ML20203E033

Insp Rept 99900732/97-01 on 971002-03.Noncompliance Noted. Major Areas Inspected:Implementation of Selected Portion of Licensee Facility QA Program

ML20203E033
Person / Time
Issue date:	12/10/1997
From:	NRC (Affiliation Not Assigned)
To:
Shared Package
ML20203D954	List: ML20203D950 ML20203E009 ML20203E033
References
REF-QA-99900732 NUDOCS 9712160371
Download: ML20203E033 (7)

Text

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INSPECTION REPCRT U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION DIVISION OF REACTOR CONTROLS AND HUHAN FACTORS ORGANIZATION: Gould's Pumps, Incorporated Industrial Products Group Engineered Products Division 240 Fall Street Seneca Falls, New York 13148 REPORT NO.: 99900732/97-01 ORGANIZATIONAL Mr. James F. Heid, CONTACT: Quality Systems Manager Engineered Products Division Industrial Products Group Gould's Pumps, Incorporated (315) 568-2811 NUCLEAR INDUSTRY Provides Gould's pumps, pump replacement ACTIVITY: parts, pump refurbishment, and field service.

INSPECTION CONDUCTED: October 2-3, 1997 INSPECTOR: Joseph J. Petrosino, NRR APPROVED BY: Robert A. Gramm, Chief Quality Assurance and Safety Assessment Section Quality Assurance, Vendor Inspection and Maintenance Branch Division of Reactor Controls and Human Factors Office of Nuclear Reactor Regulation Enclosure 2 9712160371 971210 PDR GA999 EMVGOUP 1 99900732 PDR

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I INSPECTION

SUMMARY

During this inspection, the NRC inspector reviewed the implementation of seltcted portior.s of the Gould's Pumps, Incorporated, Industrial Products Group, Engineered Products Division (EPD) facility Quality Assurance (QA)

Program, and reviewed activities associated with " commercial grade items" and " dedication," as defined in 521.3 of 10 CFR Part 21."

The inspection bases were:

• Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to Part 50 of Title 10 of the [pda of Federal Reaulations (10 CFR Part 50) 10 CFR Part 21, " Reporting ct Defects and Noncompliance" During this inspection, one instance where EPD failed to comply with NRC requirements imposed upon them by NRL licensees was identified. This nonconformance represents a long standing practice that EPD has been performing for its safety-related dedication process and is discussed in Sections 3.2 and 3.3 of this report.

2 STATUS OF PREVIOUS INSPECTION FINDINGS There were no open findings from the last NRC inspection at Gould's Pumps, Incorporated, NRC Report 99900732/80-01.

3 INSPECTION FINDINGS AND OTHER COMMENTS 3.1 10 CFR Part 21 Proaram

6. Scope The inspector reviewed EPD's Quality Assurance Instruction (QAI)-231,

" Procedure for 10 CFR Part 21," Revision 10, dated September 24, 1997, for reporting in accordance with 10 CFR Part 21, and observed the required posting of the requirements.

b. Observations and Findinus lhe inspector determined that both QAl-231 and the posting complied with the Part 21 requirements. However, the inspector noted that QAl-231 did not define terms used in QAl-231 that have specific meaning as defined in $21.3 of 10 CFR Part 21 such as, deviation, discovery, defect, evaluation and substantial safety hazard. The inspector also noted in the narrative of QAl-231 that the term " defect" was used incorrectly in a few sections of the procedure. That is, circumstances and conditions that should have been characterized as being deviations or potential defects were referred to as being defects; therefore, the procedure would not be consistent with 10 CFR Part 21.

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l The inspector also noted that the point at which " discovery" occurs was not clearly specified in the narrative body of QAI-231. The inspector discussed the above aspects with EPD QA Management and EPD committed to reviewing and revising QAl-231 within 120 days of the exit meeting of this inspection.

c. Conclusions The inspector concluded that although some portions of the QA instruction adopted by EPD would benefit from additional clarification QAl-231 adequately implemented the relevant provisions of 10 CFR -

Part 21, 3.2 Licensee Purchase Order Packaaes and Certified Material Test Reoorts

a. Jpsoection Scool The inspector selected several licensee purchase order (P0) files and Certified Material Test Reports (CMTR's) for review. The P0s that were chosen were for replacement parts used at licensee facilities, and the CMTRs were selected from foundries that supplied commercial castings that could be selected for dedication as safety-related components.

b. Observations and Findinos The EPD personnel stated that very few pump assemblies are currently sold to licensee facilities because the Gould's Pumps are designed for long term application with internal part replacements as components wear out. The inspector noted that each P0 file included a copy of the customer's P0 tnat showed the imposed requirements, EPD's certificate's of compliance /conformance (CoCs), inspection and test records such as, "metallographic inspection results-alloy analyzer," dimensional verificationrecords,andassociatedrepordssuchas, manufacturer's certified material test reports (CMTRs) and Cots for the pump components. The licensee P0's typically imposed the requirements of 10 CFR Part 50, Appendix B,10 CFR Part 21 and EPD's Quality Control Procedure (QCP)-187, " Inspection / Test Plan for Dedication of Commercial Grade Replacement Parts," Revision 9, dated September 19, 1997, for the components ordered.

One P0 package that was reviewed by the inspector was for a 316 series stainless steel impeller replacement. The customer P0, Commonwealth Edison PO 470744, dated June 17, 1997, requested one 7 3/8 inch pump impeller, Part Number R76793-1203, material: American Society for Testing and Materials (ASTM) type ASTM A-296, Grade CF8M. The ASTM A-296 standard requires the manufacturer to heat treat each casting in accordance with the requirements in Table 1 and to conform with the specific chemical composition prescribed in Table 2 of the standard.

' Manufacturer's CMTRs are obtained by~EPD only when the EPD customer specificaliy requires a manufacturer _'s CMTR to be provided.

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l The inspector noted that the "Gould's Pumps, Incorporated," c< tificate of Compliance (CoC) for Commonwealth Edison PO 470744, dated m 1y 24, 1997, stated that the replacement parts supplied were in compi ince with the original parts supplied on the original pump and the customer's purchase order requirements and applicable specifications.

A review of the P0 package records and subsequent discussion with EPD staff identified.that it used its portable rretal analyzer (Texas Nuclear Analyzer, Model 9277-XL Metallurgist) to verify the applicable elements of the ASTM chemical composition. The alloy analyzer inspection results sheet in the P0 package indicated that only four chemical elements had been verified. EPD staff stated that the four elements verified with EPD's portable metal analyzer were Molybdenum (Mo), Nickel (Ni),

Chromium (Cr), and Manganese (Mn) for the CF8M alloy. EPD did not verify the chemical composition levels fc, Carbon (C), Silicon (Si), .

Sulfur (S) or Phosphorus (P). The EPD staff stated that its portable metal analyzer is not capable of verifying Carbon, Silicon, Phosphorus, or Sulfur for the CF8M material. The inspector was told by EPD that the portable metal analyzer is used for all chemical composition analyses for the dedication of commercial castings. The inspector also determined that EPD did not verify that the appropriate heat treatment was performed.

