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NRC INSPECTION MANUAL DQASIP

MANUAL CHAPTER 1230

QUALITY ASSURANCE PROGRAM FOR RADIOLOGICAL CONFIRMATORY MEASUREMENTS

1230-01 PURPOSE

This chapter establishes criteria for a quality assurance (QA)

program for radiological measurements performed by Regional Offices

as a part of the inspection and investigation process.

1230-02 OBJECTIVE

The objective of the QA program is to ensure that all measurements

being performed by Regional Offices or their contractors are of

acceptable precision and accuracy so that the measurements are a

proper reflection of actual conditions and of licensee performance.

1230-03 DEFINITIONS

03.01 Quality Assurance (QA): Planned and systematic actions

necessary to provide adequate confidence in the results of a

measurement or measurement program. Quality assurance includes

"quality control."

03.02 Quality Control (QC): QA actions that provide a means to

control and measure the characteristics of measurement equipment and

processes to established requirements.

03.03 Radiation Protection Instruments: For the purpose of this

manual chapter, radiation protection instruments are defined as

portable health physics survey meters used for detection and

measurement of levels of ionizing radiation fields or levels of

radioactive surface contamination.

03.04 Radiological Confirmatory Measurements: Radiological

confirmatory measurements are those measurements of radiation or

radioactivity that are performed by NRC inspectors or IE contractors

as checks on the ability of licensees to make accurate measurements.

03.05 Cooperative Agreement: A written agreement between NRC

and an entity (State, etc.) under which the entity performs a

service and is reimbursed from NRC funds. The Office of Administra-
1230 - 2 - Issue Date: 10/01/83

tion is responsible for officially consummating the cooperative

agreement.
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1230-04 RESPONSIBILITIES AND AUTHORITIES

04.01 Director, Division of Quality Assurance, Safeguards, and

Inspection Programs

a. Establishes criteria and guidance for the QA program for

radiological confirmatory measurements.

b. Evaluates regional radiological measurements activities and

the implementation of the QA program.

c. Monitors those activities of the Department of Energy's

Radiological Environmental Sciences Laboratory and the

National Bureau of Standards that are related to contracted

analytical laboratory support to the NRC.

04.02 Regional Administrators, NRC Regional Offices

a. Develop and implement instructions and procedures necessary

to implement the provisions of this chapter.

b. Audit the performance of their regional confirmatory measurements activities to ensure adherence to requirements of the

QA program.

c. Appraise the performance of States under cooperative agreement

to the NRC according to the provisions of IE MC 1415.

1230-05 BASIC REQUIREMENTS

05.01 Applicability. This chapter and appendix apply to the

Office of Inspection and Enforcement, NRC Regional Offices, and

contractors. All radiological confirmatory measurements performed

by these organizations in fulfillment of the NRC mission are subject

to the quality assurance program established in this chapter.

05.02 Appendix 1230. The appendix sets forth the main elements,

criteria and guidelines to implement the QA program.

05.03 Audits. Periodic audits shall be planned and conducted to

verify implementation of the quality assurance program. Regional

Offices shall plan and conduct audits of their own operation. An

overall assessment of the quality assurance program and its

implementation shall be completed periodically by the Division of

Quality Assurance, Safeguards, and Inspection Programs.

05.04 Implementation. Regional Offices shall develop and

implement a system of procedures and records which are consistent

with their operations and necessary to implement the requirements

of the quality assurance program described in the appendix.

05.05 References

a. ANSI N323-1978, Radiation Protection Instrumentation Test and

Calibration.
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b. Regulatory Guide 4.15, Quality Assurance for Radiological

Monitoring Programs (Feb. 1979), contains guidance and a list

of references on the subject of quality assurance for

radiological measurements.

END

Appendix
Issue Date: 10/01/83 A-1 1230 Appendix

APPENDIX 1230

A. PURPOSE AND SCOPE

This appendix establishes requirements for a program to assure the

quality of the results of independent radiological measurements made

by Regional Offices and contractors during the conduct of inspection

and investigation activities.

The scope of the requirements established here is limited to the

basic elements of the quality assurance program. Regional Offices

and contractors shall develop and implement a system of procedures

and records which are consistent with operations and necessary to

implement the requirements of the quality assurance program.

B. BASIC ELEMENTS AND REQUIREMENTS

1. Organizational Responsibilities

There shall be a written designation of assignment of the

person(s) responsible for performing quality assurance

functions in the Regional Office. The assignment(s)

shall include a written expression of authorities,

duties, and responsibilities for quality assurance,

including the responsibilities for review and approval of

written procedures, and for the preparation, review, and

evaluation of measurements data and reports. The

assignment(s) shall also grant authority and assign

responsibility to identify quality problems; to initiate,

recommend, or provide solutions; and to verify

implementation of solutions.

2. Personnel Qualifications

Persons performing independent radiological measurements

activities, including the functions of quality assurance,

must have training and experience in health physics or

radioisotope technology fields, including experience in

handling and using radiation measurement instrumentation.

Persons performing quality-related activities must have

experience in principles, practices, and techniques of

the activities performed.

