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7~A~S/25 2 TECHNICAL & MANAGEMENT SUPPORT SERVICES WS: 1-2.9Revision'No.: DOCUMENT TRANSMITTALJACKNOWLEDGMENT RECORD A: WA

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TRANSMITTAL DATE: 05/30/91WASHINGTON, DC 20555-0000

COPY NO.: 223

DOCUMENT TITLE: QUALIFICATION OF QUALITY ASSURANCE PROGRAM AUDIT PERSONNEL

DOCUMENT REVISION: 3 DOCUMENT IDENTIFICATION NUMBER: QMP-02-02

DIRECTIONS

REPALCE: QMP-02-02, Rev. 2, dated 10/10/90 withQMP-02-02, Rev. 3, dated 05/31/91.

*** Destroy or mark obsolete material wSuperseded" *

SIGN/DATE IN BLACK INK BELOW TO CONFIRM THAT THE ABOVE DIRECTIONS HAVE BEEN FOLLOWED,AND RETURN THIS TRANSMITTAL RECORD, WITH THE OBSOLETE MATERIAL, AS APPROPRIATE, TO THEABOVE ADDRESS BY: 0 6 /20Z91

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II- - YUCCA MOUNTAIN PROjECT OFFICE Y-AD-002DOCUMENT APPROVAL SHEET 1/22/91

Title -~- NO. QMP-02-02QUALITY MANAGEMENT PROCEDURE: QUALIFICATION OF QUALITY I L]QASSURANCE PROGRAM AUDIT PERSONNEL INonO

APPROVAL

PROJECT MANAGER:

DIRECTOR OF QUALITY ASSURANCE

OASC OA ieNr

M. E. Kunich a.ec=% 10/29/84Signature Date

Ldi a( 5 t\z /84John Rina]

S. H. Klein(OTHER, AS REQUIRED) Signature

REVISION 0 EFFECTIVE DATE:

REVISIONS

INITIAL AND DATEREVISION 1 REVISION 2

WRD for CPG

REVISION 3

A4 sr/28h,REVISION 4

PROJECT MANAGER:

DIRECTOR, QA:

T&HSS Proj gr(OTHER, AS REQUIRED)

EFFECTIVE DATE:

Carl Gertz2/19/88

8 8 lock

9/26/90 W I

nIl (i XL If

M. E. Spaeth2/22/88

2/22/88

NAV for DGH _____L______t_

9/21/90 )

N/A N/A

10/10/90 5/31/91

page 1 of 27

TRAINING REQUIRED 13 YES EJ N/A NUMBER OF DAYS REQUIRED FOR TRAINING

COMMENTS:

pRIIGsI cTRAIN A NGA D

Slo w ups L~~~~~TRINING OFFICERRINING MANAGER DATE

UMP-06-04

. YUCCA MOUNTAIN PROJECT Y-AD-001' - ~~~PROCEDURE 0

Procedure No.: QMP-02-02 PO evsioR:QUALIFICATION OF QUALITY ASSURANCE 3 Page 2 of 27PROGRAM AUDIT PERSONNEL

1.0 PURPOSE AND SCOPE

1.1 PURPOSE

This procedure documents how the Yucca Mountain Site CharacterizationProject Office YMPO) qualifies and certifies personnel who direct orparticipate in YMPO Quality Assurance (QA) audits.

1.2 SCOPE

The scope of this procedure covers the training requirements, education,employment, experience, and previous audit activities of candidates for thepositions of Auditors-In-Training, Auditors, Lead Auditors, and TechnicalSpecialists. It also covers the responsibilities of candidates for thesepositions and the Director, Office of Quality Assurance (OQA) responsibilitiesduring the qualification and certification.

2.0 APPLICABILITY

This procedure is applicable to the YMPO QA staff and all individualsthat participate as audit team members during YMPO QA audits.

3.0 DEFINITIONS

NOTE: Terms in this procedure are used as defined in the Office ofCivilian Radioactive Waste Management (OCRWM) QA Requirements and ProgramDescription Documents or the Project Glossary. The following additionaldefinitions are adopted for the purposes of this procedure.

3.1 AUDITOR

Any individual qualified by this procedure to participate in a YMPO QAAudit.

