IR 07100102/1997211
| ML20216B686 | |
| Person / Time | |
|---|---|
| Site: | 07100102 |
| Issue date: | 08/28/1997 |
| From: | Shankman S NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20216B669 | List: |
| References | |
| 71-0102-97-211, 71-102-97-211, NUDOCS 9709080127 | |
| Download: ML20216B686 (26) | |
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NUCLEAR REGULATORY COMMISSION
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INSPECTION REPORT Spent Fuel Project Office Office of Nuclear Material Safety and Safeguards Docket No:
71-0102 Report No:
71-0102/97-211 Organization:
Source Production and Equipment Company, Inc.
Facility Location:
113 Teal Street St. Rose, LA 70087 NRC Inspection Teams: June 1619.1997 ti Thomas Matula, Team Leader
- William Ward David Tiktinsky Michele Burgess Juiv 9-10.1997 Thomas Matula, Team Leader William Ward
Approved by:
Susan F. Shankman, Acting Deputy Director Spent Fuel Project Office Office of Nuclear Material Safety and Safeguards
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9709080127 970828
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DR ADOCK 071
C Enclosure 1
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Source Production and Equipment Company, Inc.
Docket No. 710102
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EXECUTIVE SUMMARY Source Production and Equipment Company, Inc, U.S. Nuclear Regulatory Commission Inspection Report No. 71-0102/97 211 The U.S. Nuclear Regulatory Commission performed two inspections at Source Production ano Equipment Company, Inc. (SPEC) between June 1619,1997, and another on July 910,1997.
The June inspection concerned the design testing of transportation packages, performed in accordance with the requirements of 10 CFR 71,71, " Normal conditions of transport," and 10 CFR 71,73, " Hypothetical accident conditions " The July inspection concemed SPEC's fabrication activities.
During the Aa 16-19,1997, inspection, the team identified concerns about SPEC's design test performance and evaluation, the test pad SPEC used to perform design tests, and SPEC's quality assurance (QA) program regarding its oversight of design tests and fabrication activities.
SPEC voluntarily stopped fabricating Type B transportation packaging until the concems identified by the team were resolved. On June 24,1997, NRC issued a Confirmatury Action Letter to SPEC co' firming that SPEC had suspended fabrication of all Type B transportation packagings, that SPEC will test the Model SPEC-150 package design, and that SPEC will -
obtain the services of an independent QA expert to audit the effectiveness of SPEC's QA i
program in complying with the requirements of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."
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On June 26,1997, SPEC performed the free drop test and puncture test in accordance with the requitaments of 10 C'FR 71,73 for the Model Nos, SPEC-150, SPEC 2-T, and C-1 Type B transportation packages. On July 2,1997, SPEC submitted the test results to NRC verifying the integrity of the Type B transportation packages.
On July 9-10,1997, NRC inspected SPEC's implementation of its QA program for fabrication activities. The inspection team noted inadequate implementation of SPEC's procedures and inadequate documentation of quality related activities.
The team concluded the following from the June 16-19 and July 9-10,1997, inspections:
Desian Develooment
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SPEC did not document its design development process. SPEC did not document approimately 60 percent of the Model No. SPEC-150 design development,on Design Activity Records. SPEC could not produce Completed Design Review Checklists.
Test Performance and 5 valuation
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SPEC did not perform the hypothetical accident conditions tests for the Model No, SPEC-150 in accordance with the requirements of 10 CFR 71.73, SPEC did not
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perform the tests at the most unfavorable temperature for the feature under consideration. SPEC did not determine the optimallength of the puncture bar to cause maximum damage to the test unit and did not mount the puncture bar on the test pad.
SPEC did not complete documentation for hypothetical accident condition tests.
Dron Taroet
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SPEC did not present an accurate description of its drop target in its application for an NRC Certificate of Compliance (COC).
Fabrication Control
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SPEC used an unapproved and uncontrolled design drawing to procure a part for Type B transportation packaging. SPEC did not formally control changes made to fabrication and test documentation and did not complete required test data sheets.
SPEC did not follow its calibration procedures and was not able to produce training records for personnel calibrating survey meters. SPEC did not control calibrated calipers and used calipers that did not meet calibration requirements. SPEC did not maintain and update its calibration log for calipers.
Quality Assurance
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SPEC did not follow its procurement procedures. SPEC had no procedure that addresses the control of nonconforming material and did not maintain its status report i
for nonconforming material. SPEC did not disposition nonconforming materialin a i
timely manner. SPEC had not approved revisions to drawings. SPEC did not complete Engineering Change Evaluations (ECEs) for revisions made to drawings and used preliminary drawings to fabricate design test prototype units. SPEC used, but did not control, fabrication sketches. SPEC did not control the procurement and receipt inspection of a component important to safety. SPEC did not identify and control the penetration bar and puncture bar used for hypothetical accident testing. SPEC did not perform complete in-process or finalinspections of prototype units. SPEC stored nonconforming parts and components used in Type B transportation packaging in an unsecured fabrication area. SPEC performed no intemal audits since 1991 On July 14,1997, SPEC submitted a " Corrective Action Implementation Plan," to NRC. SPEC stated in its submittal that it planned to resume limited fabrication (maximum of five packagings per week) upon implementation of Phase I corrective actions and authorization by NRC. SPEC enclosed the following documents in its submittal:
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" Corrective Action implementation Plan," which presented its three-phased corrective action plan;
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QA Procedure No. 97 01," Phase I of Corrective Action Implementation Plan for SPEC QA Program"(Plan), which presented the specific actions that SPEC will take in Phase 1 of its corrective action efforts; 3.
" Internal Audit Report,"which describes the findings of SPEC's internal audit of Type B transportation packaging fabrication activities; 4.
"NRC Observations From June 1619,1997, inspection and SPEC Corrective Action,"in which SPEC sumrrarizes what it believes to be the team's preliminary findings resulting from the June 16-19,1997, inspection and the corrective action SPEC took to correct the findings;
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"NRC Observations From July 910,1997, inspection and SPEC Corrective Action,"in which SPEC summarizes what it believes to be the team's preliminary findings resulting from the July 9-10,1997, inspection and the corrective action SPEC took to correct the findings, in its letter dated July 15,1997, NRC informed SPEC that its Plan was acceptable. NRC asked SPEC to report to NRC in writing when the corrective actions described in SPEC's Plan had been completed, i
On July 18,1997, SPEC submitted a letter stating that the activities and corrective actions specified in its Plan had been completed, in that letter, SPEC requested authorization to -
resume limited fabrication. Following a telephone conversation with NRC on July 18,1997, SPEC submitted (on July 21,1997) all corrective actions taken and additional information requested by NRC regarding the corrective action activities.
