ML19259A844
| ML19259A844 | |
| Person / Time | |
|---|---|
| Site: | 07100173 |
| Issue date: | 12/22/1978 |
| From: | Richmond W Battelle Memorial Institute, PACIFIC NORTHWEST NATION |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 7901110073 | |
| Download: ML19259A844 (11) | |
Text
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7/~d/73 0Ba11elle P3cil;c No thwes' Laboratories December 22, 1978
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14r. Charles E. fiacDonald, Chief 2
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ED Office of Nuclear Materials Safety 86 and Safeguards Te Nuclear Regulatory Commission Washington, DC 20555 s
Dear Mr. MacDonald:
QUALITY ASSURANCE PROGRAM FOR SHIPPING PACKAGES OF RADI0 ACTIVE MATERIAL Enclosed are six copies of our Quality Assurance Program Description for Shipping Packages of Radioactive Materials. This Quality Assurance Program is a revision of the plan we submitted to you June 30, 1978. Since the Pacific Northwest Laboratories will not be: 1) shipping high level waste;
- 2) irradiated fuel; 3) plutonium in excess of the amounts listed in Part 150 of 10 CFR; or 4) designing and fabricating radioactive material packages, we feel that only nine of the eighteen points listed in Appendix E, Part 71 of Title 10 of Code of Federal Regulations, need to be addressed.
We request, therefore, that you review this revised plan for acceptability rather than the one submitted to you in June.
Any questions you might have regarding the program description, should be directed to John Taylor. His phone number is 509-946-2811.
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W. D. Richmond, Director UMRC Operations and Services y'.
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4 QUALITY ASSURANCE PROGRAM DESCRIPTION FOR SHIPPING PACKAGES OF RADI0 ACTIVE MATERIAL O
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Pacific Northwest Laboratory Richland, Washington 99352
RECORD OF REVISI0tlS Approved ulltO[
/2-2z-7e Directo", Operations and Services Date xM9 WlM I'79 As gt Dire $or f4r Program Support Dato Manual Purpose For Date Revision No.
Revision Released 0
Initial issue 6/28/78 1
To revise scope and reflect the requirements 12/22/78 of December 1978 revision of the PflL QA Manual, PNL-MA-65 ii
SUMMARY
The Pacific Northwest Laboratory's (PNL) quality assurance program for shipping packages of radioactive material, is described. The purpose of the report is to describe how PNL will comply with the Code of Federal Regulations', Title 10, Part 71, Appendix E.
In compliance with the instructions from the Nuclear Regulatory Commission (NRC), the applicable criteria from Appendix E are covered.
iii
TABLE OF CONTENTS Item Paae No.
Cover Page i
Record of Revisions ii Summary iii Table of Contents iv Introduction 1
I Organization
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2 II Quality Assurance Programs 2
III Procurement Control 4
IV Doucment Control 4
V Control of Measuring and Test Equipment 5
VI Handling, Storage and Shipping 5
VII Inspectior. Test and Operating Status 5
VIII Quality Assurance Records 6
IX Audits 6
iv
QUALITY ASSURNACE PROGRAM DESCRIPTION FOR SHIPPING PACKAGES OF RADI0 ACTIVE MATERIAL INTRODUCTION The Pacific Northwest Laboratory (PNL), which is operated by Battelle Memorial Institute, will make radioactive material shipments in complf.ance with Code of Federal Regulations, Title 10 (10 CFR), Part 71.
The quality assurance program su=narized in the following sections is provided by the Manager, Quality Assurance Office, who reports to the Assistant Director for Program Support. This QA program covers shipments of radioactive material that do not include high-level waste, irradiated fuel, or plutonium in excess of the amounts listed in Part 150 of 10 CFR.
DATE ISSUCD:
SUPERSEDES PNL 2686 ISSUE DATED:
12/22/78 6/30/78 Paas 1 of 6
I ORGANIZATION The Pacific Northwest Laboratory (PNL) has a Quality Assurance Office that is responsible for developing the quality assurance program for PNL, assisting in its implementation, and auditing for compliance. An organiza-tion chart (Figure 1) shows the relationship of the Quality Assurance Office with other PNL components.
The Transportation Safety Officer, who is associated with the Safety and Nuclear Materials Management Section, is responsible for the training and qualification, document control, inspection, and auditing activities associated with controlling radioactive material shipments.
He has the authority to stop any shipment of radioactive material that does not meet regulations.
He works with the Quality Assurance Office to maintain the documents relating to purchase of specification containers, inspection, and test results.
He also interacts with representatives from the Quality Assurance Office and the Radiation Standards and Engineering Section concerning audits.
