ML20118A356

Scientific Ecology Group,Supplier Implementation & Qualification Audit 92050S

ML20118A356
Person / Time
Site:	Pilgrim
Issue date:	03/24/1992
From:	Ryan J PACIFIC GAS & ELECTRIC CO.
To:
Shared Package
ML20118A352	List: BECO-92-080, Forwards Audit Rept for Scientific Ecology Group,Inc Performed by Util Under Auspices of Nuclear Procurement Issues Committee ML20118A356
References
NUDOCS 9208310156
Download: ML20118A356 (11)

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PG&E PROCUREMENT GUALITY ASSURANCE '

SCIENTIFIC ECOLOGY GROUP SUPPLIER IMPLEMENTATION AND QUALIFICATION AUDIT 92050S Dates: March 24-27, 1992 Conducted by: Jeffrey C. Ryan - PC&E David L. Clivinski - Portland General Electric Allan R. Barker - American Electric Power Hoda S. Elguindy - Co=monwealth Edison ec: (vithout ATR attachnents)

RCAnderson/NECS A1411/333 Market VDBatkhuff/QC-DCPP/104/3/303 EADettman/NPC/1453/77 Beale RCDoner/Engg/F1780/1 Calif.

RLRussell/NSARA/A1110/333 Market JBHoch/A1113/333 Market RTNelson/NPC-HBPP/Buhne Point JASexton/QA/F1864/1 Calif.

?JEToback/NOS/1485/77 Beale JCToung/QA/F1876/1 Calif.

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1 TABLE OF CONTENTS [

1.0 SCOPE 2.0 OVERVIEW 3.0 PERSONS CONTACTED 4.0 AUDIT P2SULTS ,

4 .1. Adequacy of Vritten Quality Progra:  !

4.2 Implementation of Quality ProEra: . .

4.3 Audic Su==ary 4.4 Audit Findings 5.0 EFFECTIVENESS EVALUATION 6.0 P2FEPINCES Attach =ent: AFR 92-019 ATR 92-020 ATR 92-021  ;

AFR 92 022 AFR 92-023 AFR 92-024 i

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- Audit 92050S l Issue Date: 05/05/92 Page 1 of 9

. l PACITIC CAS AND ELECTRIC COMPANY I

QUALITY ASSURANCE DEPARTMINT

Title:

Supplier Quality Assurance Program )

Implementation and Qualification Audit 92050s Audited Organisation/ Scientific Ecology Group, Inc. (SEC)

Facility: 1560 Bear Creek Rd./Callaher Rd.

Oak Ridge, TN 37831-2530 (615) 376-3147 Product or Service: On-Site Radvaste Processing, Packaging, Transportation, Volume Reduction, and Decontamination Auditors: Jeffrey C. Ryan - PC&E (Audit Team Leader)

David L, Clivinski - Portland General Electric (Audito,r) _

Allan R. Barker - American Electric Power (Auditor)

Hoda S. Elguindy - Commonwealth Edison (Technical Specialist)

Dates Performed: March 24 27, 1992 1.0 SCOPE The audit was esnducted on behalf of PG&E and the Nuclear UtFilities Procurement Issues Council (NUPIC) to determine if SEC's quality assurance _(QA) program was adequate to provide the following radvaste services: On-site Processing (devatering, demineralization, and solidification); Packaging; Transportation: Volume Reduction (incineration, eccpaction, and resin drying); and Decontamination. The audit was performed to NUPIC Aadit Checklist, Revision 2, the criteria of which meet the applicable QA requirements of 10CTR71/Subpart H, 10CFR50/ Appendix B, 10CTR21, and Regulatory Guide 1.143. In addition, this checklist was supplenented-to meet the requirements of PC&E Supplier Specification FC-B Radvaste Solidification, Revision 1 and Procurement Category 15. " Packaging for Radioactive Material," .in order to meet PG&I's specific supplier qualification needs.