In a letter dated July 23,1997, NRC informed SPEC that the staff had completed its review of the documentation describing SPEC's corrective action activities, that the implementation of Phase I corrective action was acceptable, and that SPEC was authorized to resume limited fabrication (maximum of five packagings per week) of new Type B transportation packaging.
NRC has reviewed the corrective actions that SPEC described in its July 21,1997, letter. The corrective actions that SPEC presented there, and the acceptability of those corrective actions, are referenced in this Inspection Report and enclosed Notice of Nonconformance.
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' The team found 16 instances of nonconformance with the requirements of 10 CFR Part 71; these nonconformances are summarized in Table 1.
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Table 1 Summary of Nonconformances 10 CFR Report Section Description of Nonconformances No.
Section 71.73 Hypothetical accident conditions
3.1.2 71.105 Quality assurance program
3.2 71.107 Package design contre!
3.1.1 3.2 71,109 Procurement document cortrol
3.3 71.111 Instructions, procedures, and drawings
3.1.2 3.2 3.3 71.113 Document control
3.3 71.115 Control of purchased material, equipment, and services
3.3 i
71,117 Identification and control of materials, parts, and
3.3 components 71.121 Internalinspection
3.3 71.123 Test control
3.1.3 71.125 Control of measuring and test equipment
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71.131 Nonconforming materials, parts, or components
3.3 71.137 Audits
3.3 PERSONS CONTACTED The team held entrance meetings on June 16 and July 9,1997, to present the scope and objectives of the NRC inspections. The team presented its preliminary inspection findings to members of SPEC's management staff at exit meetings on June 19,1997, for the inspection of SPEC's design testing activities and on July 10,1997, for the inspection of SPEC's fabrication
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Docket No. 71 0.102 activities. SPEC management acknowledged the findings after each inspection exit meeting and outlined corrective actions that it planned to take. Individuals present at the entrance and exit meetings are listed in Table 2.
Table 2 Entrance / Exit Meeting Attendees
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June 16-19,1997, inspection M. Burgess NRC, Technical Specialist
K. Carrington SPEC, Special Projects Manager R. Dicharry SPEC, President M. Frizell SPEC, Quality Assurance Manager M. Henry Louisiana Division of Radiation Protection
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J. Jankovich NRC, Section Chief, Transportation and Storage
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Inspection Section T. Matuta NRC, inspection Team Leader G. Moran SPEC, Vice President D. Tiktinsky NRC, Technical Specialist W. Ward NRC, inspector P. Weber SPEC, General Manager July 910,1997, inspection K. Carrington SPEC, Special Projects Manager R. Dicharry SPEC, President M. Frizell SPEC, Quality Assurance Manager J. Fryer SPEC, Engineering Manager T. Matula NRC, inspection Team Leader G. Moran SPEC, Vice President W. Ward NRC, inspector P. Weber SPEC, General Manager Present at entrance meeting only.
- Present at exit meeting only.
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Docket No. 71-0102 ACRONYMS USED COC Certificate of Compliance ECE Engineering Change Evaluation DU Depleted Uranium MoC Manufacturing Sciences Corporation NCR Nonconformance Report NRC U.S. Nuclear Regulatory Commission PO Purchase Order -
QA Quality Assurance SPEC Source Production and Equipment Company, Inc.
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SPEC DOCUMENTS REFERENCED
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" Corrective Action Implementation Plan," Revision 0, July 14,1997.
" Internal Audit Report," Revision 0, July 12,1997.
"NRC Observations From July 9-10,1997, inspection and SPEC Corrective Action," July 11, 1997.
"NRC Observations From June 16-19,1997, inspection and SPEC Corrective Action," July 11,
'1997.
" Revised Application for NRC Certificate of Compliance" for the Model SPEC 150, Rev'.',lon 1, March 5,1995,
" Test Report To Validate Previous 10 CFR Part 71 Puncture Tests M'odel SPEC-150 Type B(U)
Package," Supplement No. 4, July 1,1997.
Drawing No. 102089-11, "C-1 Outlet Nipple Boss," Revision 0.
Drawing No.15B000, " SPEC 150 Type B(U) Package - Isometric View," Revisions 1 and 2, March 6,1995, and April 4,1995, respectively, Drawing No.15B0002A, " SPEC 150 Exposure Device - Full Sectional View," Revision 4, September 21,1995.
Drawing No.15B008, " SPEC 150 Type B(U) Package - Deplated Uranium Shield," Revisions 0, 1, and 2, December 18,1994; March 1,1995; April 13,1995, respectively.
Procedure No. QAM 3.0," Design Control," Revision 3, March 11,1992.
Procedure No. QAM 4.0, " Procurement Document Control," Revision 3, July 31,1995.
Procedure No. QAM 5.0, " Instructions, Procedures, and Drawings," Revision 1, January 21, 1992.
Procedure No QAM 6.0," Document Control," Revision 5, July 10,1995.
Procedure No. OAM 10.0, " Inspection," Revision 5, April 20,1996.
Procedure No. QAM 11.0," Testing," Revision 3, April 20,1996.
Procedure No. QAM 12,1,* Calibration of Radiation Survey Meters," Revision 0, May 9,1990.
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Procedure No. QAM 15.0, " Control of Nonconforming Material," Revision 3, March 17,1993.
Procedure No, QAM 18.0, " Quality Assurance Audits," Revision 2, January 21, "992.
Procedure No. 6.10, " Survey Meter Calibration," Revision 2, June 17,1996.
Procedure No. 6.15," Calibration of Radioactive Source Activity Measurement instrumentation,"
Revision 1, June 17,1996.
Procedure No. 7.22, " Caliper Calibration," Revision 0, June 17,1992.
QA Procedure No. 97-01, " Phase I of Corrective Action implementation Plan for SPEC QA Program," Revision 0, July 13,1997.
