office of river protection - hanford site

15-QAD-0038

OFFICE OF RIVER PROTECTION P.O. Box 450, MSIN H6-60

Richland, Washington 99352

AUG O 6 2015

Mrs. Margaret McCullough, Project Director Bechtel National, Inc. 2435 Stevens Center Place Richland, Washington 99354

Mrs. McCullough:

1230688 [u l > </l 1f/ (ajij

CONTRACT NO. DE-AC27-01RV14136-AUDIT REPORT U-14-QAD-RPPWTP-003 -U.S. DEPARTMENT OF ENERGY, OFFICE OF RIVER PROTECTION AUDIT OF BECHTEL NATIONAL, INC. COMMERCIAL GRADE DEDICATION PROGRAM

This letter transmits the results of the U.S. Department of Energy, Office of River Protection (ORP) audit of Bechtel National, Inc.'s (BNI) Commercial Grade Dedication (CGD) program. The audit team evaluated a portion ofBNI's CGD program for adequacy, implementation, and effectiveness. The audit identified issues with the reviewed CGD packages from the 2010 through 2014 time frame, resulting in concern over reasonable assurance that these items would successfully perform their intended safety functions.

The attached audit report contains a Priority Level 2 finding covering the spectrum of CGD related activities, one opportunity for improvement, and one audit follow-up item. Although the audit team concluded that BNI's current CGD program was generally compliant with NQA-1 requirements, additional improvements are warranted to ensure effective and consistent implementation. The audit team identified instances where CGD was not performed in accordance with BNI procedures and the quality records supporting the dedication were not compliant with BNI Quality Assurance Manual requirements. Discussions have identified that there are differing interpretations between our organizations related to acceptable CGD processes and contractual clarification will follow in separate correspondence.

ORP recognizes that BNI issued a Level A Condition Report during the course of the audit. As requested, BNI may elect to take credit for the causal analysis performed to address the Level A Condition Report and corrective actions identified as a result of the root cause analysis, but must ensure that the causal analysis and resultant actions are of sufficient rigor to address all the aspects of the attached audit report.

Please brief the ORP Manager within 15 days on BNI's investigative actions, the compensatory measures being implemented, the updated Level A Condition Report, and the justification for continuing CGD procurement activities. Within 60 days of the date of this letter, BNI shall respond to the audit finding and provide a corrective action plan for our approval that includes:

• Immediate and remedial actions to correct the specific deficiencies identified • The extent of condition

OFFICE OF RIVER PROTECTIONP.O. Box 450, MSIN H6-60

Richland, Washington 99352

AUG O 6 2015

15-QAD-0038

Mrs. Margaret McCullough, Project DirectorBechtel National, Inc.2435 Stevens Center PlaceRichland, Washington 99354

Mrs. McCullough:

CONTRACT NO. DE-AC27-01RV14136 - AUDIT REPORT U-14-QAD-RPPWTP-003 -U.S. DEPARTMENT OF ENERGY, OFFICE OF RIVER PROTECTION AUDIT OFBECHTEL NATIONAL, INC. COMMERCIAL GRADE DEDICATION PROGRAM

This letter transmits the results of the U.S. Department of Energy, Office of River Protection(ORP) audit of Bechtel National, Inc.'s (BNI) Commercial Grade Dedication (CGD) program.The audit team evaluated a portion of BNI's CGD program for adequacy, implementation, andeffectiveness. The audit identified issues with the reviewed CGD packages from the 2010through 2014 time frame, resulting in concern over reasonable assurance that these items wouldsuccessfully perform their intended safety functions.

The attached audit report contains a Priority Level 2 finding covering the spectrum of CGDrelated activities, one opportunity for improvement, and one audit follow-up item. Although theaudit team concluded that BNI's current CGD program was generally compliant with NQA-1requirements, additional improvements are warranted to ensure effective and consistentimplementation. The audit team identified instances where CGD was not performed inaccordance with BNI procedures and the quality records supporting the dedication were notcompliant with BNI Quality Assurance Manual requirements. Discussions have identified thatthere are differing interpretations between our organizations related to acceptable CGD processesand contractual clarification will follow in separate correspondence.

ORP recognizes that BNI issued a Level A Condition Report during the course of the audit. Asrequested, BNI may elect to take credit for the causal analysis performed to address the Level ACondition Report and corrective actions identified as a result of the root cause analysis, but mustensure that the causal analysis and resultant actions are of sufficient rigor to address all theaspects of the attached audit report.

Please brief the ORP Manager within 15 days on BNI's investigative actions, the compensatorymeasures being implemented, the updated Level A Condition Report, and the justification forcontinuing CGD procurement activities. Within 60 days of the date of this letter, BNI shallrespond to the audit finding and provide a corrective action plan for our approval that includes:

* Immediate and remedial actions to correct the specific deficiencies identified* The extent of condition

Mrs. Margaret McCullough 15-QAD-0038

-2- AUG O 6 2015

• The root cause analysis report identifying the root cause(s) • Corrective actions to correct the cause(s), preventing recurrence • Compensatory actions to be instituted until final corrective actions are implemented • Actions to correct previous deficiencies identified by the extent of condition analysis • The date when all corrective actions will be completed, verified, and compliance to

applicable requirements is achieved.

"The action taken herein is considered to be within the scope of work of the existing contract and does not authorize the Contractor to incur any additional costs (either direct or indirect) or delay delivery to the Government. If the Contractor considers that carrying out this action will increase contract/project costs or delay of delivery, the Contractor shall promptly notify the Contracting Officer orally, confirming and explaining the notification in writing within ten (10) calendar days, and otherwise comply with the requirements of the Contract clause entitled 52.243-7, -- "Notification of Changes." Following submission of the written notice of impacts, the Contractor shall await further direction from the Contracting Officer."

If you have any questions, please contact me, or your staff may contact Jeffrey D. May, Director, Quality Assurance Division, (509) 373-7884, or [email protected].

Ronnie L. Dawson Contracting Officer

QAD:SAV

Attachment

cc w/attach: M. W. Costas, BNI S.L. Daw, BNI S.C. Foelber, BNI M.L. Johnson, BNI D.E. Kammenzind, BNI W.L. Smoot, Northwind Administrative Record BNI Correspondence

Kevin W. Smith, Manager Office of River Protection

Attachment15-QAD-0038

(75 Pages)

U.S. Department of Energy, Office of River Protection Audit of BechtelNational, Inc. Commercial Grade Dedication Program

Audit Report U-14-QAD-RPPWTP-003


Quality AssuranceAudit Report

U-14-QAD-RPPWTP-003

Organization: Quality Assurance Division

Surveillance/QAIS Team: Samuel A. Vega, Audit Team LeaderWalter B. Scott, AuditorWilliam L. Smoot AuditorIvan A. Bolanos, Engineer Subject MatterExpertBill R. Clamo, Auditor in TrainingTimothy W. Masters, Auditor in Training

IAS-ID: 15269

Date Completed: March 12, 2015

Contractor: Bechtel National, Inc. Project Office

Facility: Waste Treatment and Immobilization Plant,Richland, Washington

Title of Independent Surveillance: U.S. Department of Energy, Office of RiverProtection Audit of Bechtel National, Inc.Commercial Grade Dedication Program

Audit Purpose:

The purpose of this audit was to evaluate the adequacy, implementation, and effectiveness of theBechtel National, Inc. (BNI) Commercial Grade Dedication (CGD) Program as implemented by24590-WTP-QAM-QA-06-001, Quality Assurance Manual, which incorporates a tailoredversion of the NQA- 1-2004, Quality Assurance Requirements for Nuclear Facility Applicationsrequirements for CGD. This audit was also conducted to verify that BNI had incorporated therecommendations provided by the Sequoia Consulting Group, Inc. review conducted in 2014,and to review CGD procurement activities not addressed during the 2013 U.S. Department ofEnergy, Office of River Protection BNI Quality Assurance Program audit.

Audit Scope:

This audit reviewed the implementation of BNI's CGD Program including BNI-performedtechnical evaluations, selection of critical characteristics for acceptance, performance of

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acceptance methods, documentation of acceptance method evaluation, and testing results. Theaudit also evaluated BNI's oversight of supplier and subtier vendor CGD activities, BNIself-assessment activities, and the management of corrective actions implemented as a result ofpast U.S. Department of Energy oversight, enforcement activities, and BNI self-assessments.The audit reviewed CGD activity from 2010 to March 2015 and reviewed simple and complexCGD packages.

Approved: , Date:Audit Team Leader

Approved: Date: 6'0 22"I'Assuranc~ vision Director

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EXECUTIVE SUMMARY

The U.S. Department of Energy, Office of River Protection (ORP) conducted an audit of theBechtel National, Inc. (BNI) processes for performing commercial grade dedication (CGD) fromDecember 1, 2014, through March 12, 2015.

In accordance with contract DE-AC27-01RV14136, in Section C, Standard 7, Paragraph (e)(3),BNI developed and submitted for ORP approval 24590-WTP-QAM-QA-06-001, QualityAssurance Manual (QAM). The requirements in the QAM are contractually specified byDOE 0 414.1C, Quality Assurance, and ASME NQA-1-2000, Quality Assurance Requirementsfor Nuclear Facility Applications. Additionally, 10 CFR 830, "Nuclear Safety Management,"Subpart A, "Quality Assurance Requirements," requires BNI to develop a quality assurance(QA) program for ORP approval. BNI is required to implement the QAM and to conduct workin accordance with "procedures, instructions, plans, and manuals used to implement theContractor's QA program..."'. For CGD, BNI applies a tailored implementation strategydefined in the Preliminary Documented Safety Analysis (24590-WTP-PSAR-ESH-01-002-01,Preliminary Documented Safety Analysis to Support Construction Authorization- GeneralInformation, Chapter 14, Table 14-1), which requires the use of NQA-1-2004, Requirement 7,Section 700. In addition, Waste Treatment and Immobilization Plant waste affecting activitiesare required to be compliant with the Office of Civilian Radioactive Waste ManagementDOE/RW-0333P, Quality Assurance Requirements and Description, Rev. 20. The scope of theaudit addressed the DOE/RW-0333P requirements related to CGD.

The audit team evaluated the adequacy, implementation, and effectiveness of the BNI CGDProgram in addressing the above contract and QA program requirements. The audit team'sreview included:

* The BNI contractual commitment to have a QA program that:

- Addresses all applicable CGD procurement requirements and to implement thoserequirements through approved procedures that "specifies or describes how anactivity is to be performed"

- Implements a corrective action management program to resolve and correctdeficiencies and implement corrective actions to prevent recurrence

* The contractual QA program requirements for performing the following QAM-requiredCGD activities:

- Performance of technical evaluations

- Selection of critical characteristics for acceptance

- Acceptance methods

- Acceptance criteria

- Performance of acceptance activities

1 WTP Contract No. DE-AC27-01RV14136, Section C, Standard 7, paragraph (e)(3).

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The contractual requirement to oversee CGD performance of suppliers and acceptance ofsupplier-dedicated items and services.

Because CGD is performed both by BNI and its NQA-1 qualified suppliers, the audit reviewedCGD packages performed by both BNI and its suppliers. The audit team reviewed 27 CGDpackages developed between early 2010 through January 2015. This included samples of CGDactivities using current procedures (issued in July 2014) and samples of CGD activitiesperformed before current procedures were issued. The packages reviewed included a mixture ofsimple individual items or components and complex items, such as assemblies comprised ofmultiple components.

The audit resulted in the identification of deficiencies in many of the CGD packages reviewed.These packages contained deficiencies in each of the contractually required activities listedabove. This resulted in the determination that CGD activities performed between 2010 andJuly 2014 were suspect, and based on the sample, not consistently performed, did not complywith procedural requirements in all cases, and, in many cases, did not establish "reasonableassurance that the item or service would perform its safety function."

The audit identified one Priority Level 2 finding, one opportunity for improvement, and oneaudit follow-up item. The conclusions drawn, based on the sample of 27 CGD packagesreviewed, were:

* Performance of BNI CGD activities were not always in accordance with procedures.

* Some of BNI-performed and supplier-performed CGD activities did not fullydemonstrate, with reasonable assurance, that an item or service procured through theCGD process would perform its intended safety function.

* Previous BNI oversight activities of its suppliers did not identify the issues noted duringthis audit.

* Subsequent BNI reviews that were initiated as a result of this audit also found issues thatshould have been identified by past BNI oversight activities.

* Quality of the CGD procurements performed between early 2010 and July 30, 2014, aresuspect and the CGD products have a high potential of not being fully acceptable for usein safety or quality affecting applications until the finding and topical issues identified inthis audit are addressed and appropriate corrective actions are implemented.

* Some past corrective actions to improve and sustain the quality and performance of CGDactivities have not all been effectively maintained.

* Current procedures lack implementation processes for some key BNI CGD workactivities.

* The BNI CGD procurement process does not provide adequate direction to assureprocurements of items with incomplete design activities are controlled, tracked, and whenthe designs are completed, the CGD packages are reviewed to assure any neededreconciliation of impacts to the CGD plan with the completed design occurs.

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* CGD related records do not meet QAM requirements for retrievability and tractability tothe CGD activities.

During the course of the audit, these issues, as they were identified, were presented to anddiscussed with BNI procurement engineering. As a result, BNI began to investigate the auditteam's issues and found sufficient evidence to warrant the issuance of a BNI Level A conditionreport, 24590-WTP-GCA-MGT-15-00338-A, Commercial Grade Dedication (CGD) of ComplexEquipment. As required by BNI procedures, a root cause analysis team was chartered. Earlyextent of condition reviews by the root cause team identified additional examples of"inadequate" technical evaluations in other BNI and supplier performed CGD packages.Additionally, subsequent BNI reviews of CGD packages have resulted in additional deficienciesthat have been documented in condition reports (see Appendix A, Section A.8 for additionaldetails).

These BNI efforts increase the number of identified deficient CGD packages and furtherreinforce the audit conclusions.

As a result of the sample of CGD packages reviewed, ORP issued a Priority Level 2 finding:

* U-14-QAD-RPPWTP-003-FO1 (Priority Level 2): The BNI CGD Program elementsexamined were not consistently implemented, and was not fully effective in establishingreasonable assurance that BNI- and vendor-procured items met the required safetyfunction(s); including, but not limited to, deficiencies in: 1) technical evaluations;2) vendor CGD performance; 3) completion of CGD activities; 4) CGD procedures; and5) performance of CGD surveys.

For the current state of the program, the audit team concluded that BNI's CGD Program, ascurrently established, was generally compliant with NQA- 1 requirements but lacked sufficientprocess detail of some key CGD activities to ensure effective and consistent implementation andsustainment of CGD performance. At the time of the audit, BNI was still developingimplementation guides to augment the CGD procedures. Further, at the time of the audit, onlytwo CGD procurements using the revised procedures were completed for review by the auditteam. The audit team identified a number of problems in these two new CGD procurementswhere CGD was not performed in accordance with the new BNI procedures indicating BNIperformance still requires improvement. However, the review population of just two examples isinsufficient to form a conclusion on the effectiveness of the current CGD program. As a result,the new CGD processes requires further review and oversight by ORP once the remainder of theguides have been developed and additional procurements are available for review. The auditteam identified an audit follow-up item to conduct this review at a future time:

* U-14-QAD-RPPWTP-003-AO1: Subsequent to the commencement of the ORP audit ofCGD, BNI issued Rev. 1 to the 24590-WTP-3PS-GOOO-TOO19, Engineering Specificationfor Acquisition of Commercial Items and Services for the Use in Safety Applications atWTP, January 21, 2015, for flowdown of BNI requirements for vendor performance ofCGD and plans to issue two new desk instructions for performance of CGD activities.ORP was not able to review drafts of the documents being issued until after thecompletion of field work. This audit follow-up item is for the ORP Quality Assurance

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Division to perform a review of the revised procedure, the engineering guides, andprocurements implen enting these procedures and guides.

Conclusion:

The deficiencies noted by ORP from reviewing 27 CGD packages resulted in the conclusion thatCGD activities performed by BNI and its NQA-1 suppliers have not always fully implementedprocedure processes, implementation and documentation of CGD activities had not beenconsistent, and CGD results have not always been effective in establishing "reasonable assurancethat the item or service would perform its safety function." As such CGD activities performedby both BNI and its suppliers between early 2010 and July 2014 are suspect and the CGDproducts may not be fully acceptable for use in safety or quality affecting applications.

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TABLE OF CONTENTS

EXECUTIVE SUMMARY................................................3

LIST OF ENCLOSURES.................................................7

LIST OF APPENDICES..................................................7

ABBREVIATIONS AND ACRONYMS.......................................8

1.0 DETAILS.......................................................9

2.0 FINDING......................................................10

3.0 OPPORTUNITIES FOR IMPROVEMENT...................................11

4.0 AUDIT FOLLOW-UP ITEM..........................................12

LIST OF ENCLOSURES

ENCLOSUREI PERSONS CONTACTED DURING AUDIT....................13

LIST OF APPENDICES

ENCLOSURE 1 PERSONS CONTACTED DURING AUDIT........................13

ENCLOSURE 2 DOCUMENTS REVIEWED DURING THE AUDIT..................14

APPENDIX A REQUIREMENTS BASIS......................................20

APPENDIX B DISCUSSION OF PROCESS ACTIVITIES ......................... 30

APPENDIX C DETAILED LIST OF IDENTIFIED DEFICIENCIES PER COMMERCIALGRADE DEDICATION PACKAGE ................................... 44

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ABBREVIATIONS AND ACRONYMS

ADS ammonia dilution systemASTM ASTM InternationalB&PVC Boiler and Pressure Vessel CodeBNI Bechtel National, Inc.CCFA critical characteristics for acceptanceCFM credible failure mechanismCGD commercial grade dedicationCGI commercial grade itemDOE U.S. Department of EnergyEPDM Commercial term for ethylene propylene diene monomer rubberFAT factory acceptance testHEPA high-efficiency particulate airHLW high-level wasteHOP HLW Melter Off gas Treatment Process SystemID inside diameterLOI line-of-inquiryM&TE measuring and testing equipmentMAP material acceptance planMCS material control sheetMTR material test reportNAIC National Association of Insurance CommissionersORP Office of River ProtectionPIER project issues evaluation reportPMI positive material identificationPTI Premier Technology, Inc.QA quality assuranceQAM quality assurance manualTCO thermal catalytic oxidizerWTP Waste Treatment and Immobilization PlantXRI XRI, Inc.

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1.0 DETAILS

This audit evaluated the Bechtel National, Inc. (BNI) Commercial Grade Dedication (CGD)Program with respect to the contractual, 24590-WTP-QAM-QA-06-001, Quality AssuranceManual (QAM); Code ofFederal Regulations; and NQA-1-2004, Quality AssuranceRequirements for Nuclear Facility Applications requirements for the performance of CGD. Theaudit team selected a sample of CGD plans and packages performed between early 2010 and July2014 to evaluate the adequacy, implementation, and effectiveness of CGD activities performedprior to the recent revision of BNI's CGD procedures. The team also reviewed two CGDprocurements completed using the revised procedures after July 2014.

The Priority Level 2 finding is based on the detailed analysis performed by the team. The resultsare presented in the following appendices:

* Appendix A provides the contractual and quality assurance program requirement basisthat supports the audit finding.

* Appendix B summarizes the identified audit deficiencies by each topical area of CGDprocess activities where problems were noted.

* Appendix C presents the detailed results of the audit team's review of each individualCGD package.

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2.0 FINDING

U-14-QAD-RPPWTP-003-FO1 (Priority Level 2): The BNI CGD Program elements examinedwere not consistently implemented, and was not fully effective in establishing reasonableassurance that BNI- and vendor-procured items met the required safety function(s); including,but not limited to, deficiencies in: 1) technical evaluations; 2) vendor CGD performance;3) completion of CGD activities; 4) CGD procedures; and 5) performance of CGD surveys.

Requirements:

Requirements associated with this finding are presented in Appendix A.

Discussion:

Based on the objective evidence reviewed and contrary to the requirements, the implementationof the BNI CGD processes did not always meet U.S. Department of Energy contractrequirements and direction as specified in the QAM (24590-WTP-QAM-QA-06-001) andimplemented by BNI procedures for performance of CGD.

The audit team determined, based on its review of a sample of 27 CGD packages, review of BNIand vendor procedures, reviewing implementation of CGD activities; including BNI oversight ofits vendors, that CGD activities did not always produce consistent or acceptable results. As such,all CGD procurements performed by BNI and its vendors from early 2010 through July 2014 aresuspect in demonstrating the ability of dedicated items and services to perform their intendedsafety function(s). The deficiencies identified during the audit and documented in Appendices Athrough C are the basis for the Priority Level 2 finding. Failure to fully comply withrequirements in the implementation of CGD processes represents a major breakdown in BNI'sprocurement activities. If not corrected, the issues will have significant impact in the ability tosuccessfully complete the commissioning and startup activities required to safely operate theWaste Treatment and Immobilization Plant facilities.

The audit team identified several supporting examples where implementation of the previous andcurrent CGD requirements resulted in CGD plans and CGD records that did not demonstrate thatprocured items could perform their intended safety function. Specific examples of deficienciesfound in each CGD package reviewed are described in Appendix C. Examples of CGD processdeficiencies are listed below, with a detailed discussion provided in Appendix B:

* Technical evaluations in a sample of 27 CGDs performed by BNI and by BNI-approvedNQA- 1 vendors did not meet all requirements for establishing critical characteristics foracceptance and acceptance criteria to demonstrate reasonable assurance that the item orservice would perform required safety function(s).

* BNI reviews did not identify that the CGD programs, implementation, and performanceof three of four NQA- 1 vendors did not meet requirements and did not demonstratereasonable assurance that an item or service would perform required safety function(s).

* BNI's development and execution of material acceptance plans, as defined in24590-WTP-GPP-MGT-013, Acceptance ofProcured Material, to demonstrate

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completion of CGD activities was not always in accordance with BNI procedures, anddid not always demonstrate reasonable assurance that an item or service would performits required safety function(s).

* BNI procedures lack process direction for some key BNI CGD work activities to ensurethat prescribed results consistently met requirements.

* The BNI CGD procurement process does not provide adequate direction to assureprocurements of items with incomplete design activities are controlled, tracked, and whenthe designs are completed, the CGD packages are reviewed to assure any neededreconciliation of impacts to the CGD plan with the completed design occurs.

