter 18 of MARLAP provides guidance on monitoring key laboratory PERFORMANCE

INDICATORS to determine whether a laboratory’s measurement processes are in control. The chapter also

provides information on likely causes of excursions for selected laboratory performance indicators, such as

chemical yield, instrument background, and QC samples. Appendix C to MARLAP provides the rationale

and guidance for developing MQOs for select method performance characteristics and gives guidance on

developing criteria for QC samples.

Performance criteria for radioanalytical measurements should be selected to provide a management

tool for tracking and trending performance and to identify precursors to nonconforming conditions. 

Laboratories should satisfy program-specific criteria for all measurement processes, including necessary

levels of PRECISION, acceptable BIAS, and applicable detection levels.

6.1 Calibration and Quality Control of Instruments, Measuring Devices, and Test Equipment

Instruments, devices, and test equipment used for measuring radioactivity should be operated,

calibrated, and maintained to ensure that analytical specifications are met. All equipment should be

operated, calibrated, and maintained in adherence to any applicable standards and methods and as specified

in the laboratory’s quality manual and standard operating procedures. Instrument configurations during

calibration should match those used for subsequent analytical measurements of samples.

Calibrations of instruments should be made using CERTIFIED REFERENCE MATERIALS of known and

documented value and stated uncertainty and should be traceable to a national standards body, such as the

National Institute of Standards and Technology (NIST) in the United States. CALIBRATION SOURCES

should be prepared in a manner that provides comparability to TEST SOURCES with respect to source

geometry, positioning relative to the detector, source composition, and distribution of the test-source

material within a container or on a source mount (see Section 15.2 of MARLAP, Ref. 20).
Rev. 2 of RG 4.15, Page 10

The frequency of calibrations should be consistent with the stability and performance of the

instrument. Complete system calibration should be performed before initial use or following system

maintenance, repair, or any other changes in environment or operating conditions that could affect

performance (ASTM D7282-2006, Ref. 30). In addition, Sections 15.2 and 15.3 of MARLAP (Ref. 20)

present general guidance regarding calibrations of instruments. Chapter 15 of MARLAP also presents

guidance specific to calibrations of different instrumentation types.

The continuing validity of calibrations should be checked periodically as specified in a laboratory’s

quality manual (see Chapter 18 of MARLAP, Ref. 20). Quality control checks of radioanalytical

instrument calibration parameters, such as detector response or energy and resolution calibrations for

spectrometers, should be performed by measuring the response of each radiation detection system to

appropriate CHECK SOURCES. Instrument QC frequencies are generally performed daily for systems used

continually or before use for those systems periodically employed, but frequencies may vary by instrument

type. Instrument QC checks should meet predefined acceptance criteria for the respective calibration

parameter and should ensure that conditions have not significantly changed since initial calibration (ASTM

D7282-2006, Ref. 30).

Instrument-calibration QC check results should be tracked, trended, and compared with

predetermined ranges of acceptable performance. For example, if a monitor’s response to a daily check

source showed a trend that may lead to a condition outside of established acceptance criteria, a calibration

may be needed to reestablish acceptable operation. Section 18.5 of MARLAP (Ref. 20) and ASTM D7282-

2006 (Ref. 30) discuss radioanalytical instrument-calibration QC parameters.

Additional method-specific quality controls (e.g., chemical yield, spectral quality, resolution) may

apply to certain methods and should be tracked and trended using control or tolerance charts to identify

conditions that could be adverse to quality.

The laboratory quality manual and standard operating procedures should address the use,

calibration, maintenance, and QC of all nonradiological instruments, measuring devices, and test equipment

used for measuring or quantifying other necessary data (e.g., sample masses or volumes, temperatures). All

measurement and test equipment should be calibrated before use and adjusted to maintain accuracy within

established limits. Quality control checks should be performed at specified frequencies and should verify

that instruments are operating to specified performance levels.

Nonradiological instruments, measurement, and test equipment should be operated according to

manufacturers’ instructions, according to established standards, or as specified in the laboratory quality

manual and procedures. Section 18.6.7 of MARLAP (Ref. 20) provides guidance on control, calibration,

and maintenance of calibration of apparatus used for mass and volume measurements. ISO/IEC 17025-

2005 (Ref. 17) provides general guidance on establishing quality controls for nonradiological instruments. 

Items that do not conform to specified criteria should be controlled to prevent inadvertent use. These items

should be tracked through the corrective action program.

Careful control of contamination and routine monitoring of instrument background are integral

parts of a measurement QC program. Determination of the background counting rate should be performed

on a regular, predefined frequency for systems in routine use and should ensure that analytical

specifications for applicable programs can be met. Instrument backgrounds used to determine a net count

rate should replicate actual sample measurement conditions as closely as possible (i.e., using appropriate

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

Rev. 2 of RG 4.15, Page 11

Section 18.5.1 of MARLAP (Ref. 20) provides guidance on measurement and control of instrument

backgrounds. Section 18.3 and Attachment 18A of MARLAP contain guidance on the statistical evaluation

of performance indicators and on using control and tolerance charts.

Sections 10-13 and 20-25 of ASTM D7282-2006 (Ref. 30) and Section A.5.2 of ANSI N42.23-

2003 (Ref. 22) provide additional guidance on instrument response source checks, background checks, and

the use of control charts. ASTM MNL 7A-2002 (Ref. 31) provides guidance on setting up and using

control charts.

6.2 Internal Quality Control Samples and Analysis

The use of QC samples should be an integral element of a laboratory QA program. Chapter 18 of

MARLAP (Ref. 20) defines the different types of laboratory QC samples and provides guidance on

evaluation techniques for QC samples. The laboratory should have as part of the normal operational

sample load the following QC samples:3

• BLANK

• MATRIX SPIKE

• LABORATORY CONTROL SAMPLE

• LABORATORY DUPLICATE

Analysis of QC samples should be performed as a part of the routine operation of a laboratory to

verify that laboratory operations are consistent with applicable specifications. The QC program should

specify the type of and minimum frequency for processing QC samples. For example, this frequency may

be defined as a minimum percentage of the total number of samples analyzed, a certain number per

operational time interval (e.g., once per shift) or per sample batch, or a licensee-specified frequency based

on laboratory-specific parameters. As part of its QC program, the laboratory may prepare and analyze

BLIND SAMPLES, provided the individuals responsible for preparing the samples are not directly responsible

for conducting the laboratory analysis. For example, the laboratory’s assigned QC specialist may have the

responsibility for preparing and submitting blind samples (blank, duplicate, laboratory control sample, and

matrix spike). Blind samples are used primarily as a tool for evaluating the performance of individuals

rather than as part of the laboratory QC load.