3.2 AUDITOR-IN-TRAINING (AIT)

A member of an audit team with either insufficient audit experience toconduct any auditing without close supervision or without previous YuccaMountain Site Characterization Project YMP) audit experience. Auditors-In-Training may not make judgments or identify deficiencies without concurrenceof the Audit Team Leader or a supervising Lead Auditor.

3.3 LEAD AUDITOR (LA)

An individual whose qualifications are certified by the Director, OQA, inaccordance with this procedure to organize, perform, and direct a DOE QAaudit; report audit findings; and evaluate related corrective actions.

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3.4 AUDIT TEAM LEADER (ATL)

A certified Lead Auditor appointed to lead the audit team and to ensurethe audit team is prepared prior to initiation of the audit.

3.5 TECHNICAL SPECIALIST

An individual with specific technical background assigned to provideadvice to Auditors and/or Lead Auditors in the preparation or performance of aYMPO QA audit when it is determined that the scope, complexity, and/or specialnature of the audit warrants the need of technical advice. The specialistsmay perform as an Auditor of technical activities or may act only as anadvisor as requested by the Lead Auditor.

4.0 RESPONSIBLE PARTIES

The following OCRWM individuals or designees are responsible foractivities identified in Section 5.0 of this procedure:

1. Director, OQA

2. Audit Team Leader (ATL)

5.0 PROCEDURE

NOTE: A flowchart of the following processes described in this procedureis attached as Figure 1.

RESPONSIBLE PARTY STEPS PROCEDURE

QUALIFICATION OF AUDITORS-IN-TRAINING

Director, OQA/Designee 1. Document on the Employee TrainingAssignment Form the minimum reading andtraining requirements an Auditor mustcomplete prior to performing on anAudit. Refer to Figure 4 of QMP-02-01for form. Training requirements are onpage 1 of Attachment 2.

2. Assign the AIT to complete all requiredauditor reading and training under theguidance of the DOE Training Manager asspecified in QMP-02-01.

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Director, OQA/Designee 3. When the employee Training AssignmentForm has been completed, establish anauditor qualification folder for eachAIT and file the completed form.

ATL 4. Assign the AIT to accompany an LA on aminimum of one audit to work under thedirect supervision of an LA or ATL. TheLA or ATL critiques the AIT's perform-ance on Attachment 6, adds the auditinformation to Attachment 3, and filesboth attachments in the qualificationfolder.

Director, OQA/Designee 5. If the AIT has demonstrated satisfactoryperformance, qualification as an Auditoris documented by completing Attachment1, blocks 9, 10, and 12, and filing in aqualification folder.

QUALIFICATION OF AUDITORS

6. At the discretion of the Director, OQA,individuals judged to be adequatelyversed in the audit process may beexempted from the Auditor-In-Trainingrequirement of being closely supervisedby a Lead Auditor. The trainingspecified in Step 1 above must be com-pleted prior to being assigned as anAuditor and any statement of exemptionsfrom AIT requirements and the rationaleis filed in the individual's qualifica-tion folder. If an individual is judgedqualified as an Auditor without perform-ing first as an AIT, the individual isqualified on Attachment 1 the same inStep 5 above.

7. Formal qualification for auditors isrequired. If the required training hasbeen completed and demonstratedperformance as an AIT, as applicable,has been completed, qualification as anAuditor is documented on Attachment 1 in

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Director, OQA/Designee blocks 9, 10, and 12 and placed in theauditor qualification folder along withAttachment 3.

8. Personnel from organizations notqualified in accordance with OCRWMprocedures may be assigned as Auditorsat the discretion of the Director, OQA.These individuals must have had previousdocumented experience as Auditors. Inaddition to audit documentation from theemployer, the Director, OQA, mustreceive a copy of the individual'sresume, and a statement from theemployer that the individual's educationand experience have been verified andare on file at the employer's office.The Director, OQA, completes block 12 ofAttachment 1 and attaches supportingdocumentation.

If a candidate's qualifications arerejected, no further effort is made atcertification and the employer isnotified of the rejection.

QUALIFICATION OF LEAD AUDITORS

9. A Lead Auditor must have completed thetraining specified on the EmployeeTraining Assignment Form. This formmust be filed in the auditorqualification folder.

10. The qualification of LAs is documentedon Attachment 1. The specificrequirements to be met are documented onAttachment 2.

11. Document the results of the examinationgiven the LA candidate on Attachment 1,and retain the examination and theexamination score as confidentialdocuments.