Discussions with EPD staff indicated that this EPD practice of certifying even though all elements are not verified has been performed for approximately 10 years without a documented engineering justifica-tion for not verifying all the chemical composition elements.

The inspector determined that EPD's practice of verifying only a limited amount of the elements in alloys such as CF8M can render the EPD supplied components indeterminate. For example, with CF8M or CF3, the potential of stress corrosion cracking increases proportionate to the level of Carbon. Additionally, the solution annealing temperatures for certain corrosion resistant alloys are important for optimum tensile strength, ductility and corrosion resistance. Therefore, the determination of the maximum level of Carbon and the adequacy and performance of heat treatment is very important. The failure to adequately verify the material characteristics is identified as Nonconformance 99900732/97-01-01, and is discussed further in Section 3.3.

The inspector also noted several CMTRs from one particular foundry that did not appear to have an actual " signature" of the QA Manager.

Instead, it was noted that each of QA Manager's signatures on the reviewed CMTR's had been stamped. Consequently, the identity of the person who affixed the stamped signature was indeterminate after the fact.

Subsequent discussions with the Quality Systems manager identified that EPD does not typically perform audits or surveillance of commercial suppliers, unless certain components have specific critical character-istics that can not be verified at EPD's facility. EPD staff stated that all critical characteristics can be verified on castings such as 4

,' impellers after manufacturing and receipt at EPD. - Therefore, the-inspector determined that the use of a signature stamp on the foundry CMTR was not a significant issue,

c. Conclusions The inspector concluded that the metallurgical quality of the supplied component regarding Commonwealth Edison P0 47D744 is indeterminate because EPD did not verify important chemical composition levels, did not have an engineering justification for not verifying all the chemical composition elements, and did not assess whether the castings manufacturer is adequately performing special processes, such as heat treatment.

The inspector also concluded that the Commonwealth Edison P0 package is not an isolated occurrence. The inspector was informed that EPD has made it a practice to certify compliance with purchase order require-ments, without verifying requirements such as chemical composition are, in fact, met.

3.3 Ouality Assurance and Dedication Procram

a. Inspection Scoce The inspector selectively reviewed the EPD QA_ Manual (QAM) 1002, Fifth Issue, Revision 3, Dated April 11, 1996, and associated procedures and work instructions related to " dedication" activities, as defined in 621.3 of 10 CFR Part 21. EPD's QAM-1002 program was established to meet the requirements of the American Society of Mechanical Engineers (ASME)

Boiler and Pressure Code,Section III " Nuclear Power Plant Components," Division 1; ANSI /ASME N45.2-1977, " Quality Assurance Program for Nuclear Facilities," and 10 CFR Part 50, Appendix B,

" Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants." The QA Manager stated that QAM-1002 program requirements were applied to all work performed in accordance with EPD's

. Quality Control Procedure (QCP)-187, " Inspection / Test Plan for Dedication of Commercial Grade Replacement Parts," Revision 9, dated September 10, 1997.

b. Observations and Findinos The definition of " dedication" in 10 CFR 21.3 specifies that dedication must provide reasonable assurance that a commercial grade item (CGI) to be used as a basic component will perform its intended safaty function, and is deemed equivalent to an item designed and manufactured under a 10 CFR Part 50, Appendix B, QA program. This assurance must be achieved by identifying the critical characteristics of the item and verifying their acceptability. A review of EPD's dedication procedure identified that QCP-187 specifies critical characteristics for the approximately 40 CGI's that are not procured as safety-related components by EPD.

Section 5. " Procurement Process, of QCP-187 requires that the managers of Engineering Systems & Standards and Quality Assurance select the critical characteristics to be verified. The QA manager establishes 5

• tests and inspections to be performed in accordance with established procedures and issues certificates of conformance with the test records.

Section 6, " Acceptance Criteria," of QCP-187 requires that parts which are in compliance with the critical characteristics shall be accepted.

-A discussion with the Manager of Engineering Systems and Standards identified that the critical ch'aracteristics have been developed based upon-the engineering drawings, specifications, and operating design parameters of the particular pump. The engineering manager stated that this delineation of maracteristics was to ensure that all important operating performance aspects as well as relevant-design and material considerations were addressed. The EPD Quality Systems Manager stated th0t the critical characteristics were chosen several years ago using indestry guidance and engineering judgement. The adequacy of those critical characteristics was not assessed by the inspector.

The inspector reviewed Chart 17, "Impiler Critical Characteristics Chart," of QCP-187 which requires material verification and CMTR, (if ordered from the manufacturer), verification using the " portable metal analyzer." The inspector noted that Chart 17, instead of specifying the actual material to be verified in accordant $ with the type and grade of steel, merely stated under the heading " material verification" two items: "CMTR" [see footnote 1] and " portable metal analyzer." The inspector determined that EPD did not include appropriate quantitative or qualitative acceptance criteria in Chart 17, QCP-187 for the critical characteristics necessary to verify compliance with the different ASTM Standards.

The inspector noted that EPD's "metallographic inspection results-alloy analyzer," form (page 45 of QCP-187 has the fol'owing chemical elements listed for analysis / verification: Molybdenum, Nickel, Chromium, Manganese, Titanium (Ti), Copper (Cu), Vanadium (V), Iron (Zn), Tin (Sn), Lead (Pb), Aluminum (Al), and Wolfram (W)2(Fe),.

Zine The ASTM A 296 elements that are listed under T 51e 2, " Chemical Requirements," for CF8M are: Carbon, Manganese, Silicon, rhosphorus, Sulfur, Chromium, Nickel, and Molybdenum. It was noted by the inspector that although Carbon, Silicon, Phosphorus, and Sulfur are important for reliability and acceptable performance of stainless steel material, EPD did not identify those elements for material verification on its material analysis "metallographic inspection results - alloy analyzer" form. As discussed in section 3.2 above, EPD's portable metal analyzer does not identify all of those chemical elements found in Table 2 of ASTM A 296.

As a result of a lack of specificity in chart 17, EPD did not verify the ASTM A 296, Table 2 chemical composition elements of Carbon, Silicon, Phosphorus, and Sulfur for the CF8M impeller casting during its dedication process for Commonwealth Edison P0 47D744 (see Section 3.2).

8 Although the symbol W was used by EPD to represent Wolfram, W is the symbol for Tungsten. Tungsten (W) is extracted from lolframite, Scheelite and other minerals.

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,T -c. Conclusions The inspector concluded that EPD does not.have an adequate basis to dedicate commercial castings because of the identified practices and methodology employed at its Seneca Falls facility. Since EPD does not survey / audit its commercial casting manufacturers and does not verify all of.the chemical composition elements (even on a sample basis), its level of assurance would be questionable.

Additionally, the _ inspector concluded that Nonconformance 99900732/97-01-01 appears to represent a departure from the-technical requirements included in a procurement document and needs to be evaluated in accordance with the provisions of 10 CFR Part 21 by EPD.

