ML20033F942
| ML20033F942 | |
| Person / Time | |
|---|---|
| Site: | 07100420 |
| Issue date: | 04/02/1990 |
| From: | Schlecht J, Shapiro P RTI, INC. (FORMERLY RADIATION TECHNOLOGY, INC.) |
| To: | |
| Shared Package | |
| ML20033F936 | List: |
| References | |
| 3.12A, NUDOCS 9004040103 | |
| Download: ML20033F942 (12) | |
Text
Proc @dur@
Rcdiatisn Tcchnsisgy, ince Proc ss Tcchnsisgy Subsidiarics Facil6ty; Department:
Pope CORPORATE QUALITY ASSURANCE 1
12 i
Sect 6en/ Number /Rev6e60n
Subject:
l 3.12 A QUALITY ASSURANCE PROGRAM Ettoct6ve Date:
FOR SHIPPI,NG RADIOACTIVE MATERIAL APRIL J,,
1990 y
Approved Techn6cally Approved By Quality C
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q 1.O PURPOSE To establish the Quality Assurance Program (QAP) for the procurement,
- use, handling and returning of shipping containers for radioactive material (RAM) in accordance with all pertinent laws.
2.0 SCOPE Applies to all RTI and PTI facilities shipping or receiving Type B
packages of Cobalt 60 for gamma irradiators.
Applicable to containers owned by another party and for which RTI is an authorized user.
Safety controls will be applied to each container and to each shipment through procedurcs, special checklists, other necessary documents and training, to the degree required, to assure the safety of each shipment.
3.O REFERENCES 3.1 10 CFR 71 4.0 DEFINITIONS 4.1
" Quality Assurance" (as defined in 10 CFR 71, subpart H) - 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 j
requirements."
RTI personnel, (the Operations and Engineering
- staff, the Quality
- staff, and other personnel assisting in each shipment of RAM) will assure that all shipments from RTI facilities are mede in a
safe manner and comply fully with existing regulations.
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APRIL 2, 1990 5.0 EQUIPMENT 5.1 Current RTI Procedure for shipping container being used.
5.2 Appropriate checklists.
~f 5.3 Information on special handling, storage and cleaning l
of the container from the owner.
6.O SAFETY REOUIREMENTS 6.1 All personnel involved will have documented training to safely accomplish the specific task.
6.2 All personnel involved shall be equipped with film badges.
6.3 At least 2 people involved will have self-reading dosimeters.
7.O PROCEDURE 7.1 RTI Inc.
through its Corporate Quality Department, shall retain and exercise responsibility for the QAP applicable to the containers in which RAM will be shipped.
7.2 A QA Program Manager (QAPM) shall be designated.
The QAPM is responsible for preparing the QAP, making changes, additions or modifications as necessary and to a
j submit the QAP, and/or changes, etc., to the RTI staff for review and approval.
The QAPM is responsible for i
l preparing supporting documents to the QAP, such as procedures, checklists, etc.
These supporting documents shall be reviewed by the RTI staff, and when appropriate, shall be, approved by the QAPM.
The QAPM shall supervise the operations performed under this plan.
i 7.3 The facility or corporate Radiation Safety Officer will exercise overall supervision of the work performed.
7.4 Senior management shall review and approve the procedure and any subsequent revisions.
7.5 Quality will appoint an auditor to audit all shipment records.
The auditor will not participate in the
- receipt, inspections,
- loading, or preparation for shipment activities.
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7.6 The-QAP and implementing procedures will be reviewed by i
the QAPM prior to each shipment.
Changes to procedures, checklists, etc.,
will be made as i
necessary, reviewed internally, and submitted to senior management for approval prior to actual use.
The QAPM, during actual container loading operations, will
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resolve any QA and/or safety questions raised by any j
member of the loading crew.
The QAPM has the' authority to cease operational functions whenever there is justifiable cause.
Only the,QAPM, or his J
representative, may direct continuance of the operation and then only after resolving the cause for the cessation of activities.
