ML20216B675
| ML20216B675 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 08/28/1997 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20216B669 | List: |
| References | |
| 71-0102-97-211, 71-102-97-211, NUDOCS 9709080125 | |
| Download: ML20216B675 (8) | |
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION e
WASHINGTON, D.C. 306 Shoot
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NOTICE OF NONCONFORMANCE Sourca Production and Equipment Company, Inc.
Docket No. 710102 Based on results of a U.S. Nuclear Regulatory Commission inspections conducted on June 1619,1997, and July 9-10,1997, it appears that certain of your activities were not conducted in accordance with NRC requirements.
A. 10 CFR 71.73, ' Hypothetical accident conditions," requires that the amblent air temperature remain constant at that value between 20' F and +100* F which is most unfavorable for the featu.., under consideration. This section also requires a free drop of the test unit through a distance of 30 feet onto a flat, essentially unyleiding, horizontal surface, striking the surface in a position for which maximum damage is expected. This section also requires a free drop of the test unit through a distance of 40 inches in a position for which maximum damags is expected, onto the upper end of a solid, vertical, cylindrical, mild steel bar mounted on an essentially uny?elding, horizontal surface. This section also roquires the bar to be a length that will cause maximum damage to the test unit, but be at least 8 inches long.
- 1. Contrary to the above, Source Production and Equipment Company, Inc. (SPEC), did not perform hypothetical accident conditions tests for the Model No. SPEC 150 at the most unfavorable temperature of 20' F.
SPEC stated in its " Test Report to Validate Previous 10 CFR Port 71 Puncture Tests Model SPEC 150 Type B(U) Package," Supplement No. 4, dated July 1,1997, that the Model No. SPEC 150 test package was ch!!Ied in dry ice to a temperature below 80* F and successfully passed the tests specified in 10 CFR 71.73. This corrective action is acceptable and no further response is required.
- 2. Contrery to the above, SPEC did not mount the puncture bar to the test pad.
SPEC stated in its ' Test Report to Validate Previous 10 CFR Part 71 Puncture Tests Model SPEC 150 Type B(U) Package" that the puncture bar was rigidly mounted to the center of the drop target pad and the Model No. SPEC 150 test package successfully passed the puncture test specified in 10 CFR 71.73. This corrective action is acceptable and no further response is required.
- 3. Contrary to the above, SPEC did not perform an analysis to determine the optimal length of the puncture bar that would cause maximum damage to the test unit.
SPEC stated in its ' Test Report to Validate Previous 10 CFR Part 71 Puncture Tests Model $PEC-150 Type B(U) Package" that it performed an analysis to determine the optimallength of the puncture bar that would cause maximum damage to the test unit.
This corrective action is acceptable and no further response is required.
9709000125 970020 PDR ADOCK 07100102 C
I Source Pret etion and Equipment Company, Inc.
Docket No. 710102 D. 10 CFR 71.105, " Quality assurance program," require 1 the licensee to provide for indoctrination and training of personnel perfomiing activities effecting quality as necessary to ensure that suitable proficiency is achieved and maintained.
Contrary to the above, SPEC was not able to provide training records showing that the individual who performed the calibration of survey meters was trained.
SPEC addressed Finding B in its letter dated July 21,1997. SPEC stated that the Quelity Assurance (QA) Manager has :ertified those persons involved in receiving, in process inspections, final inspections, surveys, calibration of survey meters, welding, and welding instruction. The QA Manager has updated the listing of persons qualified in these areas.
To prevent the condition from recurring, SPEC stated that a training coordinator will be appointed to maintain its training matrix, schedule training, and perform periodic review of training records for each employee. This corrective action is acceptable and no further response is required.
- Package design control," requires that the licensee establish measures to assure that applicable regulatory requirements and the package design are correctly translated into specifications, drawings, procedures, and instructions.
- 1. Contrary to the abuve, SPEC did not document its design development process for approximately 60 percent of the Model No. SPEC 150.
