ML19354D676
| ML19354D676 | |
| Person / Time | |
|---|---|
| Site: | 07100231 |
| Issue date: | 12/18/1989 |
| From: | Ross C CHEM-NUCLEAR SYSTEMS, INC. |
| To: | Macdonald C NRC |
| References | |
| 26193, RA-0723-9, RA-723-9, NUDOCS 8912290047 | |
| Download: ML19354D676 (10) | |
Text
'
RETURN-TO g g';
7/_ d23/
4 CHEM-NUCLEAR SYSTEMS, INC.
220 Stoneridge Drive
- Columbia, South Carolina 29210 1
mber 18, 198
.o i
n.
-9
- 9 DOCKETro on q
USNRQ SNRC
{j DEC2 01ggg y fo E
N201959 y fo WitY[non 9,
nos ooCfgRERx Mr. Charles E. MacDonald U
Docur ettex
//
//
Chief, Transportation Certification Bra h g \\ z',
'u 4
Division of Fuel Cycle and Material Safe t -
U.S. Nuclear Regulatory Commission Washington, DC 20555 m
SUBJECT:
Corrective Action Response g
U.S. NRC Container Supplier Inspection Program Report'710231/89
REFERENCE:
U.S. NRC Report Distribution and Corrective Action Request ~'
letter dated October 20, 1989 i
Dear Mr. MacDonald:
This letter addresses the five (5) items of nonconformance with U.S. Nuclear Regulatory Commission (NRC) requirements which were identified by Messrs.
-Gordon, Jankovich and Kasnicki during their June 19 - 22, 1989 inspection of Chem-Nuclear Systems, Inc. (CNSI).
Each of the nonconformances were given a good deal of. review and attention within CNSI to resolve and to ensure against recurrence.
Nonconformance #1 from US NRC Insoection Report. Section 4 10.CFR Section 71.135 requires a system which ensures that QA records maintained in-house or at other locations are identifiable and retrievable and requires that the records be maintained for the life of the package to which they apply.
In nonconformance with 10 CFR Section 71.135, some container records were neither retained nor retrievable.
CNSI Response CNSI acknowledges that design, fabrication, and related documentation packages must be more carefully developed.
The records sought by the inspectors did, however, relate to an earlier time period where subsequent internal audit attention was already effectively influencing improvement.
The problem is primarily one of follow-through with our recordkeeping requirements which received a great deal of additional attention as the result of this inspection.
/
e912290047 e9121e cE 3'0~ EQU ED I"
{DR ADOCK 07100231 PDC ff() l (803) 256-0450
- Telex: 216947
s s
Tp Mr.. Charles E. MacDonald
SUBJECT:
Corrective Action Response December 18, 1989 Page 2 To resolve this nonconformance, our focus was upon _our Engineering and Technology group's responsibility to improve recordkeeping.
These responsibilities have been adequately emphasized with cognizant engineers.
Attached is a memorandum which seeks to formally document what was being presented verbally for some time.
Additionally, we were able to develope and vastly improve the subject container records packages from other files and sources.
h To preclude recurrence, CNSI's Internal Audit program will continue to monitor our recordkeeping practices with added emphasis upon our shipping containers.
_ Nonconformance #2 from U.S. NRC Inspection Reqor_t. Section 4 L
l 10 CFR Section 71.103, requires that the authority and duties of person and organizations performing activities affecting safety-related functions must be clearly established and delineated in writing.
In nonconformance with 10 CFR Section 71.103, engineering changes and amendments / revisions to. the NRC-approved QA program were not procedurally controlled.
MSI Resoonse This_ nonconformance seeks to ensure we establish a written protocol for determining 1) whether or not an action or activity affecting a cask also l
affects the SAR and C of C which require formal design. control, and 2) whether i
or not a proposed change to our QA Program requires US NRC approval.
Regarding the engineering aspects of this nonconformance, the changes made as a result of Nonconformance #5 should suffice to resolve this nonconformance and preclude recurrence.
Changes to the CNSI QA Program, QA-AD-001 have always required the same controls as are applied to all CNSI quality-related procedures.
Previously i
undocumented was the Quality Assurance Director's additional responsibility to conduct an evaluation of the proposed change for impact upon commitments to the U.S.