QA Manual. Revision 2.2 May 25,1991.
' Status Report, Nonconforming Material," January 29,1997.
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REPORT DETAILS
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1.
INSPECTION OBJECTIVES AND SCOPE The team performed two inspections at SPEC. On June 1619,1997, NRC performed an inspection to determine whether SPEC's design and testing of transportation packages were performed in accordance with the requirements of 10 CFR 71.71 and 71.73. On July 9-10, 1997, NRC performed an inspection of SPEC's QA program implementation for fabrication activities to verify compliance with the requirements of 10 CFR Part 71, Subpart H, * Quality Assurance."
2.
BACKGROUND SPEC holds three COCs for packagings to transport special form radioactive material. NRC inspected SPEC to assure that SPEC performed design, testing, and fabrication activities in accordance with the requirements of 10 CFR Part 71.
3.
INSPECTION RESULTS 3.1 DESIGN AND TESTING CONTROLS The team reviewed SPEC's design activities, procedures, work instructions, test plans, test reports, QA audit schedules and reports, procurement records, personnel qualification records, and measuring and test equipment control documents regarding orototype design and testing of Type B transportation packages. The team also interviewed SP5C personnel responsible for
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engineering design and testing activities.
3.1.1 DESIGN DEVELOPMENT Insoection Sqqng The team reviewed SPEC's design development process. The team examined original design documents and design modifications to ensure that adequate evaluations and reviews were
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performed by qualified personnel.
Observations and Findinas The team identified a nonconformance with the requirements of 10 CFR 71.107, " Package design control." This section requires that the licensee estabhsh measures to assure that applicable regulatory requirements and the package design are correctly translated into specifications, drawings, procedures, and instructions. Likewise, Procedure No. QAM 3.0,
" Design Control," states that all new package designs will be reviewed to verify conformance with 10 CFR Part 71 and documented on the Design Review Checklist. Design meetings will be documented on the Design Activity Record that will be maintained for the life of the package.
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The team identified instances having minor safety significance where package design activities were not controlled.
SPEC did not document its design development process. Specifically, the team determined that approximately 60 percent of the Model No. SPEC 150 design development was documented only by meeting minutes and was not documented and approved on Design Activity Records. SPEC could not present the inspection team any completed Design Review Checklists.
Conclusions SPEC did not document its design development process. SPEC did not document approximately 60 percent of the Model No. SPEG-150 design development on Design Activity Records. SPEC could not produce Completed Design Review Checklists.
3.1.2 TEST PERFORMANCE AND EVALUATION Insoection Scone The team reviewed design, test, and inspection procedures, acceptance criteria, test conditions, test documentation, and QA oversight of engineering test activities. The team ensured that design control was maintained, engineering and QA personnel were qualified, and tests and inspections were controiled, comprehensive, verifiable, and traceable. The team verified that the procedures controlling testing and inspection were documented, approved, and implemented.
Observations and Findinos The team identified a nonconformance with the requirements of 10 CFR 71.73, ' Hypothetical accident conditions." This section requires that the ambient air temperature remain constant at that value between -20' F and +100* F which is most unfavorable for the feature under consideration. This section also requires a free drop of the test unit through a distance of 30 feet onto a flat, essentially unyielding, horizontal surface, striking the surface in a position for which maximum damage is expected. This section also requires a free drcp of the test unit through a distance of 40 inches in a position for which maximum damage is expected, onto the upper end of a solid, vertical, cylindrical, mild steel bar mounted on an essentially unyielding, horizontal surface. This section also requires the bar to be a length that will cause maximum damage to the test unit, but be at least 8 inches long The team identified instances where the required test conditions were not met. These findings have high safety significance because the performance of the packagirig has not been proven.
1.
SPEC did not perform hypothetical accident conditions tests at the most unfavorable temperature. Specifically, SPEC indicated in its test report for the Model No. SPEC-150 that the Prototype Serial No. 2 was tested at an ambient temperature of +85' F. In its
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Docket No. 710102
" Revised Application for NRC Certificate of Compliance" for the Model SPEC-150, SPEC stated that the test at a cold temperature was not performed because, due to the methods of construction, cold temperatures would not adversely affect the package.
However, SPEC told the team that it believed a cold temperature would be the most unfavorable condition at which to pedorm the test. SPEC could not present written justification for testing the unit at ambient temperature rather than at a cold temperature.
Likewise, SPEC tested Prototype Serial No. 4 at ambient temperature (the actual temperature was not recorded on the data sheet), also with no written justification presented.
SPEC stated in its " Test Report To Validate Previous 10 CFR Part 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 chilled in dry ice to a temperature below-80 degrees Fahrenhait and successfully passed the tests specified in 10 CFR 71.73.
This corrective action is acceptable and no further response is required.
2.
SPEC did not mount the puncture bar on the test pad. Specifically, SPEC did not secure the puncture bar to the steel plate on its test pad. The puncture bar was free to move after the test unit impacted it. The team reviewed the video of the puheture test performed on the Model No. SPEC-150 supplied by SPEC and found that the puncture bar moved laterally several inches out from under the test unit during the puncture test.
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
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acceptable and no further response is required.
3.
SPEC could not present documentation showing that it performed an analysis to determine the optimallength of the puncture bar that would cause maximum damage to the test unit. Specifically, SPEC used a puncture bar that met the minimum length requirement of 8 inches to perform the puncture test. SPEC could not present documentation to the team indicating that it performed an analysis to determine the optimallength of the puncture bar to cause maximum damage to the test unit.
SPEC stated in its " Test Report To Validate Previous 10 CFR Part 71 Puncture Tests Model SPEC-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.
The team observed that SPEC performed puncture tests required by 10 CFR 71.73 with a puncture bar that did not appear to be solid. The bar appeared to be a steel pipe, having an outside diameter of 6 inches and a wall thickness of 0.5 inch, The pipe appeared to be fillsd with a solid steel bar 5 inches in diameter and tack welded to the outer pipe at 90-degree
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Docket No. 71-0102 intervals on both ends. The team did not see any gaps t,etween the pipe and the inside bar.
