ML20044H332
| ML20044H332 | |
| Person / Time | |
|---|---|
| Site: | 07100179 |
| Issue date: | 05/18/1993 |
| From: | Arnold W NUCLEAR CONTAINERS, INC. |
| To: | Mcdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 9306080195 | |
| Download: ML20044H332 (5) | |
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NUCLEAR CONTAINERS, INC.
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Chemical & Nuclear - Engineering and Equipment Fabrication 1
Route 9, Box 2237 - Elizabethton, Tennessee 37643 Telephone: 615/543-4211 Fax: 615/543-6007 May 18, 1993 Mr. Charles E.
Mcdonald Chief Transportation Branch United States Nuclear Regulatory Commission Washington, DC 20555-0001 RE:
Reply to NRC Inspection Report No. 710179/93-05 Notice of Nonconformance
Dear Mr. Mcdonald:
This letter is in response to your letter dated April 12, 1993 concerning the Nuclear Regulatory Commission's (NRC) inspection during the dates of March 1-4, 1993.
Attached is our response to the NRC's findings of Non-Compliance.
Nuclear Containers, Inc. (NCI) has, and always will strive to meet the requirements of the NRC.
NCI has, during the last four (4) years, continued to update it's Standard Operating Procedures and to produce a quality product for the industry and it's customers.
NCI was one of the first companies to undergo inspection in 1989 and 1991 by the NRC and, at that
- time, made the necessary corrections to it's Quality Assurance Program as suggested by the
- NRC, thereby showing our willingness to comply with the requirements as interpreted by both the NRC and NCI at that time.
Upon the latest inspection, NRC Inspectors determined that NCI was deficient in the implementation and documentation of certain portions of it's Quality Assurance Program.
NCI has responded to that interpretation by completely rewriting both it's Quality Assurance Program and Standard Operating Procedures to meet these requirements, during which time NCI has voluntarily suspended manufacturing all Model NCI-21PF-1 Overpacks.
By the above actions, we hope that the Hl." can see our willingness and desire to meet the requirements as delineated by the NRC.
Respectfully, L
William M.
Arnold Operations Manager WMA/ dig h/j @
93G6080195 930518
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10CFR71.105 Response - Notice of Nonconformance Docket No. 71-0179 A.
10 CFR S 71.105, " Quality Assurance Program" 1.
No training records were available for the person who conducted the receiving of standard operating items; however, personnel who do receiving have been instructed in accordance with NCI, Standard Operating Procedure (SOP) 9.10 and receiving reports filed with purchase orders.
1 Personnel conducting in-process and final inspection are AWS-Certified Welding Inspectors and conduct inspections in accordance with NCI's SDP 7.3.
NCI is in the process of training a new QC Inspector who will be certified in accordance with ASNT-TC-1A.
Please be aware a new SOP has been written and training in accordance with the SOP has been conducted and documented.
2.
10 CFR Part 21 and 10 CFR Part 71 requirements were posted and on file along with our SOP 9.6; however, no records documenting specific training were on file, this will be corrected, per your findings, by May 31, 1993.
10 CFR part 71 requirements are being met by the issuance of other SDP's and the required training documented.
B.
10 CFR S 71.111 " Instructions, Procedures and Drawings" 1.
NCI was, at the time of this inspection, in the process of updating aad improving it's Standard Operating Procedures.
tnce this inspection, NCI has completed it's implementation of these SOP's including the required training and documentation.
2.
The design of the NCI-21PF-1 Overpack was a limited modification of the DOT-21PF-1B and was initiated and planned in a meeting at NCI which involved personnel from COGEMA and CEA (France) as well as from NCI.. The desired modifications were fully discussed and. evaluated for safety and for the testing necessary to demonstrate safety.
The results of.this design meeting were fully documented in the NCI proposal letter to COGEMA wherein the complete design, evaluation, and test program for the NCI-21PF-1 Overpack was initiated.
The complete design program evolved and was documented during this one short meeting; to develop a design checklist after the fact would have been superfluous.
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i While a design checklist can be beneficial during the design of a new package, it. is not a requirement of 10CFR71, and we have deleted the requirement for one from our revised QA Manual.
3.
The nameplates were made available to our customers'and were either sent to them or disposed of as contractually '
required.
This SDP has been revised to allow this option.
4.
The Production Manager for NCI was, up until recently, our Quality Assurance Manager and the inspection forma were inadvertently signed by 'him.
The forms were countersigned by the QA Inspector af ter this was brought to NCI's attention.
NCI has, since the time of this inspection, developed new Fabrication Control Records with designated HOLD POINTS for QA inspection with specific sign-offs for QA as well as Production and vill be in use once we are released to resume manufacturing.
C.
