ML19281A782
| ML19281A782 | |
| Person / Time | |
|---|---|
| Issue date: | 01/23/1979 |
| From: | Brown R, Costello J, Hale C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19281A770 | List: |
| References | |
| REF-QA-99900401 NUDOCS 7904040286 | |
| Download: ML19281A782 (12) | |
Text
b U.S. fiJCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND E"FC2 CEMENT REGION IV Report flo. 99900401/79-01 Program No. 51100 Company:
Combustion Engineering, Inc.
1000 Prospect Hill Road Windsor, Connecticut C6095 Inspection at: Windsor, Connecticut Inspection Conducted: January 9-12, 1979 0
/
--- /[t
/
.I/79 Inspectors:
Im/
?
J. R. Costel10, Principal Inspector, D4te Vendor Inspection Branch l
l k
An
//'s/7f
/
w R. L, Brown, Principal Inspector, D6te' '
Vendor Inspection Branch
/
Approved by:
.4 h AM i_
//2J/79 C. J. Hale, Chief, Vendor Pro 3 ram Evaluation D5te Section, Vendor Inspection Branch Summary Inspection conducted on January 9-12, 1979 (99900401/79-01)
Areas Insoected:
Implementation of the Combustion Engineering QA Program in the areas of Design Document Control, Design Corrective Action and follow-up on previous inspection findings. The inspection involved fifty-six (56) hours on site by two (2) USNRC inspectors.
Results:
In the three (3) areas inspected, two (2) deviations were identi-fied in one (1) area.
fio unresolved items were identified in any of the areas.
Deviations:
(1) Follow-up on Previous Inspection Findings - Contrary to 10 CFR 50, Appendix B, Criterion V, and implementing procedure QAP 18.1, three (3) of the six (5) audit reports for internal audits conducted in 1978 were not published thirty (30) days after the post-audit conference.
790404098b
_2_
(2) Follow-up on Previous Inspection Findings - Contrary to 10 CFR 50, Appendix B, Criterion V, and implamenting procedure QAP 16.1, Corrective Action Request QC-CAR-78-017, dated April 18, 1978, with a reply due data of May 8,1973, had not been responded to by the vendor on January 11, 1979, nor had a new CAR been generated.
- CetailsSection I (Prepared by J. R. Costello)
A.
Persons Contacted W. W. Albert, Manager Auxilliary Equipment, Plant Apparatus
- E. F. Boudreau, Planning Supervisor, Group Quality Systems
- G. S. Brunetto, Plants and Sites Supervisor, Group Quality Control E. R. D' Amaddio, Supervisor R2 actor Coolant Pumps and Primary Support, Plant Apparatus
- B. R. Davis, Manager Group Quality Systems
- E. P. Flynn, Director, Plant Apparatus and Engineering Quality Assurance
- G. J. Huba, Manager Engineering Quality Assurance
- R. J. Landrigan, Supervisor Purchasing Department K. Lillie, Quality Engineer
- D. M. Mayer, Supervisor Planning and Procedures
- R. R. Mills, Project and Generic Licensing Supervisor
- J. C. Packard, Compliance Supervisor, Group Quality Systems
- R. A. Terry, Engineer, Plant Appareus
- Denotes those present at exit meeting B.
Follow-up on Previous Insoection Findings 1.
(0 pen) Deviation (Report Number 78-02):
Contrary to conmitments, management audits prescribed in Paragraph 17.2.6 of CEMPD-210-A are not documented through written operating procedures; conse-quently, the control and execution of these audits are not per-formed consistently.
CE has corritted to develop a written procedure to control management audits by January 1979. This procedure has not been prepared, but the inspector was assured it would be prepared before the end of January 1979.
2.
