ML20199D467
| ML20199D467 | |
| Person / Time | |
|---|---|
| Site: | Paducah Gaseous Diffusion Plant, Portsmouth Gaseous Diffusion Plant, 07100832 |
| Issue date: | 01/23/1998 |
| From: | John Miller UNITED STATES ENRICHMENT CORP. (USEC) |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| REF-QA-99901322 71-0832-97-214, 71-832-97-214, 99901322-97-01, 99901322-97-1, GDP-98-0003, GDP-98-3, NUDOCS 9801300213 | |
| Download: ML20199D467 (19) | |
Text
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v f,,.USEC Af.3'1obal Energy company JAMES H. MILLER Dir. (301) 564 3309 VicE PRESIDENT, PRODUCTION Fax: (301) 571-8279 January 23,1998 United States Nuclear Regulatory Commission SERIAL: GDP 98-0003 Attn: Document Control Desk Washington, D.C. 20555-0001 Paducah Gascous Diffusion Plant (PGDP) l Portsmouth Gaseous Diffusion Plant (PORTS) l Docket Nos. 70-7001 and 70 902 l
Reply to a Notice of Violation. (NOV) in Inspection Report 999-1322/97-01; 71-0832/97-214 Nuclear Regulatory Commission (NRC) letter dated December 3,1997, transmitted the subject inspection Report (IR) which documented the results of an NRC team inspection of Westerman Companies (Westerman), a subcontractor to USEC. As stated in the cover letter to the IR, NRC determined that "USEC failed to ensure that the quality assurance (QA) requirements of ANSI N14.1 were met." Additionally, NRC stated that "USEC did not adeouately assess the effectiveness of its cor aal of quality by its contractor and subcontractor and did not ensure that
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purchased services conformed to procurement documents." Therefore, NRC identified one NOV regarding Condition 8 of the NRC Certificate of Compliance for the Gaseous Diffusion Plants.
j USEC's reply to this NOV is provided in Enclosure 1. Enclosure 2 lists the commitments that are contained in this submittal. As was indicated in USEC letter GDP-97-02i3 dated December 18,1997 NRC agreed to extend the due date fcr this NOV response to January 23,1998.
As noted in Enclosure 1, the reason for this violation was inadequate proce
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and weak communication of expectations to auditors regarding the evaluation of the implementation aspects of a vendor's Quality Assurance (QA) program.
While USEC does not contest the cited violation, USEC believes that the communications during this inspection were not consistent with previous inspections USEC. Therefore, USEC would like the opportunity to further discuss the concuct of this inspection with the NRC so that USEC has a clearer understanding of how NRC intends to conduct future inspections of our subcontractors.
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6903 Rockledge Dn,>e. Bethesda, MD 20817-1818 gg\\
Telephone 301-564-3200 Fax 301-564-3201 http://www.usec.com O$ces in t.ivermo, CA Paducah, KY Portsmouth. OH Washington. DC N1 INT
- Document Control Desk.
- January 23,1998
. UDP 98-0003, Page 2 If you have any questions regarding this submittal, please contact Russ Wells at (301)564-3245.
Sincerely, L[
a s 11. Miller ce President, Production
Enclosures:
As stated
- cc:
NRC Region til Administrator (A. Beach)
NRC Senior Resident inspectors - PGDP and PORTS
- NRC Special Projects Branch (R. Pierson) -
NRC Chief, Transportation Safety and Inspection Branch (S. Shankman) '
Westerman Companies, Vice President Quality (S. Grimm) l
ENCLOSURE 1 UNITED STATES ENRICllMENT CORPORATION (USEC)
REPLY TO NOTICE OF VIOLATION (NOV) 999-1322/97-01; 71-0832/97-214 Restatement.oLViolation NRC Certificate of Compliance for Operation of Gaseous Diffusion Plants, Certificate Number GDP-1, Condition 8 requires in part that USEC shall conduct its operations in accordance with the statements and representations contained in the Certification Application September 15,1997, and revisions thereto.
The Paducah Gaseous Diffusion Plant (PGDP) Safety Analysis Report, submitted by USEC in its application, states in Chapter 1, Appendix A, " Applicable Codes, Standards, and Regulatory Guidance" that the 1990 edition of American National Standards Institute (ANSI) N14.1," Uranium llexafluoride - Packaging for Transport," in its entirety, is applicable for all new uranium hexatiuoride (UF.) cylinders and associated valves and that PGDP will comply with the requirements of the standard.