3.4 Entrance and Exit Meetinas ,

In the entrance meeting on October 2, 1997, the NRC inspector discussed the scope of the inspection, outlined the areas to be inspected, and established interfaces with the Engineered Products Division and Industrial Products Group management. In the exit meeting on October 3, 1997, the inspector discussed his findings and concerns. Additional .

discussions were also conducted subsequent to the exit meeting in December 1997.

3.5 . Personnel Contacted S. Sakofsky Director, Quality Assurance - IPG R. Schussler Manager, Engineering Systems and Standards - IPG J. Held Quality Systems Manager - EPD P. Soscia Quality Assurance Engineer - EPD S. Mahalik Quality Assurance Auditor - EPD 4 ITEMS OPENED, CLOSED, AND DISCUSSED Nonconformance

, 99900732/97-01-01 Nonconformance Dedication Process Questionable Certifications 1

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NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 2066H001

\ *****/ December 10, 1997 Mr. Stephen Sakofsky, Director Quality Assurance Industrial Products Group Gould's Pumps, Incorporated 240 Fall Street Seneca Falls, New York 13148

SUBJECT:

NRC INSPECTION REPORT N0. 99900732/97-01

Dear Mr. Sakofsky:

On October 2-3, 1997, the U.S. Nuclear Regulatory Commission (NRF.) completed an inspection at your Gould's Pumps Incorporated, Industrial Products Group, Engineered Products Division (EPD) facility in Seneca Falls, New York. The enclosed report presents the results of that inspection.

During this inspection, the NRC inspector found that the implementation of your quality assurance program failed to meet certain NRC requirements imposed on you by your customers. Specifically, EPD has issued certificates of compliance for replacement parts without ensuring that all the material critical characteristics " a been verified. The inspector determined that EPD is not verifying th ! 'he chemical composition of castings are in compliance with the applicable American Society for Testing and Materials (ASTM) standards. Instead, it was found that for approximately 10 years, EPD has been verifying only selected chemical elements in corrosion resistant castings. Additionally, EPD did not verify that ASYM required heat treatment of certain alloys had been performed.

This nonconformance is cited in the enclosed Notice of Nonconformance (N0N),

and the circumstances surrounding it are described in detail in the enclosed report. You are requested to respond to the nonconformance and should follow t.he instructions specified in the enclosed NON when preparing your response.

This nonconformance is significant because it represents a deviation from the procurement specifications that were imposed upon EPD by its customers.

Consequently, those deviations for each licensee application of the EPD supplied components must be evaluated in accordance with $21.21, " Notification of failure to comply or existence of a defect and its evaluation," of 10 CFR Part 21.

1 yfi/[bd6

l Mr. S. Sakofsky l- December 10, 1997 in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this l letter and its enclosure will be placed in the NRC's Public Document l

Room (PDR).

Sincerely, Original signed by: Suzanne C. Black Suzanne C. Black, Chief Quality Assurance, Vendor Inspection and Maintenance Branch Division of Reactor Controls and Human Factors Office of Nuclear Reactor Regulation Docket 99900732/97-01

Enclosure:

1. Notice of Nonconformance

2. Inspection Report 99900732/97-01 QISTRIBUTION:

HQMB R/F PUBLIC DNaujock EJSullivan JDavis GDick MWebb RLaufer DSkay RPulsifer CShiraki IJLee Docket File 99900732 Central Files / RIDS IE:091JLee DOCUMENT NAM : G:\ PETRO \lR-GP To esceive a copy of tye oc bment, indicate in the box: *C" = Copy without enclosures *E* = Copy with enclosuree "N"

= No copy 0FFICE lHQMB:$tH lE HQMB:DRCH E HOMB:DRCH J6 E l NAME Pet Mo RAGramm 6 % SCBlack 7/7 DATE 12/DQ/lk l12//o /97 12/fU /97 N\ OFFICIAL RECORD COPY I

i

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NOTICE OF NONCONFORMANCE Gould's-Pumps. Incorporated Docket ~No.: 99900732 240 Fall Street Seneca Falls, New York 13148 Based on the results of an' inspection conducted on October 2 and October 3, 1997, it appears that certain of your activities were not conducted in accordance with NRC requirements.

Criterion III, " Design Control," of Appondix B, " Quality Assurance Criteria for Nuclear Power Plants and fuel Reprocessing Plants," of 10 CFR Part 50 requires in part,-that measures shall be established to assure that applicable regulatory requirements and the design basis are correctly. translated into

. specifications, drawings, procedures, and instructions, to assure that

. appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled. Measures shall also

'be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components.

Commonwealth Edison purchase order (P0) 470744, dated June 17, 1997, requested one 7 3/8 inch pump impeller, Part-Number R76793-1203, Material - American l Society for Testing and Materials (ASTM) type ASTM A-296, Grade CF8M.

Purchase Order 470744 stated that the P0 was safety-related and the requirements of 10 CFR Part 21 and 10 CFR Port 50, Appendix 8 were applicable.

ASTM A 296-1977, " Standard Specification for Corrosion-Resistant Iron-i Chromium, Iron-Chromium-Nickel, and Nickel-Base Alloy Castings for General i

Application," requires that alloys conform to the chemical composition t prescribed in Table 2.

o l Item (C), page 4 of EPD's QCP-187, states: " Critical Characteristics Chart -

l . All critical characteristics will be inspected after'the parts are selected l

from stock for use on a Non Code Safety Related order... Information shown on-the chart will be verified to be complete and accurate. The Inspection / Test i

' Record will be signed and dated by the person performing the verification,

-when complete and acceptable. The inspection test record will be certified by a QA Engineer...."

Contrary to the above requirements, the inspector determined:

a) EPD did not include appropriate quality standards in its QCP-187

, critical characteristic requirement charts regarding the material l verification' category.

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-Gould's Pumps, incorporated ,

b)- Although Gould's Pumps, Incorporated, July 24, 1997, Certificate of-Compliance to Commonwealth Edison, PO 470744, certified that the replacement part was in compliance with the original part supplied and the customer's PO requirements, EPD did not verify all of the ASTM chemical composition elements, and did not verify ASTM heat treattent.

(Nonconformance 99900732/97-01-01)

Please provide a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Chief, Special Inspection Branch, Division of Inspection and Support Programs, Office of Nuclear Reactor Regulation, within 30 days of the date of the letter transmitting this Notice of Nonconformance. This reply should be clearly ma-ked as a " Reply to a Notice of Nonconformance" and should include for each nonconformance: (1) a description of steps that have been or will be taken to correct these items; (2) a description of steps that have been or will be taken to prevent recurrence; and (3) the dates your corrective actions and preventive measures were or will be completed.

