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Rosemount Nuclear Instruments, Inc.8200 Market BoulevardChanhassen, MN 55317 USA
Tel 1 (952) 949-5210
EMERSON. Fax 1 (952) 949-5201
Process Management
February 28, 2014
United States Nuclear Regulatory CommissionAttn: Document Control DeskWashington, DC 20555-0001
Subject: Reply to Notice of Nonconformance
References:1) NRC Notice of Nonconformance, dated January 29, 2014, Docket No.
99900271, Report No. 2013-2012) NRC Inspection Report No. 99900271/2013-201
Rosemount Nuclear Instruments, Inc. ("RNII") hereby responds to the aforementionedNotice of Nonconformance (Reference 1), from the Nuclear Regulatory Commission("NRC") dated January 29, 2014. The nonconformance was identified during the NRCinspection (Reference 2) of RNII's Chanhassen, Minnesota facility conducted November18 through 22, 2013 by inspectors George Lipscomb, Jose Jimenez, Carl Jones, andLaura Micewski.
Attached, please find RN II's reply to Reference 1.
Please contact me at (952) 949-5340 if you have any questions or need to discuss thismatter further.
Sincerely,
Marc D.WB{mgarnerVice President & General ManagerRosemount Nuclear Instruments, Inc.
Attachment
Cc: Richard Rasmussen, Chief, Electrical Vendor Branch, Division of ConstructionInspection and Operational Programs, Office of New Reactors, United StatesRegulatory Commission, Washington, DC 20555-0001
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Attachment 1Reply to NRC Notice of Nonconformance
Docket No. 99900271 I Inspection Report No. 2013-201
Attachment 1 sets forth the reply of Rosemount Nuclear Instruments, Inc. ("RNII") to theNRC's Notice of Nonconformance dated January 29, 2014, relative to NRC InspectionReport 99900271/2013-201 (the "Inspection Report").
The Notice of NonconformanceThe Notice of Nonconformance provides the following description of Nonconformance99900271/2013-201-01:
"A. Criterion V, 'Instructions, Procedures, and Drawings,' of Appendix B, 'QualityAssurance Program Criteria for Nuclear Power Plants and Fuel ReprocessingPlants,' to Title 10 of the Code of Federal Regulations (10 CFR) Part 50,'Domestic Licensing of Production and Utilization Facilities,' states, in part, that'Instructions, procedures, or drawings shall include appropriate quantitative orqualitative acceptance criteria for determining that important activities have beensatisfactorily accomplished.'
Contrary to the above, as of November 22, 2013 RNII did not prescribeappropriate quantitative or qualitative acceptance criteria for determining thatimportant activities have been satisfactorily accomplished. Specifically, RNIIprocedure Operations Procedure 0720, 'Control of Purchased Safety-RelatedComponents,' and the following technical evaluations failed to includerequirements or acceptance criteria sufficient to verify critical characteristics thatwere necessary to assure that dedicated items will perform their intended safetyfunctions:
(1) TE-Common-01-01, 'Technical Evaluation of 3150 and 1150 Series MountingFasteners,' did not establish requirements or acceptance criteria to verify criticalcharacteristics of material elongation, yield strength, or tensile strength formounting bolts for safety-related 3150 and 1150 Series pressure transmitters;
(2) TE-315x-03-01, 'Technical Evaluation of 3150 Series Pressure RetainingFlanges,' did not establish requirements to verify identified critical characteristicsof tensile strength or yield strength for pressure retaining flanges on safety-related 3150 series pressure transmitters, and did not identify criteria todetermine acceptability of casting quality, hardness, or material for these flanges.
This issue has been identified as Nonconformance 99900271/2013-201-01."
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RNII's Reply
RNII Operating Procedure 0720, "Control of Purchased Safety-Related Components",describes how RNII complies with the commercial grade dedication process required by10 CFR Part 21. Part of that process involves identifying the critical characteristics ofdedicated items to ensure that the item will perform its intended safety function. As partof that process, RNII performs "technical evaluations" of those items. Performance ofthese evaluations is guided by Technical Evaluation Template DES-0720-F1 andOperating Procedure 0720. Both OP 0720 and the Technical Evaluation Template havebeen revised over time. At the time of NRC's inspection documented in NRC InspectionReport No. 99900271/2013-201, OP 0720 included definitions of "Critical Characteristicfor Design" and "Critical Characteristic for Acceptance." The former definitionreferenced the item's "intended safety function", but the latter definition did not.