ANSI N14.1 (1990 edition), Section 4, " Quality Assurance" states that: "The licensee-user shall have a documented quality assurance (QA) program that meets the applicable criteria of Subpart II, Title 10, CFR, Part 71.... The licensee user shall ensure that all applicable QA requirements in Subpart 11, Title 10 CFR, Part 71, for all parties are met to ensure that the product or service supplied meets the requirements of this standard."
10 CFR 71.115, " Control of purchased material, equipment, and services" requires in part that measures shall be established to assure that purchased material, equipment, and services conform to procurement documents. The measures must include provisions, as appropriate, for source evaluation and selection, objective evidence ofquality fumished by the contractor or subcontractor, source inspection, and examination of product on delivery, in addition it requires the assessment of the effectiveness of the control of quality by contractors and subcontractors.
Contrary to the above from March 12,1997, to August 29,1997, USEC did not adequately assess the efTectiveness of the control of quality by its contractor and subcontractor and did not ensure that purchased services conformed to procurement documents. This was evidenced by the following specific examples of where Westerman Companies (Westerman), a subcontractor to llSEC, failed to meet specified requirements in procurement documents and where Lockheed Martin Utility Services (LMUS), a contractor to USEC, failed to adequately assess the effectiveness of the control of quality by Westerman:'
'The specific examples of this violation are shown in Table I to this NOV response.
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USEC RESPONSE e
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- BackgroundJnformetion As was noted in the IR, on March 11 and 12,1997, a vendor audit of Westerman was performed by USEC. The audit resulted in six findings. On April 11,1997, Westerman was placed on the Approved Suppliers List (ASL) with a limitation that the audit findings be corrected prior to implementation of fabrication activities. On August 7,1997, the audit fmdings were verified to have been corrected and this limitation was removed from the ASL.
Subsequently, from August 25-29,1997, NRC conducted an inspection of Westerman. This inspection resulted in the fmdings identified in the cited violation and led to NRC's determination that USEC's audit of Westerman was inadequate.
It should be nated that audits of vendors are the responsibility of the PGDP and PORTS Safety and Safeguards Quality (SS&Q) Manager who are USEC employees located on-site. These individuals have contractor [e.g., Lockheed Martin Utility Services (LMUS)]
employees assigned to them who perform the audits. In the case of the Westerman Audit, the Audit Team Leader was an LMUS employee in the Quality Systems organization which is under the PGDP SS&Q Manager. Therefore, the vendor audits are perfonned under the cognizance of USEC.
II.
Reasonslotthe_Vlolation I
The reasons for the violation wen that the vendor audit of Westerman conducted by USEC was not adequate due to inadequate procedural guidance and weak communication of management expectations to auditors regarding the evaluation of the implementation espects of a vendor's Quality Assurance (QA) program. Further, detail regarding the reasons for this violation are addressed below:
Procedure UE3-QA-QS1071, " Supplier Quality Assurance Audits," requires the Audit Team Leader (ATL) to prepare a comprehensive checklist when performing a vendor audit. Ilowever, the temi " comprehensive" is not well defmed and the procedure specifically does not require that the checklist include, as a minimum, an evaluation of the implementation aspects of the vendor's QA program. As a result, the checklist that was prepared for the performance of the Westerman audit lacked the necessary detail to ensure the performance of a comprehensive audit. Specifically, the audit was conducted from a compliance-based app;oach and did not include a complete verification of the effectiveness of the imp!cmentation of Westerman's QA program.
The Westerman audit was the first vendor audit performed by USEC under the auspices of the Quality Assurance Program (QAP) and the Packaging and Transportation Quality Assurance Program (PTQAP). Prior to conducting this audit, USEC did not effectively communicate to ATLs that vendar audits must assess the implementation aspects
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of a vendor's QA program. Additionally, the ATL for the vendor audit of Westerman had been assigned to perform another vendor audit the same week of the Westennan audit.
Therefore, this individual was not able to allocate sufficient time to the Westerman audit.
Ill.
CorrectiveActions_Taken.andResults Achieved The following corrective actions address the above reason for the violation. The specific actions taken by Westerman in response to the examples of the cited violation are provided in Table 1:
On October 1,1997, as a result of the preliminary findings identified by NRC during their inspection, Westerman's ASL status was changed to " Hold" which prohibited new purchases of cylinders from this vendor.