The overall bar weighed 63.5 pounds, which is an acceptable weight given the density of steel and the volume of the bar. During the inspection, SPEC showed the team a recently procured steel bar,6 inches in diameter and 12 inches long, which SPEC will use in future tests.
The team identified a nonconformance with the requirements of 10 CFR 71.111, " Instructions, procedures, and drawings." This section requires the licensee to prescribe activities affecting quality by documented instructions, procedures, or drawings and requires that these instructions, procedures, and drawings be followed. The team identified instances having minor safety significance where procedures were not followed.
SPEC did not complete documentation for hypothetical accident conditions tests. Specifically, SPEC performed hypothetical accident conditions tests on Model No. SPEC-150 Prototype Serial No. 2 on July 23,1994, and on Prototype Serial No. 4 on August 26,1994. The team a
identified the following documentation issues in the test report:
1.
For Prototype Serial No. 2, SPEC did not record the data value for the radiation survey reference factor in the post-test. SPEC did not correct the listed source size to 150 Ci after extrapolating the final radiation levels out to a 150 Ci level.
2.
SPEC did not approve test documentation. Paragraph 8.0," Approval To Proceed," of the test report requires the dated signatures of the General Manager, Production Manager, QA Manager, and Research & Development Manager. Paragraph 10.0," Test Approval," of the test reprrt requires the signatures of the General Manager and QA Manager.
A.
For Prototype Serial No. 2, the team found that the General Manager, Production Manager, and Research and Development Manager did not sign the " Approval To Proceed" as required by Paragraph 8.0. The QA Manager did sign the Approval To Proceed, but this signature was not dated. The team also found that the General Manager did not sign the " Test Approval," as required by Paragraph 10.0. Finally, the team found that the " Report Approved By" signature on the last page of the report was missing.
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For Prototype Serial No. 4, the team found that the Production Manager and Research & Development Manager did not sign " Approval To Proceed" as required in Paragraph 8.0. The team also found that the QA Manager did not sign the " Test Approval" for Test Report No. 0628C94, as required by Paragraph 10.0.
C.
For Prototype Serial No. 4, SPEC did not indicate, for both the pre-and the post-test radiation readings, who made the measurements, what survey instrument was used to make the measurement, and what the calibration status of the instrument was when used to measure radiation levels of Prototype Unit No. 4.
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Concluelons SPEC did not perform the hypothetical accident conditions tests for the Model No. SPEC-160 in accordance with the requirements of 10 CFR 71.73. SPEC did not perform the tests at t6e most unfavorable temperature for the faature under consideration. SPEC did not determire the optimallength of the puncture bar to cause maximum damage to the test unit and did not rr ount the puncture bar on the test pad. SPEC did not complete documentation for hypothetical a ;cident condition tests.
3.1.3 DROP TARGET Insoection Scoce The team reviewed the drop target to determine if it is an essentially unyielding surface as required by 10 CFR 71.73. The team investigated the condition of the test pad to assure that it
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will still perform its intended function.
Observations and Findings The team identified a nonconformance with 10 CFR 71.123, " Test Control." This 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 accordance 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 the test is performed under suitable environmental conditions. The licensee shall document and evaluate the test results to assure that test requirements have been satisfied. The team identified an instance having minor safety significance where test conditions were not defined.
SPEC did not accurately describe its drop target in its application for an NRC COC.
Specifically, SPEC presented a description of its drop target in its Model No. SPEC-150
" Revised Application for NRC Certificate of Compliance," Revision 1 dated March 5,1995.
SPEC stated in the revised application that the drop target consists of a 1.75-inch thick solid carbon steel plate that measures 18 inches by 35 inches; the steel plate was wet-floated onto the top surface of a flat horizontal concrete block that measures 54 inches on each side; the total weight of the drop target is 14,188 pounds; and the concrete block is reinforced with metal.
The team inspected the drop target and available construction documentation and determined that:
1.
SPEC did not wet float the steel plate onto the top surface of the concreto block. SPEC wet-floated the steel plate onto a 1-inch-thick layer of "10,125 PSI Tigergrout."
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The concrete block did not measure 54 inches on each side. The concrete block measured 46 inches by 46 inches by 56 inches.
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3.
The total weight of the drop target was nc: 14,188 pounds. The total weight of the drop target was 10,500 pounds.
4.
SPEC did not reinforce the concrete block with metal.
SPEC revised the description of the drop target to NRC in the " Test Report To Validate Previous 10 CFR Part 71 Puncture Tests Model SPEC-150 Type B(U) Package." This corrective action is acceptable and no further response is required.
Conclusions SPEC did not present an accurate description of its drop target in its application for an NRC COC.
3.2 FABRICATION CONTROL Insoection Scoce
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Ooservations and Findinas The team identified a nonconformance with the requirements of 10 CFR 71.105, " Quality assurance program." This section requires the licensee to provide for indoctrination and training of personnel performing activities affecting quality as necessary to ensure that suitable proficiency is achieved and maintained. Likewise, Paragraph 2.5, " Training," of SPEC's QA Manual states that instruction of employees directly associated with QA will be performed and records of such training will be maintained. Procedure No. QAM 2.1," Training of Personnel,"
states that s7eific training for assigned functions will be given to employees in specified categories before the delegation of responsibility for the assigned QA function. The team identified an instance having minor safety significance where training was not performed.
SPEC was not able to produce records showing that the individual who calibrated survey meters in accordance with SPEC Procedure No. 6.10, " Survey Meter Calibration," Revision 2, dated June 17,1996, and SPEC Procedere No. 6.15, " Calibration of Radioactive Source Activity Measurement Instrumentation," Revision 1, dated June 17,1996, was trained.
SPEC addressed this finding in its letter dated July 21,1997. SPEC stated that the QA Manager has certified those persons involved in receiving, in-process inspections, final inspections, surveys, calibration of survey meters, welding, and welding instruction. The QA Manager has revised 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 the
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Docket No. 71-0,102 company's training matrix, to schedule training, and to periodically review each employee's training records. This corrective action is acceptable and no further response is required.
The team identified a nonconformance with the requirements of 10 CFR 71.107, " Design control." This action 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. Likewise, Section 3.0," Design Control," of the SPEC QA Manual states that procedures are established by the President to specify appropriate standards and requirements, and control revisions. The team identified an instance where packaging design was not controlled. This finding has a high safety significance because
inaccurate control can lead to unacceptable product fabrication and unsafe performance.
