ML20154H583
| ML20154H583 | |
| Person / Time | |
|---|---|
| Site: | 07100062 |
| Issue date: | 09/29/1998 |
| From: | Huddleston E INDUSTRIAL NUCLEAR CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| 71-0062-98-204, 71-62-98-204, NUDOCS 9810140260 | |
| Download: ML20154H583 (23) | |
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B lNDUSTRIAL NUCLEAR CO.,INC.
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I United States Nuchw Muculatory Commission ATT: Document Contia Desk Washington, DC 20555 i
Subject:
Reply to a Notice of Nonconformance, Docket 71-0062 Response to NRC inspection Report 71-0062/98-204, i
Notice of Nonconformances A through Q Attached are Industrial Nuclear Company's (INC) responses to NRC 1
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Inspection Report 71-0062/98-204, Notices of Nonconformance, A through Q. INC has addressed all nonconformances identified in the i
inspection report.
INC has indicated the status of all required corrective actions and has identified the scheduled corrective action completion dates as applicable.
i The development of INC's improved quality program will be complete i
as indicated in the responses, and implementation of the quality program has commenced. Implementation of the remainder of INC's l
quality program is pending resumption of fabrication activities. INC has also made numerous staffing adjustments and performed Indoctrination and training of all employees on the new program.
INC requests that we be allowed to resume fabrication activities at i
this time.
4 Sincerely, t
EW Huddleston, President /GM j
Industrial Nuclear Company l
CC: Susan S. Shankman, Chief Transpor.ation Safety and inspection Branch Spent Fuel Project Office Office of Nuclear Material Safety and Safeguards 1 Whiteflint North 11555 Rockville Pike Rockville, Maryland 20852 h.lTCG
(
9810140260 980929 PDR ADOCK 07100062 C
PDR t
CA OFFICE:
14320 Wicks Blvd, San Leandro, CA 94577 Tot (510) 3524766 68 + Fax (510) 352-6772 1
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Pcgs 1 of 22 Responses to NRC Inspection Report 71-0062/98-204 i
NONCONFORMANCES A and B A/B.
CAUSE OF THE NONCONFORMANCE l
The cause of these nonconformances was a misunderstanding, by the testing company hired by INC, of the requirements of 10CFR 71.73 regarding the qualification test prerequisites. Also, INC's review of testing activities was not adequate to identify these problems.
A/B CORRECTIVE ACTIONS AND RESULTS INC had agreed to retest our packages in accordance with 10CFR 71.73 requirements, and comply with the NRC's directive to use a
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testing agency with an NRC approved 10CFR71 quality program. INC i
has submitted, and the NRC has approved, the testing agency, test plans and test procedures. The free drop and puncture retests were conducted on July 28,1998. All packages tested passed the drop and puncture tests. INC received the test reports on September 2,1909, and has performed the initial review required by INC's new desiga control procedure, QP 3.1.
Upon completion of the required review cycle, INC will submit the test reports to the NRC.
A/B ACTIONS TO PREVENT RECURRENCE INC issued QP 3.1, " Design Control", Revision 0, 5/22/98.
This procedure includes requirements for the selection of testing agencies, review and approval of test plans and procedures by INC's Engineering Manager and QA Manager prior to performance of the tests, and the review of test results to assure that all test prerequisites have been met and that the test results are satisfactory.
A/B CORRECTIVE ACTION COMPLETION DATE All corrective actions for these nonconformances are complete.
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Responses to NRC Inspection Report 71-0062/98-204 NONCONFORMANCE C C.
CAUSE OF THE NONCONFORMANCE l-The cause of this nonconformance was an apparent misunderstanding between the President /GM and the Radiation Safety Officer (RSO).
The President /GM believed that he had communicated these responsibilities to the RSO, however, the RSO could not recall this
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communication.
These duties and responsibilities were clearly i
established in writing in INC's quality program.
C.
