ML19208B844
| ML19208B844 | |
| Person / Time | |
|---|---|
| Site: | 07100005 |
| Issue date: | 07/27/1979 |
| From: | MQS INSPECTION, INC. (FORMERLY MAGNAFLUX CORP.) |
| To: | |
| References | |
| NUDOCS 7909210478 | |
| Download: ML19208B844 (25) | |
Text
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QUALITY ASSURANCE CRITERIA FOR 2
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SHIPPING PACKAGES FOR RADIOACTIVE MATERIAL
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p 1-Organization:
DId The Quality Assurance Manual for the Magnaflux Corporation lists the executive ]ine of authority with names of those responsible for the Quality Assurance Program and Quality Control application.
The quality control managers are free of schedule and cost consider-ations and are only bound by the criteria listed on the control draw-ings and specific written inspection ins-actions where so designated on the subassembly and final assembly drawings.
2-Qualit y Assurance Program For The MX-IC-100 Camera:
A-The QA Program is outlined in the QA Manual, the QC Manual, and the inspection required pet the " Inspection Control MX-IC-100" dbawing B-211553.
(See Appendix - Item 1-2-3).
B-All materials and components of the MX-IC-100 exposure device must comply to tle QA Program and in particular to the safety related items as the lock assembly, the depleted uranium casting and its welded housing.
The QC Inspection Department, under the direction of the QC Manager, has the sole responsibliity of 100% inspection of each finished unit before it is ready to be sold.
The finished units as a group have one or more " move" tickets attached with the signature of the inspec-tor.
The units are stored in a locked metal cabinet in the stock room.
The sequence of inspections and inspection drawings for the MX-IC-100 are listed on the Inspection Control drawing, B-211553 (App.-3).
This drawing lists the inspection reports which must be signed and kept on file for the life of the MX-IC-100 unit.
The five considerations outlined in this section of the CFR, were incorporated in the QA Program by the special notations listed on the various inspection reports.
These inspection reports are sup-plied to the QC Inspection Department with each new production order.
The considerations are:
1-The importance of malfunction or failure of the item to safety is stated in:
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a-Drawing B-211552 - Inspection required for B-211600 Lock - (Appendix-4), line B-10 states:
"This lock is used to secure dangerous amounts of radio-active mater-ial.
Failsafe operation must be assured",
b-Drawing E-212819 - Inspection required for the MX-IC-100 Camera - ' Appendix-5), line C-3 states:
"If any lock mal-function eccurs, reject the unit".
c-Drawing B-211726 - Radiation Inspection; Shield Casting -
(Appendix-6) note 5 states:
"All castings with I4 larger than 200 MR/HR must be reworked".
(I4 " Present surface radiation corrected for 100 Ci IR 192).
2-The design and fabrication uniquenem were controlled by safety considerations.
Compliance to the design as approved by the NRC is assured by specific inspection procedures outlined in the inspection control drawing B-211553 (Appendix-3).
3-Special controls and surveillance of the major, safety features of the unit are assured by separate, written inspection instructions which are signed and kept on file by the Inspection Department for the life of the unit.
The major safety oriented features are:
a-Adequate radiation shielding (B-211726 Appendix-6).
b-Weld inspection (B-211607 Appendix-7).
4-Functional compliance is ast-ured by written inspection procedures which require the actual operation of each final unit without fail-ure. (B-212819 Appendix-5).
5-The quality history has been excellent with no serious malfunction resulting from design or workmanship.
Standardization of all com-ponents has been maintained since the original design.
Design charges will be made as dictated through experience.
Any major design change will be sent to the Washington N.R.C. which evaluated the original design, ao their records will be updated.
3-Design Control:
- The equipment is designed per standard manufacturing practices, and all designs are reviewed by a mec'aanical engineer, with radiographic train-ing, and the radiation safety officer for compliance with NRC codes and regulations.
All details, assemblies and inspection lists are formally drawn and kept on permanent file at the company's Chicago address.
'll changes of design are reviewed by the above parties, and formal A
change records are kept.
390'#25' The verifying process is done by the QA Inspection Department which is independent of,the Design and Manufacturing Departments.
Any changes will comply with NRC rules and regulations, and the NRC will be consulted on any major change for possible license revision requirements.
