ML20125E014
| ML20125E014 | |
| Person / Time | |
|---|---|
| Site: | 07100030 |
| Issue date: | 12/11/1992 |
| From: | Asmussen K GENERAL ATOMICS (FORMERLY GA TECHNOLOGIES, INC./GENER |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| RTR-REGGD-07.010, RTR-REGGD-7.010 696-1999, NUDOCS 9212160143 | |
| Download: ML20125E014 (12) | |
Text
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CENERAL ATOMN"S December 11,1992
)
696-999 1
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.j U.S. Nuclear Regthtory Commission l
A'ITN Document Jantrol Desk Washington, D.C. 2L535 t
j
Subject:
Reply to a Notice of Nonconformance t
l
Reference:
MacDonald, Charles E., Letter to General Atomics, ATrN: Dr. K. - E.
j
- Asmussen, "NRC Inspection Report No. 71003/92-07/ Notice of Violation, j
Notice of Non conformance," dated November 12,1992 Gentlemen:
4 Enclosed is General Atomics' (GA's) response to the Notice of Nonconformance-issued on November 12,1992 (Reference). This response was prepared pursuant to the provisions of 10 CFR 2.201.
j GA trusts you will find its corrective action measures to be appropriate and satisfactory. If you should have any questions concerning this response, please contact me l
at (619) 455-2823.
Very truly yours, Keith E. Asmussen, Director Licensing, Safety, and Nuclear Compliance-i.
KEA:shs Enclosures - as above cc:
Mr. Charles E. MacDonald, Branch Chief, Transportation Branch,'NMSS, U.S. NRC p
Mr. John B. Martin, Regional Administrator, U S. NRC Region V 150000 gj 9212160143 921211
.C
' ALDCK 07100003:
/r g l
PDR PDR.
f 3550 GENERAL ATO'11CS COURT, SAN DIEGO CA 921211194 PO BOX 85608. SAN DIEGO CA 92186-9784 1619:454 3000
Attachment to General Atomics
- Letter No. 696-1999 Dated December 11,1992 General Atomics' Response to the Notice of Nor.conformance / NRC Inspection Report No. 71003/92-07 During a U.S. Nuclear Regulatory Commission (NRC) inspection conducted at General Atomics (G A), in San-Diego, California, on September 23-24, 1992,- six nonconformances with certaic NRC commitments were identified.
Each of the nonconformances is restated below followed by GA's corresponding response.
NONCONFORMANCE A:
10 CFR 6 71.105, " Quality assurance program," requires that the licensee establish a graded approach to identify materials and components for quality assurance (QA) to an extent consistent with their importance to safety.
Contrary to the above, the GA established QA Level (OAL) classification system used in procedures implementing the clas.sification system have one level only of safety-related components (QAL 1); whereas the other categories (QAL ll and Ill) are based on commercial reliability requirements.
GA's RESPONSE TO NONCONFORMANCE A:
A-1.
Admission or Denial of the Alleaed Nonconformance:
GA admits the stated nonconformance.
A-2.
Reason for the Nonconformance:
The GA QA Level classification system was developed for Nuclear Facility projects and requires the same controls for all items identified as safety-related. Project personnel did not evaluate package components to the requirements of NRC. Regulatory Guide 7.10 when it was issued, to determine if any components identified as OAL -il or_ QAL 111 should be -
reldentified as OAL I or some other "important to safety" classification.
A-3.
Corrective Steos Taken and Results Achieved:
An internal Corrective Action Request (CAR) has been generated to address this nonconformance. ' Also, please see item A-4.
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. 2 General Atomics' Letter No. 696-1999 l
Dated 12/11/92 Page 2 of 11 -
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l A-4.