3. Procedures and Instructions

Each Regional Office and contractor shall prepare written

procedures and instructions which are consistent with the

Region's radiological measurements activities and

necessary for implementation of the requirements of the
1230 Appendix A-2 Issue Date: 10/01/83

quality assurance program. These procedures shall cover

all quality-related activities such as: the collection,

packaging, shipment, and receipt of samples; preparation

and analysis of samples, health physics surveys; operation of instrumentation; maintenance, storage, and use of

radioactive reference standards; calibration and performance checks of radiation and radioactivity measurements

systems; and reduction, evaluation, recording, and

reporting of data. The procedures shall establish a

system for coding individual samples for the purpose of

identification and tracking through the analytical

process.

4. Records

Records shall be maintained of the performance of

significant quality assurance activities. Records shall

be kept:

a. to track and control a sample in its progress through

the process sequence of collection, analysis, data

reduction and verification, final recording of

results, and reporting;

b. of calibrations and performance tests that check the

reliability and stability of radiation protection

instruments and all counting and major laboratory

analytical equipment;

c. of results of analytical measurements of spiked or

blind samples sent from the Radiological and Environmental Sciences Laboratory (RESL), and of results of

the cross-check program of the Environmental Protection Agency (EPA); and

d. to identify and maintain pertinent information on

radioactive standards and sources and audits.

These records shall be maintained for a minimum period of

two years.

5. Quality Control in Sampling

Procedures for sampling shall specify methods (type and

periodicity) designed to ensure that the sample is

representative of the material sampled. Replicate grab

samples may be used to determine the reproducibility of

sampling. The validity of the sampling process for

samples split with the licensee may be confirmed by

immediate analysis and comparison with the licensee's

analysis, or by collection of replicate samples if they

are to be shipped elsewhere for analysis or held for

analysis at a later time.

The collection efficiency of samplers shall be documented

and used throughout applicable procedure; such information is usually available from manufacturers of the
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sampling equipment or sampling media. Air samplers

should be calibrated periodically.

Procedures for sampling, packaging, shipping, and storage

of samples shall be designed to maintain the integrity of

the sample from time of collection to time of analysis.

Guidance on the principles and practices of sampling is

provided in several of the publications referenced in

Regulatory Guide 4.15.

6. Quality Control for Radiation Protection Instruments

Procedures developed and implemented by the Regional

Offices should incorporate the following requirements,

wherever possible, which reflect adoption of ANSI

Standard N323-1978, Radiation Protection Instrumentation

Test and Calibration. The requirements may be incorporated by reference.

a. Inspection, calibration and performance test requirements should be those specified in Section 4 of ANSI

N323-1978.

b. Calibration services that are used should conform to

the criteria specified in Section 5, Calibration

Equipment Required, and Section 6, Maintenance of

Quality Calibration, of ANSI N323-1978.

7. Quality Control in the Radioanalytical Laboratory

a. Radionuclide Reference Standards

Radionuclide standards used to determine counting

efficiencies of radiation measurements systems shall

have been certified by the National Bureau of

Standards (NBS) or obtained from suppliers who

participate in measurement assurance activities with

the NBS.

Counting efficiencies of radiation measurement

systems shall be determined at least once each year.

Guidance on this subject is given in Section 6.1 of

Regulatory Guide 4.15.

b. Performance Checks of Radiation Measurement Systems

Procedures shall specify the type and periodicity of

performance checks of each radiation measurement

system. The guidance in Section 6.2 of Regulatory

Guide 4.15 is adopted as minimum requirements for the

quality assurance program.

The results of the performance checks of measurement

systems shall be recorded. Appropriate statistical

methods, e.g., chi-square tests and quality control
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chart techniques, should be used to evaluate system

performance over time.

Procedures should establish criteria to effect

corrective action (adjustment, repair, calibration,

etc.) when indicated by the results of the performance checks.

These samples are to be supplied by RESL or by EPA

under its cross-check program.

1. One spike sample shall be analyzed each calendar

quarter for all types of analyses performed on

a regular basis.

2. Interlaboratory samples should be analyzed when

they are made available by the EPA.

3. RESL will operate a regional interlaboratory test

program. Under this program, RESL will run four

tests per year. Each test will include one of

the following sample types: charcoal cartridge,

particulate filter, liquid, or gas. All sample

types will be tested annually.

The regions are required to participate fully in

these tests. The regions are to meet or exceed the

acceptance criterion which states that the ratio

between the region's value and RESL's value shall

fall within the specified values expressed in

percent. These values for the various samples are

listed below:

liquid 10%

charcoal cartridge 15%

particulate filter 15%

gas 15%

All samples analyzed for quality control purposes

shall be analyzed using the same procedures normally

used for the particular sample matrix. Records shall

be kept of each analysis.

8. Computational Checks

Procedures for the computation of the concentration of

radioactive materials shall require independent verification of a substantial fraction of the results of the

computation by a person other than the one performing the

original computation.

For computer calculations, the input data shall be

verified before initial routine use and after each

modification of the program.

9. Review and Analysis of Data
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Procedures for review and analysis of data shall cover

examination of data from actual samples and from quality

control activities. General criteria for recognizing

deficiencies in data shall be established. Procedures

shall require investigation and correction of recognized

deficiencies and for documentation of these actions.

10. Audits

Regional Offices shall plan and conduct periodic audits

of their own operation to verify implementation of the

quality assurance program. The audits shall be performed

by qualified individuals (see Section B.2) who do not

have direct responsibilities in the areas audited. The

results of audits shall be documented and reviewed by

management or supervision having responsibility in the

area audited. Corrective action shall be taken where

indicated by the results.

END