ML20044C104

Summary of 930303 Meeting W/Util in Rockville,Md Re Commercial Grade Dedication at Plant.Util Procurement Status & Philosophy,Dedication Issues & Meeting Attendance List Encl

ML20044C104
Person / Time
Site:	Millstone
Issue date:	03/16/1993
From:	Norrholm L Office of Nuclear Reactor Regulation
To:	Rossi C Office of Nuclear Reactor Regulation
References
GL-91-05, GL-91-5, NUDOCS 9303170245
Download: ML20044C104 (40)

Text

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I p ueg'o UNITED S'l ATES-

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NUCLEAR REGULATORY COMMISSION n

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-p WASHINGTON, D. C. 20$55 k..... /

March 16, 1993 i

i Docket Nos.:

50-245 50-336 50-423 MEM3RANDUM FOR:

Charles E. Rossi, Director Division of Reactor Inspection and Licensee Performance i

FROM:

Leif J. Norrholm, Chief i

Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance

SUBJECT:

MINUTES OF PUBLIC MEETING WITH NORTHEAST UTILITIES ON COMMERCIAL GRADE DEDICATION AT THE MILLSTONE STATION Backaround Between December 1991 and June 1992, the NRC. completed five pilot inspections that were conducted to evaluate the implementation of licensee programs for the procurement and dedication of commercial grade. items (CGIs) and to i

finalize an inspection procedure for future inspections of this type. These t

inspections identified weaknesses in licensee CGI dedication programs and i

their implementation. During this same period, the Nuclear Regulatory Commission (NRC) received significant feedback from several utilities and the Nuclear Management and Resources Council (NUMARC) questioning the regulatory basis for the CGI dedication guidance contained in NRC Generic Letter (GL) 91-05, as well as specific interpretations of that guidance by the NRC 1

inspection teams.

Because of the need for additional discussion of the requirements and implementing guidance for dedication of CGIs, no enforcement action was taken based on any of the five pilot inspections.

Rather, it was l

1 l

l decided that a series of meetings with licensees and industry representatives

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j would be beneficial to identify, and attempt to resolve, specific areas of difference. This meeting with Northeast Utilities (NU) representatives is the last (fifth) of such meetings with licensees who were either assessed during 1991 or inspected during the pilot inspections.

i

!Le.etino Summarv On March 3,1993, the Director, Division of Reactor Inspection and Licensee Performance, and members of the Vendor Inspection Branch (VIB) met with Mr. R. J. Asafaylo, Manager of Procurement Engineering, and other representatives of NU, the Millstone Station and'the Haddam Neck Plant at the NRC's One White Flint North office building in Rockville, Maryland. The meeting provided an opportunity to discuss key procurement and commercial grade dedication issues for which the NRC and NU might have differing views.

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Charles E. Rossi These issues were identified during the five pilot inspections. The meeting agenda is included as part of NU's handout entitled, " Northeast Utilities Procurement Status and Philosophy" (Enclosure 1). The NRC stated that the objective of the meeting was to obtain input for the NRC to aid in its effort to identify the proper level of dedication necessary to assure safety and compliance with 10 CFR Part 50, Appendix B (Appendix B).

In order to facilitate the discussion, the NRC provided NU a list of generic dedication issues (Enclosure 2) that was originally provided to NUMARC in a public meeting held with the NRC on November 13, 1992. These dedication issues were also used as discussion points for the meetings with Florida Power Corporation on December 4, 1992, NUMARC on December 10, 1992, Southern California Edison on January 13, 1993, Iowa Electric Light and Power on January 26, 1993, and Nebraska Public Power District on February 3,1993. The main dedication issues include the basis for the selection and verification of critical characteristics, sampling, traceability, commercial grade surveys, like-for-like replacements, and acceptance of vendor / supplier documentation and are tied either directly or indirectly to Appendix B requirements for safety-ralated applications.

These issues were derived from previous meetings with NUMARC and represent the major points of ongoing discussion.

During the meeting, NU presented an evolution of their procurement and dedication practices and then explained their current procurement philosophy.

