G D Department of EnergyNevada Operations Office ¶BS #1.2.9.3

P Q Box 98518Las Vegas, NV 89193-8518

JUL 0 6 1989

Thomas 0. HunterTechnical Project Officer for Yucca Mountain ProjectSandia National LaboratoriesP.O. Box 5800Organization 6310Albuquerque, NM 87185

YUCCA MOUINTAX PROJECT OFFICE (PROJECT OFFICE) QUALITY ASSURANCE (QMAUDIT 89-3 OF SANDIA NATIONAL LABORATORIES (SNL) SUPPORT OF THE YUCCA MOUNLTAINPROJECT NW1-1989-2826)

Please be advised that a team from the Project Office will conduct a OA auditof the SNL Quality Assurance Program and quality related activities startingon July 17, 1989. Please arrange a pre-audit conference for appropriatepersonnel at your facility beginning at 10 a.m. on Monday, July 17, 1989.The post-audit conference is tentatively scheduled for 2 p.m. on Friday,July 21, 1989.

The audit will focus on the following areas:

Oh Program Elements

1.0 Organization2.0 Quality Assurance Program (subject to Privacy Act restrictions)3.0 Scientific Investigation and Design Control4.0 Procurement Document Control5.0 Instructions, Procedures, Plans, and Drawings6.0 Document Control7.0 Control of Purchased Items and Services8.0 Identification and Control of Items, Samples, and Data10.0 Inspection11.0 Test Control12.0 Control of Measuring and Test Equipment13.0 Handling, Shipping and Storage15.0 Control of Nonconforming Items16.0 Corrective Action17.0 Quality Assurance Records18.0 Audits

8907170072 890706PDR WASTEWM-l1 PDC

FULL EXT ASCII SCAN

a

JUL 06 1989Thomas 0. Hunter -2-

Technical Areas

Technical Specialists will review the following areas to evaluate performanceof ongoing, new, and near-term technical activities:

1. Technical Qualifications of Scientific Investigators and Design Personnel.

2. Understanding of procedural requirements as they pertain to ScientificInvestigation and Design Control Activities.

3. Adequacy of Technical Procedures.

4. Development of Study Plans and Work Supporting the Site CharacterizationPlan.

WBS ELEMENTS

1.2.1.3.11.2.1.3.21.2.1.3.31.2.1.4.21.2.3.2.1.2.21.2.4.1.21.2.4.2.1.11.2.4.2.1.21.2.4.2.1.31.2.4.2.1.5.21.2.4.3.31.2.4.6.11.2.6.1.1

Site nd Engineering Properties Data BaseInteractive Graphics Information SystemReference Information Base (RIB)Radionuclide Source TermSite Faulting Potential (Midway Valley)Basis for DesignRock Mass AnalysisField TestingLaboratory PropertiesExploratory Shaft Facility (ESF) Geoechanical TestShafts/RampsRepository Performance Code Development/CertificationESF Management, Planning, and Design

Technical work conducted for Title I Design of the ESF will not be consideredas part of the scope for this audit.

The audit team will consist of:

Stephen R. DanaWendell B. ManselJohn C. FriendWilliam . CampCatherine H. ThompsonSidney L. CrawfordDwayne A. ChesnutMartha J. MitchellWilliam R. SubletteForrest D. PetersPaul L. ClokeBarry DialLeo A. PolivkaLarry B. LamonicaKeith . ersch

Audit Team LeaderAuditorAuditorAuditorAuditorAuditorLead Technical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical Specialist

a

Thomas 0. Hunter -3- JUL 1989

Observers from the State of Nevada, U.S. Nuclear Regulatory Commission,U.S Department of Energy/Headquarters, or other interested parties mayaccompany the audit team.

If you have any questions, please contact James Blaylock of my staff at(702) 794-7913 or FTS 544-7913 or Stephen R. Dana of Science ApplicationsInternational Corporation at (702) 794-7176 or FTS 544-7176.

