ML20034F278
| ML20034F278 | |
| Person / Time | |
|---|---|
| Site: | Duane Arnold  |
| Issue date: | 02/17/1993 |
| From: | Norrholm L Office of Nuclear Reactor Regulation |
| To: | Rossi C Office of Nuclear Reactor Regulation |
| References | |
| GL-91-05, GL-91-5, NUDOCS 9303020537 | |
| Download: ML20034F278 (48) | |
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION n
WASHING 1 JN, D. C. 20555 7
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FEB 1 ~ 1993 MEMORANDUM FOR:
Charles E. Rossi, Director Division of Reactor Inspection and Licensee Performance FROM:
Leif J. Norrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance
SUBJECT:
MINUTES OF PUBLIC MEETING WITH IOWA ELECTRIC LIGHT AND POW ON COMMERCIAL GRADE DEDICATION AT DUANE ARNOLD ENERGY CEN 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 finalize an inspection procedure for future inspections of this type.
These inspections identified weaknesses in licensee CGI dedication programs and their implementation.
During this same period, the NRC received significant feedback from several utilities and the Nuclear Management and Resources Council (NUMARC) questioning the regulatory basis for the CGI dedication guidance containeri in NRC Generic Letter (GL) 91-05, as well as specific interpretations of that guidance by the NRC 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 decided that a series of meetings with licensees and industry representatives would be beneficial to identify, and attempt to resolve, specific areas of difference. This meeting with Iowa 1
Electric Light and Power (IELP) representatives is the third of such meetings with licensees inspected during the pilot inspections.
Meetina Sumary On January 26, 1993, the Director and Deputy Director, Division of Reactor Inspection and Licensee Performance, members from the Vendor Inspection Branch, the NRC Region III Engineering Branch Chief, and the NRC project i
manager for the Duane Arnold Energy Center (DAEC) met with representatives from IELP'at One White Flint North in Eockville, Maryland.- The meeting provided an opportunity to discuss key procurement and comercial grade dedication issues identified during the five pilot inspections for which the NRC and IELP might have differing views, and to discuss certain dedication packages that were identified as containing deficiencies during the NRC's May j
1992 procurement inspection at DAEC.
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 50, Appendix B (Appendix B).
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.g Charles E. Rossi In order to facilita+,e the discussion, the NRC provided IELP a list of generic dedication issues (Enclosure 1) that was originally provided to NUMARC in a public meeting held with the NRC on November 13, 1992.
These dedication issues were used as discussion points for the meetings with Florida Power Corporation on December 4, 1992, NUMARC on December 10, 1992, and with Southern California Edison on January 13, 1993. The main dedication issues include the basis for the selection and verification of critical characteristics, sampling, traceability, comercial grade surveys, like-for-like replacements, and acceptance of vendor / supplier documentation and can be tied either directly or indirectly to Appendix B requirements for safety-related applications. These issues were derived from previous meetings with NUMARC and represent the major points of discussion.
The major areas addressed during the meeting were IELP's philosophy for dedicating commercial grade items, differences in dedication philosophy between the NRC inspection results and DAEC's dedication program, and the list of generic dedication issues (Enclosure 1).
IELP representatives presented an agenda (Enclosure 2) for the meeting with attachments that provided their philosophy on dedication, comments on the generic dedication issues including areas of disagreements, and examples from the NRC inspection at the DAEC that were used to explain IELP's dedication philosophy and practices.
The items were then discussed in detail.
IELP stated that DAEC has voluntarily adopted the. guidance contained in EPRI NP-5652, " Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Application (NCIG-07)," dated June 1988, and the methodology of' identifying and accepting commercial grade items (CGIs) based on critical characteristics related to safety function.
IELP also stated that they believe that this methodology is a new process for developing procurement specifications, and is fundamentally different from that used to procure original plant equipment and exceeds existing regulatory requirements. The NRC stated that this methodology along with the guidance provided in EPRI NP-5652 is an alternative to invoking Appendix B and 10 CFR Part 21 in procurement specifications and is one method acceptable to the NRC for complying with existing regulatory requirements.
The NRC disagreed with IELP that this methodology exceeds existing regulatory requirements.
During the discussion of the DAEC dedication packages, IELP related their dedication activities to their dedication philosophy.
The need to verify the materials of construction was discussed in detail as it relates to IELP's pnilosophy for identifying critical characteristics.
IELP stated that from a review of their safety-related procurement and design documents they could, in general, determine how the original equipment manufacturer (OEM) purchased parts and material that were used in assembling their supplied component.
IELP stated that unless their purchase specificatinn invoked a specific code, standard, or requirement on a part of a component, they believed that the OEM procured this piece part to commercial standards. Also, IELP stated that if no part or material certifications were furnished by the OEM then this further supported their belief that this part was commercially purchased.
Additionally, IELP stated that unless a specific material type was originally
t Charles E. Rossi - 11 identified for a part, the material of construction was usually not considered critical (i.e. part of IELP rationale for not verifying the material of a replacement relief valve for the control building HVAC air receiver tank was that the specification did not identify the material for the valve).
oj stated that although the material of a part may not have been identified on a The NRC design specification and the OEM did not provide material certification for an individual part, this, by itself, would generally be an insufficient basis for d
not considering the material of construction as a critical characteristic.
The NRC also stated that the complete design information for a vendor supplied component is generally not available to the licensee.