The other area discussed during the meeting was NU's position with regard to the generic commercial grade procurement and dedication issues as documented in Enclosure 2.

NU identified failure modes and effect analyses, engineering judgement, and sampling as dedication issues they felt represented a change in previous NRC positions. However, most of the apparent disagreements resulted from a misunderstanding of the actual documented staff position. After the NRC clarified the issues in question, NU further stated that it agreed with the industry positions as stated in NUMARC's December 14, 1992, letter to the NRC, however, they felt these positions were the minimum actions necessary for dedicating CGIs, and that Millstone's dedication program far exceeds this minimum.

Finally, it was stated that the NRC would be conducting a public workshop which will address issues concerning the existing dedication guidance and specific interpretations of that guidance.

Prior to the public workshop, the proposed inspection procedure for future inspections will be issued for public comment and discussion at the workshop. A list of meeting attendees is included as Enclosure 3.

a Charles E. Rossi March 16, 1993 The VIB is considering all the comments provided by fiU. The meeting provided a useful exchange of information and accomplished the goal of aiding the !4RC by gaining industry insight and feedback related to the commercial grade dedication process.

/

Leif J. florrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation i

Enclosures:

l 1.

flortheast Utilities Procurement Status and Philosophy 2.

Dedication Issues 3.

Meeting Attendance List cc w/o enclosures:

W. Russell DISTRIBUTION:

VIB R/F w/ enclosures i

DRIL R/F w/ enclosures GZech, NRR, w/o enclosures l

RPettis w/o enclosures LCampbell w/o enclosures l

GCwalina w/o enclosures CPetrone, 11RR, w/o enclosures FHebdon, f4RR, w/o enclosures DJaffe, NRR, w/o enclosures JAnderson, NRR, w/o enclosures PDR/ Central. Files w/ enclosures 0FFICE VIB:DRIL VIB:DRIL C:Vp:DRIL DD:DRI,L' D:DRIL Q]

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l Charles E. Rossi March 16, 1993 The VIB is considering all the comments provided by NV. The meeting provided a useful exchange of information and accomplished the goal of aiding the NRC by gaining industry insight and feedback related to the commercial grade dedication process.

Leif J. Norrholm', Chief Vendor Inspection Branch

{

Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation-

Enclosures:

1.

Northeast Utilities Procurement Status and Philosophy i

2.

Dedication Issues 3.

Meeting Attendance List cc w/o enclosures:

W. Russell i

DISTRIBUTION:

VIB R/F w/ enclosures DRIL R/F w/ enclosures GZech, NRR, w/o enclosures i

RPettis w/o enclosures i

LCampbell w/o enclosures GCwalina w/o enclosures I

CPetrone, NRR, w/o enclosures i

FHebdon, NRR, w/o enclosures I

DJaffe, NRR, w/o enclosures JAnderson, NRR, w/o enclosures PDR/ Central Files w/ enclosures 0FFICE VIB:DRIL VIB:DRIL C:Vp:DRIL DD:DRI}/

D:DRIL NAME RP UPota ovs L

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Charles E. Rossi The VIB is considering all the comments provided by NU.

The meeting provided a useful exchange of information and accomplished the goal of aiding the NRC by gaining industry insight and feedback related to the commercial grade dedication process.

)

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Leif J. N rholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation

Enclosures:

1.

Northeast Utilities Procurement Status and Philosophy 2.

Dedication Issues 3.

Meeting Attendance List cc w/o enclosures:

W. Russell

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ENCLOSURE 1 1

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. NORTHEAST UTILITIES PROCUREMENT STATUS AND 4

PHILOSOPHY PRESENTATION TO: UNITED STATES NUCLEAR REGULATORY COMMISSION VENDOR INSPECTION BRANCH i

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- MARCH 3,1993 NU-1.

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AG5NDA i

INTRODUCTIONS ORGANIZATION DICK ASAFAYLO EVOLUTION IN NU PRACTICES RICH ROGOZINSKI 4

GENE MCNATT DUNCAN MCCORY PROCUREMENT PHILOSOPHY MIKE AHERN DISCUSSION N U-2 m

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ORGANIZATION V.P. - NUCLEAR, OPERATIONS SERVICES.