SPEC changed a design dimension referenced in COC No. 9036 and used the unapproved and uncontrolled design drawing to procure a part for the Model No. C-1 packaging. Specifically, Drawing No. 10208911 "C-1 Outlet Nipple Boss," specifies the boss height at 0.5 (+0 -1/8)
inch. This drawing is consistent with Drawing No. 11489-2 for the Model No. C 1 packaging referenced by COC No. 9036. However, the team found that SPEC photocopied Drawing No.102089-11, changed the boss height to 0.380 (t 0.005) inch, and used it to procure the boss as hdicated on SPEC Purchase Order (PO) No.11580, dated October 8,1991. The team noted that the drawing used to procure the boss did act have a drawing number but did have the approval signature and date of the original drawing. SPEC also marked this drawing with the note "Not a QA document."
SPEC addressed this findhg in its letter dated July 21,1997. SPEC stated that the corrective
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action that will be taken.o assure that drawings referenced in SPEC COC applications to NRC are correct will be to ',stablish a link between fabrication drawings and the drawings referenced in the application. 'iowever, SPEC did not address the failure in the QA program that allowed a Type B transportation packaging part to be procured and receipt-inspected using an unapproved and uncontrolled drawing.
The team identified a nonconformance with the requirements of 10 CFR 71.111," Instructions, procedures, and drawings." This section requires the licensee to prescribe activities affecting quality by documented instructions, procedures, or drawings and requires that these instructions, procedures, and drawings be followed. Likewise, Procedure No. QAM 5.0,
" Instructions, Procedures, and Drawings," states that the use and adherence to the instructions, procedures and drawings are required pursuant to the QA Manual. The team identified instances having minor safety significance where procedures were not followed.
1.
SPEC did not formally control changes made to fabrication and test documentation.
Specifically, SPEC uses travelers to control the fabrication of Model No. SPEC-150 packaging by identifying the assembly process, required parts, test points, and QA inspection points. SPEC controls changes made to travelers by Procedure No. QAM 5.0," Instructions, Procedures and Drawings." Procedure QAM 5.0 requires the use of ECEs to assure control of the fabrication process. SPEC engineering and QA
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Source Production and Equipment Company, Inc.
Docket No. 710102
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personnel told the team that changes to the travelers should be formally controlled using Procedure No. QAM 5.0 However, SPEC deleted three parts, changed two parts, and -
added three parts to the ' SPEC-150 Main Traveler,' Serial No. 458, without the using an ECE. SPEC deleted Part No. 150805, " Safety Plug," deleted from the traveler. The team reviewed the Safety Plug Traveler No.150805, Lot No. 080596, for a quantity of 32 safety plugs and found that the traveler was also changed to add a part without the use of an ECE.
'2.
SPEC did not complete required test data sheets. Specifically, Procedure No. QAM 11.0, " Testing," specifes that alI tests will be performed in accordance with
_
written test procedures. SPEC entered hand written corrections (including corrections to radiation levels) on test data sheets documenting the test results for the Model No. SPEC-150, dated July 23,1994, and did not record certain data values.
3.
SPEC did not control nonconforming material. Specifically, Procedure No. QAM 15.0,
" Control of Nonconforming Material," specifies that in receiving a nonconforming part, QA will complete a Nonconformance Report (NCR) for each defect discovered. SPEC receiving inspectors inspecteJ a Depleted Uranium (DU) shield casting, Serial No. 2970, on January 10,1996, and found that the width of the DU shield measured 4.710 inchss instead of the required maximum width of 4.687 inches. SPEC identified the DU shield dimensions in the drawings identified by the COC, and SPEC classified the shield as iniputent to safety. However, SPEC did not complete an NCR for this DU shield and accepted it without formal justification.
The team identified a nonconformance with the requirements of 10 CFR 71.125, " Control of measuring and test equipment." This section requires the licensee to establish 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; SPEC does not have a detailed procedure for verifying the accuracy of a survey meter.
Specifically, Procedure No. QAM 12.1, " Calibration of Radiation Survey Meters," states that the accuracy of any survey meter used to perform inspections will be verified immediately before conducting such inspections. However, this procedure did not contain the process for performing the survey meter verification.
SPEC told the team that it uses Procedure No. 6.10, " Survey Meter Calibration," to verify the accuracy of survey meters. However, this procedure did not contain the process to perform the verification.- Paragraph 7.5.2 of this procedure instructs the technician to adjust to within t10 percent at one-fifth and four-fifths of full scale. SPEC did not produce any further survey meter verification instructions.
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Source Production and Equipment Company, Inc.
Docket' No. 71-0102
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SPEC addressed this finding in its letter dated July 21,1997. SPEC stated that Procedure No. 6.10 has been revised and will be reviewed before the next survey of Type B transportation packages. This corrective action is acceptable and no further response is required.
2.
SPEC did not follow its calibration procedure. Specifically, Enclosure 7 to Procedure No. 6.15," Calibration of Radioactive Source Activity Measurement instrumentation,"
specifies the required distance between the ceslum 137 calibration source and the survey meter being calibrated to obtain specific activity readings. SPEC specified in Enclosure 7 a distance of 112.82 inches (for 1997) between the source and the survey meter to obtain a reading of 2 mR/hr. To reduce this distance and make it more manageable, SPEC used an attenuator to reduce the dose rate. However, Procedure No. 6.15 did not define this attenuation process and SPEC did not calibrate, identify, or control the attenuator.
SPEC addressed this finding in its letter dated July 21,1997. SPEC stated that the attenuator has been calibrated and will be logged onto the QA program. An analysis 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.
SPEC calibrated a survey meter without using a procedure. Specifically, Procedure No. 6.10 requires that survey meters be calibrated at one-fifth and four-fifths of full scale. SPEC specified in Enclosure 7 to Procedure No. 6.15 that the distance required between the calibration source and the survey meter. This table is applicable only to survey meters with measurement ranges of 0-10 mR/hr,0-100 mR/hr, and 0-1000 mR/hr. However, SPEC calibrated a Model No. E-120 survey meter, Serial No.12972, on April 1,1997, that has measurement ranges of 0-0.5 mR/hr,0-5 mR/hr, and 0-50 mR/hr. Because of the different measurement ranges, the distances specified in Enclosure 7 to Procedure No. 6.15 cannot be used to calibrate this survey meter. SPEC personnel told the team that they determined the distances required between the calibration source and the survey meter by interpolating the distances specified in Enclosure 7 to Procedure 6.15. However, SPEC could not produce the calculations or the actual distances used to calibrate the Model No. E-120 survey meter.