7.7 RTI Operations personnel may question any point of the QAP and refer this topic to the QAPM for resolution.
The RTI quality personnel, whenever they perceive an act or omission they believe to be 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.
7.8 Quality Assurance Program 7.8.1 This program includes the procurement, handling and use, operational testing prior to use,' housekeeping, and return to owner, as applicable.
I 7.8.2 The container owner will be required to l
furnish the documentation required by 10 CFR 71 relative to the container.
I 7.8.3 Implementing procedures, checklists, pre-load
- testing, loading procedures, pre-shipping checklists, instructions for truck driver, p
and housekeeping actions will be prepared.
7.8.4 Required records will be identified.
These records and other documents pertaining to l
shipment shall be filed for retention and retrieval as required by 10 CFR 71.
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7.O PROCEDURE (CONT) 7.8.5 All personnel involved in moving cobalt will have received documented training to cover, as appropriate, the purpose of the QAP, its scope, documentation requirements, review of
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audit procedures,
- safety, operational procedures, container
- receipt, inspection, operational testing, handling, loading, and audit.
7.9 Design control is not applicable.
.7.10 Procurement Document Control.
The container owner will be required to furnish evidence of compliance with 10 CFR 71, subpart H.
7.11 Instruction, Procedures and Drawings.
Instructions, procedures and drawings will be prepared and documented for actions affecting quality.
These procedures will 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.
7.12 The unloading procedures sha u be the responsibility of the consignee.
7.13 Document Control' 7.13.1 This QAP and the documents, instructions, procedures, relating thereto shall be controlled to prevent unwarranted changes being made.
Changes to the QAP shall be approved byg senior management.
The QAPM is
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authorized to review and change the L
instructions, procedures, checklists, etc.,
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implementing the QAP.
j 7.13.2 The QAPM shall maintain a current master list of applicable documents.
y 7.14 Control of Purchased Material, Equipment and Services Is not applicable to the QAP.
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APRIL 2, 1990 7.O PROCEDURE fCONT) 7.15 Identification and Control Materials, Parts and Components This paragraph is not applicable to the QAP.
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-T' 7.16 Control of Special Processes This paragraph is not applicable to the QAP.
7.17 Inspection Inspections as applied to the design, fabrication, i
assembly, and proof testing is not a part of this QAP.
7.18 Test Control.
All tests necessary to assure that the container functions properly while loading will be performed.
7.19 Control of Measuring and Test Equipment shall be-limited to that necessary to verify the container is ready and scfe for use.
7.20 Handling, Storage, and Shipping i
7.20.1 Information on special handling, storage, and cleaning will be requested of the container owner.
7.20.2 Upon receipt of this information, procedures 4-will be prepared on the loading of the cask and shipping requirements.-
Particular 1
attention will be given to advance agreement on the receipt of the RAM, and on advance notification of the actual shipment.
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's 7.20.3 Coordination with local and State officials will be done as necessary.
7.20.4 shipping papers, special notices, if any, and b
a reference to pertinent NRC and DOT shipping regulations will be identified.
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7.0 PROCEDURE (CONT) 7.21 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.
7.22 Non-Conforming Materials, Parts or Components Procedures will be prepared, as necessary, for the identification, documentation,
- tagging, segregation, and notification of the container owner of the non-confirming materials, parts and/or components.
The maintenance of the shipping container shall remain the responsibility of the container owner.
7.23 Corrective Action 7.23.1 The QAPM has the authority to cease operations and/or institute corrective actions whenever it is deemed the working conditions are adverse to the achievement of the requisite safety controls.
7.23.2 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.
7.24 Quality Assurance Records 7.24.1 All records shall be retained and readily retrievable for a period of 2 years after shipment.
7.24.2 These records shall include the
- QAP, procedures, checklist results of tests, copies of shipping
- papers, results of inspections and audits with deficiencies noted and corrective actions
- taken, procurement
- actions, and non-conformance reports.
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7.O PROCEDURE fCONT) 7.25 Audits 7.25.1 Audits of the QAP will-occur shortly after
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the shipment.