Edwin L. Wilmot, Acting DirectorQuality Assurance Division

YMP:JB-4703 Yucca Mountain Project Office

Enclosure:Audit Plan

cc w/encl:Ralph Stein, HQ (-30) FORSL. H. Barrett, HQ (W-3) FORSR. R. Richards, SNL, 310, AlbuqueJ. E. Kennedy, NRC, Washington, ;T-!eKen Hooks, NRC, Washington, DCJ. W. Gilray, NRC, Las Vegas, NVSusan Zimmerman, NWPO, Carson City, NVStephen Metta, SAIC, Las Vegas, N, 517/T-12H. H. Caldwell, SAIC, Las Vegas, N, 517/T-06L. G. Scherr, SAIC, Las Vegas, NV, 517/T-06J. J. Brogan, SIC, Las Vegas, N, 517/T-12S. R. Dana, SAIC, Las Vegas, NV, 517/T-06J. C. Friend, AIC, Las Vegas, NV, 517/T-06W. E. Camp, SAIC, Las Vegas, N, 517/T-06C. M. Thompson, SAIC, Las Vegas, N, 517/T-06M. J. Mitchell, SAIC, Las Vegas, NV, 517/T-22W. R. Sublette, SAIC, Las Vegas, NV, 517/T-24F. D. Peters, SMAC, Las Vegas, NV, 517/T-22P. L. Cloke, SAIC, Las Vegas, N, 517/T-14K. M. Kersch, SAIC, Las Vegas, NV, 517/T-T-24L.A. Polivka, SAIC, Las Vegas, N, 517/T-06D. A. Chesnut, SAIC, Las Vegas, NV, 517/T-24Barry Dial, SAIC, Las Vegas, NVS. L. Crawford, SAIC, Las Vegas, NV, 517/T-06L. B. Lamonica, SAIC, 517/4-14

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PROJECT OFFICE QUALITY ASSUR=CE AUDIT PMN

AUDIT 89-3

July 17 - 21, 1989

1.0 PURPOSE AND SCOPE

The purpose of this audit is to evaluate specific elements of the SandiaNational Laboratories (SNL) Quality Assurance Program Plan (QAPP), andto verify any implementation of the Quality Assurance program require-ments as they relate to the Yucca Mountain Project.

The scope of the audit will be to verify that the SNL QA program meetsthe requirements of QAP NNWSI/88-9, Revision 2. Verification of QAprogram implementation will be limited to those activities which havetaken place since the effective date of the SNL QAPP, Revision C.Discrepancies identified during previous Project Office audits of SNLthat have not been closed will be added to the scope of the audit todetermine whether SNL has taken effective corrective actions in thoseprogram areas. If the audit team identifies a need to verify additionalprogrammatic or technical areas during the audit, they will be added tothe audit checklist and verified accordingly. The programmatic andtechnical elements to be audited, as well as the programmatic elementsthat have not been included, are identified in Section 5.0. of the auditplan.

2.0 ORGANIZATION TO BE AUDITED

Sandia National Laboratories (SNL)Albuquerque, New Mexico

3.0 AUDIT SCHEDULE

Final Pre-Audit Team Meeting 9:00 a.m., 7/13/89Las Vegas, NV

Pre-Audit Team/Observer Meeting 8:00 a.m., 7/17/89Albuquerque, NM

Pre-Audit Conference 10:00 a.m., 7/17/89Albuquerque, NM

Audit Activities 12:30 p.m. - 3:30 p.m., 7/17/89,Albuquerque, NM

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3.0 AUDIT SCHEDULE (CONTINUED)

Audit Activities 8:30 a.m. - 3:30 p.m., 7/18 - 20/89Albuquerque, NM

Audit Activities 8:30 a.m. - 11:30 a.m., 7/21/89,Albuquerque, NM

Post-Audit Conference 2:00 p.m., 7/21/89Albuquerque, NM

4.0 REQUIREMENTS TO BE AUDITED AND APPLICABLE REFERENCES

The requirements to be evaluated through the audit process are containedin the programmatic and technical checklists. These checklists weredeveloped from the following documents:

o NNWSI/88-9, Revision 2o NNWSI Administrative Procedures (APQs)o SNL/QAPP, Revision C and applicable implementing procedureso SNL Scientific Investigation Plans, Study Plans, and applicable

technical procedureso SNL activities supporting the Site Characterization Plan (SCP)

