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Visits by Regulatory Personnel - doe-std-1128-98_ch10059
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Radiological Control Organizations - doe-std-1128-98_ch10061


DOE-STD-1128-98
Generally, an assessment is required for each onsite package containing Type B,
fissile, or highway route control quantities (HRCQ).
The packaging organization is responsible for coordinating onsite package design
and preparation of safety analysis documentation. The following information
describes typical process, review, and approval requirements for onsite safety
analysis documentation:
1. Initiation. New safety analysis documentation or reviews/changes to existing
documentation can be requested by a user organization based on programmatic
or operational requirements. The request is submitted in writing to the
packaging organization and includes proper justification and support
documentation. The packaging organization makes routine revisions as
necessary to reflect policy and regulation changes.
2. Preparation. The packaging organization coordinates the analysis, prepares
safety analysis documentation, and guides the documentation through the
review and approval process, including the resolution of review comments and
the obtaining of required approval.
3. Control. Safety analysis documentation is prepared and maintained according
to facility policy. The document control system provides an accessible,
auditable, and retrievable method for maintaining and changing safety analytic
documentation.
4. Review and Approval Cycle. Safety analysis documentation is reviewed,
approved, and changed according to facility policy. Additional reviews and
approvals include the following people and organizations:
--
User
--
cognizant engineer
--
packaging organization
--
quality assurance
--
responsible environmental assurance organization, onsite only
--
packaging, shipping, and waste safety assurance organization
--
criticality engineering analysis, if criticality analysis is required
--
packaging and shipping approval authority
--
DOE field office, if the package is to be used for HRCQ inter-area
shipments.
5. Approval for Editorial Changes. Inconsequential editorial changes to a safety
analysis document may be approved at the operating level.
3-12


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