doe-rl/doe-hq joint quality assurance audit 8801 …2. pap-404, rev. 3, paragraph 4.2.3e requires...

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6/dAm O Baltele Pacific Northwest Laboratories P.O. Box 999 Richland. Washington U.S.A. 99352 Telephone (509) 35-2979 Telex 15-2874 March 31, 1988 Mr. J. J. Keating, Acting Manager Quality Assurance Division Department of Energy Richland Operations Office P.O. Box 550 Richland, Washington 99352 Dear Mr. Keating: DOE-RL/DOE-HQ JOINT QUALITY ASSURANCE LABORATORY (PNL) ACTIVITIES Ref: RP Saget letter to the Director, above. AUDIT 8801 OF SELECTED PACIFIC NORTHWEST PTL, dated March 3, 1988, subject as Enclosed is a copy of the Pacific Northwest Laboratory (PNL) response to the subject audit. Corrective actions are now in progress as indicated in the response. Your prompt review and response is greatly appreciated. Stanley Gldsinith Director Quality Achievement SG:par Enclosures In triplicate cc wencl: CE Hughey, PNL WR Wiley, PNL DL Sours, DOE-RL RP Saget, DOE-RL R Stein, DOE-HQ SP Mathur, P-HQ G Faust, Weston N Montgomery, EEI JC Haugen, MIO CH JJ Linehan, NRC cc w/o encl: R Cook, NRC J Morris, DOE-HQ (- / I Lwfl K9jQ. DCD 1 7 luw 'I

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Page 1: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

6/dAm

O BaltelePacific Northwest LaboratoriesP.O. Box 999Richland. Washington U.S.A. 99352Telephone (509) 35-2979

Telex 15-2874March 31, 1988

Mr. J. J. Keating, Acting ManagerQuality Assurance DivisionDepartment of EnergyRichland Operations OfficeP.O. Box 550Richland, Washington 99352

Dear Mr. Keating:

DOE-RL/DOE-HQ JOINT QUALITY ASSURANCELABORATORY (PNL) ACTIVITIES

Ref: RP Saget letter to the Director,above.

AUDIT 8801 OF SELECTED PACIFIC NORTHWEST

PTL, dated March 3, 1988, subject as

Enclosed is a copy of the Pacific Northwest Laboratory (PNL) response to thesubject audit. Corrective actions are now in progress as indicated in theresponse. Your prompt review and response is greatly appreciated.

Stanley GldsinithDirectorQuality Achievement

SG:par

EnclosuresIn triplicate

cc wencl:CE Hughey, PNLWR Wiley, PNLDL Sours, DOE-RLRP Saget, DOE-RL

R Stein, DOE-HQSP Mathur, P-HQG Faust, Weston

N Montgomery, EEIJC Haugen, MIO CHJJ Linehan, NRC

cc w/o encl:R Cook, NRCJ Morris, DOE-HQ

(- /I

Lwfl K9jQ. DCD1 7

luw 'I

Page 2: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

., I K-)

Pace 1 of 2-

I QUALITY AUDIT CONCER

DEPARa= OF DNEY - RTCMJND OPERMONS

2. QAC CONTROL NO.

8801-01__

L TO: Namc Tiluc 3. LocationU VDCTTFo Mrr conj.1FT MamAnFr D0 - &ht1unA UR

4. Rfcrencc/Rcqulremcnts 5. Audit No.

PAP 901, Rev. 1, Control of Processes, Section 4.1 88ao*The PM shall assure that controlled processesto be performed by his project and shall determine . Potctial Repartabi t ,whether or not specific qualification is. .. Under 10 CFR 60.73required." DYes Ifl xo

7. Description

Attached are several procedural concerns which collectively ndicate theneed for qualification of technical procedures addressing the spent fueloperations.

a. I~yL~ui~tia gnipatusc) 9. Issue DateA 10. Respozse, puc Date

I1. Auditce Correcti-e Action Commitcent

See attached sheet.