2 Dated at Rockville, Maryland this- day of December 1997.

Enclosure 1 4

r INSPECTION RE*uRT- ,

-U.S. NUCLEAR REGULATORY COMMISSION l 0FFICE OF NUCLEAR REACTOR REGULATION- '

DIVISION OF REACTOR CONTROLS AND HUMAN FACTORS i

ORGANIZATION: Gould's Pumps, Incorporated Industrial Products Group Engineered Products Division 240 Fall Street Seneca Falls, New York 13148 9

REPORT NO.: 99000732/97-01

" ORGANIZATIONAL Mr. James F. Heid, CONTACT

- Quality Systems _ Manager Engineered Products Division Industrial Products Group Gould's Pumps, Incorporated (315) 568-2811

^

NUCLEAR INDUSTRY Provides Gould's pumps, pump replacement ACTIVITY: parts, pump refurbishment, and field-service.

INSPECTION CONDUCTED: October 2-3, 1997 INSPECTOR: Joseph J. Petrosino, NRR APPROVED BY: Robert A. Gramm, Chief Quality Assurance and Safety-Assessment Section Quality Assurance, Vendor Inspection and Maintenance Branch Division of Reactor Controls and Human' Factors Office of Nuclear Reactor Regulation J

Enclosure 2 1

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1 INSPECTION

SUMMARY

Ouring this inspection, the NRC inspe: tor reviewed the implementation of selected portions of the Gould's Pumps, Incorporated, Industrial Products Group, Engineered Products Division (EPD) facility Quality Assurance (QA)

Program, and reviewed activities assaciated with " commercial grade items" and " dedication," as defined in -121.3 of 10 CFR Part 21."

The inspection bases were:

• Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," to Part 50 of Title 10 of the [pda of Federal Reaulations (10 CFR Part 50) 10 CFR Part 21, " Reporting of Defects and Noncompliance" During this inspection, one instance where EPD failed to comply with NRC requirements imposed upor. them by NRC licensees was identified. This nonconformance represents a long standing practice that EPD has been performing for its safet; related dedication process and is discussed in Sections 3.2 and 3.3 of this report.

2 STATUS OF PREVIOUS INSPECTION FINDINGS There were no open findings from the last NRC inspection at Gould's Pumps, Incorporated, NRC Report 99900732/80-01.

3 INSPECTION FINDINGS AND OTHER COMMENTS 3.1 10 CFR Part 21 Procram

a. Sgggg The inspector reviewed ED's Quality Assurance Instruction (QAI)-231,

" Procedure for 10 CFR Part 21," Revision 10, dated September 24, 1997, for reporting in accordance with 10 CFR Part 21, and observed the required posting of the requirements.

b, Observations and Findinas The inspector determined that both QAl-231 and the posting complied with the Part 21 requirements. However, the inspector noted that QAl-231 did not define terms used in QAl-231 that have specific meaning as defined in 521.3 of 10 CFR Part 21 such as, deviation, discovery, defect, evaluation and substantial safety hazard. The inspector also noted in the narrative of QAl-231 that the term " defect" was used incorrectly in a few sections of the procedure. That is, circumstances and conditions that should have been charactcrized as being deviations or potential defects were referred to as being defects; therefore, the procedure would not be consistent with 10 CFR Part 21.

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The inspector also noted that the point at which " discovery" occurs was not clearly specified in the narrative body of QAl-231. The inspector discussed the above aspects with EPD QA Management and EPD committed to reviewing and revising QAl-231 within 120 days of the exit meeting of this inspection.

c. Conclusions The inspector concluded that although some portions of the QA instruction adopted by EPD would benefit from additional clarification, QAl-231 adequately implemented the relevant provisions of 10 CFR Part 21.

3.2 Licensee Purchase Order Packaaes and Certified Material Test Reports

a. Inspection Scope The inspector selected several licensee purchase order (P0) files and Certified Material Test Reports (CMTR's) for review. The P0s that were chosen were for replacement parts used at licensee facilities, and the CMTRs were selected from foundries that supplied comercial castings that could be selected for dedication as safety-related components,

b. Observations and Findinos The EPD personnel stated that very few pump assemblies are currently sold to licensee facilities because the Gould's Pumps are designed for long term application with internal part replacements as components wear out. The inspector noted that each P0 file included a copy of the customer's P0 that showed the imposed requirements, EFD's certificate's of compliance /conformance (CoCs), inspection and test records such as, "metallographic inspection results-alloy analyzer," dimensional verification records, and associated re certified material test reports (CMTRs)gards suchforas, and Cots themanufacturer's pump components. The licensee P0's typically imposed the requirements of 10 CFR Part 50, Appendix B, 10 CFR Part 21 and EPD's Quality Control Procedure (QCP)-187, " Inspection / Test Plan for Dedication of Commercial Grade Replacement Parts," Revision 9, dated September 19, 1997, for the components ordered.

One P0 package that was reviewed by the inspector was for a 316 series stainless steel impeller replacement. The customer P0, Commonwealth Edison P0 470744, dated June 17, 1997, requested one 7 3/8 inch pump impeller, Part Number R76793-1203, material: American Society for Testing and Materials (ASTM) type ASTM A-296, Grade CF8H. The ASTM A-296 standard requires the manufacturer to 5 eat treat each casting in accordance with the requirements in Table 1 and to conform with the specific chemical composition prescribed in Table 2 of the standard.

' Manufacturer's CMTRs are obtained by EPD only when the EPD customer specifically requires a manufacturer's CHIR to be provided.

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- . The inspector noted that the "Gould's- Pumps, Incorporated,". Certificate :

'of Compliance-(CoC) for Commonwealth Edison PO 47D744,-dated July 24. -

-1997, stated that the replacement parts ~ supplied were in' compliance ,

with the original parts supplied on the original pump and the customer's

' purchase order requirements and applicable specifications. i A review of:the PO package records and subsequent discussion with EPD staff identified.that:it used its portable metal analyzer (Texas Nuclear ,

Analyzer, Model 9277-XL Metallurgist) to verify the. applicable elements of the ASTM chemical compositim. The alloy analyzer inspection results sheet in the PO package indicated that only-four chemical elements had been. verified. EPD staff' stated that the four elements verified with EPD's portable metal analyzer were Molybdenum (Mo), Nickel (N1),

Chromium (Cr), and Manganese (Mn) for the CF8M alloy. EPD did not verify th chemical composition levels for Carbon (C), Silicon (Si),

Sulfur (S) or Phosphorus (P). The EPD staff stated that its portaole -

metal analyzer is not capable of verifying carbon, Silicon, Phosphorus, or Sulfur for the CF8M material. The inspector was told by EPD that the portable metal analyzer is used for all chemical composition analyses for the dedication of commercial castings. The inspector also determined that EPD did not verify that the appropriate heat treatment was performed.

Discussions with EPD staff indicated.that this EPD practice of certifying even though all elements are not verified has been performed for approximately 10 years without a documented engineering justifica-tion for not verifying all the chemical composition elements.