(Closed) Deviation (Report Number 78-02):
Contrary to 10 CFR 50, Appendix B, Criterion III, the adequacy of the vendor design of motor operated High Pressure Safety Injection (HPSI) valves procured by CE for five (5) nuclear plants does not, appear to have been verified adequately. The inspector verified that practices outlined in CE's letters of August 23, 1978, and November 20, 1978, are being followed.
Essentially this means that design verification is performed by a vendor with a design and build contract and no attempt is made to perform additional verification of the manufacturer's design when the manufacturer assumes full responsibility for his design.
The vendor maintains documentary evidence of the design verification performed in accordance with his quality assurance program approved by CE; adequacy of design verification is not necessarily reviewed by any other party.
_4_
However,10 CFR 50, Appendix B includes provisions for testing of structures, systems and components to demonstrate that they will perform satisfactorily in service.
These system tests are performed as part of the overall design verification process and are required because the interaction between the individual components that comprise the system are very difficult to predict.
After the failure to meet cerformance requirements was discovered in the system tests, CE took corrective and preventive action to rectify the differences in the HPSI valves.
The inspector verified that CE is meeting its commitments in CEtiPD-210-A for the preparation of engineering and purchasing documents and is placing the responsibility for design verifi-cation of vendor designs on the vendor.
There is no evidence of violation of their commitments, therefore, CE's respsnses in their letters of October 5,1978, and t;ove-6er 20,1978, are complete and this item is not considered a deviation.
3.
(Closed) Deviation (Report t; umber 78-02):
Contrary to 10 CFR 50, Appendix B, Criterion XV, no Field Acticn Report was generated for HPSI valves returned for rework.
CE did not believe that a FAR was necessary to document the initial performance of the valves since it appeared the safety analysis could accomodate the measured performance.
However, a FAR should have been used to document the valve modification which has since been done (FAR 6370-356). The Site and Project Offices have since been instructed in the use of FARs to document this type of change.
4.
(Closed) Deviation (Report flumber 78-02):
Contrary to 10 CFR 50, Apr.endix B, Criterion V, equipment with incomplete records was released for shipment without proper documented approvals.
The original intent of QAP 8.1 was to document approval of conditions discovered at a vendor's facility which were unknown at.the time of preparation of the Certification of Equipment (C of E) in Uindsor. QAP 8.1 has been revised (Revision A).
In the neu QAP 8.1, the resident GQC representatives may contact their supervisors to obtain the necessary releases from Windsor...
or they may contact the PSG cognizant engineer by telephone for approval, document the telecon, which will be referenced and attached to the C of E.
5.
(0 pen) Deviation (Report Number 78-03): Contrary to 10 CFR 50, Appendix B, Criterion III, and implementing procedure PE QA Number 001, the transmittal sheet for unreviewed documents did not indicate when the documents would be reviewed. The inspector verified that the current issue of Project Specification 14273-PE-410, Revision 2 has been verfied and that a memo was prepared reminding all personnel in the affected group to indicate on the transmittal docunent when unverified documents are to be verified.
However, CE was unable to locate the transmittal document for Revision 2 to Specification 14273-PE-410, so the item still remains open.
6.
(Closed) Deviation (P,eport Number 78-03):
Contrary to 10 CFR 50, Appendix B, Criterion VI and implementing procedure QADF 6.0, Supplement 3B to P.O. 9403833 did not receive the same review and approval as the original P.0 although quality affecting changes were involved.
The inspector verified that the cognizaat buyer printed a copy of this supplement together with eleven (11) similar supplements on other purchase orders for System 80 pumps and requested the necessary sign-offs with the date of the sign-offs so the records would be clear that they were retroactive signatures.
Copies of the signed supplements were in the pur-chase order files.
In addition, section 26.1 of the Purchasing Manual has been revised to more specifically delineate those purchase order supplements which fall under the commercial auth-ority of the buyer.
7.
(0 pen) Deviation (Report Number 78-04):
Contrary to 10 CFR 50, Appendix B, Criterion V, procedures do not exist for the evalu-ation and reporting of significant changes in the evaluation model as referenced in Criterion II.6 of 10 CFR 50, Appendix K.