Next, the need to verify the material of construction of a cable for the refueling platform
)
auxiliary hoist was discussed. The applicable DAEC specification identified I
the cable as stainless steel, however material was not identified as a critical characteristic.
verifying the cable's material of construction.The NRC questioned IELP's rationa IELP indicated that the results of a cable strength pull test and frequent in-service visual inspections of the cable for signs of corrosion or wear provide reasonable assurance without verifyir.J material.
IELP further stated that they believe that the practice of the OEM during the supply of original plant safety-related equipment was, in some cases, to use standard commercial controls where specific code or procurement specifications were not applicable.
IELP stated that since the OEM used standard commercial controls for certain parts of a component, ANSI N18.7, " Quality Assurance Program Requirements replacement for these(Operations)," permits IELP to essentially procure a parts as commercially "off the shelf" with care exercised to ensure at least equivalent performance. NRC questioned IELP's rationale for determining the quality assurance requirements used by the OEM for procuring parts used in their components as well as their interpretation of ANSI N18.7 requirements.
NRC discussed and identified that one of the basic procurement requirements in ANSI N18.7 is extending the quality and technical requirements invoked by the licensee on the OEM to the OEM's lower tier subcontractors and suppliers.
The NRC further stated that if the OEM did not invoke the requirements on its subcontractors and suppliers, then the OEM was not meeting the licensee's requirements.
The NRC informed the IELP representatives that these discussions and their written comments on the NRC generic issues were very helpful and would be reviewed ir detail and taken into consideration in finalizing the NRC positions on these issues.
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NAME LCAMPBELL UPOTAPOVS LNORRHOLM RZDMERMAN~
CEROSSI DATE 01/28/93*
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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.
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S Lb Leif J. Norrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance
Enclosures:
l.
Dedication Issues 2.
Meeting Agenda 3.
Meeting Attendees cc: w/o enclosures W. Russell i
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EECLOSURE j t
i NRC MEETING WITH IOWA ELECTRIC LIGHT AND POWER JANUARY 26, 1993 DEDICATION ISSUES FOR DISCUSSION
- 1. BASIS FOR THE SELECTION AND VERIFICATION OF CRITICAL CHARACTERISTICS a.
Consideration of Item's Safety Function i
Critical characteristics should be based on the item's safety function. The licensee is responsible for identifying the important design, material, and performance characteristics for each item, 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 pr igram.
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.
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, reasonable assurance consists of the purchaser providing control over the activities affecting the iten.'s quality to an extent consistent with the item's i
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.
Enoineerina Judaement The use of engineering judgement in the dedication process is acceptable providing that the bases for such judgements are documented.
1 t
g.
i 2.
SAMPLING Established Heat Traceability a.
(materials)
When heat traceability o commercial grade survey,f material is established through a the party performing dedication of this material may accept the certified materiil and (2) the heat analysis; provided that the party dedicating material performs or subcontracts the performance of all other requirements of the material specification and/or those requir identified as critical characteristics, on a representative s of that material.
b.
Established Lot / Batch Control _
When Lot class, s/ Batch (defined as units of product of a single type, gra ize and composition, manufactured under essenti ll through a commercial grade survey, the part a y the same can develop sampling plans ba:ed on standard statistical methods Such sample plans should be documented and provide for the consistent with the item's importance to safety. v c.
Bulk Commodity items When Lot / Batch traceability can not be established, each ite need to be tested. Any sampling plans for such items would need be considered on individual, item-specific ba:is 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.
location, or application of an item by means of re identification (NQA-1).
use of incorrect or defective mateTraceability is necessary to prevent the throughout the dedication process. rial and should be maintained Where the item's acceptance is the traceability must extend to the manufacturer. ba maintaining traceability should be assured by audit.
If intermediaries 2
q ENCLOSURE 2
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AGENDA NUCLEAR REGULATORY COMMISSION &
IOWA ELECTRIC LIGHT AND POWER COMPANY o introductions and Review of the Agenda items Tim Sims O lowa Electric's Philosophy for Dedicating Commercial Grade iterns - Don Church o Discussion of differences in dedication philosophy between the NRC inspection results and DAEC's dedication program. - Don Church
- D90-003 3/4 inch Relief Valve
- D90-016 Louver Pinions
- D92-0191/4 inch Wire Rope
- D90-1051/8 x 1/2 inch Woodruff Key
- D90-021 Booster Servo Motor
- D90-012 MSIV LCS Heater Element
- D90-034 Overload Heater Elements
- D90-045 SBLC Heater
- D90-092 Lubricants O NRC Dedication issues for Discussion - Don Church
- Basis for the Selection of Critical Characteristics
- Sarnpling Traceability
- Commercial Grade Sun /eys
- Like fpr Like Replacements
- Acceptance of Certified Material Test Reports and Certificates of Compliance O Questions, Concluding Remarks - Ken Peveler 3
-9 IOWA ELECTRIC PHILOSOPHY FOR DEDICATING COMMERCIAL GRADE ITEMS FOR USE IN SAFETY RELATED APPLICATIONS AT THE DAEC It is the current objective of the DAEC nuclear procurement program to procure safety related (SR) spare and replacement items from original equipment manuf acturers/ suppliers (OEM/OES) with approved 10 CFR 50 Appendix B quality assurance programs when available.
When the dedication of an item is required, Iowa Electric, through the NUMARC Commercial Grade Initiative, voluntarily adopted the guidance contained in EPRI NP-5652 as a proactive measure to control the evaluation and acceptance of commercial grade items (CGI).
Determination of item suitability of application was performed at the time the original design and procurement technical and quality requirements were established for the original plant equipment.
The specifications and drawings which were prepared during this design process establish the technical and quality requirements to be met for an item to be considered suitable for application under the NRC licensed design basis of the DAEC.