Corrective Actions that will be Taken to Avoid Further Nonconformances:
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GA will review 10CFR71 Subpart H and NRC Regulatory Guide 7.10 and determine if other safety related levels need to be developed for packages.
l This will be done in conjunction with an engineering evaluation of the Safety significance of each basic component of the packages and categorization of the components in accordance with Reg. Guide 7.10. The QA Program j
Documents for projects that use NRC-licensed packages will be revised to address definition and classification of safety related components. Applicable instructions, procedures, and drawings will be revised to show the correct l
QA level and to call out the applicable QA requirements.
l In an effort to locate / correct similar discrepancies, the requirements of NRC l
licenses,10CFR71 Subpart H, NRC Regulatory Guide 7.10, and NUREG/CR-l 5717 will be carefully reviewed. The OAPDs and applicable instructions, j
procedures, and drawings for projects that use NRC-licensed packages will be revised as necessary to meet all applicable regulatory requirements.
in order to prevent a recurrence of this nonconformance, personnel working j
on projects that use NRC-Licensed packages will be trained to the require-j ments of the applicable revised QAPDs and procedures. This training will be j
documented. Additionally, these projects will be audited periodically to verify l_
compliance with the OAPD.
4 A-5.
Date When Full Comoliance will be Achieved:
4 The above described corrective actions are scheduled for completion on l
March 31,1992.
i i
NONCONFORMANCE.B:
10 CFR l 71.111, " Instructions procedures and drawings," requires 4
the licensee to prescribe activities affecting quality by documented instructions, procedures or drawings _of a type appropriate to the circumstances.
Contrary to the above; E
1.
Procedures were not in_ place to ensure the inner canister closure i
requirements, in accordance with the drawings and safety _ analysis report, were being met on the Model Nos. TRIGA-1 and TRIGA-2.
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1 l
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e Attachment t3 General Atomics' Letter No. 696-1999 Dated 12/11/92 Page 3 of 11 2.
Certain Model Nos. TRIGA-1 and TRIGA-2 were not constructed in accordance with approved drawings. One Model No. TRIGA-2 and fourteen Model No. TRIGA-1 shipping containers had stenciled identification painted on the side of the drums, rather then the required stainless steel identification plate.
GA's RESPONSE TO NONCONFORMANCE B:
B 1.
Admission or Denial of the Alleaed Nonconformance; GA admits the stated nonconformance.
B-2.
Reason for the Nonconformatmg; 1.
TRIGA Fuel Operating Procedure No.14, Issue A, November 16,1990,
" Packaging and Shipping" was written to be consistent with the Application for Revalidation, Chapter 8, " Operating Procedures," as required by Certificates of Compliance Nos. 9034 and 9037. However, it was not also carefully compared with Chapter 2, " Package" and with the Specification Control Drawings (also part of the application), which refer to the requirements for the inner canister cap to be engaged at least five threads. Section 1.7 of the procedure only requires to " screw the cap tightly down."
2.
These containers were shipped to Oak Ridge National Laboratory (ORNL) in a single shipment about ten years ago and were returned to GA earlier this year. Close examination of containers shows evidence (painted-over spot weld residues) that they were originally identified with-stainless steel plates and that these plates were-re' moved and replaced with I
stenciled identification and information specific to the ORNL shipment.
It is believed that the plates were removed and replaced by stencils about ten years ago either by GA or ORNL personnel, who were not-trained on NRC requirements for correct maintenance and identification i
of containers.
i B-3.
Corrective Steos Taken and Results Achieved:
An internal Corrective Action Request'(CAR) has been generated to address this nonconformance. Also, please see item B-4.
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k
I Attachment t3 General At:mics' 4
i Letter No. 696-1999 Dated 12/11/92 Page 4 of 11 a
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B-4.
Corrective Actions that will be Taken to Avoid Further Nonconformancfai:
- ^
The packaging and shipping procedure will be revised to also be consistent with specification control drawings and Chapter 2 of the Application for 4
i Revalidation.
l Deficient containers will be tagged and segregated.
As necessary, a Nonconformance Report will be prepared.
Any such Nonconformance Reports and nonconforming containers will be processed in accordance with Quality Procedure No.15, " Control of Nonconforming items."
l In an effort to locate / correct similar discrepancies, the followli.g action items have been identified:
j a)
Review TRIGA Procedures and Drawings for compliance with the NRC-license, and revise if necessary.
b) Inspect present stock of TRIGA-1 and TRIGA-2 containers. if deficient containers are found, tag and segregate deficient containers and process i
a Nonconformance Report as described above.