Acceptability of QC sample results should be evaluated based on criteria from the QC program,

which include specific equations based on METHOD UNCERTAINTY. Chapters 7 and 18 of MARLAP

(Ref. 20) provide guidance on the evaluation of QC samples.

Quality control sample results should be tracked, trended, and compared with predetermined ranges

of acceptable performance to identify conditions that are in, or may lead to, nonconformance with program

specifications. Such conditions should be tracked through the corrective action program.

6.3 Performance Evaluation Program (Interlaboratory Comparison)

Participation in an external PE program is an important independent check on the accuracy,

possible bias, and precision of some radioanalytical or measurement methods used in a radiological

monitoring program. Internal and contract radioanalytical laboratories used in the monitoring program

should participate in one or more applicable PE programs that are administered by organizations that have

an active measurement assurance (traceability) program with NIST (ANSI N42.22-1995, Ref. 32). Chapter
4 Frequencies should be appropriate to the instrument under consideration and may be dictated by license conditions.

Rev. 2 of RG 4.15, Page 12

5 of MARLAP (Ref. 20) recommends incorporating the criteria for a radioanalytical laboratory to

participate in a PE program into the statement of work for services. Several external PE programs

administered by government agencies or commercial radioactive-source suppliers are available for

radionuclides and matrices germane to radiological monitoring programs. The PE program should provide

fundamental sample types (e.g., solid, liquid, gas) and radionuclides (e.g., alpha-, beta-, and gammaemitting nuclides) of interest at the facility. When available, laboratories should analyze samples as offered

by a PE program on a frequency stipulated by the monitoring program’s QA criteria, with all types of

samples and analyses repeated at least biennially. Chapter 18 of MARLAP (Ref. 20) provides information

on organizations that administer PE programs.

Acceptable performance criteria for results of performance-testing samples should be established

that are consistent with the MQOs for the radiological monitoring project or program. For certain

monitoring activities, the acceptance criteria of the PE program may be satisfactory. The performance in a

PE program should be tracked and trended as one of the performance indicators for the laboratory and

evaluated as part of the corrective action program.

7. Quality Control for Radioactive Effluent Monitoring Systems

7.1 Radioactive Effluent Process Monitors

An initial, primary radiation monitor calibration that meets the specifications of ANSI N42.18-

2004 (Ref. 33), should be performed with radioactive sources traceable to a national standards body (such

as NIST). Calibrations should be repeated periodically using (1) STANDARD REFERENCE MATERIALS or (2)

certified reference materials that can be directly traced to the initial, primary calibration. Complete system

calibration — including electronics, detector, and any support functions (such as alarm, display, and

recording devices) — should be performed at a frequency that ensures system reliability and accuracy or

after repair or maintenance that may affect instrument calibration. Unless otherwise specified in license

requirements, the licensee should verify and validate the complete effluent monitoring system every 12

months. This frequency may be extended to longer time periods coinciding with facility maintenance

schedules, such as refueling for nuclear power plants, if the licensee has verified proper system operation

through established system reliability and more frequent source checks and functional checks.

Detectors should be response-checked periodically4

 for continuous effluent release points

(e.g., ventilation systems and secondary water systems) and before release for batch discharges

(e.g., primary boundary or containment purges and liquid waste tank releases). Licensees should ensure

that check sources are of sufficient radiochemical purity so that the activity of the source may be corrected

for decay to the date of measurement. These check sources need not be traceable to a national standards

body (e.g., NIST). Whenever practicable, check sources should be an integral part of the monitoring

system and should be remotely actuated. The functionality of isolation or alarm functions should be

verified periodically, preferably by use of a radiation source.

Trends of process radiation monitor readings versus total radionuclide concentrations in the

monitored release path should be performed routinely. These trends should be based on the results of

analyses for specific radionuclides in samples taken from the release path that will yield a monitor

response. Deviations in the trend may occur if concentrations or the mixture of radionuclides changed

significantly (for example, during a fuel cycle in which significant fuel defects exist). The licensee should

define the monitor-response parameter for all radiation monitors. The monitor-response constant should be

adjusted to maintain this correlation between effluent radionuclide concentration and monitor response.
Rev. 2 of RG 4.15, Page 13

7.2 Flow Monitoring Instrumentation

Continuous sampling of liquids and gases involves the measurement of sample flow rates and/or

sample volumes. The accuracy and associated uncertainty of the devices used for this purpose should be

determined on a regularly scheduled 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 calibrations should be specified and should be based on the necessary accuracy,

purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.

Any flow-rate measuring devices associated with the system should be calibrated to determine

actual flow rates at the conditions of temperature and pressure under which the system will operate. These

flow rate devices should be recalibrated annually, but the frequency may be extended to that established for

the radiation detector system, provided sufficient operating experience exists and an accelerated

measurement check frequency gives sufficient data to ensure reliable performance.

Flow measuring devices should be checked periodically on an established frequency, considering

the variability of the instrument, and recalibrated when established control limits are exceeded. HPS/ANSI

N13.1-1999 (Ref. 27) provides additional guidance on QA and QC measures for the use, maintenance, and

calibration of airborne sampling instrumentation. ANSI N42.18-2004 (Ref. 33) provides additional

guidance on the calibration of liquid flow monitors.

7.3 Grab Sampling of Effluent Process Streams

Whenever practicable, effluent releases should be batch-controlled and released when the volume

to be released has been mixed sufficiently to ensure uniform concentration. Sampling and analysis for each

batch should be performed, and release conditions set, before release. A certain percentage of all batch

releases should have field duplicates taken either before or during the release to assess the reproducibility

of sampling and the effectiveness of the mixing process before release. Where possible, samples that are

spatially or temporally separated should be collected periodically to verify representativeness.

For continuous-effluent discharges, composite samplers should be employed. However, periodic

grab samples may be used when composite sampling of a continuous discharge point is not feasible. When

grab samples are collected instead of composite samples, licensees should design the sampling program to

sample at the time, location, and frequency that ensures each sample is representative of the radioactive

materials released.

