U. S. NUCLEAR REGULATORY COMMISSION

OBSERVATION AUDIT REPORT OAR-00-02 

OF THE YUCCA MOUNTAIN QUALITY ASSURANCE DIVISION 

AUDIT M&O-ARP-00-001 

OF THE 

CIVILIAN RADIOACTIVE WASTE MANAGEMENT SYSTEM

MANAGEMENT AND OPERATING CONTRACTOR

4*i~dAX?4 /11 /00 

Ifen Hooks 

Uranium Recovery and Low-Level 

Waste Branch 

Division of Waste Management 

+Y& ,o/00 

Thomas Trbovich 

Center for Nuclear Waste Regulatory 

-Analyses

a4e, e ,.qi- 11/00 

Charles Greene 

High-Level Waste and Performance 

Assessment Branch 

Division of Waste Management 

Center for Nuclear Waste Regulatory 

Analyses

Reviewed and Approved by: 

'.')(ing Stablein, Chief 

Projects and Engineering Section 

High-Level Waste and Performance 

Assessment Branch 

Division of Waste Management

Enclosure
1.0 INTRODUCTION

Staff and consultants of the U.S. Nuclear Regulatory Commission (NRC) Division of Waste 

Management observed the U.S. Department of Energy (DOE), Office of Civilian Radioactive 

Waste Management (OCRWM), Office of Quality Assurance (OQA), Yucca Mountain Quality 

Assurance Division (YMQAD), limited scope, performance based audit of the Waste Package 

Process Model Report (PMR) at the Management & Operating Contractor (M&O) facilities. The 

audit, M&O-ARP-00-001, was conducted on November 8-12, 1999, for work being performed at 

the facilities in Las Vegas, Nevada and involved the review of selected Analysis Model Reports 

(AMRs) prepared by the Lawrence Livermore National Laboratory (LLNL). 

The objective of this audit by YMQAD was to evaluate the implementation of the OCRWM 

program requirements and the technical activities associated with development of the Waste 

Package AMRs. 

The NRC staff objective was to gain confidence that the M&O and OQA are properly 

implementing the provisions contained in the OCRWM Quality Assurance Requirements and 

Description (QARD) and the requirements contained in Subpart G, Quality Assurance, to Part 

60, of Title 10 of the Code of Federal Regulations (10CFR Part 60). Because of the anticipated 

DOE submittal of the Site Recommendation (SR) In November 2000, the following observation 

activities were emphasized: (1) confirming that data, software, and models supporting SR are 

properly qualified; and (2) reviewing the progress being made by DOE and its contractors in 

meeting the qualification goals for SR. 

This report addresses the NRC staff determination of the effectiveness of the OQA audit and 

the adequacy of implementation of QARD controls by the M&O in the areas of AMR 

development. 

2.0 MANAGEMENT SUMMARY 

The NRC staff has determined that OQA Audit M&O-ARP-00-001 was useful and effective. 

The audit was organized and conducted in a professional manner. Audit team members were 

independent of the activities they audited. The audit team was qualified in their respective 

disciplines, and its assignments and checklist items were adequately described in the audit 

plan. 

The audit team concluded that the OCRWM QA program had been satisfactorily implemented 

in the areas evaluated. However, the selected AMRs were still in the revision process and the 

associated software, data, and model packages had not been qualified, verified or validated, 

therefore no packages were reviewed by the audit team or NRC staff. One deficiency was 

identified during the audit. Thirty-four recommendations were offered by the audit team during 

the closing meeting as improvements or enhancements to the AMR development process and 

to the QA program procedures. The NRC staff agrees with the audit team's conclusion and 

recommendations. The NRC staff determined that this audit was effective, that the QA 

program implementation was adequate and the recommendations should prevent future 

discrepancies in the AMR/PMR development process.