4-Procurement Document Control:
All procurement records are kept on file as standard company policy.
The most critical detail, the depleted uranium casting, is recorded by serial number on the inspection report.
This report is kept on file for the life of the camera in our Inspection Department.
5-Instructions, Procedures, and Drawings:
Each part is made and inspected per formal drawings to ensure compliance to the original design as approved by the N.R.C.
Specific instructions for inspections or procedures are on the required drawings or are referred to by the inspection drawing number.
6-Document Control:
With each neu production order, a complete new set of drawings and inspection lists are issued. All changes are reviewed per step 3 above, and changes are formally recorded and kept on permanent file.
7-Control of Purchased Material, Equipment, and Services:
All parts and materials are purchased from permanent company " Purchase-Cards" which contain exact descriptions of the material or part, and space for recording the vendor, date, quantity, and price.
The purchase-card information is typed onto a purchase order form.
Copies are kept on company file and also sent to our Incoming Inspec-tion for verification of the ircoming parts and material. Any deviations from the purchase card specifications must be cleared with appropriate Engineering personnel.
8-Identification and Control of Materials, Parts, and Components:
Each part of any assembly which is manufactured is drawn and assigned
- a specific part number and drawing number.
All purchased parts are assigned a purchase part number and corresponding purchase-card.
All purchased and manufactured parts are stored in a central Stock Room by their part numbers until final assembly.
The assembly drawing and/or Bill of Material contain all part numbers required to make the assembly. All parts are traceable by their part numbers for specifi-cation verification or detail drawing comparison.
9-Control of Special Processes:
All safety related procedures and inspections are in written form and outlined on Drawing B-211553 - Inspection Control (Appendix-3).
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10- Inspection:
AllinspectionsubicharerequiredfortheMX-IC-100unitarein written form and outlined on Drawing B-211553 Inspection Control.
Specific hold points for inspections before proceeding with work are so specified on the work drawings.
11-Test Control:
All required tests have written instructions, specific written inspe-tions, or recorded and signed documents which are kept on permanent file as outlined on Drawing B-211553 - Inspection control.
Defective parts must be repaired and reinspceted.
12-Control of Measuring and Test Equipment:
The survey meter which is used during the depleted uranium casting radiation test, is calibrated by an outside certified party at three month intervals per 10 CFR 34.24.
13-Handling, Storage, and Shipping:
The depleted uranium casting is a low grade source material and requires special handling, storage and shipping per our source material license.
a-Handling - the castings are handled in a nornal manner but notification has been given to all parties who might contact then to wash thier hands before eating or smoking.
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Storage - The castings are kept in a locked metal storage cabinet within the main stock room. After the completion of the packaging, the units are again stored in the same cabinet.
Production records are kept of the castings entering and leaving and finished MX-IC-100 units entering and leaving, c-Shipping -
1-Depleted uranium castings:
rejected castings are returned
.to vendor in their original heavy, double-walled boxes.
Labeling and shipping papers conform to 49 CFR 173.389 C2, and 173.392, 49 CFR 172.400 LABELING, 172.200 SHIPPING PAPERS and 172.300 MARKING.
2-Finished MX-IC-100 Exposure Devices -
It is ampany policy to not ship any units with live sources from ot_ plant. Therefore the empty exposure device is shipped in a sturdy carton, wooden box, or metal drum with appropriate labeling (49 CFR 172.400) and shipping papers (49 CFR 172.200.) Depleted Uranium when in the metal housing 390.tES
e of the finished package is exempt from specification pack-aging,. carking, and labeling per 49 CFR 173.391C.
For orders which require loading the MX-IC-100 with a live source, the packaging is sent to a source manufacturer who loads the device and then ships it in a type "B" drum over-pack.
14-Inspections, Test and Operating Status:
The depleted uranium castings are marked with " ace" date and initials if tests indicate acceptance. The casting serial number is also recorded on the radiation test record for verification of acceptability (B-211726 Appendix-6).
The finished packaging run is tagged with a signed " Move Ticket" to indicate acceptance and movement to next operation of storage for eventual sale.
15-Nonconforming Materials, Parts, or Components:
All incoming inspection must verify that the material or part numbers are per ordered description on their copy of the purchase order.
