ML20214W856
| ML20214W856 | |
| Person / Time | |
|---|---|
| Site: | 07100420 |
| Issue date: | 04/30/1987 |
| From: | RTI, INC. (FORMERLY RADIATION TECHNOLOGY, INC.) |
| To: | |
| Shared Package | |
| ML20214W844 | List: |
| References | |
| 28170, NUDOCS 8706160213 | |
| Download: ML20214W856 (10) | |
Text
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RADIATION TECHNOLOGY, INC.-
Quality Assurance Program for Shipping Radioactive' Material Introduction This document establishes the quality assurance program (QAP) of Radiation Technology, Inc. (RTI), for the procurement,
- use, handling and returning of
. shipping containers
.for radioactive material (RAM) in accordance with Title 10, Code of.
Federal Regulations, Part 71, Subpart H,
effective January 1,
i-1986.
Each paragraph of Subpart H,_ is addressed, if only to specifically exclude those topics where RTI does not anticipate any activity relating thereto.
l As defined in Subpart H,
' Quality assurance' comprises all
(
those planned and systematic actions necessary to provide-adequate confidence that a system or component will perform satisfactorily in service.
Quality assurance includes quality control which comprises those quality assurance actions related to the control of the physical characteristics and quality of the material or component to predetermined requirements."
The RTI personnel:
the Operations and Engineering staff, the Quality staff and other personnel assisting in each shipment of RAM, are determined to see that all shipments from RTI facilities are made in a safe manner and comply fully with existing regulations.
The shipment of radioactive materials are categorized as; exempt, Type A, Type B and large quantities.
This QA program is specifically concerned with the Type B, large quantity shipments including CO 6o, and Cs 137 pencils for gamma irradiators.
Safety control will be commensurate with the radioactivity and the form of the material being shipped.
This QAP is applicable to containers owned by another party and for which RTI is registered as an authorized user.
The graded approach to safety control will be applied to each container and to each shipment through special procedure checklists, other necessary documents and training to the' degree required to be certain the shipment will be accomplished safely.
1.
cruanization j
Radiation Technology, Inc., through its Quality Department, shall retain and exercise responsibility for the QAP applicable
]
to the containers in which RAM will be shipped.
8706160213 870430 PDR ADOCK 07100420 C
PDR:
Page.Two RTI QA Program (Organization cont).
l The Vice President, Quality, shall designate the QA Program
-l l.
Manager (QAPM).
The QAPM is responsible for preparing the_QAP,-
making changes, additions or modifications as necessary and to i
submit the QAP, and/or changes, etc., to the RTI staff-for review' i
t and approval.
The QAPM is-responsible for preparing supporting i
documents to the QAP, such as procedures, checklists, etc. fThese supporting documents shall be reviewed by the RTI staff, and when appropriate, shall be approved by the QAPM.
The QAPM 1 shall 4
supervise the operations performed under this plan. The QAPM shall report to the Vice President, Quality.
The personnel performing the QA/QC functions under the QAP shall not. participate in either the actual physical receipt and inspection of the shipping container or -loading and preparation for shipment.
The Vice president,. Operations-and Engineering, has-overall I
responsibility for the operation of RTI facilities, including shipping radioactive materials.
In the capacity as Corporate Radiation Safety
- Officer, the Vice President will exercise overall supervision of the work performed in accordance with this
)
QAP.
4 The Vice President,
- Quality, and the -Vice President,
}
Operations and Engineering shall review and approve this QAP as well as any subsequent changes or modifications thereto.
The Vice Pv.esident, Quality shall appoint auditors:to review j
the application of this QAP to shipments of RAM from.RTI.
l The position of each mentioned individual within the ' RTI-organization are shown in Figure _1.;
The QAP and implementing procedures will be reviewed by the QAPM prior to each shipment.
Changes to procedures, checklists, etc., consistent with the degree of safety control applicable to the imminent shipment will be made as necessary, reviewed 4
internally, and submitted to the Vice President,-Quality and the Vice President, Operations and Engineering, for approval prior to actual use.
The
- QAPM, during actual container loading operations, will resolve any QA and/or safety questions raised by-any member of the loading crew.
The QAPM has the authority to i
cease operational functions whenever there is justifiable cause, only the QAPM, or his representative, may direct continuance of the operation and then only after resolving the cause. for the cessation of activities.
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Page Three RTI QA Program RTI operations personnel may question any point of the QAP and refer this topic to the QAPM for resolution. The RTI quality personnel
- actually performing quality
- assurance
. functions whenever they perceive an act or omission they believe to.be, or is improper, or unsafe, have the authority to halt the immediate operation and refer the, matter to the QAPM for resolution.