7.4 General Quality Control Considerations

The QC plan should address the following items:

• Sampling should be performed using calibrated instruments and equipment when taking a

composite sample.

• Collection efficiencies based on the physical configuration of the sampling point and the type of

collector should be documented. Vendor-supplied data may be used where adequate

documentation exists to ensure the reliability and accuracy of data.

• Volumes of tanks and containers should be established during initial installation and should be

verified again following any physical changes that could alter the system configuration.
5 Replicate samples may be prepared by removing separate ALIQUANTS from the same grab sample.

6 The Institute of Electrical and Electronics Engineers (IEEE) Standard 1063, “IEEE Standard for Software User

Documentation” (Ref. 35); EPA Directive 2185, “Good Automated Laboratory Practices” (Ref. 36); Subpart 2.7

of ASME NQA-1-1994 (Ref. 11); Regulatory Guide 1.168, “Verification, Validation, Reviews, and Audits for Digital

Computer Software Used Safety Systems of Nuclear Power Plants” (Ref. 37); and Section 8 of ANSI N42.14-1999,

“Calibration and Use of Germanium Spectrometers for the Measurement of Gamma-Ray Emission Rates

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

Rev. 2 of RG 4.15, Page 14

• The frequency of duplicates and REPLICATES5

 should be established based on time (for continuous

discharges) or number of batches (for batch discharges).

• Sample integrity should be maintained through chain of custody procedures.

Procedures for continuous sampling should use methods that are designed to ensure that the sample

is representative of the volumes being discharged.

8. Verification and Validation

The V&V of certain aspects and support activities of the radiological measurement process or

monitoring program are essential to the QA program. These aspects and activities include data and

computer software V&V and project method validation.

Project method validation is the demonstration that a method (radioanalytical or radiation

measurement) using performance-based method selection is capable of providing analytical results to meet

a project’s MQOs and any other criteria in the analytical protocol specification (APS). Acceptable method

validation is necessary before the radiological analysis of samples or the taking of measurements in a

monitoring program. Chapter 6 of MARLAP (Ref. 20) presents detailed guidance on project method

validation for radioanalytical methods. In addition, Section 5.2.7 of ANSI N42.23-2003 (Ref. 22) and

Section 5.4.5 of ISO/IEC 17025-2005 (Ref. 17) provide limited guidance for radioanalytical method

validation.

Chapter 8 of MARLAP (Ref. 20) gives detailed guidance and applicable tools for the

radioanalytical data V&V evaluation process as well as information for developing a data V&V plan,

determining acceptable criteria and tests, and applying data qualifiers for radioanalytical data validation, as

related to MQOs. EPA QA/G-8-2002 (Ref. 34) provides guidance for nonradioanalytical data V&V.

Computer programs used in the implementation of the radiological environmental monitoring

program should be documented, verified, and validated before initial routine use and after each

modification of the program. As described in Section 5.4.3.2 of MARLAP (Ref. 20), the laboratory’s

quality manual should include the criteria for computer software V&V and documentation. The software

data reduction and reporting functions should be verified to perform as expected.6

9. Assessments and Audits

Assessments, audits, and surveillances are elements used to evaluate the initial and ongoing

effectiveness of the QA program to monitor and control the quality of a radiological monitoring program. 

Management having responsibility in the area being reviewed should document and review the results of

these activities. Assessments that are independent of the day-to-day operations should be performed

routinely, including management surveillance, peer reviews, and READINESS REVIEWS for new or revised

systems and methods. Key performance indicators should be tracked and trended, with periodic

management reporting. The QA program or project plan should outline the scope, frequency, and schedule

of assessments, audits, and surveillances. A plan should be developed for each assessment audit or
Rev. 2 of RG 4.15, Page 15

surveillance for each area of the monitoring program being evaluated. A report of these activities should be

generated according to the outline, format, and content established in the plan.

Only qualified QA staff (see Regulatory Position 2, above), supported as needed by experts in the

technical areas under evaluation, should conduct assessments, audits, and surveillances. (See ASME

NQA-1-1994, Supplement 2S, Ref. 11.) Deficiencies, areas for improvement, and observations noted

should be incorporated into the corrective action program and tracked. Section 18 of ASME NQA-1-1994

(Ref. 11) and Section 4.10 of ISO/IEC 17025-2005 (Ref. 17) provide guidance on establishing and

conducting an audit program.

When the monitoring program will depend upon the services of a radioanalytical laboratory, prior

onsite audits of the laboratory may be conducted to ensure that the laboratory is capable of fulfilling the

project criteria in accordance with the APS (including MQOs) outlined in a statement of work (MARLAP

Chapter 5 and Appendix E). The ongoing evaluation of the laboratory’s QUALITY SYSTEM and operations is

accomplished through onsite audits and desk audits. These audits are focused more on whether the

laboratory is meeting project or program specifications than whether the laboratory has the capability to

meet monitoring program or project criteria. Chapter 7 of MARLAP provides guidance and statistical tests

to determine whether a laboratory is meeting the MQOs, especially the REQUIRED METHOD UNCERTAINTY. 

Section 5.2.10 of ANSI N42.23-2003 provides additional guidance for radioanalytical laboratory

assessments.

Audits of the QA programs of contractors providing materials, supplies, or services affecting the

quality of the laboratory’s operations should be performed periodically (Section 4.6 of ISO/IEC 17025-

2005, Ref. 17).

10. Preventive and Corrective Actions

Integral components of a QA program include identifying areas for improvement, defining

performance or programmatic deficiencies, and initiating appropriate corrective or preventive actions. The

QA program for radiological effluent and environmental monitoring programs should contain both a

continuous-improvement program and a program for implementing corrective actions when conditions

adverse to quality have been identified. In addition, needed improvements and potential sources of

nonconformance should be identified and reported as part of a preventive action initiative of the

continuous-improvement program (ISO/IEC 17025-2005, Sections 4.10–4.12) — for example, a conditionreporting program. Investigations should be initiated for degrading conditions, and corrective actions

should be taken when conditions fall outside quality or regulatory acceptance criteria. For conditions that

are adverse to quality, the corrective action process includes the following basic elements:

• identification and documentation

• classification

• cause analysis

• corrections

• followup

• closure

Findings and corrective actions should be documented, tracked, and reported to management. 

Followup reviews should be performed to verify the effectiveness and adequacy of the corrective actions. 

