ML19254F347
| ML19254F347 | |
| Person / Time | |
|---|---|
| Site: | 07000190, 07100190 |
| Issue date: | 08/03/1979 |
| From: | TEXAS INSTRUMENTS, INC. |
| To: | |
| Shared Package | |
| ML19254F346 | List: |
| References | |
| NUDOCS 7911090093 | |
| Download: ML19254F347 (13) | |
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TEXAS INSTRUMENTS INCORPORATED (TI)
QUALITY ASSURANCE PROGRAM FOR THE PACKAGING OF USNRC/ DOT LICENSED CONTAINERS w.
AUGUST 3, 1979 O
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TABLE OF C 'NTENTS Foreward....................i Introduction................l w~
Plan.......................
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TI HFIR PROJECT QUALITY ASSURANCE PROGRAM FOR THE PACKAGING OF USNRC/ DOT LICENSED CONTAINERS Foreward 9
These statements present Texas Instruments Incorporated's (TI) Quality Assurance Program for packacing radioactive materials when packages are to contain 235U in quantities greater than exempted by 10 CFR 71.7.
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5R _
Prepared by:
S.
Roman Mgr., HFIR Quality
.issurance
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..pproved by:
th F.L.
Sherman Mgr., HFIR Project 1301 261
- i-
E.N.
79-60 TI HFIR PROJECT Page 1 9/28/79 QUALITY ASSURANCE PROGRAM FOR THE Rev. A PACKAGING OF UONRC/ DOT LICENSED CONTAINERS
==
Introduction:==
- Containers to be used for packaging of fissile radioactive material prior to shipment by the customer are customer supplied, certified to be in proper physical repair, and are NRC/ DOT approved for use in the transportation of the intended contents.
Only specific and physically discrete items (e.g., powder metallurgic compacts, aluminum clad fuel plates, research reactor fuel elements, and leak-tight plastic bottles of U 0 ) are packaged by the HFIR Project for shipment.
38 As such, the entire quality assurance plan for transportation packages is dependent upon:
1.
Customer supplied " Certified for Use" containers.
2.
HFIR Project Quality Assurance assuring that customer supplied certification is available prior to each packaging.
3.
HFIR Project procedural control of visual and functional-ity examinations throughout the packaging process.
4.
HFIR Project Quality Assurance reviewing that procedural controls were executed.
5.
HFIR Project Quality Assurance supplying a certification to the customer that the containers received and utilized in packaging were " certified for use" by the customer and that the visual and functionality examinations rere accomplished in accordance with established procedures for each container type.
- The quality assurance of procurement of materials, adequacy for intended use, fabrication, and maintenance of containers is the responsibi.lity of the U.S.D.O.E.
contractor, HFIR Project customer, in :ncordance with appropriate U.S.D.O.E. quality assurance plano for packages as approved by U.S.N.R.C.,
Docket Number 71-0203.
1301 262
E.N.
79-60 Page 2 9/23/"9 Rev. A I.
Orcanization 1.
the HFIR Project of Texas Instruments Incorporated retains anu exercises the responsibility for the " Texas Inst aments Incorporated HFIR Project Quality Assurance Program for the Packaging of US NRC/ DOT Licensed Containers" (TI QAPP).
2.
The QA/QC functions performed by various HFIR Project organizations are:
QA - Responsibility for TI QAPP for conformance to 10 CFR Part 71, Appendix E criteria.
4
- Initiate changes in TI QAPP.
- Initiate procedures to carry out TI QAPP.
- Approves Proccdures.
- Reviews procedures for corrections and initiates corrections as required.
- Assures proper " certifications for use" for as received containers.
- Provides releases for conformance to requirements.
QC - Follow written instructions (route cards).
- Identify non-conformance and initiate Quality Control Inspection Notice (QCIN).
- Provide records of inspections as directed.
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HFIR Project Engineering:
- Author procedures (route cards) for implementing TI QAPP.
- Review non-conformance and determine correct activity and record on QCIN.
- Request containers and required certifications.
HFIR Project Nuclear Safety:
- Ini_ late procedures necessary to assure proper labeling and contamination / radiation control of containers.
- Comply with written procedures for container labeling and contamination / radiation control monitoring.
- Assure "in-house" approval and control; of containers within the HFIR Project for nuclear criticality safety purposes.
HFIR Project Nuclear Materials Management Group:
Initiate procedures necessary to assure adequate identification and accountability of materials.
- Authorizes removal of SNM from the HFIR Project.
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79-49 Page 2A 8-3-79 Rev. O t
HFIR Project Security:
- P7; ovide authorized admittance and exit of personnel and materials.
Manufacturing Foreman and Group:
- Perform operations according to written instructions (route cards and standard operations).
- Provide a record of operations by dating and initiali'g route cards m.a providing any information requesten.
s 3.
The organizational chart that identifies the organizational elements which function under the control of the TI QAPP are shown on Figure 1 and includes all personnel assigned to the HFIR Project.
4.
The Manager HFIR Project has the authority and responsibility for overall, planning, coordination, and administration of TI QAPP.