RTI personnel, as well as the QAPM, may suggest possible solution (s) to problems, but only the QAPM or his designated representative-may approve a procedural change.
l 2.
Quality Assurance Procram This program includes the. procurement operationaanother owner's (of l testing prior container or cask), handling and use, to use, housekeeping, and return to owner, when applicable.
..As a part of the procurement action, the container owner will be requested to advise the RTI staff on such matters as special tools (specific sizes), equipment, spare parts, special instructions and whether or not the owner's checklists would be made available.
Further, the container owner would be required to furnish the documentation required by 10CFR71 relative to the container.
i Based upon the information received from the container
- owner, implementing procedures, checklists, pre-load testing, loading procedures, pre-shipping checklists,. instructions for i
truck driver, and housekeeping actions will be prepared.
These documents will reflect the safety sensitivity ~: of these topics commensurate with the activity.and form of the RAM to be l
contained in the shipment.
The records to be made of the shipment will be identified.
These records and other documents pertaining - to the shipment shall be filed for retention and' retrieval as required by 10CFR71.
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i Shipment of RAM.as a
regular routine event is not anticipated.
Therefore, each shipment shall be treated as a "new i
or not previously accomplisl ed" task by the RTI staff.
- Hence, 3
the personnel to perform container
- receipt, inspection,
)
operational testing, handling, loading, and-the audit functions 4
will.be selected for each shipment, and trained to accomplish the specific shipment in accordance with this QAP and'its supporting documents prior to the receipt of the shipping' container.
This training program will include instructions on the purpose of the
- QAP, its scope, its implementing documents, a review' of the auditing procedures, and a discussion of the graded approach to l
safety.
i z
-l i
l
s 7 -
Desian Control j
This QA function is aqt included in the RTI QAP at ' this.
time.
If, in'the future,.this activity is to be undertaken, an-amendment to this.QAP will.be prepared and approved through the channels described elsewhere.
l l
4.
Procurement Document Control i
" Procurement" as used in-this QAP means the arranging / rental to use the container-owned by another party.
In this sense, the I
container owner. will be required.to furnish evidence of.'
compliance.with 10CFR71, Subpart H, that he provide the necessary.
documents required by Part 71 and/or the Certificationof a
Compliance for' the containea, and to provide information on tools, equipment, checklists, etc.,- that would facilitate the safe handling and use of the container.
The container owner shall be requested to state the period when the container was designed, fabricated, etc.
If the container has been fabricated after 1 January 1979, the owner shall.be requested to. furnish I
satisfactory evidence that the container was
- designed, fabricated, tested, etc.,
in accordance with an approved QAP.
The requests and receipts will be documented.
5.
Instruction. Procedures and Drawinas l.
Instructions, procedures and drawings will be prepared - and documented for' actions affecting quality. 'These procedures will l
be in sufficient detail to describe the sequence of events essential to achieving the desired. quality objective.
These instructions, procedures, etc.,
will-be reviewed prior to the time of intended usage to insure their applicability.
In arranging for the transportation of the shipping container,~a transportation organization shall be selected who is i
experienced in this phase of the transportation business.and.is recognized as such by possessing all' Federal and State licenses -
and permits.
The unloading procedures shall be the responsibility of the consignee.
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Page Five
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Document Control This QAP and the documents, instructions,' procedures, etc.,
relating thereto shall be controlled to prevent unwarranted changes being made.
Changes to the-QAP shall.be' approved by the Vice President,-Quality and by the Vice President, Operations and Engineering.
The QAPM is - authorized _ to review and change the instructions, procedures, checklists, etc., implementing the QAP.
The QAPM shall maintain a current master list.of applicable documents.
7.
Control ~of Purchased Material,-Eauloment and Services This paragraph is Dg1 applicable to the QAP.
4 8.
Identification and Control Materials.-Parts and Components This paragraph is Dpt applicable to the QAP.
9.
Control of Special Processes i
This paragraph is Dgi applicable to the QAP.
- 10..Inscection Inspections as applied to the design, fabrication, assembly, and proof testing is Dpi a part of this QAP.
Procedures for the conduct-of inspections to verify compliance' with this QAP and its supporting - documents shall be prepared.
Personnel conducting these inspections will not be the same personnel performing the quality assurance actions.
11.
Test Control Testing of containers at RTI shall be limited to that, necesrary to be certain that the container will function satisfactorily while loaded with the RAM being shipped from an RTI facility.
Procedures specifying the tests to be undertaken and the acceptance criteria shall be prepared in advance. of testing.
In the preparation of these test procedures, the pertinent requirements of the package approval will be followed.
. These procedures identify any testing equipment needed, provide for verification of. calibration, and conclude with a statement of test.results obtained.
These test results shall be reviewed and accepted prior to utilization of the shipping - container.
