| (iii) the use of generic organizational charts to indicate
functional relationships, authorities, and responsibilities, or alternatively,
the use of descriptive text, provided that there is no substantive
change to the functional relationships, authorities, or responsibilities;
(iv) the elimination of quality assurance program information
that duplicates language in quality assurance regulatory guides and
quality assurance standards to which the quality assurance program
approval holder has committed to on record; and
(v) organizational revisions that ensure that persons
and organizations performing quality assurance functions continue
to have the requisite authority and organizational freedom, including
sufficient independence from cost and schedule when opposed to safety
considerations.
(C) Each quality assurance program approval holder
shall maintain records of quality assurance program changes.
(v) Quality control program. Each shipper shall adopt
a quality control program to include verification of the following
to ensure that shipping containers are suitable for shipments to a
licensed disposal facility:
(1) identification of appropriate container(s);
(2) container testing documentation is adequate;
(3) appropriate container used;
(4) container packaged appropriately;
(5) container labeled appropriately;
(6) manifest filled out appropriately; and
(7) documentation maintained of each step.
(w) Handling, storage, and shipping control. The licensee,
certificate holder, and applicant for a CoC shall establish measures
to control, in accordance with instructions, the handling, storage,
shipping, cleaning, and preservation of materials and equipment to
be used in packaging to prevent damage or deterioration. When necessary
for particular products, special protective environments, such as
inert gas atmosphere, and specific moisture content and temperature
levels shall be specified and provided.
(x) Inspection, test, and operating status. Measures
to track inspection, test and operating status shall be established
as follows.
(1) The licensee, certificate holder, and applicant
for a CoC shall establish measures to indicate, by the use of markings
such as stamps, tags, labels, routing cards, or other suitable means,
the status of inspections and tests performed upon individual items
of the packaging. These measures shall provide for the identification
of items that have satisfactorily passed required inspections and
tests, where necessary to preclude inadvertent bypassing of the inspections
and tests; and
(2) The licensee, shall establish measures to identify
the operating status of components of the packaging, such as tagging
valves and switches, to prevent inadvertent operation.
(y) Nonconforming materials, parts, or components.
The licensee, certificate holder, and applicant for a CoC shall establish
measures to control materials, parts, or components that do not conform
to the licensee's requirements to prevent their inadvertent use or
installation. These measures shall include the following, as appropriate:
(1) procedures for identification, documentation, segregation,
disposition, and notification to affected organizations; and
(2) nonconforming items shall be reviewed and accepted,
rejected, repaired, or reworked in accordance with documented procedures.
(z) Corrective action. The licensee, certificate holder,
and applicant for a CoC shall establish measures to assure that conditions
adverse to quality, such as deficiencies, deviations, defective material
and equipment, and nonconformances, are promptly identified and corrected.
(1) In the case of a significant condition adverse
to quality, the measures shall assure that the cause of the condition
is determined and corrective action taken to preclude repetition.
(2) The identification of the significant condition
adverse to quality, the cause of the condition, and the corrective
action taken shall be documented and reported to appropriate levels
of management.
(aa) Quality assurance records. The licensee, certificate
holder, and applicant for a CoC shall maintain written records sufficient
to describe the activities affecting quality for inspection by the
department for three years beyond the date when the licensee, certificate
holder, and applicant for a CoC last engage in the activity for which
the quality assurance program was developed. If any portion of the
written procedures or instructions is superseded, the licensee, certificate
holder, and applicant for a CoC shall retain the superseded material
for three years after it is superseded. The records must include the
following:
(1) instructions, procedures, and drawings to prescribe
quality assurance activities, and closely related specifications such
as required qualifications of personnel, procedures, and equipment;
(2) instructions or procedures which establish a records
retention program that is consistent with applicable regulations and
designates factors such as duration, location, and assigned responsibility;
and
(3) changes to the quality assurance program as required
by subsection (u)(6) of this section.
(bb) Audits. The licensee, certificate holder, and
applicant for a CoC shall carry out a comprehensive system of planned
and periodic audits, to verify compliance with all aspects of the
quality assurance program, and to determine the effectiveness of the
program. The audit program shall include:
(1) performance in accordance with written procedures
or checklists by appropriately trained personnel not having direct
responsibilities in the area being audited;
(2) documented results that are reviewed by management
having responsibility in the area audited; and
(3) follow-up action, including reaudit of deficient
areas, shall be taken where indicated.
(cc) Transfer for disposal and manifests.
(1) The requirements of this section and subsection
(ff) of this section are designed to:
(A) control transfers of LLRW by any waste generator,
waste collector, or waste processor licensee, as defined in this section,
who ships LLRW either directly, or indirectly through a waste collector
or waste processor, to a licensed LLRW land disposal facility, as
defined in §289.201(b) of this title;
(B) establish a manifest tracking system; and
(C) supplement existing requirements concerning transfers
and recordkeeping for those wastes.
(2) Beginning March 1, 1998, all affected licensees
shall use subsection (ff) of this section.
(3) Each shipment of LLRW intended for disposal at
a licensed land disposal facility shall be accompanied by a shipment
manifest in accordance with subsection (ff)(1) of this section.
(4) Any licensee shipping LLRW intended for ultimate
disposal at a licensed land disposal facility shall document the information
required on the uniform manifest and transfer this recorded manifest
information to the intended consignee in accordance with subsection
(ff) of this section.
(5) Each shipment manifest shall include a certification
by the waste generator as specified in subsection (ff)(10) of this
section, as appropriate.
(6) Each person involved in the transfer for disposal
and disposal of LLRW, including the waste generator, waste collector,
waste processor, and disposal facility operator, shall comply with
the requirements specified in subsection (ff) of this section, as
appropriate.
(7) Any licensee shipping LLRW to a licensed Texas
LLRW disposal facility shall comply with the waste acceptance criteria
in Title 30, Texas Administrative Code, Part 1, Chapter 336.
(8) Each shipper shall submit a list for approval by
the department of shipping containers that they intend to use to ship
LLRW to the Texas LLRW site. If the shipper is licensed in Texas and
is the holder of a CoC, the shipper shall also submit written documentation
of its program for quality assurance and control and handling, shipping
and control measures that comply with the requirements of subsections
(s), (t), and (v) - (bb) of this section.
(dd) Fees.
(1) Each shipper shall be assessed a fee for shipments
of LLRW originating in Texas or originating out-of-state being shipped
to a licensed Texas LLRW disposal facility and these fees shall:
(A) be $10 per cubic foot of shipped LLRW;
(B) be collected by the department and deposited to
the credit of the department's Radiation and Perpetual Care Account;
(C) be used by the department for emergency planning
for and response to transportation accidents involving LLRW, including
first responder training in counties through which transportation
routes are designated in accordance with this section; and
Cont'd... |