* Previous corrective actions to prevent recurrence of previous CGD deficiencies were notsuccessful in maintaining an effective CGD program as required by the Waste Treatmentand Immobilization Plant Contract (DE-AC27-01RV14136), the QAM (24590-WTP-QAM-QA-06-001), and BNI procedures.

* BNI's performance and documentation of commercial grade surveys (Method 2) did notfully meet BNI procedure and QAM requirements.

* BNI CGD procedure processes for assembling and maintaining the CGD records werenot sufficient to meet QAM requirements for retrieving records, and the requirements forassuring records are "traceable to associated items and activities..."

3.0 OPPORTUNITIES FOR IMPROVEMENT

U-14-QAD-RPPWTP-003-O01: The BNI CGD procedure (24590-WTP-3DP-GO6T-00904,Evaluation of Commercial Grade Items and Services, Rev. 0) does not include a formaldeclaration and signature by an appropriate level of engineering that the CGD process for anitem or service has been completed, and after reviewing the item or service will perform itsintended safety function and as such, has been deemed a basic component.

Discussion:

Review of the MAP 24590-MAP-AS-04-00037, Rev. 5 for head flow instruments noted that theprocurement engineer performed and documented the verification that all CGD activities havebeen completed and issued a memorandum (CCN: 275314, "CGD Release of ConcentricRestriction Orifice Plate on 24590-CM-POB-JFOO-00001 in accordance with 24590-WTP-MAP-AS-04-00037, Rev. 5, Step 17") attesting to the review. Based on the CGD procedure thisdocument releases the CGD item for use without a final review by engineering and qualityassurance management that the item or service has met all requirements and is in fact a basiccomponent.

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Nonmandatory guidance in NQA-1-2004 (Part III, Nonmandatory Appendix 7A-2, "Guidance onCommercial Grade Items and Services"), Section 800(j) amplifies the basic records requirementfor CGD documentation and states:

Documentation on the commercial grated item or service dedication processshould be traceable to the item, group of items, or services and should contain thefollowing types of documents, depending on the applicable dedication method:

(j) dedication report containing sufficient data to accept the item or service.

The CGD release expectation is not discussed in 24590-WTP-3DP-GO6T-00904. Review of therelease memorandum issued on December 17, 2014, for concentric restriction orifice plates statesin the subject line, "CGD Release of Concentric Restriction Orifice Plate," and states in thememorandum body that the specific component tag numbers meet the CGD requirements. Thememorandum was sent to the procurement engineering manager from the responsibleprocurement engineer. This process does not establish that the item or service is a basiccomponent, does not establish the expectation that items and services be controlled as a Q item,and does not release them for use.

4.0 AUDIT FOLLOW-UP ITEM

U-14-QAD-RPPWTP-003-AO1: Subsequent to the commencement of the U.S. Department ofEnergy, Office of River Protection (ORP) audit of CGD, BNI issued Rev. I to 24590-WTP-3PS-GOOO-TOO 19, Rev. 0, for flowdown of BNI requirements for vendor performance of CGD andplans to issue two new desk instructions for performance of CGD activities. ORP was not ableto review drafts of the documents being issued until after the completion of field work. Thisaudit follow-up item is for the ORP Quality Assurance Division to perform a review of therevised procedure, the engineering guides, and procurements implementing these procedures andguides.

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ENCLOSURE 1PERSONS CONTACTED DURING AUDIT

* Paul Bowen - Supervisor and Inspector, Receiving Inspection and Test* Michael Costas - Manager Quality and Functions* Spencer Daw - Acting Manager Procurement Engineering* John Fink - Procurement Engineer, Contract Support* Steve Foelber - Manager* Barbara Gillespie, Manager, Receiving Inspection and Test* Mike Hanson, Supervisor, Receiving Inspection and Test* Bernie IP - Procurement Engineer* Mark Johnson - Manager, Productivity Engineering* Bonnie McVicker - Level III Inspector, Receiving Inspection and Test* Duane Ripplinger - Lead, Supplier Quality* Mitchell Roberts - Procurement Engineer, Contract Support* Steve Short - Responsible Engineer, Emergency Turbine Generator* Dennis Weaver - Procurement Engineer, Contract Support* David Willford - Procurement Engineer.

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ENCLOSURE 2DOCUMENTS REVIEWED DURING THE AUDIT

Resource documents:

* 24590-WTP-GPP-MGT-0 13, "Acceptance of Procured Material," Rev. 19

* ASTM International A240/A240M - 15a, Standard Specification for Chromium andChromium-Nickel SS Plate, Sheet, and Strip for Pressure Vessels and for GeneralApplications

* ASME NQA-1-2000 and NQA-1-2004, Quality Assurance Requirements for NuclearFacility Applications

* Electrical Power Research Institute, Palo Alto, California 5652 and TR-102260,Guideline for the Acceptance of Commercial-Grade Items in Nuclear Safety-RelatedApplications, Rev. 0 and Rev. 1

* ASME B31.3-2008, Process Piping - ASME Code for Pressure Piping, B31, 2010Section VIII - Division 1, Section UNF-65

* ASME B575 - 14, Specificationfor Low-Carbon Nickel-Chromium-Molybdenum,Low-Carbon Nickel-Chromium-Molybdenum-Copper, Low-Carbon Nickel-Chromium-Molybdenum-Tantalum, Low-Carbon Nickel-Chromium-Molybdenum-Tungsten, andLow-Carbon Nickel-Molybdenum-Chromium Alloy Plate, Sheet, and Strip, Table 1,"Chemical Properties"

* 24590-WTP-PSAR-ESH-01 -002-01, Preliminary Documented Safety Analysis to SupportConstruction Authorization; General Information, Rev. 4v

* 07-WTP-196, "Contract No. DE-AC27-01RV14136 - Partial Approval of BechtelNational, Inc. (BNI) Authorization Basis Amendment Request (ABAR) 24590-WTP-SE-ENS-06-0166, Revision 0, Safety Requirements Document (SRD) Revision to allow theuse of NQA-1-2004 for Commercial Grade Dedication (CGD)," dated October 2, 2007

* 08-WTP-027, "Contract No. DE-AC27-01RV14136 - Approval of Bechtel National, Inc.(BNI) Authorization Basis Amendment Request (ABAR) 24590-WTP-SE-ENS-06-0179,Rev. 1, 'Incorporation of DOE 0 414.1.C and ASME NQA-1-2000 into the SRD andPSAR and Modification of Commercial Grade Dedication Process to include ElectricPower Research Institute (EPRI) Guidance."'

Corrective action management documents:

* NTS-RP-BNRP-RRPWTP-2001-0001, "Vendor/Supplier Qualification," datedNovember 7, 2001

* NTS-RP-BNRP-RRPWTP-2005-0005, "Failure of a WTP Supplier to Control aSub-Supplier," dated September 14, 2005

* NEA-2008-04, "Fabrication and Procurement of Black Cell Piping," Preliminary Noticeof Violation, dated December 3, 2008

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* NTS-ORP-BNRP-RRPWTP-2006-0003, "Commercial Grade Dedication," datedJune 26, 2006

* NTS-ORP-BNRP-RRPWTP-2009-0004, "Vendor Commercial Grade Dedication," datedAugust 10, 2009

* NCO-2010-03, "Consent Order for NTS 2009-0004," dated September 13, 2010

* A-10-ESQ-RPPWTP-004, "Audit of BNI Supplier Qualification Performance at OregonIron Works," Section 1.5, "Control of Purchased Items and Services - CGD," datedOctober 5, 2010

* S- 11-ESQ-RPPWTP-025, "Review of BNI Receiving Inspection Process," datedFebruary 13, 2012

* S-13-QAT-RPPWTP-001, "BNI ETG Procurement Activities," dated April 25, 2013

* U-13-QAT-RPPWTP-001, "BNI Quality Assurance Program Requirements -Requirement 7," dated October 28, 2013

* 24590-WTP-SAR-PROC-11-0001, Effectiveness of SQR use in CGD, Rev. 0, datedDecember 16, 2011

* 24590-WTP-SAR-PROC-1 1-0006, Evaluate effective use of VCGD inadequaciesidentified during audits, Rev. 0, dated December 16, 2011

* 24590-WTP-SAR-PROC-1 1-0004, NQA-1 Suppliers - CGD Program Effectiveness,Rev. 0, dated December 21, 2011

* 24590-WTP-IAR-QA-12-0002, Commercial Grade Dedication Audit, Rev. 0, datedJune 20, 2012

* 24590-WTP-SAR-PROC-12-0016, Evaluate the Effectiveness of the CGD CM SupplierList ofAnnual Performance Evaluations, Rev. 0, dated June 27, 2012

* 24590-WTP-SAR-PROC-12-0021, Effectiveness Review - NQA-1 Supplier's DedicationProgram Implementation Submittals, Rev. 0, dated September 27, 2012

* 24590-WTP-SAR-PROC-13-0002, NQA-1 Flowdown into CGD Procedures, Rev. 0,dated March 18, 2013

* 24590-HLW-SAR-ENG- 14-0004, Procurement Engineering, Rev. 1, dated October 15,2014

* 24590-WTP-SAR-PROE-14-0001, CG Supplier Survey Criteria Flowdown to PurchaseOrders, dated December 18, 2014.

Century Corporation:

* 24590-QL-POA-MACS-00004, "Purchase Order," Rev. 4

* 24590-WTP-3PS-MACS-T0005, "Specification," Rev. 0

* N0049-CEN-330-0001, "Commercial Grade Dedication Documentation Procedure andPlans"

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N0049-CEN-330-0002, "Commercial Grade Dedication Documentation Report"

- General requirements

- Bearings (prototype and production)

- Oil seals (production)

- Shaft coupling (prototype and production)

- Spiral wound gasket (prototype and production) (third report dated 2013)

- Sealant (production).

IONEX:

* 24590-WTP-SSV-MATL-13-007, Commercial Grade Survey Report, Rev. 0, datedNovember 12, 2013

* 24590-WTP-CGS-MATL-13-004, Commercial Grade Survey Checklist, Rev. 0, datedNovember 15, 2013

* 24590-WTP-CGD-MATL- 13-0003, LAW Thermal Catalytic Oxidizer/Selective CatalyticReducer Skid and Ammonia Dilution Skid, Rev. A, dated September 10, 2013

* 24590-WTP-CGD-MATL-12-0013, LAW TCO/R and Ammonia Dilution Skid Ball Valve,Rev. 0, dated December 4, 2012

* 24590-WTP-CGD-MATL-13-0001, LAWTCO/R and Ammonia Dilution Skid Gas FlowMeter, Rev. 0, dated January 14, 2013

* 24590-WTP-CGD-MATL-12-0046, LAW TCO/R and Ammonia Dilution Skid AmmoniaGas Flow Meter, Rev. 0, July 27, 2012

* 24590-WTP-CGD-MATL-1 1-0022, LAW TCO/R and Ammonia Dilution Skid StaticMixer, Rev. 0, dated December 4, 2012

* 24590-WTP-CGD-MATL- 11-0039, LAW TCO/R and Ammonia Dilution Skid ProcessOff Gas Heater, Rev. 0, dated May 6, 2014

* 24590-WTP-CGD-MATL- 11-0074, LAW TCO/R and Ammonia Dilution Skid HEPAFilter, Rev. A, dated June 13, 2013

* 24590-WTP-CGD-MATL-1 1-75, LAW TCO/R and Ammonia Dilution Skid HEPA FilterHousing, Rev. 0, dated December 2, 2012

* 24590-LAW-MKD-LVP-000 12, Mechanical Data Sheet - LAW CatalyticOxidizer/Reducer, Rev. 11, dated October 21, 2014

* 24590-LAW-3PS-MBTV-TOOO1, Engineering Specification for LAW CatalyticOxidizer/Reducer, Rev. 3, dated October 21, 2014.

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Premier Technology, Inc.:

* TP-3.4, Commercial Grade Dedication Procedure, Code Status 1, dated December 9,2010

* 11/79, "PTI CGD Plan ASME SB575, C276 (UNS N10276) Plate," Code Status 1, datedJune 23, 2011

* 11-79, "PTI CGD Plan and Verification Package for PO-99896," dated October 3, 2011

* 14/027, "PTI CGD Plan ASME B16.34 Ball Valves," Rev. 1, Code Status 1, datedJune 27, 2014

* 13-047, "PTI CGD Plan N7A-N&D UNS N10276 Spray Lances," Rev. 2, Code Status 2,dated February 25, 2014

* EMNO-MR63, "24 inch, 3 inch, and 1.5 in Spiral-Wound Gaskets," Rev. 4, CodeStatus 3, dated September 24, 2014

* EMNO-MR-64, '2' and '3' spiral-Wound Gaskets," Rev. 4, Code Status 3, datedAugust 13, 2014

* 11-116, "PTI CGD Plan for ASME, SB575, C276 (UNS N10276)," completed packagefrom 11/79, dated March 19, 2012

* 11-109, "PTI CGD Plan for ASME SB575, C276 (UNS N10276)," completed packagefrom 11/79, dated March 19, 2012

* 11-80, "PTI CGD Plan for ASME SA240, 316L (UNS S31603) Plate," Code Status 1,dated June 23, 2011; additionally, have the completed package for verification.

Jordon Valves (Proctor Sales):

* 24590-CD-POA-JVO5-00001, "Purchase Order"

* Section 2, "Technical Specification"

* 24590-WTP-3PS-GOOO-T0002, "Engineering Specification for Positive MaterialIdentification"

* 24590-WTP-3PS-GOOO-T0003, "Engineering Specification for Packaging, Handling, andStorage Requirements"

* 24590-WTP-3PS-JVO5-TOO1, "Engineering Specification for Q Pressure Regulators"

* SP81097-Bechtel, "Shell Test of Assembled Sliding Gate Valves"

* SP81027-Bechtel, "Test Procedure for MK60, 61, 64, 601, & 602"

* Section 3, "Drawings and Data Requirements."

Philadelphia Mixing Solutions:

* 24590-WTP-3PS-MACS-T0003, "Engineering Specification for Mechanical Agitators"

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* 24590-WTP-CGD-MATL-09-0050, "HLW HFP MRPV Agitators by PhiladelphiaMixing Solutions, Ltd." dated May 18, 2010

* 24590-WTP-MAP-AS-04-00220, Rev. 3

* 24590-WTP-CGS-MATL- 10-021, Commercial Grade Survey Report, FeRRALLOY,Inc., Rev. 0, dated February 7, 2011.

XRI Testing:

* 24590-WTP-CGD-MATL-13-0030, "Service: NDE Radiographic Examination of theHLW MFPV Agitator Impellers," Rev. 0, dated March 18, 2014

* 24590-WTP-CGS-MATL-13-006, XRI Testing - Commercial Grade Survey Checklistand Survey Report, Rev. 1, dated June 2, 2014

* 24590-WTP-SSV-MATL-14-001, Commercial Grade Survey Report -XRJ Testing, Inc.,Rev. 0, dated June 2, 2014

* 19302, "PMS Purchase Order to XRI," dated February 24, 2013

* 24590-QL-POA-MFAO-00001-01-00058, Submittal - Status 2, XRI to PhiladelphiaMixing Solutions to BNI, 4004, "Radiographic Inspection Process."

Set Point Control - Head Flow Instruments:

* 24590-CM-MRA-JFOO-00001, "Material Requisition - Head Flow Instruments." Rev. 4

* 24590-WTP-CGD-PROE-14-0041, CGD Plan for Concentric Restriction Orifice Plate,Rev. 0, dated November 17, 2014

* 24590-WTP-MAP-AS-04-00037, "Head Flow Instruments," dated November 21, 2014

* 24590-WTP-MRR-PROC-0029379, "Material Receiving Report - Orifice Plates,"Rev. 0, dated December 30, 2014

* 24590-LAW-MOQ-LMP-00001, "Equipment Qualification Data Sheet for LAW-LMPOrifice Plates," Rev. 0, dated October 23, 2009

* 24590-CM-POB-JFOO-00001-07-00006, 00012, 00013, 00014, and 00015, "OrificeDrawings - Dimensions"

* 24590-WTP-M6C-M47T-00002, "Thickness Calculation for Safety Restriction OrificePlates Used in LAW and PTF," dated July 5, 2011.

Process Pressure Gauges:

* 24590-WTP-MAP-AS-10-00191, Material Acceptance Plan, dated November 5, 2014

* 24590-WTP-LBTR-MATL-14-0006, "Laboratory Test Report - Process PressureGauges," dated October 30, 2014

* CCN: 274360, "CGD Release for Stock Codes JPO1QLOO2006 and JPO1QLOO2007, for24590-CD-MRA-JPO1-00001," dated November 20, 2014

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* 24590-WTP-CGD-MATL-10-0072, "CGD Plan for Process Pressure Gauges," datedJuly 25, 2014

* MTC-LTR-14-0006, "Laboratory Testing Request," dated September 29, 2014

* CCN: 274331, "Component Tag Numbers Related to NCR 13-0140 for Seismic andEnvironmental Quals," dated November 13, 2014

* MRR SRR-37220, "Receiving Inspection Report," dated December 3, 2014.

Badger Thermal - Circular Expansion Joints:

* 24590-WTP-CGD-PROE-14-0040, "Commercial Grade Dedication Plan - CircularExpansion Joints," dated December 25, 2014

* 24590-WTP-MAP-AS- 11-00020, Material Acceptance Plan, dated December 23, 2014

* CCN: 276630, "CGD Release of LAW Circular Expansion Joints," dated February 12,2015

* 24590-WTP-NCRA-CON-15-0020, "LAW Expansion Joints Failed Pneumatic LeakTest," dated February 17, 2015

* 24590-CD-POA-PYO5-00004-01-00011, "Badger Industries Drawing," Rev. OOB, datedJanuary 31, 2012

* 24590-LAW-M6D-LVP-00006, "Mechanical Data Sheet - Expansion Joint Bellows,"Rev. 2, dated October 18, 2012

* 24590-QL-MRA-PYO5-00004, "Part 2 - Technical Requirements - Mechanical DataSheets," Rev. 1, July 13, 2011

* 24590-WTP-LBTR-MATL-14-0008, "MTC Laboratory Test Report (LBTR), CGD ofMarkovitz Enterprises Inc. LAW Off-Gas Circular Expansion Joints," Rev. 0, datedDecember 18, 2014.

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APPENDIX AREQUIREMENTS BASIS

There are three paths of requirements that flow down from the Bechtel National, Inc. (BNI)contract to the BNI procedures used to implement, control, and perform commercial gradededication (CGD). These paths are from the Waste Treatment and Immobilization Plant (WTP)Contract and 10 CFR 830.120, "Nuclear Safety Management," "Scope," to the 24590-WTP-QAM-QA-06-001, Quality Assurance Manual (QAM); DOE 0 414.1 C, Quality Assurance; andNQA-1-2000, Quality Assurance Requirements for Nuclear Facility Applications (2004 forCGD).

Requirements to Prepare and Submit QAM to the U.S. Department of Energy, Office of RiverProtection for approval

* WTP Contract No. DE-AC27-01RV14136, in Section C, Standard 7, Paragraph (e)(3), statedin part:

The Contractor shall develop a QA Program, documented in a QA programmanual(s), and supported by documentation that describes overall implementationof QA requirements. Supporting documentation shall include procedures,instructions, plans, and manuals used to implement the Contractors QA programwithin the Contractors scope of work... The Contractor's QA program manual(s)shall be submitted to DOE for review and approval (Table C.5-1.1,Deliverable 7.2).

* Contract No. DE-AC27-01RV14136, Section J, "List of Attachments," Attachment E, "Listof Applicable Directives (List B-DEAR 970.5204.78)," states is part (b) of the table:

DOE 0 414.1C CRD [Contractor Requirements Document], Chg. 1 (349),June 17, 2005, Quality Assurance (M066), Contract Clause C.6, Standard7(e)(3)(i) & (iv) (M175)

Requirement 2, "General Quality Requirements," states:b. Quality Assurance Program Approvals and Changes. The contractormust-

(1) Submit a QAP to DOE for approval before beginning work under aDOE contract.(2) Implement the QAP as approved and modified by DOE.

* 10 CFR 830.120, Subpart A, "Quality Assurance Requirements," 10 CFR 830.212, "QualityAssurance Program (QAP)," paragraph (b)(1) states:

(b)(1) Submit a QAP to DOE for approval and regard the QAP as approved90 days after submittal, unless it is approved or rejected by DOE at an earlierdate.

(b)(4) Conduct work in accordance with the QAP.

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(c) The QAP must:

Describe how the quality assurance criteria of § 830.122 are satisfied.

Integrate the quality assurance criteria with the Safety ManagementSystem, or describe how the quality assurance criteria apply to the SafetyManagement System.

Describe how the contractor responsible for the nuclear facility ensuresthat subcontractors and suppliers satisfy the criteria of § 830.122.

Note that Contract Clause 1.117, DEAR 970.5204-78, "Laws, Regulations, and DOE Directives(Jun 1997)," requires the contractor to comply with applicable federal, state, and local laws andregulations, including DOE regulations. Specifically, it states:

(a) In performing work under this Contract, the Contractor shall comply with therequirements of applicable Federal, State, and local laws and regulations(including DOE regulations), unless relief has been granted in writing by theappropriate regulatory agency. A List of Applicable Laws and regulations(List A) may be appended to this Contract for information purposes. Omission ofany applicable law or regulation from List A does not affect the obligation of theContractor to comply with such law or regulation pursuant to this paragraph.

Requirements for Design Control, Procedures, Procurement, and Records

These requirements affect the content of CGD activities. These are the requirements for controlsof design activities, the performance of quality affecting work using procedures, the procurementof items and services, and the identification and retention of quality assurance records.DOE 0 414.1C and NQA-1-2000 also impose these requirements.

* 10 CFR 830.120, Subpart A, 10 CFR 830.212, require records be maintained; work becontrolled by procedures; requirements and standards incorporated into designs; and itemsand services procured and evaluated to meet established requirements and criteria.Specifically, it states:

(d)(2) Specify, prepare, review, approve, and maintain records.

(e)(1) Perform work consistent with technical standards, administrative controls,and other hazard controls adopted to meet regulatory or contract requirements,using approved instructions, procedures, or other appropriate means.

(f)(1) Design items and processes using sound engineering/scientific principlesand appropriate standards.

(f)(2) Incorporate applicable requirements and design bases in design work anddesign changes.