The inspector determined that EPD's practice of verifying only a limited amoJnt of the elements in alloys such as CF8M can render the EPD m plied components indeterminate. For example, with CF8M or CF3, the ,

potential of stress corrosion cracking increases proporticnate to the level of Carbon. Additionally, the solution annealing temperatures for certain corrosion resistant alloys are important for optimum tensile strength, ductility and corrosion resistance. Therefore, the determination of the maximum level of Carbon and the adequacy and 4

performance of heat treatment is very important. The failure to adequately verify the material characteristics is identified as Nonconformance 99900732/97-01-01, and is discussed further in

.Section 3.3.

The inspector also noted several CMTRs from one particular foundry that did not appear to have an actual " signature" of the QA Manager.

Instead, it was noted_that each of QA Manager's signatures on the

, reviewed CMTR's had been stamped. Consequently, the-identity of the

person who affixed the stamped signature was indeterminate after the fact.

Subsequent discussions with the Quality Systems manager identified that E*D does not typically perform audits or surveillance of commercial suppliers, unless certain components have specific critical character-istics that can not be verified-at EPD's facility. EPD staff stated that all crf tical characteristics can be verified on castings such as 4

impe11ers after manufacturing and receipt at EPD._ Therefore, the inspector determined that the use of a signature stamp on the foundry CMTR was not a.significant issue'.

c. Conclusions The inspector concluded that the metallurgical quality of the supplied componsnt regarding Commonwealth Edison P0 470744 is indeteminate because EPD did not verify important chemical composition levels, did not have an engineering justification for not verifying all the chemical composition elements, and did not assess whether the castings manufacturer is adequately performing special processes, such as heat treatment.

The inspector also concluded that the Commonwealth Edison P0 package is not an isolated occurrence. The inspector was informed that EPD has made it a practice to certify compliance with purchase order require-ments, without verifyirg requirements such as chemical composition are, in fact, met.

3.3 Ouality Assurance and Dedication Procram

a. 10.soection Scope The inspector selectively reviewed the EPD QA Manual (QAM) 1002, Fifth Issue, Revision 3, Dated April 11, 1996, and associated procedures and work instructions related to " dedication" activities, as defined in 621.3 of 10 CFR Part 21. EPD's QAM-1002 program was established to meet i

the requirements of the American Society of Mechanical Engineers (ASME)

Boiler and Pressure Code,Section III " Nuclear Power Plant Components," Division 1; ANSI /ASME N45.2-1977, " Quality Assurance Program for Nuclear Facilities," and 10 CFR Part 50, Appendix B,

" Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants." The QA Manager stated that QAM-1002 program requirements were applied to all work performed in accordance with EPD's Quality Control Procedure (QCP)-187, " Inspection / Test Plan for Dedication of Commercial Grade Replacement Parts," Revision 9, dated September 19, 1997.

b. Observations and Findinos The definition of " dedication" in 10 CFR 21.3 specifies that dedication must provide reasonable assurance that a commercial grade item (CGI) to be used as a basic component will perform itt. intended safety function, and is deemed equivalent to an item designed and manufactured under a 10 CFR Part 50, Appendix B, QA program. This assurance must be achieved by identifying the critical characteristics of the item and verifying their acceptability. A review of EPD's dedication procedure identified

-that QCP-187 specifies critical characteristics for the approximately 40

, CGI's that are not procured as safety-related components by EPD.

Section 5, " Procurement Process, of QCP-187 requires that the managers of En'gineering Systems & Standards and Quality Assurance select the critical characteristics to be verified. The QA manager establishes 5

tests and inspections to be performed in accordance with established -

procedures and issues certificates of conformance with the test records.

Section 6, " Acceptance Criteria," of QCP-187 requires that parts which are in compliance with the critical characteristics shall be accepted.

A discussion with the Manager of Engineering Systems and Standards identified-that the critical characteristics-have been developed based upon the engineering drawings, specifications, and operating design parameters of the particular pump. The engineering manager stated that this delineation of characteristics was to ensure that all important operating performance aspects as well as relevant design and material considerations were addressed. The EPD Quality Systems Manager stated that the critical characteristics were chosen several years ago using industry guidance and engineering judgement. The adequacy of those critical characteristics was not assessed by the inspector.

The inspector reviewed Chart .?, " Impeller Critical Characteristics Chart," of QCP-187 which requires material verification and CMTR, (if ordered from the manufacturer), verification using the " portable metal analyzer." The irspector noted that Chart 17, instead of specifying the actual material to be verified in accordance with the type and grade of steel, merely stated under the heading " material verification" two ,

items: "CMTR". (see footnote 1] and " portable metal analyzer." The inspector determined that EPD did not include appropriate quantitative or qualitative acceptance criteria in Chart 17, QCP-187 for the critical characteristics necessary to verify compliance with the different ASTM Standards.

The inspector noted that EPD's "metallographic insnection results-alloy analyzer," form (page 45 of QCP-187 has the following chemical elements listed for analysis / verification: Molybdenum, Nickel, Chromium, Manganese, Titanium (Ti), Copper (Cu), Vanadium (V), Iron (Fe), Zinc (Zn), Tin (Sn), Lead (Pb), Aluminum (A1), and Wolfram (W)2 The ASTM A 296 elements that are listed under Table 2, " Chemical Requirements," for CF8M are: Carbon, Manganese, Silicon, Phosphorus, Sulfur, Chromium, Nickel, and Molybdenum. It was noted by the inspector that although Carbon, Silicon, Phosphorus, and Sulfur are important for reliability and acceptable performance of stainless steel material, EPD did not identify those elements for material verification on its material analysis "metallographic inspection results - alloy analyzer" form. As discussed in section 3.2 above, EPD's portable metal analyzer does not identify all of those chemical elements found in Table 2 of ASTM A 295.

As a result of a lack of specificity in chart 17, EPD did not verify the ASTM A 296, Table 2 chemical composition elements of Carbon, Silicon, Phosphorus, and Sulfur for the CF8M impeller casting during its dedication process for Commonwealth Edison P0 47D744 (see Section 3.2).

2 Although the symbol W was used by EPD to represent Wolfram, W is the symbol for Tungsten. Tungsten (W) is extracted from Wolframite, Scheelite and other minerals.

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c. _[ gar.lusions-

- The inspector concluded'that EPD does not have an-adequate basis to dedicateicommercial castings because of the identified practices and methodology employed at:its Seneca Falls facility. :Since EPD does not

- survey / audit its commercial 1 casting manufacturers and does not' verify. 1 all;of the chemical composition elements (even on a sample basis), its  ;

level of assurance would be questionable, q Additionally, the inspector concluded that'Nonconformance- l 99900732/97-01-01 appears to represent a departure from the technical requirements included in-a procurement document and needs to be

- evaluated in accordance with the provisions of 10 CFR.Part 21 by EPD.'

3.4 Entrance and' Exit Meetinas In the. entrance meeting on October 2, 1997, the NRC inspector discussed

. the scope of. the inspection, outlined the areas to be inspected, and established interfaces with the Engineered Products Division and Industrial Products Group management.. In the exit meeting on October 3, 1997, the inspector discussed his findings and concerns. Additional '

discussions were also conducted subsequent to the exit meeting in December 1997.