I
,b

3.0 AUDIT PARTICIPANTS 

3.1 NRC

Thomas Trbovich 

Charles Greene 

Ken Hooks 

Darrell Dunn

Observer (Team Leader- CNWRA) 

Observer (Technical Specialist) 

Observer (QA Specialist - NRC Task Force Member) 

Observer (Technical Specialist - CNWRA)

3.2 DOE Audit Team 

Emily Jensen 

Kristi Hodges 

Victor Barish 

Richard Powe 

Robert Hartstem 

Frank Wong 

Robert Fish

Audit Team Leader (ATL) 

Auditor 

Auditor 

Auditor 

Auditor 

Technical Specialist 

Technical Specialist

OQNQuality Assurance Technical Support 

Services (OQA/QATSS) 

OQA/QATSS 

OQANQATSS 

OQA/QATSS 

OQA/QATSS 

Management and Technical 

Services (MTS) 

MTS

4.0 REVIEW OF THE AUDIT AND AUDITED ORGANIZATION 

This OQA audit of the M&O was conducted in accordance with OCRWM Quality Assurance 

Procedure (QAP) 18.2, "Internal Audit Program," and QAP 16.10, "Performance/Deficiency 

Reporting." The NRC staff's observation of this audit was based on the NRC procedure, 

"Conduct of Observation Audits," issued October 6, 1989 (Draft). 

4.1 Scope of the Audit 

The audit team conducted a limited scope, performance based audit of activities and processes 

supporting the development of the Waste Package AMRs. The audit included review of the QA 

program procedures directly associated with preparation of the AMRs which included:

S 

0 

S 

S 

0 

0 

S 

S 

S 

S

AP-2.13Q "Technical Product Development Planning" 

AP-Sl.1Q "Software Management" 

AP-3.150 "Managing Technical Product Inputs" 

AP-SIII.2Q "Qualification of Unqualified Data and the Documentation of Rationale for 

Accepted Data" 

AP-3.1OQ "Analysis and Models" 

AP-2.14Q "Review of Technical Products" 

AP-SIII.3Q "Submittal and Incorporation of Data to the Technical Data Management 

System (TDMS)r 

AP-3.1 1Q "Technical Reports" 

AP-2.15Q "Work Package Planning Summaries" 

AP-SI11.10 "Scientific Notebooks"

2
The following AMRs supporting the Waste Package PMR were eValuated by the audit team: 

"* Analysis of Mechanisms for Early Waste Package Failure (ANL-EBS-MD-000023, Rev 

00) 

"* General Corrosion and Localized Corrosion of the Waste Package Outer Barrier (ANL

EBS-MD-000003, Rev 00C Draft) 

"* Aging and Phase Stability of the Waste Package Outer Barrier (ANL-EBS-MD-000002, 

Rev OOC Draft) 

"* Environment on the Surface of the Drip Shield and Waste Package Outer Barrier 

(ANL-EBS-MD-000001, Rev OOB Draft) 

The critical process steps examined in relationship to accomplishing the performance based 

aspect of this assessment included the following: 

* Planning 

* Resources 

* Inputs to Analysis and Models 

* Development and Documentation of Analysis and Models 

"* Validation of Models 

"* Use of Software or Models 

* Documentation Check and Review 

* Approvals 

"* Analysis or Model Revisions or Change 

"• Verification and Qualification of Data 

. Submittal of Data and Models to the Technical Data Management System (TDMS) 

4.2 Conduct and Timing of the Audit 

The audit was performed in a professional manner and the audit team was prepared and 

demonstrated a sound knowledge of the M&O organization and DOE QA programs. The LLNL 

Principal Investigators (PIs) for the selected AMRs were brought to the M&O offices to be 

interviewed by the audit team members. Audit team personnel were persistent in their interviews, 

challenged responses when appropriate, and performed an acceptable audit. For each AMR, 

LLNL staff was present at the Nevada office for one day and contacted at LLNL by telephone for 

the remainder of the audit to resolve open items or questions. The NRC staff believes the timing 

of the audit was appropriate for the auditors to evaluate the ongoing activities and implementation 

of the QA program even though it was very early in the Waste Package AMR development 

process. QA audits at this stage of the AMR process development are crucial. Relatively minor 

corrections made at this point will result in a better quality product; however, delaying corrections 

to problems found by such an audit until the models are complete may result in non-qualifiable 

models and wasted effort. 

The DOE audit team and NRC observers caucused at the end of each day. Also, meetings of the 

audit team and M&O management (with the NRC observers present) were held each morning to 

discuss the current audit status and preliminary findings or recommendations.