(g)(1) Procure items and services that meet established requirements and performas specified.

(g)(2) Evaluate and select prospective suppliers on the basis of specified criteria.

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QAM (24590-WTP-QAM-QA-06-001), Policy Q-03.1, "Design Control," address the controlof design and states in part:

3.1.2.5.1 When an assembly or component part ... is a commercial grade item,the critical characteristics of the item to be verified for acceptance andthe acceptance criteria for those characteristics shall be documentedand in accordance with Policy Q-07.1, Control ofPurchased Items andServices. (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis to SupportConstruction Authorization- General Information, Chapter 14,Table 14-1); QARD, Rev 20, 3.2.2.H)

3.1.2.5.2 Critical characteristics to be verified are those that provide reasonableassurance that the item will perform its intended function. ("Critical"added to "characteristics" in accordance with NQA-1-2000, RQMT 3,300(C)(3), NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis to SupportConstruction Authorization- General Information, Chapter 14,Table 14-1)

QAM (24590-WTP-QAM-QA-06-001), Policy Q-05.1, "Instructions, Procedures, andDrawings," requires all work to be performed using procedures. Specifically, Section 5.1.2,"Requirements," states:

5.1.2.1 Activities affecting quality and services shall be prescribed by andperformed in accordance with documented instructions, procedures, ordrawings that include or reference appropriate quantitative orqualitative acceptance criteria for determining that prescribed resultshave been satisfactorily attained. (NQA-1-2000, RQMT 5, 100;QARD, Rev 20, 5.2.A; 5.2.2.B)

5.1.2.2 The activity shall be described to a level of detail commensurate withthe complexity of the activity and the need to assure consistent andacceptable results... (NQA-1-2000, RQMT 5, 100)

QAM (24590-WTP-QAM-QA-06-001), Policy Q-07.1, "Control of Purchased Items andServices," establishes requirements for general procurement and acceptance of purchaseditems and services, including CGD items and services. With regard to the use of CGD fordesign, QAM Section 7.1.2.12.2, states:

7.1.2.12.2.1 The utilization of CGIs or CGSs shall include the following:

7.1.2.12.2.1.1 Technical evaluation to determine that the item or serviceperforms a safety function. (NQA-1-2000 as tailored in24590-WTP-PSAR-ESH-01-002-01, Preliminary DocumentedSafety Analysis to Support Construction Authorization -General Information, Chapter 14, Table 14-1)

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7.1.2.12.2.1.3 Identification of the critical characteristics, includingacceptance criteria. (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented SafetyAnalysis to Support Construction Authorization - GeneralInformation, Chapter 14, Table 14-1)

7.1.2.12.2.1.4 Selection, performance, and documentation of the dedicationmethod(s) for determining compliance with acceptance criteria.(NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis to SupportConstruction Authorization - General Information, Chapter 14,Table 14-1)

QAM (24590-WTP-QAM-QA-06-001), Section 7.1.2.12.3 defines requirements for theidentification of critical characteristics in the design of CGD and states:

7.1.2.12.3.1 Critical characteristic selection for acceptance shall address thefollowing. (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis to SupportConstruction Authorization - General Information, Chapter 14,Table 14-1)

7.1.2.12.3.1.1 Identifiable and measurable attributes or variables appropriatefor the safety function. (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented SafetyAnalysis to Support Construction Authorization - GeneralInformation, Chapter 14, Table 14-1)

7.1.2.12.4.3 Prior to acceptance of the CGI or CGS, the dedicating entity shalldetermine the following, as applicable: (NQA-1 -2000 as tailored in24590-WTP-PSAR-ESH- 01-002-01, Preliminary DocumentedSafety Analysis to Support Construction Authorization - GeneralInformation, Chapter 14, Table 14-1)

7.1.2.12.4.3.2 The item or service has satisfied the specified acceptancecriteria for the identified critical characteristics. (NQA- 1-2000as tailored in 24590-WTP-PSAR-ESH-01-002-01, PreliminaryDocumented Safety Analysis to Support ConstructionAuthorization - General Information, Chapter 14, Table 14-1)

7.1.2.12.4.3.3 Specified documentation was received and is acceptable.(NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis to SupportConstruction Authorization - General Information, Chapter 14,Table 14-1)

7.1.2.12.5.1 A commercial grade survey is performed in accordance with achecklist or plan at the supplier's facility and includes or addressesthe following: (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis to

23


Support Construction Authorization - General Information,Chapter 14, Table 14-1)

7.1.2.12.5.1.1 Identification of the item(s), or product line, or serviceincluded within the scope of the survey. (NQA- 1-2000 astailored in 24590-WTP-PSARESH-01-002-01, PreliminaryDocumented Safety Analysis to Support ConstructionAuthorization - General Information, Chapter 14, Table 14-1)

7.1.2.12.5.1.2 Identification of the critical characteristics to be controlled bythe supplier. (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis toSupport Construction Authorization - General Information,Chapter 14, Table 14-1)

7.1.2.12.5.1.3 Verification that the supplier's processes and quality programcontrols are effectively implemented for control of the criticalcharacteristics. (NQA-1 -2000 as tailored in 24590-WTP-PSAR-ESH-0 1-002-01, Preliminary Documented SafetyAnalysis to Support Construction Authorization - GeneralInformation, Chapter 14, Table 14-1)

7.1.2.12.5.1.4 Identification of the survey methods or verification activitiesperformed with results obtained. (NQA-1-2000 as tailored in24590-WTP-PSARESH-01 -002-01, Preliminary DocumentedSafety Analysis to Support Construction Authorization -General Information, Chapter 14, Table 14-1)

7.1.2.12.5.1.5 Documentation of the adequacy of the supplier's processes andcontrols. (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis toSupport Construction Authorization - General Information,Chapter 14, Table 14-1)

7.1.2.12.6.1 Source verification is only applicable to the actual item(s) orservice(s) that are verified at the supplier's facility or otherapplicable location. Commercial grade source verification shall beperformed in accordance with Section 7.1.2.7, "SourceVerification" of this policy, including a checklist or plan with thedocumented evidence of the source verification furnished to thededicating entity, and shall include or address the following:(NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01,Preliminary Documented Safety Analysis to Support ConstructionAuthorization - General Information, Chapter 14, Table 14-1)

7.1.2.12.6.1.1 Identification of the item(s) or service(s) included within thescope of the source verification. (NQA-1-2000 as tailored in24590-WTP-PSAR-ESH-01-002-01, Preliminary DocumentedSafety Analysis to Support Construction Authorization -General Information, Chapter 14, Table 14-1)

24


7.1.2.12.6.1.2 Identification of the critical characteristics, includingacceptance criteria, to be controlled by the supplier. (NQA- 1-2000 as tailored in 24590-WTPPSAR-ESH-01-002-01,Preliminary Documented Safety Analysis to SupportConstruction Authorization - General Information, Chapter 14,Table 14-1)

7.1.2.12.6.1.3 Verification that the supplier's processes and controls areeffectively implemented for the identified criticalcharacteristics. (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented SafetyAnalysis to Support Construction Authorization - GeneralInformation, Chapter 14, Table 14-1)

7.1.2.12.6.1.4 Identification of the activities witnessed during the sourceverification and the results obtained. (NQA-1-2000 as tailoredin 24590-WTP-PSAR-ESH-01-002-01, PreliminaryDocumented Safety Analysis to Support ConstructionAuthorization - General Information, Chapter 14, Table 14-1)

7.1.2.12.6.1.5 Documentation of the adequacy of the supplier's processes andcontrols. (NQA-1-2000 as tailored in 24590-WTP-PSAR-ESH-01-002-01, Preliminary Documented Safety Analysis toSupport Construction Authorization - General Information,Chapter 14, Table 14-1)

QAM (24590-WTP-QAM-QA-06-001), Policy Q-17.1, "Records," contains the requirementsfor all records generated under the contract, including those generated in CGD activities.Specifically, Section 17.1.2 states:

17.1.2.1, General:

17.1.2.1.1 Records shall furnish documentary evidence that items oractivities meet specified quality requirements. (NQA-1-2000,RQMT 17, 100; QARD, Rev 20, 17.1.A)

17.1.2.1.2 Records shall be identified, generated, authenticated, andmaintained, and their final disposition specified. (NQA- 1-2000,RQMT 17, 100; QARD, Rev 20, 17.1.A)

17.1.2.1.3 Requirements and responsibilities for these activities shall bedocumented. (NQA-1-2000, RQMT 17, 100)

17.1.2.2 Generation of Records

17.1.2.2.1 Records shall be legible and complete. (NQA-1-2000,RQMT 17, 200(a); QARD, Rev 20, 17.2.2.B)

17.1.2.2.2 Records shall be traceable to associated items and activitiesand accurately reflect the work accomplished or information

25


required. (NQA-1-2000, RQMT 17, 200(a); QARD, Rev 20,17.2.2.B)

Requirements for the use of a national consensus standard, NQA-1, for quality assurance.

* The WTP Contract No. DE-AC27-01RV14136, in Section C, Standard 7, "Environment,Safety, Quality, and Health," Paragraph e.(3) states:

(ii)(B) QA for process development, waste form qualification and testing shall beconducted as described in Standards 2 and 6. QA program requirements for allHLW and ILAW work shall be covered by the approved QA program. The QAprogram manual(s) shall address the following requirements: (M066)

(v) The Contractor shall implement the National Consensus Standard ASMENQA-1-2000, Part I and Part II, Subpart 2.7 for elements of the Contractor'sscope that may affect product quality of the Immobilized Low-Activity Waste(ILAW) product, entrained solids, and sludge washing, including, but not limitedto, waste form development, qualification, characterization, production processcontrol, certification of ILAW product, entrained solids, and sludge washing.Furthermore, all research and technology activities (other than IHLW - see (A))shall be conducted in accordance with NQA-1. (M066)

* Contract No. DE-AC27-01RV14136, in Section C, "Specification 2: Immobilized Low-Activity Waste Product," Section 2.3, "Quality Assurance," states:

A QA Program (Table C.5-1.1, Deliverable 7.2) for ILAW Product development,qualification, characterization, and certification is required and shall be basedupon NQA-1 (2000). The QA Plan shall address the QA/quality controlrequirements addressed in SW-846 and WAC 173-303-806. (M066)

* 10 CFR 830.120, "Nuclear Safety Management," Subpart A, "Quality AssuranceRequirements," 10 CFR 830.212, "Quality Assurance Program (QAP)," paragraph (c)(3)states:

Use voluntary consensus standards in its development and implementation, wherepracticable and consistent with contractual and regulatory requirements, andidentify the standards used.

* DOE 0 414.1C, contractor requirements document, Chg. 1 (349), June 17, 2005, QualityAssurance (M066), Contract Clause C.6, Standard 7(e)(3)(i) & (iv) (M175), Section 2,"General Quality Requirements," paragraph a. "Quality Assurance Program Developmentand Implementation," states:

(2) Uses the appropriate national or international consensus standard where practicableand consistent with contractual or regulatory requirements, and identifies the standardused. Appropriate standards include the following.

26


(a) ASME NQA- 1-2000, Quality Assurance Requirements for Nuclear FacilityApplications (for nuclear-related activities).

For CGD activities, the QAM (24590-WTP-QAM-QA-06-001) implements tailoredrequirements as defined in 24590-WTP-PSAR-EH-01-002-01, Preliminary DocumentedSafety Analysis to Support Construction Authorization; General Information, Chapter 14,"Quality Assurance," Table 14-1.

The following tailoring [Table 14-1] of ASME NQA-1-2000 is required for use by the WTPproject as an implementing standard to perform CGD activities using ASME NQA-1-2004.

Requirements for procedures governing the performance of commercial grade dedication. All ofthe above requirements govern the development, use, and content of contractor procedures forthe performance of CGD activities. BNI developed a suite of CGD procedures, as required toimplement the above requirements:

* BNI Procedure 24590-WTP-GPP-MATL-0 10, Evaluation and Acceptance ofCommercial Grade Items and Services, Rev. 1, March 8, 2012, through Rev. 4, July 10,2014, Sections 5.3.4 or 5.3.5 (depending on the revision), Quality Function, states in part:

Include information on the safety significance of the item by describingthe likelihood of failure, consequences of failure, failure mechanism,design margin, etc.

... the dedication package contains sufficient explanation to provide thebasis for conclusions reached and an understanding of how the abovefunctions were determined which is documented on the CommercialGrade Dedication Package form (24590-MATL-F00007).

Requirements flow down to BNI NOA-1 qualified vendors for the performance of CGD. BNIplaces a contract specification in each purchase order for orders that include the CGD of itemsand services:

* 24590-WTP-3PS-GOOO-TOO 19, Engineering Specification for Acquisition of CommercialItems and Services for Use in Safety Applications at WTP, Rev. 0, flows down CGDrequirements to vendors performing CGD. Section 3, "Mandatory Requirements for theUse of CGD for Safety Items in WTP," paragraph 3.1.1 states:

When CGIs or CGSs are utilized, the Supplier shall utilize therequirements of this section for procurement and acceptance of items orservices as an acceptable alternative to procuring them from qualifiedASME NQA-1 sub-suppliers. The applicable requirements of thisspecification shall apply to dedication activities for acceptance. Industryguidance for CGD is included in EPRI NP-5652, Guideline for theUtilization of Commercial Grade Items in Nuclear Safety RelatedApplications (NCIG-07), and EPRI TR-102260, Supplemental Guidance forthe Application ofEPRI Report NP-5652 on the Utilization of Commercial

27


Grade Items. This guidance provides the methodology and expectations fora successful CGD process.

The specific BNI procedural requirements for BNI performance of CGD and supplier qualityassurance program and procedural requirements are enumerated within each CGD packagediscussion in Appendix C.

BNI oversight of vendor performance, processes, procedures, procedure/plan submittals, andrecords is required by the following QAM (24590-WTP-QAM-QA-06-001) requirements andprocedures:

7.1.2.1.1 The procurement of items and services (Q/CM) shall be controlledto assure conformance with specified requirements. Such controlshall provide for the following, as appropriate:

7.1.2.1.1.2 Evaluation of objective evidence of quality furnished by thesupplier.

7.1.2.1.2.5 Supplier deficiencies shall be documented and controlled inaccordance with the applicable requirements of PolicyQ-15.1, Control ofNonconforming Items, Policy Q-15.2,Control of Suspect/Counterfeit Items or Q-16.1, CorrectiveAction, or in accordance with the supplier's applicableprogram.

7.1.2.5 Controls shall be implemented to assure that the submittal and evaluationof supplier-generated documents are accomplished in accordance with theprocurement document requirements. These controls shall provide for theacquisition, processing, and recorded evaluation of the quality assurancetechnical, inspection, and test documentation or data against acceptancecriteria.

* 24590-WTP-GPP-MGT-051, Supplier Quality Assurance Audits, Section 5.5.2.2 states:

Audits shall focus on adequacy of supplier work performance, implementation ofprocesses, and be performed to promote continuous improvement.

* 24590-WTP-GPP-MGT-051, Section 5.5.2.3 states:

The audit team will review representative samples of documents/records, real-time observations, and personnel interviews to determine if audited areas arebeing implemented effectively. Objective evidence is documented on the auditchecklist. When any area is not applicable or is not audited, an explanation isprovided.

24590-WTP-GPP-MGT-0 13_Rev_1 7A, Acceptance ofProcured Material states:

The MAP is the primary document used to define hardware and qualityverification document (QVD) oversight, verification, and/or acceptance

28


(including Quality Program Verification by BNI up to, and including receiptinspection.

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APPENDIX BDISCUSSION OF PROCESS ACTIVITIES

This appendix outlines the contractual and quality requirements for the technical performance ofcommercial grade dedication (CGD) and the contractual requirements to control these activitieswith procedures. The Bechtel National, Inc. (BNI) Contract requires BNI to develop a qualityassurance program implemented by procedures2 . The quality assurance rule also requires BNI toperform work in accordance with approved procedureS3. The audit team evaluated theperformance of CGD work activities specified in BNI and supplier procedures and identifiedseven areas of noncompliance with procedural requirements for CGD.

B.1 TECHNICAL EVALUATIONS

The CGD process defined in these requirements4 begins with the identification of the safetyfunction of the item or service and the performance of a technical evaluation to determine thecreditable failure mechanisms, mitigation of the failure mechanisms, and identification of criticalcharacteristics, acceptance criteria for the critical characteristics, and the methods of acceptance.

The audit team reviewed the technical evaluations in a sample of 27 CGD packages to evaluateboth BNI's performance of technical evaluations and the performance of technical evaluations bytheir qualified suppliers.

Technical evaluations in 26 out of 27 CGD plans performed by BNI and by BNI-approvedNQA-1 suppliers were not performed, in all cases, in accordance with the contractualrequirements listed in Appendix A and the specific BNI and supplier procedures listed inAppendix C.

Discussion:

Contrary to contractual requirements, which include the requirements for performing CGD andthe requirements for following procedures, the audit team identified numerous examples in theCGD packages reviewed in which the technical evaluation documented by BNI or by an NQA-1qualified vendor on BNI's evaluated suppliers list did not meet the procedural requirement' toprovide a "sufficient explanation" to substantiate the selection of critical characteristics,acceptance criteria, and final acceptance of a CGD item or service as required by BNI andsupplier procedures.

2 DE-AC27-01RV14136, in Section C, Standard 7, Paragraph (e)(3).1 10 CFR 830.120, "Nuclear Safety Management," Subpart A, "Quality Assurance Requirements," §830.212, "QualityAssurance Program (QAP)," paragraph (e)(1).4 24590-WTP-GPP-MATL-010, "Evaluation and Acceptance of Commercial Grade Items and Services," forBNI-performed CGD and 24590-WTP-3PS-G000-T0019, Acquisition of Commercial Items and Services for Use inSafety Applications at WTP, for NQA-1 supplier-performed CGD.5 Ibid, paragraph 5.3.5 that states in part, "...The dedication plan contains sufficient explanation to provide the basisfor conclusions reached and an understanding of how the above functions were determined which is documented onthe Commercial Grade Dedication (CGD) Evaluation & Acceptance Plan form (24590-MATL-F00007)."

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Appendix C lists, by CGD package, numerous examples of deficiencies in the performance anddocumentation of technical evaluations. The deficiencies included the failure to fully define thesafety functions of CGD items and services, the failure to fully identify critical characteristics,the failure to fully justify the selection of the critical characteristics, the failure to fully establishthe acceptance criteria for the critical characteristics, and the failure to specify the methods ofacceptance for critical characteristics.

B.2 BNI OVERSIGHT OF VENDOR-PERFORMED CGD ACTIVITIES

Appendix A outlines the contractual and quality requirements for BNI's oversight of supplierCGD activities. The oversight process defined in these contractual requirements6 identifies fourbarriers to ensure CGD is properly performed and documented. These barriers are:

* BNI supplier qualification audits of the supplier's quality assurance program and itsimplementation

* BNI review and acceptance of the supplier's CGD procedure required to be submitted toBNI by purchase order requirements

* BNI review and acceptance of CGD plans required to be submitted to BNI by purchaseorder requirements

* BNI's acceptance review of the final CGD report of all activities supporting thededication.

The audit team reviewed four qualified suppliers on the BNI evaluated suppliers list that hadbeen audited and approved by BNI to perform CGD. In three of four cases, three suppliersproduced CGD packages that were not compliant, in all cases, with the requirements listed inAppendix A and the specific BNI and supplier procedures listed in Appendix C.

Discussion:

Based on the CGD packages reviewed by the audit team, the four barriers for assuringeffectiveness of CGD activities were not fully effective in identifying supplier CGD deficienciesand weaknesses. Specifically, BNI did not identify that the CGD programs of the threeBNI-qualified vendors reviewed in the audit, did not meet contractual requirements. Thespecific details of these deficiencies are enumerated in Appendix C for Flowserve; NuclearLogistics, Inc.; Century; and Premier Technologies, Inc.

B.3 CGD ACCEPTANCE VIA MATERIAL ACCEPTANCE PLAN

Appendix A outlines the contractual and quality requirements for BNI's acceptance ofcommercial grade services and commercial grade items as basic components procured fromsuppliers. The acceptance process for commercial grade items defined in these contractualrequirements utilizes the material acceptance plan7 (MAP) as the vehicle to specify and

6 24590-WTP-GPP-MGT-05 1, Supplier Quality Assurance Audits, and 24590-WTP-3DP-GO4B-00058, SupplierEngineering and Quality Verification Documents.7 24590-WTP-GPP-MGT-013, Acceptance ofProcured Material.

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document the acceptance activities for CGD. The MAP requires documentation of the criticalcharacters for acceptance, the acceptance methods, and the criteria for acceptance as documentedin the CGD plan. Acceptance activities specified in the MAP are documented in the inspectionreceiving reports, the surveillance verifications reports, and/or the procurement engineer'smemorandum.

Discussion:

The audit team identified instances in which the MAPs used by BNI to document acceptance ofall required actions for a procurement, including those to document CGD actions, did notdocument all witness and hold points, did not include all acceptance criteria, and did not generatedocumentation of acceptance. Deficiencies, such as missing verifications of criticalcharacteristics, missing source verification inspections, incorrectly specified inspection methods,and missing acceptance criteria for critical characteristics, were some of the deficiencies listed inAppendix C. These deficiencies are noncompliances with contractual requirements to performwork in accordance with procedures that stipulate the requirements of the MAP procedure.

B.4 CGD PROCEDURES

Appendix A outlines the contractual and quality requirements for performing allquality-affecting work, including CGD activities, with approved procedures8',9"o. The definitionof "procedure" from both the 24590-WTP-QAM-QA-06-001, Quality Assurance Manual(QAM) " and NQA-1 12 state that a procedure "specifies or describes how an activity is to beperformed."

Discussion:

The audit team concluded that BNI's CGD program, as currently established, was generallycompliant with NQA-1 requirements but lacked sufficient detail to ensure effective andconsistent implementation and sustainment of CGD performance. Specifically, the audit teamfound that BNI procedures did not fully describe how some BNI specific CGD activities were tobe performed to assure consistent acceptable results, and to assure that documentation wassufficient to demonstrate prescribed results were satisfactorily attained as required by the QualityAssurance Manual (QAM) (24590-WTP-QAM-QA-06-001). Examples of proceduredeficiencies included:

* There was no criteria for reviewing supplier submittals for accepting supplier CGD plans,procedures, and packages' 3. Discussions with BNI indicated that NQA-1 suppliersubmitted CGD packages were reviewed against the mandatory section of the T0019specification; however, these reviews should have been against the CGD procedures

S 24590-WTP-QAM-QA-06-001, Rev. 2 through Rev. 16, Policy Q-05. 1, "Control of Purchased Items andServices," paragraphs 5.1.2.1, 5.1.2.2, 5.1.2.3, and 5.1.2.4.1.9 NQA- 1-2000, Requirement 5, "Instructions, Procedures, and Drawings."o DOE 0 414.1C, Quality Assurance, Attachment 2, "Contractor Requirements Document," paragraph 3.e.(1).