The documentation of'this testing and the results obtained shall be included in the file pertaining to the shipment of the RAM..
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_,,-,.r,
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-Page Six RTI QA Program (Test Control cont).
The operational testing stated or implied herein shall not replace nor negate the testing' required to -obtain NRC/ DOT certification-of the' shipping container.
12.
Control of Measurina and Test EauiDuent Measuring and~ testing shall.be limited to that necessary to verify. the container is ready and safe for use; eg. the drain line is open (not plugged),
the. pressure relief. valve.is functional, etc..
Those items of equipment necessary in the pre-operational testing of a
container will be identified' and calibration maintained to the required
- accuracy, purpose, stability and other conditions affecting the measurement.
13.
Handlina Storace, and ShiDoina Information on special handling, storage and cleaning will be requested of the container owner.
Upon receipt of this information, procedures will be prepared on these topics, on the loading of the cask and on shipping requirements.
Particular attention will be given to advance agreement on the receipt of the RAM, and on advance notification of the actual shipment.
These procedures will include steps of coordination with local i
and State officials as necessary.
These procedures will identify the shipping papers and special notices, if any, to be placed
- thereon, and a reference to pertinent NRC and DOT shipping regulations.
14.
Inspection. Test and Operational Status Markings, tags, labels, etc.,
affixed to the container by its owner.to show evidence of satisfactory testing and operational status will not be removed or obliterated.
4 Marking, tags, labels, etc., required by tests accomplished by the operations and engineering staff shall - be attached in accordance with RTI' procedures.
The QAPM has the authority to j
omit tests of components that are not required by the RAM being shipped.
15.
Non-Conformina Materials ~ Parts or Components Procedures will be prepared,as necessary,-
for the identification, documentation, tagging and segregation,.
and notification of the container owner of the non-conforming a
materials, parts and/or components.
The maintenance of the shipping container shall remain the responsibility of the container owner.
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1 Page Seven j
I 16.
Corrective Action The QAPM has the authority to. cease operations and/or institute corrective actions whenever he deems the working conditions are. adverse or inimical' to the ' achievement of the requisite safety controls applicable-to the current shipment.
Necessary corrective action shall be accomplished prior to the use ' of any container and/or prior to the continuance of procedure during which a
deficiency, deviation, etc.,
-is recognized.
The deficiency, etc., and the requisite corrective action shall be documented.
17.
Quality Assurance Records All records shall be retained for a period of 2 years, after the shipment and.readily retrievable.
These records shall
~
include the QAP, implementing procedures, checklists, results of
- tests, copies of shipping papers, results of inspections and audits - with deficiencies noted and corrective actions taken, l
procurement actions,-and non-conformance reports.
I 18.
Audits Audits of the RTI QAP will occur prior to and shortly after the-shipment.
Beforehand, the audit will be concerned with the preparation and planning for the - shipment to - ~ be certain the appropriate degree of safety control has been. identified and adequately considered; that the necessary documents, procedures, checklists have been properly completed on a timely basis.
After
~
the shipment, the audit objective will be to make certain the-records have been properly completed, assembled, and prepared for storage.
Personnel to accomplish these audits will not be selected from the individuals who performed the safety-related functions.
i Written procedures and/or checklists will be prepared to assure a= thorough checking and-verification of the actions'being i
audited.
The results of the audits will be given to the President, Vice President,
- Quality, the Vice President, Operations and Engineering, and the QAPM.
Deficiencies will be corrected 'before proceeding with the loading operation or the storage of records.
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e Page Eight
-RTI QA Program 19.
APPROVAL OF PROGRAM The RTI Quality Assurance Program (QAP) will be approved by the Vice President of Quality, Vice President of Operations and Engineering and shall be submitted to Director, Office of Nuclear Safety and Safeguards, U.S.
Nuclear Regulatory-commission, Washington, DC 20555.
Commission approval is required prior to the use of any package for the shipment of licensed material.
FIGURE 1.
BOARD CHAIRMAN SMITH PRESIDENT, CEO LEVITT l
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-s i
V.P. OPERATIONS /
V.P. SALES EXECUTIVE V.P.
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- y. P. QUAuTY SHAPIRO ORLANDER SADEK V
S FINANCE DIR. ENGINEERING jR
- -ACCOUNTING VACANT ROSS
- CORP. DEV.
-, PTI (NC)
BURGESS PTI (AR)
HALL SJPTI RUSSEN i
ROCKAWAY OPERATIONS MANAGER *
- CONSTANTINE SUPEbkfkNDENT SItiGLETON
- CERTIFIED OPERATORS
- TRAINEES
- Responsible Individuals j
- Pending NRC Approval j
MATERIAL
_MANDLERS
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