CORRECTIVE ACTIONS AND RESULTS INC's QA Program, Revision 8, no longer identifies the QA Manager j
and the RSO as the same person. Section 1.0, " Organization", clearly provides unique position descriptions and responsibilities for the QA Manager and the RSO. INC hired a new QA Manager, who has been on staff since June of 1998, to perform the duties identified in INC's QA Program for the QA Manager.
INC has retained the RSO to perform RSO duties only. INC has also retained the services of the NRC-approved QA experts to provide program development expertise l
and training to the entire INC staff in procedural requirements and j
methods of implementation of our quality program.
C.
ACTIONS TO PREVENT RECURRENCE The new QA Manager has received documented QA Program indoctrination and training and is aware of his duties and responsibilities under INC's quality program.
C.
CORRECTIVE ACTION COMPLETION DATE All corrective actions for this nonconformance are complete.
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Responses to NRC Inspection Report 71-0062/98-204 NONCONFORMANCES D.1 - 3 D.1-3 CAUSE OF THE NONCONFORMANCE l
l As stated in the response to Nonconformance C above, INC's QA i
Manager was not aware of his duties and responsibilities under the QA Program, therefore, these duties were not accomplished as required.
D.1-3 CORRECTIVE ACTIONS AND RESULTS As stated in the response to Nonconformance C, INC issued QA Program, Revision 8, and trained all employees on the requirements of j
this program. INC's QA Manager is aware of the requirements of this program and has begun implementing the quality program, including QP 6.1, " Document Control". QP 6.1 requires that all previous issues of the QA Program be collected and superseded or discarded. This action is complete.
All INC employees.are aware of the current l
revision of the INC quality program.
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INC has issued, or is preparing to issue, the following procedures to l
control the activities described in the referenced sections of 10CFR 71 Subpart H as noted in this nonconformance:
Section 71.115:
QP 7.1,
" Control of Purchased
- items, Materials, and Services", Revision 0, dated 6/22/98, i
Section 71.117:
QP 8.1, " identification and Control of Materials, Parts and Components", Revision 0, dated 7/21/98.
Section 71.123 QP 11.1, " Test Control", Revision 0, dated 6/25/98.~
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Section 71.129 QP 14.1, " Inspection, Test, and Operating l
Status", Revision 0, dated 9/11/98.
Maintenance Work Instruction 7, entitled " Maintenance Program", is in the review cycle.
This WI L
includes requirements for documenting the as-l.
found condition of all packages received by INC for maintenance and a review of the inspection records for generic safety problems.
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l Responses to NRC Inspection Report 71-0062/98-204 INC has revised the QA Program to indicate that we perform no l
special processes. INC will control suppliers that perform special j
j processes via QA Program Sections 7.0 and 9.0, and QP 7.1, " Control l
of Purchased items, Materials And Services".
l D.1 ACTIONS TO PREVENT RECURRENCE l
lNC has developed new procedures that include more detailed guidance for implementation, more clearly assign responsibilities, l
identify specific quality records, and provide for more detailed reporting of activities that affect quality. Verification of implementation of these procedures is included in INC's new comprehensive internal audit j
program.
The new QA Manager has received QA Program indoctrination and i
training and is aware of his duties and responsibilities under INC's QA l
Program. Section 2.0 of the QA Program requires training whenever j
l the QA Program is revised, as well as the performance of an annual
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assessment of the adequacy and effectiveness of the QA Program by the QA Manager.
D.1-3 CORRECTIVE ACTION COMPLETION uATE l'
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The programmatic changes should be complete by October 31,1998, and implementation of these programmatic elements is pending resumption of fabrication activities.
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Pags 5 of 22 Responses to NRC Inspection Report 710062/98-204 NONCONFORMANCES E.1 - 6 j
E.1-6 CAUSE OF THE NONCONFORMANCE.
The deficiencies noted in items 1 through 6 are related to either design or document control weaknesses in INC's program, as well as
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inadequate implementation of these elements of the program. The
.cause of these weaknesses is attributed to a failure, by INC i
management, to assume responsibility for development of INC's j
quality program, and a lack of an adequate program for the verification j
of implementation of INC's program via the internal audit process.
