ML20140B250
| ML20140B250 | |
| Person / Time | |
|---|---|
| Issue date: | 01/21/1986 |
| From: | Ankrum G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Grimes B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| References | |
| NUDOCS 8601240031 | |
| Download: ML20140B250 (7) | |
Text
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JAN 21 1996 i
MEMORANDUM FOR: Brian K. Grimes, Director Division of Quality Assurance, Vendor, and Technical Training Center Programs
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Office of Inspection and Enforcement FROM:
G. Ted Ankrum, Chief Quality Assurance Branch Division of Quality Assurance, Vendor, and Technical Training Center Programs Offlde of Inspection and Enforcement
SUBJECT:
FORTHCOMING MEETING WITH FRAMATOME*
DATE & TIME:
Friday, January 24, 1986 10:00 a.m.
1 LOCATION:
IE Conference Room EWS 465 PURPOSE:
Working meeting to clarify issues as per attached agenda.
PARTICIPANTS:
NRC Framatome G. T. Ankrum R. Voin J. G. Spraul C. Buchelet
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4' G. Ted Ankrum, Chief Quality Assurance Branch Division of Quality Assurance, Vendor, and Technical Training Center Programs Office of Inspection and Enforcement
Enclosure:
As Stated cc: See next page
- Meeting is open for interested members of the public to attend as observers pursuant to "Open Meeting Statement of NRC Staff Policy," 43 Federal Register 28058, 6/28/78.
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- AGENDA -
CLARIFICATION ISSUES FRAMATOME (SUBMITTAL OF 12/19/85) 1.
In the first sentences of the Foreword, Section 2, Section 3, and Section 4 of the topical report, the expression " quality-related products and services" has been changed to " safety related products and associated services." Elsewhere in the text of the topical report, however, the expression is unchanged.
Clari fy.
Is there a difference? If so, what is it?
If not, so indicate or use the latter expression throughout.
(See also the Framatome Position on page 25 regarding Section 5.2 of ANSI /ASME NQA-1.) This position refers to " safety-related equipment" and should be expanded to include services.
To make the top'ical report itself more responsive to the NRC's standard 2.
review plan (NUREG-0800), all or a portion of the responses to the following questions should be incorporated into the report.
NRC Suggested Incorporation Suggested Question Page A.1 All but first paragraph 7
B.1.c Basic criterion and 2 supplemental criteria.
(Also 4
indicate where these 3 iriteria are documented)
B.1. d Framatome policy & its location 4
Quality Committee Membership 4
Assessment discussion 7
B.1. f Portions of first paragraph 6
B.1.g Responsibilities of the Quality Division 5
and QA personnel involvement
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B.1.1 Framatome activities at U.S. plant sites 6
and how accomplished.
(Also clarify if maintenance includes modifications)
B.2.b.5 All but first (and last?) sentence 29 B.3.f Last sentence of first paragraph 8
B.6.a Commitment in second sentence 10 B.6.b All but first paragraph 10 B.6.c First 3 sentences (plus... "such that 10 as-built documentation can be prepared")
B.7.f Required records 11 B.15.c Entire responses (revised to address trend 16 analyses of suppliers and reporting of trend data)
B.17. c First sentence plus the fact that the record 17 storage facility meets Supplement 175-1 of NQA-1-1983 B.18.a "These audits ensure that procedures and activities 18 comply with the overall QA program and provide a comprehensive independent verification and evaluation of quality-related procedures and activities.
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. 3.
The response to NRC question B.2.c revised the Foreword to state that the topical report describes the QA program applicable to design, procurement, fabrication, construction, and maintenance activities.
The response to NRC question B.l.i states that no activities by the Framatone construction organization are presently contemplated for the U.S.
Reconcile these responses.
4.
The last paragraph of the response to NRC question B.2.a states that any computer code used in any way to influence design will be verified and controlled.
The question of control of other safety-related computer codes (for example, codes for computer control of coordinate measuring machines or for a computer-integrated manufacturing operation) needs to be answered.
The point is that there are computer codes that need to be verified and controlled that don't " influence design."
5.
The sentence in the response to NRC question B.2.c which states:
" Commercial grade items are procured without any specific requirements,"
needs clarification.
6.
The revised fourth paragraph of FSAR section 2 no longer has the commitment that Framatome organizations and manufacturing facilities for U.S. customers " provide for special equipment, environmental conditions, and processes as necessary." Replace this commitment or justify not doing so.
7.
The last paragraph of the response to NRC question B.3.d indicates review of a sample of design documents by a " quality reviewer." Clarify that, as indicated in the first sentence of the response, the quality reviewer is from the QA organization.
Specify that technical drawings are included in the sample.
Also discuss the qualifications of the reviewer ~
to review the technical contents of these documents if, indeed, such a review is made.
8.
Section 3 of the topical report no longer includes the statement that:
" Design verification (other than qualification testing) may be deferred provided the justification is documented and the status of affected design documents is clearly identified." This appears consistent with the response to NRC question B.3.f which states:
"Only documents having obtained all required reviews and approvals, including design verifications, can be used for manufacturing, construction or design."
Clarify the reason for the deletion or replace the statement.
E.
The response to NRC question B.7.g, as inserted into the topical report, indicates that safety-related commercial items are inspected upon receipt "to verify that all requirements of the procurement document have been met."
Since the procurement document will probably specify only a catalog item number (or equivalent), it does not appear that this receipt inspection would be adequate.
Describe measures which ensure that special quality verification requirements are established by the
< purchaser to provide the necessary assurance of acceptable safety-related commercial items.
Reflect this in Framatome's clarification-to subsection 2.3 of section 5.2 of NQA-1 (topical report page 25).
- 10. The response to NRC question B.9.a, as inserted into the second paragraph of section 9 of the topical report is too limiting.
Revise this insertion to read:
"and other processes which meet the definition specified above," or justify not doing so.
11.
The last sentence of the response to NRC question B.9.c states:
"The periodic reviews (of qualification records) are consistent with the validity periods specified in the appropriate QA Manual." Clarify.
12.
Clarify the response to NRC question B.10.c to show that level 1 inspectors are not assigned the responsibility for evaluating the validity and acceptability of inspection, examination, and test results or justify not doing so.
13.
In response to NRC question B.11.a, revise item a under Test Control to directly address test equipment accuracy or justify not doing so.
14.
Verify the validity of the response to NRC question B.15.b which states:
"The authority for the disposition of non-conforming items belongs to the quality organization having jurisdiction over the organizational element (Maintenance Division, Manufacturing Facility or Nuclear Operations) which is responsible for the quality of the item involved."
15.
The last sentence of Framatome's alternative to subsection 2.2 of supplement 45-1 of NQA-1 (topical report page 24) is garbled.
Clarify.
16.
Framatome's alternative to Section C.3.2 of Regulatory Guide 1.28
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(topical report page 26) may indicate that suppliers holding ASME certificates of authorization are not audited by Framatome.
Clarify whether or not this is the case.
If it is, justify this position.
If it isn't, clarify the alternative.
17.
Clarify in'Framatome's provisions for the period validity of NDT certification (topical report page 36) that working authorizations will be effective for no more than 3 years and that documentation will show the bases of extensions (or renewals).
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