The purchase order is copied from the information on the part number purchase cards. The Bill of Material, for a given assembly, specifies all part numbers required to complete the assembly.
Incorrect or defective parts are returned to vendors for correction and must be reinspected when returned.
The only crucial incoming inspection required is for the depleted uranium casting. These inspections are controlled by the written procedures list-ed in section E-10, Inspection, of this report.
16-Corrective Action:
QC Inspection Department is responsible for the compliance of all parts to their respective drawings.
Should excessive and persistent reject-tions occur, the manager of the QC Department would so report to the President of Manufacturing for corrective action from the executive level.
17-Quality Assurance Records:
Permanent signed records are kept c f all changes to drawings and Bills of Ibterial.
Signed inspection reports are ketp for the life of the MX-IC-100 units, per the inspection control drawing (B-211553 Appendix-3).
All records are identifiable by drawing numbers and can be retrieved through use of the Bills of Material which designate part numbers with their respective drawing numbers.
The Bills of Material also designate the inspection drawings and the storage location for those records to be filed.
l 3901150 18-AUDITS:
7 Audits of Product, Records, and Corrective Action are described in the QA Manual (section 7) (Appendix -1).
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APPENDIX Details referred to but not included with this report may be examined by the Commissior during their regional regulatory operations programs.
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}bgnaflux Quality Assurance Manual 2-Magnaflux Quality Control Manual for Equipment 3-(Drawing B-211553) Inspection Control MX-IC-100 4-(Drawing B-211552) Inspection required for B-211600 lock 5-(Dr uing B-212819) Inspection required for the MX-IC-100 Camera 6-(Drawing B-211726) Radiation Inspection; Shield Casting 7-(Drawing B-211607) Body weld assembly and inspection report 9 It C 390:E52
Issued to:
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MAGNAFLUX CORPORATION QUALITY ASSURAf1CE MANUAL I
Approved:
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' h kident Date 4/.ze/7c L & 6x < _
Quality Assurance Mana,>r Date s90138 4
TABLE OF CONTEf1TS I
1.
INTRODUCTI0ft Page 1
2.
QUALITY ASSURAllCE - MAf1AGEMEllT Afl0 PLAfif11f1G Page 3
3.
DOCUMEllTATI0fi Page 4
4.
DESIGil AND DEVELOPMEllT.
Page 5
5.
PROCUREMEtiT.
Page 6
6.
, MATERIAL PRODUCTI0fl Page 8
t 74 QUALITY ASSURAflCE AND VERIFICATI0fl AUDITS Page 13.
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1 1.1 Scope and Purpose i
This manual sets forth the general requirements for a Quality Assurance Program for Magnaflux Corporation, which is also in accordance with the stipulations of Federal Regulation 10 CFR 50, Appendix B (Section II); ASME Boiler and Pressure Vessel Code,Section III; and RDT Standard F2-4T, Amendment 1, (Section I).
These requirements are based on proven practices and controls, and are intended to assure that in fact Magnaflux products are produced and evaluated in accordance with those practices and controls.
1.2 Definitions A.
Batch -- Any individual lot of material of the same type produced at one time.
B.
Characteristic -- Any property or attribute of an item that is distinct, describable and measurable in relation to the specified quality requirements.
I C.
Purchaser -- The individual and/or company responsible j
for the issuance and administration of a purchase order to Magnaflux Cr eporation for manufactured products, covered by or or more of the standards listed in Section 1.1 or comparable documents.
D.
Quality Assurance -- The actions necessary to provide confidence that the ordered products will be produced under those prescribed and controlled conditions and i
therefore comply with the requirements specified by the purchaser.
i E.
Quality Verification -- The actions required to confirm that the Quality Assurance activities have been carried out and that the products do conform to the specified requirements of the purchase order.
F.
Quality Control -- The Quality Verification actions that measure the characteristics of the material for conformance to predetermined requirements.
1.3 Applicability This manual shall apply to the production and testing of all Magnaflux manufactured products and is intended to be a basic document that can be supplemented by the specific requirements g
of a related standard for a specific item.
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t 1.4 Responsibility It is the responsibility of Magnaflux Corporation to apply the Quality Assurance Program to the products produced against the purchaser's purchase order.