The conduct of the audit will be guided by the documents listedbelow:

o QMP-18-01, "Audit System for the Waste Management Project Office,"Revision 3

o QMP-16-03, "Standard Deficiency Reporting System," Revision 1

o Q Audit Task Organization

o Audit Observer Inquiry

o Policy for Participation of State, Tribal, and NRC Representativesobservers on Department of Energy (DOE) Audits, dtd. July 14, 1987

o High Level Waste Division Procedure for Conducting Observation Auditsof Department of Energy High Level Waste Repository program AAudits

o Headquarters Observation of Project Office Q Audits

5.0 ACTIVITIES TO BE AUDITED

The activities to be audited during the audit include:

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5.0 ACTIVITIES TO BE AUDITED (CONTINUED)

Programmatic elements:

1.0 Organization2.0 Quality Assurance Program (subject to Privacy Act restrictions)3.0 Scientific Investigation Control and Design Control4.0 Procurement Document Control5.0 Instructions, Procedures, Plans, and Drawings6.0 Document Control7.0 Control of Purchased Items and Services8.0 Identification and Control of Items, Samples, and Data10.0 Inspection11.0 Test Control12.0 Control of Measuring and Test Equipment13.0 Handling, Shipping and Storage15.0 Control of Nonconforming Items16.0 Corrective Action17.0 Quality Assurance Records18.0 Audits

The following programmatic elements will not be audited during thisaudit:

9.0 Control of Processes (no activity at this time)14.0 Inspection and Test Status (no activity at this time)

Technical Elements:

Technical Specialists will review the following areas to evaluateperformance of on-going, new, and near-term SNL technicalactivities:

o Technical Qualifications of Scientific Investigators and DesignPersonnel

o Understanding of Procedural Requirements as they pertain toScientific Investigation and Design Control Activities

o Adequacy of technical procedures

o Development of Study Plans and work supporting the SCP

WBS ELEMENTS

1.2.1.3.1 Site & Engineering Properties Data Base1.2.1.3.2 Interactive Graphics Information System1.2.1.3.3 Reference Information Base (RIB)1.2.1.4.2 Radionuclide Source Term1.2.3.2.1.2.2 Site Faulting Potential (Midway Valley)1.2.4.1.2 Basis for Design

Page 4 of 5

5.0 WBS ELEMENTS (CTtCNTIED)

1.2.4.2.1.11.2.4.2.1.21.2.4.2.1.31.2.4.2.1.5.21.2.4.3.31.2.4.6.11.2.6.1.1

Rock Mass AnalysisField TestingLaboratory PropertiesExploratory Shaft Facility (ESF) Geomechanical TestShafts/RampsRepository Performance Code Development/CertificationESF Management, Planning, and Design

Technical work conducted for Title I Design of the ESF will not beconsidered as part of the scope for this audit.

6.0 AUDIT TEAM MEMBERS

Stephen R. DanaWendell B. ManselJohn C. FriendWilliam H. CampCatherine M. ThompsonSidney L. CrawfordDwayne A. ChesnutMartha J. MitchellWilliam R. SubletteForrest D. PetersLeo A. PolivkaBarry DialPaul L. ClokeLarry B. LamonicaKeith M. Kersch

Audit Team LeaderAuditorAuditorAuditorAuditorAuditorLead Technical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical SpecialistTechnical Specialist

SAIC, Las Vegas, NVYMP, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NVSAIC, Las Vegas, NV

7.0 AUDIT CHECKLISTS, ANEXES, AND ATUXMDENTS

89-3-01

89-3-02

Annex A

Annex B

Annex C

Programmatic Audit Checklist

Technical Audit Checklist

DOE Procedure on Protocol (July 1987)

NRC Draft QA Procedure for Observing DOE/OGR HLWR ProgramAudits

DOE/HQ/0GR Observation of YMP QA Audits (Draft)

Attachment 1 YMP Audit Observer Inquiry

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Prepared By:

Prepared By:

Approved By:

Approved By:

S. R. Dad_,Audit Team Leader

D. A. ChednutLead Technical Specialist

G. P. F arDeputy Assistant P ject ManagerQuality Assurance

Wan L. Wilmot, AtngDrector"lity Assurance ision

Date: (|2 i/ @

Date: Zg/ 7/£9

Date: ___-_ _7- 85

Date: 718-

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hay 25. 19_8

HLV DIVISION PROCEDURE FOR CONDUCTINGOBSERVATION AUDITS OF DOE HIGH LEVEL WASTE

REPOSITORY PROGRAM QA AUDITS

1.0 PURPOSE

This procedure describes the High-Level aste Management Division's methodologyfor conducting observation audits of quality assurance (A) audits performed bythe Department of Energy (DOE). These audits my be prformed on DOE, itscontractors and subcontractors, ts participating oranizations, and mayinclude contractor audits of their subcontractors. For example, the staff mayobserve a USGS audit of one of their contractors.