NRC.
To resolve, the following procedural statement was added directly to the original cover sheet of the QA Program:
"IN ADDITION TO ALL APPLICABLE CNSI DOCUMENT CONTROL REQUIREMENTS, ANY PROPOSED CHANGE TO QA-AD-001 REQUIRES FORMAL US NRC APPROVAL IN ACCORDANCE WITH 10 CFR 71 OR A SIGNED STATEMENT BY THE DIRECTOR, CNSI QA UPON THE CHANGE REQUEST '(SUBSEQUENT TO REVISION F) WHICH JUSTIFIED THAT SUCH APPROVAL IS UNHARRANTED."
L V
- Mr. Charles E. MacDonald
SUBJECT:
' Corrective Action Response.
December 18, 1989 Page 3 This action should suff ce to prec u e recurrence because this statement will i
ld appear on all subsequent copies of the QA Program as well as all future revisions.
This -system also provides our other change request reviewees (Preparers, ALARA, Engineering, Safety and members of the CNSI Safety Review
- Board) the opportunity to evaluate the justification should U.S. NRC approval seem unwarranted.
A copy of this coversheet has been attached.
See also memorandum attached.
Nonconformance #3 from U.S. NRC Inspection Report. Section 4 10 CFR Section 71.137, requires that audits be conducted with a comprehensive system of planned and periodic audits, to verify compliance with all aspects of the QA program.
These audits must be performed by personnel not having direct responsibilities in the areas being audited.
In nonconformance with 10 CFr Section 71.137, periodic audits of the effectiveness of the QA program were not made by an independent and objective source.
CNSI Resoonse The.CNSI Internal Audit Program consists of a series of audits completed annually which collectively verify implementation of the Quality Assurance Program as well as evaluating its effectiveness.
These audits are performed in accordance with written procedures and checklists by Lead Auditor qualified QA Personnel.
Audit personnel have no direct responsibilities within the activity to be audited and measures are employed to avoid other conflicts which could hinder objective evaluation.
In the long run, the independency of an audit function is evidenced in the quality and effectiveness of the audits, rather than in the lines of an organizational chart.. I am encouraged that this aspect of our audit system was considered satisfactory.
This nonconformance, as we understand it. relates to the additional evaluation of -our Program's effectiveness performed by independent CNSI management at least once a year.
Our long-accepted practice, involving a Presidential assessment letter needed to be and has been -improved.
To resolve this nonconformance, the letters presenting the results of these assessments will be more specific concerning what was reviewed and how the valuation was conducted.
The U.S. NRC inspectors could not determine, for example, that the results of a large number of highly independent audits of our QA Program (licensed utility audits) were a factor being considered.
Additionally, records such as checklists and reports will support these assessments.
4
(
Mr. Charles E. MacDonald
SUBJECT:
Corrective Action Response December 18, 1989 Page 4 j
Such an evaluation ~ of CNSI's QA Program was performed from December 5 through December-11,-1989.
Attention was focused primarily on the present status of the program and QA functions performed during the year 1989.
The overall QA program was evaluated for compliance with applicable sections of the Code of Federal Regulations (CFR); 10 CFR 50 Appendix 0; 10 CFR 71 Subpart H and NOA-1-1986.
The evaluation was performed by a management level individual solected by the President, CNSI, for his qualifications and independence.
The formal report of this evaluation (dated December 14, 1989) was reviewed with me and is currently awaiting review and considerr. tion by the President, CNSI.
I anticipate his summary comments (with possible tasks and goals) to accompany formal distribution of the report soon.
These records will be maintained for regulatory review.
To preclude recurrence, CNSI is committed to this more credible presentation
.of future annual evaluations and has develcped an overall plan and checklist for their conduct.
Nonconformance #4 from U.S. NRC Insoection Reoort. Section 4 10 CFR Section 71.109, requires that measures must be established to assure adequate quality in the documents for procurement of material, equipment and services, whether purchased directly or through contractors or subcontractors.
In nonconformance with 10 CFR Section 71.109, shelf life is not specified on purchase orders and in shipping documentation; storage tags in the store room do not specify shelf life.