I E.1-6 CORRECTIVE ACTIONS AND RESULTS INC issued QP 3.1, " Design Control", Revision 0, 5/22/98, and QP 6.1,
" Document Control", Revision 0, 5/22/98, to better define design and document control requirements.
INC has trained responsible individuals to the requirements of these proceduret Both procedures are being implemented at this time. OP 3.1 assigns responsibilities L
and establishes'a system for the preparation, review, and approval of i
design documents, including changes. QP 6.1 establishes a system for the preparation, review, approval,. control, and distribution of INC I
instructions and procedures. Design drawings are prepared, reviewed i
and approved in accordance with QP 3.1, but are controlled and distributed in accordance with QP 6.1. This procedure also provides those controls necessary to assure that the appropriate document and 1
revision are available and in use.
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INC is in the process of issuing new design drawings as required by OP 3.1 for each package. QP 6.1 includes controls for distributing i
design documents to suppliers for fabrication and/or procurement.
INC is also in the process of issuing new procedures for the fabrication of the IR-50, IR-100 and OP-100. Each package will have a unique i
. procedure for the control of fabrication of the specific package.
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E.1-6 ACTIONS TO PREVENT RECURRENCE INC has developed new procedures that include more detailed guidar.ca for implementation, more clearly assign responsibilities, identify specific quality records, and provide for improved reporting of activities that affect quality.
Verification of implementation of these procedures is included in INC's new comprehensive internal audit program.
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Responses to NRC inspection Report 71-0062/98-204 l
All responsible INC employees have been trained in the requirements of these procedures.
E.1-6 CORRECTIVE ACTION COMPLETION DATE INC has implemented QP 3.1 and QP 6.1 for the issuance and control l
- of design drawings and many other documents. INC has generated l
design drawings for all packages and parts, and is progressing with the review and approval process. This activity should be completed by l
10/31/98.
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Prgs 7 of 22 Responses to NRC Inspection Report 71-0062/98-204 c
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NONCONFORMANCES F.1 - 2 F.1-2 CAUSE OF THE NONCONFORMANCE The cause of this nonconformance was a failure to implement program requirements as well as a weakness in the written program. INC's procedure FQAA 2.4, " Procurement Control", allowed employees to
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make purchases without the use of written purchase orders. This
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created an environment whereby employees did not feel obligated to comply with procedural requirements in cases where written purchase 4
orders were used.
F.1-2 CORRECTIVE ACTIONS AND RESULTS FQAA 2.4 has been superseded and replaced with QP 4.1,
" Procurement Document Control", Revision 0,6/10/98. QP 4.1 requires p
i the use of written purchase orders for all procurements. QP 4.1 also requires inclusion of appropriate quality and technical requirements on the PO; review of the PO by the QA Manager; verification that the supplier is qualified to provide the item or service being procured; and l
issuance of the written PO to the supplier. This procedure will be j
implemented with the resumption of fabrication activities.
F.1-2 ACTIONS TO PREVENT RECURRENCE
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INC has developed new procedures that include more detailed guidance for implementation, more clearly assign responsibilities, and provide improved documentation of these activities. The use,' review, issuance and revision of purchase orders are now clearly defined.
Verification of implementation of this procedure is included in INC's new comprehensive internal audit program.
All responsible INC employees have been trained in the requirements of this procedure.
4 F.1-2 CORRECTIVE ACTION COMPLETION DATE i
All programmatic changes and required employees training have been
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completed. implementation will be complete with the resumption of fabrication activities.
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Responses to NRC Inspection Report 71-0062/98-204 9
NONCONFORMANCES G.1 - 5 l
G.1-5
' CAUSE OF THE NONCONFORMANCE The deficiencies noted in Items 1 through 5 are related to design and document control weaknesses in INC's program, as well as inadequate implementation of these elements of the program. The cause of these weaknesses is attributed to a failure of INC management to assume l'
responsibility for development of INC's quality program, and a lack of i
an adequate program for the verification of implementation of INC's program via the intemal audit process.