USEC performed a quality history evaluation to review Westerman's past i
performance at both plants. The results of this evaluation indicated a past issue with Measuring and Test Equipment (M&TE) calibration. Westerman took corrective actions to address this issue. USEC performed a follow-up surveillance and verified that Westerman had taken adequate corrective actions to address the M&TE issue and was also making satisfactory progress in resolving the other discrepancies that led to the cited violation. Consequently, USEC removed the " Hold" status on Westerman.
The USEC QA Supervisor conducted a conference call with both plant's SS&Q Managers, Quality Systems Managers, and their vendor audit staff. The QA Supervisor addressed the expectations that vendor audits must include an assessment of the effectiveness of the implementation of the vendor's QA program.
Additionally, the QA supervisor emphasized that adequate time must be allocated to perform an effective and comprehensive vendor audit.
ATLs at both sites (i.e., PGDP and PORTS) have been instructed to ensure that checklists that are developed for future vendor audits include verification attributes that the vendor is implementing applicable elements of their QA program. They were also reminded not to let perceived plant pressures influence the performance or results of a vendor audit.
Work Assignments within the SS&Q organizations have been reallocated to assure
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that auditors have sufficient time to perform more comprehensive audits of vendors.
IV.
CorrectiveAction to_Be_Taken toAvoid.Eurther_ Violation PGDP and PORTS are reviewing past audit reports of suppliers placed on the ASL to evaluate the comprehensiveness of the audit as a result of the NRC findings of El-3
l Westerman. This action is expected to be completed by February 16,1998. Ifthis review indicates that a comprehensive audit was not performed, the vendor will be removed from the ASL until a comprehensive audit is conducted.
Procedure UE3-QA-QS10'" will be revised to provide better guidance regarding auditing the implementation aspects of a vendor's QA program. This action is expected to be completed by March 2,1998.
Following the completion of the above corrective actions, USEC will perform a re-audit of Westerman.
V.
Date_offulLCompliance Table 1 describes the corrective actions that Westerman is taking to address the
. specific examples of the cited violation. As indicated in Table 1, these actions are expected to be completed by May 31,1998. The corrective actions that USEC is taking to achieve compliance with the reasons for this violation are expected to be completed by March 2, 1998, upon completion of the revision to procedure UE3-QA-QS1071.
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Tchle 1 Action Taken by Westerman to Address Violation Examples Cited Violation Examples Corrective Actions Taken or Being Taken by y'esterman A.
10 CFR 71.105 " Quality assurance program" states: "(d) The licensee shall p-for 1.
Training procedures have been written and indoctrination and training of personnel performing activities aff mg quality as necessary to developed assure that suitable proficiency is achieved and maintained."
2.
A new QA manual svill be written for the flow ever, Westerman did not have a program established to ensure that all personnel performing requirements of NQA-1 by January 31,1998. This activities affecting quality were provided indoctrination or position training to assure proficiency.
action will also address the concerns related to j
Furthermore, records of training for all personnel involved in activities affecting quality were not training of personnel and record retention.
i maintained. Specifically, Westennan's " Quality Control Manual for Cylinders Built Under Lockheed Martin Utility Services Contract 437aa.,, er Equipment Specification JSP-553, Revision 18, for 48G Cy linders," Issue 11, Rev. 3,7-10-96 (QC Manual) did not contain and did not discuss provisions to ensure that all personnel performing activities affecting quality were provided indoctrination or po3ition training to assure proficiency. Training records were not available for personnel involved in fabrication activities such as plate rolling, material assembly, cylinder cleaning, and cenain fabrication testing.
B.
10 CFR 71.121," Internal inspections" states: "The licensee shall establish and execute a program for The functions and responsibilities of the Quality Control inspection of activities afTecting quality by or for the organization performing the activity, to verify Manager and the Manager of Engineering are now being conformance with the documented instructions, procedures, and drawings for accomplishing the performed by separate mdividuals.
activity. The inspection must be performed by individuals other th n those who performed the activity being inspected."
la vever, Westerman's Vice President of QA inspected work affecting quality that he performed while acting as the Engineering Manager. Specifically, on August 26,1997, Westerman's Vice President of QA reviewed and approved fabrication drawing 2D0870, Revision 6 that he also reviewed and approved while acting as the Engineering Manager. Westerman's Vice President of QA was responsible for, and acted in the capacity of, both the Engineering Manager and the QC Manager. The
" Corporate Structure" in Westerman's QC Manual shows both the Manager of Engineering and QC Manager reporting to the President. Ilowever, Westerman's Vice President of QA performed both the Manager of Engineering and the QC Manager functions. Therefore, the QC Manager cannot independently verify that engineering activities are in conformance with documented instructions, procedures, and drawings.