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Director, OQA/Designee 12. The Director, OQA, may accept LAcertificates from programs notimplementing OCRWM procedures. Thisacceptance will be based on documenta-tion demonstrating qualification, andshall include, as a minimum, an LAcertification, objective evidence ofaudit participation within the pastyear, resume, and a statement from thecandidate's employer that the candi-date's education and experience havebeen verified and that the results ofthis verification are on file at theemployer's office.

If the certification was made under anuclear QA program overviewed by theNuclear Regulatory Commission (NRC), theDirector, OQA, accepts the certificationby completing block 12 of Attachment 1and filing the documentation in thequalification folder.

If a candidate's qualifications arerejected, no further effort is made forqualification and the individual'semployer is notified of the rejection.

QUALIFICATION OF TECHNICAL SPECIALISTS

13. If it is determined that an auditrequires the use of a technicalspecialist, the Director, OQA, requeststhe appropriate management to assign aspecialist of the proper discipline toassist on the audit.

14. If the technical specialist does nothave a valid Attachment 7 on file, theDirector, OQA, will review the special-ist's resume and training records andensure that as a minimum Attachment 5has been read and signed. A qualifi-cation folder containing the requireddocuments on Figure 2 is set up andmaintained as in Section 8 of thisprocedure.I

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MAINTENANCE OF PROFICIENCY

Director, OQA/Designee 15. Develop and maintain a status log ofqualified Auditor and certified LAs thatidentifies, as a minimum:

a. Auditor/Lead Auditor's name

b. Date of initial certification orqualification

c. Date of next evaluation

16. Perform an annual assessment ofAuditors/LAs to determine maintenance oftheir proficiency through one or more ofthe following:

a. Regular and active participation inthe audit process;

b. Review and study of codes,standards, procedures, instructions,and other documents related to QAprogram and program auditing; and

c. Participation in training programs.

17. Document the results from Step 16 aboveon Attachments 3 and 4, identifyingspecific related information (i.e.,audit number and date of participation).If proficiency has been acceptablymaintained, sign and date block 13 ofAttachment 1. This extends thequalification or certification for aperiod of one year from the date ofevaluation.

RECERTIFICATION OF DOE LEAD AUDITORS

18. If an LA has not maintained proficiencyfor one year as stated in Step 16 above,the Director, OQA, has the choice ofextending the recertification for oneyear, or requiring requalification as inStep 19 below.

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Director, OQA/Designee 19. If the LA has not maintained proficiencyfor two years, requalification as statedbelow must be required.

a. Receive training for Auditors asstated in Attachment 2;

b. Take a re-examination in accordancewith Step 11; and

c. Participate as an Auditor in atleast one YMP QA Audit.

RECERTIFICATION OF ALL OTHER LEAD AUDITORS

20. LAs from other organizations oremployers must be recertified to theirQA Program requirements.Recertification documentation must bereceived from the employer by theDirector, OQA, before he may recertifythese individuals under the YMPO QAProgram. The Director, OQA, completesblock 13 of Attachment 1 and attachessupporting documentation.

VERIFICATION OF EMPLOYMENT AND EXPERIENCE

21. The various Human Resource organizationswithin OCRWM do verification ofexperience and education of allemployees. A statement that experienceand education has been verified shall berequested and filed in each Auditor, LA,and Technical Specialist's qualificationfolder.

6.0 REFERENCES

NOTE: Refer to the latest revision of the documents listed below unlessotherwise stated.

K-,YUCCA MOUNIAIN PROJECT Y-AD-OO1

PROCEDURE 8/90Procedure No.: QMP-02-02 Revised:QUALIFICATION OF QUALITY ASSURANCE 3 Page 9 of 27PROGRAM AUDIT PERSONNEL

6.1 REQUIREMENTS DOCUMENTS

Quality Assurance Requirements Document, DOE/RW-214

Quality Assurance Program Description Document, DOE/RW-215

QMP-02-01, Project Office Indoctrination and Qualification Training

QMP-17-01, Records Management: Record Source Implementation

7.0 FIGURES AND ATTACHMENTS

Figure 1, Qualification of Quality Assurance Program Audit PersonnelFlowchart

Figure 2, QA Record Requirements

Attachment 1, Yucca Mountain Project Office Record of Auditor/Lead AuditorQualification (YMP-041)

Attachment 2, Auditor/Lead Auditor Qualification Requirements

Attachment 3, Record of Audit Participation (YMP-042)

Attachment 4, Record of Lead Auditor Qualification Requirements

Attachment 5, Audit Guide for Technical Specialists

Attachment 6, Auditor-In-Training Evaluation (YMP-043)

Attachment 7, Technical Specialist Qualification (YMP-044)l

8.0 RECORDS

The Director, QA shall ensure that the following QA records aremaintained as up-to-date Working Files in the YMP QA Office and processed inaccordance with QMP-17-01, Records Management: Record Source Implementation.