He may delegate this authority to various members of the Nuclear Safety Group, Material Management Group, or the Engineering Group.
The Manager HFIR QA has the responsibility and authority for all HFIR Project QA/QC activities.
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The Manager HFIR Project Nuclear Safety has the responsibility and authority for HFIR Project Nuclear Safety.
The Manager Nuclear Materials has the responsibility and authority for HFIR Project nuclear material planning and record keeping.
II.
Quality Assurance Program 1.
The Manager, nFIR Project, independent of the QA organizat ion, regularly assesses the scope, status, implementation, and effectiveness of the 'i program to assure that the progrsn is adequate and complies with 10 CFR Part 71, Appendix E criteria.
2.
All shipping packages loaded in the HFIR Project will be inspected according to written instructions.
All shipping packages loaded in the HFIR Project will be processed according to written instructions (route card).
The processing will be documented (route card).
3.
No operations are permitted without written instructions, and this policy is imbued in all HFIR Project personnel.
4.
The safety-related systems, structures, and components controlled by the QA program are limited to NRC/ DOT and/or DOE licensed 1301 264
ORGAt:1ZATION CllART OF T.
ATTLEBURO SITE *
- Rev. A page 3.,
Figure 1 E.N.
79-60 VICE PRESIDEI.T MATERIAL AND ELECTRICAL PRODUCTS GROUP 9/28/79 William Sick l
PERSO::::CL GROUP OPERATING jASST. VICE PRESIDENT
- OPERATING SERVICES DIV I ASST. VICE PRESIDE::T DIRECTOR SERVICES I-1A.AGER I.
f MMD DIV.
T. Sn. der G.
Perkins L.
B o n r :. e k l
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MANUFACTURING GROUP
- AS RELATED TO TfiE TECilN IAN INS C ION l
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IIFIR PROJECT 11. Vickers
E.N.
79-60 Page 4 9/28/75 Rev. A
.t 4.
containers utilized at the HFIR Project.
As such, only (cont) those safety-related systems, structures, and components requiring visual and functional inspections are identified (e.g.,
gasketing, nuts, bolts, washers, cover, closures, presence of insulation, etc.).
5.
Disputes involvi.g quality arising from a difference of opinion between QA/QC personnel and other department (engineering, procurement, manufacturing, etc.) personnel will be resolved by consulting process engineering, quality engineering, and the cognizant supplier.
6.
A training program is established such that:
(a) Personael responsible for performing quality-related activities are instructed as to the purpose, scope, and implementation of the QA manuals, instructions, and procedures.
(b) Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.
(c) The scope, the objective, and the method of implementing the indoctrination and training program are documented.
(d) Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.
- 7.
Quality-related activities are performed with specified equipment under suitable environmental conditions, and prerequisites are satisfied prior to inspection and test.
^*,III.
Design Control No container designs are performed by the HFIR Project.
IV.
Procurement Document Control 7
- 1.
Procedures are established that clearly delineate the sequence of actions to be accomplished in the preparation, review, acceptance, and cont col of precurement dtcuments for customer supplied and " Certified for Use" containers.
- 2.
Tne procurement document, customer supplied " Certificate for Use" certification, is in conformance with applicable 10 CFR Part 71, Appendix E requirements as approved by U.S.N.R.C.
Docket Number 71-0203.
i301 266
E.N.
79-60 Page 5 9/28/79 Rev. A 9.,
- 3.
Only customer supplied, current U.S.N.R.C.
licensed containers are used and customer procurement documents contain or reference the design basis technical require-ments including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standard test and inspection requirements, and special process instructions as dictated by the applicable QA Program for Packaging as authorized by the U.S.N.R.C. Docket Number 71-0203.
4.
TI will not make any procurement requiring documentation of parts, materials, designs, processing, procedures, inspection and fabrication plans, inspection and test records, personnel and procedures qualifications, and chemical and physical test results of material prepared to be maintained and submitted for review and approval other than customer supplied " Certified for Use" Certification.
- 5.
TI has no responsibility to have the right of access to suppliers' facilities and records for source inspection and audit as this function is assured via customers' approved U.S.N.R.C. QA Program for Packaging, Docket Number 71-0203.
V.
Instructions, Procedures, and Drawings w.
Activities affecting quality at TI are prescribed and accomplished in accordance with documented instructions and procedurec.
VI.
Document Control The review, approval, and issue of TI internal quality-related documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
Changes to TI internal quality-related documents are reviewed and approved by the same organization that performed the original review and approval.
Approval is required of Engineering and Qual'.ty Assurance.
Approved changes arc included in route cards and standard operations and other documents prior to implementation of a change.
Approved instructions in the form of route cards are avail-able at the location of the operation prior to commencing work.
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79-60 Page SA 9/28/79 Rev. O
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VI.
Document Control (cont)
Master files are maintained to identify current revisions of route cards and standard operations.
VII.
Cop *.rol of Purchased Materials, Equipment, and Services Materials, equipment, and services will not be purchased for shipping packages.
'VIII.
Ident.ification and Control of Materials, Parts, and Components
- 1.