Comtem-plated corrective and preventive action will not be completed until April 1,1979.
8.
(0 pen) Unresolved Item (Report Number 78-02): No internal audits are being conducted by either EQA or GQS personnel relative to the activities of Licensing and Project Management personnel in the Commercial Department.
The reasons for CE's decision not to audit these two organizations are th t no significant quality affecting activities are performed by them and the quality affec-ting activities they are involved in can be audited in other organizations.
CE will document their rationale in a memorandum to the inspector which will be further investigated during the next inspection.
9.
(0 pen) Unresolved Item (Report Number 78-02):
It is not clear whether ANSI N45.2.6 is applicabie to surveillance personnel.
CE has revised QAP 2.1 Appendix A removing all references to ASNI fl45.2.6. However, topical report CENPD-210-A, section 17.10 states that PSG Wir.dsor personnel perfoming surveillance activities are qualified to ANSI N45.2.6-1973, whereas Table 17-3 of CENPD-210-A states that this standard is not applicable to the surveillance personnal organization (5072 - Group QA).
This matter will remain open until the conflict of requirements in the tcpical report and CEs interpretation of these require-rrents are resolved.
10.
(Closed) Unresolved Item (Report tio. 78-02):
Contrary to CE topical report CENPD-210-A, Group Quality Systems is not fully implementing the CE internal audit program.
This was originally reported as a deviation and then changed to an unresolved item as CE still had some time to complete the remaining required audits.
CE has since completed the required remaining audits, but in so doing they failed to issue some of the audit reports on time. (See Notice of Deviation enclosure item A and the Findings paragraph below.)
11.
(0 pen) Unresolved Item (Report No. 78-04); Verification has not been completed on two (2) calculations which resulted in input to the CESSAR System 80 FSAR.
This item will continue to be considered unresolved until NRR/NRC has completed their review to determine what constitutes " final analysis" for purposes of FSAR submittals.
12.
Findings In this area of the inraction one (1) deviation was identified.
(See Notice of Deviation.nclosure item A and additional infor-mation below.)
There ware six (6) internal audits conducted by Group Quality Assurance in 1978. Three (3) of these audit reports were not published thirty (30) days after the post-audit conference. One audit report was twenty-eight (28) days late, one was forty-eight (48) days late and the third audit report which was due on January 8,1979, was not published at the time of this in-spection (January 9-12,1979).
C.
Exit Peeting A meeting was conducted with management representatives at the con-clusion of the inspection on January 12, 1979.
In addition to the individuals indicated by an asterisk in the Details Sections, those in attendance were:
W. G. Blowers, Valve Engineer, Plant Apparatus G. R. Fargo, Manager, Group Quality Control M. R. Etheridge, Vice President, General Services The inspector sur:1arized the scope and findings of this inspection for those present at the meeting. Management representatives ac-knowledged the statements of the inspector.
DetailsSection II (Prepared by Ross L. Brown)
A.
Persons Contacted W. W. Albert, Manager Plant Component Engineering (PCE)
- E. F. Boudreau, Supervisor, Group Quality Control (GQ:)
- R. J. Brcoks, Supervisor, Nuclear Contract Control
- G. S. Brunetto, Supervisor, GQC E. R. D' A:naddio, Supervisor, Plant Apparatus Engineer
- B. R. Davis, Manager, Group Quality Systems (GQS)
P. A. Gaughan, File Room Supervisor
- F. G. Harvey, Engineering Quality Assurance (EQA)
- C. W. Hoffman, Director, Group Quality Assurance
- G. J. Huba, Manager, EQA
- R. J. Landrigan,. Purchasing R. M. MacDonald, Aide, Physics and Ccmputer Analysis (P&CA)
N. J. Martin, Secretary, P&CA
- J. C. Packard, Supervisor, GQS V. A. Paggen, Supervisor, Corrective Action M. F. Pepe, Records Controller, PCE J. R. Rec, Quality Assurance, P&CA R. F. Webb, Supervisor, Drafting Section
- Attended exit meeting B.