W. D. ROMBERG DIRECTOR-NUCLEAR DIRECTOR -

PRODUCTION MATERIALS QUALITY SERVICES G. D. BASTON D. O. NORDQUIST MANAGER-PROCUREMENT l

MANAGER-PROCUREMENT ENGINEERING j

QUALITY SERVICES R. J. ASAFAYLO D. D. MCCORY 1

I SUPERVISOR -

SUPERVISOR -

SUPERVISOR -

SUPERVISOR -

i PROCUREMENT PROCUREMENT HADDAM NECK MILLSTONE STATION VENDOR SERVICES INSPECTION SERVICES PROCUREMENT PROCUREMENT M.A.SURPRENANT J. N. COLEMAN ENGINEERING ENGINEERING R. M. ROGOZINSKI M. F. AHERN 4 - POSITIONS FILLED 14 - POSITIONS FILLED 7 POSITIONS 15 POSITIONS APPROVED APPROVED NU-3

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i EVOLUTION IN NU PRACTICES PRIOR TO JUNE 1988

. NU MAINTAINED A STRINGENT APPROVED SUPPLIERS LIST ENGINEERING AND QUALITY SERVICES REVIEWED SAFETY RELATED REQUISITIONS

. QUALITY SERVICES INSPECTED SAFETY RELATED ITEMS (INCLUDING SERVICES) AT RECEIPT NU-4

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EVOLUTION IN NU PRACTICES EPRI DEDICATION GUIDANCE ISSU ED - JU N E 1988 HADDAM NECK IMPLEMENTS - JUNE 1988 PROCUREMENT ENGINEERING GROUP STAFFED

- FEBRUARY 1989 TASK GROUP COMPLETES CORPORATE IMPLEMENTING PROCEDURES - JUNE 1989 Nij-5

I 4

EVOLUTION IN NU PRACTICES NRC VENDOR BRANCH INS 3ECTION O r TH E HAJDAV N EC < PLA N T FE B RUARY

' 989 RESULTS:

10CFR21 WAS NOT ALWAYS PROPERLY INVOKED l

NRC CONSIDERED NU PRACTICES WEAK FOR COMMERCIAL PROCUREMENTS AND VENDOR TECHNICAL INFORMATION CONTROL NU AGREED TO REVIEW PAST COMMERCIAL PROCUREMENTS (NO OPERABILITY CONCERNS RESULTED FROM PAST PRACTICES)

NU-6

EVOLUTION IN NU PRACTICES

\\ RC GEh ERIC LETTER 89-02 i

MARC-l

' 989

. AIMED AT DETECTION OF COUNTERFEIT OR FRAUDULENTLY MARKED PRODUCTS ENDORSED EPRI DEDICATION GUIDE (NP-5652)

WITH ONLY TWO EXCEPTIONS:

COMMERCIAL SUPPLIER SURVEYS PERFORMANCE HISTORY ENDORSED ENGINEERING INVOLVEMENT IN THE PROCUREMENT PROCESS NU-7

e EVOLUTION IN NU PRACTICES l

N U FULLY I V 3 _ EVENTS CO.V V ERCIA_

GRADE ITEM PROGRAM - JUNE '989 BASED ON HADDAM NECK PLANT PROCEDURE o

AND NRC INSPECTION RESULTS MET GENERIC Lt-i IER 89-02 o

IN EFFECT 6 MONTHS IN ADVANCE OF NUMARC o

COMMITMENT PROCUREMENT ENGINEERING PERSONNEL o

ASSIGNED AT MILLSTONE NU-8

N*'

l EVOLUTION i

IN NU PRACTICES o

NU ADDS CONTRACT STAFF TO MILLSTONE PROCUREMENT ENGINEERING - FEBRUARY 1990 o

NUMARC COMPREHENSIVE PROCUREMENT INITIATIVE ISSUED - JUNE 1990 COMBINED UTILITY ASSESSMENT TEAM o

REVIEWS COMMERCIAL GRADE PROGRAM JUNE 1990 CORPORATE DEDICATION PROCEDURE REVISED o

TO ADDRESS ASSESSMENT RESULTS -

OCTOisD R 1990 NU-9 1

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EVOLUTION l

IN NU PRACTICES NRC ISSUES GENERIC LETTER 91 MARCH 1991 o

NRC VENDOR BRANCH ASSESSMENT AT MILLSTONE i

o JUNE 1991

- STRENGTHS:

FREQUENT SELF ASSESSMENT QUALITY, ATTITUDE. AND DEDICATION OF PERSONNEL MANAGEMENT SUPPORT COMMERCIAL SUPPLIER SURVEYS SAFETY CLASSIFICATION SITE AND CORPORATE TESTING CAPABILITY NEWLY DEVELOPED TRAINING COURSE

- WEAKNESSES:

NUMEROUS MINOR PROCEDURAL DISCREPANCIES SOME GOOD PRACTICES WERE NOT PROCEDURALIZED NU-10

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i EVOLUTION

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IN NU PRACTICES

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i hRC CONCLUSION:

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"With approariate modifications to address l

the concerns noted herein, the existing program, if properly implemented, shoulc l

provice adequate contro s over the NNECO l

procurement and dedication process."

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NU-11

I, EVOLUTION

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IN NU PRACTICES NU COMPLETED ASSESSMENT PHASE OF NUMARC PROCUREMENT INITIATIVE - JUNE 1991.

l RECOMMENDED ACTIONS INCLUDED:

- PROCEDURAL IMPROVEMENTS ADDITIONAL UTILITY STAFF ADDITIONAL INSPECTION EQUIPMENT SAFETY CLASSIFICATION UPGRADE PROGRAM RECOMMENDED ACTIONS APPROVED FULLY ADDRESSED NRC ASSESSMENT RECOMMENDATIONS NU-12

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EVOLUTION IN NU PR.ACTICES NRC REGION INSPECTION OF MILLSTONE STATION - JANUARY 1992

- PROCUREMENT ENGINEERING EFFECTIVELY DEALT WITH ASSESSMENT WEAKNESSES NU FULLY IMPLEMENTS NUMARC COMPREHENSIVE PROCUREMENT INITIATIVE -

JULY 1992

- INCLUDES INPUT FROM VENDOR BRANCH INSPECTIONS AND ASSESSMENTS, NUMARC COMMITTEES AND WORKSHOPS, AND EPRI GUIDELINES NU-13

EVOLUTION I~

IN NU PRACTICES CURRENT STATUS PROGRAM CONSISTENTLY EXCEEDS MINIMUM o

REQUIREMENTS BY MEETING GENERIC LETTER 89-02 NEW PROCUREMENT PERSONNEL ATTEND A o

FORMAL PROCUREMENT-SPECIFIC CLASS HADDAM NECK SAFETY CLASSIFICATION o

APPROACH IS BEING IMPLEMENTED AT MILLSTONE IMPLEMENTATION AUDIT WITH INTERUTILITY o

SUPPORT - NOVEMBER 1992

- NO FINDINGS NU-14

EVOLUTION IN NU PRACTICES CURRENT 1NITIATIVES CONTINUED ACTIVE PARTICIPATION IN INDUSTRY FORUMS ENHANCEMENTS INCLUDING:

- PROCESS MAPPING

- PROCEDURE REVISIONS

- FREQUENT QUALITY-FOCUSED DEPARTMENT MEETINGS MORE RIGOROUS RESOLUTION OF NONCONFORMANCES NU-15

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l EVOLUTION l

IN NU PRACTICES QSD PROCU3EMENT ACTIVITIES i

UP FRONT ENGINEERING INVOLVEMENT o

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- TECHNICAL INPUT FROM PEG FOR SOURCE / RECEIPT INSPECTION PLANNING, NUCLEAR AND COMMERCIAL i