G.1-5 CORRECTIVE ACTIONS AND RESULTS l
INC issued QP 6.1, " Document Control", Revision 0, on 5/22/98. This procedure established methods for the control of documents such as Quality Procedures, travelers, test plans, test procedures, design drawings and fabrication documents. This procedure requires the use of l
a Controlled Document Master Log to identify all documents that are included in the document control system. The Controlled Document Master Log is required to include as a minimum, the document number, title, revision number, and effective date.
QP 6.1 has established requirements for the distribution of controlled p
documents. QP 6.1 requires the use of a Controlled Document Master Distribution Log for each controlled document to be distributed both intemally and extemally. This log includes the identification of the document and the recipient of the document. The Document Control Clerk is responsible for maintaining this log.
The Controlled Document Master Log and the Controlled Document Master Distribution Log are required to be updated by the QA Manag er i
L whenever revised documents or new documents are issued.
The Document Control Clerk is responsible for the control and distribution of new and revised documents in accordance with the Controlled Document Master Distribution Log.
INC issued QP 3.1, " Design Control", Revision 0, 5/22/98 that established a system for the preparation, review, and approval of design j
documents, including changes. As described above, INC it. sued QP 6.1 for the control and distribution of design documents after completion of l
the approval process.
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Pags 9 of 22 Responses to NRC Inspection Report 71-0062/98-204 l
l G.1-5 ACTIONS TO PREVENT RECURRENCE l
INC has developed new procedures that include more detailed guidance for implementation, more clearly assign responsibilities, and provide for improved documentation of these activities.
INC has trained all responsible employees in the requirements of these new procedures.
INC has implemented the requirements of these procedures since their effective date of 5/22/98 for the preparation, review, approval, control, and distribution of newly developed INC procedures and drawir.gs.
G.1-5 CORRECTIVE ACTION COMPLETION DATE Most corrective actions for this nonconformance are complete, with the exception of the completion of the design drawing review and approvals. This activity should be complete by October 31,1998.
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1 Pcgs 10 of 22 Responses to NRC Inspection Report 71-0062/98-204 l
j NONCONFORMANCES H.1 - 4 1
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H.1-4 CAUSE OF THE NONCONFORMANCE -
The cause of these nonconformances is attributed to a failure of INC management to assume responsibility for development of INC's quality i
program. These nonconformances were not identified and corrected l
internally due to a lack of an adequate program for the verification of implementation of INC's program via the internal audit process.
An additional cause of these nonconformances was a lack of 1
l understanding of the requirements for evaluation and verification of j
l-material conformance under 10CFR71 Subpart H
and a
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misinterpretation of 10CFR Part 21 concerning the use of commercial j
' grade materials.
i H.1-4 CORRECTIVE ACTIONS AND RESULTS I
INC has issued QP 7.1, " Control Of Purchased items, Materials and Services", Revision 0, dated 6/22/98, to establish a system and assign responsibilities to assure that purchased materials, equipment and services conform to the design and/or procurement documents. INC has also issued QP 3.2, " Commercial Grade item Dedication", Revision 0, 6/10/98, to establish requirements for the dedication of commercial grade items.
INC has issued QP 18.1, " Audits", Revision 0, dated 7/21/98, which establishes meti ods for supplier audit planning, scheduling and performance. !NC has issued QP 10.1, " Inspection", Revision 0, dated 6/26/98, which includes requirements for the receipt inspection of materials, parts and components. INC has issued QP 14.1, " Inspection, l
Test and Operating Status", Revision 0, dated 9/11/98, which describes INC's new traveler process.