No. 9036 and used the unapproved and uncontrolled design drawing to procure a part for the Model No. C 1 packaging.
SPEC addressed Finding C.2 in its letter dated July 21,1997. SPEC stated that the corrective action that will be taken to assure that drawings referenced in SPEC COC applications to NRC are correct will be to establish a link between fabrication drawings and the drawings referenced in the application. However, SPF.C did not address what failed in the QA program that allowed a Type B transportation packaging part to be procured and receipt inspected using an unapproved and uncontrolled drawing.
D. 10 CFR Part 71.109, ' Procurement document control," requires the licensee to establish mepures to assure that adequate quality is required in the documents for procurement of mateiial, equipment, and services.
Contrary to the above, SPEC processed a Purchase Order (PO) No. 3152 without the review and approval of the QA Manager and QA requirements were not identified on the PO.
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Source Froduction and Equipment Company, Inc.
Docket ;,o. 710102
= E. 10 CFR 71.111 " Instructions, procedures, and drawings," requires the licensee to prescribe
- activities affecting quality by documented instructions, procedures, or drawings and requires that these instructions, procedures, and drawings be followed.
- 1. Contrary to the above, SPEC did not complete documentation for hypothetical accident cont'ition tests for the Model No. SPEC-150 Prototype Serial Nos. 2 and 4.
g A. SPEC did not record the data value for the radiation survey reference factor in the post-test for Prototype Serial No. 2.
B. SPEC did not approve test documentation.
- 1. The General Manager, Production Manager, and Research and Development Manager did not sign the " Approval to Proceed," for Prototype Serial No. 2, The QA Manager did sign the Approval to Proceed but this signature was not dated.
The General Manager did not sign the " Test Approval." SPEC did not sign the
" Report Approved By" on the last page of the report.
- 2. The Production Hansger and Research & Development Manager did not sign Approval to Proccoc for Prototype Serial No. 4. The QA Manager did not sign the Test Approval for Test Report No. 0628C94.
- 3. SPEC did not indicate for both the pre-and the post-test radiation readings, who made the mWaw ents, what survey instrument was used to make the.
.i measuremn m et the calibration status of the instrument was when used for Prototype bWI No. 4.
- 2. Contrary to the above, SPEC did not formally control changes made to fabrication and lost documentation. SPEC did not use Engineering Change Evaluations (ECEs) to chatege fabw.;ation travelers.
- 3. Contrary to the above, EPEC did not complete required test data sheets. Test data -
sheets documenting thr test results for the Model No SPEC-150 dated July 23,1994, contained hand corrections and data values were not recorded.
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- 4. Contrary to tne above, SPEC did not control nonconforming material. - SPEC did not complete a Nonconformance Report and provide justification for accepting nonconforming Depleted Uranium (DU) shields.
5-5.' Contrary to the above, SPEC did not have a procedure for tracking the status of nonconforming material to assure that all nonconforming material is controlled and a
dispositioned.
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Source Production and Equipment Company, Inc.
Docket No. 71-0102 A. SPEC did not have a procedure that addresses the control of nonconforming material.
B. SPEC did not maintain its status report for nonconforming material.
C. SPEC did not disposition nonconforming materialin a timely manner.
Nonconformance Reports issued from December 20,1995 until March 1997, were still open.
F. 10 CFR 71.113, ' Document control," requires the licensee to establish measures to control the issuance of documents such as Instruction, procedures, and drawings, including changes, which prescribe all activities affecting quality.
- 1. Contrary to the above, SPEC did not approve revisions to the following drawings:
Drawing No.15B000, " SPEC 150 Type B(U) Package - Isometric View," Revision 1 Drawing No.15B0002A, " SPEC 150 Exposure Device - full Sectional View,"
Revision 4 Drawing No.15B008, " SPEC 150 Type B(U) Package - Depleted Uranium Shield,"
Revisions 0 and 2
- 2. Contrary to the above, SPEC did not complete ECEs for revision made to the following drawings:
Drawing No.15B000,
- SPEC 150 Type B(U) Package - Isometric View," Revisions 1 and 2 Drawing No.15B008, " SPEC 150 Type B(U) Package - Depleted Uranium Shield,"
Revisions 1 and 2
- 3. Contrary to the above, SPEC used preliminary drawings to fabricate design test prototype units.