3
4.3 Audit Team Qualification and Independence 

The qualifications of the Audit Team Leader and audit team members were found to be 

acceptable in that they each met the requirements of OCRWM QAP 18.1, "Auditor Qualification," 

as checked by the NRC Observation Audit Lead. The audit team OCRWM members did not 

have prior responsibility for performing the activities they audited. In addition, training, education 

and experience records for audit team members were reviewed and found acceptable. 

The audit team members were prepared in the areas they were assigned to audit and were 

knowledgeable of applicable procedures. The checklist was adequately formulated and covered 

the subject matter well. 

4.4 Examination of Programmatic Quality Requirements 

Programmatic audit activities were conducted in accordance with the OCRWM QA Audit Plan for 

Audit M&O-ARP-00-001. The auditors reviewed documents identified in the audit plan and used 

checklists as a basis for inquiries. In addition, related documentation supporting report 

conclusions was reviewed to verify data source and status of qualification. Personnel directly 

responsible for document products or appropriate representatives with sufficient levels of 

knowledge were interviewed by the auditors. The checklists used were effective and additional 

inquiries were made beyond specific checklist items, when appropriate. The NRC observers 

were briefed on audit conduct procedures, including the inquiry process and method for raising 

concerns. The NRC observers were given ample opportunity to review documents, ask questions 

and provide comments. 

The NRC observers found that the requirements of QA Procedure 18.2 were implemented in an 

effective and satisfactory manner. These planning and implementation activities were 

accomplished and observed by the NRC observers as follows: 

(1) distribution of a quality assurance audit plan, M&O-ARP-00-001; 

(2) development of a performance based audit checklist; 

(3) coordination and communications with all team members; 

(4) conduct of an introductory pre-audit kickoff meeting with the audit team and observers; 

(5) conduct of a kickoff meeting with M&O personnel including high level waste 

management; 

(6) daily caucus meetings held for the audit team and observers; 

(7) daily management status meetings held for M&O management; and 

(8) conduct of a post audit meeting with M&O management, audit team members and 

NRC observers. 

In addition, implementation of corrective measures were evaluated on the significant deficiencies 

documented in existing Corrective Action Requests (CARs) that could impact the AMR 

development process. The following is a status of the CARs as a result of the evaluation: 

CAR LVMO-99-C-001 

The assessment of procedures AP-3.1 00, Revision 1, ICN 1, "Analysis and Models," was found 

to be satisfactory in addressing the traceability and technical adequacy of data. There was one 

recommendation regarding the checking process; however, there is no adverse impact on the

4

P• at
AMRs/PMR based on this recommendation to this point. Additional verification of implementation 

is required in order to adequately assess the effectiveness of the AP-3.100 development and 

checking process of the AMRs/PMR. This CAR remains open. 

CAR LVMO-98-C-002 

AP-3.15Q, Data or Technical Information Confirmation Checklists continue to be completed. Two 

checklists, addressing a total of 10 data tracking numbers used as inputs to AMR ANL-EBS-MD

000023, were reviewed during the audit. Problems are still occurring during the completion of the 

checklists with respect to the transparency of conclusions and accuracy. However, positive steps 

are being taken to address these issues. This CAR remains open. 

CAR LVMO-98-C-006 

Additional corrective'actions are necessary to address deficiencies identified during the audit. 

Although recent changes to AP-SI.10. Revision 2, ICN 1, "Software Management,' authorized 

use of unqualified software while in the process of being qualified, specific requirements found in 

AP-SI.1Q (Section 5.12) were not implemented for software associated with the audited AMRs. 

In addition, instances of inadequate documentation to support verification for software macros 

and routines were identified during the audit. The results of this audit are included in the 

unsatisfactory verification documented as part of the OQA Phase 3 verification of the CAR 

Management Plan. This CAR remains open. 

CAR LVMO-98-C-010 

The remaining CAR-01 0, corrective action. i.e., generation of "family trees," a general schematic 

of AMRs that are inputs to the TSPA. were found to be adequate; however, there was not 

sufficient implementation of AP-3 100. Revision 1, ICN 1, "Analyses and Models,' in regard to 

model validation. Therefore. additionat verification of Implementation is required in order to 

adequately assess the effectiveness of the model process. This CAR remains open. 