The primary objective of the Nuclear Regulatoy Comission's (NRC) observationaudit program is to gain confidence that the DOE s implementing a programwhich meets the NRC's.QA program requirements established in 10 CFR 60.Subpart G. This confidence is gained by assessing DOE's ability to dentifyand correct problems through their audit program. Observation audits will bethe principal means for the staff to assess the implementation of the DOEprogram prior to the start of extensive site characterization activities.Observation audits also enable the staff to provide guidance to the DE on QAprogram implementation and the overall DOE audit program. The staff willfollow-up on staff concerns with respect to the audit and/or deficienciesidentified by the audit team. This will assure the staff that correctiveaction is being performed and QA programs are being properly implemented.

2.0 OBJECTIVE

The objective of ts procedure s to describe techniques for assessing theoverall effectiveness of a quality assurance program audit conducted n the DOEprogra. Guidance on the following areas s provided:

a Qualifications required for the observers.b Responsibilitiesc Criteria for selection of audits for observation

Areas to be observedI Protocol during the observation auditf Reporting requirements9 Follow-up b

3.0 UALIFICATIOSIF THE OBSERVERS

Personnel selected for observation audits shall have experience or tratiningcommensurate with the scope, complexity, or special nature of the activities tobe audited (e.g., technical observers shall be selected based on theireducation and experience n the technical area being udited). The observersshall be selected based on the following qualifications: auditing and technicalexperience, education, auditor training, commuoication skills, and knowledge ofQA, technical, and regulatory requirements. All observers shall meet therequirements of ANSI/ASME NQA-1-1983 for auditor qualifications.

The training program for observers should address the following:

3.1 (a) The basics of the audit process

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0 ANNEX B

HQ OBSERVATION O VPO QUALITY ASSURANCE AUDITS

Audit No. _

Audited Organization _and Location _

Date of Audit _

Observer , _ _

General Observation Areas

1. was the content of the Audit Plan and Checklist dequate?

2. Did the audit team have adequate knowledge of the audited organisation(I.e., scope of work3 procedures, policies, etc.)t

3. a) If appropriate, were technical areas as well as Q& programmaticareas audited? b) Was the extent and depth of review of thetechnical areas adequate? c) Were the technical specialistsknowledgeable In the areas being audited?

4. Were known problem areas dentified from previous audit& Investigated?

S. Was the scope of the audit clearly presented to the audited organisation?

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6. War the audit results clearl coumunicated to the audited organization?-

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Did. the auditor obtain comaItmente froa the audited organization tocorrect noted discrepancies?

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. :. ac. - , c0: 8,W- If ppilcabld, were &II IS citeria of OCFRSO, Appendls 3 overed?

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HLW DIVISION PROCEDURE FOR CONDUCTINGOBSERVATION AUDITS OF DOE HIGH LEVEL WASTE

REPOSITORY PROGRA A AUDITS -

1.0 PURPOSE

This procedure describes the High-Level Waste Management Division's methodologyfor conducting observation audits of quality assurance (QA) audits performed bythe Department of Energy (DOE). These audits may be performed on DOE, itscontractors and subcontractors, ts participating organizations, and Sayinclude contractor audits of their subcontractors. For example, the staff mayobserve a USGS audit of one of their contractors.

The primary objective of the Nuclear Regulatory Comission's (NRC) observationaudit program is to gain confidence that the DOE is implementing a programwhich meets the NRC's.QA program requirements established n 10 CFR 60,Subpart G. This confidence is gained by assessing DOE's ability to identifyand correct problems through their audit program. Observation audits vill bethe principal means for the staff to assess the implementation of the DOEprogram prior to the start of extensive site characterization activities.Observation audits also enable the staff to provide guidance to the DOE on QAprogram implementation and the overall DOE audit program. The staff will

.follow-up on staff concerns with respect to the audit and/or deficienciesidentified y the audit team. This will assure the staff that correctiveaction is being performed and QA programs are being properly implemented.

