Department of EnergyYucca Mountain Site Characterization

Project OfficeP. 0. Box 98608

WBS 1.2.11

Las Vegas, NV 89193-8608

NOV 0 4 1992

Larry R. HayesTechnical Project Officer

for Yucca MountainSite Characterization Project

U.S. Geological Survey101 Convention Center DriveSuite 860Las Vegas, V 89109

ISSUANCE OF CORRECTIVE ACTION REQUEST (CAR) Y-93-012 TROUG Y-93-015RESULTING FROM YUCCA MOUNTAIN QUALITY ASSURANCE DIVISION YNQAD) AUDITYMP-93-01 OF U.S. GEOLOGICAL SURVEY

Enclosed are CARs Y-93-012 through Y-93-015 generated as a result of Y4MQADAudit YMP-93-01.

Please identify the corrective actions to be taken and implemented to correctthe deficiencies. CAR Continuation Sheets and instructions for completionhave been provided. Send the originals of your responses to Nita J. Brogan,Science Applications International Corporation, Las Vegas, Nevada. Responsesto the CARs are due 20 working days from the date of this letter. Extensionsto due dates must be requested in writing, with appropriate justification,prior to the due dates.

If you have any questions, please contact either Robert B. Constable at794-7945 or Kenneth T. McFall at 794-7280.

Joel C"""'.-16 ilez

YMQAD:RBC-748Richard E. Spence, DirectorYucca Mountain Quality Assurance Division

Enclosure:CAR Y-93-012 through YM-93-015

10(30-1013

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YMP-5 bk 6 /Y.

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Larry R. Hayes -2- NO 0 4 W

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S.~W;-2lmmerman71NWO7,Carson-CIty,_Iw\_J. D. Verden, M&O/TEW, Las Vegas, NVT. H. Chaney, USGS, Denver, COR. W. Craig, USGS, Las Vegas, NVJ. H. Rusk, HACTEC, Las Vegas, NV

ccJ.N.D.

w/o encl:W. Gilray, NRC, Las Vegas, NVJ. Brogan, SAIC, Las Vegas, NV, 517/T-12D. Porter, SAIC, Golden, CO

ORIGINA11'.THIS IS A RED STA,-

OFFICE OF CIVILIAN CARN: 10-23-92RADIOACTIVE WASTE MANAGEMENT DATE: 102-

U.S. DEPARTMENT OF ENERGY SHEE: . OF 1WASHINGTON, D.C.

CORRECTIVE ACTION REQUESTI Controlling Document 2 Related Report No.YNP-USGS-QMP-7.0l Rev. 4 1 YP-93-01

3 Responsible Organization 4Discussed WthUSGS W. Causseaux

5 Requirement:Q!MS 7.01, R4-M2 Para. 5.1.4 allows project personnel to use vendors not on the approved vendorslist subject to conditions. These conditions include:

1. Addition to the QA office working vendors list by the QA Manager, and2. A Nonconformance Report shall be written if the vendor is not qualified for the

Approved Vendors List within 60 calendar days of addition to the working vendors list.

6 Adverse Condition:Contrary to the above

1. There is no QA office working vendors list, and2. A Nonconformance Report has not been issued after the A Manager agreed by

memo to allow the use of a vendor on July 23, 1992, and the vendors hasnot been added to the Approved Vendors List.

9 Does a significant condition I 0 Does a stop work condition exist? 11 Response Due Date:adverse to quality exist? Yes- No.L Yes NoL; K Yes - Attach copy of SWO 20 working daysIf Yes, Circle One: A B C If Yes, Circle One: A B C D from issuance

12 Required Actions: E Remedial Extent of Deficiency IX Preclude Recurrence IX] Root Cause Determination13 Recommended Actions:

7 Iiator fiJ~mr fat t7 r 14 Issuance Apr ved byJ. Blaylock nd C. Prate Oi fiwCADDfig =lPDt >

QAD - Date& /

16 Response Accepted 16 Response Accepte

OAR Date QADD Date17 Amended Response Accepted 18 Amended Response Accepted

OAR Date QADD Date19 Corrective Actions Verified 20 Closure Approved by:

OAR Date QADD Date

ENCLOSUREREV. 08/91

i ~ Forat for Corrective Action Respmse

7he CAR respose shall include the following fontis

1. Corrective Action Response for CAR #

A. Rmadial Action - Actions taken to correct specific deficiencies noted.

(Required for all CAs)

B. Investigative Action - Actions taken to determine the extent of thecondition.

(Required for all significant conditions adverse to quality or anyQxdition Adverse to Quality if requested by OCO)

C. Root Cause Determination - Identification of the root cause of thecondition.

(Reqired for all significant conditions adverse to quality or anyCOndttion Adverse to Quality if requested by OMl)

D. Corrective Action to Preclude Recurrence - Actials taken to address theroot cause and preclude recurrence of the condition.

(Required for all significant axnlitions adverse to quality or anyCndition Adverse to Quality if requested by OMk)

2. For each action above, identify the name of the individual assignedresponsibility for ompletion and the anticipated (or actual, if complete)copletion date.

3. Response Approved: a_ te:Responsible Manager

OFFICE OF CIVILIANRADIOACTIVE WASTE MANAGEMENT

U.S. DEPARTMENT OF ENERGYWASHINGTON, D.C.

CAR NO.__

ATE:

GA

I S , a I 11 .I. I~~~~~W4tlilf- u_a R sp r eNe

RE. 091

ORIGINALTHIS IS A RED STA V:

OFFICE OF CIVILIAN 8 CAR NO.: 10-93013

RADIOACTIVE WASTE MANAGEMENTU.S. DEPARTMENT OF ENERGY SHEEr: 1 OF 1

WASHINGTON, D.C.

CORRECTIVE ACTION REQUESTI Controlling Document 2 Related Report No.

YHP-USGS-QHP-7.0l Rev. 4 1 YMP-93-01

3 Responsible Organizaton 4 Discussed With

USGS W. CaU33eaux

5 Requirement:

QMP-7.01 R4, M2 Paragraph 5.1.3 states in part "An approved vendors list will be initiated,maintained, updated, and distributed by the QA Office. The list shall include... *a detaileddescription of the service or item...

QMP-12-0l, R5 Paragraph 5.22 require calibration service be provided by vendorson the Approved Vendors List in accordance with QP-7.01.

6 Adverse Condition:Contrary to the above

LI-COR provided calibration services on April 29, 1992, after being removed from the Approved VendorList on April 21, 1992.

9 Does a significant condition | 1 Does a stop work condition exist? 11 Response Due Date:adverse to quality exist? Yes_ NoL Yes_ No_.X.; f Yes - Attach copy of SWO 20 working daysIf Yes, Cirde One: A B C If Yes, Circle One: A E C D from issuance

12 Required Actions: FE Remedial Extent of Deficiency I Preclude Recurrence IX Root Cause Determination13 Recommended Actions:

7 initator ( ( i 14 Issuance proved:J. laylock nd C. Prtter A* lD>zDaey/?/9

A42 Z~~AD~t -e' 4f Date15 Response Accepted 16 Response Accep)6d

0ADate_ _ QADD Date17 Amended Response Accepted 18 Amended Response Accepted

QAR Date GADD Date19 Corrective Actions Verified 20 Closure Approved by:

QAR Date QADD Date

REV. 091

Fomat for Corrective Action Response

7he CAR response shall include the follo;Ang in tiout:

1. Corrective Action Response for CAR #

A. al Action - Actions taken to oort specific deficiencies noted.

(Rquired for all CRs)

B. Imestigative Action - Actions taken to determine the extent of thecxdStion.

(Required for all ignificant cotion adverse to quality or anyNaxtion Adverse to Quality if reuested by OWL)

C. Root Cause Dete tio - Identification of the root cause of thecordition.

(Rquired for all significant adverse to quality or anyCition Averse to Quality if requested by OM)

D. Corrective Action to Preclude Recurren - Actions taken to address theroot cause and preclude i r of the ordition.

(Required for all significant Ttimg adverse to quality or anyQdition Adverse to Quality if requested by OMA)

2. For each action above, identify the namx of the individal assignedresponsibility for zletion ari the anticipated (or actual, if cazplete)caption date.