" 24590-WTP-QAM-QA-06-001, Appendix C, "Glossary."12 NQA-1-2000, Introduction, paragraph 400, "Terms and Definitions."13 BNI and Office of Enforcement Consent Order, NCO-2010-03, dated September 13, 2010.

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approved by BNI when the supplier was approved as an NQA-1 supplier. NQA-1suppliers are required to work to their BNI approved procedures, not the specification.

* 24590-WTP-3DP-GO6T-00903, Commercial Grade Source Verification, does not includethe QAM requirement 4 derived from NQA-1-2004, paragraph 704.2 for planning anddocumentation of a source verification to support CGD. The procedure did not requirethat a CGD source verification be implemented in accordance with plans to performinspections, examinations, or tests including a checklist or plan with the documentedevidence of completion of the source verification1 5 . Furthermore, the CGD procedure ineffect from 2010 to July 2014, 24590-WTP-GPP-MATL-010 did not implement thisQAM requirement. As a result, all CGD activities involving Method 3 sourceverifications are deficient.

* The CGD survey procedure does not provide sufficient detail on how a reviewed andapproved critical process evaluated during a CGD survey is then documented in thetechnical evaluation as the acceptance criteria for a critical characteristic selected to beverified by Method 2.

* The BNI procedures did not describe how to implement the requirements for dedicatingwaste affecting items (catalog items only) as required by DOE/RW-0333P, QualityAssurance Requirements and Description, Rev. 20 and the BNI QAM, Rev. 2 through 14(24590-WTP-QAM-QA-06-001). BNI previously identified this deficiency, and thecorrective actions remain to be implemented.

* The BNI QAM (24590-WTP-QAM-QA-06-001), Policy Q-03.1, "Design Control,"paragraphs 3.1.2.8.4 through 3.1.2.8.4.2, states that "Design verification shall beperformed prior to releasing the design for procurement, manufacture, construction, oruse by another design organization except where this timing cannot be met..." The QAMalso requires that "In those cases, the unverified portion of the design shall be clearlyidentified and controlled. In all cases the design verification shall be completed prior torelying upon SSCs... to perform its safety function and before installation becomesirreversible." The U.S. Department of Energy (DOE), Office of River Protection (ORP)discussed with BNI the fact that the BNI CGD procedure lacks a formal process to assureprocurements of items with incomplete design activities are controlled sufficiently toassure any needed reconciliation of impacts (e.g., the need to add and address additionalcritical characteristics) to the procurement with the completed design occurs. The auditfound that no process for reconciling procurements was released prior to final designverification.

* 245 90-WTP-GPP-MGT-0 13, Acceptance ofProcured Material, did not describe theprocess for documenting objective evidence for completion of each CGD acceptancecriteria required by the CGD plan, nor did it describe the process to accept each MAPstep with sufficient detail to produce a QA record of objective evidence of completion ofa required CGD activity (see definition of quality assurance record in NQA- 1-2000,Quality Assurance Requirements for Nuclear Facility Applications). MAPs reviewed by

14 24590-WTP-QAM-QA-06-001, Rev. 2 through Rev. 16, Section 7.1.2.12.6, "Commercial Grade SourceVerification."15 Ibid.

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the audit team did not document all witness and hold points, acceptance criteria, or CGDacceptance. CGD procedures were not clear in indicating what constituted a completeCGD record/package or how the CGD process was to satisfy QAM requirements inPolicy Q-17.1 to have records traceable to associated items and activities, and for recordsto be retrieval. The audit team noted difficulties in these areas.

* BNI CGD procedure processes for assembling and maintaining the CGD records werenot sufficient to meet QAM requirements in Policy Q-17.1 for retrieving records, and therequirements for assuring records are "traceable to associated items and activities andaccurately reflect the work accomplished or information required." The audit team notedBNI had difficulty in assembling complete CGD packages, all the associateddocumentation (plans, inspection reports, test results, etc.) was not traceable to the CGDactivity or item. In many cases each individual document referenced the CGD planand/or the related item, but there was never made clear to the audit team how BNIassured tractability and a complete "CGD package" was assembled.

The audit team also identified several instances where CGD activities were performed that werenot governed by procedures. The details of these procedure deficiencies are enumerated inAppendix C, and include:

* Dedication of complex equipment (e.g., thermocatalytic oxidizers, ammonia dilutionskids) and the lack of a process for managing a complex CGD procurement activity.

* Software used by commercial suppliers whose product is being dedicated:

- Criteria for passing toolbox approved software from BNI to commercial suppliers.

- BNI CGD procedures do not address the use of software by subtier suppliers to CGD

suppliers when the software impacts the critical characteristics of a CGD plan.

B.5 Previous CGD Corrective Actions

Appendix A outlines the contractual and quality requirements for implementing a correctiveaction management program to correct conditions adverse to quality as soon as practicable'6 17 18

Discussion:

Since 2006, DOE ORP surveillances and audits identified weaknesses in BNI's implementationof its CGD program for procurement of nuclear safety related items not fabricated within anNQA-1-based quality assurance program. The DOE Office of Enterprise Assessments, Office ofEnforcement reviewed ORP findings and, based on their independent review, BNI issuednoncompliance reports NTS-ORP-BNRP-RRPWTP-2006-0003, Commercial Grade Dedication,

16 24590-WTP-QAM-QA-06-001, Rev. 2 through Rev. 16, Policy Q-16.1, "Corrective Action," paragraphs 16.1.2,most particularly paragraph 16.1.2.4.1.4, "After verification of completion of corrective actions, follow-up reviews,surveillances, or auditing shall be performed to determine whether actions taken have been and continue to beeffective. (NQA-1-2000, Appendix 16A-1, 305)," emphasis added.1 7NQA-1-2000, Requirement 16.1 DOE 0 414.1C, contract requirements document, paragraph 3.c. (3).

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June 26, 2006, relating to weakness in the Waste Treatment and Immobilization Plant CGDprogram, and NTS-ORP-BNRP-RRPWTP-2009-0004, Vendor Commercial Grade Dedication,August 10, 2009, stating that BNI supplier oversight activities had identified an issue whereinCGD activities performed by qualified BNI suppliers, did not consistently provide assurance thatitems will perform their intended safety functions.

To support the required improvements to the BNI CGD Program, BNI and the DOE Office ofEnforcement agreed to a consent order, NCO-2010-03, on September 13, 2010, relating to theabove issues. Examples of specific deficiencies by vendors included:

* Inadequacy in determining the critical characteristic of material and components

* Sampling techniques and sample lot formation were not properly conducted

* Methods used for material and component acceptance and acceptance testing were notclearly defined.

The consent order also stated that the ineffectiveness of BNI's corrective action managementprogram in preventing recurrence of CGD issues had been a longstanding concern of the DOEOffice of Enterprise Assessments, Office of Enforcement.

Contrary to the requirements for corrective action management intended to prevent recurrence ofthe deficiencies, the audit team identified recurring deficiencies similar to this long standingissue. The audit team identified numerous examples of BNI not meeting the requirements ofBNI procedures, the QAM (24590-WTP-QAM-QA-06-001), and NQA-1. An independent auditand ORP's surveillances documented deficiencies with the determination of critical characteristicof material and components, acceptance, acceptance testing, and BNI's vendor qualificationprogram relative to their CGD Program. These issues were similar to those previously identifiedin ORP surveillances, Office of Enforcement noncompliance reports, and the consent orderdiscussed above.

The audit team found that BNI's corrective actions did not result in effective implementation ofCGD corrective actions taken in response to prior conditions adverse to quality identified byORP1 9 and the DOE Office of Enterprise Assessments, Office of Enforcement 20.

ORP's surveillances were issued in April 2013 and reissued in May 2014 documenting issueswith the vender oversight program that included vendor CGD programs as outlined below:

* 13-QAT-0014, "Contract No. DE-AC27-01 RV1 4136 - Transmittal of U.S. Departmentof Energy, Office of River Protection (ORP) Surveillance Report S-12-ESQ-RPPWTP-001, Focused Procurement Process Vertical Slice Surveillance of Bechtel National, Inc.

19 A- 10-ESQ-RPPWTP-004, "Audit of BNI Supplier Qualification Performance at Oregon Iron Works," Section 1.5,"Control of Purchased Items and Services - CGD," S-1 1-ESQ-RPPWTP-025, "Review of BNI Receiving InspectionProcess," S-13-QAT-RPPWTP-001, "BNI ETG Procurement Activities," and U-13-QAT-RPPWTP-001, "BNIQuality Assurance Program Requirements - Requirement 7."20 NEA-2008-04, "Fabrication and Procurement of Black Cell Piping," and NCO-2010-03, "Consent Order for NTS2009-0004."

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(BNI) Vessel Procurements from Northwest Copper Works (NWC)," April 11, 2013,identified the following issues:

- BNI approved Northwest Copper Works CGD plans that omitted the requirement formechanical testing per Northwest Copper Works procedural requirements based onthe supplier's inability to perform testing, rather than on an evaluation of the criticalcharacteristics. BNI oversight of Northwest Copper Works did not identify that the"Lamination Scan Report" for VSL-RLD-00002 used a micrometer withoutdocumenting the calibration date.

- BNI Audit Report (24590-WTPAR-QA-12-003) from the January 2012 BNI audit ofNorthwest Copper Works was incomplete. The report did not provide objectiveevidence of CGD plan reviews performed. Specifically, Table 11, listing the CGDplans reviewed in the audit, was missing from the audit checklist.

* S-12-QAT-RPPWTP-003, "ORP Surveillance of BNI Commercial Grade Survey ofRolls-Royce Corporation for Procurement of Turbine Engines," May 16, 2014, identifiedthe following issues:

- The BNI CGD plan, the CGD report, and the CGD checklist for the emergencyturbine did not fully identify, define, map, verify, and document the criticalcharacteristics for acceptance identified in the turbine CGD plan.

- The BNI commercial grade survey team did not detect that Rolls-Royce Corporationdid not impose nor enforce requirements on its subtier suppliers to identify potentialsuspect counterfeit items in, or prevent their procurement for, the turbines supplied tothe Waste Treatment and Immobilization Plant. The BNI survey report did notresolve the unsatisfactory Rolls-Royce Corporation Quality Manual result(CCN: 243959, "Quality Assurance CM Program Review for Rolls-RoyceCorporation") for a lack of controls to prevent and identify suspect/counterfeit items.

- The material specifications listed in some of the approved BNI CGD plans differedfrom the material specifications on the Rolls-Royce Corporation design drawings(e.g., RRC drawing 23007311, "First Stage Compressor Wheel," and RRC drawing23076564, "Liner Assembly Transition Combustor").

- Some commercial grade survey information to be recorded as part of the qualityassurance record in the commercial grade survey checklist was not complete/legible.Some Rolls-Royce Corporation procedures documented in the survey checklist didnot contain issue (revision) numbers, effective dates, or titles. The BNI commercialgrade survey team modified the commercial grade survey checklist from the initialversion to eliminate presentation of pertinent objective evidence without adocumented basis.

In conclusion, a review of recent ORP surveillances documented deficiencies in determining thecritical characteristic of material and components, acceptance, acceptance testing, and vendorqualification programs. These deficiencies were similar and repetitive of the deficienciesidentified in this audit, and were similar to the deficiencies identified in noncompliance reportNTS-ORP-BNRP-RRPWTP-2006-0003, June 26, 2006; noncompliance report NTS-ORP-BNRP-RRPWTP-2009-0004, August 10, 2009; and the NCO-2010-03 Consent Order,

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September 13, 2010. Under the Consent Order, BNI committed to sustain their CGD Programimprovements as part of their Nuclear Safety Quality Imperative.

As a part of this audit, the audit team reviewed the results of nine BNI self-assessments of CGDactivities conducted since the Consent Order was issued. The audit team found that BNI'sself-assessment activity did not identify the types of issues identified during this audit or, ifissues were identified, they were categorized as find/fix or opportunities for improvement thatdid not receive causal analyses or extent of condition analysis that would have potentiallyidentified the larger, more extensive, CGD problems.

BNI CGD self-assessments and results over this period include:

* 24590-WTP-SAR-PROC-11-0001, "Evaluate Effectiveness of SQR [supplier qualityrepresentative] Use in Commercial Grade Dedication Activities - Commercial GradeDedication Activities," December 16, 2011, was performed to "Evaluate if SupplierQuality Representatives are being utilized effectively to support vendor CGD complianceand Bechtel CGD activities." The surveillance concluded they were effective.

* 24590-WTP-SAR-PROC-1 1-0006, "Evaluate Whether VCGD [vendor commercial gradededication] Inadequacies Identified During Audits are being Effectively Transmitted tothe Responsible Engineers and Buyers for use in Bid Evaluations - Vendor CommercialGrade Dedication," December 16, 2011, concluded "BNI's supplier's CGD activity fromNQA-1 audits are being effectively communicated to the RE and procurement engineergroups for consideration in bid evaluations."

* 24590-WTP-SAR-PROC- 11-0004, "NQA-1 Suppliers - Commercial Grade ProgramEffectiveness," December 21, 2011, was performed to "Evaluate the results of a reviewof all Vendors performing CGD during the period of 1 January to 31 October 2011 asmeasured by the percent of supplier submittals that are assigned a Code 1 within twosubmittal cycles," and determined the vendors to be partially effective.

* 24590-WTP-SAR-PROC-12-0016, "Evaluate the Effectiveness of the CGD CM[commercial] Supplier List of Annual Performance Evaluations," was performed to"Conduct a follow-up assessment to determine the effectiveness of the CGD CM supplierlist development, and management of annual reviews." This assessment was conductedin response to PIER-1 1-1065, "Status of Commercial Grade Suppliers." No issues wereidentified.

* 24590-WTP-SAR-PROC-12-0021, "Follow-Up Assessment to Determine Effectivenessof Actions Taken to Improve the Performance of WTP NQA-1 Supplier's DedicationProgram Implementation Submittals - VCGD," September 27, 2012, which stated"Follow-up assessment to determine effectiveness of actions taken to improve theperformance of WTP NQA-1 supplier's dedication program implementation submittals,resulting in improvement in gaining CODE 1 status. No Issues were identified."

* 24590-WTP-SAR-PROC-13-0002, "NQA-1 flow down into project CGD procedures,"March 13, 2013, which stated "it was identified that the procedure needed to addresscomplex, active-mechanical items (e.g., Emergency Turbine Generator) to assureconsistent and acceptable results."

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* 24590-WTP-SAR-ENG-14-0002, "Readiness to procure material for TCO [thermalcatalytic oxidizer] and ADS [ammonia dilution system] specifically focusing on theheater (IONEX)," June 11, 2014. BNI identified issues associated with updating CGDplans, material acceptance plan, procurement, and calculations to the current designrequirements and that the responsible engineer was managing the changes throughmarkups to the specification and verbal communication.

* 24590-HLW-SAR-ENG-14-0004, "HLW TCO 24590-CM-POA-MBTO-00002 PO andassociated CGDs which stated multiple issues were identified with the 25 CGD packagesreviewed by BNI," October 15, 2014. Two Level C project issues evaluation reports(PIER) were written to address the purchase order part of the issue and the CGD part ofthe issues. An extent of condition was established due to the designation of enhancedcommercial designation.

* 24590-WTP-SAR-PROE-14-0001, "CG Supplier Survey Criteria Flow down to PO,"December 18, 2014. The results were as follows:

- WTP procurement engineering is generally effective in flowing supplier process andcontrol requirements from a CGD plan through the supplier survey to the purchaseorder requirements in compliance with the department's procedure,24590-WTP-3DP-GO6T-00905, Performance of Commercial Grade Surveys andAnnual Supplier Evaluations.

- Some issues identified during the assessment such as a single process did not getflowed down from the CGD Plan to the survey checklist, a CGD plan had theMethod 2 dedication process misidentified, and one survey set of compensatoryactions had yet to be incorporated into updated procurement documents. Other minorissues were discovered that provided opportunities for improvement of the overallCGD process.

In June 2014, a team of independent CGD experts (Sequoia) completed a review of BNI's CGDProgram under 24590-WTP-IAR-QA-12-0002, Commercial Grade Dedication Audit, issued onJune 20, 2012. The independent review team reviewed 15 CGD packages and maderecommendations that were documented on 16 PIERs. The PIERs were either Level C orLevel D and broken down into the following areas:

* Training issues were documented under two PIERs: 24590-WTP-PIER-MGT-12-0376-Dand 24590-WTP-PIER-MGT-12-0377-D.

* Process issues were documented under five PIERs: 24590-WTP-PIER-MGT-12-0376-D,24590-WTP-PIER-MGT-12-0377-D, 24590-WTP-PIER-MGT-12-0378-C, 24590-WTP-PIER-MGT-12-0384-C, and 24590-WTP-PIER-MGT-12-0387-C.

* Lack of or incorrect acceptance criteria was documented under five PIERs: 24590-WTP-PIER-MGT-12-0379-C, 24590-WTP-PIER-MGT-12-0382-C, 24590-WTP-PIER-MGT-12-0383-C, 24590-WTP-PIER-MGT-12-0384-C, and 24590-WTP-PIER-MGT-12-0388-C.

* Missing or problems associated with approval documentation was documented under sixPIERs: 24590-WTP-PIER-MGT-12-0385-C, 24590-WTP-PIER-MGT-12-0386-C,

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45090-WTP-PIER-MGT-12-0389-D, 24590-WTP-PIER-MGT-12-0392-C, 24590-WTP-PIER-MGT-12-0393-C, and 24590-WTP-PIER-MGT-12-0394-C.

24590-WTP-IAR-QA-12-0002 stated that:

... based on the results of this audit, the audit team concluded that for CommercialGrade Dedication to be effective issues identified need to be evaluated by NM&SManagement and corrected. The report further stated that the work wastechnically reliable; however, increased process detail needs to be achieved. Theaudit team identified 12 issues that require NM&S Management attention andcompensatory action. In addition the audit team made 4 recommendations. Theseissues and recommendations were documented on PIERs in accordance withprocedure 24590-WTP-GPP-MGT -043, Corrective Action Management.[Emphasis added]

The audit team found that BNI did not implement the recommendations and issues in a timelymanner to improve the quality and rigor of CGD activities.

B.6 Commercial Grade Survey

Appendix A outlines the contractual and quality requirements for performing CGD usingMethod 2 - Commercial Grade Surveys of commercial suppliers to support BNI dedication ofproducts and services from suppliers without a qualified NQA-1 quality assuranceprogram 2 1,2 2,23

Discussion:

BNI's performance and documentation of commercial grade surveys (Method 2) did not fullymeet 24590-WTP-GPP-MATL-0 10, Evaluation and Acceptance of Commercial Grade Items andServices, paragraph 5.4.2, "Method 2 - CGD Survey of Supplier"; QAM (24590-WTP-QAM-QA-06-00 1); and NQA- 1 requirements.

The audit team reviewed BNI's documentation of the commercial grade surveys (Method 2) ofthree commercial vendors in support of two procurements 24 (low-activity waste thermal catalyticoxidizer/selective catalytic reducer skid and ammonia dilution skid and the high-level waste[HLW] melter feed process melter feed preparation vessel agitators) and three associated CGD

21 24590-WTP-QAM-QA-06-001, Rev. 2 through Rev. 16, Policy Q-07.1, "Control of Purchased Items andServices," paragraph 7.1.2.12.5, "Commercial Grade Survey."22 24590-WTP-GPP-MATL-010, Evaluation and Acceptance of Commercial Grade Items and Services, paragraph5.4.2, "Method 2 - CGD Survey of Supplier."23 NQA- 1-2000, Requirement 7, paragraph 700, "Commercial Grade Items."24 IONEX TCO, PMS Paddlewheel,

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plans and identified instances in which the surveys were not performed in accordance withprocedural requirements2 5. The surveys included:

* 24590-WTP-SSV-MATL- 13-007, Commercial Grade Survey Report, IONEXResearchCorporation, Lafayette, Colorado, Rev. 0)

* 24590-WTP-CGS-MATL-10-021, Supplier Commercial Grade Survey Report -FeRRALLOY, Inc. - Cleveland, OH, Rev. 0, in support of CGD Plan 24590-WTP-CGD-MATL-09-0050, HLWHFP MRPVAgitators by Philadelphia Mixing Solutions Ltd.

* 24590-WTP-SSV-MATL-14-001, Commercial Grade Survey Report -XRI Testing -Cleveland, OH, Rev. 0, date June 2, 2014.

Appendix C describes these specific CGD survey deficiencies in detail.

B.7 CGD Method 1 Special Tests or Inspections

Appendix A outlines the contractual and quality requirements for performing using Method 1 -Special Tests or Inspections of commercial items purchased from suppliers in support of BNIdedication of products and services from suppliers without a qualified NQA-1 quality assurance

26,27,28program

Appendix A outlines the contractual and quality requirements for using Method 129,30

Discussion:

The audit ream reviewed one BNI CGD package that employed the performance of inspectionsand tests (Method 1) to validate critical characteristics identified in a CGD plan. CGD Report24590-WTP-CGD-PROE-14-0041, CGD Plan for Concentric Restriction Orifice Plate,contained errors. The full description of the errors is presented in Appendix C.

B.8 BNI In-Process Response to Audit Issues

During the course of the audit, these issues, as they were identified, were presented to anddiscussed with BNI procurement engineering. As a result, BNI began to investigate the audit

25 24590-WTP-GPP-MATL-0 10, paragraph 5.4.2.26 24590-WTP-QAM-QA-06-00 1, Rev. 2 through Rev. 16, Policy Q-07.1, "Control of Purchased Items andServices," paragraph 7.1.2.12.4.1.1.27 24590-WTP-GPP-MATL-010, paragraph 5.4.1, "Method 1 - Special Tests and Inspections."28 NQA-1-2000, Requirement 7, paragraph 700, "Commercial Grade Items."29 24590-WTP-QAM-QA-06-001, Rev. 2 through Rev. 16, Policy Q-10.1, "Inspection," paragraph 10.1.2, asinvoked by Policy Q-07.1, paragraph 7.1.2.12.4.1.1.1o 24590-WTP-GPP-MATL-010, Section 5.4.1.