The plant unique specifications and drawings developed during-the-original plant design process established suitability for application by invoking design codes and standards, specifying functic.a1 requirements to be met and identifying test, inspection and cer cification requirements.
These plant unique specifications provide the technical and quality requirements for dedicating items intended for safety related applications.
Iowa Electric has voluntarily adopted the methodology of also identifying and accepting CGI based on critical characteristics related to sa a* v fune-tion but recognizes that this methodology is r
a new process tor developing procurement specifications, it is fundamentally different than that used to procure original plant equipment and it exceeds existing regulatory requirements (10 CFR 50 App. B and RG 1.33).
i Assurance that the items dedicated by Iowa Electric will perform satisfactorily in service is achieved through a dedication program that is driven by the Iowa Electric Engineering organization who is responsible for maintaining the design and equipment qualification, providing a technical evaluation and specifying the acceptance methods and criteria that is commensurate with the items complexity and importance to safety.
1 1
5 DEDICATION 090-003 DRESSER, ASME SECTION VIII UV STAMPED RELIEF VALVE,3/4-1990C.XDAI, FOR COMPRESSED AIR Application:
Pressure Relief Valve for Control Building HVAC Air !
Receiver Tank Critical Characteristics:
1.
Configuration-size, weight, dimensions, part number ASME UV Code Stampset pressure, manufacturer's trade mark, capac 2.
3.
Pressure Integrity-Seat Leakage @ max system pressure 4.
Popping Point of valve 9 set point of 125 psig NRC Concerns:
1.
System over protection was not listed as a Safety Function 2.
Material of construction was not listed as a
critical i
characteristic and was not verified 3.
Engineering evaluation did not address material substitution IELP Responses:
1.
Over pressure protection of the air receiver is not'a nuclear safety related function, but rather an ASME Section VIII code compliance requirement.
function and was verified bPressure integrity is the safety related' system operating pressure (y performing a leakage test at maximum 88 psi).
function (popping point) was verified in order to meet the originalT technical requirement (ASME Section VIII UG-136 1974) of DAEC Specification 7884-M-86 Section 5.5.3 but not as. a critical characteristic in support of a nuclear safety function.
2.
The DAEC Specification 7884-M-86 was developed during the desi and construction of the DAEC and established the suitability of the application by invoking the requirement for a " full capacity ASME Code relief valve" as the technical requirement for the relief valve.
Quality Requirement for the certification of materials for this relief valve were not required by the original plant specification 7884-M-86 or the code of construction ASME Section VIII UG-136 (74 w/addm).
3.
and construction of the DAEC and established the application by invoking the requirement for a " full capacity ASME Code relief valve" as the technical requirement for the relief valve.
No technical requirement for the material of the valve was specified.
During the performance of this dedication an alternate replacement was made to compensate for the failure of the OEM 2
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l valves dedicated during Rev.
O of this package.
A conscious decision was made by the engineer to replace the poorly performing valve with a new valve that " exceeds the original valve design requirements".
This change was implemented by a reviewed and approved engineering evaluation which is part of the technical evaluation.
The material of construction for this valve was not stated in the original DAEC procurement specification nor required by the original code of construction.
The valve was tested by Iowa Electric in accordance with ASME Section VIII, UG-136, " Minimum Requirements for Prescure Relief Valves", (d) Production Testing.
A popping point test and a tightness test were performed and found to be acceptable. This technical evaluation and acceptance results provide reasonable assurance that the items will meet the original technical requirements and perform its intended nuclear safety related function (i.e., pressure boundary).
Cost:
Commercial Item Cost 378.00 Technical Evaluation Cost
- $3,861.00 Acceptance Cost 294.00 3
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DEDICATION D90-016 CONSTRUCTION SPECIALTIES (CSI), LOUVER PINIONS
. Application:
Louver Parts for HVAC Air Isolation Dampers Critical Characteristics:
1.
Part Number 2.
Dimensions 3.
Material 4.
CGI Survey performed at CSI, Certificate of Compliance NRC Concerns:
1.
CSI does not verify the correctness of certification documents with regard to materials.
Therefore the use and validity of the CoC from CSI, as the basis for accepting these materials is not considered consistent with ANSI N45.2.13.
2Property "ANSI code" (as page type) with input value "ANSI N45.2.13.</br></br>2" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process..
There was no documented basis to support the vendor's lot or batch control process, nor was it evident how the supplier contrciled product consistency for the purpose of determining lot homogeneity.
IELP Responses:
1.
This dedication was developed over a time frame that allowed the original technical evaluation to be completed well before the Quality Assurance CGI survey was performed.
.The CGI survey was completed 4-11-90 and the first purchase order (S55127) that procured parts was issued by Iowa Electric 4-13-90.
Acceptance of SS5127 occurred on 5-15-90 under revision 1 of the dedication evaluation that added the requirement to do dimensional inspection-of a sample of the items to be accepted, since CGI's M&TE program was not acceptable as reported by the CGI survey..Unfortunately, the requirement to do a sample material analysis for chemical composition was overlooked due to the wording of the CGI survey results.
This oversight was discovered later by an Iowa Electric Internal QA audit.
As part of the immediate corrective actions, the dedication was revised to require the testing of materials procured in the future and test those pinions in warehouse stores.
It was later determined that all 1,800 pinions initially received under S55127 were installed in non-safety applications requiring no further corrective actions.
The 1,000 pinion ordered under.
purchase order S58948, were sampled and destructively tested.to determine material composition and found to be acceptable.