3. Response Approved: Date:Responsible Manager

OFFICE OF CIVILIAN 8 CAR NO.: YN-93014RADIOACTIVE WASTE MANAGEMENT DATE: 10/23/92

U.S. DEPARTMENT OF ENERGY SHEET: 2 OF 2WASHINGTON, D.C.

CORRECTIVE ACTION REQUEST (Continuation Page)

E

6 Adverse Condition (continued)

Omitted requirements from Appendix E (ICN-8):

* 4.1 REQUIREMENTS PHASE

A specification of software requirements shall be provided ......This specification shall address the following:

d. attributes - non-time-related issues of software orations such asportability , correctness, security, maintainability, etc. ; and

e. external interfaces - interactions with hardware, other software, andother participants.

* 4.2 DESIGN PHASE

In this phase the overall structure . T..... this description shalladdress the following:

b. A technical description of the software with respect to control flow,data flow, control logic, and data structure; and

c. The allowable and tolerable ranges for inputs and outputs.

* 4.3.2 METEOD OF SOFTWARE VALIDATION

2nd paragraph: When testing is the selected method of softwarevalidation, test cases shall be developed and executed with inputs andconditions sufficient to invoke all elements of the code that representimplementation of the software requirements. These tests shall alsoidentify boundary conditions, and provide a suitable benchmark.

13 Recomended Aetionls) (continued)

3. Determine the reason that two related documents (Appendix H, CN-8 andQHP-3.03, R3-Ml), with identical effective dates, were reviewed and issuedwithout identification and correction of the noted discrepancies. Proposesuitable corrective action to prevent recurrence if such action is necessary.

REV. 08191

Fomat for Corrective Action Response

7 e R response shall iclude the following ifonrticzs

1. Corrective Action Response for C #

A. U1 Action - Actions taken to correct specific deficiencies noted.

(Required for all CARs)

B. Investigative Action - Actions taken to determine the extent of thecondition.

(Required for all igs adverse to quality or anyQxdton Adverse to Quality if requested by OM)

C. Root Cause I~teninan - Identification of the rot cause of thecoxzsHtion.

(Required for all significant itions adverse to quality or anyOxxitto Adverse to Quality f requested by oQ&)

D. Corrective Action to Preclude Recurrenc - Actions taken to address thezot cause and preclude - of the condition.

(Rqired for all significant c ltios adverse to quality or anyOTition AdTerse to Quality if requested by OOMe)

2. Er each action above, identify the name of the individual assigndresponsibilty for czpletion and the anticipated (or actual, if ccuplete)clp~letion date.

3. Response Aprpved: Date:Responsible Manager

OFFICE OF CIVILIANRADIOACTIVE WASTE MANAGEMENT

U.S. DEPARTMENT OF ENERGYWASHINGTON, D.C.

£ CAR NO.DATE:PAGE OF

GA

___X* *- S * 5 0 O 0 .0

REV.t Cw

THIS IS A RED STA"

OFFICE OF CIVILIAN 8ATN: 10-22-92

RADIOACTIVE WASTE MANAGEMENT DATE: 10O292U.S. DEPARTMENT OF ENERGY OA

WASHINGTON, D.C.

CORRECTIVE ACTION REQUESTI Cotrolling ocument 2 Related Report No.

AP 5.19Q, 2 AP5.lQ, 2 1YNP-93-01

3 Resposible Organization 4Discussed WithUSGS Ardell hiteside, R. Spangler

5 Requirement:AP 5.19Q, Step b, stated in part: "Data Supplier-If IMOU and/or PIRN have no impact oncontrolled documents and are acceptable, sign and return original signature document...to the processor.'

