Information Notice No. 88-35: Inadequate Licensee Performed Vendor Audits
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR REACTOR REGULATION
WASHINGTON, D.C. 20555
June 3, 1988
Information Notice No. 88-35: INADEQUATE LICENSEE PERFORMED VENDOR AUDITS
Addressees:
All holders of operating licenses or construction permits for nuclear power
reactors.
Purpose:
This information notice is being provided to alert addressees to potential
problems resulting from inadequately performed licensee audits at vendor
facilities which may not reveal the vendor's failure to implement critical
portions of its quality assurance (QA) program. It is expected that
recipients will review this information for applicability to their facilities
and consider actions, as appropriate, to avoid similar problems. However,
suggestions contained in this information notice do not constitute NRC
requirements; therefore, no specific action or written response is required.
Description of Circumstances:
NRC reviews during January-April 1988 of documents obtained from Piping Sup-
plies, Incorporated (PSI) of Folsom, New Jersey and West Jersey Manufacturing
Company (WJM) of Williamstown, New Jersey identified several inconsistencies
that indicate potential generic safety implications with pipe fittings and
flanges supplied by PSI and WJM to nuclear power plants. (This issue is
discussed further in NRC Bulletin No. 88-05, "Nonconforming Materials Supplied
by Piping Supplies, Inc. at Folsom, New Jersey and West Jersey Manufacturing
Company at Williamstown, New Jersey.") The NRC inspectors reviewed such
typical licensee-auditable manufacturer/supplier records as certified material
test reports (CMTRs), certificates of compliance, and heat treat records. The
NRC believes the inconsistencies found should have been identified by a
licensee during the performance of its own audit.
An NRC inspection on June 10-15 and June 24-28, 1985 at the Nuclear Energy
Services Company (NES) at Greensboro, North Carolina identified 22 conditions
that did not conform to the NES QA program implementation and one 10 CFR
Part 21 violation (reference NRC inspection report 99901018/85-01). The NRC
performed these inspections at the request of the Department of Energy to
determine the adequacy of the NES QA program relative to the fabrication of
canisters to collect, transport, and store the Three Mile Island, Unit 2 core
debris. The inspection results raised a concern in regard to the adequacy of
the implementation of the QA program at the NES facility in Greensboro, North
Carolina because of the collective impact of the numerous deviations from the
vendor's program. Before the NRC inspections, General Public Utilities and
Bechtel Power Company had jointly performed surveillance activities. On the
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cover sheet of the report the results of the surveillance were summarized as
unsatisfactory. However, no nonconformances were issued to NES, nor was the
vendor requested to perform any corrective actions other than to develop a
specific non-destructive testing examination procedure which, required by
contract, should have already been established.
An NRC inspection on November 16-20, 1987 at the Nutherm International Indus-
tries, Incorporated (NI) facility in Mount Vernon, Illinois identified six
nonconforming areas of implementation failures (reference NRC inspection
report 99900779/87-01). Considering a number of identified problems,
substantiated allegations, and the breakdown of the QA program in certain
areas, the NRC became concerned about the validity of NI's certificates of
conformance. Before the NRC audit, inspections had been performed by several
licensees. NRC's review of the audit reports produced by licensees indicates
that only one licensee identified any deviations, and that that licensee
failed to correctly interpret the audit findings.
An NRC inspection on August 25-29, 1986 at the Amerace Corporation facility in
Union, New Jersey (Amerace is the manufacturer of Agastat 7000 series timer
relays) identified that the vendor had failed to adequately establish and
implement a QA program in several areas. One violation of 10 CFR Part 21 and
nine nonconformances to the vendor's QA program were identified (reference NRC
inspection report 99900296/86-01). The NRC inspection found, in part, that
"The failures are indicative of a lack of management involvement in the
quality assurance functions...." A review of several audits previously
performed by licensees indicated that licensees had identified few or no
problems with either the vendor's QA program or its implementation.
An NRC inspection on July 11-12 and August 5-9, 1985 at the Air Balance Incor-
porated facilities at Westfield, Massachusetts and at Wrens, Georgia found
that the vendor had failed to (a) establish a 10 CFR Part 21 program, (b)
effectively implement a QA program, and (c) obtain QA program support from
management. Two violations of 10 CFR Part 21 and 17 nonconforming items were
identified (reference NRC inspection report 99901005/85-01). Again, a review
of several audits that licensees had previously performed indicated that
licensees had identified few or no problems.