3.5 Personne', Contacted S. Sakofsky Director, Quality Assurance - IPG R. Schussler . Manager, Engineering Systems and Standards - IPG J. Heid Quality Systems Manager - EPD-P. Soscia Quality Assurance Engineer - EPD S. Mahalik Quality Assurance Auditor - EPD 4 ITEMS 0PENED, CLOSED, AND DISCUSSED

. - Nonconformance

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99900732/97-01-01 Nonconformance Dedication Process Questionable Certifications 7

• 1.

________z___ . , _ _ _ . _ . - . _ . _ . - _ _ _ _ _ , . _ . .- - . _.

, pm at p t UNITED STATES -

j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. so66dke001 -

\*****l*

December-10, 1997 Mr. Stephen Sakofsky, Director Quality Assurance Industrial Products Group _

Gould's Pumps. Incorporated 240 Fall Street Seneca Falls, New York 13148 S'JBJECT: _NRC INSPECTIDN REPORT _N0. 99900732/97-01

Dear Mr. Sakofsky:

On October 2-3, 1997, the U.S. Nuclear Regulatory Commission (NRC) completed an inspection at your Gould's Pumps, Incorporated, Industrial Predacts Group, Engineered Products Division (EPD) facility in Seneca Falls, New York. The enclosed report presents the results of that inspection.

During this inspection, the NRC inspector found that the implementation of your quality assurance program failed to meet certain NRC requirements imposed on you by your customers. Specifically, EPD has issued certificates of compliance for replacement parts without ensuring that all the material critical characteristics have been verified. The inspector determined that EPD is not verifying that the chemical composition of castings are in compliance with the applicable American Society for Testing and Materials (ASTM) standards. Instead, it was found that for approximately 10 years, EPD has been verifying only selected chemical elements in corrosion resistant castings. Additionally, EPD did not verify that ASTM required heat treatment of certain alloys had been performed.

This nonconformance is cited in the enclosed Notice of Nonconformance (NON),

and the circumstances surrounding it are described in detail in the enclosed report. You are requested to respond to the nonconformance and should follow the instructions specified in the enclosed NON when preparing your response.

This nonconformance is significant because it represents a deviation from the procurement specifications that were imposed upon EPD by its customers.

Consequently, those deviations for each licensee application of the EPD supplied components must be evaluated in accordance with 521.21, " Notification of failure to comply or existence of a defect and its evaluation," of 10 CFR Part 21.

& ~712 T C~C3 % '

Mr. S. Sakofsky December 10, 1997 In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosure will be placed in the NRC' Public Document Room (PDR).

Sincerely, Original signed by: Suzanne C. Black Suzanne C. Black, Chief Quality Assurance, Vendor Inspection and Maintenance Branch Division of Reactor Controls and Human factors Office of Nuclear Reactor Regulation Docket 99900732/97-01

Enclosure:

1. Notice of Nonconformance

2. Inspection Report 99900732/97-01 DISTRIBUTIQU:

HQMB R/F PUBLIC DNaujock EJSullivan JDavis GDick MWebb RLaufer DSkay P.Pul si fer CShiraki IJLee Docket File 99900732 Central Files / RIDS IE:09IJLee DOCUMENTNAMfyG:\ PETRO \IR-GP To r ceive & copy of the pohment. Indicate in the teca: "C" = Copy without enclosures *E* = Copy with enclosures "N* = No copy 0FFICE HOMB:$CH lE HQMB:DRCH_ l E HQMB:DRCH_j C E I ll NAME Pet Mpo RAGramm (/,(, SCBlack ' R >

D_ ATE 12/DR/M 12/10 /97 12/f u /97

'4 \ OFFICIAL RECORD COPY l

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NOTICE OF NONCONFORMANCE Gould's Pumps Incorporated Docket No.: 99900732 240 Fall Street Seneca Falls, New iork 13148 Based on the results of an inspection conducted on October 2 and October 3, 1997, it appears that certain of your activities were not conducted in accordance with NRC requirements.

Criterion III, " Design Control," of Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," of 10 CFR Part 50 requires in part, that measures shall be established to assure that applicable regulatory requirements and the design basis are correctly translated into specifications, drawings, procedures, and instructions, to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled. Measures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components.

Commonwealth Edison purchase order (PO) 470744, dated June 17, 1997, requested one 7 3/8 inch pump impeller. Part Number R76793-1203, Material - American Society for Testing and Materials (ASTM) type ASTM A-296, Grade CF8M.

Purchase Order 470744 stated that the P0 was safety-related and the requirements of 10 CFR Part 21 and 10 CFR Part 50, Appendix 8 were applicable.

ASTM A 296-1977, " Standard Specification for Corrosion-Resistant Iron-Chromium, Iron-Chromium-Nickel, and Nickel-Base Alloy Castings for General Application," requires that alloys conform to the chemical composition prescribed in Table 2.

Item (C), page 4 of EPD's QCP-187, states: " Critical Characteristics Chart -

All critical characteristics will be inspected after the parts are selected from stock for use on a Non Code Safety Related order... Information shown on the chart will be verified to be complete and accurate. The Inspection / Test Record will be signed and dated by the person performing the verification, when complete and acceptable. The Inspection test record will be certified by a QA Engineer...."

Contrary to the above requirements, the inspector determined:

a) EPO did not include appropriate quality standards in its QCP-187 critical charat.teristic requirement charts regarding the material verification category.

Gould's Pumps, Incorporated' -

b) Although Gould's Pumps, Incorporated, July 24, 1997, Certificate of Compliance to Commonwealth Edison, PO 47D744, certified that the

-replacement part was in corpliance with the original part supplied and .

the customer's PO requirements, EPD did not verify all of the ASTM chemical composition elements, and did not verify ASTM heat treatment.

(Nonconformance 99900732/97-01-01)

J Please provide a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document. Control Desk, Washington, D.C. 20555, with a copy to the Chief, Special Inspection Branch, Division of Inspection and Support Programs, Office of Nuclear Reactor Regulation, within 30 days of the date of the letter transmitting this Notice of Nonconformance. This reply should be clearly marked as a " Reply to a Notice of Nonconformance" and should

. include for each nonconformance: (1) a description of steps that have been or

. will be taken to correct these items; (2) a description of steps that have-been or will be taken to prevent recurrence; and (3) the dates your corrective actions and preventive measures were or will be completed.

d Dated at Rockville, Maryland this day of December 1997.

Enclosure 1

1 INSPEC110N REP 6RT U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION DIVISION OF REACTOR CONTROLS AND HUKAN FACTORS ORGANIZATION: Gould's Pumps, Incorporated Industrial Products Group Engineered Products Division 240 Fall Street Seneca falls, New York 13148 REPORT NO.: 99900732/97-01 ORGANIZATIONAL Mr. James F. Heid, CONTACT: Quality Systems Manager Engineered Products Division Industrial Products Group Gould's Pumps, incorporated (31S) 568-2811 NUCLEAR INDUSTRY Provides Gould's pumps, pump replacement ACTIVilY: parts, pump refurbishment, and field service.

