ML20148G469
| ML20148G469 | |
| Person / Time | |
|---|---|
| Site: | 07100420 |
| Issue date: | 01/06/1988 |
| From: | Shapiro P, Varaklis T RTI, INC. (FORMERLY RADIATION TECHNOLOGY, INC.) |
| To: | |
| Shared Package | |
| ML20148G190 | List: |
| References | |
| 3.12.ORIG, NUDOCS 8803290157 | |
| Download: ML20148G469 (13) | |
Text
- - - - -
RadiationTechnology,Inc, Procedure ProcessTechnology Subsidiaries FacMiy CORPORATE M ALITY ASSURANCE 1
o,12 Section/ Number / Revision
Subject:
QUALITY ASSURANCE PROGRAM 3.12. ORIG FOR SHIPPING RADIOACTIVE MATERIAL Effective Date:
p January 6,
1988 s
S IkPh 0 AUL O SNA I N
LS L
1.O PURPOSE To establish the Quality Assurance Program (QAP) for the procurement, use, handling and returning of shipping containers for redioactive material (RAM) in accordance with all pertinent laws.
2.0 SCOPE Applies to all R.T.I.
and P.T.I.
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 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.
3.0 REFERENCES
3.1 10 CFR 71 4.O 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 requirements."
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.
8803290157 080107 PDR ADOCK 07100420 C
PDR R111001 Instructions Not Written are instructions Not Given
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Pige CORPORATE QUALTIY ASSURANCE 2'
12 Subiect.
Sectron Number F4evision QUALITY ASSURANCE PROGRAM 3.12. ORIG FOR SHIPPING RADIOACTIVE MATERIAL git ci,,, o,i,.
January 6,
1988 5.0 EOUIPMENT 5.1 RTI Procedure 9.401 current revision "Shipping type B
packages of Cobalt 60 Sources" and its checklists.
5.2 RTI Procedure 9.402 current revision "Loading / Unloading of AECL F-168 Shi.pping Container".
6.0 SAFETY REOUIREMENTS 6.1 All personnel involved will be trained 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.
7.0 PROCEDURE 7.1 Radiation Technology, 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 submit the QAP, and/or changes, etc., to the RTI staff for review and approval.
The QAPM is responsible for 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.
7.3 The 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.
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Pace CORPORATE QUALTIY ASSURANCE 3'
12 subieci.
secuon Numon nemion QUALITY ASSURANCE PROGRAM 3,12.OnIG FOR SHIPPING RADIOACTIVE MATERIAL gn,ci,,, o,,,,
January 6, 1988 7.O PROCEDURE (conti.
I 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.
[
7.6 The QAP and implementing procedures will be reviewed by the QAPM prior to each shipment.
Changes to procedures, checklists, etc.,
will be made as necessary, reviewed internally, and submitted to senior management 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 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.
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.
7.8.2 The container owner will be required to furnish the documentation required by 10 CFR 71 relative to the container.
7.8.3 Implementing procedures, checklists, pre-load
- testing, loading procedures, pre-shipping checklists, instructions for truck
- driver, and housekeeping actions will be prepared.
QEy Orpirtment:
Pr,;e CORPORATE QUALTIY ASSURANCE 4 "'
12 subiect 5" b o" N ""*" "" o" QUALITY ASSURANCE PROGRAM 3.12. ORIG FOR SHIPPING RADIOACTIVE MATERIAL eneet,a o.,,
January 6, 1988 7.0 PROCEDURES (cont).
7.8.4 Required-records will be identified.
These records-and other documents pertaining to the shipment shall be filed for retention and retrieval as required by 10 CFR 71.
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 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 af fecting quality.
These procedures will be in sufficient detail to _ desct.'.be 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 shall 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 by senior management.
The QAPM is authorized to review and change the instructions, procedures, checklists, etc.,
implementing the QAP.
7.13.2 The QAPM shall maintain a current master list of applicable documents.
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- '.OP.10 FOR SHIPPING RADIOACTIVE MATERI AL i n,c n,, o,i, January 6, 1988 7.0 PROCEDURE (cont).
7.14 Control of Purchased Material, Equipment and Services Is not applicable to the QAP.
7.15 Identification and Control Materials, Parts and Components This paragraph is not applicable to the QAP.
7.16 Control of Special Processes This paragraph is not applicable to the QAP.
7.17 Inspection Inspections as applied to the design, fabrication, 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 safe for use.
7.20 Handling, Storage, and Shipping 7.20.1 Information on special handlir.g,
storage and cleaning will be requested of the container owner.
7.20.2 Upon receipt of this information, procedures will be prepared on these topics, on the loading of the cask, and on the shipping requirements.
Particular attentic,a will be given to advance agreement on the receipt of the RAM, and on advance notification of the actual shipment.
7.20.3 Coordination with local and State officials will be done as necessary.
7.20.4 Shipping papers, special notices, if any, and a reference to pertinent NRC and DOT shipping regulations will be identified.
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QUALTIY ASSURANCE C
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s <m,n w,,t,e. u m oc QUlsLITY ASSURANCT PROGRAM
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.ORIC FOR SHIPPING RADIOACTIVE MATERIAL
'uteuive one January 6, 1988
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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-conforming 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 tne 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 the shipment.
7.24.2 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, procurement
- actions, and non-conformance reports.