AP 5.19Q, Step 11, states in part: "Data Supplier-Compile and send data to therequester send and control data per P-5.lQ....)n

AP 5.1Q, Step 2, states in part: YEP Participant- Submit the DPS to the appropriateparticipant data archive... Include a DIF...."

AP 5.1Q, Section 3.12 states in part: "The TDIF... is used to provide input to the ATDTSystem. The form is included with DPSs and Data Transmittal Packages."

6 Adverse Condition:Contrary to the above:

(A) Acquired Data has been transmitted to LAHL without documented evidence of processed IMOU.

(B) Acquired Data has been transmitted to LARL without evidence of a DIF beingprepared and Data entered into the Participant Data Archive.

Example: 6-10-91 "Potental Sr-Isotope Stratigraphy Eigh-Silca Rhyolite."

10-12-92 'Isotope Stratigraphy in the Topopah Springs igh-SilicaPhyolite"

9 Does a significant condition I0 Does a stop work condition exist? 1 Response Due Date:adverse to quality exist? Yes_ No.x Yes NoX_; if Yes - Attach COpy Of SWO 20 working daysff Ys, Cirde One: A B C If Yes, Circle One: A B C D from issuance

12Required Actions: i Remedial I[! Extent of Deficiency ] Preclude Recurrence IX Root Cause Determination13 Recommended Actions:

(A) Process ZHMU and get number assigned prior to transmittal of Data

(B) Transmit Acquired Data to DA with TDIF

(C) Evaluate status of all IMOUS between USGS and other participants. Assure all havebeen processed and have been assigned a number per AP 5.19Q

7 Initiator I4JssuanceAppved tR. L. Maudlin(:4a5*ebt: /e&.jt.. I's. Iy

Date OADD/f Date15 Response Accepted 16 Response Acoep

OAR Date QADD Date17 Amended Response Accepted 18 Amended Response Accepted

OAR Date QADD Date19 Corrective Actions Verified 20 Closure Approved by:

OAR Date OADD Date

REV. 0191

OFFICE OF CIVIUAN 8 CAR NO: 193-015

RADIOACTIVE WASTE MANAGEMENT SEET: 2 OF 2

U.S. DEPARTMENT OF ENERGY CAWASHINGTON, D.C.

CORRECTIVE ACTION REQUEST (Continuation Page)

13 Recommended Action(s) (continued)

(D) Evaluate all Data Transmitted to date and determine:(1) is there a valid IMU for transmittal of this data(2) has data been transmitted to PDA via TDIF prior to being sent to participant

(E) Determine cause of condition and what action would be taken to preclude recurrence

REV. 08/91

Fo~at for Crrective Action Response

7he CR response shall include the following infation:

1. Corrective Action Response for CAR _#

A. RD Action - Actions taken to correct specific deficiencies noted.

(Required for all CRs)

B. Investigative Action - Actions taken to deteridne the extent of theoixdition.

(Recpired for all signifiant conditions adverse to quality or anyCrdition Adverse to Quality if reuested by OCA)

C. Root Cause atictio- Identification of the root cause of theoitimn

(Required for all signific t itionS adverse to quality or anyrlmition Adverse to Quality if requested by 0Q)

D. active Action to Preclude Recurne - Actions taken to address theroot cause ad preclude urr of the cordition.

(RPquired for all s ficin adverse to quality or anyCOaition Adverse to Quality if requested by OM)

2. For each action above, dentify te nam of the indivi assignedresponsibility for letion ad the ipated (or actual, if caxplete)ccipletion date.

3. Response pproved: Date:Responsible Manager

4

OFFICE OF CIVILIANRADIOACTIVE WASTE MANAGEMENT

U.S. DEPARTMENT OF ENERGYWASHINGTON, D.C.

.CAR NO. _ _DATE:_-

PAGE OF_ _

QA

__6** ' S * S - 4* I

REV. C891