CNSI RESPONSE CNSI is implementing a written Quality Plan with which to control the procurement, inspection, and storage of gaskets /O-rings used on our casks
. licensed by the U.S. NRC.'
This plan will provide shelf-life control which we acknowledge is necessary. _ A draft of this plan i s currently in our review / approval process and will be implemented no later than January 31, 1990. When implemented, these control measurers should adequately resolve the nonconformance and preclude recurrence.
Nonconformance #5 from U.S. NRC Insoection Report. Section 4 10 CFR Section 71.107, requires that design changes, including field changes, must be subject to design control measures commensurate with those applied to the original design.
g-V.
Mr. Charles E. MacDonald
SUBJECT:
Corrective Action Response 3
- Page E
-18, 1989 December In nonconformance with 10 CFR Section 71.107, the check list used for design review did not explicitly indicate that the Certificate of Compliance and its supporting SAR should be referenced.
See also memorandum attached.
CNSI RESPONSE The checklist used for design review is being changed to explicitly reference
- the-Certificate of Compliance and its supporting SAR.
A copy of the change request -(used for appendix type changes) is attached.
This action should adequately resolve the nonconformance and preclude recurrence.
I hope these responses will suffice for your needs.
I anticipate further
-communication regarding the completion and verification of my corrective action commitments.
Sincerely, CHEM-NUCLEAR SYSTEMS, INC.
Ca>JL R M Carl H. Ross 4
Director, Quality Assurance CHR/nhs
' Attachments
- };[
+
)
- ] Q CEVCoows i
1 i
E l,.!
L E V.
DESCRIPTIOg -
DATE APPROVE D j
1 i
1..
3
-4 s
IN ADDITION TO ALL APPLICABLE CNSI DOCUSE\\T CONTROL CNSI SAFEri F.EV.iEW.
REQUIRBENTS, ANY PROPOSED CHANGE 1V QA-AD-001 B C A?;D '5D'
'Al
'\\-
REQUIRES FORNRL US h4C APPROVAL IN ACCORDANCE h'ITH
~
10 CFR 71 OR A SIGNED STATSE\\T BY TriE DIRECIDR, 3Y m ~M ~
CNSI QA UPON 1HE CPANGE REQUEST (SUBSEQUENT TO g /j f REVISION F) hMICH JUSTIFIES TIMT SUCH APPROVAL IS DS_J bs INiMRRA\\TED.
REVISION STATUS SHEET' 1
IA 2
3 4.
5 6
7 8
9 10 11 12 13 14 15 16 REv.-
F-F F
F F
F F
F F
F F
F F
F F
F F
'5 26 27 28 29 30 31 l
8""7 -
'17
'18 19 20 21 22 23 24 2
REv-F F
F F
F F
F F
F' F
F F
F F
F j
SHEET i
REV.
SHEET REV.
PREPARED DATE CHEM - NUCLEAR SYSTEMS, INC.
j gp g, gy ALMA TITL E
.?%L.JY.~
3/tS r
QUALITY ASSURANCE PROGRAM Nk h I)hlec OUALITY frWJa t?m$r.215]I A-W A's AP, PROVE D 3 ATE i ~-
DOCUMENT NO.
REV.
SHEET hMUsd C
rs
,72/ / u QA-A]-001 F.
1
.t
- c.. - -. - --
1 1.1.
cf
}
gg DATE: DECEMBER 15, 1989 611-0374-89 T0:
DISTRIBUTION LOCATION: COLUMBIA LOCATION: COLUMBIA FROM:
R. ANDERSON ENGINEERING DOCUMENTATION RESPONSIBILITIES FOR LICENSE, CASK
SUBJECT:
DESIGN / REPAIR PROJECTS U.S. NRC QUALITY ASSURANCE INSPECTION REPORT, DATED 10/20/89
REFERENCE:
(1)
(2) 0.A. LETTER RA-0611-9, DATED 10/27/89 (3) - Q. A. LETTER RA-0618-9 DATED 10/31/89 y
Attached for your immediate attention is information regarding the U.S. NRC 19 - 22, 1989 at CNSI.