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team's issues and found sufficient evidence to warrant the issuance of a Level A ConditionReport:

24590-WTP-GCA-MGT- 15-00338-A, Commercial Grade Dedication (CGD) of ComplexEquipment -

Data from recent CGD reviews indicate some potential issues requiring managementattention for certain complex equipment with multiple dedication plans. Complexequipment reviewed includes Century HOP Fans, PTI LAW Scrubbers, and On PowerETG. Reviews to date indicate potential issues relating to the following barriers for someof the equipment: Supplier and sub-supplier qualification and oversight objectiveevidence, clarity of technical evaluation documentation, and review of NQA-1 vendorCGD submittals. This CR will address the data from CGD reviews and the CGD processbarriers holistically, and will determine if strengthened barriers are warranted for CGD ofcomplex equipment.

As required by BNI procedures, a root cause analysis team was chartered 31. Early extent ofcondition reviews by the root cause team identified additional examples with other BNI andsupplier performed CGD packages where technical evaluations did not provide the required levelof detail.

Additionally, subsequent BNI reviews of CGD packages have resulted in additional deficienciesthat have been documented in condition reports. These BNI efforts significantly increase thenumber of identified deficient CGD packages and further corroborate the audit conclusions ofdeficient CGD performance. To date, the following BNI condition reports have been issued:

* 24590-WTP-GCA-MGT-CR 15-00155-C, HL WMelter Offgas Treatment Process (HOP)Fan CGD Technical Evaluation Inadequacies - CGD plans for HLW HOP fans preparedby Kyungwon Century America, Inc. did not document adequate technical evaluations inaccordance with requirements and guidance identified in the order. Additional detail isneeded to support the selection of critical characteristics and acceptance methods.

* 24590-WTP-GCA-MGT- 15-00161-B, Supplier Audit Objective Evidence Less thanAdequate - Review of the 2011 implementation audit of Kyungwon Century America,Inc. report 24590-WTP-AR-QA-1 1-025 finds a lack of objective evidence documented tovalidate program acceptability and implementation in multiple areas, and in particular inthe areas of Section 7 - Control of Purchased Material, Equipment & Services.

* 24590-WTP-GCA-MGT-15-00416-C, CGD Plan Configuration & Qualification ScopeLT [Less Than] Adequate - The CGD plan, 24590-WTP-CGDMATL-09-0010, Rev. 2,was not processed correctly when it was superseded by CGDMATL-1 1-0078, Rev. 0.This contradicts 24590-WTP-GPP-PADC-009, Project Document Control, Section 4.1,"Cancelling or Superseding a Document." Also the plan includes wording that does notalign with current environmental qualification scope.

31 24590-WTP-GCA-MGT-15-00338-A, Commercial Grade Dedication (CGD) of Complex Equipment, attachment"15-0033 8 RCA Charter May 12 2015.pdf."

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24590-WTP-GCA-MGT-15-00673-C, PO Changes Missed from CG Surveys; Method 3CGD Activities Missed due to Lack ofProcurement Engineering Being Notified -Changes to 24590-QL-POA-MFAO-00001 for mechanical agitators, as a result ofcommercial grade surveys of the prime supplier Philadelphia Mixing Solutions andsub-supplier FeRRALLOY, Inc./Coronado Steel were not incorporated into the order asrequired. Procurement engineering was not notified to perform source verification perCGD plan 24590-WTP-CGD-MATL-09-0050 Method 3 source verification attributesrequired at casting sub-supplier FeRRALLOY, Inc./Coronado Steel. Production impellercastings were manufactured without the required commercial grade survey compensatorymeasures incorporated into the order and without procurement engineering presence toperform required Method 3 source verifications for CGD of the impellers.

24590-WTP-GCA-MGT-15-00687-C, LVP & LMP Orifice Plate Discrepancies betweenDesign Documents and Impacting Dedicated Material - Calculation 245 90-WTP-M6C-M47T-00002, calculates the required thickness for safety restriction orifice plates in theLow-Activity Waste Facility and Pretreatment Facility. Calculations for three componenttag numbers, LVP-RO-00001, LMP-RO-00001, and LMP-RO-00002, are included in thiscalculation. The required thicknesses for these three orifice plates were calculated to be0.3125 inches for LVP-RO-00001 and 0.1875 inches for LMP-RO-00001/00002.Contrary to the thicknesses determined under calculation 24590-WTP-M6C-M47T-00002, existing procurement and related design documents identify the requiredthickness for these three orifice plates to be 0.125 inches. The affected documents are:

- Material Requisition 24590-CM-MRA-JFOO-00001

- Code 1 orifice plate drawings, 24590-CM-POB-JFOO-00001-07-00012, 24590-CM-POB-JFOO-00001-07-00014, and 24590-CM-POB-JFOO-00001-07-00015

- Code 1 orifice plate mechanical datasheets 24590-CM-POB-JFOO-00001-04-00001,24590-CM-POB-JFOO-00001-04-00002, and 24590-CM-POB-JFOO-00001-04-00018.

Reconciliation of these dimensional differences between design documents is required.A review is also required to determine why the results of calculation 24590-WTP-M6C-M47T-00002 were not incorporated into the existing design data above for the affectedcomponent tags with the appropriate procurement changes made to ensure procurementof correctly configured orifice plates. Associated with this issue, during review of CGDplan 24590-WTP-CGD-PROE-14-0041, Rev. 0 (CGD for Tri-Flo restrictive orificeplates), in support of the DOE audit of the WTP CGD process, the orifice plate thicknessissue described above was found to exist for the thickness acceptance criteria specifiedfor the three orifice plate component tag numbers identified above. The orifice platethickness for LVP-RO-00001 and LMP-RO-00001/00002 is presently specified at0.125 inches within the CGD plan. Received orifice plates for these component tagnumbers have been dedicated using the 0.125-inch thickness acceptance criteria andreleased per procurement engineering memorandum CCN: 275314, "CGD Release ofConcentric Restriction Orifice Plate on 24590-CM-POB-JFOO-00001 in accordance with24590-WTP-MAP-AS-04-00037, Rev. 5, Step 17." As these orifices have been deliveredand CGD has been completed, it is important that the affected items be tagged and placedon hold until the dimensional discrepancies are reconciled and dispositioned.

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* 24590-WTP-GCA-MGT-15-00876-C, Vendor CGD issues with HLWAuto-SamplerProcurement - The HLW auto-sampler equipment procured under order24590-QL-POA-HAHH-00003 was chosen for independent review. A representativesample of completed code 1 and 2 status CGD plans and CGD report packages werereviewed to determine if similar issues exist with this equipment CGD documentation.Eleven CGD packages were randomly selected for review of a cross-section of the typesof items being dedicated.

Note: The preliminary BNI procurement engineering corrective action plan sent viaemail to ORP indicated that this issue "would necessitate a complete re-review ofapproximately fifty submittals that they [procurement engineering] had previouslyreturned code one."

General problems identified by BNI via 14-QAD-0048, HL WAuto-Sampler CGD Plan/ReportReviews (email), as they reviewed CGD packages include the following:

* Lack of clear lot size delineation; some discrepancies with sample sizeformulation

* CC's not identified by a fabricator from the supplier's technical evaluation

* Missing documentation from report packages

* Lack of technical justification for changes made by the fabricator to CC's andacceptance criteria specified by the supplier

* Acceptance of out-of-specification results

* Lack of or confusing or indeterminate specific and measurable acceptancecriteria

* Incomplete CGD procedures at the supplier and fabricator levels

* Lack of evidence of sub-vendor CGD procedure submittal to BNI for reviewand acceptance

* Lack of objective evidence of implementation of CGD Survey (Method 2)when called out in CGD plans

* Gaps in verification packages as well as disconnects in the vendor CGD plansresulting in inadequate objective evidence of dedication. 32

32 14-QAD-0048, HL WAuto-Sampler CGD Plan/Report Reviews (email).

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APPENDIX CDETAILED LIST OF IDENTIFIED DEFICIENCIES PER COMMERCIAL GRADE

DEDICATION PACKAGE

Century Corporation - General Comments

* N0049-CEN-330-0001, Commercial Grade Dedication Documentation Procedure andPlans, Rev. 1, paragraph 4.3.1.2, Method 2 - Supplier Survey and Periodic Evaluation,stated that Method 2 was not applicable to the Bechtel National, Inc. (BNI) job. Centuryobtained certificate of conformances from their suppliers; however, certificate ofconformances are only used in commercial grade dedication (CGD) when Method 2 isselected as the dedication method because the performance of the survey validates thecertificate of conformances 3 3. As such, the use of a certificate of conformance for safetyrelated items that are purchased as commercial products did not have a basis and did notestablish acceptability of a commercial item in a nuclear safety application as required byNQA-1 and 24590-WTP-3P-G000-T001 9, Engineering Specification for Acquisition ofCommercial Items and Services for the Use in Safety Applications at WTP.

* BNI oversight activities did not identify issues with Century performance of CGD. Thesewere: 1) the BNI audit of Century's NQA-1 program to be placed on the BNI evaluatedsuppliers list 34 ; 2) the BNI review and approval of the Century CGD procedure; 3) theBNI review and acceptance of the Century CGD plan; and 4) the BNI review andacceptance of the CGD report of all activities supporting the dedication.

* All of the deficiencies listed in the following sections regarding Century CGD plans andreports were found by the audit team in documents that BNI had accepted as CodeStatus 1, meaning the supplier can proceed to use the documents in the production of theitems listed in the purchase order and accompanying specifications.

1. Century Corporation - N0049-CEN-330-0002 - Attachment 1, "Bearing - Prototype"

* Exhibit 1, "Commercial Grade Item (CGI) Evaluation and Verification Report," Bearing,did not document the evaluation of the "suitability of the commercial grade item (CGI) toperform the required safety function(s)" as required by N0049-CEN-330-0001, CenturyCommercial Grade Dedication Documentation Procedure and Plans, paragraph 4.1.1.

* Exhibit 1, did not list the safety related function(s) required to be performed by the CGI,the potential causes of failure, the consequences of the failure, or provide a technicaljustification for the determination that the item would perform satisfactorily in service asrequired by the Century CGI Evaluation and Verification Report, Exhibit 1.

* The CGD plan, paragraph 5.1.6 did not provide a complete list of credible failuremechanisms for the bearing. Corrosion/Erosion were the only creditable failuremechanisms (CFM) listed. CFMs not addressed, for example, included bearing failuredue to overheating, structural failure due to improper material, and loss of lubrication.

33 24590-WTP-3PS-GOOO-TOO19, Engineering Specificationfor Acquisition ofCommercial Items and Services for theUse in Safety Applications at WTP, Rev. 0, paragraph 3.4.2.34 24590-WTP-GPP-MGT-051, Supplier/Subcontractor Quality Assurance Audits, Rev. 2, paragraph 5.6.12.

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* The CGD plan, paragraph 5.1.6 was inaccurate in stating that the CFM ofcorrosion/erosion was not credible because the bearings were in lubricating oil. BNIEngineering Specification 24590-WTP-3PS-MACS-T0005, Rev. 0, paragraph 3.8.4.1,"Bearings," stated that multi-stage blowers shall be supplied with grease-lubricated,radial roller bearings.

* The grease used to lubricate the bearings was not procured from an NQA-1 supplier ordedicated as a CGI as required by the purchase order specification, 24590-WTP-3PS-GOOO-TOO 19, and NQA-1-2004, Part I, Section 400, "Terms and Definitions,Commercial Grade Item."

* Exhibit 1, "Physical Characteristics," did not list the material of the rollers as a criticalcharacteristic even though the material of a roller is critical to the ability of the bearing toperform its safety function.

* Heat treatment of the bearing is referenced by the certificate of conformance from SKFKorea, Ltd., but the details of the heat treatment process were not identified or defined asa physical characteristic of the bearing. If the heat treatment was improperly performed,the bearing's ability to perform its safety function is not assured, as required.

* The method of verification and acceptance was not identified, as required by Centuryprocedure N0049-CEN-330-0001, Rev. 1, paragraph 4.3.1.

* A critical characteristics for acceptance (CCFA) supporting physical characteristics wasthat the bearing cage assembly was to be made of steel and the acceptance method wasvisual inspection. The criteria for the visual inspection was "1) no deformation anddamage and (2) both received bearings in Century Corporation and required bearing typefrom purchase specifications were identical." The receiving inspection report form didnot demonstrate that the acceptance criteria were satisfied for each bearing. The resultsof the visual inspection were not recorded. As such, N0049-CEN-330-0002 lacked thecontractually required basis for the determination that material of the 36 bearings wassteel based on a visual inspection.

* A visual inspection cannot be used to determine that the casing was steel, and not someother metal.

* The acceptance criteria for the vibration test performed for the prototype bearings listedin the CGI dedication checklist, Section 4, was less than 1.0 mil displacement at3,600 rpm. The actual test was performed at approximately 1,775 rpm. An explanationwas not provided addressing the difference between the speed requirement from theacceptance criteria and the actual speed used during the test.

* BNI Engineering Specification 24590-WTP-3PS-MACS-T0005, "EngineeringSpecification for High Integrity Centrifugal Blowers - Multi-stage," Rev. 0, October 20,2010, paragraph 6.6.3, stated that:

... vibration performance shall be checked and reported at 10% incrementsof full speed blower tests. Vibration testing shall not be performed within+/- 20% of the blower's critical speed.

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There was no indication that the bearing incremental speed testing was performed inaccordance with the purchase specification based on review of the provided data sheets.Contrary to the requirements of 24590-WTP-3PS-MACS-T0005, the datasheets onlyrecorded data for 1,768 rpm and 1,775 rpm and the critical speed was not listed toprovide assurance that it was not tested near its critical speed.

2. Century Corporation - N0049-CEN-330-0002 - Attachment 3. "Bearinz Oil Seal -Prototype and Production"

* Exhibit 1, "Commercial Grade Item (CGI) Evaluation and Verification Report, Bearingoil Seal," did not document an evaluation of the suitability of the CGI to perform therequired safety function(s) as required by Century Commercial Grade DedicationDocumentation Procedure and Plans, paragraph 4.1 .1.

* Exhibit 1 did not list the safety related function(s) required to be performed by the CGI,the potential causes of failure, the consequences of failure, nor provide the technicaljustification for the determination that the item will perform satisfactorily in service, asrequired by Century CGI Evaluation and Verification Report, Exhibit 1.

* The CGD plan, paragraph 5.3.6, did not provide a complete list of credible failuremechanisms for the bearing oil seal. Corrosion/Erosion was the only CFM listed. CFMsthat were not addressed that could be credible include oil seal failure due to the rubbermaterial, failure of the retaining spring, and the steel ring failure.

* The CGD plan, paragraph 5.3.6, was inaccurate in stating that the CFM ofcorrosion/erosion was not credible because oil seals were made from rubber andcorrosion is not credible failure mechanism for rubber, and that any other factor forerosion was not available. The retaining spring and steel ring were not considered forcredible failures, as required by the Century CGD procedure. Additionally, because afactor (or more correctly, any information) for erosion is not available, does not validatethat a credible failure does not exist.

* Critical characteristics for acceptance did not list the material specifications for thebearing oil seal steel ring and the spring, as required by the Century CGD procedure.

* The Century CGI Dedication Request stated that the material for the bearing oil sealwould be documented by a material test report (MTR) or certificate of conformance. Theacceptance criteria was listed as the "purchase specification." The certificate ofconformance provided by Century was from a subtier supplier, Shin Ryung Ki-Kong Co.,LTD, and did not meet the 24590-WTP-3PS-MACS-T0005 purchase order specificationrequirements for a certificate of conformance.

* The purchase order number listed on the certificate of conformance did not match thepurchase order for the items being dedicated.

* Century presented a certificate of conformance to support the dedication of the bearingoil seal. However, Century's CGD program does not use Method 2 surveys fordedicating items, therefore a certificate of conformance from a subtier supplier fordedication of an item is invalid because it is not supported by a Century CGD survey ofShin Ryung Ki-Kong Co., LTD, as required by 24590-WTP-3PS-GOOO-TOO 19,

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Section 3.4.2. Furthermore, the certificate of conformance did not meet the procurementspecification requirements35 for certificates of conformance; for example, it did notaddress the material acceptance processes for the bearing oil seal, the spring, and the steelring.

* The CGI dedication request listed the acceptance criteria for the dimension as"procurement specification, PS-NDO411-19." The CGI Evaluation and VerificationReport listed the dimensions to be verified as bore diameter, outer diameter, and width, asshown on the purchase specification. The purchase specification stated that thedimensions were to be in accordance with attached drawings. The attached drawingswere not in English, therefore, the dimensional acceptance criteria could not bedetermined and the acceptability of the dimensions relative to the acceptance criteriacould not be verified.

* The Receiving Inspection Report listed measurements for inside diameter (ID), outsidediameter, and material schedule. However, the report did not list the tolerances formeasurement acceptance, as required.

* The "Dimension Check List (Cross Reference)" listed the actual measurements recordedfor each bearing. However, the columns were titled as A, B, and C, were not alignedwith ID, outside diameter, and material schedule from the Receiving Inspection Report orbore diameter, outer diameter, and width from the CGI Evaluation and VerificationReport.

3. Century Corporation - N0049-CEN-330-0002 - Attachment 6, "Shaft Coupling -Prototype"

* Exhibit 1, Commercial Grade Item (CGI) Evaluation and Verification Report, shaftcoupling, does not document an evaluation of the suitability of the CGI to perform therequired safety function(s) as required by the Century Commercial Grade DedicationDocumentation Procedure and Plans, paragraph 4.1 .1.

* Exhibit 1, does not list the potential causes of failure, the consequences of failure, norprovide a technical justification for the determination that the item will performsatisfactorily in service, as required by the Century CGI Evaluation and VerificationReport, Exhibit 1.

* The CGD plan, paragraph 5.6.6, did not provide a complete list of credible failuremechanisms for the shaft coupling. There was a disconnect in the plan between theidentification of critical characteristics and the final results documented in the plan.Specifically, corrosion/erosion was the only CFM listed. The plan stated that becauseshaft couplings consisted of powder-coated covers, greased metal parts, and an ethylenepropylene diene monomer (EPDM) gasket, corrosion was a not credible failuremechanism. Nevertheless, the justification in the CGD plan presented a list ofcompensatory measures to address credible failure mechanisms that were not listed. Theresults of this discussion contribute to the CCFA.

s 24590-WTP-3PS-GOOO-T0019, paragraph 3.4.2.

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* The CCFA include "materials," however, the acceptance of material selected wasverification by an MTR or certificate of conformance. The acceptance criteria referred tothe purchase specification for the actual values. An MTR was not provided. Thepurchase specification listed the materials for the oil seal material as EPDM and thegasket material as EPDM. The purchase specification did not include specifications forany of the metal components of the shaft coupling.

* The Falk Steelflex Catalog stated that the tapered grids, made of high strength alloy steel,are quenched and tempered to spring hardness. The grid surface is then precision shotpeened to compress the surface molecules. Material composition and special processeswere not addressed as CCFA.

* The special Falk grease developed and specified for the coupling was not discussed in theCGD Plan. Based on the discussion provided in the Falk literature, failure to use, orfailure of, the special grease could result in failure of the coupling to perform its intendedsafety function. The grease was not procured as a basic component or as a CGI asrequired by the purchase order specification, 24590-WTP-3PS-MACS-TOO19.

* The method of verification and acceptance was not specified on Exhibit 1 of the CGDPlan as required by the Century CGD procedure.

* An MTR, including chemical and physical properties, was not provided as required by24590-WTP-3PS-MACS-T0005, Materials, Rev. 0, paragraph 4.1.2.

* The certificate of conformance did not list the purchase order number, as required byCentury purchase specification PS-N00411-12.

* The receipt inspection report required that materials and testing equipment (M&TE)(Vernier calipers) be used for dimensional verifications, but did not specify themeasurements of the couplings to be verified. The "Dimensional Check List (CrossReference)" documented measurements but did not list the M&TE used for theinspections, as required by purchase order specification 24590-WTP-3PS-GOOO-TOO19,paragraph 5.6.4.2.7. There is no connection between the two documents as to what theactual measurements were and what M&TE was used.

4. Century Corporation - N0049-CEN-330-0002 - Attachment 8, "Spiral Wound Gaskets(Prototype)"

* The CGI Evaluation and Verification Report in N0049-CEN-330-0002 identified asphysical characteristics the inner/outer ring material as 304 stainless steel and the fillermaterial as nonasbestos. The acceptance criteria for the material critical characteristicswas deficient because verifying that the filler material was nonasbestos did not reflectwhat the material should have been. In follow-up discussions with BNI procurementengineering, they clarified that the material was intended to be Kevlar@36. TheEvaluation and Verification Report was deficient because it did not provide assurancethat the material was actually Kevlar.

* The "Century CGI Dedication Request" form required that the material be accepted basedon an MTR and/or a certificate of conformance in accordance with the purchase

36 Trademarks and registered trademarks are property of their respective owners.

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specification. There was no MTR. The material acceptance was based on an inspectioncertificate from a non-NQA-1 vendor and a certificate of conformance from Fuji PackingCo., Ltd. The certificate of conformance confirmed that the delivery would be made onthe scheduled date and that any shortage or defective material would be covered. AMethod 2 survey was not performed to establish the basis of the certificate ofconformance as required by 24590-WTP-3P-G000-TOO 19.

The Receiving Inspection Report and the "Dimension Check List (Cross Reference),"dated September 23, 2011, and March 20, 2012, listed dimensions but did not provideany reference to the measurement and test equipment that was used to perform themeasurements as required by the purchase order specification, 24590-WTP-3PS-GOOO-T0019, paragraph 5.6.4.2.7.