A recent NRC inspection of Elgar Corporation identified several concerns with
the vendor's QA program. These include 1) failure to perform independent
design review (12 of 55 engineering change notices audited were prepared,
reviewed, and approved by the same individual), 2) failure to ensure that the
cumulative effects of multiple design changes on an individual drawing did not
adversely affect the ability of the equipment to perform its intended
function, 3) failure to maintain previous versions of revised drawings, 4)
failure to establish duties and authorities of engineering personnel, and 5)
failure to perform 10 CFR Part 21 evaluations of identified design errors and
deviations. Again, a review of audits licensees had previously performed
indicated that these concerns were not identified.
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On April 29, 1988, in accordance with the requirements of 10 CFR Part 21, IMO
Delaval, Inc. (Delaval) notified the NRC of potential problems with certain
engine control devices in the air start, lube oil, jacket water, and crankcase
systems in their DSR or DSRV standby diesel generators. In response to a
number of reported failures, Delaval performed an audit of the manufacturer of
these components, California Controls (Calcon) which identified a concern
regarding the implementation of the Calcon QA program. Delaval concluded that
there was no objective evidence of product testing having been performed by
the sub-vendor. The NRC staff is not certain as to whether any licensees have
previously audited Calcon.
Discussion:
The NRC is concerned that the inspections discussed above appear to indicate
that licensees may not be adequately implementing their established 10 CFR
Part 50 Appendix B program requirements, particularly Criterion VII.
Licensees are reminded that it is their responsibility to ensure, by such
actions as verifying the validity of and the basis for such
manufacturer/vendor records as CMTRs, certificates of compliance, and heat
treat records, that purchased equipment and components are able to perform
their intended functions. Licensees are further reminded that, as discussed
in 10 CFR Part 50 Appendix B Criterion VII, "the effectiveness of the control
of quality by contractors and subcontractors shall be assessed by the
applicant or designee at intervals consistent with the importance, complexity,
and quantity of the product or services." On the basis of the NRC inspections
discussed here, it appears that, in some cases, licensee audit efforts have
not been effective. The NRC believes that additional attention in this area
may be appropriate.
No specific action or written response is required by this information notice.
If you have any questions about this matter, please contact the technical
contact listed below or the Regional Administrator of the appropriate regional
office.
Charles E. Rossi, Director
Division of Operational Events Assessment
Office of Nuclear Reactor Regulation
Technical Contact: Joseph J. Petrosino, NRR
(301) 492-0979
Attachment: List of Recently Issued NRC Information Notices
. Attachment
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Page 1 of 1
LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________
Information Date of
Notice No._____Subject_______________________Issuance_______Issued to________
88-34 Nuclear Material Control 5/31/88 All holders of OLs
and Accountability of or CPs for nuclear
Non-Fuel Special Nuclear power reactors.
Material at Power Reactors
87-61, Failure of Westinghouse 5/31/88 All holders of OLs
Supplement 1 W-2-Type Circuit Breaker or CPs for nuclear
Cell Switches power reactors.
88-33 Recent Problems Involving 5/27/88 All Agreement
the Model Spec 2-T States and NRC
Radiographic Exposure licensees
Device authorized to
manufacture,
distribute or
operate radio-
graphic exposure
devices and source
changers.
88-32 Promptly Reporting to 5/25/88 All NRC material
NRC of Significant licensees.
Incidents Involving
Radioactive Material
88-31 Steam Generator Tube 5/25/88 All holders of OLs
Rupture Analysis or CPs for
Deficiency Westinghouse and
Combustion
Engineering
designed nuclear
power plants.
88-30 Target Rock Two-Stage 5/25/88 All holders of OLs
SRV Setpoint Drift or CPs for nuclear
Update power reactors.
88-29 Deficiencies in Primary 5/24/88 All holders of OLs
Containment Low-Voltage or CPs for nuclear
Electrical Penetration power reactors.
Assemblies
88-28 Potential for Loss of 5/19/88 All holders of OLs
Post-LOCA Recirculation or CPs for nuclear
Capability Due to power reactors.
Insulation Debris Blockage
_____________________________________________________________________________
OL = Operating License
CP = Construction Permit
Page Last Reviewed/Updated Tuesday, March 09, 2021