4.
SPEC did not evaluate the consequences of using calipers that were out of calibration.
Specifically, Paragraph 12, " Control of Measuring and Test Equipment," of the QA Manual states that whenever an instrument is determined to be out of calibration the consequences will be evaluated and documented. The team asked the SPEC QA Manager how calipers are removed from service. The QA manager located three calipers in his desk drawer that had been removed from service before the end of their calibration cycles because their performance was questionable. However, SPEC could not produce documentation showing that the consequences of the calipers being out of calibration during use had been evaluated. The team also noted that the three calipers
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Sour,ce Production and Equipment Cor"pany, Inc.
Docket No. 71-0102
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had calibration stickers st.ll att.
.ed to them. To avoid inadvertent use, industry practice is to remove or tieface c libration stickers when an item is considered to be out of calibration.
S.
SPEC did not control calibrated calipers The team identified the following instances where SPEC did not update its calibration log with current information and where SPEC put a defective caliper back in use:
,
A.
SPEC used calipers that do not meet calibration requirements. Specifically, Paragraph 7.1 of Procedure No. 7.22,' Caliper Calibration," requires a tolerance of i 0.0005 inch for calipers used calibrate jigs and fixtures. The team identified three calipers, Serial Nos 0022729,0022723, and G802273, that differed from the standard by 10.0010 inch. SPEC assigned these calipers to and QA personnel who were using them.
B.
SPEC did not maintain its calibration log for calipers. Specifically, SPEC maintains a calibration log to track caliper calibration cycles. The log contains one row for each caliper, each containing six columns of information. The current log, dated December 19,1996, listed 36 calipers. Of the 36 calipers listed on the log, SPEC had made handwritten changes to the information for 20 calipers in at least one of the columns.
C.
SPEC failed to update its calibration log for calipers. Specifically, SPEC entered into its calibration log, for caliper Serial No. 111893, the calibration date of November 8,1996, and a calibration due date of May 8,1907. The team inspected the caliper and found that the calibration sticker showed a calibration date of May 9,1997, and a calibration due date of November 9,1997. SPEC did not update the log to show the current calibration information. Additionally, the calibration log had a note in the comment column which read "First 0 Bad."
SPEC's QA manager told the team that a segment of the left-most digit of the caliper's digital display had failed and this is why the caliper was removed from service on December 19,1996. However, on May 9,1997, SPEC calibrated, and put back in use, this defective caliper.
D.
SPEC used a caliper with a known defect. SPEC entered a comment in the note column of its calibration log for caliper Serial No. Starret #120 which read *-0.006 FR DEP." SPEC's QA manager told the team that this note was meant to be an instruction for the user to subtract.006 inches from depth measurements. SPEC attached a note next t> the calibration sticker on the caliper with the instruction
" Subtract 0.006 inch from depth reading for the true depth." However, SPEC
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modified this typed nnte by changing the 0.006 inches to either 0.004 inches or 0.005 inches. SPEC mad?e his change with blue ink and it was illegible.
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Source Production and Equipment Company, Inc.
Docket No. 710102 SPEC addressed this finding in its letter dated July 21,1997. SPEC stated that the caliper procedure will be reviewed and revised as needed. All calipers will be removed from service untJ proven that they are in calibration and marked accordingly, Fixtures and jigs will be recalibrated. QA personnel will be retrained. This corrective action is acceptable and no further response is required.
Conclusions
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SPEC used an unapproved and uncontrolled design drawing to procure a part for Type B transportation packaging. SPEC did not formally control changes made to fabrication tnd test documentation and did not complete required test data sheets. SPEC did not follow its calibration procedures and was not able to produce training records for personnel calibrating survey meters. SPEC did not control calibrated calipers and used calipers that did.not meet calibration requirements. SPEC did not maintain and update its calibration log for calipers.
3.3 QUALITY ASSURANCE Insoection Secoe The team reviewed the implementation of SPEC's QA program for controlling the packaging certification process, overseeing engineering and testing activities, and controlling fabrication activities. The team reviewed activities regarding procurement, development and implementation of plans and procedures, document control, fatrication, inspection, testing, control of test equipment, and QA oversight.
Observations and Findinas The team identified a nonconformance with 10 CFR Part 71,109, " Procurement document control." This section requires the licensee to establish measures to assure i;mt adequate quality is required in the documents for procurement of material, equipment, and services.
Likewise, Section 4.0, " Procurement Document Control," of the QA Manual states that procurement documents pertaining to materials and services will be reviewed and approved by signature or the QA Manager. The team identified an instance where the procurement of material was not controlled.
SPEC processed a PO without the review and approval of the QA Manager Specifically, SPEC issued PO No. 3152, to Mid South Tool Supply, West Memphis, Arizona, on April 25,1997, to purchase a steel bar to be used to perform the puncture test soecified in 10 CFR 71,73. The QA Manager did not sign the PO for the steel bar, and SPEC did not identify the QA requirements.
The team identified a nenconformance with the requirements of 10 CFR 71.111, " Instructions, procedures, and drawings.' This section requires the licensee to prescribe activities affecting quality by documented instruction, procedures, or drawings. Likewise, Section 5.0 of the QA
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Source Production and Equipment Company, Inc.
Docket No. 71-0102 Manual states that all functions performed during fabrication, assembly, use and maintenance that affect package quality will be specified by written procedures, instructions, and drawings.
The team identified an instance having minor safety significance where SPEC did not have a required procedn.
SPEC did not have a procedure for tracking the status of nonconforming material t) assure that all nonconforming msterialis controlled and dispositioned. Specifically, the team laspected SPEC's process for controlling nonconforming material. SPIC's QA Manager gave the team a documem, " Status Report, Nonconforming Material,' dated January 29,1J97. The team raised the followin,1 concerns about SPEC's ability to maintain control cf nonconforming material:
1.