4.5 Examination of Technical Activities 

The work supporting these AMRs was conducted at LLNL. The four AMRs audited are indicated 

in Section 4.1. 

4.5.1 NRC Observation Team Technical Specialists General Comments 

Technical specialists on the YMQAD audit team were competent and independent. Appropriate 

programmatic and technical questions were asked by the DOE auditors and technical specialists, 

The technical specialists had sufficient knowledge of technical issues associated with the 

Analysis of Mechanisms for Early Waste Package Failure and Environment on the Surface of the 

Drip Shield and Waste Package Outer Barrier AMRs. However, some lack of understanding of a 

few significant technical issues associated with the General Corrosion and Localized Corrosion of 

Waste Package Outer Barrier and the Aging and Phase Stability of Waste Package Outer Barrier 

AMRs was noted. 

The audit identified that confusion existed on which procedures to follow to ensure QA 

compliance. Demonstrated difficulty was noted in executing the new QA procedures

5
implemented program-wide in June of 1999. This may be due to lack of training or incentive to 

follow new procedures. 

Theoretically, a very effective database and system is in place for documenting all inputs, codes 

and models; however, confusion of Pis and Administrators about entering the correct documents 

in the proper databases was evident during the audit. 

These AMRs had gone through quite extensive review and checking, yet were still plagued by 

editing errors such as referring to the wrong section due to the addition/deletion of sections. 

None of the AMRs exhibited a model in a form near enough to completion for final presentation. 

The DOE technical specialists inquired about the model for each of the AMRs. With the exception 

of the Analysis of Mechanisms for Early Waste Package Failure, which is largely based on the 

probability of human error, all of the AMR authors indicated that the model development was 

incomplete. In several cases, the AMR authors indicated that additional data had been collected 

for the development of the models. This additional data was not included in the version of the 

AMR under review since this would slow the review process. 

It is apparent in many cases that the output or result from one AMR is needed for input to another 

AMR, yet work on the AMRs is progressing in parallel, not waiting for the necessary input, but 

rather making assumptions that can later be modified. For example, the, output of the 

Environment on the Surface of the Dnp Shield and Waste Package Outer Barrier AMR should 

feed into the General Corrosion and Localized Corrosion of Waste Package Outer 6arder AMR in 

order to calculate corrosion rates and assess the possibility for localized corrosion. Because the 

experimental work on the Environment on the Surface of the Drip Shield and Waste Package 

Outer Barrier AMR was initiated within the last year, long term corrosion tests were performed in 

a range of environments that were assumed to be possible at the waste package and drip shield 

surfaces. 

Several technical comments brought up by the observers during the audit were similar to those 

previously brought to the attention of the PIs during interactions with the DOE. Those comments 

did not appear to have been addressed in these AMRs. The most important examples of such 

comments are: (1) The deposition of SiO. and corrosion products on specimens from the Long 

Term Corrosion Test Facility (LTCTF); (2) The effect of welding and thermal treatments on the 

corrosion resistance of Alloy 22; and (3) The inconsistent use of critical potentials for the initiation 

of localized corrosion. 

In the first example, DOE acknowledged during the July 7, 1999, Appendix 7 meeting at LLNL 

that there was deposition of corrosion products and SiO2 on the test specimens of Alloy 22 from 

the LTCTF. The validity of the weight loss measurements was questioned by NRC at that time. 

The response from DOE was that the cumulative distribution curve (Figure 23 in the General 

Corrosion and Localized Corrosion of Waste Package Outer Barrier AMR) probably should be 

shifted to the right so that there are no specimens with a weight gain. The NRC believes this is 

not a defensible approach if there is no information regarding the rate of SiO2 deposition. 

Another recommendation by NRC to DOE regarding the LTCTF tests prior to and at the time of 

the Appendix 7 meeting was the measurement of the corrosion potential of the specimens. 

Although this would have taken little additional effort to accomplish, measurement of the 

corrosion potentials was never performed in the LTCTF by DOE.