5. Century Corporation - N0049-CEN-330-0002 - Attachment 9, "Sicone Sealant -Prototype and Production"

* The CCFAs for the silicon sealant were based on the product identification from thepurchase specification and verified during receipt inspection. The physicalcharacteristics were taken from the purchase specification and the sealant manufacturer'scatalogue. The MTR listed on the receipt inspection report was actually satisfied basedon a certificate of conformance and a copy of the material safety data sheet for thestandard product from the manufacturer. A certificate of conformance was not providedand the material safety data sheet did not provide any validation that the silicone met theDow Coming specification cited in N0049-CEN-330-0002. There was no objectiveevidence that the silicone will perform its safety function. No evidence was provided thatthe tubes of silicone had been sent to a certified laboratory and analyzed to demonstratethat the silicone met the manufacturer's catalogue information and the Century purchaseorder specification.

6. Century Corporation - N0049-CEN-330-0002 - Attachment 11, "Bearings -

Production"

* Exhibit 1, Commercial Grade Item (CGI) Evaluation and Verification Report, Bearing,did not document an evaluation of the suitability of the CGI to perform the requiredsafety function(s) as required by Century Commercial Grade Dedication DocumentationProcedure and Plans, paragraph 4.1 .1.

* Exhibit 1, did not list the safety related function(s) required to be performed by the CGI,the potential causes of failure, the consequences of failure, nor provide a technicaljustification for determination that the item will perform satisfactorily in service asrequired by the Century CGI Evaluation and Verification Report, Exhibit 1.

* The CGD plan, paragraph 5.1.6, did not document a complete list of credible failuremechanisms for the bearing. Corrosion/Erosion was the only CFM listed. Some CFMsthat could affect the bearing's safety performance were not included in the failureanalysis, for example, bearing failure due to overheating, structural failure due toimproper material, and bearing failure due to loss or failure of the lubrication.

* The CGD plan, paragraph 5.1.6, was incorrect in stating that the CFM ofcorrosion/erosion was not credible because the bearings were lubricated in oil. BNI

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Engineering Specification 24590-WTP-3PS-MACS-T0005, Rev. 0, Paragraph 3.8.4.1,"Bearings," required that multi-stage blowers shall be supplied with grease-lubricated,radial roller bearings.

* The grease used to lubricate the bearings was not procured from an NQA-1 supplier ordedicated as a CGI as required by purchase order specification 24590-WTP-3P-GOOO-T0019, and NQA-1-2004, Part I, Section 400, "Terms and Definitions," CGI.

* Exhibit 1, Physical Characteristics, identified the "Material of Cage: steel" as a physicalcharacteristic. The material of the rollers was not specified, even though the rollerbearing material is critical to the ability of the bearing to perform its safety function.

* The Century CGI Dedication Request listed vibration testing as a performancecharacteristic. These were listed as Operation Number 6 dated December 26, 2011, andOperation Number 8 dated December 3, 2012. The acceptance criteria for the vibrationtests of the 12 High-Level Waste (HLW) Melter Offgas Treatment Process System(HOP) fans was less than 1.0 mil displacement at 3,600 rpm. The following 12 HOP fanvibration tests were conducted at the speeds indicated:

- HOP-FAN-00001A 1,772 rpm- HOP-FAN-OOOO B 3,556 rpm- HOP FAN-00001C 1,768 rpm- HOP-FAN-00009A 1,779 rpm- HOP-FAN-00009B 1,770 rpm- HOP-FAN-00009C 1,769 rpm- HOP-FAN-00008A 1,778 rpm- HOP-FAN-00008B 1,775 rpm- HOP-FAN-00008C 3,558 rpm- HOP-FAN-00010A 1,776 rpm- HOP-FAN-OOlOB 1,779 rpm- HOP-FAN-00010C 1,782 rpm.

Only 2 of the 12 HOP fans, HOP-FAN-00001B and HOP-FAN-00008C, were tested nearthe test speed. The dedication report did not provide the justification for acceptance of 10out of 12 vibration tests performed at approximately 1,770 rpm instead of 3,600 rpm asspecified in the acceptance criteria. It is noted that the remaining two tests wereperformed at approximately 3,550 rpm, which is still less than the required 3,600 rpm.

* Engineering Specification 24590-WTP-3PS-MACS-T0005, Engineering Specification forHigh Integrity Centrifugal Blowers - Multi-stage, Rev. 0, October 20, 2010,paragraph 6.6.3, states that

... vibration performance shall be checked and reported at 10% incrementsof full speed blower tests. Vibration testing shall not be performed within+/- 20% of the blower's critical speed. There is no indication that this wasperformed based on review of the provided data sheets.

* Two of 12 fan vibration test reports were incomplete in that they were missing the motorframe axial vibration reading, as required by the test specifications for the vibration

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critical characteristic. No basis or rationale was provided for the missing readings or whythe test results were acceptable without the specified data.

* A CCFA supporting physical characteristics was that the bearing cage assembly was tobe made of steel and the acceptance method was listed as a visual inspection. The CGIchecklist, Section 5, indicated material of cage as "accept." However, the CGI dedicationpackage did not indicate when the visual inspection was performed. The receivinginspection report form had a block for visual inspection. The attributes for thatinspection were "(1) no deformation and damage and (2) both received bearings inCentury Corporation and required bearing type from purchase specifications wereidentical." While this may be when the visual inspection for material of the cage wasperformed, the acceptance criteria and the results were not identified. As such,N0049-CEN-330-0002 lacks a basis for the determination that material of the 36 bearingswas steel based on a visual inspection.

* The CGI dedication request form listed "material" as a physical characteristic and statedthat the method of acceptance was a visual inspection to determine that the bearing casingwas steel, as specified in the procurement specification. A visual inspection cannotdetect that the casing was steel as opposed to some other metal alloy.

7. Century Corporation - N0049-CEN-330-0002 - Attachment 16, "Shaft Coupling -Production"

* Exhibit 1, Commercial Grade Item (CGI) Evaluation and Verification Report, shaftcoupling, does not document an evaluation of the suitability of the CGI to perform therequired safety function(s) as required by Century Commercial Grade DedicationDocumentation Procedure and Plans, paragraph 4.1 .1.

* Exhibit 1, does not list potential causes of failure, consequences of failure, and providetechnical justification for determination that the item will perform satisfactorily in serviceas required by Century CGI Evaluation and Verification Report, Exhibit 1.

* The CGD plan, paragraph 5.6.6 did not provide a complete list of credible failuremechanisms for the shaft coupling. Corrosion/Erosion was the only CFM listed.Additionally, the plan stated that because shaft couplings consisted of powder-coatedcovers, greased metal parts, and EPDM gasket, corrosion is not credible failuremechanism. The justification provided a list of compensatory measures that addresscredible failure mechanisms that were not listed. The results of this discussion contributeto the CCFA.

* The CCFA include "materials," however, the acceptance of material was based on anMTR or certificate of conformance and the acceptance criteria was listed as the purchasespecification. An MTR was not provided. The purchase specification listed acceptancecriteria as oil seal material as EPDM and gasket material as EPDM. The purchasespecification did not discuss metal components of the shaft coupling.

* The Falk Steelflex Catalog stated that the tapered grids, made of high strength alloy steel,are quenched and tempered to spring hardness. The grid surface is then precision shotpeened to compress the surface molecules. Material composition and special processeswere not addressed as CCFA.

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* Century accepted the shaft coupling when the acceptance criteria were not met. BNI didnot detect this deficiency. Specifically, N0049-CGI-DDCI.006-01, Dimension Check.List, listed dimension A and B readings for the shaft couplings. The "Dimension CheckList (Cross Reference)" documented that the Century shaft coupling serial numbers 08,09, 10, 13, 14, 15, and 16 did not meet the specification criteria specification high on the"B" dimension. They were not identified as out of tolerance.

* Century accepted the shaft coupling when the acceptance criteria were not met. BNI didnot detect this deficiency. Specifically, N0049-CGI-DDCI.006-01, Dimension CheckList listed Century serial numbers and dimensions A and B not consistent with thesupplied drawings. Specifically, the drawing for CR 03 - 08 listed dimension A as15.875 and dimension B as 67.61. The dimension check list recorded values fordimension A of 12, instead of 15.875.

* Century accepted the shaft coupling when the acceptance criteria were not met. BNI didnot detect this deficiency. Specifically, N0049-CGID-DOTR, Operability Test Report,dated December 4, 2012, listed noise readings in decibels, A-scale (dBA) for 12 shaftcouplings. All 12 readings exceeded the maximum noise reading of 85 dBA at 3 feet asspecified in 24590-WTP-3PS-MACS-T0005, High Integrity CentrifugalBlowers-Multi-Stage Technical Specification, Rev. 0. The Operability Test Report,however, listed the test results as "accept" and did not provide the justification foraccepting the out-of-specification noise readings, as required by 24590-WT3PS-MACS-T0005.

* The CGI dedication request listed "Operability" as a Performance Characteristic. Theacceptance criteria was "No visible mechanical trouble during testing." The out ofspecification noise readings did not meet the CGD performance critical characteristicacceptance criteria and the shaft couplings, yet the couplings were accepted.

* The receiving inspection report dated April 18, 2012, listed "review of the MTR" as arequired examination for accepting shaft coupling critical characteristics. An MTR wasnot included as part of the dedication package. The contents section of the report stated,"Shaft Coupling's C of C is verified in accordance with PS and PO." The CGD surveyplan did not specify a Method 2 survey on which to establish the commercial controlsimplemented by Rexnord as acceptable and as such establish the basis for the certificateof compliance as required by 24590-WTP-3P-GOOO-T-0019, Section 3.4.

8. Flowserve - CGD-121, CGD Dedication Plan for BX2 Packin' Gland, Adjuster, andPacking- Ring Sets

Note that these CGD deficiencies were the subject of the U.S. Department of Energy (DOE),Office of River Protection (ORP) audit U-14-QAD-RPPWTP-001, Performance Audit ofBechtel National, Inc. Supplier Flowserve Corporation, previously transmitted to BNI onDecember 5, 2014, in letter 14-QAD-0065, "Contract No. DE-AC27-01RV14136 -Transmittal of U.S. Department of Energy, Office of River Protection Audit ReportU-14-QAD-RPPWTP-001, 'Performance Audit of BNI Supplier Flowserve Corporation,'and BNI has initiated the appropriate corrective action documents for the six Priority Level 3findings contained therein. The CGD findings of that report are repeated here as additional

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evidence of CGD process deficiencies and to illustrate the similarity to the findings identifiedin this audit.

The CGD plan developed by Flowserve did not follow the format of, nor include the informationrequired by the BNI-accepted Flowserve procedure for CGD plan development.

* Flowserve procedure NQP7-1-4, Paragraph 7.3 stated that the CGD plan headinginformation shall establish traceability of the CGD plan to a distinct item or service.Several items were listed as required to establish and sustain that traceability. The CGDplan heading did not contain the name of the customer, the contract/purchase order, theCookeville Valve Operation sales order number, the items' recognized identification/partnumbers, and a description of the items as required.

* NQP7-1-4, Paragraph 7.4, part A, "Identification," did not list all of the required entries.Seven of the 13 required entries not listed included:

- Quantity of each item

- Applicable Flowserve customer name and supplier nomenclature, including drawingnumber with revision/date, part number

- Anticipated service and operating conditions/environment

- Design features

- A statement whether the item can or cannot be ordered from a catalogue

- Suppliers of the items including the suppliers' approved supplier list address

- Relevant commercial grade survey number that was identified as appropriate for theCGD process being documented.

* Paragraph 7.5, Part B (6) of NQP7-1-4 stated, in part "Identify the credible failuremechanism(s) associated with the item's functions and enter the CFMA results."

- The critical failure modes analysis discussion did not address use of the wrongmaterial makeup of the packing material as a potential failure. The purchase orderspecifically required the use of a graphite gasket. Because the type of gasket materialfor this application was not analyzed as a potential failure mode, the design criticalcharacteristic(s) was not established and a CCFA was not identified in either Table Dor in the material code sheet for the packing material.

- Incorrect size was discussed as a credible failure mechanism; however, the planstated, in paragraph 6.1, that dimensions and component mating will be proved duringshell testing. Hydrostatic testing will only demonstrate that the packing gland can betightened to hold pressure. Experience has shown that improperly sized packing canresult in valve stem binding and galling, which ultimately results in valve stemleakage. Since the Flowserve Method 2 - Commercial Grade Survey of Garlock (thepacking material supplier) discussed how the company manages physical dimensions,the dedication plan could have referenced (but did not) the critical process formanaging packing size in the commercial grade survey as a way to address a crediblepacking failure mechanism (packing size).

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Paragraph 7.7, Part D - CCFA

- The CGD plan included a table required by the procedure identifying specificinformation to be included in specific columns. The layout of the columns referencedin the procedure was not the same as those included in the table in the CGD plan.

- Table Critical Characteristic CC. 1, "Identification," stated that acceptance will be byMethod 1 (special test or inspection) and be conducted during the receivinginspection.

* Criterion for this inspection was omitted for the packing gland.

* Although the criteria column stated that the adjuster shall have the materialidentified on it, it did not reference the acceptance criteria (i.e., the material thatthe adjuster should be). For other items being dedicated, the material controlsheet (MCS) was referenced in the CGD plan as the document to provideacceptance criteria. In this case, the markings section of the MCS listed theappropriate acceptance criteria for the adjuster. However, the MCS was notreferenced in the CGD plan.

* The commercial grade survey for the labeling critical process, discussed how eachcontainer of packing was labeled to link the material to the customer requirements(purchase order). The label for the packing was not evaluated during the receiptinspection.

- Table CC.2, "Material Verification," stated that acceptance will be by Methods 1 and2.

* Some inspection criteria were provided for Method 1; however, acceptancecriteria for critical processes to be evaluated were not provided for Method 2.

* The test/inspection for the method listed positive material identification/externaltesting; however, the use of an external testing activity and name of the subtiervendor that would perform it was not referenced in the acceptance criteria for thepacking, packing gland, or adjuster.

* Acceptance criteria for the packing CCFA stated that a certificate of conformancefrom the supplier shall verify compliance to the applicable MCS. The MCS forpacking did not list a material section; however, in the documentation section itrequired a certificate of conformance stating the component complied with theFlowserve material code; Flowserve drawing; and a statement the materialsupplied was manufactured, sampled, tested, and inspected in accordance withany applicable ASTM International (ASTM) standards. The appropriate ASTMstandard for this set of packing and the acceptance criteria was not listed.Therefore, the plan was deficient in identifying the criteria for acceptance of thecritical characteristic.

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- Table CC.3, "Performance," stated the test/inspection method will be performed byCookeville Valve Operation manufacturing.

* The test/inspection method did not list the specific type of inspection required(i.e., visual, dimensional, marking, etc.). In this instance, the test/inspectionmethod should have been specified as a hydrostatic test.

* The criteria section specified performance of a hydrostatic test but did not specifythat the test be performed in accordance with the Inspection and Test Plan for theassembled valve. The criterion did not reference hydrostatic test pressure, the testfluid, or the hold time. It should be noted that while the above information andacceptance criteria was not listed in the CGD plan as required, this informationwas in the corresponding Inspection and Test Plan, Rev However, the inspectionand test plan was not referenced in the table.

- NQP7-1-4 stated that the documentation for the acceptance criteria column should:

... identify the specific results associated with the test/inspectionprocess consistent with the verification method selected. Include thetolerance, limits or range of readings considered acceptable. Forexample, a length may be expressed as 1" ±0.005", or hardness asRC45-50. Insert a drawing number, test name, specification, standardor test procedure, test jig or fixture to provide a frame of reference foracceptance.

* The criteria section for this CGD plan did not list the acceptance criteria asrequired.

* The MCS for the cast adjuster included heat treat (a design critical characteristics)and nondestructive examination (inspection requirement). CCFA were notidentified to address these MCS expectations.

* Paragraph 7.8, Part E, "Commercial Grade Survey Verification," did not list thesurvey number, the supplier, the expiration date for the survey, or list the criticalprocesses for the CCRA included as part of the survey, as required. In addition, astatement was not documented in the plan that the scope of the current CGD planwas within the scope of the survey performed and that all CCFA were valid underthe same survey, as required.

Contrary to the requirements of BNI's purchase order specification, 24590-WTP-3PS-GOOO-TOO 19, Flowserve issued two purchase orders and performed the CGD of the threeitems covered by the purchase orders prior to the CGD plan and CGD survey procedurebeing submitted to BNI for acceptance as required by BNI purchase order.

- On May 15, 2014, and May 21, 2014, Flowserve issued purchase orders to GarlockSealing Technologies and Post Precision Castings, respectively. The CGD plan thatwas to be used to dedicate the three components, and adjuster, packing glandassembly, and packing, covered by the two purchase orders was issued Rev. 0 byFlowserve on May 22, 2014.

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- The CGD plan was returned to Flowserve with comments on August 4, 2014, as CodeStatus 3 (revise and resubmit; work may not proceed). The CGD plan had not beenapproved prior to these comments and had not been authorized by BNI to be used todedicate the components.

- NQP7-1-4 used by Flowserve to develop the CGD plan was submitted to BNI forreview and acceptance. BNI completed their review and on June 20, 2014, approvedthe procedure for use as Code Status 2 (revise and resubmit; work may proceedsubject to resolution of indicated comments). BNI's comment stated:

No specific instructions for conducting commercial grade surveys. Ifdedicating items or services via method 2/survey, revision of thisprocedure will be required, or provide a method 2/survey specificprocedure that aligns with NQA- 1 Requirement 7, Paragraph 704.1and 24590-WTP-3PS-GOOO-T0019, Section 3.4 for review.

BNI did not have a record that the CGD survey procedure was submitted to BNI forreview as required. Flowserve performed a Method 2/survey on Garlock onAugust 31, 2012, and on Post Precision Casting, Inc., on September 13, 2012.

Flowserve purchase orders did not direct the use of procedures reviewed and approved inthe CGD survey for use in performing the Flowserve contracted work. Additionally, thepurchase order did not specify that a certificate of conformance be provided by thesubtier suppliers to Flowserve attesting to the implementation of the identified processesand controls as required.

IONEX General Comment on Method 2 Survey supporting all CGD Packages

Review of the commercial grade survey report and checklist for IONEX (24590-WTP-SSV-MATL-13-007, Commercial Grade Survey Report, IONEXResearch Corporation, Lafayette,Colorado, Rev. 0) in support of the low-activity waste thermal catalytic oxidizer (TCO)/reducerskid and ammonia skid identified instances in which the documented expectation was not met yetthe item was marked as satisfactory. An explanation was not provided as to why the line-of-inquiry (LOI) was satisfactory even though the requirements were not met.

* Evaluation of the survey checklist, item 9, "Evaluation of Testing and InspectionActivities, Material Testing," stated, "Verify traceability is maintained during materialtesting. Verify traceability on the material as well as the paperwork." The objectiveevidence stated, "There is no procedure that directs this activity, and there were notactivities happening during the survey to be witnessed." The area was graded assatisfactory; however, it was not consistent with NQA-1 or the 24590-WTP-QAM-QA-06-001, Quality Assurance Manual.

* LOI Section 1, "Evaluation of Testing and Inspection Activities, Inspection," checklist 6,states, that "the product acceptance and inspection map legend do not contain the actualresults of the inspections, just whether or not the inspections were performed and if theywere acceptable." This does not meet the LOI that required objective evidence of theinformation reviewed. The LOI was graded satisfactory and reference was not made asto where that information was contained.

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* The LOI Section 1, checklist 8, stated, "Verify the receipt inspection process addressesapplicable specification requirements." The survey checklist recorded, as objectiveevidence, that "the PO, Product Acceptance, and the shipment Receipt Checklist did notlist any codes, standards, or specifications which the procured products must comply andwith which the products were checked against upon receipt. However, this is incompliance with the IONEX procedure." The item was graded as satisfactory. The basisfor the difference between the LOI and the IONEX procedure was not documented in theLOI.

* The survey checklist, LOI Section 4.5.a.ii sought objective evidence that IONEX hasreviewed purchase orders for accuracy of quality and technical requirements. Thechecklist objective evidence stated, "IONEX does not send their PO back to Engineeringfor review to determine if the appropriate requirements have been flown down.Engineering does review the PO's on a case-by-case basis, but there is no documentedproof." The line was marked satisfactory. The rationale for accepting the LOI assatisfactory was not documented.

9. IONEX - 24590-WTP-CGD-MATL-13-0003, LA W Thermal Catalytic Oxidizer/SelectiveCatalytic Reducer Skid and Ammonia Dilution Skid

* The CGD plan for the Low-Activity Waste Catalytic Oxidizer/Reducer Skid andAmmonia Dilution Skid assembly did not document, through the technical evaluation, thecritical characteristics representing those characteristics of the item that supported theability of the host equipment to perform the required safety functions during and after adesign basis accident. Additionally, the individual CGD plans for the components of theskid did not address the need for system performance to meet the safety function duringand after a seismic event.

* The TCO/ammonia dilution skid (ADS) CGD plan, 24590-WTP-CGD-MATL-13-0003,did not identify a special test or inspection for the assembled skid as part of the method ofacceptance. The only functional tests were required by the component subassembly CGDplans. The skid CGD plan was deficient because it did not test the overall skid assemblyto demonstrate it was capable of performing the required safety functions, namelyconfinement and structural integrity during a design basis event.

* 24590-WTP-CGD-MATL-1 3-0003 identified all of the critical processes required for thededication of the TCO/ADS. The critical processes were also listed in the "Basis ofSelection" section and the "Acceptance Methods" sheet for Method 2. The audit teamfound that the individual IONEX CGD subcomponent CGD plans did not capture all ofthe applicable critical processes identified in 24590-WTP-CGD-MATL-13-0003. Forexample, IONEX CGD Plan 24590-WTP-CGD-MATL-1 1-0039, LA W TCO/R andAmmonia Dilution Skid Process Off Gas Heater, Rev. A and Rev. 0 required welding.Under the "basis of selection" section of the plans, both the skid and off gas heater plansdiscussed acceptable welds; however, IONEX's welding and nondestructive testingcritical processes were not identified in the off gas heater CGD Plan as part of theacceptance of the critical characteristic, "pressure boundary material integrity."

* The material acceptance plan (MAP) for the IONEX TCO/reducer skid and ammoniaskid for review included the entire purchase order of 20 plus CGD plans for components

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of the two skids. The MAP did not require a sufficient level of specificity to demonstratethat each of the CGD plan requirements have been completed and accepted. The MAPdid not meet the requirements of 24590-WTP-GPP-MGT-013.