SPE.C had no procedure addressing the control of nonconforming material. Specifically, SPEG has not formalized its status report.
2.
SPEC did not maintain its status report for nonconforming material. Specifically, the status report has ons row for each NCR issued, each containing seven columns for information. SPEC last updated the status report on March 21,1997. The status report has 19 NCRs listed and the NCR numbers start with No. 502 and end with No. 723, SPEC could not account for 203 NCRs missing from the status report.
3.
SPEC did not disposition nonconforming materialin a timely manner. Specifically, the first NCR listed on the status report is No. 502, which was issued on December 20, 1995. SPEC issued six more NCRs in 1996 and SPEC issued 12 more NCRs in 1997.
SPEC closed only the last five NCRs, which SPEC issued in March 1997. SPEC did not close the remaining 14 NCRs.
The team identified a nonconformance with the requirements of 10 CFR 71.113, ' Document control." This section requires the licensee to establish measures to control the issuance of documents such as instruction, procedures, and drawings, including changes, which prescribe 311 activities affecting quality. Likewise, Procedure No. QAM 6.0,' Document Control," states that the procedure is applicable to all drawings and instructions, that the President will approve all radioactive material package design changes, and that indexes of all drawings and work instructions are maintained by the QA Department. The team identified instances having minor safety significance where design documents were not controlled.
1.
SPEC did not approve revisions to drawings. Specifically, the team determined that the following drawing revisions were not approved:
Drawing No.15B000, "SPFO 150 Type B(U) Package - Isometric View,"
.
Revision 1 Drawing No.15B0002A, " SPEC 150 Exposure Device - Full Sectional View,"
.
Revision 4
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Source Production and Equipment Company, Inc.
Docket No. 71-0,102 Drawing No.15B008," SPEC 150 Type B(U) Package Depleted Uranium
.
Stjeld," Revisions 0 and 2 2.
SPEC did not complete ECEs for revisions made to drawings. Specifically, changes made to drawings are controlled by Procedure No. QAM 5.0, " Instructions, Procedures and Drawings." Procedure QAM 5.0 requires the use of ECEs to assure control of the design change process. SPEC could not show the team ECEs for the following drawing revisions:
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.
SPEC used preliminary drawings to fabricate design test prototype units. Specifically, the team found th t SPEC's drawings defining the Model No. SPEC-150 prototype units are marked "Prehminary," and are not approved by the President. SPEC used these preliminary drawings to fabricate the units used in design testing.
4.
SPEC did not control fabrication sketches. Specifically, SPEC used the following v. etches to fabricate Model No. SPEC-150:
SK 150202, " Lock End Plate Button Head Socket Bolt,' Revision 1,
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September 15,1994 SK 150406," Outlet Panet Assembly," Revision 1, December 6,1994
.
SK 150508," Source Lock and Shaft Assembly," Revision 1, September 2,1994
.
SK 150520," Device Lock Shaft and Lock Arm Assembly," Revision 1
.
August 31,1994 SK 150703, * Sear Linkage," Revision 1, September 22,1994 a
Regarding SPEC's use of sketches in its fabrication of Type B transportation packaging, the team found the following:
A.
SPEC's Procedure No. QAM 6.0 did not address the control of fabrication sketches.
B.
SPEC approved Sketch No. SK 150406; however, SPEC did not approve the remaining sketches.
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Source Production and Equipment Company, Inc.
Docket No. 710102 C.
SPEC did not reference the use of Sketch No SK 150703 on the fabrication traveler.
The team identified a nonconformance with the requirements of 10 CFR 71.115, * Control of purchased material, equipment, and services.' This section requires the licensee to establish
.
measures to assure that purchased material, equipment, and services conform to the
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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 subantractor 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. The team identified an instance where the purchase equipment was not controlled.
SPEC did not control the procurement and receipt inspection of a component important to safety. This finding has high safety significance because of the potentialimpact on'the operation of the Type B transportation packaging and safety to the public. Specifically, SPEC classified u important to safety the DU chields installed in Type B transportation packaging.
The team Lund the following problems regarding the procurement and receipt inspection of the DU shields:
1.
SPEC placed PO No 59590, dated February 14,1995, with Manufacturing Sciences Corporation (MSC), Oak Ridge, Tennessee SPEC issued the PO was for the manufacture of Model Nos. SPEC 2 T and SPEC 150 DU shields. Procedure No. QAM 4.0, ' Procurement Document Control,' states that each supplier will be evaluated by the QA Manager and the type of evaluation will depend on the aritical nature of the product to be purchased. In this instance SPEC determined that the DU shields were critical because they are important to safety. The team determined that MSC was not on SPEC's ' Approved QA Vendor Master File Listing' for 1994 when the o, der was placed. The team also determined that SPEC did not perform an onsite evaluation of MSC's capabilities nor did SPEC audit MSC's QA program.
.
2.
SPEC Procedure No. 4.0 states that the manufacturer of DU shields must complete and return tho SPEC Certificate of Supplier Conformance (Form No. QA 4.2) with each shipment of material to SPEC. In its PO, SPEC required MSC to send h signed copy of SPEC's Certliicate of Supplier Compliance with each shipment certifying that the QA requirements have been met. SPEC was not able to show the team the Certificates of Supplier Compliance for 108 Model No SPEC 150 and 23 Model No. 2 T DU shields shipped from MSC to SPEC between September 1995 and May 1996.
.
The team identified a nonconformance with the requirements of 10 CFR 71.117, " identification and control of materials, parts, and components.' This section requires the licensee to entablish 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 i
number, or other appropriate means, either on the item or records traceable to the item
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Source Production and Equipment Company, Inc.
Docket No. 710,102
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throughout use of the item. Likewise, Section 8.0," Identification and Control el Materials, Parts and Components," of the QA Manual states that all material will be identified by part number, which will be located either on the item or on records associated with the item. The team identified an instance having minor safety significance where mater'al was not controlled.
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. Specifically, SPEC was not able to product documentation regarding the procurement of the penetration and puncture bars.
SPEC also could not produce documentation indicating that the bars were receipt inspected and accepted as meeting the requirements of 10 CFR Part 71. Lastly, SPEC did not identify the bars with unique part numbers and did not control them to prevent their use for other purposes.