2.0 OVERVIEW SEC is a wholly-owned subsidiary of Vestinghouse Electric Corporation, maintains an independent QA program, and currently has over 700 employees.- A significant part of SEC's capabilities came from acquisitions (desi'gns, assets, and procedures) from vestinghouse Radiological Services. Hittman Nuclear and 13 Technologies. They have two facilities in Oak Ridge. The Central Volume Reduction Facility (radvasta receiving, sorting, compacticn, incineration, and shipping) is located at the Bear Creek Road plant. All other activities (cask maintenance, equipment services, container refurbishment and f abrication, engineering, quality assurance, and document control) take place at the

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Callaher Road facility. SEG markets additional radvaste products and services beyond the scope of,this qualification, and they are currently comp 1 sting construct'on on an induction furnace Metal Processing  ;

Facility. l i

3.0 PEM ONS CONTACTED

+ H. V. " Bud" Arrowsmith President

+* Dale Hedges Director, Quality Assurance

+* Marsha Wilson Supervisor. Health Physics Peter P. Keegan Vice President, Project Management 4* James F. Morrison CPA, Financial Manager

+* John E. Hess Analytical & Technical Services Manager

+* Steven Norris Deputy Esdiation Safety Officer

+* B. S. (Pete) Mays Manager Gallaher Operations, Field Services Equipment

+ Joe J. Albenze Vice President. Human Resources /

Ad=inistration

+* George Quinn Production Manager

• Jay Pride Executive Vice President- -

+* R. Mike McCa': ley Radvaste Operations Manager

+* Paula Yarborough Manager, Document Control Villiam F. Clarke Equip =ent Services Specialist

+* Laticia Hodges QA Engineer

+* Bryan Roy Manager, Engineering

+ TL=othy R. Ramsey Senior Engineer

+* Steven Sugar:an H.P. Supervisor

• Andy Ross QA Engineer

• Larry Harris QA Engineer

• Patricia Valsh Manager, Incineration Progra: .

• Bill Horsey. Manager, Field Operations

• Roger Betov Equipment Supervisor Teresa Bell Supervisor of Data Systems Mitch Parker HP Shipping Technician Sue Nelson Central Stores and Receiving Fred Vicker Container Supervisor

-Scott Thur an Container Technician

+ Attended preaudit conference on March 24, 1992

• Attended postaudit conference on March 27. 1992 4.0 AUDIT RESULTS 4.1 Adequacy of Written Quality Program SEC's Quality Assurance Program, Revision 3, as amended by DCN 92-065, and applicable lower-tier procedures-vere reviewed for co=pliance with 10CFR71/Subpart H,10CFR50/ Appendix B, 10CTR21, and Regulatory Guide 1.143 as they apply to SEG's operations. The audit

_ team found that SEG's written program satisfactorily meets applicable regulatory requirements with no deficiencies identified.

One observation was =ade in the following area: SEG recently changed the method of defining which quality requirements apply generally (to all of their vaste processing activities), and which requirements apply only to "NRC-related activities" (see DCN 92-065, issued to controlled QA Progra= holders). However, certain

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Audit 920$0S Pago 3 of 9 terminology used throughout the QA program and procedures, such as

" quality related," and ." safety-related and affecting" are not specifically defined (as being distinct from "NRC-related").

Despite this, the audit team concluded that SEG personnel in all areas audited vere aware of the QA requirements which apply to their activities and were vell-trained in their responsibilities portaining to them. It was recom= ended during the exit conference that SEC review all terminology used to establish the quality requirements being applied to their operations, and clarify their intent and usage, as appropriate.

The following specific comments pertain to regulatory requirements applied to SEG operationst 4.1.1 The N2C has approved SEG's program for applicable 10CTR71/

'Subpart H transportation package activities (Approval 0496, '

Revision $).

4.1.2 Although SEG's QA program meets 10CFR50/ Appendix B, there is no regulatory requirement invoking Appendix B on any of SEC's operations, and no customer purchase order reviewed invoked it. SEG stated that they treat the containment boundary components of shipping casks as nuclear safety related.

These components are identified in the cask safety analysis reports, and the audit team treated these items (from a procurement, dedication, and control standpoint) as nuclear safety-related.

4.1.3 Regulatory Guide 1.143 applies to on-site radvaste processing systems operated-by SEG. The QA requirements of,Section 6 of Regulatory Guide 1.143 are satisfactorily covered by SEG's program.