10. IONEX - 24590-WTP-CGD-MATL-12-0013, LA W TCO/R and Ammonia Dilution SkidBall Valves

* The technical evaluation in 24590-WTP-CGD-MATL-12-0013, CGD Plan for the LAWTCO/R and Ammonia Dilution Skid Ball Valves, listed two CFM for the ball valves, fivevalve components that might be affected, and material characteristics to address theCFMs.

- A technical discussion was not provided that addressed the cause of the corrosion(environmental chemical exposure) and why the selected material mitigated thecorrosion as required by 24590-WTP-GPP-MATL-010, Section 5.3.5.

- Packing and O-rings were listed under material subject to failure but not addressedunder material physical/mechanical properties. As such, the consequence of failurewas not established for packing and O-rings as required by 24590-WTP-GPP-MATL-010, Section 5.3.5.

* The CGD plan, 24590-WTP-CGD-MATL-12-0013, "Basis of Selection" section, under"Material Integrity" stated that material strength properties do not require individualverification as valves designed in accordance with ASME B 16.34 are sufficiently ruggedto withstand the stress levels of the bounding conditions. An evaluation(Method 2/survey) was not performed of the valve supplier's commercial program usedto manufacture the valves to demonstrate that the valves were actually manufactured tomeet ASME B 16.34 requirements as required by 24590-WTP-GPP-MATL-010,Section 5.4.2.

* The selection of critical characteristics for acceptance did not address ANSI K61.1,Requirement for Anhydrous Ammonia, as required by 24590-LAW-3PS-MBTV-TOOO1for determination of the valve for acceptable use in an anhydrous ammonia application.Proper labeling of the valve for anhydrous ammonia use provided a CCFA that the valvewill perform its safety function in the environment of use as required by 24590-WTP-GPP-MATL-010, Section 5.3.5.

* Under Basis for Selection, Chemical Composition, 24590-WTP-CGD-MATL-12-0013stated that the ball and stem must also be made from proper material to provide therequired corrosion resistance to maintain system pressure integrity. The acceptancecriteria was "no Yellow Metal," which is not consistent with the CCFA for other pressureboundary components. The technical evaluation does not provide the basis for why thevalve ball and stem CCFA have different CCFAs than the valve body or end connectionsfor maintaining system pressure integrity. The criteria of "no yellow metal" is not ajustified CCFA as required by 24590 WTP-GPP-MATL-010, Section 5.3.5.

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Four separate ball valve source verifications are identified in the ball valve CGD plan(24590-WTP-CGD-MATL-12-0013). The following issues with the source verificationswere identified:

- 24590-WTP-CGD-MATL-12-0013 specified that visual verification of the "NoYellow Metal" material critical characteristic was to be performed to a "normal"sampling plan. A sampling plan was not provided as part of the dedication package.Additionally, the CGD plan stated that a sample plan justification and basis for lotdetermination was "not applicable." This did not meet 24590 WTP-GPP-MATL-010,Section 5.4 requirements.

- 24590-WTP-CGD-MATL-12-0013 designated Method 3, source verification, as themethod of acceptance for the ball valve factory acceptance test (FAT). The CGDplan stated that the FAT may be performed by a pressure test, a sensitive leak test, ora bubble test. The MAP, 24590-WTP-MAP-AS-10-00014, identified the test as ahold point; however, neither the CGD Plan (24590-WTP-CGD-MATL-12-0013),24590-LAW-3PS-MBTV-T0001, nor ASME B16.34 specified the acceptance testmethod or the acceptance criteria for the FAT. The CGD plan for the valve did notspecifically state which test was to be performed and the value for acceptance, asrequired by 24590 WTP-GPP-MATL-010, Section 5.3.6.

- The MAP, 24590-WTP-MAP-AS-10-00014, Rev. 4, line item 15, required thesupplier quality representative witness all functional testing of the TCO and ADS skidcomponents, including, as applicable, the pressure test, the sensitive leak test, or thebubble test. The MAP acceptance criteria for the FAT referenced 24590-LAW-3PS-MBTV-TOOO1, Sections 6.4 and 3.16.4. These sections of the specification did notspecify the CGD acceptance method or criteria, as required by 24590-WTP-GPP-MATL-010, Section 5.3.6. The following are examples of the lack of clearperformance testing methods, acceptance criteria, and acceptance values:

* 24590-LAW-3PS-MBTV-TOO01, paragraph 3.16.4.5 required pressure boundaryintegrity testing to be performed in accordance with ASME B 16.34, Section 7.While 24590-LAW-3PS-MBTV-TOOO1 did not require 100 percent testing; itallowed the test to be performed using a normal sampling plan. A sampling planwas used, however, the CGD plan did not describe nor provide the justificationfor its use, as required by 24590-WTP-GPP-MATL-010, paragraph 5.3.4.

* The ball valve CGD plan, 24590-WTP-CGD-MATL-12-0013, required thepressure testing be performed in accordance with ASME B31.3, Section 345.4 or345.5, at 450 psi or 330 psi, respectively. Neither the CGD plan, thespecification, nor ASME B31.3 provided information to guide the selection of thepressure test method and testing requirements.

* Both the ball valve CGD plan and the MAP require a FAT for acceptance of theTCO and ADS subcomponents. Acceptable tests are described in specification24590-LAW-3PS-MBTV-TOO01, paragraph 6.4.13, but the paragraph onlyapplies to the testing of the fully assembled TCO and ADS, not for the individualcomponents.

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- The forth source surveillance listed under Method 3 of the CGD plan was to reviewall CGD related testing documentation (e.g., positive material identification (PMI),leak test) and MTRs for compliance with applicable codes and/or standards. A listingof all required documents to be reviewed was not provided and the acceptance criteriawas not established as required by 24590-WTP-GPP-MATL-010, Section 5.3.6.

* The MAP did not list specific inspections or surveillances that were required by the CGDplan to be performed and the acceptance criteria that were required to be met todemonstrate that the critical characteristics had been met, specifically:

- The method of acceptance to verify the critical characteristic of material chemistrywas to verify that the PMI test laboratory was accredited. 24590-WTP-CGD-MATL-12-0013 provided the acceptance criteria but it was not identified and placed in theMAP to complete verification of the critical characteristic.

- The MAP specified the method of acceptance for verification of the stem and the ballmaterial critical characteristic as a visual inspection to verify there was "No YellowMetal" in the ball and stem based on a normal sampling plan for each ball valve size.The MAP did not implement this requirement. Furthermore, the use of the normalsample plan was not justified or described in 24590-WTP-CGD-MATL-12-0013 andthe lot identified did not meet the requirements of 24590-LAW-3PS-MBTV-TOO01.

11. IONEX - 24590-WTP-CGD-MATL-13-0001, LAW Ammonia Dilution Skid GasFlowmeter

* 24590-WTP-CGD-MATL-13-0001 did not address the ANSI K61.1 requirement foranhydrous ammonia, paragraph 2.3 which states that an "approved" component means:

- Listed by a recognized testing laboratory

- Recommended by the manufacturer as suitable for use with anhydrous ammonia andso marked.

* The method of acceptance to verify the critical characteristic of material chemistry was toverify that the PMI test laboratory was accredited. 24590-WTP-CGD-MATL-13-0001provided the acceptance criteria but it was not identified and placed in the MAP tocomplete verification of the critical characteristic.

* One source surveillance listed for Method 3 in 24590-WTP-CGD-MATL-13-0001 was toreview all CGD related testing documentation (e.g., PMI, leak test) and MTRs forcompliance with applicable codes and/or standards. A listing of all required documentsto be reviewed was not provided and the acceptance criteria was not established asrequired by 24590-WTP-GPP-MATL-010, Section 5.3.6.

12. IONEX - 24590-WTP-CGD-MATL-1-0022, LA W-TCO/R Static Mixer

* 24590-WTP-CGD-MATL-11-0022 did not address the ANSI K61.1 requirement foranhydrous ammonia, paragraph 2.3 which states that an "approved" component means:

- Listed by a recognized testing laboratory


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* The critical characteristic for material chemistry lists three chemical components thatmake up the static mixer, the pipe, the pipe flanges, and the weldolet. The valuesselected for acceptable material chemistry are based on ASTM A312, ASTM A82, andASTM A403, respectively. In all three cases, the acceptance criteria did not list thecomplete suite of chemical constituents for each material and the correspondingconcentrations as specified in the ASTM standard nor did the CGD plan provide arationale for not measuring all chemical constituent concentrations. Failure to fullyjustify the acceptance criteria is noncompliant to 24590-WTP-GPP-MATL-0 10,Section 5.3.6.

* Method 2, "Survey of Supplier," does not list the critical process for welding andnondestructive examination, which were included in the survey of IONEX to control thecritical characteristics as required by 24590-WTP-GPP-MATL-010, Section 5.4.2.

* 24590-WTP-CGD-MATL-1 1-0022, for Method 3, "Source Verification," only requiredverification that the laboratory performing the chemistry evaluations was accredited andthat the testing documentation was in compliance with the applicable codes and/orstandards. A source verification was not performed of the actual performance of thelaboratory's testing activities through witnessing, monitoring, or observing activitiesassociated with the critical characteristic(s) as required by 24590-WTP-GPP-MATL-010,Section 5.4.3.

* 24590-WTP-CGD-MATL-1 1-0022 for Method 3, item 2 required witnessing a testperformed by the vendor "in accordance with BNI approved procedures." The specifictesting activity was not listed, the approved procedure was not specified, and theacceptance criteria was not provided for the required test as required by24590-WTP-GPP-MATL-010, Section 5.4.3.

13. IONEX - 24590-WTP-CGD-MATL-11-0039, LAW TCO/R Skid Process Offigas Heater

* In 24590-WTP-CGD-MATL- 11-0039, the basis of selection of the technical evaluationstated "....a reduced rigor in the verification of the critical characteristics may be appliedthrough the pressure test, chemical composition verification, and dimensionalinspections." This is not consistent with the sample plan justification on page 7, whichstated, "100% dimensional inspections, pressure test, and chemistry check is justifiedbecause of the small quantities."

* The sample plan justification is not consistent within the section. The first line specifies100 percent chemistry check and then the second line states that first operation inspectionfor PMI is required.

* Method 2 - CGD Survey of Supplier lists six critical processes from the BNI survey ofIONEX that are being relied on to address the critical characteristics for acceptance. Thebasis for selection states that welding/brazing inspections will be performed. The basisfor selection of critical characteristics for the pressure boundary material integrityincluded "welded/brazed joints." 24590-WTP-CGD-MATL- 11-0039 did not identifyspecial processes as a survey critical process to validate the integrity of welded/brazedjoints.

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* Method 3 - Source surveillance 1 references physical testing and surveillance 4references hardness testing. Specific testing and acceptance criteria are not specified inthe testing plan as required by 24590-WTP-GPP-MATL-010, Section 5.3.6.

14. IONEX - 24590-WTP-CGD-MATL-11-0074, LA WAmmonia Dilution Skid HEPA Filter

* The technical evaluation for 24590-WTP-CGD-MATL- 11-0074, LA WAmmonia DilutionSkid HEPA Filter, Rev. A, listed the failure of the filter media and the failure of the sealas a credible failure mechanisms for the high-efficiency particulate air (HEPA) filters.The technical evaluation did not identify and evaluate CFMs for the filter media and/orseal, as required by 24590-WTP-GPP-MATL-010, Section 5.3.5.

* The "Material Integrity" section of the technical evaluation for the filters stated that thefilter was required to filter out 99.97 percent of airborne particulate and remain intact toensure that there is no gross leakage from one side of the filter to the other.24590-WTP-CGD-MATL- 11-0074 identifies two performance critical characteristics;confinement boundary integrity and filtration efficiency. The confinement boundaryintegrity critical characteristic stated "All filters shall be inspected and tested at a DOEFilter Test Facility (FTF) prior to Buyer acceptance." This is a standard DOE testrequired of all filters independent of their use in commercial or quality relatedapplications. The test is not intended by DOE to establish the quality level of the filtermedia. The filter must either be purchased from a qualified supplier or dedicated for usein Q applications.

IONEX, a commercial supplier, purchased the filter media from Flanders as acommercial item to be shipped directly to the Waste Treatment and Immobilization Plantsite. No CGD activities (e.g., tests, surveys, or source verifications) were performed byBNI to demonstrate that the filter media will meet its Q performance functions.

15. IONEX - 24590-WTP-CGD-MATL-11-0075, LA WAmmonia Dilution Skid HEPA FilterHousing

* 24590-WTP-CGD-MATL-1 1-0075, the CGD Plan for HEPA filter housing, listedmaterial chemistry of the housing, the top cover, the pipe flanges, and the pipe as thecritical characteristic for acceptance. The critical characteristic was to be validated by asource verification confirming that the PMI laboratory was accredited by an InternationalLaboratory Accreditation Cooperation organization and that the certification covered thePMI test method that the supplier [IONEX] has chosen to use. It is noted that IONEX isnot the dedicating entity; BNI is. This is contrary to the requirement of 24590-WTP-GPP-MATL-010, Section 5.3.6, paragraph 2, that the BNI procurement engineerdetermines how each critical characteristic will be verified, not the supplier.

* 24590-WTP-CGD-MATL-1 1-0075 classified the HEPA filter housing as Q for air permitrequirements and was designed to seismic category IV. However, the justification for theAir Permit Q function stated

Pressure Boundary Confinement: Confinement of C3 air is accomplishedby all components (housing, top cover, flanges and seal) of the filterhousing which form the piping pressure boundary that prevents leaks tothe area outside the piping. Confinement must be maintained during

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normal operations and during a seismic category III DBE. Structuralfailure of internals shall not breach confinement boundary.

The function to maintain confinement during a seismic category III design basis eventconstitutes a safety function over and above the air permit Q function. The CGD plan didnot identify the safety function of the filter housing and establish critical characteristics,CCFAs, methods of acceptance, and acceptance criteria to provide reasonable assurancethat the housing would perform its safety function of maintaining confinement during thedesign basis event. 24590-WTP-GPP-MATL-010, Section 5.3.5 requires that theQ function of the item be determined and whether the item has an active or passive safetyfunction or an air permit function. In this case the passive safety function was not listedalthough it was discussed as justification for the air permit.

* The CFM states that "credible failures for the HEPA filter housing are material corrosionand material overload failure (fracture or plastic deformation)." The materials for thisitem that would be subject to failure are listed as:

- Housing- Housing cover- Door latch fasteners- Pipe stub- Flange- Housing cover gasket.

The technical evaluation did not provide a discussion of the CFMs for the componentsthat were listed. Without this discussion, the CGD Plan did not provide a basis for thecritical characteristics identified in the plan37

* The door latch fasteners were listed as a component of the filter housing that could fail;however, no further discussion was provided in the technical evaluation as to what thefailure mechanism was, the mitigation, the CCFA and, acceptance criteria as required by24590-WTP-GPP-MATL-010, Section 5.3.5.

* The housing cover gasket was not selected as a CFM and the basis for not identifyingCFMs did not support the decision. The plan merely stated, "The seal material is notverified because it is not a strength carrying component." The safety function of thehousing is confinement, therefore strength is not the issue of concern, leak-tightness is.This discussion does not address the typical leak-types of gasket failure mechanisms,such as the chemical environment, pressure of the system, and torque requirements.

* The basis for selection for chemical composition states that the weld material must bemade from proper materials to provide the required structural strength and corrosionresistance to maintain system pressure integrity. 24590-WTP-CGD-MATL-1 1-0075 didnot identify a critical characteristic to ensure the weld filler metal was made from theproper material. Further discussion of weld material was not included in the technical

37 24590-WTP-GPP-MATL-0 10, Section 5.3.5, required the technical evaluation to "Include information on the safetysignificance of the item by describing the likelihood of failure, consequences of failure, failure mechanism, designmargin, etc."

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evaluation. Neither was a CCFA listed for weld material and acceptance criteria were notestablished38

* The section titled "Critical Characteristics for Material/Physical/Mechanical Properties"stated under "Material Chemistry" that the pipe flanges were to be made of ASTM A 182316L stainless steel. The list of chemical constituents did not list concentrations of allelements required by ASTM Al 82. The carbon concentration, the primary differencebetween 316 and 316L (low carbon stainless steel), was not listed as a criticalcharacteristic for verification during dedication. As such, acceptance criteria was notestablished as required by 24590-WTP-GPP-MATL-010, Section 5.3.6.

* The technical evaluation in 24590-WTP-CGD-MATL-1 1-0075 for the filter housing didnot identify that the flange and other welds in the housing were important to maintainingthe confinement safety function. As a result, a credible failure mechanism of weld failureor leakage was not identified and not evaluated in the credible failure mechanismanalysis. Failure to assure that the welds provide confinement resulted in a failure toprovide reasonable assurance that the filter housing could perform its safety function39

* Method 3 verified that the laboratory performing the chemistry evaluations wasaccredited and that the testing documentation was in compliance with the applicablecodes and/or standards. However, a Method 3 source verification required, per24590-WTP-GPP-MATL-010, Section 5.4.3 that the dedicating entity witness, monitor,or observe the specific activities performed to validate a critical characteristic. Nolaboratory activities were witnessed.

16. IONEX - 24590-WTP-CGD-MATL-11-0085, Stainless Steel Welding Electrodes and Rod

The critical characteristic for chemical composition did not list the complete chemicalrequirements for each welding rod item as required by the American Welding Standardslisted for each weld material specified in the CGD plan.

17. Jordan Valves - 24590-WTP-CGD-PROE-14-0036, Jordan Valve/Pressure RegulatorModel MK60

* Review of Jordan Valve CGD Plan, 24590-WTP-CGD-PROE-14-0036, JordanValve/Pressure Regulator Model MK60, Rev. 0, October 28, 2014, Section 2, Table 2.1,listed the acceptance criteria as SA479/316L for the diaphragm upper and lower platesmaterials. The differentiating characteristic of low carbon alloy found in 316L versus316 stainless steel was not specified and verified as required when selecting criticalcharacteristics in accordance with 24590-WTP-GPP-MATL-010, Section 5.3.6. As aresult, the dedication did not verify that the low carbon stainless steel was actually used,as required.

* BNI did not verify that anhydrous ammonia components from Proctor Sales, Inc.conformed to purchase order specifications, Section 2, paragraph 2.4.12 (24590-QL-POA-MKAS-00003). Specifically, the design/suitability review required that valves usedfor anhydrous ammonia shall meet the labeling requirements in accordance with

3 Ibid, Section 5.3.6 lists the requirements to select critical characteristics, acceptance criteria, and how the criticalcharacteristic will be verified.39 Op Cit.

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ANSI K61.1-1999, Safety Requirements for the Storage and Handling ofAnhydrousAmmonia, Section 2.3. The American National Standards Institute standard requiredcomponents to be stamped "2.3 approved." In this standard the word approved means thecomponent is listed by a recognized testing laboratory and recommended by themanufacturer as suitable for use with anhydrous ammonia and so marked. Therefore,without the marking, the dedicator cannot verify that the critical characteristic forcomponents suited for anhydrous ammonia service was not verified.

* The BNI MAP, 24590-WTP-MAP-AS-10-00196, step 16, required BNI "verify taggingand nameplate data conforms to specified requirements in Section 1.7 of 24590-WTP-3PS-JVO5-TOOO1, Engineering Specifications for Q Pressure Regulators, Rev. 0." Thetagging requirements of Section 1.7 were not specific to the tagging required in24590-WTP-3PS-JVO5-T0001, Section 5.4.1.1 regarding suitability for anhydrousammonia use. Since the credible failure mechanism analysis considered both minor leaksand complete failure of the pressure regulators as a CFM, no critical characteristic wasselected to ensure the regulators were suited for the service as required by ANSI K6 1.1,Section 2.340

* 24590-WTP-3PS-JVO5-TOOO, paragraph 6.3 references ASME B16.34-1988 for testingrequirements. Section 7.1 of ASME B16.34-1988 states:

Shell Test: Each valve shall be given a shell test at a gauge pressure noless than 1.5 times the 100 0F rating, rounded off to the next higher 25 psiincrement. The test shall be made with water, which may contain acorrosion inhibitor.

Contrary to the requirement, the Jordan Valve CGD Plan states in Section 2.3 - Method 3,2.3.3, that all 14 regulator assemblies (100 percent) are shell tested at a shell test pressureof 450 psi and that the test media will be nitrogen gas at 120 0 F maximum.

* The Jordan Valve CGD Plan listed material chemistry for the body, end connections, andfasteners as a critical characteristic for acceptance to be performed by PMI. The CGDplan did not include complete chemistry specifications for the alloys selected (acceptancecriteria).

* The Jordan Valve CGD Plan identified as a Method 3, source verification activity to"verify that all M&TE used in the assembly and testing of the 14 valves [regulatorassemblies] are currently calibrated by an ISO 17025 accredited laboratory and obtaincopies of the calibration reports. This activity verifies the following CCs: - leaktightness, bolt torqueing and material strength." 41 This source verification was notidentified on the MAP for verification of the stated critical characteristics. As a result,there is no objective evidence to provide reasonable assurance the regulators will performtheir safety function.

40 ANSI K61.1, Section 2.3 requires that valves shall be listed by a recognized testing laboratory and be recommendedby the manufacturer as suitable for use with anhydrous ammonia and so marked.41 24590-WTP-CGD-PROE-14-0036, Jordan Valve/Pressure Regulator Model MK60, Rev. 0, October 28, 2014,Section 2.3, "Source Verification."

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* The third source verification listed in the CGD plan was to witness performance of thefactory acceptance test and verify that the testing was performed in accordance with aprocedure accepted by BNI. The Jordan Valve CGD Plan did not list acceptance criteria.The MAP referenced 24590-WTP-3PS-JV05-T0001, paragraph 6.3, as acceptancecriteria. 24590-WTP-3PS-JV5-T0001, paragraph 6.3 in turn referenced ASME B16.34,"Valves Flanged, Threaded, and Welding End," Section 7. It further states that theperformance of this test will be at 1.5 times the system design pressure in lieu of the100F pressure rating. The design pressure was not provided and was not referenced. Assuch, acceptance criteria was not provided as required to validate the criticalcharacteristic and no objective evidence was generated to demonstrate acceptance.

* 24590-WTP-MAP-AS-10-00196 did not include one of the five witness points identifiedin the Jordan Valve CGD Plan, paragraph 2.3.1, which required, as part of a sourceinspection, that BNI witness all 14 regulator assemblies and verify they are assembled perRichards Industries procedure SP-81068, MK60 Assembly Procedure, Rev. 3. Since theMAP did not address this source verification activity, objective evidence was notgathered to validate that the critical characteristics were verified.