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 instructions, procedures, and drawings for accomplishing the v1vity. Similarly, Procedure No. QAM 10.0,
"Irispection," states that parts, components, and subassembliss throughout their intermediate stages of fabrication are inspected at specified points in the fabrication procedure. These inspections are recorded on the appropriate in process inspection report form. Finalinspect!on will not be performed on parts or assemblies until the inspector has verified that all required in-process inspections have been satisfactorily tmmpleted. The completed finalinspection report forms will be maintained on file. The team identified an instance having miaor safety significance where internal inspections were not performed.
SPEC did not perform complete in process or finalinspection of prototype units. Specifically, SPEC used Model No. SPEC 150 prototype units (Serial Nos. 2 and 4) to perform design testing in accordance with 10 CFR 71.7S. However, SPEC could not present the team with records documenting allin process and final inspections for the Model No. SPEC 150 prototype units Serial Nos. 2 or 4. SPEC produced records of in process weid inspections but did not show any documentation demonstrating that the prototype units were fabricated in accordance with the design drawings. SPEC also could not produce records documenting performance of final inspection for the Model No. SPEC 150 prototype unit, Serial No. 4.
The team identified a nonconformance with the requirements of 10 CFR 71,131,
- Nonconforming materials, parts, or components.' This section requires the licensee to establish measures to control materials, parts, or components that do not conform 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. Likewise, Procedure No. QAM 15.0, ' Control of Nonconforming Material,' states that a Nonconforming Material Repc'rt, Form 15.1, will be filled out, nonconforming material will be tagged with a red reject tag, and nonconforming material will be placed in a hold area accessible to QA and management staff only. The team identified an instance having minor safety significance where nonconforming parts were not controlled.
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Source Production and Equipment Company, Inc.
Docket No. 71-0102
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The team found nonconforming parts and components used in Type B transportation packaging in an unsecured fabrication area, SPEC did not have Nonconforming Material Reports, did not have red reject tags, and did not segregate the nonconforming parts and components.
SPEC addressed this finding in its letter dated July 21,1997. SPEC stated that nonconforming material will be separated in a QA controlled, locked area. Allin process work will be reviewed and tagged properly. This corrective action is acceptable and no further response is required.
The team identified a nonconformance with the requirements of 10 CFR 71.137, ' Audits.' This section requires the licensee to carry out a comprehensive system of plannsd and periodic audits, to verify compliance with all aspects of the QA program, and to determine the effectiveness of the program. Likewise, Procedure No. QAM 18.0, * Quality Assurance Audits,"
states that internal management audits will be performed annually. In addition, QA will periodically audit procedures to assure compliance. This QA audit will be completed on every procedure at least annually. The team identified an instance where audits were not performed.
Thit. finding has high safety significance because many of the findings identified by the team would be identified by a qualified aud!!or during a comprehensive audit.
SPFC did not perform internal audits in the last 4 years. Specifically, SPEC performed its last internal audit on February 18,1993. SPEC could not produce an audit plan or schedule for 1997. The team noted that audits were performed by independent auditors in January 1994 and February 1995. However, the independent auditor should have identified the findings found by the team during a comprehensive QA audit.
,
SPEC addressed this finding in its letter dated July 21,1997. SPEC stated that an in house audit has been performed and corrective actions are being taken. An independent audit and a root cause analysis are scheduled, This corrective action is acceptable and no further response is required.
Conclusions SPEC did not follow its procurement procedures. SPEC had no procedure that addresses the control of nonconforming material and did not maintain its status report for nonconforming material. SPEC did not disposition nonconforming materialin a timely manner. SPEC had not approved revisions to drawings. SPEC did not completa ECEs for revisions made to drawings and used preliminary drawings to fabricate design test prototype units. SPEC used, but did not control, fabrication sketches. SPEC did not control the procurement and receipt inspection of a component important to safety. SPEC did not identify and control the penetration bar and puncture bar used for typothetical accident testing. SPEC did not perform complete in process or finalinspections of prototype units. SPEC stored nonconforming parts and components used in Type B transportation packaging in an unsecured fabrication area. SPEC performed no internal audits since 1993,
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Source Production and Equipment Company, Inc.
Docket No. 71 0,102
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4.0 OVERALL CONCLUSIONS SPEC did not document its design development process. SPEC did not document approximately 60 percent of the Model No. SPEC 150 design development on Design Activity Records. SPEC could not produce Completed Design Review Checklists.
SPEC did not perform the hypothetical accident conditions tests for the Model No. SPEC 150 in accordance with the requirements of 10 CFR 71.73. SPEC did not perform the tests at the most unfavorable temperature for the feature under consideration. SPEC did not determine the optimallength of the puncture bar to cause maximum damage to the test unit and did not mount the puncture bar on the test pad. SPEC did not complete documentation for hypothetical accident condition tests.
SPEC did not present an accurate description of its drop target in its application for an NRC COC.
SPEC used an unapproved and uncontrolled design drawing to procure a part for Type B transportation packaging. SPEC did not formally control changes made to fabrication and test documentation and did not complete required test data sheets. SPEC did not follow its calibration procedures and was not able to produce training records for personnel calibrating survey meters. SPEC did not control caWrated calipers and used calipers that d;d not meet calibration requirements. SPEC did not maintaln and update its calibration log for calipers.
SPEC did not follow its procurement procedures. SPEC had no procedure that addresses the control of nonconforming material and did not maintain its status report for nonconforming material. SPEC did not disposition nonconforming materialin a timely manner. SPEC had not approved revisions to drawings. SPEC did not complete ECEs for revisions made to drawings and used preliminary drawings to fabricate design test prototype units. SPEC used, but did not control, fabrication sketches. SPEC did not control the procurement and receipt inspection of a
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component important to safety. SPEC did not identify and control the penetration bar and puncture bar used for hypothetical accident testing. SPEC did not perform complete in process or finaiinspections of prototype units. SPEC stored nonconforming parts and components used in Type B transportation packaging in an unsecured fabrication area. SPEC performed no internal audits since 1993.
5.0 EXIT MEETING
.
The team presented its inspection findings on June 19 and July 10,1997, to members of SPEC's, management. SPEC managers acknowledged the inspection findings and outlined conctive actions that they planned to take.
26