It is the responsibility of the purchaser to state explicitly that the product to be supplied is intended for use in a system subject to 10 CFR 50 Appendix B, or other applicable standard.
1.5 Purchaser Actions The purchaser shall have the privilege of access to any pertinent aspect of the Quality Assurance Program at any time, including any period prior to the execution of the purchase order.
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QUALITY ASSURAllCE - MAtlAGEMEllT AllD PLATINIf1G This section covers the actions required to develop, implement, and maintain a Quality Assurance Program.
2.1 Planning
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This manual sets forth and formally documents the basis for the Quality Assurance Program.
The manual shall be available to qualified and responsible purchasers.
Procedural changes in the Quality Assurance Program shall be reflected in corresponding revisions to this manual.
2.2 Organization The final responsibility for developing and administering all aspects of this Quality Assurance Program rests with the Magnaflux Corporation President.
It is implemented by the Quality Assurance Manager, who is a subordinate of the President. These relationships as well as those of personnel performing quality control and verification functions are depicted in the Organization Chart, page 14.
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DOCUMENTATION 3.1 Procedures The Quality Assurance Program incorporates all the standards, procedures and criteria set forth in the Magnaflux Quality Control Manual for Expendable Materials or the Quality Control Manual for Equipment, and the maintenance of adequate separate records.
Magnaflux shall permit on-site examination of its Quality Control Manuals by responsible parties, but the manuals in whole or in part may not be removed from Magnaflux facilities.
Specifications covering raw materials and purchased components may be supplied to vendors, as necessary, to assure delivery of acceptable goods.
3.2 Audits, Data and Reviews Magnaflux shall audit the Quality Assurance Program in accordance with Section 7 of this manual and allow reviews with the purchaser on its performance.
The Quality Control System, as a part of the Quality Assurance Progrcm per Subsection 3.1 of this standard, provides the means for the control of the quality of the product and for the detection and correction of product deficiencies, per Section 7 of this manuoi.
3.3 Records Results of all tests and inspections shall be recorded and be readily identifiable, per Subsections 4.7 and 5.6.
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DESIGilAtlDDEfELOPMEllT 4.1 Scope This section lists the general developmental activities to be performed as part of the Quality Assurance Program.
4.2 Material Design The purchaser shall be responsible for all design planning and other designations of inspection material or equipment characteristics, if different from our standard products.
Magnaflux shall be responsible for meeting accepted require-ments in accordance with the specifications stipulated by the purchaser.
4.3 Design Definition and Control Magnaflux shall review design or other purchase order criteria for inspection materials or equipment to assure compatibility with the purchaser's requirements.
i 4.4 Design Reviews i
Magnaf'ux will participate and assist in all proposed and
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documented reviews in relation to product characteristics
~i whenever deemed necessary by the purchaser.
4.5 Development As requested, Magnaflux shall establish and impose criteria t
for evaluating whether a product specified in a purchase order will meet the requirements per Subsection 4.4.
i 4.6 Failure Reportina and Corrective Action l
1 Magnaflux shall establish and implement procedures for reporting, verifying, analyzing, and correcting failures or deviations in relation to Magnaflux products, per Subsection 6.8 of this standard.
4.7 Quality Records
- i Magnaflux shall compile and maintain required records and data pertaining to inspection materials or equipment produced for and supplied to the purchaser.
4.8 Quality Audits Magnaflux shall regularly audit Quality Assurance activities in accordance with the requirements of Section 7 of this standard.
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PROCUR ElHENT 5.1 Scope This section identifies the Quality Assurance Program require-ments to be satisfied by Magnaflux in respect to raw material procurement.
Implementation procedures for these requirements are detailed in the Quality Control Manuals, including the receiving and inspection activities and controls to be used for acceptance and disposition of purchased raw materials.
5.2 Evaluation and Selection of Procurement Source 5.2.1 General Requirements -- Magnaflux shall select procure-ment sources primarily on the basis of a demonstrated capability to provide proper materials and components of consistent quality.
5.2.2 Acc;pptable-Source List -- Magnaflux shall establish ar.d maintain lists of suppliers that have demonstrated their capability to provide acceptable materials and components and shall use such lists in selecting sources for similar materials.