CG SURVEYS BASED ON CG DEDICATIONS AND j

IDENTIFIED CRITICAL CHARACTERISTICS TECHNICAL SPECIALISTS PARTICIPATING IN AUDITS / SURVEYS SINCE JULY 1992 o

AUDIT AND SURVEY TEAMS INCREASED TO 2 OR MORE MEMBERS SINCE JULY 1992 SOURCE INSPECTIONS PERFORMED AS MINI-AUDITS o

75-80 PERCENT OF NU AUDITS ARE PERFORMED BY o

NUPIC NU-16

e EVOLUTION IN NU PRACTICES QSD APPROVED SUPPLIERS STRICT APPROVAL CRITERIA

- 175 APPROVED APPENDIX B SUPPLIERS

- 17 APPROVED COMMERCIAL GRADE SUPPLIERS

- PRODUCT EXAMPLES:

l BULK GASEOUS HYDROGEN BULK LIQUID. NITROGEN CALIBRATION FUEL OIL ANALYSIS METALLURGICAL TESTING INSTRUMENT VALVES FLEXIBLE CONDUlT

- SURVEYS PERFORMED ANNUALLY 4

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L EVOLUTION IN NU PRACTICES I

QSD RECEIPT INS 3ECTION ACTIVITIES ADDITIONAL PROCEDURAL CHANGES o

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- INCLUSION OF FRAUD DETECTION GUIDELINES FOR BOTH RECEIPT AND SOUR.CE INSPECTIONS l

- SAMPLING INSPECTION DEFINED TO EXCLUDE CGI EXCEPT AS l

DIRECTED BY PEG BASED ON DETERMINATION OF HOMOGENEOUS I

LOTS 1

INCREASED INSPECTION STAFF SIZE FROM 10 TO 12 o

ENHANCED INSPECTOR TRAINING o

ENHANCED INSPECTION / TEST CAPABILITIES o

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- TWO TEXAS NUCLEAR METALLURGIST - XR MATERIAL ANALYZERS

- TWO EQUOTIP PORTABLE HARDNESS TESTERS

- MISC. INSPECTION EQUIPMENT e.g., DUROMETER, ELECTRONIC CALIPERS OFF-SITE CGI DEDICATION TEST FACILITIES o

- HERGUTH LAB - LUBRICANTS

- WEST SPRINGFIELD STATION - FUEL OIL & JET FUEL

- MATERIALS ENGINEERING - OUR OWN BERLIN TEST FACILITY

- DIRATS TEST LAB - MISC. MECHANICAL

- NEW HAVEN TEST LAB - GROUT l

NU-18

PROCUREMENT

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PHILOSOPHY

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CURRENT GUIDANCE:

NU QUALITY ASSURANCE PLAN COMMITS TO o

REGULATORY GUIDE 1.33, REVISION 2 REGULATORY GUIDE 1.33, REVISION 2 ENDORSES o

ANSI N18.7-1976 WITHOUT EXCEPTION FOR REPLACEMENT PARTS ANSI N18.7-1976 ALLOWS COMMERCIAL REPLACEMENTS o

"BUT CARE SHALL BE EXERCISED TO ASSURE AT LEAST EQUIVALENT PERFORMANCE" CURRENT POLICY IS TO MEET GENERIC LETTER 89-02 o

AS WELL NU-19

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PROCUREMENT PHILOSOPHY

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CURRENT PRACTICES:

NU'S DEDICATIONS ARE DRIVEN BY o

SAFETY FUNCTION NU FORMALLY UPGRADES ORIGINAL PLANT o

SPARES CONFORMANCE TO APPROVED DESIGN IS o

VERIFIED BY THE PROCUREMENT PROCESS NU-20

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- ~... _

PROCOREMENT

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PHILOSOPHY

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NU BELIEVES THAT:

FOR COMPLEX EQUIPMENT, THE MOST o

ASSURANCE IS OBTAINED BY STRONG VENDOR QUALITY PROGRAMS FOR S!MPLE PARTS, THE MOST ASSURANCE o

IS OBTAINED BY DEDICATING IN ANY CASE, BOTH APPROACHES o

EFFECTIVELY MEET REQUIREMENTS e

NU-21

PROCUREMENT PHILOSOPHY CURRENT TESTING POSITION:

QUALIFIED PERSONNEL AND TESTING CAPABILITY ARE KEY TO ASSURING QUALITY NU HAS EXTENSIVE RECEIPT AND CORPORATE CAPABILITIES NU BELIEVES THAT INFREQUENT, HIGHLY SOPHISTICATED TESTING (E.G. SPECTROSCOPY)

IS BEST DONE BY EXTENSIVELY TRAINED LABORATORY EXPERTS NU-22

e PROCUREMENT PHILOSOPHY PROCUREMENT IS ONLY ONE PART OF AN OVERALL QUALITY' SYSTEM.