Section 2.10 of ANSI/ASQC E4-1994 (Ref. 21) provides specifications and guidelines for developing the

process, programs, and procedures necessary to detect and correct items of nonconformance and for

implementing continuous quality improvement.
Rev. 2 of RG 4.15, Page 16

When conducting an audit or surveillance of laboratory services, a prime area of review should be

the effectiveness of the laboratory’s corrective action program (Section 7.4.2 of MARLAP, Ref. 20). 

Section 4.11 of ISO/IEC 17025-2005 (Ref. 17) provides general guidance on preventive and corrective

action programs for laboratories. Annex C of ANSI N42.23-2003 (Ref. 22) provides additional guidance

that should be considered in developing a corrective action program, including root cause analysis for

radioanalytical services.

D. IMPLEMENTATION

The purpose of this section is to provide information to licensees regarding the NRC staff’s plans

for using this regulatory guide. No backfit is intended or approved in connection with its issuance.

Non-nuclear power reactor applicants and licensees may continue to use Revision 1 of Regulatory

Guide 4.15, dated February 1979, or may adopt other procedures or practices that reflect generally accepted

standards for ensuring quality in environmental data collected for effluent monitoring purposes. Except in

those cases in which a nuclear power reactor applicant or licensee proposes or has previously established an

acceptable alternative method for complying with specified portions of the NRC’s regulations, the methods

and practices described in this guide will be used in evaluating QA practices for environmental radiological

monitoring programs.
7 Certain terms included in this glossary are not used in the main body of this regulatory guide, but are included

because they are used within other definitions.

Rev. 2 of RG 4.15, Page 17

GLOSSARY7

accuracy—The closeness of a measured result to the true value of the quantity being measured. 

Various recognized authorities have given the word “accuracy” different technical definitions,

expressed in terms of bias and imprecision. Following the Multi-Agency Radiological Laboratory

Analytical Protocols (MARLAP) Manual (Ref. 20), the U.S. Nuclear Regulatory Commission

(NRC) avoids all of these technical definitions and uses the term “accuracy” in its common,

ordinary sense, which is consistent with the definition established by the International Organization

for Standardization (ISO) in the “International Vocabulary of Basic and General Terms in

Metrology” (Ref. 39).

aliquant—A representative portion of a homogeneous SAMPLE removed for the purpose of analysis or

other chemical treatment. The quantity removed is not an evenly divisible part of the whole

sample. An aliquot, by contrast, is an evenly divisible part of the whole.

analyte—See TARGET ANALYTE.

analytical protocol specification (APS)—The output of a DIRECTED PLANNING PROCESS that contains the

project’s analytical data needs and criteria in an organized, concise form. The level of specificity

in the APS should be limited to those criteria that are considered essential to meeting the project’s

analytical data criteria to allow the laboratory the flexibility of selecting the protocols or methods

that meet the analytical criteria.

as low as reasonably achievable (ALARA)—“As low as is reasonably achievable taking into account the

state of the technology and the economics of improvements in relation to benefits to the public

health and safety and other societal and socioeconomic considerations, and in relation to the use of

atomic energy in the public interest” [10 CFR 50.34a(a)].

assessment—A planned and documented activity performed to determine whether various elements within

a quality management system are effective in achieving stated quality objectives (ANSI N42.23-

2003, Ref. 22).

audit—A planned and documented activity performed to determine by investigation, examination, or

evaluation of objective evidence the adequacy of, and CONFORMANCE with, established procedures,

instructions, drawings, and other applicable documents as well as the effectiveness of

implementation. An audit should not be confused with surveillance or inspection activities

performed for the sole purpose of process control or product acceptance (after ANSI N42.23-2003,

Ref. 22).

background, instrument—Radiation detected by an instrument when no SOURCE is present. The

background radiation that is detected may come from radionuclides in the materials of construction

of the detector, its housing, its electronics, and the building as well as the environment and natural

radiation.

background level—A term that usually refers to the presence of radioactivity or radiation in the

environment. From an analytical perspective, the presence of background radioactivity in samples
Rev. 2 of RG 4.15, Page 18

needs to be considered when clarifying the radioanalytical aspects of the decision or study

question. Many radionuclides are present in measurable quantities in the environment.

bias (of a measurement process)—A persistent deviation of the mean measured result from the true or

accepted reference value of the quantity being measured, which does not vary if a measurement is

repeated.

blank (analytical or method)—A SAMPLE that is assumed to be essentially free of the TARGET ANALYTE

(the “unknown”), that is carried through the radiochemical preparation, analysis, mounting, and

measurement process in the same manner as a routine sample of a given matrix.

blind sample—A SAMPLE with a concentration not known to the analyst. Blind samples are used to assess

analytical performance. A double-blind sample is a sample whose concentration and identity as a

sample is known to the submitter, but not to the analyst. The analyst should treat the double-blind

sample as a routine sample, so it is important that the double-blind sample is identical in

appearance to routine samples.

calibration—The set of operations that establish, under specified conditions, the relationship between

values indicated by a measuring instrument or measuring system, or values represented by a

material measure, and the corresponding known value of a parameter of interest.

calibration source—A prepared SOURCE, made from a CERTIFIED REFERENCE MATERIAL OR STANDARD

REFERENCE MATERIAL, that is used for calibrating instruments.

certified reference material—A reference material, accompanied by a certificate, with one or more

property values certified by a procedure that establishes its traceability to an accurate realization of

the unit in which the property values are expressed, and for which each certified value is

accompanied by an UNCERTAINTY at a stated level of confidence (ISO Guide 30, Ref. 40). See

STANDARD REFERENCE MATERIAL.

chain of custody—Procedures that provide the means to trace the possession and handling of a sample

from collection to data reporting.

check source—A material used to validate the operability of a radiation measurement device, sometimes

used for instrument quality control. See TEST SOURCE and SOURCE, RADIOACTIVE.

condition adverse to quality— an all-inclusive term used in reference to any of the following: failures,

malfunctions, deficiencies, defective items, and nonconformances. A significant condition adverse

to quality is one which, if uncorrected, could have a serious effect on safety or operability.

conformance—An affirmative indication or judgment that a product or service has met the criteria of the

relevant specifications, contract, or regulation; also the state of meeting the criteria (ANSI/ASQC

E4-1994, Ref. 21).