5.3 Calibration and Standardization 5.3.1 Testing Equipment -- Testing equipment used to evaluate quality and uniformity of procured materials shall be calibrated in accordance with Subsection 6.7 of this standard and the Quality Control Manuals.
5.3.2 Standard Solutions -- Reagents must be of standard strength, shall be standardized in accordance with Subsection 6.7 of this standard, and the Quality Control Manual.
5.4 Receivino Inspection Magnaflux shall establish and implement procedures for receipt, inspection, test, and distribution of items delivered by suppliers, per Subsection 5.1.
Inspection instructions and test procedures shall provide for verification of characteristics in accordance with acceptance criteria. All data generated from inspection and testing of items delivered by suppliers shall be documented.
5.5 Control of Nonconforming Items Magnaflux shall develop and implement procedures, and describe them in the Quality Control Manuals, to handle purchased items that do not conform to acceptance criteria.
The procedures shall provide for prompt identification, documentation, segregation, and disposition of nonconforming purchased items.
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5.6 Contro' of' Received Items Magnaflux shall establish and implement procedures, and describe them in the Quality Coni ~rol llanuals, to identify, handle and store received materials.
5.7 Quality Audits Magnaflux shall regularly audit Quality Ast,urance Functions related to procurement, in accordance with Section 7 of this standard.
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6 MATERI AL CID iQUIPMEllT PRODUCTI0ft l
6.1 Scope This section includes auality Assurance requirements to be i
satisfied by Magnaflux during production.
The requirements include production planning; control of materials and l
processes; inspection or testing of in-process or completed items; preparation for shipping; recording and auditing of activites.
The requiremeats are intended to assure and I
confirm that the items produced by Magnaflux conform to specification requirements.
I 6.2 Planning Magnaflux shall establish and implement those procedures and instructions required to assure that production activities are carried out in accordance with the stant d practices set forth in the Quality Control Manuals, and follow any special requirements of the purchaser.
flagnaflux's planning activities shall include identification and sequencing of processing functions and their associated inspection and testing activities.
6.3 Inspection and Test Plan fi Magnaflux's Quality Assurance Program shall provide for the necessary inspection and test activities related to production operations.
The Quality Control Manuals shall contain a narrative description of the sequence of activities for production, inspection and testing of the characteristics to be measured.
6.4 Material Identification and % :rol To cssure traceability, al1 3terials shall be identified and followed throughout each operation.
Identification shall be placed on the actual material containers or components and entered on related records.
Controls shall be exercised at all points to assure that only accepted materials are further processed.
6.5 Control of Processes 6.5.1 Production Processes -- Process controls shall encompass those standacd practices, methods and procedures established for the manutacture of the item, and documented in the log books, shop orders, engineering drawings, or other i
records.
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<6.5.2 To~ sting Peacesses - Examination procedures f or i
inspection materi?ls and equipment shall.be controEcd
.J to assure that results provide accurate, uniform and i
reproducibh leve~)s.of quality.
Examinations shal1 be
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performed in accordance with standard pracedures and specified acceptance criteria, as recorded in the Quality Control Manuals.
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6.5.3 Personnel Training & Oualification -- As part of the Quality Assyrance Program, Magnaflux personnel who perform the b ality Control tests must be qualified.
Original qualification consists of a three-month 3
training regimen, with the ftnager of Quality Control, Supervisor of Quality Control or an experienced and qualified QC Technician or Inspector monitoring every test the. novice technician performs.
Successful completion
'nf the three-month program signifim qualification.
Qualification is maintained by two lev 21s of audits.
The Manager and Supervisor of Quality Control. cerform the first level in their capacity of Supervisors.
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aregularbasistheymustconnorthethoroughnessof record-keeping iuld the care performing tests and compel adherence to the standards set forth in the Quality Gbr, trol Manuals.
Additional auditing shall be performed Oc per Section 7 of this plan.
j 6.6 Inspection and Tests 6.6.1 General Requirements -- Throughout the production cycle Mcgnqflux shall perform or have performed inspections, tests and other verification methods in accordance with procedures set furth in the Quality Control Manuals.
Magnaflux shall verify that inspection and test pre-requisites are met, that appropriate instruments and s
devices are used, that inspections and tests are performed in the proper sequence under suitable environmental conditionstand that results are recorded and are traceable to the individual responsible.