I. Reason for the Noncompliance
Root Cause Investigation: The definitions of Critical Characteristic for Acceptance andCritical Characteristic for Design in Operating Procedure OP 0720, "Control ofPurchased Safety-Related Components", Rev AL (datedl/16/13), were inappropriateand did not align with the Technical Evaluation Template DES-0720-01, Rev AA(datedl/16/13). As a result, when using the procedure and template for guidance, usersdid not include the appropriate quantitative or qualitative acceptance criteria fordetermining that important activities have been satisfactorily accomplished.
In previous revisions of Operating Procedure OP 0720, Rev AA to AK (dated6/23/03 to 5/8/12 - based on 10 CFR Part 21), only Critical Characteristic wasdefined.
From RNII OP 0720, Rev AA to AK
"Critical CharacteristicCritical characteristics are those important design, material, andperformance characteristics of a commercial grade item that, once verified,will provide reasonable assurance that the item will perform its intendedsafety function."
Rev AL of Operating Procedure OP 0720 deleted the definition for Critical Characteristicand substituted the definitions for Critical Characteristic for Design and CriticalCharacteristic for Acceptance. These new definitions were carried over into Rev AM(dated 9/23/13).
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From RNII OP 0720, Rev AL & AM
"Critical Characteristic for DesignThose properties or attributes which are essential for the item's form, fit andfunctional performance and are necessary to provide reasonable assurancethat the item will perform its intended safety function.
Critical Characteristic for AcceptanceThose important design, material, and performance characteristics of acommercial grade item that, once verified, will provide reasonable assurancethat the item received is the item specified."
These two definitions were based on the definitions in EPRI-NCIG-1 1 combined with thedefinition in 10 CFR Part 21. However, in combining the 10 CFR Part 21 and the EPRINCIG-1 1 definitions, RNII erroneously failed to change "safety function" to "designfunction" in the definition of Critical Characteristic for Design in Rev AL of the procedure.
From EPRI's Guidelines for the Technical Evaluation ofReplacement Items in Nuclear Power Plants (NCIG-1 1):
"2.1.8 Critical Characteristics for Design - Thoseproperties or attributes which are essential forthe item's form, fit and functional performance.Critical characteristics for design are theidentifiable and/or measureable attributes of areplacement item which provide assurance thatthe replacement item will perform it designfunction (See discussion contained in Sections3.4 and 3.6).
2.1.9 Critical Characteristic for Acceptance -Identifiable and measurable attributes/variablesof a commercial grade item, which onceselected to be verified, provide reasonableassurance that the item received is the itemspecified (EPRI NP-5652)."
This definition error was carried over into the Critical Characteristics for Design andCritical Characteristics for Acceptance when using the Technical Evaluation TemplateDES-0720-01, Rev AA, to create technical evaluations.
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When using the template to create a technical evaluation, the RNII engineers identifiedCritical Characteristics for Design that were characteristics related to design function,contrary to the definition in OP 0720. The RNII engineers also identified CriticalCharacteristics for Acceptance that were characteristics related to acceptance andsafety function, contrary to the definition in OP 0720.
Since the inappropriate definitions in OP 0720 were used in creating the technicalevaluations based Upon the template, the appropriate quantitative and qualitativeacceptance criteria were not documented and therefore could not be satisfactorilyaccomplished. See Table 1: Misapplication Summary.
Table 1: Misapplication SummarvDescriptionDefinitions
CriticalCharacteristic
Critical Characteristicfor rghairan
Critical Characteristic
OP 0720"Control ofPurchasedSafety-RelatedComponents",Rev AA to AK
OP 0720"Control ofPurchasedSafety-RelatedComponents",Rev AL & AM
"Critical characteristics arethose important design,material, and performancecharacteristics of acommercial grade item that,once verified, will providereasonable assurance thatthe item will perform its
I.. i nose properties or attributeswhich are essential for the item'sform, fit and functionalperformance and are necessaryto provide reasonable assurancethat the item will perform itsintended safety function."