Quality Assurance inspection report conducted on June The inspection report identified three nonconformances which affect the These Engineering and Technology (E & T) Department's operations.E & T recognizes the need nonconformances are identified as Nos.1, 2, and 5.
for records management and design control relative to 10 CFR Sections 71.135, It is Quality Assurance Records and 71.107. Package Design Control.
imperative that all cognizant Project Engineers read and understr.nd these I
nonconformances to ensure that they do not re-occur.
l In regard.to Nonconformance 1, you are reminded of the requirements of Engineering Procedure, EN-AD-004, Engineering Records, for ensuring that the It
-salient records for a project are appropriately developed and maintained.
is incumbent upon each cognizant Project Engineer to comply with these It is essential that these requirements are followed when the
,{-
requirements.
projecc involves NRC licensed equipment or processes so as to fully comply l
with the regulations as stated.
The following points reiterate the requirements of EN-AD-004 and are noted herein to stress their importance, and require your special attention for currently active and future projects.
The cognizant Project ingineer is responsible for initiating a documentation package ii a timely manner following receipt of an NRC Certificate of Compliance (C of C) or modification to a C of C for a new or modified shipping package.
L The documentation package includes any design documentation which nate that the modification or repair fully comply with current 10 CFR 71 regulations, the C of C and the Safety Analysis Report (SAR).
(See EN-AD-002, Design Control Procedure).
The cognizant Project Engineer is responsible for completing a documentation package within 30 days following:
The completion of fabrication of a licensed shipping package.
The repair or non-routine maintenance of a licensed shipping package.
CHEM-NUCLEAR SYSTEMS,INC.
c 31 y
CHEM-NUCLEAR SYSTEMS, INC.
"f'..C PROCEDURE APPENDIX CHANGE REQUEST 4
g l
DATE:
12/15/89 TO:
DOCUMENT CONTROL LOCATION:
COLUMBIA PATRICKL.PAQUlil LOCATION:
COLUMBIA FRM
SUBJECT:
APPENDIX CHANGE TO CNSI PROCEDURE:
i TITLE:
Desion Control Procedure LIST APPENDIX (ES) TO BE CHANGED AND DESCRIBE CHANGES:
Change EN-AD-002, Appendix A, Page 2.
1.
Item 1 from:
"1."
To:
'"1.a" i
2.
"1.b Effect of design package on compliance with the Safety f.nalysis Report or Certificate of Compliance identified and documented?"
t l
REASON FOR CHANGE:
j u
Clarification resulting from U.S. NRC inspection hl A,,,,
ug, Q g 9 &yQ,fgljf 00ALITY ASSURANCE DATE OPERATIONS DATE ENGINEERINT/
DATE
' NOTE: PCP PROCEDUFIS FIQUIFE ALL THREE APPROVAL SIGNATURES ABOVE. OTHER PROCEDURES ONLY REQUIPS Tr!E SIGNATUF2 OF THE SUPERVISOR OR MANAGER OF THE ORIGINATING DEPARTMENT.
fl f
DISTRIBUTION Page 2 12/15/89 The Project Engineer will forward one copy of the documentation package to CNSI Records Management and will ensure that one copy is maintained in the Engineering file.
In regard to Nonconformance 2 and 5, the following has been implemented:
Appendix A to EN.AD-002, Design Control Procedure, has been revised to ensure that any design package, which includes design modifications, is identified and documented as to its effect in compliance with the Safety Analysis Report or Certificate of y
Compliance. This documented evaluation is, by procedure, the responsibility of the Manager or. Director of Engineering and will be reviewed by the Qua11ty Assura,c,e Department.
n
Enclosure:
As stated DISTRIBUTION:
M. AHEARN w1 Enclosure T. CARRAHAY w/.Epciosure R. BYARS B. FAUCHIER S. KINTNER C. McGOVERN w/ Enclosure P. PAQUIN w/ Enclosure H. PETER w/ Enclosure G. RAE w/ Enclosure C. ROSS H. SHAMKHANI w/ Enclosure L. TONER C. WITT w/ Enclosure f
i
lir
'l.
N
(
bi
~
l t
00CKeiNO,_
lN CONTROL N0 ca._2h,8 5*
3 out Or 00d FiS1 out aCvo.
FCUF _
PDR FCAF_
LPDR I& E REF, !
SAFEGU ARDS _
FCTC OTHER om a,u y,am-_
f l
.-