2.0 OBJECTIVE

The objective of ts procedure Is to describe techniques for assessing theoverall effectiveness of a quality assurance program audit conducted n the DOEprogram. Guidance on the following areas s provided:

a Qualifications required for the observers.(b Responsibilitiesc Criteria for selection of audits for observationd Areas to be observed

Protocol during the observation auditf Reporting requirements9 olow-up

3.0 QUALIFICATIONSOF THE OBSERVERS

Personnel selected for observation audits shall have experience or trainingcommensurate with the scope, complexity, or special nature of the activities tobe audited (e.g., technical observers shall be selected based on theireducation and experience in the technical area being audited). The observersshall be selected based on the following qualifications: auditing and technicalexperience, education, auditor training, communication skills, and knowledge ofQA, technical, and regulatory requirements. All observers shall meet therequirements of ANSI/ASME NQA-1-1983 for auditor qualifications.

The training program for observers should address the following:

3.1 (a) The basics of the audit process

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(b) Applicable requirements documents

(c) DOE/NRC protocol for observers

(d) Conduct of observers

Attendance and successful completion of an exam covering the topics aboveshould be completed prior to any staff member participating as an observer.

4.0 RESPONSIBILITIES

The following Identifies the responsibilities of individuals nvolved n theobservation audit process:

4.1 Operations Branch Chief(a) Approval of observation audit schedule.(b) Reviewing and approving the final report.(c) Transmitting the final report to the DOE.

4.2 Functional Section Leaders (QA and technical sections)(a) Preparation of observation audit schedule in consultation with PN

and tchnical branch (QA Section Leader only)(b) Selection of observers.(c) Assuring that observers are indoctrinated and trained for the audit

observation. This information shall be documented and rtained.(d) Concurring on final report.(e) Revising observation audit procedure as needed.

4.3 Project Manager (HLOB)(a) Coordinating the arrangements for the observation, ncludin eeting

notices for the State. letters to DOE, coordinating with T and QAsection to assure ntegration.

(b) Acting as the principal spokesperson for the NRC during the audit.P/M will rely on functional staff to explain observations or othertopics within their discipline.

(c) Ensuring during the audit that all concerns, positions, methods, etc.are consistent with Comission and Office policies.

(d) Writing the transmittal letter to OE.a Co-authoring report.if Integrating evaluations of technical section and QA section

observers, as necessary.(g) Leading observation audit team during the audit.

4.4 Observers(a) Evaluating the DOE audit program in accordance with this procedure,

reviewing pertinent background information (such as the DOE auditplan, previously identifled open items, the checklist, the QA plan,and any necessary technical procedures or documents).

b Completing the checklist described in Attachment A.e Writing the report (for their are& of responsibility).d Concurring on report.e Explaining NRC observations to DOE audit team, as necessary.

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Technical staff members will b primarily responsible for evaluating theeffectiveness of the DOE audit team in assessing the quality of the technicalwork. QA staff will primarily be responsible for evaluating the audit team'sassessment of the controls applied to work. Because these areas overlap, andbecause individual team members may possess qualifications in areas outside oftheir specific responsibilities, A and technical staff should coordinate andintegrate their review of the DOE audit.

5.0 CRITERIA FOR SELECTION OF AUDITS FOR OBSERVATION

The selection of audits for observation should be based on the following:

(a) The importance of the activity being audited (for example, criticalpath activities which provide sit' charecterization data which areimportant to public radiological health and safety and/or wasteisolation).

(b The time since the last audit NRC, DOE, WMPO, etc).(Ci The results of previous audits, observation audits, or other reviews

by NRC or DOE, particularly those which dentified major concerns.

The OCRWM Consolidated Audit Schedule should be used for determining whichaudits are planned by DOE.

6.0 AREA$ TO BE OBSERVED

See Attachment A for instruction on the areas to be observed and the use of achecklist to document results.

7.0 PROTOCOL DURING AUDIT

During the observation audit, the staff shall conduct themselves in aprofessional and cooperative manner. Observers should coordinate with the DOEaudit team leader to assure that the effectiveness of the audit team is notdisrupted. Observers are encouraged to participate fully by furnishing theirquestions, observations, and recoamendations to the DOE audit team lader.Efforts should be made by the observer to minimize direct questions of theaudited organization. It may be necessary to exclude observers from certainportions of the audit (such as procurement actions that are in-process, orsensitive personnel records). Observers should obtain a copy of the auditchecklist as soon as it s available and should prevent predisclosure of thelist to the audited organization.