--rHose important design,material, and performancecharacteristics of a commercialgrade item that, once verified,will provide reasonableassurance that the itemreceived is the item specified."
Misapplication: RNII engineersidentified CriticalCharacteristics for Design thatwere characteristics related todesign function, contrary tothe definition in OP 0720.
Misapplication: RNII engineersidentified CriticalCharacteristics for Acceptancethat were characteristicsrelated to acceptance andsafety function, contrary tothe definition in OP 0720.
TechnicalEvaluationTemplate DES-0720-01, RevAA Acceptance Criteria were not
included for CriticalCharacteristics for Design.
Acceptance Criteria wereincluded for CriticalCharacteristics forAcceptance.
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Extent of Condition Review: After reviewing technical evaluations created since therelease of Technical Evaluation Template DES-0720-01, Rev AA, RNII determined thatthe characteristics and acceptance methods to assure that a dedicated item will performits intended safety functions were included in the Critical Characteristics for Acceptance.
By reviewing the applicable RNII engineering drawings, BOMs (bill of materials),collection plans (based upon receipt inspection procedures) and CGI (commercial gradeitem) survey results, the acceptance criteria and requirements can be determined.
For items dedicated based upon Technical Evaluation Template DES-0720-01, Rev AA,the Critical Characteristics (as now defined in RNII OP 0720, Rev AN (dated 1/8/2014))have been verified to provide reasonable assurance that the items will perform theirintended safety function.
II. Corrective Steps Taken and Results Achieved
To include appropriate quantitative or qualitative acceptance criteria for determining thatimportant activities have been satisfactorily accomplished, the definition of CriticalCharacteristic in RNII OP 0720, "Control of Purchased Safety-Related Components",and Technical Evaluation Template DES-0720-Fl have been aligned.
Only the definition for Critical Characteristic per 10 CFR Part 21 will be used. CriticalCharacteristics for Design and Critical Characteristic for Acceptance definitions havebeen removed. As a result, only characteristics related to the item's intended safetyfunction(s) will be listed on the technical evaluation.
The Acceptance Method used to dedicate an item is unchanged. Acceptance Criteriaare now clearly included on the technical evaluation and are not inferred from the RNIIengineering drawings, BOMs, collection plans, and CGI survey results. See Table 2:Update Summary.
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Table 2: UDdate SummaryDescription IDefinitions
OP 0720"Control ofPurchasedSafety-RelatedComponents",Rev AN
CriticalCharacteristic
Critical Characteristicfor Desian
Critical Characteristic forAcceDtance
"Critical characteristics arethose important design,material, and performancecharacteristics of acommercial grade item that,once verified, will providereasonable assurance thatthe item will perform itsintended safety function."
TechnicalEvaluationTemplateDES-0720-01, Rev AB
Application: When the RNIIengineers use the templateto create a technicalevaluation, characteristicsrelated to the item'sintended safety function(s)will be listed in thetechnical evaluation.
Acceptance Criteria arenow clearly included on thetechnical evaluation.
In response to Notice of Nonconformance 99900271/2013-201-01, RNII issued aninternal Corrective Action Preventive Action (CAPA) CAPA001525. Pursuant to theCAPA, RNII took the following steps:
1) Revised RNII OP 0720, "Control of Purchased Safety-Related Components", toremove the definitions of "Critical Characteristic for Design" and "CriticalCharacteristic for Acceptance". These two definitions were replaced by the definitionfor "Critical Characteristic" based upon 10 CFR Part 21.
From RNII OP 0720, Rev AN (dated 1/8/2014)
"Critical CharacteristicThose important design, material, and performance characteristicsthat, once verified, will provide reasonable assurance that the itemwill perform its intended safety function (As defined by IOCFR2 1)."
