ML20035B465
| ML20035B465 | |
| Person / Time | |
|---|---|
| Issue date: | 03/22/1993 |
| From: | Norrholm L Office of Nuclear Reactor Regulation |
| To: | Rossi C Office of Nuclear Reactor Regulation |
| References | |
| NUDOCS 9304020015 | |
| Download: ML20035B465 (9) | |
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HBORANDUM FOR:
Charles E. Rossi, Director Division of Reactor Inspection Y
and Licensee Performance Office of Nuclear Reactor Regulation FROM:
Leif J. Norrholm, Chief j
Vendor Inspection Branch Division of Reactor Inspection and Licensee. Performance Office of Nuclear Reactor Regulation
SUBJECT:
MINUTES OF PUBLIC MEETING WITH NUMARC ON COMMERCIAL GRADE DEDICATION l
On March 15, 1993, the Director of the Division of Reactor Inspection and Licensee Performance and other NRC staff members met with NUMARC to discuss commercial grade dedication issues identified during the five pilot l
inspections. The objective of the meeting was to obtain input from NUMARC on each dedication issue and, where possible, to resolve any differences.
The NRC staff informed NUMARC that the key dedication issues identified in Enclosure I would be part of the guidance provided in the revised NRC i
inspection procedure for commercial grade item dedication.
The staff also noted that these issues are identified as Revision I and address comments resulting from licensee / industry meetings conducted over the last three months.
Each of the dedication issues was discussed in detail and the NRC staff agreed to changes to address several NUMARC comments.
NUMARC indicated that these changes resolved many of the identified disagreements on specific l
issues. However, NUMARC indicated that they would probably provide additional 1
comments on the issues during the public ccmment process for the revised
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A meeting was tentatively scheduled for March 22, 1993, to discuss the revised inspection procedure on commercial grade dedication and to discuss the upcoming NRC commercial grade dedication wo s op.
Leif J. N rrholm, Chief Vendor Inspection Branch Division of Reactor Inspection i
and Licensee Performance Office of Nuclear Reactor Regulation i
Enclosures:
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Dedication Issues 2.
Meeting Attendees cc/without enclosure;:
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MEMORANDUM FOR:
Charles E. Rossi, Director Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation FROM:
Leif J. Norrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
SUBJECT:
MINUTES OF PUBLIC MEETING WITH NUMARC ON COMMERCIAL GRADE DEDICATION On March 15, 1993, the Director of the Division of Reactor Inspection and Licensee Performance and other NRC staff members met with NUMARC to discurs commercial grade dedication issues identified during the five pilot inspections.
The objective of the meeting was to obtain input from NUMARC on each dedication issue and, where possible, to resolve any differences.
The NRC staff informed NUMARC that the key dedication issues identified in would be part of the guidance provided in the revised NRC inspection procedure for commercial grade item dedication. The staff also noted that these issues are identified as Revision 1 and address comments resulting from licensee / industry meetings conducted over the last three months.
Each of the dedication issues was discussed in detail and the NRC staff agreed to changes to address severa! NUMARC comments. NUMARC indicated that these changes resolved many of the identified disagreements on specific issces.
However, NUMARC indicated that they would probably provide additional comments on the issues during the public comment process for the revised inspection procedure.
A meeting was tentatively scheduled for March 22,19
, to discuss the revised inspectionprocedureoncommercialgradededicAion'adtodiscussthe upcoming NRC commercial grade dedicati,n wor hop.
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eif"J.bNorrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
Enclosures:
1.
Dedication Issues 2.
Meeting Attendees cc/without enclosures:
W. Russell
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DEDICATION ISSUES Rev. 1 1.
BASIS FOR THE SELECTION AND VERIFICATION OF CRITICAL CHA Consideration of Item's Safety function a.
Critical characteristics should be based on the item's safety function.
The licensee is responsible for identifying the important design, material, and perfonmance characteristics which have direct impact on the item's cbility to accomplish its intended safety function, establishing acceptance criteria for these characteristics, and providing reasonable assurance of conformance to these criteria. Criterion II of Appendix B provides for the application of quality control over activities affecting the quality i
of structures, systems, and components to an exter.t consistent with their importance to safety.
b.
Selection of critical characteristics to be verified An evaluation of credible failure modes of an item in its operating environment and the effects of these failure modes on the item's safety function may be used as a basis for the selection of critical characteristics which are to be verified during the dedication process.
c.
Reasonable Assurance The dedication process is not substitute for Appendix B.
Rather, it represents a method of achieving compliance with Appendix B with the purchaser assuming many of the responsibilities for assuring quality and functionality of an item which had previously been the responsibility of the vendor.
In this context, reasonabic assurance consists of the purchaser providing control over the activities affecting the item's quality to an extent consistent with the item's importance to safety or assuring that these activities are adequately controlled by the supplier.