The corrective actions described in this Table are actions being taken by Westerman to address the spn Mc examples of the cited violation. These actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions throus uture audits.
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Tcble 1 Action Taken by Westerman to Address Violation Examples Cited Violation Examples Corrective Actions Taken or BeingTaken by Westerman C.
10 CFR 71.131," Nonconforming materials, parts, or componer.ts" states: "The licensee shall :stablish 1.
The nonconfonnance report as specified in the measures to control material, parts, or components that do not conform to the licensee's requirements to current Quality Control Manual is currently being prevent their inadvertent use or installation.
Nonconforming items must be reviewed and used.
accepted, rejected, mpaired, or reworked in accordance with documented procedures."
2.
A log has been developed to track nonconformance flowever, Westerman's procedure for the control of nonconformances was not implemented and a reports.
" trial" process used in its place was inadequate. Specifically, Westerman's QC Manual, Section 4.0, "Non-Conformities and Corrective Actions," Paragraph 4.2, requires the completion of a " rejection 3.
A nonconformance procedure has been written.
l I
report." The rejection report requires the concurrence (initials) of both the Quality Control Manager (QCM) and Authorized Inspector (AI) to the recommended corrective action and final close-out.
flowever, the QCM's or Al's concurrence as required by the approved procedure were not obtained on rejection reports. Furthermore, nonconformances were not reworked in accordance with documented procedures. In addition, Westerman did not have a system for tracking outstanding nonconformances, audit findings, or inspection findirigs.
The corrective actions described in this Table are actions being taken by Westerman to address the specific examples of the cited violation. These actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions through future audits.
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-m-Tchle 1 Action Taken by Westerman to Address Vialation Examples Cited Violation Examples Corrective Actions Taken or Being'Taken by Westerman D.
10 CFR 71.111, " Instructions, procedures, and drawings" states: "The licensee shall prescribe activities 1.a Drawings have been issued to all critical locations affecting quality by documented instmetions, procedures, or drawings of a type appropriate to the involving fabrication and quality control l
circumstances and shall require that these instructions, procedures, and drawings be followed."
Fabrict.: ion procedures have been develop (d. Work instructions are being developed based on tiese i
1.
Ilowever, Westerman did not prescribe the following activities affecting quality by procedures.
documented instructions, procedures, or drawings:
1.b A training meeting was held with shop employees on a.
Westerman did not have instructions, procedures, or drawings for all fabrication August 28,1997, by the Quality Control Manager, to and inspection activities. Specifically, Westerman stated that all fabrication and discuss the requi ements of the ASME Section Vill.
inspection activities are performed using Drawing No. 2D0632. Ilowever, Shop employees were informed of the above Westerman did not have a copy of the subject drawing at the locations u here referenced UW-42 requirements and that any surface fabrication and in process inspection activities were performed. Funhermore, buildup had to be approved and documented by Westerman did not have instmctions or procedures describing the numerous Quality Control Depanment. A follow-up training processes performed in the fabrication of the 48G cylinders.
meeting was held on December 15,1997, by the Quality Control Manager. Also, procedures and s or procedures in place or available for work instructions are being developed as discussed 13.
Westerman did not have instrucme ensuring the requirements of Amen.m Society of Mechanical Engineers in I.a above.
(ASME), Section Vill - Division I, UW-42," Surface Weld Metal Buildup " were
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met.
l.c The individuals involved were given specific instructions during a training meeting provided by Westerman did not have instructions or procedures in place for ensuring that the the Quality Control Manager held on September 2, c.
weld travel speed for the shell longitudinal seam weld was within specification.
1997. Rose individuals now record actual travel speeds daily. A follow-up training meeting was held d.
Westerman did not have a procedure development program. Specifically, by the Quality Control Manager on December 15.
Westerman's QC Manual did not include a procedure for controlling the 1997. Also, procedures and work instructions are deselopment of procedures used in activities affecting quality, being developed as outlined in I.a above.
I.d A Quality Assurance Manual will be developed by January 31,1998, to meet the standards of NQA-1 including a written procedure for controlling the development of procedures used in activities that affect quality.