The supplier certification process with the IELP controls (dimensional inspection and material certification) were used to accept the louver parts which is consistent with ANSI N45.2.13 for those purchase orders initiated after the audit corrective actions were in place.
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2.
When a purchase order line item is presented for acceptance there is reason to assume a certain level-of lot homogeneity for those items.
In the case of the pinions, two heats / lots were stamped into the items by the OEM (stamped with heat #) without being e
requested by Iowa Electric.
Of those heats 130 of 10,000 items were tested with one rejection (high on moly).
This is more than reasonable assurance that the product is acceptable without the supplier controlling the actual heats of the material.
Cost:
Commercial Item Cost (pinion) -$
5.00 Technical Evaluation Cost
- $1,650.00 Acceptance Cost 116.00 5
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i DEDICATION D92-019 YALE HOIST, WIRE ROPE ASSEMBLY i
Application:
Refuel Platform Auxiliary-Holst.used to support tools CRD and Control Rod Blades.used in manipulating core Critical Characteristics:
1.
Part Number 2.
Configuration 3.
Dimensions 4.
Material Strength, Source Surveillance to witness destructive testing of rope sample.
NRC Concerns:
1.
Section 4.6.6.5.3 of General. Electric Specification 21A9246
" Requirements for Refueling Platform" Rev.
1, Jan.
13, 1970 required that material was not considered as a critical characteristicth 2.
t Source Surveillance report did not indicate that the suppli tester of the cable (Yale Holst) performed any independent er and overchecks to support the validity of the raterial listed on the
- CoC, as specified by Section 10.2 of. ANSI N45.2.13-1976.
IELP Responses:
1.
The referenced specification requires that the wire rope be~
stainless steel but makes no provisions to certify or verify thi materials to meet the specification requirements.
was purchased from The wire rope the UEM and verified to meet the required material strength to perform the items intended safety functiorr The item was specified in the IELP purchase order exactly as 1
required by the GE specification which included the OEM part numb which designates the rope as. being stainless steel as well as stating the requirement for the rope to be stainless steel.
are performed to verify the integrity of the rope pri When For the application stated in this dedication evaluation shiftly checks for excessive wear and corrosion are performed on
- 1H208, the rope.
The following standards (ANSI B30.'2.0, B30.9-1971)'for cranes and slings have no-requirement for the'- material certification of wire rope.
2.
Iowa Electric did not require the supplier to certify the mat composition since the material was.not a critical characteristic to erial support the safety function of the hoist.
involved Both of the suppliers with this item (Yale, Wire Rope of America) are very i
reputable and have a high regard for safety.
product -reliability and its intended safety function. Reasonable assurance exists that this item 6
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. Cost:
f.
Ct.,mmercial Item Cost
- $1,633.00 Technical Evaluation Cost - $1,614.00 Acceptance Cost
- $1,208.00
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o DEDICATION 990-105 FISHER CONTROLS,
- 40 1/8 X 1/2 INCH WOODRUFF KEY Application:
arm for inflation of T-seals for torus and d exhaust inboard and outboard isolation valves.
Critical Characteristics:
1.
Part Number 2.
Chemical Analysis 3.
Dimensions NRC Concern:
1.
keys since they were purchased from Fisher Con e eight grade; therefore, testing two keys had no correlation to the mmercial remaining keys.
place to con',rol lot or batch homogeneity.DAEC did not estab IELP Response:
"1.
ThesG the OEM part number and material type as called drawing. bill of material.-
e valse.
The certification of.the key material is' not required by.- th'e original valve specification or the valve drawing.
Material verification was performed as a measure of added assurance that the keys as ordered ; fulfilled. the specification.
When a purchase order linecitem is presented for procurement acceptance, there is a reason to assume a certain level of homogeneity for those items.
These-items were, procured from the
- OEM, randomly selected and l submitted..for verification for 2/8 of the keys.
destructive material item, and good assurance of some homogeneity, reasonable assur exists that these remaining items will nce safety function.
A commercial perform.their intended establish lot control of these items. grade survey is not requir d to Cost:
Commercial Items cost 0.35 Technical Evaluation Cost -
$2,211.00 Acceptance Cost 499.00 8
e DEDICATION D90-021 BOOSTER SERVO MOTOR FOR WOCDWARD MODEL NO. EGB-10-C GOVERNOR Application:
Emergency Diesel Generator Governor Critical Characteristics:
1 Part Number 2.
Seal Integrity
- 3.
Spring Servo Travel
- 4.
Mounting Dimensions Verified by IELP Source Inspection NRC Concern:
1.
(Paraphrased) Critical characteristics are not representative of DAEC design / operational characteristics required to support the safety function of the emergency diesel generator governor.
IELP Response:
1.
This item was purchased as a commercial grade item from the emergency diesel generator OEM. This item was purchased commercial grade as a proactive effort by Icwa Electric to compensate for.the OEM's failure to maintain an ef fective dedication program for those items that the OEM did not have under its design control program.
This. breakdown in the suppliers quality program.was identified as-the result of an Iowa Electric Quality Assurance supplier audit.
One of the Iowa Electric internal corrective actions as a response to'this audit was for Iowa Electric to dedicate those items that the OEM did not have under their design control. program.
The item was procured from the OEM by the OEM part number..-Iowa Electric Engineering with as sistance from Colt and Woodward derived. the critical characteristics that were defined-in the IELP dedication evaluation.