All staff concerns should be communicated to the audit team lader in a clearand timely manner. Observers shall indicate the acceptable areas of the auditprogram as well as express concerns, or rcommendations to the DOE audit teamleader prior to leaving the site. Every attempt should be made to expresstheir concerns daily to the DOE audit team leader. henever possible, theobservers should attend the entrance and exit meetings and audit team caucuses.The observers should also xpress their concerns about the adequacy andimplementation of the audited organization's QA program to the audit teamleader prior to the xit meeting. Observer concerns about the conduct of theaudit should be addressed only to the audit team leader unless directedotherwise by the audit team leader. The audit team leader should be given theopportunity to respond to staff concerns. The observer should consider any new

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information provided to determine if concerns are still valid. Efforts shouldbe ade to reach agreement with the audit team lader on the nature of theconcern and where necessary, that appropriate corrective action will be taken.All observations should be based on facts nd personal opinions should beavoided.

8.0 REPORTING REQUIREMENTS

A report shall be written upon completion of the audit and will be sent to theDirector, Office of Systems Integration and Regulations, Office of CivilianRadioactive aste Management, Department of Energy. The DOE Project Office(WMPO), the State of Nevada. and the organization that conducted the auditshall also receive a copy of the report. The report shall evaluate the overalleffectiveness of the DOE audit n assessing the implementation of the QAprogram. Needed improvements in the audit, which would make future auditsacceptable to the staff, should be dentified. The areas addressed n thechecklist (Attachment A) should be included in the report to the xtent thateach was observed. In addition, ach report shall address the udit results.The report should address the positive as well as the negative aspects of theaudit.

The format of the report should include the following headings:

8.1 Summary(&) Objective of audit nd audit observation(b) Scope of audit(c) amn conclusions on overall effectiveness of audit nd major areas

needing Improvement.

8.2 Introduction(a) Contents of report (observations, DOE findings, audit team members,

etc.)(b) Date(s) of audit observation and the organization being observed(c) General background nformation about the audited organization (e.g.,

their scope of work and Importance to safety or waste isolation.

8.3 Audit Purpose and ScopeW Based on DE's and NRC's perspectiveb QA criteria and technical work audited

8.4 Audit Team Members and Observers (name, title, and affiliation)

8.S NRC Observations of the Audit Team(a) Addresses each rea described n the checklist (Attactment A) to the

extent that each was observed.(b) Conclusions should b based on facts. Subjective judgements should be

minimized(c) Supporting detail (i.e., xamples) should be provided as necessary to

clearly support the observations.

8.6 Preliminary Results/Findings of Audit Team(a) Attach a copy of the draft results or summarize the results.

8.7 Appendices ay be attached which ddress specific observations such as:

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(a) bservations and open tems with respect to the uditedorganization's Q program identified by the audit observer.9.0 FOLLOW-UP

The staff may elect to observe follow-up audits or surveillances by DOE whichare needed to verify that the audited organization is implementing thenecessary corrective action. Likewise, follow-up audits by the staff may benecessary to ensure that those recommendations for improving the DOE auditprogram are being implemented. It is the responsibility of the observers totrack all staff concerns. All concerns shall be documented and subsequentlyclosed out upon satisfactory resolution of the concern. The actions taken toresolve the issue shill be documented.

10.0 REFERENCES

ASHE/ANSI NQA-1-198310 CFR Part 50 Appendix BOCRWM Consolidated Audit ScheduleDOE Memo on Observer Protocol (July 14, 1987)

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ATTACHMENT A

AREAS TO BE OBSERVED AND CHECKLIST COMPLETION

This attachment provides guidance on the reas to be addressed before or duringthe observation audit. A checklist (attached) shall be used which documentsthe area investigated and the results. The checklist is intended to be a guidefor the audit observers. Observers should rely on their professional judgementIn deciding which areas to emphasize or de-emphasize in the checklist. Thestaff should place greater focus on performance of the audit team rather thanJust programatic compliance. This means dd the audit t verify that theaudited organization's QA program is producing quality products (i.e., reports,data, test procedures) and the documentation necessary to defend that work inlicensing. In addition, concerns should be put Into perspective. For example,does a missing signature have negative ffect on the effectiveness of theaudit? If not, the staff should clearly indicate that a noncompliance existsbut t did not result in reduced product quality. The product, n this cse,Is an ffective udit.