Magnaflux shall furnish inspection and test results and related data to the purchaser on request.
These general requiremerits are detailed in the Quality Control Manuals.
6.6.2 procedures -- Magnaflux shall prepare procedures and instructions that clearly describe the appropriate inspections and tests for materials, work in process, and completed items as required by specification.
In addition, the criteria for acceptance or rejection of product shall be established.
All characteristics required to be reported shall be examined as prescribed by specified procedures and 8 b instructions, and the results recorded on documents g q g appropriate to the inspection or test.
Instructions and procedures shall be revised and up-dated as required to reflect specification changes.
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6.6.3
_ Certification -- When requested, flagnaflux shall certify in writing that each item conforms to the epplicable code, standard specification, or purchase order requirements.
Certification shall include reports of the results of all required tests, analyses, inspections, and examinations, and shall be identified with the applicsble item by batch number or serial nuraber as applicable.
j 6.7 Calibratien and Standards:
I liagnaflux shall undertake th9 selection, acquisition, calibration, adjustment, maintenance, and control of inspectiot, teasuring and test equipment and reagents necessary to determin3 tonformance of products to applicable requirements.
6.7.1 Equipment Evaluation -- flagnaflux shall evaluate inspection, measuring and test equipment to determine its accuracy and tolerance before it is used, and the results shall be documented.
6.7.2 Control of Insnectinn l'easuring and Test Eauirgent_ --
Inspection, measuring and test equipment shall be cali-brated at scheduled intervals against certificd standcrds having known and valid relationships to national standards, where such exist.
Records shall be mainteiried that indicate the last calibration date.
The calibration interval for each item shall be based on the type of equipment, required accuracy, use, and other conditions affecting measurement control.
Equipment that has not been properly maintained or calibrated in accordance with specified schedules shall be identified and removed from service.
6.7.3 Calibratien Standards -- (4agnaflux may provide its own services or use those of an approved standards laboratory for the calibration of inspection, measuring and test equipment.
Standards shall be maintained, calibrated, and used in an environment compatible with the required accuracy and operating characteristics of the standards.
6.7.4 Discrepant Equipment -- When discrepancies in inspection and testing equipment are found at calibration,14agnaflux shall determine the required corrective action.
i 6.7.5 Standard Solutions -- Reagents which must be used at l
accurately known concentrations shall be standardized before use, and restandardized under conditions set forth in the Quality Control rianual.
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6.8 Control of' Nonconforming Items:
Magnaflux shall establish, implement, and maintain procedures for control of products that do not conform to applicable purchase order requirements. The procedures shall provide for the prompt detection, recording, verification, technical review, and disposition of nonconforming items.
Magnaflux shall identify and segregate nonconforming items to prevent their unauthorized use or shipment.
Hold areas shc.ll be provided for storage of nonconforming items.
Magnaflux shall maintain records of all nonconformances and the corrective actions taken. Acceptance, rejection, rework or retest of nonconforming items shall be accomplished in accordance with documented instructions.
The acceptance or rejection of nonconforming items offered for delivery shall be the prerogative of the purchaser.
Unless otherwise specified in the purchase order, delegation of this authority by the purchaser on his own responsibility shall be limited to instances involving minor incidental discrepancies that do not adversely affect product characteristics.
!!onconforming items furnished by suppliers shall be controlled as prescribed in Subsection 5.5.
6.9 Corrective Action:
Quality Assurance functions shall provide for detection of conditions adversely affecting quality, and for corrective action and feedback in accordance with the requirements of Subsection 3.2.
j 6.10 Handling, Packagina, Storace and Shipping:
i 6.10.1 Handling -- fiagnaflux shall develop and implement handling practices, procedures, and instructions as required by applicable specifications.
Special precautions in handling shall be taken when damage due to handling might result.
6.10.2 Packaging and Storage -- Magnaflux shall provide
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procedures and instructions for packaging (and storage if required) in accordance with specification require-ments.
Items subject to damage shall be packaged in such a manner, and with such materials, as prescribed by the purchase order to prevent damage.
Packaging y
shall allow for conditions that could reasonably 3
affect quality of the item at fiagnaflux, in transit j
to destination, and at destination.