12. Responsible Action Ucna ge (Slgature 13. Date 14. Action Completion Due Date<- 'v 1 3A1;'/40 See attached sheet.

-' .ACTION tERFID

15. Lead Auditor (Signature) jI&. Date

18. Final Distribution 17. Final Review and Approval (Audit Concern Closed)

ORIGAL-Audit Report FTle

D-3- ~~~~~D1}ZCTOR - Quality Systems Division Date

Page 3: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

OUALITY AUDIT CONCERN Page 2 of 2 8801-01

MCC-TP-8. Sent Fuel tentffIeation and Control

1. Means to prevent loss of fuel from segmented rods during handling{nd storage were not apparent in 'this procedure. Such means shouldbe devised (e.g., capping'the ends) and appropriate steps beincorporated Into'the procedure.

2. The procedure does not specify the maximum length of time duringwhich fuel samples can be exposed-to the hot cell amsphere. Aconcern exists that the fuel ay partially oxidize under theseconditions and thereby undergo a change in ts chemicalcharacteristics. This concern also extends to cutting operationswhereby oxidation could be accelerated as a result of highertemperatures generated during cutting. (This effect has beenreported in the Canadian Waste Management Program.) The procedure

_---jhould at least specify a maximum length of time that fuel samplesmay remain in the hot cell atmospheres and nerting the cuttingoperations should be evaluated.

MCC-TP-. Feuel Rod Scanning Procedure

1. The procedure should reference a design report for the Fuel RodScanning System where the operating limits and requirements areclearly identified. Such a report could serve as a basis for 1)training the operators, 2) maintaining the system. and 3)implementing future upgrades. This report could be critical ifthe original staff responsible for the design are no longeravailable.

MCC-TP-10. Fission Gas SRllng

1. The procedure should reference a design report for the Fission GasSampling Systems where the operating limits and requirements areclearly dentified. Such a report could serve as a basis for 1)training the operators, 2) maintaining the system, and 3)ftplementing future upgrades. This report could be critical ifthe original staff responsible for the design are no longeravailable.

2. The procedure does not provide a method to calibrate the Baritronpressure gauge after it-has been-installed. It Is recommendedthat the system be modified to permit on-line calibration checksbefore and after fission gas sampling. The operational limits andvulnerability of the Baritrons e.g., sensiltvity to particulargases and temperature, etc.# should be identified in the designreport. (See preceding concern.)

Page 4: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

I)

CONCERN 8801-01 - PNL RESPONSE: Page 1 of 2

MCC-TP-8The two areas of concern that were identified are discussed below.

1. Fuel could be lost from segmented rods during handling and storage.

Experience gained in preparing a large number of samples from six differentATM rods has shown this not to be a problem. The ATMs are moderate tohigh burnup fuel rods and, as a result of cladding creepdown, the fuelis very difficult to remove from the cladding. To date 132 analytical(<1 in. long) samples have been prepared. The only fuel loss problemshave occurred when attempting to cut very short (1/4 in. long) samplesof ATM-105 (a larger diameter BWR fuel rod). As a result 1/4 in. longsamples of ATM-105 are no longer prepared. The archive and testingsegments which are stored for indefinite periods are considerably longerthan the analytical samples. No significant fuel loss has been observedduring cutting, installation in storage tubes or subsequent retrieval.This has also been true for ATM-101 rod segments which have been storedfor five years and occasionally retrieved for additional segmenting. Itis recognized that fuel loss could be a problem with low burnup fuels orif the samples are cut from the low burnup region (ends) of the BWR rods.

Corrective Action: An ICN to MCC-TP-8 will be prepared. It will identifythat test instructions should include the requirements: (1) BWR samplesshould not be cut less than 1/2 in. long and (2) samples cut from lowburnup areas may require the use of end caps or potting. The ICN willbe prepared by May 20, 1988.

2. The maximum length of time that fuel samples may remain in the hot cellatmosphere should be included in the procedure and inerting the cuttingoperations should be evaluated.

MCC-TP-8 was reviewed by PNL and the repository projects before approvaland implementation. It requires the use of storage containers which areto be purged with argon to "reduce exposure of the fuel to air". Theserequirements of MCC-TP-8 have been followed for segmenting of ATMS 103,104, 105 and 106 (ATM-101 was segmented before implementation of PNL-MA-60and these procedures). At this time an inert atmosphere is required forstored archive and repository samples only--all analytical samples arestored in air before they are analyzed.