Refer to Figure 2 for record requirements for individual auditpersonnel.

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' . YUCCA MOUNTAIN PROJECT Y-AD-001PROCEDURE 890


QUALIFICATION OF AUDITORS/LEAD AUDITORS

Audit ide for Technical SpecialistAuditor in TrainingAuditor Qualification FolderAudit Team LeaderDirector OQAEmpwloe Training Assignment FormLead AuditorLocal Records CentrRecord of Auditor/Lead AuditorQualificationRecord of Audit Participation

Stec 16

Page 1 of 40MP024ZO43M5-2t4t

Figure 1 - Qualification of Quality Assurance Program AuditPersonnel Flowchart

YUCCA MOUNTAIN PROJECT

QUAUFICATION OF AUDITOR/LEAD AUDITORFROM OUTSIDE ORGANIZATIONS

I

Page 2 of 4OMP02O43S-21-O1

Figure 1 - Qualification of Quality Assurance Program AuditPersonnel Flowchart (continued)

, Procedure No.: QMP-02-02QUALIFICATION OF QUALITY ASSURANCE

QUALIFICATION OF TECHNICAL SPECIALIST

Page 3 of 4QM=0021-91


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PROCEDUREProcedure No.: QMP-02-02 'Revision:QUALIFICATION OF QUALITY ASSURANCE 3 Page 13 of 27PROGRAM AUDIT PERSONNEL