TO ILLUSTRATE:

P(e)

= p(e) + p(e)

(1-p(d e))

n n-1 n

p(e) =

PROBABILITY OF ERROR OF A SINGLE STEP (eg: REPLACEMENT PART WILL NOT PERFORM SAFETY FUNCTION) n=

NUMBER OF STEPS IN THE QUALITY SYSTEM PROBABILITY OF ERROR DETECTION p(d e) =

4 GIVEN A PRE-EXISTING ERROR P(e) =

OVERALL PROBABILITY OF AN UNDETECTED ERROR NU-23

PROCUREMENT PHILOSOPHY ILLUSTRATION ONLY PRE-1989 TODAY LIMIT DESIGN p(e),

0.01 0.01 0.01 p(dle)

N/A N/A N/A x-p_

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PROCUREMENT p(e)2

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RECEIPT p(e)3 b.0b Ab0 0.00 l

INSPECTION p(dle) 0.90 0.99 0.99 INSTALLATION p(e)#)

0.01 0.01 0.01 p(de 0.90 0.90 0.90 TEST p(e) 0.00 0.00 0.00 p(de) 0.80 0.80 0.80 SURVEILLANCE p(e)e W

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PROCUREMENT PHILOSOPHY 1

1 ILLUSTRATION CONCLUSION:

MOST OF THE POTENTIAL IMPROVEMENTS RELATING TO PROCUREMENT HAVE ALREADY BEEN REALIZED NU-25

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PROCUREMENT

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PHILOSOPHY NU BELIEVES THAT THE DEDICATION ISSUES DOCUMENT IS A CHANGE IN NRC POSITION:

PROVIDES FOR MINIMAL IMPROVEMENT IN THE PROTECTION OF PUBLIC SAFETY IS EXTREMELY COSTLY

- EXAMPLES INCLUDE DOCUMENTING ALL ENGINEERING JUDGEMENTS AND PERFORMING FMEA's IN LIGHT OF THE ABOVE, NU AGREES WITH THE INDUSTRY POSITIONS STATED IN NUMARC'S LETTER OF DECEMBER 14, 1992 NU-26

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%-.u, 1-

SUMMARY

NU IS CONTINUOUSLY' IMPROVING ITS o

NUCLEAR PROCUREMENT ACTIVITIES NU GOES BEYOND MINIMUM REQUIREMENTS o

TO ASSURE QUALITY NU AGREES WITH INDUSTRY POSITIONS o

REGARDING THE NRC'S " DEDICATION ISSUES" NU-27

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ENCLOSURE 2

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DEDICATION ISSUES

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1.

BASIS FOR THE SELECTION AND VERIFICATION OF CRITICAL CHARACTERISTICS a.

Consideration of Item's Safety Function Critical characteristics should be based on the item's safety function. The licensee is esponsible for identifying the important design, material, and performance characteristics for each item, i

establishing acceptance criteria for these characteristics, and providing reasonable assurance of conformance to these criteria.

Upon the completion of the dedication process, 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.

b.

Failure Modes and Effects Analysis Failure modes and effects analysis can be a valuable tool which can be used for both, classification of an item as safety-related or nonsafety-related and for identifying the critical characteristics of an item. An evaluation of credible failure modes of an item in its operating environment and the effect of these failure modes on the item's safety function should be used as the basis for selection of critical attributes to be verified during the dedication process.

t c.

Reasonable Assur.gn,q_g 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, reasonable assurance consists of the purchaser providing control over the activities affecting the item's quality to an extent consistert with the item's importance to safety.

For more complex items, dialogue with the original equipment manufacturer may be necessary to identify the,

design and functional parameters of specific piece parts.

d.