Items to be stored shall be protected against reasonable risk of damage.
Periodic inspections
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shall be performed to detect damage to stored items, l
and corrective action taken as required.
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t 6.10.3 Shipping -- Magnaflux shall provide for inspection and control of all items shipped to assure that (1) they have received and satisfactoril the required inspections and tests, (2) y passed they have been packaged in accordance with applicable specifications, (3) they and the packaging have been properly identified.
6.11 Quality Records:
In accordance with the requirements of Subsections 3 and 6.6, inspection, test, and other data related to the quality of product shall be collected, processed, analyzed, and distributed to pertinent areas within the Magnaflux organization, to sources of supply when appropriate, and to the purchaser as requircd by the purchase order or specification.
Examples of records include acceptance test data, inspection end test reports, material certifications, quality audit reports, summaries of nonconformances, and corrective actions.
i 6.12 Quality Audits:
Magnaflux shall regularly audit Quality Assurance functions related to production operations in accordance with the i
requirements of Section 7 of this standard.
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QUALITY ASSURANCE Afl0 VERIFICATI0ft AUDITS
7.1 Scope
This section covers requirements for auditing and evaluating the Quality Assurance Program established by flagnaflux in accordance with requirements of this standard.
The elements comprise:
planning and execution of audits and evaluations; assessment of liagnaflux's procedures, activities, and products; reporting of results to management, including recommendations for any required corrective action; follow-up to assure effectiveness of corrective actions.
The requirements of this section shall apply to Magnaflux in performing self-audits or as a guideline to the purchaser or his designated agency in conducting independent audits of Magnaflux's Quality Assurance Program.
Surveillance and audit by the purchaser with proper planning is encouraged by Magnaflux.
7.2 Planning
Magnaflux shall plan audit and evaluation of specific areas, as indicated.or required.
Check lists may be prepared for each activity or product to be audited, including the quality characteristics to be evaluated.
7.3 Evaluation of Methods:
As part of Quality Verification program, Magnaflux shall evaluate its quality control system by experienced personnel not having direct responsibilities for the control areas to be audited.
7.3.1 Product Audits -- Magnaflux shall periodically audit inspection areas and shall re-inspect randomly selected products, already inspected, accepted, and identified as accepted.
The extent of the re-inspection must be sufficient to provide objective evidence of inspection effectiveness.
7.3.2 Record Audits -- Records of inspections and tests shall be audited by Magnaflux to assure adequacy and availability.
7.3.3 Reportino and Corrective Action -- The results of each audit and evaluation of quality assurance methods and activities conducted by Magnaflux shall be reported to and reviewed by management with recommended summaries of corrective actions if required.
Such results may be submitted to the purchaser as required.
Magnaflux Quality Assurance personnel shall take necessary action to assure that any deficiency in Quality Assurance activities is corrected.
Deficient areas shall be re-audited as frequently as necessary until the required correctioi:s
!. ave been made operable.
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ORGANIZATI CHART PRESIDENT P
MANAGER OF QUALITY ASSURANCE MANAGER OF MANUFACTURIf;G MANAGER RESEARCH & Ef: git!EERING
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- P MANAGER OF MANAGER OF PRODUCTION IGNAGER OF MANAGER OF RODUCTION CONTROL MATERIAL C0i4 TROL SUPERINTENDENT QUALITY CONTROL MATERIALS ENGINFFRTNF, INSPECTORS If4VENTORY SUPERVISOR OF CONTROL PURCHASING QUALITY P.',0J ECT SPECIALIST CONTROL SUPERVISOR TECHNICIANS DEVELOPMENT CHEMISTS EXPENDABLE MATERIALS FOREf'AN (c
COMPOUNDERS LC
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Y Fcem asiC418 U.S. NUCLEAR REGuLATCRY COMMISSloN M-M p
02M A CF R 71 CERTIFICATE OF COr.iPL!ANCE
[ *T For Rajicactive Materials PJckages j.
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f 1.(a ) Certificate Nurrter 1.(b'),ftevision No.
1.f c) Package Identification No.
1.(d) Pages No. 1.(e) Total No. Pase j.