corrective actions—Those measures taken to prevent, rectify, or eliminate conditions adverse to quality or

detected nonconformities and — as necessary — to preclude repetition of those conditions.

data quality objective (DQO)—Qualitative and quantitative statements that clarify the study objectives,

define the most appropriate type of data to collect, determine the most appropriate conditions from

which to collect the data, and specify tolerable limits on decision error rates. Because DQOs will

be used to establish the quality and quantity of data needed to support decisions, they should
Rev. 2 of RG 4.15, Page 19

encompass the total UNCERTAINTY resulting from all data collection activities, including analytical

and sampling activities.

directed planning process—A systematic framework focused on defining the data needed to support

an informed decision for a specific project. Directed planning provides a logic for setting welldefined, achievable objectives and developing a cost-effective, technically sound sampling and

analysis design that balances the data user’s tolerance for UNCERTAINTY in the decision process and

the available resources for obtaining data to support a decision. Directed planning helps to

eliminate unnecessary, poor, or inadequate sampling and analysis designs.

dose equivalent—Quantity that expresses all radiations on a common scale for calculating the effective

absorbed dose. This quantity is the product of absorbed dose (GRAYS (Gy) or rads) multiplied by a

quality factor and any other modifying factors (MARSSIM, Ref. 28). The quality factor adjusts the

absorbed dose because not all types of ionizing radiation create the same effect on human tissue. 

For example, a dose equivalent of one SIEVERT (Sv) requires 1 Gy of beta or gamma radiation, but

only 0.05 Gy of alpha radiation or 0.1 Gy of neutron radiation. Because the sievert is a large unit,

radiation doses often are expressed in milliSIEVERTS (mSv). See TOTAL EFFECTIVE DOSE

EQUIVALENT.

duplicate, field—Two samples of the same material, collected at the same location at the same time and

under the same conditions, which are used to verify representativeness of the sampled material.

duplicate, laboratory—Two ALIQUANTS of a SAMPLE, which are prepared and analyzed separately as part

of the same batch, used in the laboratory to measure the overall PRECISION of the sample

measurement process, beginning with laboratory subsampling of a field SAMPLE.

field duplicate—See DUPLICATE, FIELD.

graded approach—A process of basing the level of management controls applied to an item or work on

the intended use of the results and the degree of confidence needed in the quality of the results. 

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

diversity of environmental data collection activities. This diversity in the type of project and the

data to be collected impacts the content and extent of the detail to be presented in the project

planning documents.

gray (Gy)—The International System of Units (SI) unit for absorbed radiation dose. One Gy is 1 joule of

energy absorbed per kilogram of matter, equal to 100 RAD. See SIEVERT.

laboratory control sample—A standard material of known composition or an artificial SAMPLE (created

by fortification of a clean material similar in nature to the sample), which is prepared and analyzed

in the same manner as the sample. In an ideal situation, the result of an analysis of the laboratory

control sample should be equivalent to (give 100 percent of) the TARGET ANALYTE concentration or

activity known to be present in the fortified sample or standard material. The result normally is

expressed as percent recovery. See also QUALITY CONTROL SAMPLE.

laboratory duplicate—See DUPLICATE, LABORATORY.

matrix spike—See SPIKE.
Rev. 2 of RG 4.15, Page 20

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

which are project- or program-specific and can be quantitative or qualitative. These analytical data

criteria serve as measurement performance criteria or objectives of the analytical process. 

MARLAP (Ref. 20) refers to these performance objectives as MQOs. Examples of quantitative

MQOs include statements of required analyte detectability and the UNCERTAINTY of the analytical

protocol at a specified radionuclide concentration, such as the action level. Examples of qualitative

MQOs include statements of the required specificity of the analytical protocol (e.g., the ability to

analyze for the radionuclide of interest (or TARGET ANALYTE) given the presence of interferences).

method uncertainty—Reference to the predicted UNCERTAINTY of the result that would be measured if the

method were applied to a hypothetical laboratory SAMPLE with a specified analyte concentration. 

Although individual measurement uncertainties will vary from one measured result to another, the

REQUIRED METHOD UNCERTAINTY is a target value for the individual measurement uncertainties and

is an estimate of uncertainty before the sample is actually measured. See also UNCERTAINTY and

REQUIRED METHOD UNCERTAINTY.

method validation—The demonstration that the method selected for the analysis of a particular analyte in

a given matrix is capable of providing analytical results to meet the project’s MEASUREMENT

QUALITY OBJECTIVES and any other criteria in the ANALYTICAL PROTOCOL SPECIFICATIONS. 

Compare with data and software VALIDATION.

minimum detectable concentration—The minimum detectable value of the analyte concentration in a

sample. The smallest (true) value of the net state variable that gives a specified probability that the

value of the response variable will exceed its critical value (i.e., that the material analyzed is not

blank).

minimum quantifiable concentration—Minimum quantifiable value of the analyte concentration, defined

as the smallest concentration of analyte whose presence in a laboratory SAMPLE ensures that the

relative standard deviation of the measurement does not exceed a specified value, usually 10

percent.

nonconformance—a deficiency in characteristic, documentation, or procedure that renders the quality of

an item or activity unacceptable or indeterminate

performance-based approach—Definition of the analytical data needs and criteria of a project in terms of

measurable goals during the planning phase of a project. In a performance-based approach, the

project-specific data objectives that are determined during a DIRECTED PLANNING PROCESS serve as

measurement performance criteria for selections and decisions regarding the conduct of the

laboratory analyses. The project-specific analytical data objectives are also used for the initial,

ongoing, and final evaluation of the laboratory’s performance and the laboratory data. In method

selection, a performance-based approach is the process wherein a validated method is selected

based on a demonstrated capability to meet defined quality and laboratory performance criteria.

performance evaluation (PE) program—A laboratory’s participation in an internal or external program

of analyzing performance-testing samples appropriate for the analytes and matrices under

consideration (i.e., PE program traceable to a national standards body, such as the National

Institute of Standards and Technology (NIST) in the United States). Reference-material samples

used to evaluate the performance of the laboratory are called performance-evaluation or

performance-testing samples or materials. See CERTIFIED REFERENCE MATERIAL and STANDARD

REFERENCE MATERIAL.
Rev. 2 of RG 4.15, Page 21

performance indicator—Instrument- or protocol-related parameter routinely monitored to assess the

laboratory’s estimate of controls such as chemical yield, instrument background, UNCERTAINTY,