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The specific updates to the operating procedure are noted in Appendix A: Excerptfrom RNII OP 0720, "Control of Purchased Safety-Related Components", Rev AMand Appendix B: Excerpt from RNII OP 0720, "Control of Purchased Safety-RelatedComponents", Rev AN.
2) Revised Technical Evaluation Template DES-0720-F1 to Rev AB (dated 1/8/2014) toalign Critical Characteristics with the updated definition in RNII OP 0720 Rev ANand add a column to specifically include Acceptance Criteria within the template.
The specific updates to the template are noted in Appendix C: Excerpt from DES-0720-Fl, Rev AA, and Appendix D: Excerpt from DES-0720-F1, Rev AB.
3) Revised TE-Common-01-01 Technical Evaluation of 3150 and 1150 SeriesMounting Fasteners and TE-315X-03-01 Technical Evaluation of 3150 SeriesPressure Retaining Flanges to remove "Critical Characteristics for Design" and"Critical Characteristics for Acceptance" and replace with "Critical Characteristics"which aligns with the definition in OP 0720, Rev AN. A column titled "AcceptanceCriteria" was also added.
With these updates, the requirements and acceptance criteria to verify CriticalCharacteristics (as now defined in RNII OP 0720, Rev AN) to assure that thededicated items will perform their intended safety functions have been clearlydefined. Design Characteristics not related to safety function have been removedincluding those listed in the description of the Notice of Nonconformance.
Ill. Corrective Steps That Will be Taken
Review all of the technical evaluations that were created using Technical EvaluationTemplate DES-0720-F1, Rev AA, and update them to follow the format in Rev AB.
IV. Date Full Compliance Achieved
By the end of calendar year 2014, RNII plans to complete the review and update of alltechnical evaluations.
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Appendix A: Excerpt from RNII OP 0720, "Control of Purchased Safety-RelatedComponents", Rev AM
OP 0720, Rev AMSeptember 23, 2013
Critical Characteristic for AcceptanceThose important design, material, and performance characteristics of a commercial grade item that onceverified, will provide reasonable assurance that the Rem received is the Rem specified.
Critical Characteristic for DesignThose properties or attributes which are essential for the item's form, fit and functional performance and arenecessary to provide reasonable assurance that the item will perform its intended safety function.
DedicationDedication is an acceptance process undertaken to provide reasonable assurance that a commercialgrade item to be used as a basic component will perform its intended safety function and, in this respectis deemed equivalent to an Rem designed and manufactured under a I OCFR50, Appendix B, qualityassurance program. This assurance is achieved by identifying the critical characteristics of the Rem andverifying their acceptability by inspections, test or analyses performed by the purchaser or a third partydedicating entity after delivery, supplemented, as necessary, by one or more of the following: commercialgrade surveys, product inspections or witness at hold points at the manufacturer's facility, and analysis ofhistorical records for acceptable performance. In all cases, the dedication process must be conducted inaccordance with applicable provisions of 10CFR50, Appendix B. The process is considered completewhen the item is designated for use as a basic component.
FileNetElectronic documentation storage system.
Inter-Company Purchase AgreementThe equivalent of a purchase order, used to obtain items or services from other Emerson ProcessManagement divisions.
Non Safety-Related ItemAn Item which does not perform a safety-related function.
Product Change Notification (PCN)A notification from a manufacturer which details some type of change that affects the applicablecomponent/product.
Procurement DocumentContractually binding documents that identify and define the requirements which items or services mustmeet in order to be considered acceptable by the purchaser.
Reasonable AssuranceA justifiable level of confidence based on objective and measurable facts, actions, or observations, whichinfer adequacy.
Safety-Related ComponentA plant structure, system, component or part thereof, necessary to assure:a) The integrity of the reactor coolant pressure boundary;b) The capability to shutdown the reactor and maintain din a safe shutdown condition; orc) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite
radiation exposures.
Safety-Related ServiceA service which verifies the safety function or critical characteristics of a safety-related component.
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Appendix B: Excerpt from RNII OP 0720, "Control of Purchased Safety-RelatedComponents", Rev AN
OP 0720, Rev ANJanuary 08, 2014
Critical CharacteristicThose important design, material, and performance characteristics that once verified, will provide reasonableassurance that the item will perform its intended safety function (As defined by 10CFR21).