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Page CORPORATE
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QUALTIY ASSURANCE 7 *'
12 SubMct.
Sec tionz Number / Remion QUALITY ASSURANCE PROGRAM 3.12. ORIG FOR SHIPPING RADIOACTIVE MATERIAL gir,et,y oai, January 6, 1988 7.O PROCEDURE (cont).
7.25 Audits 7.25.1 Audits of the QAP will occur shortly after the shipment.
The audit cbjective will be to assure the records have been properly completed, assembled, and prepared for storage.
7.25.2 Personnel to accomplish these audits will not be selected from the individuals who 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, the Vice President Operations and Engineering, and the QAPM.
7.25.4 APPROVAL OF PROGRAM The RTI Quality Assurance Program Procedures (QAP) shall be submitted to Director, Office of Nuclear Safety and Safeguards, U.S.
Nuclear Regulatory Commission, Washington, D.C.
20555.
Commission approval is required prior to the use of any package for the shipment of licensed material.
8.0 EXHIBITS A
Quality Assurance Checklist B
Cask Procurement Checklist C
Pre Shipment Checklist D
Pre Opertions Checklist E
Receiving / Shipping Checklist 3
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N CORPORATE QUALTIY ASSURANCE.
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s,c i,on m.mne, s....m,c QUALITY ASSURANCE PROGRAM 3.12. ORIG FOR SHIPPING RADIOACTIVE MATERIAL unecim Date.
January 6, 1988 EXHIBIT A QU;,LITY ASSURI NCE CHECFL:ST for SHIPTING RADIOACTIVE - MATERI AL This program details the operations concerning the movement of cobalt from tne facility in compliance to the requirements of the program format' submitted to the NRC on 1
OA Program Manager is
References:
i 100TR.71.10~ Subpart H - Quality Assurance RT1 Quality Assurance Program dated rr>wa v...
r,)
I 2.
g Applicable procedures:
9.301.E dated 1/7/S7 "Calibration and Use of the Counter Scaler".
9.302.A dated 10/1/86 "Water Sampling and Analysis".
- 9. 3 03. A dated 10/1/86 "Radiation Surveys".
9.304. orig. dated 10/1/86 "Contamination Test of inside of Shipping Containers".
9.401.crig. dated 11/5/86 "Shippine T.v.o e 5 Pachac.es cf 00-60 Sources" ( N d-
12)
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9.4C2. orig. dated 1/19/E7 "Loading /Unicading cf J.ICL F-l 16E Shipping Centainer" (E::hibit 2)
QA Auditer is 1
Applicable checklists:
Cash Procurement (pace 2)
Pre-Shipnent (page 2)
Pre Operations (page 4)
Receiving / Snipping (page E)
User Checheff Sheet, see Proc. 9.40; Approvals:
T. Varahl:.s V.F.
Datt F.C.
SnapLrc V.7.
Date RTI 1002
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Subject:
Section/ Number / Revision QUALITY ASSURANCE PROGRAM 3.12.OPIG FOR SHIPPING RADIOACTIVE MATERIAL
[g;ggi,g January 6, 1988 EXHIBIT B Cask Procurement Checklist
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Page CORPORATE QUALTIY ASSURANCE 10 *' 12 Suciect:
Section/ Number / Revision -
QUALITY ASSURANCE PROGRAM FOR SHIPPING RADIOACTIVE MATERIAL 3.12. ORIG-gitectiv, o,,,:
January 6, 1988 EXHIBIT C Pre-cnipment enecklist
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2 Implementing procedures 2-Checklists 3-Pre-load testing 4-Loading proceddres S-Instructions for truck criver 6-Housekeeping actions Training of personnel Names of personnel trained Reviewed and approved by QA Program Manager date l
Reviewed by Auditor date_
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Page CORPORATE QUALTIY ASSURANCE 11 of 12
Subject:
Cection/ Number / Revision QUALITY ASSURANCE PROGRAM
~~
3.12. ORIG FOR SHIPPING RADIOACTIVE MATERIAL E:tective oate?
~~
January 6, 1988 EXHIBIT D ore-operat; ens One:r..si Equipment Calibrated ionizatien chamber Cclibrated su:n/ey instrunent wrenenes socnets crane witn proper slings under water lign:s disposable gloves survey swipes swipe envelopes radioactive materials instruction anc sn:.pping terms vehicle survey for security seals self reading pocket dosimeters (at least two) film badges (one per person) shipping lacels and placards special icng handled tecis crivers certification to transpcrt ran_cact:,ve materini Reviewed by Auditor date
5-A' Facility:
Department:
Page CORPORATE QUALTIY ASSURANCE 12 12
Subject:
SGCllon/ Number / Revision QUALITY ASSURANCE PROGRAM 3.12. ORIG i
FOR SHIPPING RADIOACTIVE MBTERIAL ett,ets,e o,te:
January 6, 1980 EXHIBIT E l
Receiving / Shipping checklist
]
(for receipt of cobalt) prior to placing cask in the pool:
measure external surface radiation of cask swipes taken on external cask surface pool water sample taken and analyzed 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 from pool:
raise the cask to within two feet of water surface radiation monitor acceptable rinse outside of cask and allow to drain into pool replace plugs and bolt cover replace protective jacket measure surface dose rate take swipes over surface secure cask measure dose rate at 1 meter measure doso rate in cab of truck __
measure dose rate around the outside of - the truck and record the highest reading complete shipping papers l
remove old labels and tags as required attach new required labels QC Audit performed by:
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