* The Jordan Valve CGD Plan and MAP did not provide and/or reference a sourceverification plan or checklist required by 24590-WTP-QAM-QA-06-001, Rev. 11,Section 7.1.2.12.6.1.

18. Bad2er - 24590-WTP-CGD-PROE-14-0040, Circular Expansion Joints, Rev 0 (Did notMeet Acceptance Criteria)

24590-LAW-M6D-LVP-00006, Mechanical Data Sheet: Expansion Joint Bellows, Rev. 2, datedOctober 18, 2012, contained specific requirements for the material used for the bellows.Specifically, note 3 in the remarks stated "Bellows material shall be solution annealed andcooled to below 800 0 F within 3 minutes after forming. Other materials for bellows shall eitherbe annealed or stress relieved depending on the specific application."

* 24590-WTP-CGD-PROE-14-0040 for the bellows expansion joints did not address theheat treatment requirements for the bellows material to either include them or excludethem as critical characteristics. Therefore, the technical evaluation was not sufficientlythorough to demonstrate that the CCFA selected were adequate to provide reasonableassurance that the expansion joints would perform their safety function of confinement42.Because these material properties were not identified as critical characteristics, noobjective evidence was gathered during the dedication either through a Method 1 test orinspection, a Method 2 survey, or a Method 3 source verification.

* 24590-WTP-CGD-PROE-14-0040, Section 1.12, "Basis for Selection," the fourth andfifth paragraphs discuss nondestructive examination of welds. One note stated that somewelds are not accessible after fabrication. The CGD plan did not establish the method ofacceptance for the inaccessible welds or provide a rationale for not examining theinaccessible welds.

42 24590-WTP-GPP-MATL-010, Section 5.3.6

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* 24590-WTP-CGD-PROE-14-0040, Section 1.12, sixth paragraph states "The dedicationactivities are commensurate with the likelihood and consequence of failure, both ofwhich are low based on the following considerations." Two of the four listed conditionsare general in nature and do not provide the validity of the stated case, specifically:

- Second bullet lists the B31.3 allowable stress of 316L and states that it is more thanadequate to retain the design pressure without providing any basis or rationale for theconclusion.

- Third bullet states that the bellows cyclic design life stated in the supplier's drawingsexceeds that specified in the bellows datasheets. No rationale or technical basis wasstated to validate this general conclusion.

* 24590-WTP-CGD-PROE-14-0040, Section 2.1, "Method 1 for the CC of PressureConfinement Boundary Integrity," the test method was listed as a Pneumatic Leak Test ofthe assembly performed in accordance with ASME B31.3, Section 345.5. 24590-WTP-CGD-PROE-14-0040 defined the test acceptance criteria the same as the bellows designpressure of 15 psig. ASME B31.3, Section 345.5.4, however, required that the testpressure shall be 110 percent of design pressure or 16.5 psig. Therefore, the test was notperformed as required.

* Review of CCN: 276630, "CGD Release of LAW Circular Expansion Joints," noted thatonly two of the eight full penetration welds on each bellows were accessible for visualinspection. Furthermore, the two welds that were accessible were only partiallyaccessible. Based on the number of welds that could not be visually inspected and thetwo bellows that failed the visual inspection, BNI procurement engineering should havechanged the method of acceptance or modified the critical characteristics43 to justifyacceptance of the bellows welds.

- CCN: 276630 also documented small areas of weld undercut observed on most of theassemblies; however, joint configuration is such that a gage could not accuratelymeasure the depth of indications. BNI procurement engineering did not implementthe requirement of 24590-WTP-GPP-MATL-010, Section 5.2, note 1", once it wasdemonstrated that this method of acceptance failed to demonstrate reasonableassurance.

- The CGD plan covers 14 expansion joints for use in various applications in the Low-Activity Waste Secondary Offgas/Vessel Vent Process System and the HLW MelterSecondary Offgas Treatment Process System. The technical evaluation did notdocument that the CGD plan for multiple items used in different applications arebeing dedicated to the most severe conditions within the area of use4 5 .

19. REOTEMP Pressure Gaug~e - 24590-WTP-CGD-MATL-10-0072, Process PressureGauzes (Does not meet Acceptance Criteria)

43 24590-WTP-GPP-MATL-010, Section 5.2, note 1, stated "When one or more CCs cannot be verified by thededication methods, this procedure shall not be used to procure or accept CGI or CGS."" Ibid.45 24590-WTP-GPP-MATL-010, Section 5.3.3, stated "If an item is for a broad application, describe the scope tobound the items used, if necessary."

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* CGD Plan 24590-WTP-CGD-MATL-10-0072, Process Pressure Gauges, covers thededication of four gauge ranges with ammonia and nonammonia application. A CCFAwas not established for the verification of gauges that would be used in an ammoniasystem as "evaluated and acceptable for use in the ammonia system" and so marked.ANSI K61.1, paragraph 2.3 states that an "approved" component means:

- Listed by a recognized testing laboratory.


- This is similar to the identification and marking of items for use in ammonia systemsthroughout the project.

* The technical evaluation CFM analysis states that the pressure boundary, as shown bymanufacture's drawing, is stainless steel. The Method 1 - Special Tests and Inspectionsfor verification of critical characteristic for pressure boundary material integrity forammonia service requires 100 percent inspection. The three components that make upthe pressure boundary are the bourdon tube, the stem, and the National Pipe Threadconnection. The inspection is a visual inspection for no yellow material. The basis forselection states that the bourdon tube and stem are housed within the gauge and only theNational Pipe Thread connection is exposed for visual inspection. Only inspecting one ofthree components of the gauge does not meet the 100 percent inspection as required bythe CGD plan. BNI procurement engineer did not implement 24590-WTP-GPP-MATL-010, Section 5.2, note 1, which states "when one or more CCs cannot be verified by thededication methods, this procedure shall not be used to procure or accept CGI or CGS."

* The selection of acceptance criteria for "no yellow metal" does not establish that thegauge boundary components are made of stainless steel. The technical evaluation doesnot provide a rationale as to why a visual inspection is sufficient for acceptance of thecritical characteristic as required by 24590-WTP-GPP-MATL-010, Section 5.3.6.

20. 24590-WTP-CGD-PROE-14-0041, Concentric Restriction Orifice Plate (Incorrectacceptance criteria)

* 24590-WTP-CGD-PROE-14-0041, Appendix A under material, listed low carbon 304Land 316L as types of material necessary to address the critical failure mechanism offracture or deformation under fluid pressure due to lack of strength (incorrect materialconstruction). Appendix A also listed the ASME SA240 as the source for the acceptancevalue/range. On December 1, 2014, a laboratory test report was issued for four orificetag numbers in which the material of construction was again specified as 304L and 316Lwith assigned material percentages that did not list the low carbon value to meet the lowcarbon specification listed in ASME SA240 as required by 24590-WTP-GPP-MATL-010, Section 5.3.6.

* 24590-WTP-CGD-PROE-14-0041, Section 2.1, stated that the critical characteristic of"Bore ID/roundness" would be verified with a Vernier caliper; however, review of thereceipt inspection results performed on the orifice plate bore diameter identified that theactual inspections were performed using a bore gauge. While this may be the more

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appropriate gauge, it was not the instrument-specified in the 24590-WTP-CGD-PROE-14-0041 and the plan was not revised to be consistent with the work performed.

* 24590-WTP-CGD-PROE-14-0041, Section 2.1, required that the critical characteristic"Bore ID/roundness," be taken with two data points 90 degrees apart; however, review ofthe material requisition, 24590-CM-MRA-JF00-00001, Rev. 4, Section 2.4.3 states thatorifice bore diameter is "the mean (arithmetic average) of four or more evenly spaceddiameter measurements at the inlet edge." The arithmetic average of four measurementsis not discussed in 24590-WTP-CGD-PROE-14-0041 and was not documented on aninspection report in the CGD report as required by 24590-WTP-GPP-MATL-010,Section 5.3.6.

Review of Premier Technologies, Inc. Commercial Grade Dedication Procedure

The Premier Technologies, Inc. (PTI) CGD procedure, TP-3.4, Commercial Grade Dedication,Rev. 5, dated February 23, 2013, contained several instances in which the requirements of BNIspecification 24590-WTP-3PS-GOOO-T0019 were not included in the procedure or, if included,were optional. Examples include:

* Technical evaluation

* Seismically or environmentally qualified items

* Method 1 misconceptions

* Method 2 misconceptions

* How to deal with other ASME certifications during CGD (PTI Quality AssuranceManual 1.3).

BNI did not identify this nonconformance and require correction of the condition by the supplier.

21. PTI Technologies - CGD 11-80 - ASME SA240, 316L (UNS S31603) Plate

* The PTI CGD Plan, No. 11-80, supporting Purchase Order 99896, for ASME SA240,3 16L (UNS N10276) Plate did not provide sufficient evidence that the plate steal, whichwas being used to fabricate the caustic scrubber vessel, head, and internals that form thepressure vessel boundary could perform its safety function. The CGD plan anddocumentation of testing contained errors, specifically:

- The technical evaluation used the Boiler and Pressure Vessel Code (B&PVC)UNF-65 allowance to not perform brittle fracture testing; however, the technicalevaluation did not discuss or contain the additional evaluation for suitability testingthat is discussed in the UNF-65 allowance. 46

46 2010 Section VIII - Division 1, UNF-65, states "The materials listed in Tables UNF-23.1 through UNF-23.5 maybe used at lower temperatures than those specified herein and for other weld metal compositions provided the usersatisfies himself by suitable test results such as determinations of tensile elongation and sharp-notch tensile strength(compared to un-notched tensile strength) that the material has suitable ductility at the design temperature."

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- Acceptance criteria was not provided in the CGD plan, instead the plan referencedstandards. As such, the CGD plan did not provide criteria for acceptance as requiredby 24590-WTP-3PS-GOOO-TOO19.

- The CGD plan calls for testing of chemical composition, material tensile, yield, andelongation using an approved laboratory and establish a sample size based on whenproduction traceability exists or a single product manufacturer traceability exists. Asample plan was not provided as part of the CGD plan as required by24590-WTP-3PS-GOOO-TOO19.

- The CGD plan called for measurement of plate thickness with appropriate instrument.Sample per EPRI TR017218, Rev. 1, Table 2-1, "Normal Plan." A sample plan wasnot provided in accordance with 24590-WTP-3PS-GOOO-TOO19.

- While the package includes multiple laboratory reports documenting physical andchemical test results and various heat numbers, a final documented summary of eachlot was not listed that demonstrated that all the material met the CCFA acceptancecriteria as required by 24590-WTP-3PS-GOOO-TOO19.

22. PTI - CGD 11-116 - ASME SB575, C276 (UNS N10276) Plate

* The PTI CGD Plan, No. 11-116, supporting Purchase Order 99896, for ASME SB575,C276 (UNS N 10276) Plate did not provide sufficient evidence that the plate steal, whichwas being used to fabricate the caustic scrubber vessel, head, and internals that form thepressure vessel boundary could perform its safety function. The CGD plan anddocumentation of testing contained errors, specifically:

- The technical evaluation used the B&PVC UNF-65 allowance to not perform brittlefracture testing; however, the technical evaluation did not discuss or contain theadditional evaluation for suitability testing that is discussed in the U.NF-65allowance. 4 7

- Acceptance criteria was not provided in the CGD plan, instead the plan referencedstandards. As such, the CGD plan did not provide criteria for acceptance as requiredby 24590-WTP-3PS-GOOO-TOO19.

- The CGD plan calls for testing of chemical composition, material tensile, yield, andelongation using an approved laboratory and establish a sample size based on whenproduction traceability exists or a single product manufacturer traceability exists. Asample plan was not provided as part of the CGD plan as required by 24590-WTP-3PS-GOOO-TOO19.

- The CGD plan called for measurement of plate thickness with appropriate instrument.Sample per EPRI TR017218, Rev. 1, Table 2-1. A sample plan was not provided inaccordance with 24590-WTP-3PS-GOOO-TOO19.

- While the package includes multiple laboratory reports documenting physical andchemical test results and various heat numbers, a final documented summary of each

47 Ibid.

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lot was not listed that demonstrated that all the material met the CCFA acceptancecriteria as required by 24590-WTP-3PS-GOOO-TOO19.

23. PTI - CGD 11-79 - ASME SB575. C276 (UNS N10276) Plate

The PTI CGD Plan, No. 11-79, supporting Purchase Order 99896, for ASME SB579,C276 (UNS NI 0276) Plate did not provide sufficient evidence that the plate steal, whichwas being used to fabricate the caustic scrubber vessel, head, and internals that form thepressure vessel boundary could perform its safety function. The CGD plan anddocumentation of testing contained errors, specifically:

- The technical evaluation used the B&PVC UNF-65 allowance to not perform brittlefracture testing; however, the technical evaluation did not discuss or contain theadditional evaluation for suitability testing that is discussed in the UNF-65allowance. 4 8

- Acceptance criteria is not listed in the CGD plan, instead the plan referencedstandards. As such, the CGD plan did not provide criteria for acceptance as requiredby 24590-WTP-3PS-GOOO-TOO 19.

- The CGD plan calls for testing of chemical composition, material tensile, yield, andelongation using an approved laboratory and establish a sample size based on whenproduction traceability exists or a single product manufacturer traceability exists. Asample plan was not provided as part of the CGD plan as required by 24590-WTP-3PS-GOOO-TOO19.


- While the package includes multiple laboratory reports documenting physical andchemical test results and various heat numbers, a final documented summary of eachlot was not listed that demonstrated that all the material met the CCFA acceptancecriteria as required by 24590-WTP-3PS-GOOO-TOO 19.

24. PTI - CGD 11-116 - ASME SB575, C276 (UNS N10276) Plate from Samuel, Sons & Co.

* The PTI CGD Plan, No. 11-116, supporting Purchase Order 99896, for ASME SB575,C276 (UNS N10276) Plate did not provide sufficient evidence that the plate steal, whichwas being used to fabricate the caustic scrubber vessel, head, and internals that form thepressure vessel boundary could perform its safety function. The CGD plan anddocumentation of testing contained errors, specifically:

- The technical evaluation used the B&PVC UNF-65 allowance to not perform brittlefracture testing; however, the technical evaluation did not discuss or contain theadditional evaluation for suitability testing that is discussed in the UNF-65allowance. 49

48 Ibid.49 Ibid.

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- Acceptance criteria is not listed in the CGD plan, instead the CGD plan referencedstandards. As such, the CGD plan did not provide criteria for acceptance as requiredby 24590-WTP-3PS-G000-TOO 19.

- The CGD plan calls for testing of chemical composition, material tensile, yield, andelongation using an approved laboratory and establish a sample size based on whenproduction traceability exists or a single product manufacturer traceability exists. Asample plan was not provided as part of the CGD plan as required by 24590-WTP-3PS-GOOO-T0019.


- While the package includes multiple laboratory reports documenting physical andchemical test results and various heat numbers, a final documented summary of eachlot was not listed that demonstrated that all the material met the CCFA acceptancecriteria as required by 24590-WTP-3PS-GOOO-T0019.

25. PTI - CGD 14-027 - ASME B16.34 Flan2ed Ball Valves

* CGD was improperly used for this procurement. The dedication was based only on theacceptability of the manufactures ASME NCA-3800/4000 program. This would havebeen appropriate if the procurement applied the Q procurement process with anappropriate vendor audit, the manufacture's quality program meets NQA-1 requirementsand results in a basic component meeting Q requirements. By performing CGD without abasis other than the ASME 3800 program without a Method 2 CGD survey, the valvesdid not meet reasonable assurance based on the following comments:

- The PTI CGD Plan for isolation valves discussed CCFAs in general terms in the"Design Output Criteria/Critical Characteristics for Acceptance" section of the PTICGD Plan; however, a listing of specific CCFAs was not established in the plan asrequired by 24590-WTP-3PS-GOOO-T0019, Rev. 0, January 21, 2010,paragraph 3.2.1.3.1.

- The methods of acceptance section in the PTI CGD Plan for isolation valvesidentified only one method of acceptance. Acceptance of the valves was based ondocumentation that the seller had an ASME NCA-3800 program; however, PTI didnot perform a commercial grade survey or vendor audit prior to acceptance of theASME certificate as required by PTI procedures.

- The "Design Output Criteria/Critical Characteristics for Acceptance" section stated inparagraph 4 that peek seats and Viton 0-rings were selected due to their resistance toexcessive temperature and chemical presence. Critical characteristics for acceptancewere not established for these components as required by 24590-WTP-3PS-GOOO-TOO19. Instead, the items were accepted based on their fabrication to themanufacture's NCA 4000 program, which was not allowed at the time by PTIprocedures.

- The PTI CGD Plan specifies testing of material tensile, yield, and material elongationusing an approved laboratory and test material chemical composition. The

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acceptance criteria for material characteristics was not specified in the PTI CGD Planas required by 24590-WTP-3PS-G000-T0019.

- Because critical characteristics were not established, PTI did not identify acceptancecriteria as required by 24590-WTP-3PS-G000-T0019 for the critical characteristics.PTI also did not have documented evidence of the CCFAs, acceptance criteria, andmethods of acceptance.

- During discussions between ORP, BNI, and PTI, it was stated that BNI was placed onthe PTI approved suppliers list based on a National Association of InsuranceCommissioners (NAIC) audit reviewed and determined to be acceptable by PTI. PTIstated they could not provide a copy of the NAIC audit due to NAIC restrictions ofdissemination of audit reports. Without the report, or a documented evaluation of thereview, there is not sufficient objective evidence or record sufficient to satisfy24590-WTP-3PS-GOOO-TOO19, paragraph 4.2.4 requirements.

* The CCFAs did not address the seismic III concerns. The ASME B16.34 flanged ballvalve is a seismic category III item; however, the technical evaluation did not documentconsideration of the seismic qualification requirements in the development of the CCFAfor the valve as required by 24590-WTP-3PS-GOOO-T0019. One of the credible failuremechanisms that contributed to valve failure was stress on bolts, studs, nuts, body, cap,and spring housing caused by seismic load.

* BNI reviewed the above noted CGD plan on June 25, 2014, and documented the plan asCode Status 1 without identifying that the plan did not meet 24590-WTP-3PS-GOOO-T0019 requirements.

26. PTI - CGD 13-047, "PTI CGD Plan N7A-N&D UNS N10276 Spray Lances," Rev. 2-Spray Nozzles

* PTI submitted CGD Plan 13-047, "PTI CGD Plan N7A-N&D UNS N10276 SprayLances," Rev. 2 (24590-QL-POA-MKAS-00003-02-00032, Procedure - CommercialGrade Dedication (CGD) Form - 24590-LAW-MKD-LVP-0001 11, LA WMelters OffgasCaustic Scrubber - N7A-N7D UNS N1 0276 Spray Lances, Rev. OOC) to BNI. The BNIresponsible engineer assigned Code Status 2 and returned the submittal to PTI onFebruary 20, 2014. Based on review of BNI's acceptance procedure, the ORP audit teamdetermined that these changes should have been designated Code Status 3, requiringrevision by PTI and resubmittal to BNI prior to use.

The BNI responsible engineer review included 10 comments from procurementengineering and 4 comments from the responsible engineer. Several of the commentsidentified additional information that was required to be submitted by specification24590-WTP-3PS-GOOO-TOO19. Some of the missing information included:

- The PTI CGD Plan did not include acceptance criteria, such as attribute, materialproperties, performance criteria, values, acceptance range, etc.

- The PTI CGD Plan technical evaluation did not include a discussion on crediblefailure mechanisms, including failure under seismic design basis event (scrubber isSC-III).

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- The PTI CGD Plan did not include flange and packing gaskets that contribute to theconfinement safety function.

- The PTI CGD Plan did not include a sampling plan or basis for sample lot formation.

- The PTI CGD Plan did not include references to the supplier dedication proceduresthat implemented the specification requirements.

- Lack of evidence that the correct version of the ASME code requirements wereflowed down to the subvendor.

- No requirement for 100 percent radiography on all butt welds.

- Subvendor welding procedure specification and nondestructive testing proceduresapplicable to the scope were not submitted for buyer review.

27. Philadelphia Mixingz Solutions - 24590-WTP-CGD-MATL-09-0050. HL WHFP MFPVAritators

* The MAP approved by BNI on November 4, 2011, to document completion of activitiessupporting acceptance of the CGD for HL WHFP MFPVAgitators by PhiladelphiaMixing Solutions does not include all CCFA as documented in 24590-WTP-CGD-MATL-09-0050, dated May 18, 2010. Examples of CCFA that were not included in theMAP include:

- Perform a source surveillance (Method 3) of Pro Machine to ensure they can performmachining and related work to BNI specifications. This is to be performed by BNI orPhiladelphia Mixing Solutions.

- Perform a source surveillance (Method 3) of Carver Machine.

- The MAP does not specify that the Supplier Quality Representative witness thespecimen from the pin bar stock is shipped to a BNI laboratory. The MAP onlyrequires that the pin bar stock is checked per BNI-approved PMI procedures.

- The MAP does not specify that the BNI-qualified test laboratory verify tensilestrength, yield strength, and elongation of pins.

- The MAP does not specify that a Method 1 test for internal defects be performed byradiographic testing.

* The MAP does not list specific acceptance criteria for identified CCFA as required by24590-WTP-3PS-GOOO-TOO19, for example:

- Tensile strength of pins - Tensile strength, yield strength, and elongation, perASTM A276 316L.

- Chemistry of pins - Verify all major elements in the material including carbon, perASTM A276 316L

- Radiographic testing per ASTM E94, acceptance per ASTM E446.

- All physical dimensions reference drawings.

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The completed Commercial Grade Survey dated June 2, 2014, and the purchase orderfrom Philadelphia Mixing Solutions to XRI, Inc. dated November 8, 2013, did notdemonstrate the contractual relationship between BNI and XRI testing such that once thecommercial grade survey was complete, the XRI procedures reviewed could be passedback to XRI via a revised purchase order and with direction for a certificate ofconformance to BNI specifying that the directed procedures were used as required by24590-WTP-GPP-MATL-010, Section 5.4.2.

BNI's CGD procedure does not address how BNI could perform dedication activities twoor three levels deep into a purchase order in which the NQA-1 subtier vendor cannotperform CGD or place another NQA-1 vendor on their evaluated suppliers list.

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