I t
in order to prevent a recurrence of this nonconformance, the affected j
personnel will be trained to implement the requirements of the revised j
procedures; the training will be documented.
B-5.
Date When Full Comoliance will be Achieved:
{
The above described corrective actions are scheduled' for completion on-March 31,1992.
i NONCONFORMANCE C:
10 CFR H 71.115, " Control of purchased material, equipment, and services," requires the licensee perform source evaluation and selection to assure that purchased materials, equipment, and services conform to the QA requirements.
Contrary to the above, the depleted uranium billet for the Model FSV-1 packaging, classified as a QAL I component, was procured.
4-from an unapproved vendor.
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1 2 General Atomic 3' Letter No. 696-1999
- i Dated 12/11/92 Page 5 of 11 GA's RESPONSE TO NONCONFORMANCE C:
C-1.
Admission or Denial of the Alleoed Nonconformance:
GA admits the stated nonconformance.
C-2.
Reason for the Nonconformance:
The Quality Engineer (OE) who reviewed the final Purchase Order (PO) in Purchasing neglected to verify that NL Industries (the vendor) was on the QA Approved Suppliers List at the time of order placement. The QE also neglected to get the approval of the QA Director on the PO before allowing the use of an unapproved supplier in accordance with QA Manual requirements. A copy of the Purchase Request, which could have had the QA Director's approval signature, could not be located during the NRC inspection.
C 3.
Corrective Steos Taken and_Fesults Achieved:
An internal Corrective Action Request (CAR) has been generated to address this nonconformance. It has been determined that the original Purchase Request has been destroyed. The CAR specifies the following action be J
taken:
" Attempt to locate a legible copy of Purchase Request.(PR) 812053 to determine if the QA Director approved the PR. If unsuccessful, place a 1
document in the FSV-1 Cask Modification Project records acknowledging the i
deficiency and providing justification why the depleted uranium billet was i
acceptable. The memo will be approved by the QA Director. Since this item was delivered more than ten years ago, amending the PO at this time would serve no useful purpose."
Also, please see item C-4.
C-4.
Corrective Actions that will be Taken to Avoid Further Nonconformances:
In an effort to locate / correct similar discrepancies, other procurement documents for this project will be reviewed to determine if there were any other purchase orders for safety-related items that were placed with vendors that were not on the QA ASL and were not approved by the QA Director.
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} 3 General Atomics' i
Letter No. 696-1999 Dated 12/11/92 Page 6 of 11 i
if any others are found, a document will be placed in the FSV-1 Cask Modification project records acknowledging the deficiency and providing justification why the items are acceptable.
5 With regard to steps taken to prevent a recurrence,it should be noted that j
this deficiency was identified by GA in September 1983 and documented in i
Audit Report 83005, Finding #2, dated 10/4/83. The corrective action i
commitment required that QA personnelinvolved in PO review at that time i
receive training in the requirements of procurement document control. The training session was conducted on 10/4/83, i
l Additionally, personnel currently involved in final PO review / approval will be provided refresher training in the procurement document control requirements.
i C-5.
Date When Full Comollance will be Achieved:
i GA believes it is now operating in compliance with NRC requirements. The i
above described corrective actions are scheduled for completsen on January j
29,1993.
NONCONFORMANCE D:
10 CFR 5 71.117, " identification and control of materials, parts, and components," requires that the licensee establish measures for 4
j -
the identification and control of materials, parts, and components.
These measures must assure that the identification of the item is l
maintained by heat number, part number, or other appropriate -
i means, either on the item or on records traceable to the items, as-required throughout fabrication, installation or use of the item.
Contrary to the above; 1
1.
Fourteen Model No. TRIGA-1 containers and one Model No. TRIGA-2 container were identified in storage that did not have serial numbers, or any method of identification attached.
l 2.
The O-ring gaskets replaced during leak testing of the Model No. FSV-1 packagings were not traceable to any material specifications.
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Attachment ts General Atomics' Letter No. 696 1999 Dated 12/11/92 Page 7 of 11 GA's RESPONSE TO NONCONFORMANCE D:
General Atomics response to nonconformance D is divided into two parts, D1 and D2, corresponding to the two above described items 1 and 2.