PRECISION, and BIAS. See BACKGROUND, INSTRUMENT.

performance testing—See PERFORMANCE EVALUATION PROGRAM.

precision—The closeness of agreement between independent test results obtained by applying the

experimental procedure under stipulated conditions. Conversely, imprecision is the variation of the

results in a set of REPLICATE measurements. Precision may be expressed as the standard deviation

(IUPAC, Ref. 41).

quality assurance (QA)—An integrated system of management activities involving planning,

implementation, assessment, reporting, and quality improvement to ensure that a process, item, or

service is of the type and quality needed and expected. Quality assurance includes QUALITY

CONTROL.

quality assurance project plan (QAPP)—A formal document describing in detail the necessary QUALITY

ASSURANCE, QUALITY CONTROL, and other technical activities that must be implemented to ensure

that the results of the work performed will satisfy the stated performance criteria. The QA project

plan describes policy, organization, and functional activities and the DATA QUALITY OBJECTIVES

and measures necessary to achieve adequate data for use in selecting the appropriate remedy.

quality control (QC)—The overall system of technical activities that measures the attributes and

performance of a process, item, or service against defined standards to verify that they meet the

stated objectives established by the project; operational techniques and activities that are used to

fulfill objectives for quality. This system of activities and checks is used to ensure that

measurement systems are maintained within prescribed limits, providing protection against out-ofcontrol conditions and ensuring that the results are of acceptable quality.

quality control (QC) sample—An uncontaminated SAMPLE matrix spiked with known amounts of analytes

from a source independent of the calibration standards.

quality system—A structured and documented management system describing the policies, objectives,

principles, organizational authority, responsibilities, accountability, and implementation plan of an

organization for ensuring quality in its work processes, products (items), and services. The quality

system provides the framework for planning, implementing, and assessing the work performed by

an organization and for carrying out required QUALITY ASSURANCE and QUALITY CONTROL

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

readiness review—The formal process of performing a written or verbal assessment of key attributes of a

program or project measured against defined minimum criteria, standards, or quality metrics before

initiation of activities under that project or program.

record—A retrievable document that furnishes objective evidence of the quality of products, services, or

activities and that has been verified and authenticated as technically complete and correct.

rem—The common unit for the effective or equivalent dose of radiation received by a living organism,

equal to the actual dose (in rads) multiplied by a factor representing the danger of the radiation. 

Rem is an abbreviation for roentgen equivalent man, meaning that it measures the biological effects

of ionizing radiation in humans. One rem is equal to 0.01 Sv. See SIEVERT and DOSE EQUIVALENT.
Rev. 2 of RG 4.15, Page 22

replicates—Two or more ALIQUANTS of a homogenous SAMPLE whose independent measurements are used

to determine the PRECISION of laboratory preparation and analytical procedures.

reproducibility—The closeness of the agreement between the results of measurements of the same

parameter carried out under changed conditions of measurement. A valid statement of

reproducibility depends upon specification of the conditions changed. The changed conditions

may include principle of measurement, method of measurement, observer (or analyst), measuring

instrument, reference standard, location, conditions of use, and time. Reproducibility may be

expressed quantitatively in terms of the dispersion characteristics of the results. Results are usually

understood to be corrected results.

required method uncertainty (uMR)—METHOD UNCERTAINTY at a specified concentration. This is a key

MEASUREMENT QUALITY OBJECTIVE.

sample—(1) A portion of material selected from a larger quantity of material, or (2) a set of individual

samples or measurements drawn from a population whose properties are studied to gain

information about the entire population.

sievert (Sv)—The Système International (SI) unit for the effective dose of radiation received by a living

organism. This unit represents the actual dose received (GRAYS in SI or rads in traditional units)

times a factor that is larger for more dangerous forms of radiation. One Sv is 100 REM. Radiation

doses are often measured in mSv. An effective dose of 1 Sv requires 1 GRAY of beta or gamma

radiation, but only 0.05 Gy of alpha radiation or 0.1 Gy of neutron radiation.

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

spike—A known amount of TARGET ANALYTE added to the environmental sample to establish whether the

method or procedure is appropriate for the analysis of the particular matrix and how the TARGET

ANALYTE responds when the environmental sample is prepared and measured, thereby estimating

the bias introduced by the sample matrix. Also termed MATRIX SPIKE.

standard reference material—A CERTIFIED REFERENCE MATERIAL issued by NIST in the United States. 

NIST certifies a standard reference material for specific chemical or physical properties and issues

it with a certificate that reports the results of the characterization and indicates the intended use of

the material.

surveillance—Continual or frequent monitoring and verification of the status of an activity and the

analysis of records to ensure that specified requirements are being fulfilled. A surveillance is less

extensive and more frequent than an AUDIT and concentrates on a single item or activity.

survey—A systematic evaluation and documentation of radiological measurements with a correctly

calibrated instrument or instruments that meet the sensitivity required by the objective of the

evaluation.

target analyte—A radionuclide on the list of radionuclides of interest or a radionuclide of concern for a

project.

test source—The final radioanalytical processing product or matrix (e.g., precipitate, solution, filter) that is

introduced into a measurement instrument. A test source is prepared from laboratory sample

material for the purpose of determining its radioactive constituents. See CALIBRATION SOURCE,

CHECK SOURCE, and SOURCE, RADIOACTIVE.
Rev. 2 of RG 4.15, Page 23

total effective dose equivalent (TEDE)—The sum of the effective dose equivalent (for external exposure)

and the committed effective dose equivalent (for internal exposure), expressed in units of Sv or rem

(MARSSIM, Ref. 28). See DOSE EQUIVALENT.

uncertainty—A parameter, usually associated with the result of a measurement, that characterizes the

dispersion of the values that could reasonably be attributed to the measurement of interest

(Chapter 19 of MARLAP, Ref. 20).

validation—(1) Data validation, the evaluation of data to determine the presence or absence of an analyte

and to establish the UNCERTAINTY of the measurement process for contaminants of concern. Data

validation qualifies the usability of each datum (after interpreting the impacts of exceptions

identified during data VERIFICATION) by comparing the data produced with the MEASUREMENT

QUALITY OBJECTIVES and any other analytical process criteria contained in the ANALYTICAL