INSPECTION COPDUCTED: October 2-3, 1997 INSPECTOR: Joseph J. Petrosino, NRR APPROVED BY: Robert A. Gramm, Chief Quality Assurance and Safety Assessment Section Quality Assurance, Vendor Inspection and Maintenance Branch Division of Reactor Controls and Human Factors Office of Nuclear Reactor Regulation Enclosure 2 1

1 INSPECTION

SUMMARY

Daring this inspection, the NRC inspector reviewed the implementation of selected portions of the Gould's Pumps, incorporated Industrial Products Group.. Engineered Products Division (EPD) facility Quality Assurance (QA)

Program, and reviewed activities associated with " commercial grade items" and " dedication," as defined in $21.3 of 10 CFR Part 21."

The inspection bases were:

• Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprccessing Plants " to Part 50 of Title 10 of the (qde of Federal Reaulations (10 CFR Part 50)

• 10 CFR Part 21, " Reporting of Defects and Nnncompliance" During this inspection, one instance where EPD failed to comply with NRC requirements imposed upon them by NRC licensees was identified. This nonconformance represents a long standing practice that EPD has been performira for its safety-related dedication process and is discussed in Sections 3.2 and 3.3 of this report.

2 STATUS OF PREVIOUS INSPuLTION FINDINGS There were no open findings from the last NRC inspection at Gould's Pumps, incorporated, NRC Report 99900732/B0-01.

3 IdSP2CTION FINDINGS AND OTHER COMMENTS 3.1 10 CFR Part 21 Proaram

a. 1 rang The inspector reviewed EPD's Quality Assurance Instruction (QAI)-231,

" Procedure for 10 CFR Part 21," Revision 10, dated September 24, 1997, for reporting in accordance with 10 CFR Part 21, and observed the required posting of the requirements,

b. Observations and Findinas ,

The inspector determined that both QAl-231 and the posting complied with the Part 21 requirements. However, the inspector noted that QAl-231 did not define terms used in QAl-231 that have-specific meaning as defined '

in 621.3 of 10 CFR Part 21 such as, deviation, discovery, defect, evaluation and substantial safety hazard. The inspector also noted in the narrative of QAl-231 that the term " defect" was used incorrectly in a few sections of the procedure. That is, circumstances and conditions that should have been characterized as being deviations or potential defects were referred to as being defects; therefore, the procedure would not be consistent with 10 CFR Part 21.

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The inspet. tor also noted that the point at which " discovery" cccurs was not clearly specified in the narrative body of QAl-231. The inspector discussed the above aspects with EPD QA Management and EPD committed to reviewing and revising QAl-231 within 120 days of the exit meeting of this inspection.

c. Conclusions The inspector concluded that although some portions of the QA instruction adopted by EPO would benefit from additional clarification.

0Al-231 adequately implemented the relevant provisions of 10 CFR Part 21, 3.2 Licensee Purchase Order Packaaes and Certified Material Test Reports

a. Inspection Scope The inspector : elected several licensee purchase order (PO) files and Certified Material Test Reports (CMTR's) for review. The P0s that were chosen were for replacement parts used at licensee facilities, and the CMTRs were selected from foundries that supplied commercial castings that could be selected for dedication as safety-related components,

b. Observations and Findingi The EPD personnel stated that very few pump assemblies are currently sold to licensee facilities because the Gould's Pumps are designed for long term application with internal part replacements as components wear out. The inspector noted that each P0 file included a copy of the customer's P0 that showed the imposed requirements, EPD's certificate's of compliance /conformance (CoCs), inspection and test records such as, "metallt.,raphic inspection results-alloy analyzer," dimensional verification records, and associated re certifiedmaterialtestreports(CMTRs)pordssuchas,and CoCs formanufacturer's the pump components. The licensee P0's typically imposed the requirements of 10 CFR Part 50, Appendix B, 10 CFR Part 21 and EPD's Quality Control Procedure (QCP)-187, " Inspection / Test Plan for Dedication of Commercial Grade Replacement Parts," Revision 9, dated September 19, 1997, for the components ordered.

One P0 package that was reviewed by the inspector was for a 316 series stainless steel impeller replacement. The customer P0, Comunwalth Edison PO 470744, dated June 17, 1997, requested one 7 3/8 inch pump impeller, Part Number R76793-1203, material: American Society for Testing and Materials (ASTM) type ASTM A-296, Grade CF8M. The ASTM A-296 standard requires the manufacturer to heat treat each casting in accordance with the requirements in Table 1 and to conform with the specific chemical composition prescribed in Table 2 of the standard.

' Manufacturer's CMTRs are obtained by EPD only when the EPD customer specifically requires a manufacturer's CMTR to be provided.

3

The inspector noted that the "Goulf s Pumps, incorporated," Certificate of Compliance (CoC) for Commonwealth Edison P0 470744, dated July 24, 1997, stated that the replacement parts supplied were in compliance with the original parts supplied on the original pump and the customer's purchase order requirements and applicable specifications.

A review of the P0 package records and subsequent discussion with EPD staff identified.that it used its portable metal analyzer (Texas Nuclear Analyzer, Model 9277-XI. Metallurgist) to verify the applicable elements of the ASTM chemical composition. The alloy analyzer inspection results sheet in the P0 package indicated that only four chemical elements had been verified. EPD staff stated that the four elements verified with EPO's portable metal analyzer were Molybdenum (Mo), Nickel (N1),

Chromium (Cr), and Manganese (Mn) for the CF8M alloy. EPD did not verify the chemical composition levels for Carbon (C), Silicon (51),

Sulfur (S) or Phosphorus (P). The EPO staff stated that its sortable metal analyzer is not capable of verifying Carbon, Silicon, Plosphorus, or Sulfur for the CF8M material. The inspector was told by EPD that the portable metal analyzer is used for all chemical compositicn analyses for the dedication of commercial castings. The inspector also determined that EPD did not verify that the appropriate heat treatment was performed.

Discussions with EPD staff indicated that this EPD practice of certifying even though all elements are not verified has been performed for approximately 10 years without a documented engineering justifica-tion for not verifying all the chemical composition elements.

The inspector determined that EPD's practice of verifying only a limited amount of the elements in alloys such as CF8M can render the EPD supplied components indeterminate. For example, with CF8M or CF3, the potential of stress corrosion cracking increases proportionate to the level of Carbon. Additionally, the solution annealing temperatures for certain corrosion resistant alloys are important for optimum tensile strength, ductility and corrosion resistance. Therefore, the determination of the maximum level of Carbon and the adequacy and performance of heat treatment is very important. ine failure to l sdequately verify the material characteristics is identified as

, Nonconformance 99900732/97-01-01, and is discussed further in Section 3.3.

l The inspector also noted several EMTRs from one particular foundry that did not appear to have an actual " signature" of the QA Manager.

Instead, it was noted that each of QA Manager's signatures on the reviewed CMTR's had been stamped. Consequently, the identity of the person who affixed the stamped signature was indaterminate after the fact.