Corrective Action: In the future, test instructions will include arequirement to inert the segments within a time limit recommended anddocumented by a panel of PNL staff who have fuel behavior expertise.The panel recommendations will be obtained by May 20, 1988. If therecommendations indicate the need, an ICN to MCC-TP-8 will include timelimits in the procedure. This action is expected to be completed by May20, 1988.

Page 5: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

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Concern 8801-01Page 2 of 2

MCC-TP-9This concern was that MCC-TP-9 should have a design report

Corrective Action: A design report which identifies the operating limitsand requirements will be completed for the Fuel Rod Scanning System; thedraft report will be ready for review by July 1, 1988.

MCC-TP-10The twoareas of concern are discussed below.

1. A design report is needed for the Fission Gas Sampling System

Corrective Action: The fission gas sampling system will be discussed inthe report prepared for MCC-TP-9.

2. A system is needed to permit on-line calibration, and operation of theBaratron gauge should be identified in the design report.

Corrective Action: An on-line calibration check of the Baratron gaugehas been completed and documented. The gauge's calibration results wereacceptable. The procedure will be revised to include information on thegauge and as well as a requirement for completing on-line calibrationchecks. The procedure will be revised by July 1, 1988.

Additional Clarification:

Spent fuel operations test procedures fall under the requirements of PAP-liOl,Test Planning, Performance and Evaluation rather than PAP-901, Control ofProcesses cited in this concern. Controlled processes as defined by PAP-901are those which, if improperly performed could adversely affect the qualityof items or services. Examples include the production of test or referencematerials, laboratory analyses (meaning routine, repetative type analyses),and fabrications that include aspects such as material controls, cleanlinessor environmental controls, or special handling. Test processes as defined byPAP-1101 include those performed to acquire data. Therefore PAP-901, citedin the concern, is not considered to be applicable to these procedures. Rather,they are considered test processes to acquire data and performed in accordancewith PAP-liOl, Test Planning, Performance, and Evaluation. This determinationis confirmed by the MCC QA plan. PAP-901, Control of Processes, Section 4.1(a) requires controlled processes to be performed within the projectorganization to be identified in the QA plan. Spent fuel test procedures arenot identified as controlled processes in the MCC QA plan WTC-002, Rev. 1(11/18/87).

Page 6: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

K>Page 1 of 2

i QUALITY AUDIT CONCERNDEPARIED OF EERGY - RICAND OPERlIONS

2 QAC CONTROL NO.

8801-02*1� �

C. E. HUGHEY,Title

QAO Manager3. Location

PNL - Richland, WA

4. Referenc/Requirements S. Audit No.PAP 201, Revision 2, ICNs 1, 2, 3 and 4 - seat

"Indoctrination and Training"

Section 4.3.2 - 6. Potential Reportability'Personnel shall receive the Under 10 CFR 60.73appropriate indoctrination and training. a Yes i No

7. Description

Training to detailed procedures and revisions is considered to beineffective. Examples of this concern are attached.

8 Lead Auditor (Signature) 9. Issue Date 1O. Response Due Date

11. Auditee Correcttve Action Commiteat

See attached sheet.

12. Responsible Action Manager (Signature] 3. Date 14. Action Completion Due Date

tl~49 e- A., . '/99 See attached sheet.

& V ACTION VE ED

1S. Lead Auditor (Signature) 16. Date

18. Final Distribution 17. Final Review and Approval (Audit Concern Closed)

ORIGIAL-Audit Report File

1--

2- -

3- DIRECTOR - Quality Systems Division Date

Page 7: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

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QUALITY AUDIT CONCERN PAGE 2 OF 2 8801-02

1. PAP-404, Revision 3, Paragraphs 4.2.1 and 4.2.3b require theProject Manager to include quality levels in SOWs and the QADRep. to verify incorporation of quality levels. MCC SOW M28071,Rev. 1 Approved on 12/21/87, does not include a quality levelhowever, QA requirements are included in SOW.

2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Managergive final approval of SOWs for quality Level 1 services. TuffSOW M37615. Rev. O, issued 1/4/88, was approved by Task Leaderand not Project Manager.