Iraineerina Judaement The use of engineering judgement in the dedication process is acceptable providing that the bases for such judgements are j

documented.

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2.

SAMPLING 2

a.

Established Heat Traceability (materials) l When heat traceability of material is established through a commercial grade survey, the party performing dedication of this material may accept the certified material test report (CMTR) that certifies activities which must be performed during (1) the melting, and (2) the heat analysis; provided that the party dedicating the material performs or subcontracts the performance of all other requirements of the material specification and/or those requirements identified as critical characteristics, on a representative sample of that material, b.

Established Lot / Batch Control i

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When Lot / Batch (defined as units of product of a single type, grade, class, size and composition, manufactured under essentially the same conditions, and at essentially the same time) control is established through a commercial grade survey, the party performing dedication 4

can develop sampling plans based on standard statistical methods.

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.

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c.

Bulk Commodtty Items 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 a.

Material / Items Purchased from Distributors Traceability can be defined as the ability to verify the history, location, or application of an item by means of recorded identification (NQA-1). Traceability is necessary to prevent the use of incorrect or defective material and 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, their capability of maintaining traceability should be assured by audit.

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4.

COMMERCIAL GRADE SURVEYS a.

Verification of Vendor's Control of Specific Characteristics A commercial grade survey should be specific to the scope of the commercial grade item or items being purchased. The vendor's controls of specific critical characteristics to be verified during 1

the survey should be identified in the survey plan. The j

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.

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b.

Identification of Anolicable Proaram/ Procedures The vendor must have documented program and/or procedures to control i

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 2

may be sufficient to demonstrate that adequate controls exists. If the vendor's controls are determined to be satisfactory, purchase 4

orders for these items should invoke these controls as contract requirements by referencing the applicable program / procedure and

]

revision. Upon completion of the work, the vendor should certify compliance with the purchase requirements.

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c.

Documentation of Survev results i

Commercial grade survey documentation should include the j

identification of item or items for which the vendor is being 3

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 controie:

3 or by utilizing other verification and acceptance methods.

j 5.

LIKE FOR LIKE REPLACEMENTS a.

Replacement with identical Item If it can be demonstrated that the replacement item is identical to the item that it replaces, review of the replacement item's safety i

fLnctions and-identification of the critical characteristics are not necessary. /m example of such replacement would be the replacement of an installed commercial grade item with an item from warehouse which has the same model/part number and which was purchased from the same vendor at the same time.

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b.

Like-for-Like Verification If it can not be demonstrated that the replacement item is identical 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 i

function.

6.

ACCEPTANCE OF CERTIFIED MATERIAL TEST REPORTS (CMTRs)-AND CERTIFICATES OF i

COMPLIANCE (C0Cs) a.

Validity Verified Throuah Vendor /Sucolier Audit or Testina The validity of vendor (MTRs and C0Cs should be verified. This can be accomplished through a commercial grade survey or, for simple items, periodic testing of the product upon receipt. Such verifications should be conducted at intervals commensurate with the vendor's past performance.

If the item's supply chain includes a distributor, the verification survey should include warehousing i

and/or traceability controls at the distributor's facility.

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1 ENCLOSURE 3

MARCH 3, 1993 MEETING WITH NORTHEAST UTILITIES (NU)

ATTENDANCE LIST NAME ORGANIZATION Mike Wilson NU Dick Asafaylo NU Duncan McCory NU Mike Ahern NU/ Millstone Gene McNatt NU/ Millstone Rich Rogozinski NU/Haddam Neck James Peschel N. Atlantic Energy Sycs.

Richard McIntyre NRC/NRR/VIB Robert Pettis NRC/NRR/VIB Charles E. Rossi NRC/NRR/DRIL Roy Zimmerman NRC/NRR/DRIL Uldis Potapovs NRC/VIB Jim Anderson NRC/PDl-4 Larry Campbell NRC/VIB Charles Petrone NRC/NRR/RPEB Paul Swetland NRC/ Millstone SRI Leif J. Norrholm NRC/NRR/VIB Norm Blumberg NRC/ Region I Biff Bradley NUMARC

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