Industrial irradiator radiation safety program assessments

Mark A. Smith*

SteriGenics International, 10811 Withers Cove Park Drive, Charlotte, NC 28273, USA

Abstract

Considerable attention is typically given to radiation safety in the design of irradiators and initially establishing

the program. However, one component that may not receive enough attention is applying the continuousimprovement philosophy to the radiation safety program. Periodic total program assessments of radiation safety canensure that the design and implementation of the program continues to be applicable to the operations. The ®rst

step in the process must be to determine what is to be covered in the program assessment. While regulatorycompliance audits are a component, the most useful evaluation will extend beyond looking only at compliance anddetermine whether the radiation safety program is the most appropriate for the particular operation. Several aspectsof the irradiator operation, not all of which may routinely be considered ``radiation safety'', per se, should be

included: Design aspects of the irradiator and operating system, system controls, and maintenance procedures, aswell as the more traditional radiation safety program components such as surveys, measurements andtraining. 7 2000 Elsevier Science Ltd. All rights reserved.

Keywords: Radiation safety; Assessment; Program review

1. Introduction

The radiation safety program at an industrial irra-diator includes several components: Engineered fea-

tures, training of key personnel, radiationmeasurements and operating procedures.Periodically, the entire radiation safety program

should receive an evaluation that addresses all aspects

of the program to determine that the existing programis adequate in its scope and design and is being im-plemented properly. In the United States, the regu-

lations of the Nuclear Regulatory Commission requirethat a program review be performed annually

(USNRC, 1991), but details of the scope and contentof the program review is left to the individual licensee.In many cases, a radiation safety program review may

consist of a regulatory compliance audit, which deter-mines whether the procedures and practices at thefacility meet the explicit or implicit requirements of the

regulations. However, while such a program reviewprovides important information, a more detailed evalu-ation of the program is needed to ensure that existingpractices provide the highest level of protection for

personnel at the facility.Several reference documents may serve as the basis

for evaluation criteria in addition to the pertinent regu-

lations. The American National Standard N43.10(ANSI, 1984), currently in revision, provides an indus-try consensus standard within the United States, while

similar documents serve an equivalent purpose in othercountries. The International Atomic Energy Agency

Radiation Physics and Chemistry 57 (2000) 601±603

0969-806X/00/$ - see front matter 7 2000 Elsevier Science Ltd. All rights reserved.

PII: S0969-806X(99 )00429-6

www.elsevier.com/locate/radphyschem

* Tel.: +001-704-588-6877; fax: +001-704-588-3667.

E-mail address: marks@charlotte.sterigenies.com (M.A.

Smith).

also has relevant publications (IAEA, 1992). Regard-less of the reference material used, the individuals con-

ducting the assessment must be familiar with currenttrends in the industry, particularly as related to recentdevelopments in safety system and engineering features

of irradiators.

2. What to review

The operational areas that need to be reviewed for athorough evaluation of the radiation safety programinclude the traditional topics of radiation surveys and

measurements, but must extend beyond those areas.The following points are of particular importance toan evaluation of the radiation safety program.

. Design of the irradiator, and whether the design in-corporates all of the safety features from consensusstandards and other reference documents. If the irra-diator design has been modi®ed since installation,

the modi®cations require close attention during theprogram review.

. Operating procedures for the irradiator, to ensure

that the operational practice meets the design intentof the irradiator and that due consideration is givento safety precautions.

. Maintenance and inspection program, to ensure thatall required safety systems continue to operate asdesigned.

. Training program for personnel, not only on radi-

ation safety topics, but also on operations procedureand on-the-job training to ensure that safety precau-tions are being addressed.

