ML20211H683
| ML20211H683 | |
| Person / Time | |
|---|---|
| Issue date: | 02/20/1987 |
| From: | Merschoff E NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Bruggeman W GENERAL ELECTRIC CO. |
| References | |
| REF-PT21-87, REF-QA-99900403 NUDOCS 8702260246 | |
| Download: ML20211H683 (3) | |
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February 20, 1987 Docket No. 99900403/86-02 General Electric Company Nuclear Energy Business Operations ATTN: Mr. W. H. Bruggeman Vice President and General Manager 175 Curtner Avenue San Jose, California 45125 Gentlemen:
Thank you for your letter of December-1,1986, in response to our letter dated November 7, 1986. We have reviewed your reply and find that two of your correc-tive and preventative actions, (1) the October 28, 1986 GE audit of the Conax Buffalo facility (GE item #8) and (2) the January 1985 standardization of the GE procured explosive valve replacement kit drawings (GE item #7) satisfactorily respond to the concerns raised in our Notice of Nonconformance. Additionally, we find the GE Service Information Letter SIL-446 (GE Item #9) is responsive to our concern to prevent recurrence.
Additionally, we find that your numbered response items 1, 2, 3, 4, 5 and 6 are inadequate as previously identified in our inspection Report No. 99900403/86-02.
A brief summary is as follows:
1.
GE item #1, "Potentially Reportable 10 CFR Part 21 condition memo," dated January 27, 1984 - We found inadequate objective evidence to support the following GE conclusion of "...it is apparent that adequate quality assur-ance provisions are provided by the MIL-I-45208 program when manufacturing the functional explosive element of the valve..."
2.
GE item #2, GE Deviation Disposition Recuests (DDR), dated January 1984 -
No corrective action was identified cn the DDRs to verify the correctness of the applicable explosive prirer chamber (EPC) devices.
3.
GE item #3, QA and engineering evaluations of the Conax Florida QA program, various dates - The evaluations only determined that Conax had established a QA program but did not assure that the QA program was adequately implemented to control the quality activities of the components.
8702260246 870220 pgR GA999 EMVGENE 99YOO403 PDR f.
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General Electric Company February 20, 1987 4.
GE item #4, "GE evaluated the Conax Florida QA Progran to be in compliance with... ANSI-N45.2 for the specific GE purchase order and accepted the DDRs" -
GE's basis, as documented on its DDRs, was that, "The hardware is acceptable as recommended by Conax. The 0A program employed at Conax-Florida contains the same elements required by ANSI N45.2 "... (emphasis added). This is an inadequate basis for acceptance, since GE personnel did not verify what type of program was actually " employed" at the Florida facility.
- Instead, GE personnel stated that, "...all the systems in place now and in the past should have precluded manufacture of ASME Code or Nuclear Safety Related components at any Conax location other than Buffalo."
5.
GE item #5, "Potcntially Reportable 10 CFR Part 21 condition memo," dated January 27, 198/.
This reference is the same as item #1 above and does not contain any relevant infcrmation regarding corrective action, actions to preclude recurrence or dates when your actions will be completed.
This was previously discussed in 1. above.
6.
GE item #6, contrary to GE's DDR condition of acceptance that all future (after 1/84) explosive valve replacement kits would be manufactured at Conax Buffalo under the approved ANSI N45.2 program, it appears that some EPC devices were manufactured at Conax Florida after the deviation was identified and continued until 1986.
Furthermore, we disagree with your statement "...Following the October 1983 GE quality assurance audit at Conax Florida, GE did not formally disapprove the QA program at Conax Florida, although Conax Florida was not listed on the GE Approved Supplier List...."
Based on NRC/GE discussicr.s and a review of GE's audit reports and the July 29, 1986 QA audit department's clarification letter, it appears that an audit was performed only at the Buffalo facility, ard not at the Florida facility.
It is also our understanding that Conax Florida was inadvertently added to the October 1983 audit report. Therefore, the reason that Conax Florida was not on GE's approved vendors list was that an audit was not performed.
In fact, GE determined and documented, that Conax Florida did not have a nuclear QA program in place, and that ASME or Safety Related manufacturing should not have been done at any Conax location other than Buffalo.
Therefore, please provide us within 30 days from the date of this letter, a written statement to address each of the following:
(1) Describe the corrective action that GE has taken or will take regarding the indeterminate EPC devices identified en the subject DDRs.
(2) The 1984 subject DDR disposition indicates that GE verified the Conax-Florida QA program implementation and found the implementation to be equal to an ANSI N45.2 program.
Identify the methed (e.g., GE audit of Florida facility) of verifying the implerentation of the Conax-Florida QA progran.
a General Electric Company February 20, 1987 (3) For Item #1 above, state the basis for your statement "...it is apparent that adequate quality assurance provisions are provided by the MIL-I-45208 program when manufacturing the functional explosive element. [ explosive primer chamber], of the valve...."
Factor into your response that the Conax Certificates of Conformance specifically stated that MIL-I-45208 " Inspection and Test" program controlled the manufacture of subject hardware.
(4) For item #2 above, state your DDR disposition basis of hardware accept-ance without a reverification of the hardware that was not manufactured under a ANSI N45.2 or equivalent program.
(5) For item f4 above, identify the regulatory and GE bases used for accepting the Conax Florida program.
(6) State GE's rationale of allowing the manufacture of a nuclear safety-related component at a manufacturer's facility that was not on the GE approved vendors list.
(7) Review your Conax purchase orders and provide a list of any EPC devices that were manufactured at the Conax Florida facility after December 31, 1983, regardless of whether or not the part drawing number was pre-fixed by an "N."
Sincerely, original signed bv:
Ellis W. Merschoff, Acting Chief Vendor Program Branch Division of Quality Assurance, Vendor and Technical Trainino Center Programs Office of Inspection and Enforcement DISTRIBUTION:,
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