6
The second example refers to NRC recommendations to DOE regarding the effect of container 

fabrication and welding on the corrosion resistance of Alloy 22, also discussed in the July 7, 

1999, Appendix 7 meeting. These NRC comments were also expressed to the DOE at the DOE 

Waste Package Degradation Modeling and Abstraction Workshop (April 20-21, 1999, Las Vegas, 

NV). The machining of specimens from the container mockups was discussed and CNWRA staff 

indicated that the CNWRA would like to have a section of the container mockup with a section of 

the weld to support NRC staff evaluation of DOE conclusions. CNWRA staff also discussed the 

effect of welding with LLNL staff at the 1998 Materials Research Society (MRS) meeting (Boston, 

MA) and indicated that NRC was interested in the corrosion resistance of the welded alloy. LLNL 

staff have done some interesting microstructural characterization studies on both welded and 

thermally aged specimens; however, the effect of welding on the corrosion resistance has not 

been addressed by DOE. 

The third example of DOE not addressing NRC staff comments involves DOE's inconsistent use 

of critical potentials for the initiation of localized corrosion. There are inconsistencies in the 

Interpretation of critical potentials from one chapter to the next in the 1998 Engineered Materials 

Characterization report (edited by McCdght). The NRC and the CNWRA have consistently used 

the repassivation potential, and from circa 1994, the crevice corrosion repassivation potential. 

The NRC and CNWRA have published numerous reports, conference papers and journal papers 

indicating this is a valid approach and that one can easily get crevice corrosion at potentials 

below the pit initiation potential in a period of days or weeks. DOE's reluctance to use a 

consistent criteria for initiation of localized corrosion is a weakness in their evaluation of waste 

package degradation. 

Conducting the audit in Las Vegas of activities at LLNL provided some logistical difficulties, but 

overall the audit was effective. Once database management comes up to speed, logistical 

problems should be eliminated. 

4.5.2 Specific Technical Comments 

Technical questions, comments, and concerns from the NRC observers are summarized in this 

section. 

Analysis of Mechanisms for Early Waste Package Failure - ANL-EBS-MD-000023 Rev 00. 

A question was asked if there was any alternative text or opposing authority to Swain and 

Guttmann (A.D. Swain and H.E. Guttman, NUREG/CR-1278, Handbook of Reliability Analysis 

with Emphasis on Nuclear Plant Applications, August 1983), since all of the probability numbers 

come from this handbook. For example, Swain and Guttmann is used as the sole reference for 

the probability of a worker performing a task incorrectly and then missing his mistake on self

check as well as the probability of an independent Inspector missing a mistake or defect in the 

construction of an engineered repository system. The PI indicated that Swain and Guttman was 

the only source of the probability data used In this AMR and the text is the industry/discipline 

standard as well as g NUREG. 

In answering a question from the NRC technical specialist, the PI indicated base metal flaws such 

as voids, stringers, inclusions and rolling laps were considered in this AMR. These flaws were 

considered to occur at a frequency of 10 times less than the frequency of flaws in the welds.

7
These base metal flaws were considered to occur due to temporary welds and subsequent 

grinding out on plate during processing. 

The data from E. Siegman's report (Draft of AMR "Initial Condition of Cladding", ANL-EBS-MD

000048, Rev. 00, part of upcoming OQA audit of Waste Form AMRs) was considered'and the 

present AMR was developed using this data. One additional question regarding the failure rates 

published in Timmins (P.F. Timmins,"Solutions to Equipment Failures ",1999, Materials Park, 

Ohio, ASM International) was not asked since it seemed like the author had considered a 

sufficient cross section and number of reports from industrial manufacturing processes. The 

annealing time for the fabricated Alloy 22 container was stated as 24 hours. The P1 indicated that 

this did not mean that the container would be at temperature for 24 hours. The text in this section 

of the AMR will be reviewed and corrected and/or clarified. 

General Corrosion and Localized Corrosion of Waste Package Outer Barrier - ANL-EBS

MD-000003 Rev 0OC (Draft). 

LLNL indicated that localized dry oxidation of the waste package outer barrier was not considered 

but indicated that this phenomena would be considered in future versions of the AMR since the 

Ni-Cr-Mo alloys tend to suffer grain boundary attack rather than general corrosion under dry 

oxidation conditions. 