To control procurement and fabrication activities, INC will procure all materials, parts, and components and use one of the established verification methods for acceptance. INC will kit the parts and supply them to the fabricator for assembly. No important-to-safety (ITS) parts will be procured by INC's fabricator. INC will perform surveillance at the fabricator's facility as well as impose holdpoints on the travelers for required inspections by qualified INC personnel. The fabricator will not be allowed to perform any final acceptance inspections.
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Paga 11 of 22 i
Responses to NRC Inspection Report 71-0062/98-204
' H.1 4' ACTIONS TO PREVENT RECURRENCE INC has developed several new procedures that include more detailed guidance for implementation, more clearly assign responsibilities, and provide for improved control and documentation of these activities.
INC has trained all responsible employees in the requirements of these procedures.
Implementation of these procedures will provide assurance that materials, items and services used in ITS applications conform to specified technical and quality requirements.
INC has notified the fabricator of his future responsibilities concerning the fabrication of INC products. INC's new QA Manager is a former ASNT TC-1A certified Level 111 in several disciplines as well as a qualified welding inspector.
This expertise should mitigate past weaknesses of INC's staff in the inspection area.
H.1-4 CORREGy'C g TION COMPLETION DATE INC has ampieted all of the procedure development and employee training required to correct these defichncies. INC will implement these procedures upon resumption of fabrication activities.
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Paga 12 of 22 Responses to NRC inspection Report 71-0062/98-204 NONCONFORMANCES J.1 - 5 J.1-5 CAUSE OF THE NONCONFORMANCE These nonconformances were caused by a lack of understanding by INC management of special process control requirements, including controls over suppliers that perform special processes.
-J.1-5 CORRECTIVE ACTIONS AND RESULTS INC has not performed special processes under the current ownership (6/89). INC's program identified that INC personnel may perform liquid penetrant tests under certain conditions, as well as identifying " dye checks" in other INC documentation. However, INC personnel have not performed liquid penetrant tests. At this time, INC does not plan on performing special processes.
All special processes will be performed by suppliers qualified to provide INC with those services.
INC's fabricator has performed welding and the foam fill operation.
INC has evaluated these processes under QP 3.1, " Design Control",
and considers the welding an ITS activity and the foaming as a not-important-to-safety (NITS) activity.
Special processes that are performed by suppliers shall be controlled by INC under QA Program, Section 7.0, QP 7.1 and QP 9.1. Additionally, INC has added requirements to the QA Program for the review of special process procedures prior to their use by the supplier.
J.1-5 ACTIONS TO PREVENT RECURRENCE INC has developed adequate procedural requirements to control special processes performed by INC suppliers. INC has informed the fabricator of the requirements for qualification of procedures and personnel. INC's fabricator _has begun the process of qualifying welding procedures and welders to perform INC fabrication activities.
INC will review and approve these procedures and qualifications prior to the resumption of fabrication activities.
J.1-5 CORRECTIVE ACTION COMPLETION DATE All INC procedures are in place to correct the identified deficiencies.
The completion date for the fabricator's procedures is tentatively scheduled for 10/31/98. Once completed, the procedure and personnel qualifications will be reviewed by INC.
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Paga 13 of 22 Responses to NRC Inspection Report 71-0062/98-204 NONCONFORMANCES K.1 - 3 K.1-2 CAUSE OF THE NONCONFORMANCE These nonconformances were caused by a misunderstanding by INC management of the adequacy of the supplier audits that INC had performed. Until notified by the NRC that INC's supplier audits were inadequate, INC considered the audits adequate and considered our fabricator to be a qualified supplier.
.K.1-2 CORRECTIVE ACTIONS AND RESULTS INC has issued QP 14.1, " Inspection, Test and Operating Status",
Revision 0, 9/11/98, which established a traveler system that will better control the fabrication process. This system identifies holdpoints in the fabrication process that will provide INC employees an opportunity to perform and document the results of in-process inspections at the fabricator's facility.
j INC has also issued QP 10.1,'" Inspection", Revision 0, 6/26/98, which establishes inspechon and documentation requirements, personnel qualification requirements, and specifies the method for determining appropriate acceptance criteria for items to be inspected.