AUDITORILEAD AUDITOR PROFICIENCY MAINTENANCE

- ~~~~~~~~Ste 16DOQA

Documentactivities tomaintain proiciency

,RAP,WU /AL

4 Steps 16 & 17DOOA\

Ass proficiency mintenance/

activities

SP 17 4f4

/ Yes / ~~~AssessmenExind cerlification o aitssP

PsFlsoc &19

Page 4 of 4oMp204S2t-91


-1 *YUCCA MOUNTAIN PROJECT 8AD001PROCEDURE

Procedure No.: QMP-02-02K ' QUALIFICATION OF QUALITY ASSURANCE

PROGRAM ADTT PERSONNEL

I Revision:.3 I Page 14 of 27

AUDITOR-IN-TRAINING

AUDITOR

AUDITORQualification fromOutside Source

LEAD AUDITOR

LEAD AUDITORQualificatlon fromOutside Source

TECHNICALSPECIALISTS

IT

I S i ! ]jA f tX j Sgi XiI V

it I Is .X

* I appIlcablI

*- io empiloyer I jflj: __I_

x x x x

x x* x x x x

x ~~Xe x x

X ~~~~~X' X" X XI

X* X* X X X

If0 applicable**From employer

Figure2QMP-02-02.0645-22-91

Figure 2 - Quality Assurance Record Requirements

% . YUCCA MOUNTAIN PROJECT'.k I PROCEDURE

Y-AD-0018/90

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.- PROGRAM AUDIT PERSONNEL

YMP-041-RO YUCCA MOUNTAIN SITE CHARACTERIZATION PROJECT5//91 RECORD OF AUDITORILEAD AUDITOR QUALIFICATION

1. Name: Date:

Employer:OUAUFICATION CREDIT REQUIREMENTS CREDITS

2. EDUCATION - Univrsity/Degree/Date 4 Credits Max.o Undergraduabs L1velo Graduate Level

3. EXPERIENCE-Company/Dates 9CreditsMax.o Techical(0-5credits)ando Nuclear Industry (0-1 credit), oro QuatyAssurance (0-2credits),oro Audittng (0-4 credits)

4. PROFESSIONALACCOMPUSHMENT-Certflcate/Date 2 Credits Max.o Professional Engieero Society

5. MANAGEMENT -Jusificaon/Evaluator/Date 2 Credits Max.Explain:

Evaluated By (Narne and ride) Dabl

6. CREDITSAWARDED TotaIICredits

7. AUDIT COMMUNICATIONSSKIULSEvaluated By (Name and Tide) Date

S. AUDITOR TRAINING COURSESCourse Tide or Topic: I1. Data

9. ON-THE-JOBTRAINING and/or ORIENTATION (Explain) Evaluated By(Signature and Date)

1.

2.

3.

4.5.

10. AUDIT PARTICIPATION (See Attached)

11. EXAMINATION O Passed Date ofExamination

Adinistered By Date(Namne and Titde)

12. OUAUFICATION

O Auditor dBDsbQualified (sgaur n rd)Date

O Lead Auditor (Signature and Tite)Certified By- Dae

(Signature and Tide)

13. ANNUALEVALUATION (Signature and Date)

Attachment 1 - Record of Auditor/Lead Auditor Qualification

.* YUCCA MOUNTAIN PROJECT Y-AD-001

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AUDITORILEAD AUDITOR QUALIFICATION REQUIREMENTS

AUDITORS

Personnel who participate as DOE Auditors must have appropriate training and orientation to develop theircompetence for perfcrrning required QA audits.

Competence of personnel in regard to the performance of various auditing functions shall be developed byone or more of the following methods:

1. Orientation to provide a working knowledge of the Quality Assurance Requirements Document(DOEIRW-214), the Quality Assurance Program Description Document DOE/RW-21 5), and QualityManagement Procedures.

2. Training program to provide general and specialized training in audit performance. General training shallinclude fundamentals, objectives, characterisics, organization, performance,and results of quality audit-ing. Specialized training shall include methods of examining, questioning, evaluaing, and documentingspecific audit items and methods of closing out audit findings.

3. On-the-job training, quidance, and counseling under the direct supervision ofa Lsad Auditor. Suchtraining incudes planning, performing. reporting, and iollow-ap ctions irolved in conductng audits.

Development, administraton, and documentaion ofauditortrairing will be controled byQAAP 2.XXX.

LEAD AUDITORS

Lead auditors mustbe certified as qualified by meetng the requirements belowwhich are documented onAttachment 1.

Document the prospective Lead Auditor's qualification in Blocks 2 through 10 of Attachment 1.

EDUCATION (a maximurn of four credits may be awarded). Document the name of the institutionattended and the date and type of degree:

1. Award one creditfor an associate degree from an accredited institution, ortwo credits if the degreeis in engineering, physical sciences, mathematics, or quality assurance; or

2. Award tWo credits for a bachelor's degree from an accredited Institution, or thrQe credits if thedegree is in engineering, physical sciences, mathematics or quality assurance; in addition,

3. Award e creditfor a master's degree from an accre dited institution ithe degree is in engineering,physical sciences, business management. orquality assurance.

EXPERIENCE (maximum of nine credits may be awarded):

1. Award one credit for each full year of experience I engineering, manufacturing, construction, opera-tion of maintenance with a maximum of five credits. Documentthe company, dates of employmentand numberof credits awarded each;

2 Award one additional creditif two years of the technical experience have been In te nuclear field; or

3. Award two additional credits if two years of tie tehnical experience have been in quality assur-ance;or

Attachment 2 - Auditor/Lead Auditor Qualification Requirements

! _ I _

YUCCA MOUNTAIN PROJECT Y/-9D-01PROCEDURE 89