The dedication critical characteristics' that were chosen were not chosen from the standpoint.of verifying the exact operational characteristics of the DAEC unit but rather'they were derived from input from Woodward' Governor as a result of IELP's inquiry to Woodward on how they test their product to assure'what is manufactured is acceptable for use.
Iowa Electric performed a source inspection of the testing activities at the Woodward test facilities to verify that the item was tested in accordance with the Woodward procedure and to assure test traceabliity to the item that was tested.
Ccat:
Commercial Item Cost
- $2,749.00 Technical Evaluation Cost - $1,815.00 Acceptance Cost
- $2,624.00 9
3 3
-DEDICATION PACKAGE D90-012 MSIV-LCS HEATER ELEMENT Application:-
, Main Steam Isolation 1 Valve Leakage' Control? System Critical' Characteristics:
1.
Heated Length 2.
Overall Element Length 3.
Element Diameter.
4.
MPL Number' 5.
Part Number 6.
Serial ~ Number 7.
Element' Power Rating NRC Concern:
1.
Performance related attributes for the heater were n r
e.;
IELP Response:
1.
This dedication package was not 'a dedication of a commercial item.
It was the documentation of.IELP gr de 1
21 responsibilities. for' a basic compon.'s acceptance of 10CFR50 and ' '
ent.
The heater elements,were ordered-and received in'1987 In 1989, IELP received notification. that assumed 10CFR50 and 21 responsibilities...The package was gen in: response to the NRC concerns.
IELP' listed NSSS, Inc.'as a storage facility only.:
taken for any NSSS,.Inc. certification other than storage 7 Noicredit wasi N45.2.2.'.
. er'ANSIL p
performance related' attributes. Post-installation testingEof1the 1
ratei Cost:.
Commercial Item. Cost-Technical Evaluation Cost
-L$1,500'.00-(canceled plant)?"
- $2,100.00:
Acceptance Cost
- $1,080.00:
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4.
COMMERCIAL GRADE SURVEYS Verification of Vendor's Control of Specific Characteristics a.
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 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 obr,erving the actual implementation of these controls in the manufacture of items identical or similar to the items being purchased.
b.
Identification of Aeolicable Procram/ Procedures The vendor must have documented program and/or procedures to control the critical characteristics of the item or demt being procured which are to be verified dr
, the survey.
When cany items are being purchased, a survey of a representativt s:oup of similar items may be sufficient to demonstrate that adequate controls exists. If i
the vendor's controls are determined to be satisfactory, purchase orders for these items should invoke these centrols 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.
Documentation of Survey resultg 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.
5.
LIKE-FOR-LIKE REPLACEMENTS a.
Reolacement 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 functions and identification of the critical characteristics are not necessary. An 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 demonstrate'd that the replacement itemLis 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:
function.
6.
ACCEPTANCE OF CERTIFIED MATERIAL TEST REPORTS (CMTRs) AND CE COMPLIANCE (C0Cs)
Validity Verified Throuch Vendor /Susolier Audit or Testina -
a.
The validity of vendor CMTRs and COCs 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 and/or trateability controls at the-distributor's. facility.
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DEDICATION PACKAGE D90-034 THERMAL OVERLOAD HEATERS Application:
Protect the following motors from overload condition HPCI-Steam Line Isolation Valve Motor RCIC Steam Line Isolation Valve Motor Battery Room Exhaust Fan Motor Critical Characteristics:
1.
Part Number 2
Trip Time NRC Concerns:
1.
Starting, transient and full load hold in capability were not addressed as critical characteristics 2.
Testing is performed with three heaters in series.
This would not provide conclusive results on each heater.
3.
Acceptance criteria was
+/-15%
of the trip time of the manufacturer's published trip curve.
Evaluation of test data _
indicates that-15%
tolerance was the accuracy of. the test.
equipment.
IELP Responses:
1.
IELP identified part number and trip time per GMP-TEST-031 as critical characteristics The intent of performing GMP-TEST-031 was to verify the size of the heater element.
The original design selected the size of the heater that was adequate for the function.
GMP-TEST-031 tests at three points to verify tripping per.
manufacturer"s published trip curve Testing is to give reasonable assurance that the heaters are performing to the manufacturer's published trip curves 2.
GMP-TEST-031 was written from NEMA ICS 2-222.
Test circuit used in GMP-TEST-031 is per NEMA ICS 2-222 Figure 2-222-2.
-i Overload relay and three heaters perform the trip function as a unit.
Manufacturer's trip-curves are for three heaters in a three pole heater block.
One heater in a three pole heater block would not.
give accurate results.
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3.
If.one trip time out of three was_out of the.15%1 tolerance some.
credit was.given to the test not being performed.at.40*Ctas NEMA.
ICS 2-222 requires.
The.only case where this happened, the_ point out of tolerance was the.1.5_ times rated trip point. The trip time was longer ~as would be expect,u for a cold overload block..
This.is also in the' conservative direction for.;a safety related motor..
Cost:
Commercial Item Cost 29.00
- Technical Evaluation Cost - $3,929.00 Acceptance-Cost 225.00
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DEDICATION PACKAGE D90-045 STANDBY LIQUID CONTROL HEATER ELEMENT '
Application:
Maintaining the temperature of the pentaborate solution above the point where the solute would precipitate out.
Critical Characteristics:
1.
Part Number 2.
Operating Voltage 3.
Wattage 4.
Dimension "B" from Vendor Drawing 40A109295 5.
Diameter of Heater Rod from Vendor Drawing 40A109295 6.
DC Resistance NRC Concern:
1.
Insulation dielectric strength nor insulation resistance were not considered critical characteristics.
IELP Response:
1.