D 1 -1.
Admission or Denial of Alleaed Nonconformance - D1:
GA admits the stated nonconformance.
D 1 -2.
Reason for Nonconformance - D1:
The subject TRIG A containers are the same containers as in Nonconformance B. These containers were shipped to Oak Ridge National Laboratory (ORNL) in a single shipment about ten years ago and were returned to G A earlier this year. Close examination of the containers shows evidence (painted-over spot weld residues) that they were originally identified with stainless steel plates and that these plates were removed and replaced with stenciled identification and information specific to the ORNL shiprnent. Furthermore, the stenciled information did not have the manufacturing serial number of the container and therefore traceability to manufacturing records was lost. It is believed that the plates were removed and replaced by stencils about ten years ago either by GA or ORNL personnel who were not trained on NRC requirements for correct identification and traceability of containers.
D 1 -3.
Corrective Stens Taken and Results Achieved:
An internal Corrective Action Request (CAR) has been generated to address this nonconformance. This CAR specifies the following action to be taken:
- 1) Tag and segregate deficient containers. Prepare any required Noncon-formance Reports. Process Nonconformance Reports and nonconforming containers in accordance with Quality Procedure No.15, " Control of Non-conforming items"; 2) Inspect present stock of TRIGA-1 and TRIGA-2 con-
- tainers, if deficient containers are found, tag and segregate deficient containers and process a Nonconformance Report as just described.
D 1 -4.
Corrective Actions that will be Taken to Avoid Further Nonconformances:
To prevent a recurrence of this nonconformance, the following will be done:
Attachment to General Atomics' Letter No. 696-1999 Dated 12/11/92 Page 8 of 11 a)
Procedures will be prepared or revised, as necessary, to require:
e QA/QC inspection of new or repaired containers, e
Recording of serial numbers and tracking the movement of all licensed containers and verifying that name plates have not been altered before each shipment and upon receipt of each container.
o Maintenance of records for initialinspection, repair, maintenance, destruction, and shipping of containers, traceable to the serial number of each container, b) Affected personnel will be trained to implement the new/ revised procedures. The training will be documented.
l.
c) QA will perform an annual audit to verify. compliance with these l
procedures, j
D 1 -5.
Date When Full Comoliance will be Achieved:
4 i
The above described corrective actions are scheduled for completion on i
March 31,1993.
t i
D 2-1.
Admission or Denial of the Alleaed Nonconformance - D2:
i i
GA admits the stated nonconformance.
D2-2.
Reason for Nonconformance - D2:
Annual Maintenance Procedure SPE 150104 does not provide for j
documenting traceability of replaced consumable items (e.g., o-rings, bolts, l
helicoils, etc.)
i-D2-3.
Corrective Steos Taken and Results Achieved:
An internal Ccrrective Action Request (CAR) has been generated to address this nonconformance. This CAR specifies the following action to be taken:
" Retrofit current annual maintenance inspection records documenting traceability of all replaced items.
Prepare GA Quality Assurance Work i
Release for materials shipped to PSC. (Note: All items were individually i
1
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I 4 2 General Atomics' Letter No. 696-1999 j
Dated 12/11/92 Page 9 of 11 4
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identified with the applicable drawing and item numbers, manufacturers part l
number, GA Purchase Order Number, inspectors Acceptance stamp and the l
date of acceptance.)"
i j
Retrofitting of records prior to 1992 is not feasible nor productive, as these i
o-rings are changed annually (when the cask is in use).
i l
D 2-4.
Correct've Actions that will be Taken to Avoid Further Nonconformances:
l To prevent a recurrence of this nonconformance, the inspection checklist in l
the Annual Maintenance Procedure, SPE 150104, will be revised to provide' for identifying the replaced items by drawing and item number, and documenting the purchase order of the replacement item.
All project i
personnel will be trained on the revised procedure requirements.
}
D 2-5.