4.1.4 The most specific. regulatory position found on QA requirements for High Integrity Containers (HICs) is the '

NRC's " Technical Position on Vasta Form," Revision 1, January 1991 (9101280097 90118, PDR VASTE, VM 3). The QA requirements for HICs (described in Section 4.n of this document) are satisfactorily met by SEC's documented QA program.

4.1.5 Activities at the Central Volume Reduction Facility (C7RF) are governed by State of Tennessee and EPA requirements and certain radioactive package transportation activities are subject to 49CTR and DOT regulations.

4.2 Implementation of Quality Program 2ae implementation of SEG's QA program was audited for co=pliance with the applicable requirements of their QA manual and procedures and NUPIC Audit Checklist, Revision 2. The objective evidence reviewed during the audit is described in the corresponding audit checklist. Implementation of the QA program was in compliance

except for deficiencies described below and documented on the six l

Audit Finding Reports (,.FRs) issued with this report.

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- 4.3 Audit su==ary The audit summary is st,ructured in accordance with the !CFIC Audit Checklist categories.

4.3.1 Sectfen I - Order Entry SEG's documentation of a client's vaste activity values for an arriving ship:ent was verified to be correct, with one discrepancy in the 65 values recorded. SEG Data Systems personnel took immediate and appropriate corrective actions to dstermine the correct value. The audit Technical Specialist concurred with SEC that the error did not affect the vaste classification. No deficiencies were identified in this area.

4.3.2 'Section (L - Desien Control One cask safety analysis report and one HIC topical report was reviewed. All cask design changes had been appropriately submitted to and accepted by the NRC, and the certification drawings reflect these changes. There is very limited design and design change activity proceeding at this time. Two deficiencies regardbag the implementation of SEG's con =ercial grade item evaluation program were identified and docu=ented on AIR 92-021. These deficiencies are not considered by the Audit Team Leader to constitute ignificant conditicns adverse to quality.

4.3.3 Section III - Softvare Ous11tv Assurance SEC does not currently utilize any engineering s'oftvare for design, analysis, or testing.

4.3.4 Eeetion IV - Procurement Procurement of items to be used in safety-related applications (cask containment boundary components) was found to be satisfactory with the exception of the qualification of a bolting caterial supplier. docu=ented on AFR 92 020.

Because the bolting suppliar is widely used and audited by the nuclear industry, the material itself is not in question.

Procurement and source inspection records for the 1990 fabrication of two shipping casks was found to be acceptable.

Procurement controls for nonsafety related items also appears to be adequate.

4.3.5 Section V - Materisi Control The audit team vitnessed radiation surveys and inspections of incoming vaste ship:ents, compared information to customer

=anif ests and tracked the assignment of " parent" and

" daughter" bar codes throughout processing at the Central Volu:e Reduction Facility. Identification of containers, container internal parts and replacement cask parts was also reviewed. There were no deficiencies in these areas.

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- 4.3.6 Sectien VI Tabrication/Assenbiv/Sreef al Processes The Liner Tabrice. tion Area (Building 4) and Equip =ent Services Area and Cask Esintenance Areas (Building 3) were toured. Vith the exception of cask maintenance operations (which was found to meet all rev:irements), uncontrolled or unapproved procedures were noted in both areas. It was also learned that there is no QA or QC oversight (either inspections, surveillances, or Laternal audits) 'n either area. Neither of these operations is governed by 10CFR71 Subpart H, but both fall under the general requirements of SEC's QA program. See ATR 92-019 which docu=6ats these deficiencies. The audit indicated that these defic $ancies have not impacted SEG services. The procedures in the appeared both comprehensive and current. Supervisory and shop personnel interviewed were knowledgeable of their job functions, and all documentation reviewed appeared to be correctly prepared and approved by plant supervision.

4,3.7 Efetion VII - Tests and Intreerions The audit team vitnessed the loading and inspection of a Radiok container into a cask / trailer for release, reviewed the associated cask maintenance inspection records, and witnessed the leak test of a refurbished Resin Express container. (Deficiencies associated with this area have been identified previously.) One observation was made pertaining to torquing calculations. Procedure VM 014, Revision L,

" Operating Instructions for Loading and Unloading the LN 14-170 Series 1 Casks" requires that pri=ary lid torque calculations be performed. For this calculation. the individual must =easure the distance (in inches) from the torque vrench driver stud to the end of the vrench handle.