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AUDITORLEAD AUDITOR QUAUFICATION REQUIREMENTS(continued)

EXPERIENCE (continued)

4. AwardtOwes additional credits If two years of the technical experience have been in auditing; or

5. Award three additional credits If two years of the technical experience have been in nuclear qualityassurance; or

6. Award four additional credits if two years of experience have been In nuclear quality assuranceauditing.

NOTE: Iterms 2 through '6 above are not additiw Only one of these items is to be used withitm .'. The maximum numberof nine credits can only be attained by awarding themaximum credits to I and 6.

PROFESSIONALACCOMPUSHMENTS (maximum of two credits may be awarded):

Award two credits for certification of competency in engineering, science, or quality assurance special-ties isued and approved by a state agency or a natnal professional society. (One credit only for eachagency or society.) Document ieense Number and expiraton date. Membershipinsuch sociebeiasASOC or ANS does not qualdy for any credits. Certification by the society such as a certified qualityassurance engineer is acceptable for one credit

MANAGEM ENT (maximum of two credits maybe awarded):

Award up to two credits for other performance factors applicable to auditing which may not be explicitlydelineated in this procedure. Justification for awarding the additional credits shall be documented onAttachment 1. Examples of performance factors are: leadership, maturity, sound judgment, tenacity,analytical ablity, past performance, and OA training courses.

AUDITCOMMUNICATIONSKILLS:

Evaluate and attest to the effectiveness of the prospective Lead Auditor's capability to communicateeffectively both in writing and orally.

AUDITOR TRAINING COURSES:

Evaluate the training needs of each prospective Lead Auditor to the extent necessary to assure theircompetence in auditing skills. Document any course taken and attendance date to give the candidatethe needed training. Training in the following areas shall be conducted in accordance with CMP-02O1based upon tihe evaluation of fe particular needs of each prospective Lead Auditor:

1 Knowledge and understanding of ANSI/ASME NQA-1 and other nuclear-related codes, standards,orders, regulations, and regulatory guides, as applicable.

2 General structure of quality programs as a whole and applicable elements as defined in ANSVASMENOA-1.

3. Auditina technicues of examinino ouestionini. evaluatinr and moortino methods of idantifvma andfollowing up on corrective action Items; and cosing out audit findings.

Attachment 2 - Auditor/Lead Auditor Qualification Requirements (continued)

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. PROGRAM AUDIT PERSONNEL - I

AUDITORILEAD AUDITOR QUAUFICATION REQUIREMENTS(continued)

AUDITORTRAINING COURSES: (continued)

4. Audit planning In the function related to quality for the following activities: design, purchasing,fabrication, handling,sNpping, storage, ceaning, rection, installation, irspecton, testing, statistics,nondestructive examination, maintenance, repair, operation, modification ofnuclear facilites orassociated components, and safety aspects of the nuclear facility.

5. On-the-job training ID include applicable elements of the audit program.

AUDIT PARTICIPATION

1 Ensure that the prospective Lead Auditor has participated hI a minimum of five OA audits within aperiod of ime not to xceed three years prior to the date of qualikation. One of the audits shall bea nuclear quality assurance audit conducted within the year prior to certification.

2. When any audit report is issued, have copy sent to lie dividua maintaining auditor qualification/certification files. Ensure thatthe file of each tean member is updated by entering the pertinentinformation on Attachment3,YMPO Record of Participation.

EXAMINATION

1 Administer an examination that will evaluate a prospective Lead Auditors comprehension of, and theability to apply. the body of knowledge identified in AUDITOR TRAINING COURSES above. Thetest may be oral, written, practical, or any combination of the three types and shall be consistentwith the requirements i ANSI/ASMENQA-1. The examination and resulting score remain in thepossession of the Director as confidential documents. The examination score is not to be enteredan Attachment 1.

Attachment 2 - Auditor/Lead Auditor Qualification Requirements (continued)

*4. ~ KU

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YMP-042-RO YUCCA MOUNTAIN SITE CHARACTERIZATION PROJECTM 91 RECORD OF AUDIT PARTICIPATION

Name: Date:

Employer _

Audit , Date(s)of AuditedOrganization FWnc00n: Auditorer AuditReportNo. Auit and Location AuditTeam Leader Number

OMP.02-02

I

Attachment 3 - Record of Audit Participation

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. PROGRAM AUDIT PERSONNEL

YMP-041-RO YUCCA MOUNTAIN SITE CHARACTERIZATION PROJECTM2IM91 RECORD OF AUDITORILEAD AUDITOR QUAUFICATION

CONTINUATION PAGE

ATTACH TO RECORD OF OUAU-FICATION ISSUED TO_______________

OMP-02-02

Attachment 4 - Record of Lead Auditor Qualification Continuation Page