3. PAP-706, Rev. 1, ICN PAP-706-Rl-1, Paragraph 4.1.3, requires theuse of an Inspection/Test 4nstruction (ITI) when per-formingreceiving inspections. No ITI was completed for an autoclavereceived on 1/2/88 (PR/PO Q8633.) Documentation in the QC filesprovides evidence that the item was in fact- inspected by QC uponreceipt. This discrepancy was corrected during audit by issuanceof internal letter (QC-072-GRA) and completion of an ITI.

4. PAP-705, Rev. 1. Paragraph 4.2.1 requires that the QC Rep. reviewsubmitted documents, verify applicable material numbers, and recordthe information. QC Review Plan and Record (RPR) for PR/PO T1713(cylinders of dry air) received during 1/88, did not reflectverification of cylinder numbers to submitted material certifications.This discrepancy was corrected during audit by issuance of internalletter QC-073-NWG) and correction to RPR.

{NOTE: Audit concerns 8801-04, 06 & 07 issued independent from this concern.]

Page 8: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

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CONCERN 8801-02 - PNL RESPONSE:

Prior to the audit, during an informal overview of training at PNL coordinatedthrough the Quality Assurance Department, the following opinion expressed byPNL management was noted:

The indoctrination/orientation type of training currently being performedis mostly a simple review of requirements which most people could getfrom the read/study training. More emphasis needs to be placed on thepurpose or reason for the requirement and how compliance would bebeneficial or value added".

It is felt that due to this fact, staff are not placing emphasis on detailedcompliance by referring to the procedure each time actions occur which arenot routine.

Corrective Action:

During the next regularly scheduled project or staff meetings in each projectand the Quality Engineering and Quality Control Sections, the appropriatemanagers will discuss the need to specifically refer to (i.e. reread) applicableadministrative procedures when performing a new or nonroutine action. Emphasiswill also be placed on requesting additional QAD assistance to help assureall areas of compliance are covered when performing the new or nonroutineactions. This will be documented in meeting minutes or agenda and retainedin project and QE/QC Section files.

Action to Preclude Recurrence:

As part of long range planning, the QAD had begun evaluating the entire trainingprogram prior to the audit. This effort will continue with upgrades beingmade to the training system as deemed necessary by the evaluation.

Completion Schedule:

The short term corrective action is expected to be completed by the end ofApril, 1988. QE Section discussion took place on 3/2/88. Action to precluderecurrence is an ongoing PNL action and will not be tracked with this auditconcern.

Page 9: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

K-I

Pace 1 of 2

QUALITY AUDIT CONCERN 2. QAC CONTROL NO.

WD EPARr1IT OF =GY - P1CAND oPERnOwS 8801-03

1. TO: Nae TItle 3. Location

MAX KREITER MCC PROJECT MANAGER PNL- Richland. WA

4. Rcecrece/Recquirements S. Audit No.

PAP 901, Rev. 1, Control of Processes', 801Section 4.1 - Processes shall be identified andcontrolled. 6. Potential Reportablity

Under 1 CFR 60.73.*D Yes ED No

7. Descriptiou

The attached concern addresses the reference of a Technical Procedure in -several documents. The revision of the TP may not be the same.

8. Lea! Auditor Siguature) 9. ssue Date 10. Respons Due Date

;629_'-~ 3 ~** e s +*LS. Auditec Corrective Action Co itment

See attached sheet. .

12. Responsible Action Manager (Siguature' 13. DaLe 14. Action Completio Due Date

Q W+ I., t 4 ( #A 4R4Xr :+J" I 3 /f-7. 1ie See attached sheet.

-9 .ACTION VERIEF

15. Lead Auditor (SignaLure) I16. Date -

la. Fizal Dlistribution 17. Final Review and Approval (Audit Couceru Closed)

ORGINAL-Audit Rcport File

1--

_ J)IR~~~~DECOR -Qt Systemas Divson Datc

Page 10: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

QUALITY AUDIT CONCERN PAGE 2 OF 2 8801-03

Concern on MCC-TP-S, Rev. 2, MCC-1P. and MCC-3S, Glass TestingProcedures and Methods".