This measurement introduces a variable into the esiculation which can change based on the accuracy of this measurement.

It is reco== ended that SEG measure each vrench and l permanently record this on the vrench itself. Additionally, this data could be incorporated into the procedure by calculating the torque values for each specific vrench.

Note: There were no calculation errors noted for the cash release inspection vitnessed.

4.3.8 Section VIII - Handline. Storere. and Shirpine The audit team reviewed overpack ship =ent bracing and various material, container and spare parts in Buildings 3, 4, and 6.

No deficiencies were noted in these areas. One potential personnel safety concern has been brought to SEC's attention.

Operation of the lift trucks at the Bear Creek facility is

- conducted in a relatively small area, and several trucks may be operating at one tica. The trucks are not equipped with back-up buz:ers or lights, and the noise level in the plant is high enough that truck movement may not be heard by plant personnel in the immediate vicinity.

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Audit 920$0S l . Page 6 of 9 4.3.9 Eeetien II - Calibratien Calibration cortrols for survey meters, pulse generators, cultimeters, torque vranches, pressure gages, and duromoters were reviewed. All were found acceptable with the exception of durometers, as documented on AYR 92-024. The frequent field checka of the durometet to test blocks, hevever, show that the readings are stable ever time, so no significant impset due to this deficiency is antic! pated.

4.3.10 Section I - Doeurent control /Ptreedure Adecuery One minor docu=ent control deficiency concerning the filing of Docu=ent Change Notices (DCNs) was identified. See ATR 92-022. Otherwise, document controls and procedures were considered well-administered.

4.3.11 Section IT - Procram Ceroliance The following QA program areas were reviewed: Organi:ation structure, audits, canage=ent assessments, personnel training records and certifications, nonconfor=ance and corrective action reports, 10CTR31 program, and records identification, retention, and storage. ATR 92-019, regarding QA oversight in certain areas, and described under Section VI above, is also noted under the " internal audit" question. ATR 92 023 was written in the area of Corrective Action Reports (CARS).

Because there is no CAR for= requiring specific documentation, it is not clear that CARS involving significant conditions adverse to quality are having root cause evaluations and corrective actions to prevent recurrence performed. SEG has been requested to review their files to assure that appropriate evaluations were performed for such CARS. The audit team reviewed 1990 and 1991 CARS and did not feel that any of these issues vould be cause for i==ediate concern by SEG tlients. One final observation was made regarding the QA Manager's report to the President on the effectiveness of the QA program. Rather than relying solely on the results of the annual QA program audit for this assessment, other indicators of the progrrm's effectiveness should be considered. These vould include nonconformance reports , corrective action reports , custorer-identified problems, and internal, utility, and NRC audit results.

Overall, the QA program areas were considered satisfactory.

4.3.12 Attachments to the Audit Checklist A variety of supplemental information is attached to the audit checklist, which is distributed to NUPIC member utilities. Attachments include:

• Infer:ation provided in response to requewts iro: Northern States Power Detroit Edison, Portland General Electrie, and Co::envealth Edison.

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Page 7 of 9 e Follow-up information on corrective actions taken by SEC in response to the previous NUPIC audit (conducted in 1990 by Union Electric), and a 1991 NRC Inspection. Corrective actions (for both closed and pending issues) vete found to be neceptable.

4.4 Audit Findings the attached ATRs were issued to describe the deficiencies identified in SEG's QA progra=. The findings are listed belov:

4.4.1 There is insufficient objective evidence that QA/QC is fulfilling its QA progrts responsibilities to oversee Liner Fabrication and Equipment Services (exclusive of cask maintenance) activities. There is no direct QC inspection and these areas have not been subject to QA internal audits or surveillances. The following unapproved / uncontrolled precedures were noted in these areas: STD-P-03-055, Revision 0, " Installation of Press Pack Devatering Internals in Radioks" (Liner Fabrication Area); STD P 03 053. Draft Revision 1. " Resin Express Container Inspection and Refurbish =ent Procedure (Container Refurbish =ent Area);

S5 007, Revision C, "Preshipment Check Procedure fer LN Radvaste Solidification Systems" (Equipment Services Area).