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AUDIT GUIDE FOR TECHNICAL SPECIALIST

Print Name

Technical Specialist Signature Date of Completicn

Attachment 5 - Audit Guide for Technical Specialists

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Page 1 of 4

I. introduction

This document is written on the basis of the current requirements of theQuality Assurance Requirements Document, DOE/RW-0214 and the QualityAssurance Program Description Document, DOE/RW-0215 that relate toQuality Assurance (QA audits, and Quality Assurance AdministrativeProcedure (QAAP) 18.2, Audit Program. These requirements apply to thepreparation, performance, reporting, and follow-up of QA audits.

The purpose of this document is to provide sufficient basic informationto Technical Specialists so that they can effectively advise audit teammembers and make optimum contributions to the QA audit. The establishedmethods and requirements for QA audits are delineated in QAAP 18.2.

QA audits are unique opportunities to gain in-depth understanding of non-technical activities which are not normally related to the TechnicalSpecialist's work. The management systems, procedures, work controls,and other mechanisms which are included in the audit scope are frequentlyunfamiliar because of the pressure of day-to-day problems in one's owndiscipline. The QA audit experience provides an opportunity toparticipate in an orderly analysis of such systems. Therefore, timespent in preparation for participation in a QA audit can be worthwhileand can significantly improve the overall value of the QA audit.

You are urged to take sufficient time prior to the first meeting of theaudit team to become as-familiar as possible with the informationprovided herein. If you have any questions about the audit process, talkto the Audit Team Leader ATL) before the QA audit.

: The Audit Process

As an advisor to the audit team, you will be primarily concerned with thepreparation and performance of the audit. You may also participate inwriting the report as directed by the ATL. The audit follow-up is theresponsibility of the ATL.

The first audit function in which you may participate is the developmentof the audit plan. This plan will identify the audit scope, theactivities to be audited, the applicable documents to be audited against,-he audit schedule, and the written checklists to be utilized by theauditors.

One of the major activities in planning the audit will be a review ofdeficiencies or problems reported during previous audits or pastexperience with the audited organization. The past audit records andother related reports provide information pertaining to -both pastDroblems for which corrective action has been established and for openitems which have not been closed out.

Attachment 5 - Audit Guide for Technical Specialists (continued)

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Page 2 of 4

The ATL will conduct a pre-audit team meeting t discuss details of theaudit plan and establish individual responsibilities. A pre-auditconference will be conducted with the audit team and representatives ofthe audited organization in attendance to outline the audit scope, theaudit plan, and other details of the audit. The pre-audit conferencewill also introduce the auditors to the audited organization personnelwith whom the auditors will work. The proposed sequence of events forthe audit will be reviewed, and tentative plans for the exit meeting willbe made.

During the conduct of the audit, it may be advantageous to split theaudit team into several groups. The technical specialists of the auditteam will be in a group which includes the ATL or another auditor. Thiswill assist the technical specialists in concentrating on his/herspecialized areas.

The rincipal audit method is to verify compliance with the QA Programand other stated requirements. Objective evidence may take the form ofrecords such as, drawings, specifications, logs, data sheets, testresults, or other documents which will assist the auditor in drawingmeaningful conclusions in regard to effective implementation ofapplicable requirements. The ATL should be kept fully aware of any needs

_ for special information and should be advised if it is necessary to talkto people or examine outside the scope of the audit as originallyplanned.

Whenever deficiencies are identified or suspected during an audit, theyshould be pursued to the point of a thorough understanding. Wheneverpossible, the auditors should determine the cause of such deficienciesand evaluate their effect on other work. When possible, it is goodpractice to determine the extent of corrective action required. However,it Is not the function of the audit team to initiate the correctiveaction. The deficiency should be pointed out to the responsible membersof the organization being audited. It is their function to take propercorrective action. The audit team should maintain cognizance of suchcorrective action since it will have a bearing on the exit meeting andthe audit report.