PROTOCOL SPECIFICATIONS developed in the planning process. (2) Software validation, the

confirmation by examination and provision of objective evidence that the particular criteria for a

specific intended use are fulfilled. Validation for a system is the set of activities ensuring and

gaining confidence that the system is able to accomplish its intended use, goals, and objectives

(ISO/IEC 15288-2002, Ref. 42).

verification—(1) Data verification, a process that ensures that laboratory conditions and operations were

compliant with the statement of work, sampling and analysis plan, and QUALITY ASSURANCE

PROJECT PLAN and that identifies problems, if present, that should be investigated during data

validation. Data verification compares the material delivered by the laboratory to these criteria

(compliance) and checks for consistency and comparability of the data throughout the data package

and for completeness of the results to ensure that all necessary documentation is available. (2)

Software verification, the confirmation by examination and provision of objective evidence that

specified criteria have been fulfilled. A set of activities compares a system life cycle product

against the necessary characteristics for that product. The system life cycle products may include,

but are not limited to, specified criteria, design description, and the system itself (ISO/IEC 15288-

2002, Ref. 42).
8 All NRC regulations listed herein are available electronically through the Public Electronic Reading Room on the

NRC’s public Web site, at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Copies are also available for

inspection or copying for a fee from the NRC’s Public Document Room at 11555 Rockville Pike, Rockville, MD;

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

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

9 This regulation is available electronically through the U.S. Environmental Protection Agency’s public Web site,

at http://www.epa.gov/epacfr40/chapt-I.info/.

10 Purchase information is available through the American Society of Mechanical Engineers (ASME) Web site

at http://catalog.asme.org/Codes/PrintBook/NQA1_1994_Quality_Assurance.cfm.

Rev. 2 of RG 4.15, Page 24

REFERENCES

1. 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities,”

U.S. Nuclear Regulatory Commission, Washington, DC.8

2. 10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” U.S. Nuclear

Regulatory Commission, Washington, DC.8

3. 10 CFR Part 61, “Licensing Requirements for Land Disposal of Radioactive Waste,” U.S. Nuclear

Regulatory Commission, Washington, DC.8

4. 10 CFR Part 72, “Licensing Requirements for the Independent Storage of Spent Nuclear Fuel,

High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste,”

U.S. Nuclear Regulatory Commission, Washington, DC.8

5. 10 CFR Part 76, “Certification of Gaseous Diffusion Plants,” U.S. Nuclear Regulatory

Commission, Washington, DC.8

6. 10 CFR Part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material,”

U.S. Nuclear Regulatory Commission, Washington, DC.8

7. 10 CFR Part 40, “Domestic Licensing of Source Material,” U.S. Nuclear Regulatory Commission,

Washington, DC.8

8. 10 CFR Part 70, “Domestic Licensing of Special Nuclear Material,” U.S. Nuclear Regulatory

Commission, Washington, DC.8

9. 10 CFR Part 20, “Standards for Protection Against Radiation,” U.S. Nuclear Regulatory

Commission, Washington, DC.8

10. 40 CFR Part 190, “Environmental Radiation Protection Standards for Nuclear Power Operations,”

U.S. Environmental Protection Agency, Washington, DC.9

11. ASME NQA-1-1994, “Quality Assurance Program Requirements for Nuclear Facilities

(with Addenda),” American Society of Mechanical Engineers, New York, NY, 1994.10
11 Generic Letter 79065 is available electronically through the NRC’s public Web site at http://www.nrc.gov/reading-rm/

doc-collections/gen-comm/gen-letters/1979/gl79065.html.

12 All regulatory guides listed herein were published by the U.S. Nuclear Regulatory Commission or its predecessor,

the U.S. Atomic Energy Commission. Most are available electronically through the Electronic Reading Room

on the NRC’s public Web site, at http://www.nrc.gov/reading-rm/doc-collections/reg-guides/. Active guides may be

purchased from the National Technical Information Service (NTIS). Details may be obtained by contacting NTIS at

5285 Port Royal Road, Springfield, Virginia 22161, online at http://www.ntis.gov, by telephone at (800) 553-NTIS

(6847) or (703) 605-6000, or by fax to (703) 605-6900. Copies are also available for inspection or copying for a fee

from the NRC’s Public Document Room (PDR), which is located at 11555 Rockville Pike, Rockville, Maryland; the

PDR’s mailing address is USNRC PDR, Washington, DC 20555-0001. The PDR can also be reached by telephone at

(301) 415-4737 or (800) 397-4209, by fax at (301) 415-3548, and by email to PDR@nrc.gov.

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

Purchase information is available through the ISO Web site at http://www.iso.org/iso/en/ISOOnline.frontpage.

14 Copies of all EPA quality system publications are available for download free of charge from the EPA public Web site

at http://www.epa.gov/quality/qa_docs.html.

Rev. 2 of RG 4.15, Page 25

12. Generic Letter 79065, “Radiological Assessment Branch Technical Position on Radiological

Environmental Monitoring,” Revision 1, U.S. Nuclear Regulatory Commission, Washington, DC,

November 27, 1979.11

13. Regulatory Guide 1.21, “Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and

Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled

Nuclear Power Plants,” U.S. Nuclear Regulatory Commission, Washington, DC.12

14. Regulatory Guide 4.1, “Programs for Monitoring Radioactivity in the Environs of Nuclear Power

Plants,” U.S. Nuclear Regulatory Commission, Washington, DC.12

15. Regulatory Guide 4.14, “Radiological Effluent and Environmental Monitoring at Uranium Mills,”

U.S. Nuclear Regulatory Commission, Washington, DC.12

16. Regulatory Guide 4.16, “Monitoring and Reporting Radioactivity in Releases of Radioactive

Materials in Liquid and Gaseous Effluents from Nuclear Fuel Processing and Fabrication Plants

and Uranium Hexafluoride Production Plants,” U.S. Nuclear Regulatory Commission, Washington,

DC.12

17. ISO/IEC 17025-2005, “General Requirements for the Competence of Testing and Calibration

Laboratories,” International Standards Organization/International Electrotechnical Commission,

Geneva, Switzerland, May 2005, Correction 1, August 2006.13

18. EPA QA/G-4-2006, “Guidance on Systematic Planning Using the Data Quality Objectives

Process,” U.S. Environmental Protection Agency, Washington, DC, EPA 240/B-06/001,

February 2006.14

19. EPA QA/G-5-2002, “Guidance for Quality Assurance Project Plans,” U.S. Environmental

Protection Agency, Washington, DC, EPA/240/R-02/009, December 2002.14

20. NUREG-1576 (MARLAP), “Multi-Agency Radiological Laboratory Analytical Protocols

Manual,” Volumes 1–3, U.S. Nuclear Regulatory Commission, Environmental Protection Agency,

Department of Energy, Department of Defense, Department of Homeland Security, National
15 Copies are available electronically through NRC’s public Web site at http://www.nrc.gov/reading-rm/doc-collections/

nuregs/staff/sr1576/ and from EPA’s public Web site at http://www.epa.gov/radiation/marlap/links.htm.