Desian Document Control 1.
Objectives To deten.:ine that approved procedures have been established and are be'ng implemented for the control and distribution of design docun.ents that provide for:
a.
Identification of personnel positions or organizations responsible for preparing, reviewing, approving, and issuing design documents.
b.
Identification of the proper documents to be used in per-forming the design.
c.
Coordination and control of design (internal and external) interface documents.
d.
Ascertaining that proper documents, and revisions thereto, are accessible and are being used.
.g.
e.
Establishing distribution lists which are updated and maintained current.
2.
Methods of Accomolishment The preceding objectives were accomplished by:
a.
Review of the Combustion Engineering Inc. (CE) Topical Report CEliPD-210-A, Revicion 3, dated November 1977, Sections 17.3, 17.1.3 and 17.6, to determine the CE ccm-mitments relative to engineering document control.
b.
Review of the following Quality Assurance of Design Pro-cedures (QADP) to determine that a method has bee:> estab-lished for the control of design documents in the different engineering disciplines; (1) QADP 5.0, " Design Process," Revision 0, dated May 3, 1976, provides a flow chart that shows the steps that must be taken to ensure the quality of the design.
(2) QADP 5.1, Revision 0, dated May 3,1976, " Design Input," assigns the Project Manager the responsiblity to supply information regarding any specified design bases.
(3) QADP 5.2, Revision 2, dated June 7, 1977, " Design Analysis," establishes the requirement for all anal-yses (including calculations) for component design or evaluation of safety related system performance.
(4) QADP 5.3, Revision 0, dated May 3, 1976, " Interface Control," describes the procedure to be used to assure that interfaces are identified and appropriately co-ordinated.
(5) QADP 5.4, Revision 0, dated May 3, 1976, " Design Verification," establishes the requirement for a list of qualified reviewers and states the items to be considered as a minimum.
(6) QADP 5.5, Revision 1, dated February 21, 1977, " Pre-paration, Control and Retention of Drawings," which provides the responsibilities and procedure for these functions.
_9_
(7) QADP 5.6, Revision 2, dated May 6,.1977, " Procedure for the Preparation and Quality Assurance of Speci-ficat;crs," describes the three (3) types of speci-fications and assigns the responsibilities for preparing and the review of specifications and their revisions.
(8) QADP 5.8, Revision 0, dated May 3, 1976, "Other Design Documents."
(9) QADP 7.0, Revision 4, dated May 6, 1977, " Collection, Storage and Maintenance of Quality Records (other than drawings)," which defines a quality record and des-cribes their identification and storage.
Review of the following documents and records to verify c.
that the requirements of described in B.2.a. and b. were implemented; (1) EQA Audit schedule for 1978 and 1979 of the engineering disciplines (2) Three (3) EQA Audit Reports (3) Two (2) EQA Auditor qualifications (4) Four (4) Engineering Change and Drafting Requests (5) Quarterly Engineering Drawing Progress Report (computer printout)
(6) Project Print distribution (7) Four (4) Drawing Releases (8) Two (2) Approved Reference Design Drawings (9) Document Controllers Log for the following engineering sections EQA, P&CA and PCE (10) Manufacturing Order (MO) Log (11) M0 Supplements, MOs and acknowledgements for one project (12) Seven (7) documents withdrawn from control files.
. 3.
Findinas No deviations from commitments or unresolved items were identi-fied.
C.
Desian Corrective Action 1.
Objectives The objectives of this area of the inspection were to examine and verify that:
a.
Procedures have been established and implemented for identi-fying deficiencies of a significant or recurring nature, determinitg the cause of the deficiencies, and initiating corrective action to prevent recurrence.
b.