3. How to perform the assessment

A radiation safety program assessment includesmore than a compliance audit. The actual programreview should begin before entering the irradiator facil-

ity by obtaining copies of all applicable operationsdocuments, including procedure manuals, irradiatoroperating manuals, license application and associateddocumentation, and training program content. All of

the documentation should be reviewed in advance ofthe on-site portion of the program assessment toensure that the documents agree with the design

assumptions of the irradiator manufacturer and thatall appropriate areas of concern are addressed.Before beginning the program assessment, a check-

list should be developed that is, as far as possible, site-speci®c. This checklist should address all of therequired components of the radiation safety program,

including irradiator operations, maintenance andinspection programs, and other areas discussed above.

The checklist serves the primary purpose of ensuringthat none of the pertinent items are forgotten duringthe program assessment. However, it is equally import-

ant not to slavishly follow the checklist to the exclu-sion of pursuing any area of inquiry that appears to bequestionable. In other words, have the checklist, but

do not feel too obligated to follow it restrictively.A thorough radiation safety program assessment will

require several days on site, in addition to the time

spent in reviewing documentation beforehand. The on-site portion of the assessment should include athorough review of the important records documentingactions related to radiation safety, including system

maintenance, irradiator design modi®cations, andother functions related to radiation safety. In addition,the assessment must include an extensive inspection of

the facility, including observing all aspects of the irra-diator operation, to ensure that operations meet thedesign. Interviews with key personnel, including irra-

diator operators, must be included to ensure that therehave been no ad hoc changes in the procedures andpractices and to ensure that the training requirements

have been met.

4. When to perform the assessment

For a new irradiator facility, the radiation safetyprogram assessment needs to be divided into two sec-tions. The ®rst should be completed before operations

begin at the site to ensure that all of the required sys-tems and programs are in place prior to processingany product. The second phase should follow oper-

ational start-up by a few months, which will provideadequate time to test operating procedures againstactual operations. After a few months, it should be

possible to determine the adequacy and completenessof the program, partly by simply asking the operatorswhat is working well and what is not. Once the pro-gram has been determined to be adequate, future

assessments should be done on a periodic basis. Typi-cally, a thorough review should be done every 1 to 2years.

5. Who should perform the assessment

One of the more critical aspects of a radiation safetyprogram assessment is the quali®cation of personnelperforming the assessment. It may be necessary to

have multiple persons performing the assessment toensure that adequate expertise is available in all of theapplicable operational areas. A ``quali®ed expert'' will

M.A. Smith / Radiation Physics and Chemistry 57 (2000) 601±603602

be an individual, or combination of individuals, whohas had extensive experience with various aspects of

irradiator operations and has a thorough understand-ing of the philosophy of radiation safety pertinent tothe irradiator. The individual(s) will ideally be some-

one with a non-parochial viewpoint (e.g., does notfocus exclusively on a particular area) and external tothe daily operations of the irradiator. Since the number

of consultants with the necessary level of expertise maytend to be limited, it may be di�cult to obtain a trulyoutside perspective. At SteriGenics International, there

has been some success in using inspection teams com-posed of several individuals from the Corporate organ-ization or from other facilities to evaluate programimplementation at a di�erent facility.

6. Conclusion

Radiation safety program assessments must extendbeyond the typical regulatory compliance audits. All

operational areas that may impact radiation safetyshould be included and the individuals conducting the

assessment must have adequate expertise to evaluatethe program independently. Thorough programreviews can identify problems before they have a

chance to occur and are well worth the investment oftime and resources.

References

USNRC 1991. United States Nuclear Regulatory

Commission, Title 10, Code of Federal Regulations, Part

20.1011(c), 56 FR 23396, May 21.

ANSI 1984. American National Standards Institute, Safe

Design and Use of Panoramic, Wet Source Storage

Gamma Irradiators (Category IV), ANSI N43.10.

IAEA 1992. International Atomic Energy Agency, Radiation

Safety of Gamma and Electron Irradiation Facilities,

Safety Series Number 107, STI/PUB/896 (June).

M.A. Smith / Radiation Physics and Chemistry 57 (2000) 601±603 603