16 Copies of all ANSI publications cited in this document may be purchased from the American National Standards

Institute, 1819 L Street, NW, 6th floor, Washington, DC 20036. Purchase information is available through the ANSI

Web site at http://webstore.ansi.org/ansidocstore/default.asp.

17 Copies of all NIRMA Technical Guidance documents cited herein may be purchased from the Nuclear Information

and Records Management Association, Inc., 10 Almas Road, Windham, NH; telephone (603) 432-6476;

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

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

Rev. 2 of RG 4.15, Page 26

Institute of Standards and Technology, U.S. Geological Survey, and Food and Drug

Administration, Washington, DC, July 2004.15

21. ANSI/ASQC E4-1994, “Specifications and Guidelines for Quality Systems for Environmental Data

Collection and Environmental Technology Programs,” American National Standards

Institute/American Society for Quality Control, New York, NY, 1994.16

22. ANSI N42.23-2003, “Measurement and Associated Instrumentation Quality Assurance for

Radioassay Laboratories,” American National Standards Institute, New York, NY, 2003.16

23. NIRMA TG11, “Authentication of Records and Media,” Nuclear Information and Records

Management Association, Inc., Windham, NH, 1998.17

24. NIRMA TG15, “Management of Electronic Records,” Nuclear Information and Records

Management Association, Inc., Windham, NH, 1998.17

25. NIRMA TG16, “Software Configuration Management and Quality Assurance,” Nuclear

Information and Records Management Association, Inc., Windham, NH, 1998.17

26. NIRMA TG21, “Electronic Records Protection and Restoration,” Nuclear Information and Records

Management Association, Inc., Windham, NH, 1998.17

27. HPS/ANSI N13.1-1999, “Sampling and Monitoring Releases of Airborne Radioactive Substances

from the Stacks and Ducts of Nuclear Facilities,” Health Physics Society (HPS), McLean, VA,

1999.18

28. NUREG-1575 (MARSSIM), “Multi-Agency Radiation Survey and Site Investigation Manual,”

Revision 1 (EPA 402-R-97-016 Revision 1, DOE/EH-0624 Revision 1), U.S. Nuclear Regulatory

Commission, Environmental Protection Agency, Department of Energy, Washington, DC,

August 2000.15

29. EPA QA/G-9S-2006, “Data Quality Assessment: Statistical Tools for Practitioners,” U.S.

Environmental Protection Agency, Washington, DC, EPA/240/B-06/003, February 2006.14
19 Copies of all ASTM standards cited herein may be purchased from ASTM International, 100 Barr Harbor Drive,

P.O. Box C700, West Conshohocken, PA 19428-2959; see the ASTM International Web-based standards search tool at

http://www.astm.org/cgi-bin/SoftCart.exe/NEWSITE_JAVASCRIPT/index.shtml?L+mystore+qkyo3147+117461063.

20 Copies of this standard are available for purchase from the IEEE Web site at

http://standards.ieee.org/db/status/index.shtml.

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

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

Rev. 2 of RG 4.15, Page 27

30. ASTM D7282-2006, “New Standard Practice for Setup, Calibration, and Quality Control of

Instruments Used for Radioactivity Measurements,” American Society for Testing and Materials,

West Conshohocken, PA, 2006.19

31. ASTM MNL 7A-2002, “Manual on Presentation of Data and Control Chart Analysis,” 7th Edition,

American Society for Testing and Materials, West Conshohocken, PA, 2002.19

32. ANSI N42.22-1995, “Traceability of Radioactive Sources to the National Institute of Standards and

Technology (NIST) and Associated Instrument Quality Control,” American National Standards

Institute, New York, NY, 1995 (R2002).16

33. ANSI N42.18-2004, “American National Standard Specification and Performance of On-Site

Instrumentation for Continuously Monitoring Radioactivity in Effluents,” Institute of Electrical and

Electronics Engineers, Inc., New York, NY, 1980 (R2004).16

34. EPA QA/G-8-2002, “Guidance on Environmental Data Verification and Data Validation,” U.S.

Environmental Protection Agency, Washington, DC, EPA/240/R-02/004, November 2002.14

35. IEEE 1063, “IEEE Standard for Software User Documentation,” Institute of Electrical and

Electronics Engineers, Inc. (IEEE), Piscataway, New Jersey, December 2001.20

36. EPA Directive 2185, “Good Automated Laboratory Practices,” U.S. Environmental Protection

Agency (EPA), Office of Information Resources Management, 1995.21

37. Regulatory Guide 1.168, “Verification, Validation, Reviews, and Audits for Digital Computer

Software Used in Safety Systems of Nuclear Power Plants,” U.S. Nuclear Regulatory Commission,

Washington, DC.12

38. ANSI N42.14-1999, “Calibration and Use of Germanium Spectrometers for the Measurement of

Gamma-Ray Emission Rates of Radionuclides,” American National Standards Institute, New York,

NY, 1999.16

39. International Organization for Standardization (ISO), “International Vocabulary of Basic and

General Terms in Metrology,” 2nd Edition, Geneva, Switzerland, 1993.13

40. ISO Guide 30, “Terms and Definitions Used in Connection with Reference Materials,”

International Organization for Standardization, Geneva, Switzerland, 1992.13
22 Copies are available electronically through the IUPAC public Web site at

http://www.iupac.org/publications/pac/1994/6612/index.html.

Rev. 2 of RG 4.15, Page 28

41. International Union of Pure and Applied Chemistry (IUPAC), “Nomenclature for Radioanalytical

Chemistry,” Pure and Applied Chemistry, 66:12, pp. 2513–2526, 1994.22

42. ISO/IEC 15288-2002, “System Engineering — System Life Cycle Processes,” International

Organization for Standardization, Geneva, Switzerland, 2002.13