The audit objective will be to l
assure the records have been properly-
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completed, assembled, and prepared for
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storage.
7.25.2 Personnel to accomplish these audits ~will not be selected from the individuals who i
performed the safety-related functions.
7.25.3 Written procedures and/or checklists. will be prepared to assure a thorough checking and verification of the actions being audited.
The results of the audits will be given to the President, the Vice President Quality, and Vice President Oporations-and Engineering, and the QAPM.
7.25,4 APPROVAL OF PROGRAM
.i The RTI Quality Assurance Program Procedures (QAP) shall be subsitted to Director, Office of Nuclear safety and Safeguards, U.S.
l Nuclear Regulatory Commission, Washington, t
D.C.
20555.
Commission approval is required l
prior to tha use of any package for the f
shipment of licensed material.
8.0 EXHIBITS A
Quality Assurance Checklist B
Cask Procurement Checklist Pre Shipment Checklist;t C
Pre Operations Checklis D
E Receiving / Shipping Checklist lL l
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APRIL 2, 1990 EXKIRIT A OUA1. TTY ASSURANCS CICSCKLIST e
for SHIPFING RADICACTIVE MATERIAL of This program details the operations conoorning the movement facility in compliance to cobalt from the _
I the requirements of the program format submitted to the NRC on QA Program Manager is Reiarenoest10CFR.*ll.101 Sutpart M - Quality Assurance RTI Quality Assurance Program dated (Exhibit 61)
Applicable procedures 9.302 current revision
- Water Sampling and Analysis".
9.304. current revision
- Contamination Test of Inside of Shipping Containers *.
9.402. current revision
- Loading /Unionding of AECL F 168 Shipping Container" (Exhibit t3) 9.403. current revision
- Loading /Unionding of GE Model No.'1500 shipping Container *.
10.103 current revision dated 11/10/88
- Calibration and Vee of Counter Scaler".
QA Auditor is Applicable checklistst Cask Procurement (page 2)
Pre-Shipment (page 3)
Pre-operations (page64)
Receiving / Shipping (page 5)
User checkoff Sheet, see Proc.
9.40 or 9.403, i
whicheve.r is applicable.
I Approvals:
J. schlecht RSO Date P.O. Shapiro V.P.
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t Cask Procurement checklist j
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Cask procured fros l
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Container owner supplied informat.non ont a - special instructions b - owners chooklist supplied l
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Document required by 10CTR71 oupplied (certification of Compliance for container) 4.
Advance notification requirements completed a-notification to Governor or designee of l
each State the material is to pass through.
State Date State Date State Date i
State Date b-notification made by mail messenger e-name of individual notification made to:
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- Name, Address, Tele Number of shipper, carrier, and receiver. phone i
i description of material, shipping times i'
point of conteet ior current shirring info.
5.
State Licenses obtained:
I a-free b-via phone mail in person t
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erane with proper slings under water lights disposable gloves j
i survey swipes swipe envelopes radioactive materials iner metion and shapping forms vehicle survey fors I
security esals self reading pocket dosimeters (at least two) film badges (one per person) shipping labels and placards special long handled tools arivers certification to transport radioactive material t
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APRIL 2, 1990 EXEinTT 1 Receiving / shipping checklist (for receipt of cobalt) prior to placing cask in the pools measure external surfmoe radiation of cask swipes taken on arternal cask surfmoe pool water sample taken and analysed pool area radiation levels checked vent and drain plugs removed from cask level of pool water lowered cask washed to remove dirt when removing cask fros pools raise the cask to within two feet of water surface radiation monitor acceptable rinse outside of oask and allow to arain into pool replace plugs and bolt cover replace protective jacket measure surfaos dose rate take swipes over surfmoe escure cask measure dose rate at a meter i
measure dose rate in cab of truck l
measure dose rate around the outside of the truck and record the I
highest reading l
complete shipping papers remove old labels and tags as required attach now required labels QC Audit performed bys on k
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