The Nuclear Waste Handbook and companion document, PNL-3990, isa set of controlled documents which is widely distributed and whichincludes the 9-30-83 version MCC-1P, Static Leach Test Method.However, there have been several revisions to this method, and ithas been further modified by MCC-TP-5, Rev. 2, for use in testingWest Valley glass. Whtle PNL/MCC is internally in compliance withMA-60 requirements, holders of the Handbook may not necessarilybe aware of the latest technical changes. Furthermore, two systemsof -technical procedures seem difficult to manage and are likely -to result in technical inconsistencies.

It is recognized that recent discussions by DOE'may lead to eliminationof the programmatic requirement for the Handbook. 'However, PNL-MCCshould also evaluate positive steps to resolve this situation.Actions that should be considered include: 1) Issuing notices toholders of the Handbook apprising them of the situation, 2) incorporatinguseful test meto d directly into the MCC-TP system, and 3) recommendingto DOE steps for a controlled termination of the Handbook. Thislatter could include publishing the latest versions of the testmethods as PNL reports and providing copies of these to Handbookholders when the Handbook is recalled.

Page 11: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

CONCERN 8801-03 - PNL RESPONSE: Page 1 of 2

The two areas of concern that were identified are discussed below.

1. Holders of the Nuclear Waste Materials Handbook and PNL-3990 may not beaware of latest technical changes.

The Handbook contains only test methods that have been approved by theMaterial Review Board TMRB) review process. Users are thereby assuredthat they are using methods that have completed a rigorous review andrevision cycle and there is a consensus on their acceptability.Unfortunately this means there can be a considerable time-lag betweendeveloping and issuing an approved procedure.

The purpose of PNL-3990 is to provide users access to test methodssubsequent to their initial development but prior to their approval andinclusion in the Handbook. Users of PNL-3990 are warned that the testmethods may be changed significantly during the MRS review process. Onestated purpose of this document is to obtain user comments on theseprocedures.

Once a method has received provisional approval, it is removed fromPNL-3990 and the provisionally approved version is published in theHandbook. Handbook users are not advised of potential changes inprovisionally approved methods because these changes have not yet beensubjected to the rigorous review associated with publication in theHandbook. Once this review has been completed, the final approved versionof a method is published in the Handbook.

Unless methods are being developed specifically for MRB review, they arenot published in PNL-3990 or the Handbook. The thrust of most recentMCC work has not been directed toward development of test methods forHandbook publication. As a result, MCC-TPs which are prepared for specificwork are not included in PNL-3990.

Corrective Action: The MCC will request guidance from the DOE regardingalternatives for the protocols of documenting, distributing, anddispositioning procedures contained in the Nuclear Waste Materials Handbookand PNL-3990. The alternatives would include: 1) issuing notices toholders of the Handbook apprising them of the situation; 2) incorporatinguseful test methods directly into the MCC-TP system; and 3) recommendingto DOE steps for a controlled termination of the Handbook. Correctiveaction will be completed by May 31, 1988.

2. Two systems are difficult to manage and can result in technicalinconsistencies.

The current situation, two systems for procedure approval, occurred inresponse to findings of the August, 1985 PNL internal audit, which citedthat the MCC was using test procedures that did not comply with PAP-501requirements. MCC had successfully negotiated with the MRB a format anda control system for issuing the Handbook before the advent of MA-60.

Page 12: DOE-RL/DOE-HQ Joint Quality Assurance Audit 8801 …2. PAP-404, Rev. 3, Paragraph 4.2.3e requires that the Project Manager give final approval of SOWs for quality Level 1 services

Concern 8801-03Page 2 of 2

The MCC has continued to implement this system so that a controlleddistribution of changes could be maintained. However, the introductionof PNL-MA-60 required that the MCC follow technical procedures preparedin conformance with PAP-501 which provides specific requirements regardingprocedure preparation different from those agreed upon with the MRB.MCC test procedures being developed for the MRB follow the MRB format,other MCC test procedures use the format required by PAP-501. No technicalinconsistencies can exist because the version invoked by MCC-TP-5 istechnically consistent with the version in the Handbook.

Corrective Action: No action is proposed at this time. So long as thetwo systems have separate goals the MCC will have to conform to each.