DedicationDedication is an acceptance process undertaken to provide reasonable assurance that a commercialgrade item to be used as a basic component will perform its intended safety function and, in this respect,is deemed equivalent to an item designed and manufactured under a 1OCFR50, Appendix B, qualityassurance program. This assurance is achieved by identifying the critical characteristics of the item andverifying their acceptability by inspections, test or analyses performed by the purchaser or a third partydedicating entity after delivery, supplemented, as necessary, by one or more of the following: commercialgrade surveys, product inspections or witness at hold points at the manufacturer's facility, and analysis ofhistorical records for acceptable performance. In all cases, the dedication process must be conducted inaccordance with applicable provisions of 1OCFR50, Appendix B. The process is considered completewhen the item is designated for use as a basic component.
FileNetElectronic documentation storage system.
Inter-Company Purchase AgreementThe equivalent of a purchase order, used to obtain items or services from other Emerson ProcessManagement divisions.
Non Safety-Related ItemAn Item which does not perform a safety-related function.
Product Change Notification (PCN)A notification from a manufacturer which details some type of change that affects the applicablecomponentlproduct.
Procurement DocumentContractually binding documents that identify and define the requirements which items or services mustmeet in order to be considered acceptable by the purchaser.
Reasonable AssuranceA justifiable level of confidence based on objective and measurable facts, actions, or observations, whichinfer adequacy.
Safety-Related ComponentA plant structure, system, component or part thereof, necessary to assure:a) The integrity of the reactor coolant pressure boundary;b) The capability to shut down the reactor and maintain it in a safe shutdown condition; orc) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite
radiation exposures.
Safety-Related ServiceA service which verifies the safety function or critical characteristics of a safety-related component.
Standard Receipt InspectionActivities conducted, upon receipt of items (including commercial grade items), to check such elements asthe quantity received, part number, general condition of items and damage.
Technical Evaluation (TE) Form (DES-0720-FI)
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Appendix C: Excerpt from DES-0720-F1, Rev AA
EMERSON.Process Management
TECHNICAL EVALUATION
V. Critical Characteristics for DesionCritical characteristics for design include:
VI. Critical Characteristics for Acceptance and Acceptance Methods
The following items have been identified as critical characteristics for acceptance. Verification of these characteristicsprovides reasonable assurance that the item received is the item specified. Additional Infomiation regarding acceptancecriteria can be found on drawings, BOMs, collection plans (receipt inspection procedures) and CGI survey results.
cc Critical Characteristics f Acceptance Method Sampling Plan Record Applicability
1
23456789
10
BASIS FOR SELECTION (Justification that the selected CC s when verified will provide reasonable assurance that theitem %61l perform its intended safety function)
VII. Revision History
Internal note: all changes to this document require justification. Include references to Design Study, TCA, ECO, etc, asappropriate, for detailed results from supporting tests or analyses.
Re Dte Chne ecipinJustification forlChanges to the TechnicalRv (mniddd/wChne esrpto Evaluation
AA
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DES-0720-F1 Technical Evaluation Template, Rev AA (1116/2013)
Emerson Confidential
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Appendix D: Excerpt from DES-0720-F1, Rev AB
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TECHNICAL EVALUATION
V. Critical CharacteristicsThe following items have been identified as critical characteristics. Verification of these characteristics providesreasonable assurance that the item will perform its intended safety function.
cc Critical Characteristic Acceptance AcceptanceCriteria Method Sampling Plan Record Applicability
234
1 5 1
BASIS FOR SELECTION (Justification that the critical characteristic when verified will provide reasonable assurance thatthe item will perform its intended safety function)
AI Revision History
Internal note: all changes to this document require justification. Include references to Design Study, TCA, ECO, etc, asappropriate, for detailed results from supportng tests or analyses.
Rev Date Change Description Justification for Changes to the Technical(mm/dd/y"yy Evaluation
AA
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DES-0720-Fl Technical Evaluation Template, Rev AB (01/08/2014)
Emerson Confidential
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