- 4. Contrary to the above, SPEC did not control sketches used in the fabrication of Type B transportation packaging.
A. SPEC's Procedure No. QAM 6.0 did not address the control of fabrication sketches.
B. SPEC approved one sketch but the four remaining sketches were not approved.
C. SPEC did not reference the use of one sketch on the fabrication traveler.
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Source Production and Equipment Company, Inc.
Docket No. 71-0102 G.10 CFR 71.115, ' Control of purchased material, equipment, and services,' requires the licerisee to establish measures to assure that purchased material, equipment, and services conform to the procurement documents. These measures must include provisions for source evaluation and selection, objective evidence of quality fumished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products on delivery. The licensee shall have available documentary evidence that material and equipment conform to the procurement specifications before installation or use of the material and equipment.
Contrary to the above, SPEC did not control the procurement and receipt inspection of DU shields which SPEC designated as a component important to safety.
- 1. SPEC did not perform an on site evaluation of the supplier and the supplier was not on SPEC's approved vendors list.
- 2. SPEC did not have Certificates of Supplier Compliance for 108 Model No. SPEC-150 and 23 Model No. 2-T DU shields.
H. 10 CFR 71.117, " identification and control of materials, parts, and components,' requires the licensee to establish measures for the identification and control of materials, parts, and components. These measures must assure that identification of the item is maintained by heat number, part number, or other appropriate means, either on the item or records traceable to the item throughout use of the item.
Contrary to the above, SPEC did not identify and control the penetration bar and puncture bar used for the penetration test and puncture test described in 10 CFR 71,71 and 71.73.
1.
The team identified a nonconformance with the requirements of 10 CFR 71.121, "Intemal inspection." This section requires the licensee to establish and execute a program for inspection of activities affecting quality to verify conformance with the documented i
instructions, procedures, and drawings for accomplishing the activity.
Contrary to the above, SPEC did not perform complete in-process or final inspection of Model No. SPEC-150 prototype units used to perform des;gn testing in accordance with 10 CFR 71.73.
J. The team identified a nonconformance with 10 CFR 71.123, " Test Control." ThJs section requires the licensee to establish a test program to assure that all testing required to demonstrate that the packaging components will perform satisfactorily in service is identified and performed in accordanca with written test procedures that incorporate the requirements of 10 CFR Part 71 and the requirements and acceptance limits contained in the package approval. The test procedures must include provisions for assuring that all prerequisites for the given test are met, that adequate test instrumentation is available and used, and that 5
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Source Production and Equipment Company, Inc.
Docket No. 71,0102 the test is per*ormed under suitable environmental conditions. The licensee shall document and evaluate the test results to assure that test requirements have been satisfied.
Contrary to the above, SPEC did not present an accurate descriptica of its drop target in its application for the NRC COC for the Model No. SPEC-150.
SPEC provided an updated drop target description to NRC in its " Test Report to Validate h
Previous 10 CFR Part 71 Puncture Tests Model SPEC-150 Type B(U) Package." This corrective action is acceptable and no further response la required.
K. The team identified a nonconformance with 10 CFR 71.125," Control of measuring and test equipment." This section requires the licensee to estat:Tsh measures to assure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits. Likewise, Section 12.0, " Control of Measuring and Test Equipment," of the QA Manual states that calibration will be performed in accordance with written procedures. - The team identified instances having minor safety significance where measuring equipment was not controlled.
- 1. Contrary to the above, SPEC procedures do not provide a detailed procedure for performing survey meter verifications.
SPEC addressed Finding K.1 in its letter dated July 21,1997, SPEC stated that Procedure No. 6.10 has been revised and will be reviewed further prior to the next survey of Type B transportation packages. This corrective action is acceptable and no further response is required.