In response to a question from the NRC audit observation team, LLNL indicated test specimens 

are identified and tracked by a Metals Samples, Incorporated lot number. In addition, each 

sample is stamped with a unique number than can be traced to a Metals Samples lot number 

which has also had composition chemistry verified by an independent qualified laboratory. The 

Metals Samples procedure for assigning individual heats from the manufacturer unique lot 

numbers was audited. This traceability is maintained on a master spread sheet in Excel at LLNL 

that was not available in the database (.Record Information System - RIS web). Hardcopies are 

maintained as supplements to scientific notebooks which should also be in the database on the 

RIS web. The traceability of randomly selected samples from the AMR was not transparent and 

the documentation was not in the RIS web. 

The basis for selecting the critical potential (E.j for the initiation of localized corrosion was 

questioned by the NRC audit observation team. LLNL indicated that since some cyclic 

polarization tests did not result in a repassivation potential, the breakdown potential is used for all 

samples and environments. There exists disagreement between NRC/CNWRA and LLNL on 

selection of the critical potential. 

Critical potentials listed in this AMR are pitting corrosion repassivation potentials reported by 

Gruss et al. (K.A. Gruss, G.A. Cragnolino, D.S. Dunn, and N. Sridhar, "Repassivation Potential 

for Localized Corrosion of Alloys 625 and C22 in Simulated Repository Environments", 

Proceedings of Corrosion 98, March 22-27, 1998, San Diego, California, 149/1 to 149/15, 

Houston, Texas: NACE International) using a lead-in-pencil specimen geometry. Since Alloy 22 

is resistant to pitting corrosion, the use of pitting corrosion repassivation potentials to predict the 

onset of localized corrosion does not appear to be conservative. Crevice corrosion has been 

identified in the AMR as the most probable localized corrosion mode for the container. It was 

also noted that the repassivation potential measurements with welded specimens were not 

reported, although it is recognized that welding may increase the localized corrosion susceptibility

8
of Alloy 22. Future versions of the AMR will consider both crevice corrosion and the effects of 

welds. 

The effect of sulfate reducing bacteria on Stress Corrosion Cracking (SCC) of Alloy 22 will be 

considered in future AMRs. Nickel alloys are known to be susceptible to SCC in sulfide 

environments. In addition to SCC, questions were raised regarding the Alloy 22 corrosion rate in 

solutions inoculated with bacteria. While the weight loss of the specimen indicated the corrosion 

rate increased by a factor of 2, analyses of the corrosion products in solutions suggests 

preferential dissolution of Cr and Mo. Since these alloying additions are largely responsible for 

the localized corrosion resistance of Alloy 22, the long term effects of preferential dissolution may 

be much more severe than a 2x increase in the corrosion rate. The PI of this AMR suggested 

that the microbial Induced corrosion data in the AMR was preliminary and that additional 

investigations are underway to further investigate the effect of microbes on the corrosion rate of 

Alloy 22. 

Questions were raised on how the results of the Atomic Force Microscopy (AFM) examination of 

the Alloy 22 samples exposed for one year will be used to predict the performance of the waste 

package outer barrier. At the present time, the AFM work is relatively new and the knowledge 

that can be obtained by the examination of long term test specimens is not known. DOE stated 

that onepossibility may be to determine if a silica layer will deposit on the waste package surface 

and form a protective covering. 

There is a concern about validity of LTCTF weight loss measurements due to deposition of SiO2 

that could not be removed prior to final weight measurement. The deposition of silica on the 

specimens would alter the weight loss of the specimens. Corrosion rate calculations that do not 

properly consider the effect of silica deposition would under predict the actual corrosion rate. 

LLNL indicated that additional AFM studies are being conducted using lithography masks to 

measure metal volume loss and presumably, though not specifically mentioned, volume of Si0 2 

deposited on LTCTF coupons. 

Aging and Phase Stability of Waste Package Outer Barrier - ANL-EBS-MD-000002 Rev OOC 

(Draft). 

Overall a concern was expressed about qualifying samples and procedures or specimens 

received from Haynes International. The long term thermal aging tests of several heats of Alloy 

22 were performed by the research and development section of Haynes International. Efforts to 

qualify the data obtained from these material heats are ongoing. There is an overall concern 

about qualifying software used for calculations, e.g., THERMOCALC, used to determine phase 

stability for Ni-Cr-Mo alloy at low temperatures and long times. 