For more complex items, dialogue with the original equipment manufacturer may be necessary to identify the design and functional parameters of s parts. Upon the completion of the dedication process,pecific piece the quality assurance or compensatory measures applied to those aspects of the item which directly affect its safety function should result in the same level performance reliability as for a like item manufactured under an Appendix B program.
d.
Engineering Judgement F
Engineering judgement can be used in selecting those important design, material, and performance characteristics which will be
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verified as a part of the dedication process. The bases for such judgements should be documented.
2.
SAMPLING Established Heat Traceability (materials) a.
When heat traceability of material has been estabitshed and each piece of the material is marked with the material heat number, all analyses and tests required to verify the identified critical characteristics may be performed on one piece of this material.
b.
Established Lot / Batch Control When Lot class, s/ Batch (defined as units of product of a single type, grade, ize and composition, manufactured under essentially the same conditions, and at essentially the same time) contrcl is established through a comercial grade survey, the party performing dedication can use sampling prescribed by standard statistical methods which are based on homogeneous product lots. Such sample plans should be documented and provide for the verification of the critical characteristics with confidence level consistent with the item's importance to safety.
Items With No Lot / Batch Control c.
When Lot / Batch traceability can not be established, each item may need to be tested. Any sampling plans for such items would need to be considered on individual, item-specific basis and assure that they are capable of providing a high level of assurance of the item's suitability for service.
3.
TRACEABILITY Material / Items Purchased from Distributors a.
Traceability can be defined as the ability to verify the history, I
location, or application of an item by means of recorded identification (NQA-1). Traceability should be maintained throughout the dedication process. Where the item's acceptance is based entirely or partially on a certification by the manufacturer, the traceability must extend to the manufacturer.
If intermediaries (distributors) are included in the supply chain and have physical posession of the item during the procurement process, their capability of r'aintaining traceability should be assured by audit.
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COMMERCIAL GRADE SURVEYS
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Verification of Vendor's Control of Specific Characteristics a.
1 A comercial grade survey should be specific to the scope of the comercial grade item or items being purchased. The vendor's controls of specific critical characteristics to be verified during the survey should be identified in the survey plan.
The verification should be accomplished by reviewing the vendor's program / procedures controlling these characteristics and observing the actual implementation of these controls in the manufacture of items identical or similar to the items being purchased.
b.
Identification of Applicable Program / Procedures The vendor must have documented program and/or procedures to control the critical characteristics of the item or items being procured which are to be verified during the survey. When many items are being purchased, a survey of a representative group of similar items may be sufficient to demonstrate that adequate controls exists. If the vendor's controls are determined to be satisfactory purchase orders for these items should invoke these controls as c,ontract repirements by referencing the applicable program / procedure and revision.
compliance with the purchase requirements.Upon completion of the Documentation of Survey results c.
Commercial grade survey documentation should include the identification of item or items for which the vendor is being surveyed, identification of the critical characteristics of these items which the vendor is expected to control, identification of the controls to be applied (program / procedure and revision) and a description of the verification activities performed and results obtained.
Deficiencies identified during the survey which may affect control of the identified critical characteristics should be addressed by requiring the vendor to institute additional controls or by utilizing other verification and acceptance methods.
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LIKE FOR LIKE REPLACEMENTS Like-for-Like Verification If it can not be demonstrated that the replacement item is identical with the item that it replaces, or if differences between the items are identified, an evaluation is necessary to determine if any changes in design, material, or manufacturing process could impact the item's critical characteristics and its ability to perform the intended safety function.
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ACCEPTANCE OF CERTIFIED KATERIAL TEST REPORTS (C s
OF COMPLIANCE (C0Cs)
Validity Verified Through Vendor / Supplier Audit or Testing a.
i' The validity of vendor CMTRs and COCs should be verified.
be accomplished through a commercial grade survey or, for simple This can l
items, periodic testing of the product upon receipt.
Such verifications should be conducted at intervals commensurate wit vendor's past performance.
distributor who has If the item's supply chain includes a procurement process, physical possession of the items during the the verification survey should include warehousing and/or traceability controls at the distributor's facility.
verification consistent with his QA program commitments.T i
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ENCLOSURE 2
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MEETING WITH NUMARC ON DEDICATION ISSUES 03/15/93 NAME AFFILIATION Uldis Poatpovs NRC/VIB Biff Bradley NUMARC Larry L. Campbell NRC/VIB Charles E. Rossi NRC/DRIL Leif J. Norrholm NRC/VIB Gary Zech NRC/DRIL Geoffrey Grant NRC/EDO Joe Birmingham NRC/ DORS Charles D. Petrone NRC/DRIL 4
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