Procedures are established to identify and control customer
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supplied " Certified for Use" certified containers.
No materials, parts, or components separate from the procedurally controlled " Certified for Use" container are processed, handled, or stored.
- 2.
No safety-related materials, parts, or components beyond the procedurally controlled and traced customer supplied
" Certified for Use" containers are obtained by TI.
- 3.
No fabrication, assembly, or installation are performed by TI for shipping containers.
IX.
Control of Special Process No special processes such as welding, heat treating, nondestrrctive testing, and cleaning are performed by TI.
Routine cleaning, if performed, is limited to vacuum cleaning, alcohol, or detergent and water wiping.
X.
Inspection Inspection programs which verify conformance of containers with visual inspection criteria is established on standard operations and/or route cards.
The route cards provide the documentation that instructions are performed in accordance with written and controlled procedures.
Inspection personnel are independent from the individuals performing the activity being inspected.
XI.
Test Control 1301 268 No tests are performed.
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79-60 Page 6 9/28/79
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XII.
Control of Measuring and Test Equipment
- 1.
Measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
- 2.
Reference and transfer standards are trt'ceable to nationally recognized standards and where national standards do not i
exist, provisions are established to document the basis for calibration.
XIII.
i.andling, Storage, and Shipping Special handling, preservation, storage, cleaning, packaging, and shipping requirements are established as required and presented on route cards and standard operations (written procedures).
Experienced or supervised personnel perform all work and inspections in accordance with properly authorized route cards and starmard operations.
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All containers will be supplied by the customer and will be 2.
certified by the customer as conforming to the requirements of the container permit at intiial use.
Only visual inspection for damage will be performed on permit containers at each time of use.
3.
All necessary shipping papers will be prepared as required.
4.
All notification of transportation of packages released to customer cersonnel for DOE Transport are handled in accordance with DOE procedure.
All non-exempt quantities are transported by DOE.
XIV.
Inspection, Test, and Operating Status 1.
The visual inspection results and operaming status (no testing performed) of containers supplied by the customer will be made known to the customer representative at the time of use of the container.
2.
The application and removal of status indicators such as tags and 12tels are controlled through the use of route cards (no welding stamps and stamps are used).
1301 269
E.N. 79-4 9 Page 7 8-1-79 Rev. O
.t XIV.
Inspection, Test, and Operating Status (cont) 3.
All processing of containers is performed in accordance with route cards that have sequential operations and/or inspections.
A succeeding operation or inspection cannot be performed until the previous operation or inspection is signed.
4.
Any container or component determined to be non-conforming, inoperative, or malfunctioning cannot be continued in process and used as a package and will be labeled as to i
the defect.
XV.
Non-Conforming Materials, Parts, or Components Containers that have vis tal inspection defects will be rejected on a Quality Control Inspection Notice (QCIN).
The QCIN reguires a review and disposition by Engineering.
Containers designated for non-use will be identified and returned to the supplier with information and documentation as to the non-conforming materials, parts, or compunents.
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XVI.
Corrective Action Defects found in containers will be reviewed at the time of use and evaluation made as to any corrective action required.
XVII.
Quality Assurance Records 1.
Records of each container inspection and loading are maintattied.
2.
Records include visual inspection, disposition, loading of containers, and non-conformance reports with asarciated corrective actions.
During the use of the container a copy of the " Safety Analysis Report for Packaging" will be maintained by TI HFIR Project.
3.
Completed records of the use of each container are mat.;csined with the records of each removal of SNM from the TI HFIR Project.
4.
All records of container use or disposition are maintained by the Manager of Nuclear Materials.
No lists are required as a limited number of containers are involved and can be readily traced through each activity.
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79-49 Page 8 8-1-79 Rev. O
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XVII.
Quality Assurance Records (cont) 5.
The " Safety Analysis Report for Packaging" for each container will be maintained during the period of use of the container and for a minimum of two years.
All other records will be maintained for a minimum of two years.
6.
Inspection records (route cards) contain the following information:
Each type of observation is described in sufficient a
detail to allow its accomplishment by a supervised or experienced operator.
Each manufacturing or inspection operation is initialed and ated on 7ompletion by the operator or inspector performing the operation or inspection.
Each inspection operation is marked ' accept' for the acceptance of the inspection results or 'QCIN' when unacceptable results are found and the date is recorded.
Each QCIN written for a container defect identifies the container and the specific defects in that container.
Information related to condition adverse to quality are reported on the QCIN as part of the inspection results.
Each inspector performing an inspection initidls tiie inspection operation he performs.
XVIII.
Audits 1.
Audits on operations or inspections are performed in accordance with written audit procedures and are performeo by personnel having no direct responsibilities in the areas being audited.
2.
Audit results are documented on the written audit procedures
'e and all audit results are revieued by management having responsibility in the area audited.
3.
The responsible management takes the necessary action to correct the deficiencies revealed by the audit.
4.
Areas revealing deficiencies will be corrected and re-audited en a timely basis to verify implementation of corrective acticas.
5.
The QA container program is audited annually plus or minus one month.
1301 271
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