The ccrrective actions described in this Table are actions being taken by Westerman to address the specific examples of the cited violation. These actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions through future audits.
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Tcble I Action Taken by Westerman to Address Violation Examples Cited Violatian Examples Corrective Actions Taken or Being'Taken by Westerman -
2.
Ilow ever, Westerman did not follaw instructions, procedures, or drawings specifically, the 2.a The welding machine was replaced with one that following:
conformed with WPS W2 Rev. 0R.
a.
Westerman performed tack welds that did not conform to a Westerman weld 2.b A training meeting was held with shop employees on procedure. Specifically, Westerman Weld Procedure Specification No. W2, September 2,1997, by the Quality Control Manager Revision No. 0/0, dated March i I,1982, requires the use of a shielding gas and employees were reminded about the requirement mixture of Ar;Co, at a 90/10 percent composition and a flow rate of 20-50 cubic for the use of rod ovens to control low hydrogen feet per hour. Ilowever, the team found that tack welds, used to hold the 48G electrodes and the 4-hr limitatiort.. A follmv-up cylinder head to cylinder body, were performed using a shielding gas mixture of training meeting was held on December 15,1997, by A r/Co, at a 75/25 percent composition.
the Quality Control Manager.
b.
Westerman ' ailed to control material in accordance with procedure. Specifically, 2.c Liquid Penetrant inspection Procedure (ND-01) has Westerman's QC Manual, Section 5.0," Welding " Paragraph 5.13, states: " low been certified, regarding liquid penetrant (PT), to hydrogen electrodes shall be stored in heated ovens.. and shall be issued by allow personnel to be qualified in accordance with the Code Foreman in amounts that can be used in a four hour period." flowever, Appendix 8 of ASME Section Vill. New procedures eight le ')ydrogen electrodes (7018 weld rods) were removed from the heated will be developed to comply with NQA-I standards oven and on the shop floor for approximately 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />.
by the February 28,1998.
Westerman did not certify a procedure as required. Specifically, Westerman's c.
QC Manual, Section 6.0 "Non. Destructive Examination," Paragraph 6.2.3, states:
" Written procedures for.. liquid penetrant (PT)... examination of ASME Section VIII items are certified by the Level Ill aller they hve been proven by actual demonstration to the satisfaction of the A1." Ilowever, ND 01," Liquid Penetrant Inspection Procedure," used for ASME Section VIII items was r~
certified by a Level Ill.
'Ihe corrective actions described in this Table are actions being taken by Westerman to address the specific examples of the cited violation. These actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions through future audits.
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Tcble 1 -
Action Taken by Westerman to Address Violation Examples Cited Violation Examples Corrective Actions Taken or Being'Taken by Westerman l
E.
10 CFR 71.113, " Document control" states: "He licensee shall establish measures to control the 1.
Dese drawings were replaced with corrected and l
issuance of documents such as instructions, procedures, and drawings, including changes, which stamped approved drawings. A document control l
prescribe all activities affect!ng quality. Rese measures must assure that documents, including p:ocedure has been developed.
changes, are reviewed for adequacy, approved for release by authorized persormel, and distributed and used at the location where the prescribed activity is performed."
2.
Originally the only quality control maruals that were controlled were the ASME, Section Vill, Division 1 Ilowever, Westerman did not control the following documents which prescribe activities affecting
' quality manuals. He LMUS quality manuals (for quality:
cylinders built under the LMUS Purchase Caler) were designed for instructions and guidance only, I.
Westerman did not control its fabrication drawings. Specifically, Westerman's QC since all UF. cylinders were U stamped per LMUS Manual, Section 1.0, " Drawings, Design Calculations and Specification Control,"
specification to ASME, Setuon VIII, Division 1.
Paragraph 1.2, tates that drawings are prepared by the Manager of Engineering and Herefore, it was assumed that the ASME quality approved by the QC Manager as indicated by the use of the Drawing Approval Stamp.
manual took precedence. He LMUS maml has Two copies of Drawing No. 2D0632, one in the QC X-ray room and one in the fabrication been revised and is cow a controlled document with QC office, that were issued by the Drafting Department on March 17,1997. Ilowever, its own control log.
neither of these drawings had a Drawing Approval Stamp, indicating approval by the QC Manager. Rese drawings were used by Westerman QC personnel for inspection and
/. document control procedure has been developed.
acceptance purposes.