A concern was raised about range of chemical composition of Alloy 22 allowed by ASTM 

specification and effect of extremes in chemistry still within specification on phase stability. The 

AMR author responded that these effects can be captured by data in the literature and by 

studying other alloys such as Alloy 59 and Alloy 686. There is general disagreement on this 

issue between NRC/CNWRA staff and authors of this AMR. The statement in this AMR that 

compositional variations of Alloy 22 within the limits of ASTM B575 are not expected to have a 

significant effect on the phase stability of the alloy based on a number of alloy heats examined, 

was not justified. The compositions of the heats had not been verified and examination of the 

entire range of tungsten, cobalt, and iron compositions to determine the effects of these alloying

9
elements/contaminants on the phase stability of the alloy were not performed. It was also noted 

that the composition specification of the Alloy 22 welds, performed by an independent, qualified, 

chemical analysis vendor, indicated a maximum molybdenum concentration of 4.5 weight 

percent. The specification for Alloy 22 weldments may be detrimental to the thermal stability of 

the alloy, however, this was not examined. 

Environment on the Surface of the Drip Shield and Waste Package Outer Barrier - ANL

EBS-MD-000001 Rev 00B (Draft). 

The author was asked by the NRC technical specialist if temporal variations in chemical 

composition of the water percolating through heated tuff, were considered. This may be 

significant if mineral sites in the tuff become saturated with ions from the simulated well J-1 3 

water. The response was that this had not been considered but acknowledgment was made that 

future versions of the AMR would need to address this issue. 

The parallel development of the AMR was a cause for concern since the General Corrosion and 

Localized Corrosion of Waste Package Outer Barrier AMR is based on the results of tests using 

Basic Simulated Water (BSW) for input, yet BSW is not considered in this AMR. As a result, 

there appears to be a disconnect between this AMR and the General Corrosion and Localized 

Corrosion of Waste Package Outer Barrier AMR. It was indicated by LLNL that discrepancies 

arising from some of the assumptions necessary for the parallel development of these AMRs will 

need to be resolved. 

4.6 NRC Staff Findings 

The NRC staff has determined that OQA Audit M&O-ARP-00-001 was useful and effective. The 

audit was organized and conducted in a professional manner. Audit team members were 

independent of the activities they audited. The audit team was well qualified in the QA discipline, 

and its assignments and checklist items were adequately described in the audit plan. 

The audit team concluded that the OCRWM QA program had been satisfactorily implemented. 

The audit team performed a good review considering the early stage of development that was 

evident with the selected AMRs. However, one deficiency and thirty-four recommendations were 

identified by the audit team to improve the AMRs and associated quality program procedures. 

The NRC staff agrees with the audit team conclusion and recommendations. The NRC staff 

determined that this audit was effective and that the QA program implementation was adequate. 

4.6.1 Audit Observer Inquiries 

No NRC observer inquiries were initiated during the audit. A potential inquiry dealing with 

corrosion metal sample certification traceability was resolved with receipt of the hardcopy of 

certifications by the NRC staff. 

4.6.2 NRC Summary Comments 

The following comments were made at the closing meeting by the NRC Audit Observation lead: 

1. The audit team has conducted an effective, performance based in-process review of the 

Waste Package AMR development process.

10
I , .

2. The issuance of the new procedures from the Process Validation and Reengineering (PVAR) 

process appears to have created confusion, misinterpretation and lack of coordination, thus 

creating implementation difficulties especially in database aignagement and To Be 

Determined/To Be Verified (TBD/TBV) clearing process. 

3. Additional self assessments of the AMR/PMR process prior to outside reviews would be 

beneficial. The results of the one self assessment performed had not resulted in any 

corrective measures prior to this audit. 

4. The AMR/PMR development process, the data/model TBD/TBV clearing process and 

software qualification process appear to be conducted as separate entities when all these 

processes are interrelated and should come together before SR and Ucense Application. 

5. The comments discussed in 4.5.1 of this report have been made to PIs previously by the 

NRC staff on reports included as a basis of the AMRs at Technical Exchange meetings. 

However, the comments apparently have not been addressed.

11