Post safety function. maintenance testing indicated that the heater performed its The critical characteristics identified by the NRC are critical characteristics for acceptance. for manufacture and not critical characteristics Insulation dielectric strength and insulation resistance are indications of the reliability of the heater..
It is.not the maintenance practice at the DAEC to test the insulation dielectric strength and insulation resistance of electrical heaters.
information is only valid if trended _ to show a degradation overL This time.
a failure of the insulation material. Failure of the heater element Procedure STP Performance of Surveillance Test heater element.
44A001 monitors long term performance of the Cost:
Commercial Item Cost
- $1,177.00 Technical Evaluation Cost - $1,155.00 Acceptance Cost
-3 216.00 13
DEDICATION D90-092 VARIOUS COMMERCIAL GRADE LUBRICANTS Application:
Various Safety Related Equipment Critical Characteristics:
1.
Part Number - Product Description on Container 2.
Container Integrity - No Shipping Damage or Leakage 3.
Product Integrity - Seal has not been broken 4.
Testing Criteria - Greases (dripping point, working point, color),
Oils (viscosity, flash point, neutral number, water content) all samples taken from three places in the container.
NRC Concern:
i 1.
The sampling plan for lubricants described in the evaluation in L
which traceability to the manufacturers was to be established by lot or batch numbers, was based upon MIL-STD-105D statistical sample which assumes batch control and reasonably homogeneous i
batches (a batch being 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).
- However, it was not clear from the evaluation how IELP had determined what suppliers' controls on product consistency were verified for purposes of determining batch homogeneity.
IELP Response:
2.
For the purpose of establishing a
basis for sampling for lubricants, Iowa Electric maintains that lot or batch, based upon the marking of the batch number on barrel, is an acceptable and l
reasonable approach for these items.
Batch traceability is an essential part of the manufacturing and distribution of petroleum products initiated and performed as part of the commercial controls applied to the industry.
For the volume of products (typically 1-5 barrels, 1-5 cases) Iowa Electric procures for stores and use, the marking of lubricants used by the industry for batch traceability is more than adequate to establish the lot basis for material testing.
l Cost:
Commercial Item Cost 226.00 (5 gallon Mobil 28)
Technical Evaluation Cost
- $39,000.00 1
Acceptance Cost 355.00 l
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NRC MEETING WITH IOWA ELECTRIC LIGHT AND POWER JANUARY 26, 1993 DEDICATION ISSUES FOR DISCUSSION 1.
BASIS FOR THE SELECTION AND VERIFICATION OF CRITICAL CHARACTERISTICS 4
a.
Consideration of Item's Safety Function Critical characteristics should be based on the item's safety' function.
The licensee is responsible for identifying the important design, materini, and performance characteristics for each item, 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.
This statement is not consistent with and exceeds the existing regulatory requirements (10 CFR 50 Appendix B, ANSI N18. 7, ANSI N45.2.13) and original plant design requirements.
The original plant design was functionally /performanced based with supporting technical and quality requirements.
Some utilities have adopted the EPRI guidelines using this methodology in attempt to take a proactive approach to provide added assurance of the high quality of replacement items.
Determination of item suitability of application was performed at the time the original design and procurement technical and quality requirements were established for the original plant equipment.
The specifications and drawings which were r
prepared during this design procesa establish the technical and quality requirements to be met for an item to be considered suitable for application under the NRC licensed design basis.
The plant unique specifications and drawings developed during the original plant design process established suitability for application by invoking design codes and standards, specifying functional requirements to be met and identifying test, inspection and certification requirements. These plant unique specifications provide the technical and quality requirements for dedicating items intended for safety related applications.
In some cases, material or design requirements not included in referenced codes and standards were explicitly stated in the 15
specification.
A wide latitude was given to the equipment manuf acturer to establish specific subcomponent and part level requirements as long as the overall functional requirements of i
the specification were met.
The original plant specifications DID NOT provide OEM's with any definition of which components were safety related when a skid or system was being procured nor did the specifications require the manuf acturers to perform a detailed part level determinations of safety functions, or develop item critical characteristics based on those safety functions to be verified through a dedication program.
The practice of OEM during the supply of original plant equipment was to use STANDARD COMMERCIAL CONTROLS where specific code or procurement specifications were not applicable.
ANSI 18.7 recognizes that in many cases the result of original plant specification process was the specification of a commercial grade item without specified quality assurance requirements for use in a safety-related application.
Commercial grade items were considered suitable for certain safety-related applications without specifically identified quality requirements. ANSI 18.7 says in such cases commercially "off tae shelf" replacements are acceptable, wit.h care exercised to ENSURE AT LEAST equivalent performance.
b.
Failure Modes and Effects Analysis (FMEA)
Failure modes and effects analysis can be a valuable tool which can be used for both, classification of an item as safety-related or non-safety-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.
When performing safety classification of an item, a FMEA may be used in order to conclude that an item is non-safety related.
A FMEA may be performed to assure that failure of the item will not impair the performance of the safety function of interest.
Performance of FMEA for the purpose of determining the effect of a failure on a item's safety function as a basis for selection of critical characteristics is also inconsistent with and exceeds regulatory requirements for the same reasons as described in (la.).
Utilities should have the flexibility to perform a FMEA to support the safety classification of some items or to derive critical characteristics for items whose complexity or 16 o
importance to safety might make FMEA valuable.
or no impact on overall plant safety.not be consider
_FMEA should Reasonable Assurances c.