Also a new Quality Assurance Manual will be written by the end of January 31,1998.
2.
Westerman did not control its QC Manual in accordance with the approved procedure.
Specifically, Westerman's QC Manual, Section 11.0," Manual Control for Shop and Field," Paragraph 11.3, states:"The Quality Control Manager shall keep control of this manual by means of a Quality Control Manual Control Log (Exhibit #12). All controlled copies will be issued a number and logged into the control log with the name or title of individuals who have received copies of the Quality Control Manual." liowever, West: rman was not using Section 1 I to control its QC Manual for cylinders built under LMUS Purchase Order 437855 and therefore, a control log was not used.
The corrective actions described in this Table are actions being taken by Westerman to address the specific examples of the cited violation. Dese actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions through future audits.
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Tcble 1 Action Taken by Westerman to Address Violation Examples Cited Violation Examples Corrective Actions Taken or B-bg'Taken by Westerman 3.
A discrepancy existed between a Westerman inspection checklist and the related written 3.
ne Westerman " Inspection Check List " h.w been procedure. Specifically, Westerman's QC hianual, Exhibit 15 "USEC Procedures,"
revised to agree with Westerman's procedme for
" Cylinder Capacity," Paragraph 4.0, states: "De tare weight will be determined by adding determining "Cylindur Capacity" to reflect t,,
the weights of the empty vessel... + 10 lbs for the paint." Ilowever, the"48G addition of ten (10) ros for paint.
Westerman Companies Quality Control Depanment Process inspection Check List" reflected the addition of 9 pounds instead of the equired 10 pounds.
4.
De Westerman " Inspection Check List " has been revised to agree with Westerman's procedure for 4.
A discrepancy existed between a Westerman inspection checklist and the related written determining " Plug und Valve Installation" to reflect procedure. Specifically, Westerman's Quality Control Alanual, Exhibit 15."USEC a maximum of seven (7) threads to be showing.
Procedures."" Plug and Valve Installation," Paragraph 4.0, states: "De maximum number of visible threads showing on the valve shall be seven (7) and the minimum shall be two 5.
Lh1US was notified concerning this discrepancy (2)." llowever, the team found that the"48G Westerman Companies Quality Control since it is their specificatian that disagrees with Department Process Inspection Check List" required a maximum of 6 threads to be ANSI N14.1. USF" has issued a Problem Report showing.
(i.e., PTS-97-10737po resolve this concern.
I 5.
A disagreement between ANSI N14.1 and the requirements of a Westerman procedure and 6.
Rese discrepancies were corrected and implemented checklist existed. Specifically, ANSI N14.1, Section 6.13.6, requires that,"For the plug.
on September 2,1997, with the issuance of drawing a maximum of 8 threais shall be engaged." By contrast, Westerman's QC hianual, 2D0632 Rev.16.
Exhibit 15. "USEC Procedures,"" Plug and Valve Installation," Paragraph 3.0, requires l
that a minimum of I thread must be showing. De disagreement arises because the plugs 7.
Dese discrepancies were corrected and implemented used by Westerman have 10 complete threads; therefore, the tot.' number of threads (10) on September 2,1997, with the issuance of drawing minus the number of visible threads (1) leaves 9 engaged, which is greater than the 2D0632 Rev.16.
maximum of 8 threads allowed by ANSI N14.1.
6Property "ANSI code" (as page type) with input value "ANSI N14.1.</br></br>6" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process..
Discrepancies existed between Westerman fabrication Drawing No. 2D0632, Revision 15 and Drawing No. E-ht-1-4863A supplied by Lh1US.
7.
Discrepancies existed between Westerman fabrication Drawing No 2D0632, Revision 15 and Figure 10 of ANSI N14.1, which shows the dimensions of the Afodel 48G.
The corrective actions described in this Table are actions being taken by Westerman to address the specific examples of the cited violation. Rese actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions through future audits.
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Tr.ble I Action Taken by Westerman to Address Violation Examples Cited Violation Examples Corrective Actions Taken or Being'Taken by Westerman F.