INC has issued QP 7.1 that establishes a system and assigns responsibilities to assure that purchased materials, equipment and services conform to the design and/or procurement documents. This procedure describes the methods that will be used to accept purchased equipment, material, and services.
Conformance to procurement document requirements is required to be verified by receipt inspection, supplier audit, source inspection or dedication, depending on the nature, scope, and complexity of the item, material or service being procured.
K.1-2 ACTIONS TO PREVENT RECURRENCE l
lNC has developed new procedures that include more detailed guidance for implementation, more clearly assign responsibilities, and provide.for improved documentation of these activities. INC's procedures provide for the control of verification of material through receipt inspection, supplier audit, source inspection or dedication.
l INC has trained all responsible employees in the requirements of f
these new procedures.
l Pag 314 of 22 Responses to NRC Inspection Report 71-0062/98-204 INC's QA Manager is capable of performing all required inspections and ic 'a the process of developing a training guideline to enable INC to train and qualify other inspection personnel.
K.1-2 C.ORRECTIVE ACTIONS COMPLETION DATE All programmatic deficiencies have been corrected.
INC has staff capable of performing all required inspections. Implementation of this program is pending resumption of fabrication activities.
i K.3 CAUSE OF THE NONCONFORMANCE The cause of this nonconformance was an inadequate review of the procedures that controlled this activity. The review did not assure that the controlling procedures contained sufficient guidance and accurate acceptance criteria to ensure compliance with INC's license requirements.
K.3 CORRECTIVE ACTIONS AND RESULTS INC has superseded Inspection Procedure 3.3, Radiographic Exposure Device, IR-100, dated 6/15/92, and Quality Control Procedure 3.2, Radiographic Exposure Device, IR-50, dated 6/15/92.
Radiation surveys for the IR-50 and IR-100 are controlled by Work Instruction 1,
" Physical Inspection", which is presently in the review cycle. INC will include, on the test report, a calculation that will extrapolate the surface readings based on the actual value in curies of the source used and actual surface level readings taken. This procedure requires that all surface readings are extrapolated to the rated capacity of 120 curies.
The package will be identified as nonconforming and evaluated via the nonconformance program if the extrapolated readings exceed 200 mR/hr at the surface.
INC will review the initial test results for all packages that remain in service and notify the owners of the actual maximum rated capacity.
CARS will be issued to track corrective actions for evaluation and notification of owners of in-service IR-100s.
l K.3 ACTIONS TO PREVENT RECURRENCE INC has developed new procedures that include detailed guidance for implementation, clearly assign responsibilities, and provide for improved documentation of this activity. The QA Manager has been assigned the responsibility for the review of all maintenance inspection results and the tracking and evaluation of deficiencies.
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Prga 15 of 22 Responses to NRC Inspection Report 71-0062/98-204 i
K.3 CORRECTIVE ACTIONS COMPLETION DATE The procedure is scheduled to be completed by 10/15/98, with implementation pending resumption of maintenance activities.
Notification of the owners of IR-50 Serial Numbers 2058, 2073, and 2074 will be complete by 10/31/98. The review of the test records for in-service packages and notification of the owners in the event that the package could potentially exceed its rated capacity should be complete by 3/31/99.
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Responses to NRC Inspection Report 71-0062/98-204 NONCONFORMANCES L.1 1 L.1-2 The response to this nonconformance is the same as the response to Nonconformances A and B.
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Pc:gs 17 of 22 Responses to NRC Inspection Report 71-0062/98-204 NONCONFORMANCE M M.
CAUSE OF THE NONCONFORMANCE The cause of this nonconformanca was that the INC RSO was not aware of his responsibility to include M&TE other than radiation monitoring equipment in the calibration program.
M.
CORRECTIVE ACTIONS AND RESULT.4 INC has issued QP 12.1, " Control of Measuring and Test Equipment",
Revision 1, dated 6/25/98. This procedure requires the QA Manager to assure the system used in selection, maintenance, calibration, use and control of M&TE are implemented effectively; and required accuracy, calibration intervals, procedures and records are maintained.