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 vendor.
responsibility of the purchaser providing control over the activitie item's quality to an extent consistent with the item's.
importance to safety.
original equipmentFor more complex items, dialogue with the manufacturer may be identify the design and functional parameters of specific necessary to piece parts.
This statement does not address what is to be re assured but does support t not every item dedicated requires absolute assurance. hat requiled te dedicate an item.and complexity should be f 10 CFR 50 Appendix B
encompasses the activities that contribute to the overall assurance of quality.
components and their replacement items there are 5 key For plant activities key to achievin activities are as follows:g overall quality assurance.
These 1.
Design and Equipment Qualification The plant unique specifications and drawings develop d during ' se original plant design process established standards, specifying functional requireme and identifying
- test, inspection and certification requirements.
In some instances a wide latitude was lef t to the equipment manufacturer to establish specific subcomponent and part level requirements as long as overall functional and performance requirements of the equipment specification was met.
only requires that these replacement items meet or exceedEx these original specification Requirements.
The 4
dedication of replacement parts does not require an evaluation of the existing design or re-specification at a greater level of detail than originally performed.
This is supported by Generic Letter 91-05 (2nd para under
" discussion" on page 5 of enclosure which states in part:
"When engineering persennel specify design requirements 17
+
for inclusion on the purchase documento for replacement components, they need not reconstruct'and reverify design adequacy for procurement purposes, but need only ensure the existing design requirements -(which may reference the original design basis) are properly translated into the purchase order."
2.
Technical Evaluation ANSI 18.7 requires a technical evaluation only in those cases where "the QA requirements of the original item cannot be determined, an engineering evaluation shall be conducted..." For commercial grade ~ ANSI 18.7 states "in those cases where the original item or part is to be-commercially 'off the shelf', or without specifically identified quality assurance requirements, spare and replacement parts may'be similarly procured but care shall be exercised to assure at least equivalent performance."
The existing regulations do not require a technical, evaluation for the dedication of commercial grade items but rather that care be exercised to assure equivalent performance. Iowa Electric has adopted doing a technical evaluation for the dedication of CGI which translates original design specifications into procurement technical and quality requirements.
For Iowa Electric, there are very few instances when - the QA requirements of the original item cannot be determined.
3.
Acceptance The acceptance process provides reasonable assurance that; the item received meets the specified accepance criteria which was derived from the techr.ical and-quality REQUIREMENTS of the original.
items procurement.
specification.
The word reasonable co-notes a level of confidence which is justifiably based upon the items safety importance and its complexity.
Reasonable assurance is not absolute assurance.
4.
Supplier's Product Controls Additional assurance may also _be obtained through reliance on the suppliers manufacturing and quality controls.
Reliance, on a' ' suppliers controls for _ the acceptance of CGI should be based upon the extent a supplier controls are verifiably implemented.
5.
Post Receipt, Installation and Operating Quality Controls Post reccipt, installation and operating quality controls 18
also provide additional assurance.that the item will perform satisfactorily in service.
These controls include preventative maintenance
- testing, testing, post maintenance testing and surveillance inspections that verify the other tests and operating status of the item.
material condition and d.
Engineerino Judgment acceptable providing thatThe use of engineering judgme ocess is the bases documented.
for such judgments are The use of enginee dedication process. ring judgment is an essential part of the experience of the individual evaluating all of theJudgments available at that point in the evaluation process.information based upon the qualifications of the individ The level e
judgment to arrive at a decision, the importance'to safety er complexity of the engineering activity.
Many utilities are electing to prepare extensive document ti packages to support the decisions made during the dedicatio a
on process to avoid being second guessed by the regulator only is this expensive in the terms of time and resourcesNot takes available manpower away from those issues that
, it Documenting ALL engineering judgments bey offers no corresponding reduction in risk to t a
are safety of the public.
2.
SAMPLING a.
Established Heat Traceability (materials)
When heat commercial grade survey, traceability of material is-established thr this material may accept the certified material te tthe party p (CMTR) that certified activities which must be performed s
report during (1) the melting, and (2) the heat analysis, provided-that the party dedicating the material performs or material specification and /or those requirem as critical characteristics, that material.
on a representative sample of The portion of the statement
" performance of all other requirements of the material specification and/or"-leads one to believe that 100%
of the material specification requirements would have to be met in order to have assurance 19 1
that the material is acceptable.
is impractical and cost prohibitive.Use of.the "and" statement verification of the material specification.the prop a 100%
"or" statement without the "and" is consistent w The use of the industry practice, g
b.
Established Lot / Batch Control when Lot / Batch (defined as units of product of a single
- grade, class, size and composition, manufactured under essentially the same conditions, and at essentially the same time) control is established through survey, the party performing dedication can develop sam a commercial grade plans based on standard statistical methods.
plans should be documented and provide for the verificati Such sample the critical characteristics with confidence level with the item's importance to safety.
consistent This methodology provides a valid approach to sampling b is not necessarily reflective of the situations that u
t utilities dedicating parts in small quantities or from confront program to control lot / batch. warehouse stocks that were eyed Lots can be established without doing commercial grade surveys.
The following ar also acceptable methods of sampling without doing surveys: e 1.
Actribute sampling plans whose statistical basis is derived from recognizing that the " sampling lot" should all meet the same acceptance criteria.
Assurance is based upon a probability calculation which takes account sample size, acceptance / reject numbers, lot size into etc.
See EPRI NP-7218.
.i 2.
When a purchase order line item is presented-for i
acceptance, there is a good degree of assurance that the items received are homogeneous.
i to the same technical requirements at the same time ' and are expected to meet the same acceptance requirements.
i Sampling of this line item lot can give reasonable assurance if safety importance and complexity is factored into the sampling equation.