10 CFR S 71.113 " Document Control" 1.
Since the time of this inspection, NCI has completed the SOP's which were incomplete.
2.
An SOP Directory was available, but did not include all new SOP's not issued.
A new SOP Directory has been established and is maintained 1n the SOP file.
3.
A Distribution Log will be maintained beginning May 31, 1993.
4.
NCI maintains procedures, instructions and drawings at a central location for review by all personnel.
Special procedures and instructions for f oaming and painting will be located at the work stations as required by May 31, 1993.
5-8.
SOP revisions have now corrected the conditions which were found by the inspection team.
9.
Sheet Nos. 3 & 4 of drawing DED-206-B has been corrected to agree with the Bill of Material.
D.
10 CFR S 71.115 " Control of Purchased Material, Equipment, and Services" 1.
Since the time of this audit, NCI has established a written SOP _ (3. 0) Vendor Selection and Approval, by which -
all vendors will be surveyed.
NCI vendor surveys were reviewed by the audit team and were available with the exception of.the year 1991 which has been misplaced.
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E.
10 CFR S 71.117 " Identification and Control of Materials,-
Parts and Components" 1.
- At the time of this inspection, NCI had mill test reports available for the materials used in the manufacture of the U-Bolts, but the mill test reports did not reference i
the P. O.
Future Purchase Orders will require that a Certificate of Compliance be issued for each specific Purchase Order.
Purchase of nuts and bolts will be purchased similarly.
2.
NCI material traceability was conducted 'thru shipping bills which are traceable to NCI purchase orders.
NCI has established an SOP to maintain traceability of.
material certifications and Certificate of Compliance to be traceable to related P.O.'s.
F.
10 CFR S 71.119 " Control of Special Process" 1.
In the past, NCI has utilized specification SP-9 for installation of fire-resistant phenolic foam.
.SP-9 was supplemented with simple instruction for weights of.
individual components.
NCI has now written an SOP for the installation of phenolic foam based on SP-9.-
2.
Shelf life of resin will be monitored by the.. QA Department and is labeled on receipt as follows: DO NOT USE AFTER (DATE) and resin which is found out of date will be labeled DO NOT USE and placed in a controlled area unt11 discarded.
3.
NCI has conducted a meeting. with its welders to. re-emphasize the necessity of properly identifying their welds.
We have also increased QC inspection of welder ID's.
G.
10 CFR S 71.121 " Internal Inspection" 1.
NCI's practice, prior to this inspection, has been to track the fabrication process on a marker board.because we were unaware of the need to have a full fabrication record.
However, all QA. hold points are designated in NCI manufacturing outlines, and NCI has always had.a-Quality Assurance Checklist on which ALL inspections were listed and checked-off by the QA Inspector.
The NRC' inspection team was told that NCI personnel inspect their own work'because NCI tries to instill in.it's employees the need to produce. quality products; however, this in no way implied that the inspection performed by the worker was not _ the Quality Assurance inspection.
NCI still feels that quality has to be instilled ~into it's employees and not written 1nto the product.
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___m NCI has, due to the requirements of this inspection, 1 developed a f abrication control record which includes all the necessary hold po1nts for QA inspection.
H.
10 CFR S 71.125 " Control of Measuring and Test Equipment" 1.
All equipment report in this section has now been properly marked.
l 2.
The equipment listed in the section has been corrected.
3.
Master thermometer has been physically identified.
4.
Universal Accu-Weight Dial Scale, O to 40 pounds has been calibrated.
5.
The micrometers listed were correctly calibrated; however, the findings were recorded on the wrong form.
This has been corrected.
I.
10 CFR S 71.131 "Honconforming Materials, Parts or Components" 1.
NCI is in the process of making the necessary correct 1ons to both the Nonconforming Reports and the NR Log.
This will be completed May 31, 1993.
J.
10 CFR S 71.135 " Quality Assurance Records"-
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NCI has mainta1ned a Quality Assurance Checklist on the' inspection of all Overpacks it manufacturers.
- However,
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due to the requirements of this inspection, -HCI has developed a Fabrication Control Record to f acilitate full fabrication and quality assurance traceability.
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10 CFR 5 71.137 " Audits" 1
1.
Future audits will include adequate coverage of all
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sections of the Quality Assurance Manual.
2&4 Records were not available;
- however, reviews were conducted at the start of -each new project, this wording
' I has been removed from QA-3 Rev.
1.
3.
The internal audit for 1991 was lost during a move-of records and has not been located.
5.
A new audit schedule has been prepared for '1993, previous schedules have not been' located.
6.
These audit records were also a part of the miss1ng file and have not been found.
7.
NCI will update its Approved Vendors List to include the necessary vendors prior to any purchase of materials.
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