The purpose of the exit meeting is to review the audit findings withreso:nsible management of the audited organization. This is essential sothat if there are any misunderstandings based on insufficient orincorrect information, they can be clarified. In addition, the exitmeeting gives the audited organization a good understanding of theoverall findings so that appropriate corrective action can be initiatedas expeditiously as possible - often even before the audit report isreturned to the audited organization for formal acknowledgment.

I Attachment 5 - Audit Guide for Technical Specialists (continued)

I

YUCCA MOUNTAIN PROJECT Y-AD-001PROCEDURE 8/90

Procedure No.: QMP-02-02 Revision:QUALIFICATION OF QUALITY ASSURANCE .3 Page 24 of 27PROGRAM AUDIT PERSONNEL

Page 3 of 4

After the QA audit has been completed, the audit team usually meets oneor more times to develop the audit report. This report will be preparedin accordance with QAAP 18.2 and be signed by the ATL. It will include as ummary of the findings and a statement of effectiveness of the QAProgram audited. Corrective Action Requests CARs), which identifydeficiencies noted during the audit, will be issued prior to the auditreport in accordance with QAAP 16.1, Corrective Action Requests, and areattached to the audit report for information purposes.

III. Personal Conduct

One subject of prime importance is the matter of personal conduct of theaudit team members. Audits will have various degrees of personalinvolvement on the part of the auditors and the members of theorganization being audited.

Conflicts of opinion are frequently unavoidable; however, conflicts ofpersonalities can almost always be avoided by a skillful auditor. Thepoint to constantly remember is that an audit evaluates the performanceof others. To a varying degree, difference of opinion is almost always afactor in the audicor-auditee relationship. Consequently, it isimperative that an auditor be fully aware of the sensitivity of his/herposition. The following guidelines are provided to minimize the impactof personal involvements in the audit process.

1. The audit checklist should be used as a guide and should notrestrict the audit investigation. Departure from the auditchecklist should be discussed with the ATL.

2. Be objective and listen arefully to responses. Remember that theaudited organization will normally understand its system better thanyou will.

3. Avoid personal accusations in audit-related conversations with theaudited organizations.

4. Arguments with the audited organization should be avoided. If youfeel you are correct, accurately document the finding. Next,summarize the audited organization's opinion and read it back forconcurrence.

5. Tentatively classify each adverse finding at the time it is found inaccordance with QAAP 16.1. The reason(s) which prompted theclassification should be carefully noted for future reference.


4' \YUCCA MOUNTAIN PROJECT Y-AD-001_ ____ PROCEDURE 8/90Procedure No.: QMP-02-02QUALIFICATION OF QUALITYr PROGRAM AUDIT PERSONNEL

ASSURANCEIRevision:

3 I Page 25 of 27. .

Page 4 of 4

6. Record names, titles, places, etc., of individuals you engage withduring the audit. Material which will be required to supportfindings should be reproduced, if ossible, or its identitycarefully recorded.

7. An adverse finding which is deemed severe enough to warrantimmediate action should be brought to the attention of the ATL.

IV. References

These references provide more detailed information relative to QA auditsand should be consulted for answers to specific problems. The ATL candirect you to the reference which addresses your questions.

1. DOE/RW-0214, OCRWM Quality Assurance Program RequirementsDOE/RW-0215, OCRWM Quality Assurance Program Description Document

2. QMP-02-02, Qualification of QA Program Audit PersonnelQAAP 16.1, Corrective Action RequestsQAAP 18.2, Audit Program

3. 10 CFR 60-Subpart G - Quality AssuranceDOE 5700.6 - Quality AssuranceNV 5700.6 - Quality AssuranceDOE/RV-0005 - Mission PlanASME NQA-1 - Quality Assurance Program Requirements for NuclearFacilities

'Latest applicable revision.


K- j. I

, ''* YUCCA MOUNTAIN PROJECT Y-AD-001PROCEDURE 8/0

Procedure No.: QMP02-02 [ Revision:QUALIFICATION OF QUALITY ASSURANCE 3 Page 26 of 27' PROGRAM AUDIT PERSONNEL I

YMP-043-RO YUCCA MOUNTAIN SITE CHARACTERIZATION PROJECT52291 AUDITOR-IN-TRAINING EVALUATION I

has performed as an Auditor-In-Tralning(Individual's Name)

under my dose supervision on Audit No.

Performance Comments:

Signed:(Certified Lead Auditor)

cc: Audit Team LeaderDirector, QAAuditor Qualification File

OMP-02-02

I Attachment 6 - Auditor-In-Training Evaluation

I �

Y-AD-00 1. t 1 2 YUCCA MOUNTAINPROJECT 8/90

PROCEDUREProcedure No.: QMP-02-02 Revision:QUALIFICATION OF QUALITY ASSURANCE 3 Page 27 of 27PROGRAM AUDIT PERSONNEL

YMP-044RO YUCCA MOUNTAIN SITE CHARACTERIZATION PROJECTMIMI91 TECHNICAL SPECIALIST QUALIFICATION

I have reviewed the experience and qualifications of(Individual)

and accept him/her as a qualified Technical Spedalist. This qualification is validfor one year fom the date of qualification.

Director, QA Date

OMP2-M02

Attachment 7 - Technical Specialist Qualification