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HLWM DIVISION OBSERVATIONAUDIT CHECKLIST

1. Observation Audit No:

2. Observer:

3. Date(s) of Audit:

4. Audited Organization:

S. Audit Conducted By:

PROCEDURE: The areas listed should be addressed either before or during theudt. When inforuation used to support staff conclusions s obtained byverification of documented evidence, appropriate documents should bereferenced. However, in those instances where only verbal information can beobtained, this shall be noted and the person contacted documented, so thatappropriate follow-up action can be taken to verify that supportingdocumentation exists.

The observation audit number shall be placed on each successive checklistsheet. In addition, upon completion of the respective checklist, the NRCobserver shall sign and date each checklist sheet in the space provided.Lastly, for those areas not covered or not applicable (NA) the auditor shalldocument this and provide ustification in the RESULTS" section of thechecklist.

The following checklist has been organized in relative order of importance.This will emphasize audit performance rather than procedural compliance.

Staff should not be limited to only those questions on the list, but shouldpursue ny others which will assist n achieving the objective of theobservation audit.

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ANNEX CIt 'V

HQ OBSERVATION O WKPO QUALITY ASSURANCZ AUDIS

AudIt No.

Audited Organization _

and ocation _

Date of Audit _

Observer ,,

General Observation Areas

1. Was the content of the Audit Plan and Checklist adequatet

2. Did the audit team have adequate knowledge of the audited organization(l.e., scope of work, procedures, policies, etc.)?

3. a) If appropriate, were technical areas as well s QA programmaticareas audited? b) Was the extent and depth of review of thetechnical areas adequate? c) Were the technical specialistsknowledgeable In the areas being audited?

4. Were known problem areas identified from previous audits investigated?

5. Was the scope of the audit clearly presented to the audited organization?

M

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6. Were the audit result. clearlF, cowuuncated to the audited organization?: -

. 7.-

Did he auditor obtain jommitments from the audited organization tocorrect noted discrepancies?

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0: 8.- If appicable, were all 18 citerla of lOCFRSO, Appendi B covered?

....

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9 * Was the purpose or objective of the audit clearly presented?

10. Were te auditors knovledgeable about the documents they vre uditing to?

11. What as te nature of the findings (.e., eipificat, trivIal, etc.)t

12. Were conclusio reached on olid foundation of fcts vth objectiveevidence to back them up?

13. Did the Lead Auditor take charge and run the audit?

14. Were daily or appropriately frequent caucuses held?

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lequirements of W)Po QP-18-01, evision 1

1. Sect. 3.4

2. Sect. 4.1.6

3. Sect. 5.2.2

4. Sect. 5.3.1

S. Sect. 5.4.1

6. Sect. 5.4.1

7. Sect. 5.4.1.1

S. Sect. 5.4.1.2

Is the audit team leader certified to develop and performan audit, report audit findings, and to follow-up andevaluate corrective actions?

Are conditions adverse to quality evaluated and reportedon Standard Deficiency Reports (SDRs) per QHP-16-03?

Are the requirements of this section ett

Was a pre-audit conference held per this section?

Were pre-prepared audit checklists used In the conduct ofthe audit?

Is objective evidence eamined and documented forcompliance ith the checklist requirements?

Is ech not applicable or not audlted' entry oan thechecklist eplained?

Is reference to specific deficiencies noted on thechecklist by documenting the sequential number of the SDRrough draft (or number of the observation)t

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9. Sect. 5.4.2

10. Sect. 5.6

Were appropriate anagement personnel of the auditedorganization verbally notified by the lead auditor of allobserved nonconformances prior to the post-audit meeting?

'Was a post-audit conference held per this section?

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.~w YUCCA MOUNTAIN PROJECT NAAUDIT OBSERVER INQUIRY 4/8

Audit No.

Log No.

Name Organization

YMP Requirement Reference

Question/Concern

Response

Observers Acknowedgement

Cleared for Submtt to YMP PticpantLead Auditor / Lead Technical Specialist

0 Incorporated In VMP Audit ChieWok sf

Audit Team Leader