9110 O
1 USA /9110/M )
1 4
- 2. POEAMBLE 2.(a)
This certificate is issued to satisfy Sections Materials Re3ulations (43 CFR 170-1E3 and 14 CFR 103) and Sections 173.393a,173.334,173.335, and 173.33G of 146-19-10a and 146-19-100 cf the Department of L
g Transportanon Dangerous Cargoes Regulations (4G CFR 146-143), as amended.
2.(b)
The packaging and enntents described in item 5 below, meets the safety standards set forth in Subpart C of Title 10. Code of Federal Regulatioris, Part 71, " Packaging of Hartioactive Materials for Transport and Transportation of Radioactive Material Unj Certain Conditions.**
2.(c)
This certificate does not rtlieve the consignor from compliance with any requirement of the regu!ations of the U.S. Depart-nent cf f
Transportation cr other appliable itJulatory agencies, including the governst ent of any country through or into whicli the will bo trant;ntted.
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- 3. This certificate is issued on the basis of a safety analysis report of the pickne design or aor.Jicatiors 3.ta)
Prepared by (Name.usd addren):
3.(b)
Title and ioentification of rcport or application.
Magnaflux Corporation 7300 West t avirence Avenue Magraflux Corporation Application Dated February 16, 1978, as supplemented.
Chicago, Illinois 60656 3.(c)
Docket No.71-9110 L
4 CONDITIONS This certificate is corviitional upon the fulfilling of the requircrnents of Sutprt D of 10 CFR 71, as applicable, and the condit
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in item 5 telow.
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QDescri;. tion of Packaging arvJ Authorize.1 Contents, Model Nurr:bar. hrsile Class, Cther Conditions, and Referencas:
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(a)
Packaging P*
l (1) Model.Ho.: MX-IC-100 (2) Description f
The isotope camera is a uraniumshielded, cylindrical, stainless steel f'
container 6-5/8 inches in diameter and 6-3/4 inches long.
The special Q
form source is held in place inside a titan.ium or zircalloy "S" tube by a stainless steel cable secured with a key-operated locking device
'3 A cable-restrained spacing plug is attached at the other j
on ene end.
end of the "S" tube.
The "S" tube is surrounded with depleted
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uranium metal as a shielding naterial.
The void space between the t
i uranium and steel shell is filled with polyurethane foam.
A carrying b..
handle at the top.and a base plate are provided.
The gross weight of the container is 49.5 pounds.
(3) Drawings
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The packaging is constructed according to Magnaflux Corporation i
T drawing No. C-211626, Revisio, Dated 2-9-78.
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Page 2 i-Certificate Number USA /9110/B()
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- 'Ihis certificate is issued in accordance with the requirements of the IAEA and USA Repulations and'fn response to the June 13, 1978 petition by 1:agnaflux Corporation', Chicago, Il and in consideration of the associated information provided in the U. S. Nuclear Regulatory Cornissica Certificate H
l'o. 9110.
t, Certified by.
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G rella /'
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(DATE)
Chief, R&D 1:anagement Division g
Office of Program Support i
i Materials Transportation Bureau l
U. S. Department of Transportation M
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I I" Safety Series I:o. 6, Regulations for the Safe Transport of Radioactive Materials,1967 Edition" published by the International Atomic Energy Agency (IAEA), Vienna, /ustria, 2
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Titic 49, Code of Federal psegulations, Parts 100-199, USA.
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TELEX 25 4194 MAGNAFLUX ""
CORPORATION _,5 2 27 vaoo wESr'4waeucE 4vE~uE c ic^oo. iuinois eoese
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July 27,1979 United States Nuclear Regulatory Commission Washington, D. C.
20555 Attention: Mr. Charles E. MacDonald, Chief Transportation Branch Division of Fuel Cycle and Material Safety, NMSS Re:
FCTR: RHO 71-0005
Dear Mr. MacDonald:
In compliance with 10 CFR 71.51 the enclosed Quality Assurance Program is submitted for approval.
This application is also required for a type "B package approval which will be sent to the commission under separate cover.
Sincere;;,
MAGNAFLUX CORPORATION n
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i J n Hall i
rm 200 3902ttt.
O3g NONCESTRUCTIVE TESTINo SYSTEMS METHoOS SERVICE 1367L A
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