Each licensee is required to perform an annual review of their radiation protection
program. The information contained in this section is designed to assist the
licensee in demonstrating compliance with the regulation.
What is a
program review?
A program review is when the licensee performs their own internal
"inspection" or "audit" of the radiation protection program that has
been established at the facility. This review may be done either by a member of the
organization (usually the Radiation Safety Officer) or a third party reviewer (i.e.,
a consultant).
The audit or review of any program is an integral part of
that program. These audits/reviews allow the licensee to identify, document and
correct any deficiencies which may be present in either the program content or
implementation. This is not only a review the records of the program (e.g.
policy and procedure manual, exposure records, etc.) but also a review the implementation
of the program as well. This may include observation of employees performing their
duties, interviews with employees concerning their duties/tasks, tracking and trending of
data, evaluating effectiveness of equipment and procedures, etc. In order to ensure
the agency that these regulations have been implemented by the licensee, an auditable
record must be maintained. The licensee should also develop a method for presenting
the results of this audit to administration/management.
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What regulations deal with annual program reviews?
There are two regulations which directly apply
to the review of your radiation protection program: 15A NCAC 11 .1603(c) and
.1636. The regulations are as follows:
.1603
RADIATION PROTECTION PROGRAMS
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(a) |
Each licensee or
registrant shall develop, document, and implement a radiation protection program
commensurate with the scope and extent of licensed or registered activities and sufficient
to ensure compliance with the provisions of this Section. Recordkeeping requirements
relating to these programs are provided in Rule .1636 of this Section.
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(b) |
The licensee or
registrant shall use, to the extent practicable, procedures and engineering controls based
upon sound radiation protection principles to achieve occupational doses and doses to
members of the public and releases of radioactive materials in effluents to unrestricted
areas that are as low as is reasonably achievable (ALARA).
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(c) |
The licensee or
registrant shall annually review the radiation protection program content and
implementation.
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(d) |
To implement the ALARA
requirements of Paragraph (b) of this Rule, and notwithstanding the requirements of Rule
.1611 of this Section, a constraint on air emissions of radioactive material to the
environment, excluding Radon-222 and its daughters, shall be established by licensees such
that the individual member of the public likely to receive the highest dose will not be
expected to receive a total effective dose equivalent in excess of 0.01 rem (0.1 mSv) per
year from these emissions. If a licensee subject to this requirement exceeds this
dose constraint, the licensee shall report the excellence as provided in Rule .1647 of
this Section and promptly take appropriate corrective actions to ensure against
recurrence.
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.1636 RECORDS OF RADIATION PROTECTION
PROGRAMS
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(a) |
Each licensee or
registrant shall maintain records of the radiation protection program, including:
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(1) |
The provisions of the program; and |
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(2) |
Audits and other reviews of program
content and implementation.
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(b) |
The licensee or
registrant shall retain the records required by Subparagraph (a)(1) of this Rule until the
agency terminates each pertinent license or registration requiring the record. The
licensee or registrant shall retain the records required by Subparagraph (a)(2) of this
Rule for three years after the record is made. |
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What is an "auditable
record?"
It may be better to first define what is NOT an auditable record. An auditable
record is NOT a single summary statement such as "I have reviewed the program and all
is in good standing." Such a statement neither demonstrates a review of the
content nor the implementation of the radiation protection program. At a minimum,
the agency needs to see that the licensee has performed an in-depth look at the program,
noted any deficiencies, implemented corrective actions for those deficiencies, and have
followed-up on these corrective measures to ensure that the deficiencies do not recur.
Documentation that the findings, corrective actions, and follow-up have been
reported to management/administration should also be included in this record. Think
of the annual program review as an inspection that you or a third party performs on your
program.
In order to establish a good format for the annual program
review, a licensee should evaluate all of the information provided to the agency for
obtaining a license along with all regulations which apply to your program. The
licensee should outline the topics/items in the application, the applicable regulations,
and the provisions of the license. This should give you a "nucleus" from which
to build an all-encompassing program review.
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What should be submitted in the application?
In order for the agency to determine that the licensee's
annual program review format is adequate, you should submit a proposed format for the
annual program review in the application. The easiest way to document this is with
a checklist-type format. The licensee may develop their own checklist or they may
use the ones from DRP or NRC regulatory/licensing guidance. If you will develop you
own checklist or use one from NRC, it must be submitted for agency review. If you
use a checklist developed by DRP, then you may simply state which checklist is to be used
for your annual program review.
The agency also recognizes that not every radiation
protection program will have all of the components covered by these "model"
program review guides. If you are using one of the "model" guides, simply
indicate which parts of the guide are not applicable to your program.
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In developing your own annual program review checklist, the following should be considered (where applicable):
| 1. |
Review the oversight of the radiation safety
program (e.g. RSO, Radiation Safety Committee, etc.); |
| 2. |
Personnel who utilize radioactive materials;
have there been additions/deletions to the listing of users, were amendment made in a
timely manner, have training records been updated, etc.; |
| 3. |
Type, form, and quantity of radioactive
materials listed on the license. Have ordering and receipt been consistent with
these limitations? Were there amendments to the license to add/delete any
radioactive materials, etc.; |
| 4. |
Leak testing and physical inventory of sealed
sources; |
| 5. |
Location(s) of use of radioactive materials; |
| 6. |
Review of personnel dosimetry records,
including internal doses (body or organ burdens, etc.). Are doses consistent with
the scope and extent of licensed activities? Are doses essentially the same for each
monitoring period, or are there excessive variations; |
| 7. |
Review of the policy and procedure manual to
ensure that it is consistent with current regulations and agency requirements. Have
new uses of radioactive materials been instituted which required changes in
policies/procedures? Have amendments been made to the license for inclusion of these
policies?, etc.; |
| 8. |
Review the pertinent regulations in Sections
.0300 (Licensing of Radioactive Material), .0500 (Safety Requirements for Industrial
Radiography Operations), .0700 (Use of Sealed Radioactive Sources in The Healing Arts),
.0900 (Requirements for Particle Accelerators),.1000 (Notices: Instructions: Reports and
Inspections), .1600 (Standards for Protection Against Radiation); |
| 9. |
Surveys of use/storage/preparation areas; |
| 10. |
Daily/weekly/monthly activities that must be
documented (i.e., surveys, operability checks of survey instruments, etc.); |
| 11. |
Receipt/disposal documentation (bill of
lading, confirmation from recipient, checks of the recipients license, etc.); |
| 12. |
Method(s) of transmitting findings to the
Radiation Safety Committee and/or management. |
A licensee's ability to properly
perform, document and implement an internal audit of the program is always a consideration
when the agency evaluates the need for escalated enforcement or an increase in inspection
frequency. |