Subsequent discussions with the Quality Systems manager identified that EPD does not typically perform audits or surveillance of commercial suppliers, unless certain components have specific critical character-istics that can not be verified at EPD's facility. EPD staff stated ,

that all critical characteristics can be verified 01 castings such as 4

4 impellers after manufacturing and receipt at EPD. Therefore, the inspector determined that the use of a signature stamp on the foundry CMTR_was not a significant issue,

c. Conclusions The inspector cor.cluded that the metallurgical quality of the supplied component regarding Commonwealth Edison P0 470744 is indeterminate .

because EPD did not verify important chemical composition levels, did not have an engineering justification for not verifying all the chemical composition elements, and did not assess whether the castings manufacturer is adequately performing special processes, such as heat treatment.

The inspector also concluded that-the Commonwealth Edison P0 package is not an isolated occurrence. The inspector was informed that EPD has made it a aractice to certify compliance with purchase order require- ,

meets, wit 1out verifying requiremer*: .such as chemical composition are, in fact, met.

3.3 quality Assurance and Dedication Proaram 2

a. _ Inspection Scopf The inspector selectively reviewed the EPD QA Manual (QAM) 1002, Fifth issue, Revision 3, Dated April 11, 1996, and associated procedures and work instructions related to " dedication" activities, as defined in 121.3 of 10 CFR Part 21. EPD's QAM-1002 program was established to meet the requirements of the American Society of Mechanical Engineers (ASME)

Boiler and Pressure Code,Section III " Nuclear Power Plant Components," Division 1; ANSI /ASME N45.2-1977, " Quality Assurance Program for Nuclear Facilities," and 10 CFR Part 50, Appendix d,

" Quality Assurance Criterta for Nuclear Power Plants and Fuel Reprocessing Plants." The QA Manager stated that QAM-1002 program ,

requirements were applied to all work performed in accordance with EPD's Quality Control-Procedure (QCP)-107, " Inspection / Test Plan for Dedication of Commercial Grade Replacement Parts," Revision 9, dated September 19, 1997.

b. Observations and Findinas J The definition of " dedication" in 10 CFR 21.3 specifies that dedication must provide reasonable assurance that a commercial grade item (CGI)-to be used as a basic component will perform its intended safety function, and is deemed equivalent to an item designed and manufactured under a 10 CFR Part 50, Appendix B, QA program. This assurai.cc must be achieved by identifying the critical characteristics of the item and vsirifying their acceptability. A review of EPD's dedication procedure identified that-QCP-187 specifies critical characteristics for the approximately 40 CGI's that are not procured as safety-reltted components by EPD.

Section_5, " Procurement Process, of-QCP-187 requires that the managers of Engineering Systems & Standards and Quality Assurance select the critical characteristics to be verified. The QA manager establishes 5

h tests and inspections to be performed in accordance with established procedures and issues certificates of conformance with the test records.

Section 6. " Acceptance Criteria," of QCP-187 requires that parts which are in compliance with the critical characteristics shall be accepted. '

A discussion with the Manager of Engineering Systems and Standards ideritified that the critical characteristics have been developed based upon the engineering drawings, specifications, and operating design parameters of the particular pump. The engineering manager stated that this delineation of characteristics was to ensure that all important '

operating performance aspects as well as relevant design and material '

considerations were addressed. The EPD Quality Systems Manager stated that the critical characteristics were chosen several years ago using industry guidance and engineering judgement. The adequacy of those critical characteristics was not assessed by the inspector.

The inspector reviewed Chart 17, " Impeller Critical Characteristics Chart," of QCP-187 which requires material verification and CMTR, (if ordered from the manufacturer), verification using the " portable metal analyzer." The ins)ector noted that Chart 17, instead of specifying the actual material to ae verified in accordance with the type and grade of steel, merely stated under the heading " material verification" two items: "CHTR" [see footnote 1) and " portable metal analyzer." The inspector determined that EPD did not include appropriate quantitative or qualitative acceptance criteria in Chart 17, QCP-187 for the critical characteristics necessary to verify compliance with the different ASTM Standards.

The inspector noted that EPD's "metallographic inspection results-alloy analyzer," form (page 45 of QCP-187 has the fc11owing chemical elements listed for analysis / verification: Molybdenum, Nickel, Chromium, Manganese, Titanium (TI), Copper (Cu), Vanadium (V), Iron,(Fe), Zinc (Zn), Tin (Sn), Lead (Pb), Aluminum (A1), and Wolfram (W) . The ASTM A 296 elements that are listed under Table 2, " Chemical Requirements," for CF8M are: Carbon, Manganese, Silicon, Phosphorus, Sulfur, Chromium, Nickel, and Molybdenum. It was noted by the inspector that although Carbon Silicon, Phosphorus, and Sulfur are important for reliability and acceptable performance of stainless steel material EPD did not identify those elements for material verification on its material analysis "metallographic inspection results - alloy analyzer" form. As discussed in section 3.2 above EPD's portable metal analyzer does not identify all of those chemical elements found in Table 2 of ASTM A 296.

As a result of a latt of specificity in chart 17, EPD did not verify the ASTM A 296, Table 2 chemical composition elements of Carbon. Silicon, Phosphorus, and Sulfur for the CF8M impeller casting during its dedication process for Commonwealth Edison P0 470744 (see Section 3.2).

8 Although the symbol W was used by EPD to represent Wolfram, W is the symbol. for Ttngsten. Tungsten (W) is extracted from Wolframite, Scheelite and 4 other minerals.

6

c. Conclusions  !

The inspector concluded that-EPD does not have an adequate basis to f dedicate commercial castings because of the identified practices and  !

methodology employed at its Seneca Falls facility. Since EPD does not '

survey / audit its commercial casting manufacturers and does not verify all of the chemical composition elements (even on a sample basis), its level of assurance would be questionable. .

Additionally, the inspector concluded-that Nonconformance -

99900732/97-01-01 appears to represent a departure from the technical requirements included in a arocurement document and needs to be evaluated in accordance wit 1 the provisions of 10 CFR Part 21 by EPD. ,

3.4 [ntrance and Exit Meetinas In the entrance meeting on October 2, 1997, the NRC inspector discussed the scope of the inspection, outlined the areas to be inspected, and established interfaces with the Engineered Products Division and Industrial Products Group management. In the exit meeting on October 3, 1997, the inspector discussed his findings and concerns. Additional discussions were also conducted subsequent to the exit meeting in ,

December 1997.

3.S Personnel Contacted ,

i S. Sakofsky Director, Quality Assurance - IPG R. Schussler Manager, Engineering Sys', ems and Standards - IPG J. Held Quality Systems Manager - EPD P. Soscia Quality Assurance Engineer - EPD 5, Mahalik Quality Assurance Auditor - EPD 4 ITEMS OPENED, CLOSED, AND DISCUSSED Nonconformanqs t 99900732/97-01-01 Nonconformance Dedication Process Questionable Certifications f

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