Deficiencies and the corrective action are reported to appropriate levels of management.
c.
Follow-up action is taken to assure timely completion of corrective action of a deficiency when resolution is not completed immediately.
d.
The design process and verification procedures are reviewed and modified as necessary where a significant design change is necessary due to incorrect design, or in th2 case of recurring deficiencies.
2.
Methods of Accomplishment
~
The preceding objectives were accomplished by:
a.
Review of QADP 5.7, Revision 1, dated October 1,1976,
" Design Change and Corrective Action." This procedure describes the method used to assure that items or designs which require resolution or other actions are identified, resolved and corrective action is taken.
The procedure also assigns the responsibility for the review and analyses of all Field Action Requests (FAR) to determine if the reported problem is of a generic or repetitive nature, and to require an engineering evaluation for corrective action.
b.
Review of the following documents to verify conformance with the above requirements:
. (1)
Corrective Action Data Base - a printout used for the evaluation of generic type discrepancies.
(2) Two (2) Interoffice Correspondence - including the purpose, discussion and suggested corrective action relative to the identified problem.
(3) Response from cognizant engineer relative to status of Corrective Action Request.
(4) Two (2) Quarterly Reports (distributed to all senior management) that summarized the final disposition of proposed resolution of each major deficiency or problem identified and reports the status of previously reported items.
3.
Findings No deviations from conmitments or unresolved items were identi-fied.
D.
Action on Previous Inspection Findings 1.
(Closed) Unresolved Item (Report 78-03): The documents in the following areas relative to the purchase of Reactor Coolant Pumps were reviewed and the revisions and/or corrections appear to be satisfactory:
a.
Placement of Purchase Orders (PO) in 1974, to a vendor not on the Approved Vendor List (AVL).
These P0s contained a clause that required the vendor to obtain an ASME Certificate of Authorization to replace the Interim Letter which expired in October, 1978.
b.
Status and restrictions of CE-KSB Interim Letter from ASME which expires October 25, 1978.
This letter permitted the vendor to use it for purposes of bidding, engineering, etc. but does not authorize the issuance of a data report or the use of a code stamp.
c.
Reasons for removal of CE-KSB from CE-AVL.
CE-KSB did not pass the ASME Nuclear Survey conducted in September 1978, however, a resurvey has been scheduled for March 1979.
CE-KS3 is not on the AVL and is not being considered for any contracts at this tine.
. d.
Deletion of P0 Supplement 2 by P0 Supplement 33.
In accordance with requirements defined in Procedure QAP 4.1, Revision A, dated October 16, 1978, the P0 Supplement 3B has been reviewed and rpproved by Group Quality Control (GQC).
e.
Status of items 2, 3, and 4 of P0 Supplement 33.
These items were resolved in a CE Windsor /CE-KSB meeting and were docume ted in a letter of understanding.
These agreements have been reflected in a revision to the speci-fication, which has received the same review and approval by the same organization (s) and/or individual (s) as the original specification.
f.
Removal of hold and inspection point requirements except for final inspection by P0 Supplement 9602815 (generic) and specific P0 supplements such as Supplement 12 to P0 9403833 for Contract 14273.
The removal of this requirement will delete the CE-GQC inspections only, and these inspections will be permitted by the CE-KSB "open-door" policy.
The results of these inspections will be documented and reported as usual.
This deletion does not include the code inspector, customer, or regulatory representatives.
g.
Adequacy of procedure QAP 16.1 in iaquiring vendor correc-tive action to CARS such as QC-CAR-78-017 (reissue of QC-CAR-77-029).
Procedure QAP 16.1 was revised on October 16, 1978, to more clearly define the GQA Supervisors responsibilities and authorities relative to vendor responses to Corrective Action Requests.
2.
Deviation from Comitment During the review of corrective action taken relative to this unresolved item, it was determined that a deviation frc a the commitment exists.
(See Enclosure, Item B.)