INC has identified all M&TE needed to perform the required verification activities, and has included them on the M&TE Log. All M&TE will be calibrated by an approved supplier.
M&TE requiring calibration has been identified and will be sent to a qualified calibration service supplier upon completion of the qualification process.
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ACTIONS TO PREVENT RECURRENCE INC has developed procedures that more precisely describe the calibration program and personnel responsibilities. Responsible INC personnel have been trained to the requirements of QA Program Section 12.0 and QP 12.1.
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CORRECTIVE ACTIONS COMPLETION DATE All actions will be complete by 10/31/98.
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Pcg318 of 22 Responses to NRC Inspection Report 71-0062/98-204 NONCONFORMANCE N N.
CA'JSE GF THE NONCONFORMANCE This nonconformance was caused by a lack of management involvement in the implementation of the QA Program and a lack of effective review of implementing procedures. INC Procedure OQCP 4.5, "Nonconformance and Corrective Action" was reviewed and found to contain insufficient detail to support implementation of the nonconformance requirements in the QA Program.
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CORRECTIVE ACTIONS AND RESULTE INC has issued QP 15.1, " Control of Nonconformances", Revision 0, dated 5/22/98.
This procedure provides measures to assure that nonconforming items are identified, documented, segregated, dispositioned and ccrrected.
This procedure assigns responsibilities, clearly defines nonconforming conditions and disposition categories, provides documentation for reporting, reviewing, dispositioning, and verifying completion of corrective actions, and provides a Log as a tracking mechanism.
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ACTIONS TO PREVENT RECURRENCE INC has developed a nonconformance program that more clearly describes the entire nonconformance process and those responsible for its implementation. INC has trained all employees on the requirements of this program.
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CORRECTIVE ACTIONS COMPLETION DATE All corrective actions are comp.ete.
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Pags 19 of 22 Responses to NRC Inspection Report 71-0062/98-204
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NONCONFORMANCES O.1 - 3 0.1-3 CAUSE OF THE NONCONFORMANCE The cause of these nonconformances was a failure by INC management to develop and implement an effective corrective action
- program, including identification documentation, establishing corrective actions and follow-up. Procedural inadequacies included lack of provisions for determining the significance of conditions adverse to quality. INC employees were not adequately trained in the implementation of the corrective action or supplier audit program.
1 O.1-3 CORRECTIVE ACTIONS AND RESU.LTS INC issued QP 16.1, " Corrective Action", Revision 0, dated 6/26/98.
This procedure establishes a system and assigns responsibilities for the identification and correction of conditions adverse to quality, the determination of significant conditions adverse to quality, and the determination of the cause and measures to prevent their recurrence.
This procedure also provides for documentation and tracking of open Corrective Action Reports (CARS).
The QA Manager is required to review conditions adverse to quality,.
such as deficiencies, nonconformances, deviations, defective material, rejected _ inspection or test reports, and inspection or audit reports issued intemally or by regulatory agencies (as a minimum). The QA Manager shall determine if the identified deficiencies constitute a significant condition adverse to quality.
When a condition adverse to quality, not otherwise documented, or a significant condition adverse to quality, is identified, the condition shall be documented on a Corrective Action Report (CAR) and processed in accordance with QP 16.1. INC has issued several CARS in accordance with the requirements of QP 16.1.
Regarding deficiencies identified at supplier's facilities, INC issued QP 18.1," Audits", Revision 0, dated 7/21/98. The purpose of this procedure is to establish a system and assign responsibilities for the planning and implementation of the intemal and supplier audit program.
This procedure includes requirements for the identification and documentation of deficiencies in the supplier's quality program or its implementation, by issuance of an Audit Finding Report (AFR). This procedure provides for documenting the review of the deficient condition w~-
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Responses to NRC Inspection Report 71-0062/98-204 forimpact on INC products; review of proposed corrective actions for adequacy; and follow-up of corrective actions to determine if they are I
being effectively implemented.