10 CFR 71.135," Quality assurance records" states: "The licensee shall maintain sullicient written A record retention procedure has been developed. Also a records to describe the activities affecting quality. The records must include the instructions, new Quality Assurance Manual will be written by the procedures, and drawings required by 10 CFR 71.11 I to prescribe quality assurance activities and must January 3? 1998.
include closely related spc-ifications such as required qualification of personnel, procedures, and equipment. The records must include the instruction and procedures which establish a records retention program.
llowever, W stennan's QA record retention procedure failed to specify the retention of all records required to describe activities affecting quality. Specifically, Westerman's QC Manual, Section 9.0,
" Record Retention," Paragrapt. 9.1, states: "The following records shall be retained in the company's files for a period no less than 5 years; I - Manufacturer's Data Reports: 2 - Radiographic film and reports for full radiograph; 3 - U.T. Reports." llowever, Section 9.0 failed to require the retention of such records as audit results, personnel qualifications, approved procedures, lists of calibrated equipment used, and documentation to verify calibration.
The corrective actions described in this Table are actions being taken by Westerman to address the specific examples of the cited violation. These actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions through future audits.
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Table I
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Action Taken by Westernian to Address Violation Exasaples Cited Violation Exanspies Corrective Actions Taken or Being[TAcn
'oy Wester: nan G.
10 CFR 71. I 15. " Control of purchased material, equipment, and services" states: "(a) The licensee '
The following procedures hm been developed:
shall establish measures to assure that pue based materials, equipment and services, whether purchased i
directly or through contractors and subcoinctors, conforms to the p Am u. ent.kicuments. These
- 1) External Audit of Suppliers and SulmhEu, measures must include provisions, as appn --iate, for source esa.uation and selection, objective
- 2) Approved Suppliers; eviderce of quality furnished by the contracte or subcontracor, inspection t the contractors or 3) s' ort.xrcial Grade Dedicatior.;
subcontractors source, and examination of product on delivery... The licensee or designee shall
.1)
Supplier Evaluatiom assess the efTectiveness of the control of quality by contractors and subcontractors at intervals
- 5) Vendor Qualification by Third Party.
consistent with importance.. af the product or senices."
Commencement of the implementatien of these liowever, Westerman did not hne a program with provisions. as appropriate for source evaluation and procedure = will begin in February.1998, and uill be
-lection, source inspection, or detailed examination of product on delivery to assure that purchased completed by May 31.1998. As an intermediary step.
materials, equipment, and services conformed to procurement documents Furthermore. Westerman Westerman has developed a program of verificatior_ for did not assess the effectiveness of the control cfquality by contractors and subcontractors amty material being supplied by its currere vendors. This specified interval. Specifically. Lockheed Martin Purchase Order 437855, Revision 6. requaes that-verification includes independent testing of pressurt-(1)"The Seller shall evaluate its lower-tier suppliers which supply Q or AQ-NCS items to ensure the rataining material along with reinforcement rings, skirts, requirements of the appropnate Quality Assura ice Program are implemented; (2)"The seller shall and valve ;uards to determine their compliance to LMUS maintain a quality program acceptable to the Buyet... The quality program shall comply with, or specifications and drawings. It will also include be equivalent to NQA-1,1989... The seller s!.all insert the requirunents of this clause, verification of all existing material currently in invemory.
appropriately modified, in all subcontracts"; (3)"10 CFR Part 2f,' Reporting of Defects and Noncempliaaces*, apply to this Order.' liowe fer, Westerman failed to implement the purchase order requirements. Furthermore, Westerman Compcnies Purchase Order 50365, dated June 12.1997, for couplings used iis the fabrication of USEC 48G cylinders, did not include QA requirements or 10 CFR Part 21 requirements.
The corrective actions described in this Table are ntions being taken by Westerman to address the specific examples of the cited violation. These actions are not commitments on USEC's behalf. USEC will serify the completion of these corrective actions through future audits.
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Table I t
Action Taken by Weste man to Address Violation Examspies Cited Violation Exasupies Corrective Actions Taken or Being'Taken tw Westernian il 10 CFR 71.137. Audits" states "The licensee si.all carry out a comprehensive system of planned and internal and external audit mul have been periodic audido verify compliance with all aspects of the quality assurance program and to detennine developed. Westerman will begin the in;plementir.g of l
the effectiseness of the program?
these procedures by Febrt.ary.1998, and will be completed by May 31.1998.
l Ilowever, Westnman did not carry out a comprehed. system of planned and periodic audits to i
verify compliance with all aspects of the QA progran' Specifically, Lockheed Martin Purchase Order A third party audit procedure has been completed and a 437555 Revision 6 requires that "The v!!cr shall ma.ntain a quality program acceptable to the Buyer new Quality Assurance Manual will be written by January
... De quality progra.n shall comply with,or be equivalent to NQA-i.1989...." floweser, 31,1098.