- 2. Contrary to the above, SPEC did not follow its calibration procedure. SPEC used an unidentified, uncontrolled, and uncalibrated attenuator to calibrate survey meters.
SPEC addressed Finding K.2 in its letter dated July 21,1997. SPEC stated that the attenuator has been calibrated and will be logged onto the QA program. - An analytts revealed that the attenuator did not deviate from the specified dimensions and compromise survey meter calibrations. This corrective action is acceptable and no further response is required.
3.- Contrary to the above, SPEC calibrated a survey meter without using a procedure.
SPEC performed an undocumented data interpolation to calibrate a Model No. E-120 survey meter.
- 4. Contrary to the above, SPEC did not evaluate the consequences of using calipers that were out of calibration.
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s y-4 Source Production and Equipment Company, Inc.
Docket No. 71-0102
- 5. Contrary to the above, SPEC did not control the following calibrated calipers:
A. SPEC used calipers that do noi meet calibration requirements. Calipers requiring a tolerance of i 0.0005 inches were calibrated at 10.0010 inches.
B. SPEC did not msintain its calibration log for calipers. SPEC had made hand-written changes to the information for 20 nf the 36 calipers listed in its calibration log.
C. SPEC failed to update its calibration log for calipers. SPEC calibrated a caliper but did not record the latest calibration information in its calibration log.
D. SPEC used a calibrated csliper with a irnown defect. SPEC's calibration log indicated that a caliper had a bad first digit. SPEC calibrated, and put back in use, the defective caliper.
SPEC addressed Finding K.5 in its letter dated July 21,1997. SPEC stated that the caliper procedure will be reviewed and revised as rieeded. All calipers will be removed from service until proven that they are in calibration and marked accordingly. Fixtures and jigs will be re-calibrated. QA personnel will be retrained. This corrective action is acceptable and no further response is required.
L. -10 CFR 71.131, ' Nonconforming materials, parts, or components," rwquires the licensee to establish measures to control materials, parts, or components that do not confonTI to the licensee's requirements in order to prevent their inadvertent use or installation. These measures must include procedures for identification, documentation, segregation, disposition, and notification to affected organizations.
Contrary to the above, SPEC stored nonconforming parts and components used in Type B transportation packaging in an unsecured fabrication area. The nonconforming parts and -
components did not have Nonconforming Material Reports, did not have red reject tags, and were not segregated.
SPEC addressed Finding L in its letter dated July 21,1997. SPEC stated that non-conforming material will be separated la a QA controlled, locked area. All in-process work will be reviewed and tagged properly. This corrective action is acceptable and no further response is required.
M.,10 CFR 71.137, " Audits," requires the licensee to carry out a comprehensive system of planned and periodic audits, to verify compliance with all aspects of the QA pro' gram, and to determine the effectiveness of the program.
Contrary to the above, SPEC did nct perform intemal audits in the last four years.
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4 Source Production and Equipment Company, Inc.
Docket No. 71-0102 SPEC addressed Finding M in its letter dated July 21,1997. SPEC stated that an in-house audit has b6cq performed and corrective actions are being taken. An independent audit is scheduled and a root cause analysis is scheduled. This corrective action is acceptable and no further response is required.
Please provide a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN.: Document Control Desk, Washington, D.C. 20555, with a copy to Susan F, Shankman, Chief, Transportation Safety and inspection Branch, Spent Fuel Project Office, Office of Nuclear Material Safety and Safeguards, within 30 days of the date of the letter transmitting this Notice of Nonconformance. This reply should be clearly marked as a Reply to a Notice of iknconformance" and should include for each nonconformance: (1) the reason for the nonconformance, or if contested, the basis for disputing the nonconformance, (2) the corre etive steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further noncompliances, and (4) the date when your corrective action will be completed. Where good cause is shown, consideration will be given to extending the response
- time, Dated at Rockville, Maryland This 28th day of August.1997 0
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