Date When Full Comollance will be Achieved:
i The above described corrective actions are scheduled for completion on January 15,1993.
l NONCONFORMANCE E:
l 10 CFR 1
71.131,
" Nonconforming materials, parts, or l
components," requires the licensee establish measures to control materials, parts, or components which -do' not conform to the licensees requirements in order to prevent their inadvertent use or
[
installation.
J Contrary to-the above; a deficient Model No. TRIGA-2 was stored among useable containers and was not identified as; deficient._ The deficient packaging was not segregated from useable packagings to j
prevent inadvertent use nor was the deficient packaging tagged to l
j identify it as such.
GA's RESPONSE TO NONCONFORMANCE E:
E-1.
Admission or Denial of the Alleaed Nonconformance:
GA admits the stated nonconformance.
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l 2 General Atomics' l
Lettar No. 696-1999 j_
Dated 12/11/92 Page 10 of 11 l
1 4
i E-2.
Reason for the Nonconformance:
Although it was recognized upon receipt that the container was deficient, the person who stored containers was not trained on correct procedure for segregation and control of nonconforming items; mainly because TRIGA Fuel Operating Procedure No.14, Issue A, November 16,1990, " Packaging and
]
Shipping," did not adequately address container inspection, storage and reuse criteria.
i E-3.
Corrective Steos Taken and Results Achieved:
j An internal Corrective Action Request (CAR) has been generated to address this nonconformance. The CAR specifies the following required actions be taken:
4 j
" Inspect the present stock of TRIGA-1 and TRIGA-2 containers, if deficient i
containers are found, tag and segregate the deficient containers and prepare and process a Nonconformance Report in accordance with Quality Procedure No.15, " Control of Nonconforming items."
f E-4.
Corrective Actions that will be Taken to Avoid Further Nonconformances:
The TRIGA Fuel Operating Procedures are being revised to describe inspection, storage and reuse criteria, with particular emphasis on tagging and segregation of deficient containers. Affected personnel will be trained
]
to implement the revised procedures. The training will be documented.
l E-5.
Date When Full Comollance will be Achieved:
GA is currently operating in compliance with NRC requirements and the i
above described corrective actions are scheduled for completion on March-i 31,1993.
j NONCONFORMANCE F:
10 CFR I 71.135, " Quality assurance records," requires the i
licensee maintain sufficient written records to describe activities 4
affecting quality.
Contrary to the above; out of a sample lot of 12 engineering design changes for the Model No. FSV-1 packaging, six could not be i
located.
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.... 2 General Atomics' Letter No. 696-1999 Dated 12/11/92 Page 11 of 11 i
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GA's RESPONSE TO NONCONFORMANCE F:
}
F-1.
Admission or Denial of the Alleaed Nonconformangel GA admits the stated nonconformance.
i F-2.
Reason for the Nonconformance:
The subject engineering change orders (ECO's) were part of a group of ECO's that were lost during transfer from the old Process Engineering Division Document Control Center to corporate Configuration Management for 4
i inclusion into the Engineering Date Base. The lost records were never j
- located, i
j F-3.
Corrective Steos Taken and Results Achieved:
j An internal Corrective Action Request (CAR) has been generated to address j
this nonconformance. The CAR specifies the following required actions be l
taken:
i a) obtain copies of as many missing ECO's as possible by searching storage records and from individual's files, and turn them over to Configuration l
Management for microfilming and retention, and i
j b) identify all project ECO's and Change Notices from the design drawings.
Compare the list of identified ECO's and C/N's with those already in the i
corporate Document Control Center, identifying the missing documents.
)
Update the files in the Document Control Center by locating copies of as l
many of the missing documents as possible.
F-4.
Corrective Actions that will be Taken to Avoid Further Nonconformances:
The project _now uses, and has used for over eight (8) years-(March 19, 1984), the corporate Configuration Management system per the QA Manual l
and as described in'the Program / Resources Procedures Manual. All C/N's i
generated through the corporate -Configuration Management system are accounted for. No further action is required to prevent recurrence.
F-5.
Date When Full Comoliance will be Achieved:
G A is currently operating in compliance with NRC requirements. Additionally, the above described corrective actions are scheduled for completion on
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January 15,1993.
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