II QUALITY ASSURANCE PROGRAM The PNL quality assurance program is administered by the Manager, Quality Assurance Office, and the overall quality assurance program for shipment of radioactive materials is documented in company management guides and manuals.
These guides and manuals provide the procedures by which training, controls, and surveillance, inspection, tests and reviews, are accomplished. These guides and manuals emphasize controlling the package characteristics that are critical to safety.
DATE ISSUED:
SUPERSEDES PNL-2686 12/22/78 ISSUE DATED:
6/30/78 PAGE 2 of 6
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. SSISTANT DIRECTOR OPERAil0N gg ADMINISIRAll0N DiltlCTOR FOR PROGRAM AND 9m SUPPORT SERVICES m
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D' PROCUREMENT QUALITY ASSURANCE NUCLEAR STANDARDS RESEARCll SAFETY AND RADIATION 00,ARIENT DEPAlliKNT OfflCE MANAGER MA1ERIAL AND M NAGERS MANAGEMENT
[NGIN[ERING DEPARIM(NI IIADIAil0N j
MATERI AL SillPPING SAIElY offICEll TRANSI'ORTAll0N ntPHE5[NIATIVES
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Organization Cliart for tlio l'acific florthwest Laboratory
The Transportation Safety Officer ensures that all radioactive material shipping packages, designed or fabricated after December 31, 1978, are designed and manufactured under a quality assurance program consistent with the above guides and manuals and approved by the Nuclear Regulatory Commission (NRC).
This requirement can be satisfied by receiving a certification to this effect from the manufacturer.
The Pacific Northwest Laboratory will not design and fabricate radio-active material shipping packages.
III PROCUREMENT CONTROL Procurement activities will be planned, documented and performed in accordance with the PNL Procurexent, Quality Assurance, and Radioactive Materials Shipping Manuals.
IV DOCUMENT CONTROL Management shall ensure that controlled documents are prepared, reviewed, and approved for use.
In addition, management shall ensure that the documents are distributed and used at the location where the prescribed activity is perfo rmed.
Changes in released documents will be subject to the same controls as those applied to the original documents. The same organizations that performed the original review and approval shall review and approve all changes.
The Transporthtion Safety Officer shall ensure that all radioactive material shipments are conducted in cccordance with the latest applicable changes to these controlled documents.
DATE tSsUED:
SUPERSEDES PNL 2686 ISSUE DATED: 6/30/78 12/22/78 PAGE 4 of 6
V CONTROL OF MEASURING AND TEST E0UIPMENT Instrumentation used to inspect new packages on receipt and before shipment, will be controlled in accordance with the PNL Quality Assurance Manual.
VI HANDLING, STORAGE AND SHIPPING Written procedures for handling, storing and shipping radioactive materials will be followed. Shipments will not be made until it has been determined that the container: 1) has a current certificate of compliance;
- 2) has been inspected and released; 3) has been packaged according to written procedures, if appropriate; and 4) has packaging records compidted for future filing.
The radioactive material shipping representative from each department shall perform the critical handling, storing and shipping operations. Before the shipment is released, the Transportation Safety vi.icer shall make final inspection of the packaging. The Transportation Safety Officer shall sign a certification indicating that the shipment meets all applicable regulations.
VII INSPECTION, TEST, AND OPERATING STATUS Inspection, testing, and operating status of packages will be indicated e
and controlled by written procedures.
Status will be indicated by tag no package will be used unless an ACCEPT tag has been attac: 'd.
The Transporta-tion Safety Officer shall ensure that the container is approved for use and that the status indicators are properly applied.
The handling and status indication of noncomforming parts or packages will be controlled in accordance with the PNL Quality Assurance Manual.
DATE ISSUED:
SUPERSEDES PNL 2686 12/22/78 ISSUE DATED:
6/30/78 PAGE 5 of 6
VIII QUALITY ASSURAtlCE RECORDS Records of package approval, procurement, inspections, tests, audit results, personnel training and qualifications, and shipments will be main-tained. These records will be identifiable and retrievable. An index of the records, indicating storage location, shall be maintained by the Transportation Safety Office.
IX AUDITS
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Periodic and scheduled audits will be performed to verify the program's effectiveness. The audits wi.ll. be performed by the Quality Assurance Office and other organizations that have no responsibility in the activity being audited.
The audits will be performed using written checklists, and the findings and appropriate corrective action will be documented. Copies of the audit report wi?1 be provided to the responsible managers. Audit personnel shall perform followup action to ensure that designated corrective action has been adequately performed.
DATE ISSUED:
sU?ERSEDEs PNL.2686 12/22/78 ISSUE DATED; 6/30/78 PAGE 6 of 6
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