O.1-3 ACTIONS TO PREVENT RECURRENCE INC has developed more detailed procedures that provide for l
improved control over-these activities.
The procedures assign l
responsibilities, provide for the use of trained and qualified personnel, establish implementation controls and mechanisms that provide ease in tracking the status of deficiencies, and provide documentation requirements.
INC has trained all responsible personnel on the requirements of these procedures. INC has implemented the requirements of QP 16.1 and has assigned responsibilities in the program for effectively implementing l
these requirements on a consistent basis.
O.1-3 CORRECTIVE ACTIONS COMPLETION DATE All aspects of this corrective action will be complete by 10/31/98.
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Paga 21 of 22 Responses to NRC Inspection Report 71-0062/98-204 l
NONCONFORMANCES P.1 - 7 P.1-7 CAUSE OF THE NONCONFORMANCE The cause of these nonconformances was a procedural inadeauacy.
Procedures identified records that were required to be maintained, however, document control procedures did not provide adequate implementing detail for the maintenance of quality records.
P.1-7 CORRECTIVE ACTIONS AND RESULTS INC has made two programmatic changes to correct this deficiency.
l lNC has developed and issued QP 17.1, "QA Records", Revision 0, dated 6/19/98.
This procedure established requirements for the l
classification, filing, storage, retention and disposition of quality records l
generated by INC.
OP 17.1 assigns responsibilities for the implementation of the QA Records program.
l lNC has also added a section to each QP entitled "QA Records". This section identifies the documents generated by that procedure that are required to be maintained as quality records, i
l P.1-7 ACTIONS TO PREVENT RECURRENCE INC has developed new procedures that include more detailed guidance for implementation, more clearly assign responsibilities, identify specific quality records, and provide clear requirements for the maintenance and storage of quality records. Verification of implementation of this procedure is included in INC's recently developed comprehensive internal audit program.
All responsible INC employees have been trained in the requirements of QP 17.1. - INC has delegated the responsibility for secords control to the QA Manager who has assigned the routine duties to the Document Control Clerk.
P.1-7 CORRECTIVE ACTIONS COMPLETION DATE l
All corrective actions required by this nonconformance have been completed.
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,4 Pcgo 22 of 22 Responses to NRC Inspection Report 71-0062/98-204 NONCONFORMANCE Q Q.
CAUSE OF THE NONCONFORMANCE i
l lNC's QA Manager was not aware of his duties and responsibilities under the QA Program, therefore, these duties were not accomplished as required. There was also inadequate implementing detail in INC's program to effectively implement an internal audit program.
Q.
CORRECTIVE ACTIONS AND RESULTS INC has hired a new QA Manager and has advised him of his duties and responsibilities under Section 18.0 of the QA Program. INC has issued QP 18.1, " Audits", Revision 0, dated 7/21/98. OP 18.1 contains sufficient detail for the implementation of the internal audit program.
This procedure provides measures to assure that internal audits are planned and conducted to verify compliance with all aspects of the QA Program on an annual basis. Audit checklists are required to be used that reflect the elements of INC's QA Program and implementing procedures being evaluated.
Objective evidence of program implementation shall be examined and documented on the audit j
checklist. Personnel performing audits are required to be independent Of the activity that they are auditing, and may be contracted from an outside organization to assure independence.
l Q.
ACTIONS TO PREVENT RECURRENCE
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INC has developed a comprehensive audit procedure, assigned responsibility for its implementation, and allows for the use of cont. meted auditors to assure audit personnel are qualified to perform the audits and are independent of the activities being audited.
INC has trained responsible personnel on the requirements of this procedure.
INC has also retained a quality consultant to provide ongoing audit services and training of INC employees in this area as needed.
Q.
CORRECTIVE ACTIONS COMPLETION DATE The programmatic elements of this nonconformance have been corrected.
implementation of this program will commence with fabrication activities.