4.4.2 Purchase Order Q13141 to Hub Inc. ordered ASTM bolting material whose application could be safety-related (ratchet binder fastener). However, the Vestinghouse audit used as the basis for qualifying Hub (conducted July 31, 1990) was for their NCA-3800 (QSC) program, not Hub's ASTM program.

4.4.3 The following deficiencies were noted in the SEG, co==ercial grade ite= dedication progrs=:

• There is no Co==ercial Grade Evaluation on file for HN 190-2 ratchet binders bought under Hitt=an Purchase Order 41320 to V. V. Patterson Co=pany. This purchase order did not invoke 100TR50 Appendix B or 10CTR21, and there is no evaluation of V. V. Patterson's quality assurance progra on file at SEC.

• Co==ercial Grade Evaluations for gaskets identify caterial m as a critical characteristic, but there is insufficient basis for dedication of caterial. SEG perfor:s audits (technically, co==ercial grade surveys) of their gasket supplier, Knorville Rubber & Casket, but since Knoxville does not control the =aterial composition (they buy it in bulk, co==ercially), this audit does not constitute acceptable dedication. Reference Purchase Order 13634, Jum 5,1991, for primary lid gaske (Dvg STD-02-091, Revision 0) and associated Co==ercial Grade Evaluation.

4.4 Contrary to procedure require =ents and as contained in Procedure QA-6.1. paragraph 8.5.3, Document Change Notices (DCNs) are not being filed with the applicable drawing. This practice has apparently been discontinued because DChs have been detached and lost.

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Audit 92050s Poge 8 of 9 4-4.4.5 SEG has developed program and procedure controls to require docu=entation of ,significant conditions adverse to quality.

However, the governing procedure does not make sference to a standard corrective action request (CAR) form and, as a result, it is not clear that root cause and corrective actions to prevent recurrence are determined for those CARS that represent significant conditions adverse to quality. In addition, contrary to procedure requirements, SEG is not documenting their 10CTR21 reportability determinations for CAls issued.

4.4.6 SEG Procedure QA 12.1, Revision 2, Enclosur2 3.1, establishes recall frequency for measuring and test equipment in the calibration program. Durometers (used for hardness testing for commercial grada dedication of gaskets) are specified to be calibrated to a test block every 12 months. Durometer S/N 12041 was reviewed, and the associated test block (not traceable to NIST), was found to provide a functional check of indentor extension at one point (58 Shore A). ASTM D2240,

" Standard Test Method for Rubber Property - Dur.ometer Hardness," defines other variables which influence instrument accuracy (wear on indentor and calibration of spring at a .

range of values), and reco= mends a calibration procedure with specific test apparatus and acceptance criteria. Therefore, SEG's current durometer calibration requirements are considered unacceptable.

5.0 ETTECTIVENESS EVALUATION The auditors determined that, except in the areas identified, SEG's QA program was adequate to provide compliance with the NUPIC Audit Checklist requirements (as described in Section 1.0) for the scope of work reviewed. The auditors decernined that the findings did not have a discernible adverse impact on the quality of the radvaste services provided by SEC.

6.0 REFERENCES

6.1 10CTR50, Appendix B

.6.2 10CFR71, Subpart E 6.3 Regulatory Guide 1.143 6.4 ANSI N45.2 1971 6.5 PG&E Procurement Matriz dated October 17, 1991 6.6 PG&E Generic Supplier QA Program Requirements dated June 19,191 i

6.7 Scientific-Ecology Group Quality Assurance Manual. Revision 3 (as amended by DCN 92-065) 6.9 PG&E Quality Assurance Manual for Nuclear Power Plants -

Diablo Canyon Power Plant, Revision 28, March 3, 1992 6.9 10CTR21 m _~ -~.,.  :. . . ; ~ ~ ,,.~~.~.m..m .~-w ~ .m-,r~ v .

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Audit 92050s

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Por. Day aL-Glivinski ne pro gr Al ari' ( Barker postHop/

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Approved by: b kCud$ h [wW / '

Michael S.'Dobrzensky Senior Supervisor

Attachment:

ATR 92-019 AFR 92 020 ATR 92-021 AFR 92-022 ATR 92 023 ATR 92-024 i

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