Lots can also be formed t
through production traceability.
based upon a
i manufacturers heat number, production lot number or batch number for which traceability is a commercial practice I
for that industry.
traceability exists,For a given. lot size, if production
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a high degree of lot homogeneity exists.
Engineering - judgment should be applied to i
evaluate the various factors to establish an acceptable j
sampling plan.
i 20
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,. o Bulk Commodity Items c.
When Lot / Batch traceability can not be established may need to be tested.
Any sampling plans for such items
, each item would need to be considered on individual, item-specific basis i
and assure that they are capable of providing a high level of 3
assurance of the item's suitability for service.
As addressed in (b) above it is not lot / batch traceability in order to use sampling.necessary to establ sentence of the statement captures the essence of sampling an The second should not be limited to just should include all other items as well. bulk and commodity items but 3.
TRACEABILITY a.
Material / Items Purchased From Distributors Traceability can be defined as the ability history, location, or application of an to verify item by neans, the recorded identification of prevent the use of incorr(NQA-1). Traceability is necessary to ect of defective materia be maintained throughout the dedication process.l and should item't-acceptance is based entirely or partially on a Where the certification by the manufacturer, the traceability must extend to the manufacturer.
If intermediaries (distributors) are included in the supply
- chain, their maintaining traceability should be assured by audit. capability of The second sentence is incorrect.
Material control not defective material. traceability is necessary te prevent the use of incor r
4.
COMMERCIAL GRADE SURVEYS Verification of Vendor's Control of Specific Characteristics a.
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 critieni 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 characteristics and observing the actualcontrolling these these controls in the manufacture of items identical or implementation of similar to the items being purchased.
The first sentence should be modified to make it clear tha the words " specific to the scope of... items being purchaJed" includes items which are similar.
This needs to be changed to be consistent with the last sentence which appropriately 21
acknowledges that the same suppliers controls apply to similar items and that an additional survey is not required.
t The last phrase in the first sentence should also be modified to the items being considered for purchase. A utility may not make a decision to actually procure an item until after the results of the survey are complete.
b.
Verification 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 contract requirements by referencing the applicable program / procedure and revision.
Upon completion of the work, the vendor should certify compliance with the purchase requirements.
No comments c.
Documentation of Survey Results 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 i
control of the identified critical characteristics should be addressed by requiring the vendor to institute additional coatrols or by utilizing other verification and acceptance methods.
The last sentence implies that there is some criteria a commercial program must meet. This is incorrect. The purpose of a commercial grade survey is to determine what a supplier i
does in terms of controlling quality.
If the utility determines these controls are not adequate for their needs, the utility must compensate for the suppliers program inadequacies through the use of other acceptance methods.
A utility may negotiate with a supplier to institute additional controls but has no basis for " requiring" the commercial grade supplier to do so.
The only time. deficiencies would be identified is if the supplier does not comply with the controls prescribed by this program.
22
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5.
LIKE-FOR-LIKE REPLACEMENTS 6.
Replacement with Identical Item If it can be demonstrated that the replacement item identical to the item that it replaces, review of the replacement item's safety functions and identification critical characteristics are of the such not replacement would be the replacement of necessary.
An example of has the same model/part number and which an installed which the same vendor at the same time.
ased from This definition of like for like is so restricti little benefit to the nuclear industry.
ve it is of Through the NUMARC Commercial Grade Items Initiative, utilities have committed to perform an appropriate le engineering evaluation commensurate with the safety imp vel of of the item being dedicated, r ance b.
_Like-for-Like Verification If it can not be demonscrated that identical or if differences between the items are id the replacement item is an evaluation is necessary ' to determine if entified design, material, any changes in item's critical characteristics and its ability to perforor intended safety function.
m the This statement should be rewritten to say "If differences exist between the item to be replaced and the replaceme item, an evaluation is necessary to determi impact the ne if the changes
- material, design,
- fit, from, function,.
interchangability, etc., as defined in the original plant procurement specification requirements.
6.
ACCEPTANCE OF CERTIFIED MATERIAL TEST REPORTS (CMTRs)
AND CERTIFICATES OF COMPLIANCE (COCs) a.
Validity Verified Through Vendor / Supplier Audit or Testino The validity of vendor CMTRs This can be accomplished through a commercial gradand COCs verified.
for simple items, periodic testing of the product upon e survey, or receipt.
Such verifications should be conducted at int commensurate with the vendor's past performance.
If the item's supply chain includes a distributor s
at the distributor's facility. survey should include wareho the verification s
Audit should be changed to survey.
23
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u~ a b MEETING ATTENDEES Nuclear Reculatory Commission Charles E. Rossi, Director, DRIL Roy Zimmerman, Deputy Director, DRIL Leif Norrholm, Chief, Vendor Inspection Branch Uldis Potapovs, Chief, RIS-1, Vendor Inspection Branch Geoffery Wright, Chief, Engineering Branch, RIII Richard McIntyre, Vendor Inspection Branch.
Robert Pettis, Vendor Inspection Branch Larry Campbell, Vendor Inspection Branch Iowa Electric L1aht and Power Ken Peveler, Manager, Corporato Quality Assurance Don Church, Supervisor, Quality Assurance Harry Johnson, Supervisor, Materials Management John Howlett, Group Leader, Procurement Engineering Mike Fairchild, Group Leader, Electrical Engineering Tim Sims, Nuclear Licensing, Regulatory Communications NUHARC Biff Bradley, Senior Project Manager
,