Westerman's QC Mam.al did not conta'~ and did not discuss provisions for the conduct of audits.
Therefore, there were no regirements regarding audit schedu;es, audit checklists, the qualification of personcel performing audits, or follow-up actions associat.-d with audit findings.
1.
10 CFR 71.123, "Tesi control" states: "The test procedures must include provisions for assurine that 1.
Two (2) new 0-200 psi range gauges were purchased all prerequisites for the given test are met, that adequate test instrumentation is available and used, and on August 27.1997. Rese new gauges uere that the test is performed under suitable environmental conditions "
initially cahbrated and added to the calibr: won log.
Dey are now being calibrated on a monthly basis.
I.
Ilowever, Westerman failed to ensure that adequate test equipment was available and used Specifically, Westerman's QC Manual. Exhibit 15,"USEC Procedures "" Pneumatic Test 2.
Two (2) calibrated rhm~en.ks have bee-:
Procedure,""Special Equipment 3)." states: " Calibrated pressure gauge with range of not purchased. These thermometers will be rotated more that four (4) times and at least I % times irwded test pressure " llowever, the team every six months and calibrated.
found that an uncalibrated gauge with a range of from 0 to 600 pounds was used for a 100-pound prreumatic test. Derefore, the test gauge was 200 pounds out of range and not calibrated.
2.
Ilowever, adequate test equipn nt was not availaisle or used at Westerman. Specifically, Westerman's QC Manual. Exhibit 15. "USEC Procedures "" Cylinder Capacity,"Special Equipment 2)." requires the use of a water temperature indicating device. Furthermore.
Specification No. JSP-553, Revision 18, requires that the actual water weight used to determine cy finder capacity shall be accurate to withia +/- 0.1%. Ilowever, Westerman's Cylinder Capacity test procedure did not require the use of a cahbrated thermometer and in fact. Westerman did not use a calibrated thermometer during testing. An error in the thermometer can resul in an eraneous water v.eicht reading and therefore, an inat. rate determination of the cylinde/s capacity.
De corrective actions described in this Table are actions being taken by Westerm.i to address the specific examples of the cited violation. Dese actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions through future audits.
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Table I Ac:i.n Taken by Westerman to Add ess Violation Exaneries Cited Violation Examples Corrective Actions Taken or BeingTaken by Westerstaa J.
10 CFR 71.129," Inspection, test, and operating status' states: "The licensee shall establa measures The current Shop Traveler has been revised to include all to indicate, bj-the use of markings such as stamps, tags, labels, routing cards, or other suitable means, tne fabrication inspectens, test inspections, and operating the status ofinspectens and tests performed upon individual items of the packaging "
status tests.
Ilowever, Westerman did not indicate the inspection and test status of all components or assemblies during the fabrication of48G cy finders. In-process inspections (i.e., weld inspections, dimensional checks, etc.) wcre performed; however, Westerman was unable to provide the team with any controlled documentation indicating that these in-process inspections had been performed. Westerman also performed random inspections for other fabrication processes (e.g., rolling, and forming the cylinder shell; positioning and installing the two couplings in the two ellipsoidal heads; installing the two ellipsoidal heads; positioning and attaching the three stif fening rings; attaching the four lifting lugs; and installing the cylinder valve and plug). Ilowever, Westerman did not have procedural control of thi~.e inspections o-document their results.
The corrective actions described in this Table are actions being taken by Westerman to address the specific examples of the cited violation. These actions are not commitments on USECs behalf. USEC will verify the completion of these corrective actions through future audits.
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1 Table 1 Action Taken hy Westerman to Address Violation Examples Cited
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Violation Examples' Corrective Actions T.tken or Being Taken by Westerman K
71.125," Control of measuring and test equipment' states _
he licensee shall establish measures to An additisnal torque tester us ym 'M an,1 assure that tools, gauges, instruments, and other measuring and testing devices used in activities calibrated. The torque tester units will be rotated affecting quality are properly controlled, calibrated, and adjusted at specified times to mrintain every six months for calibratm accuracy within necessary limits.' flowever, Westerman had a torque tester used for calibrating torque wrenches th t did not have a current calibration sticker, ar.d measuring equipment t.ed in fabrication 2.
The measunng equipment discussed under thic item activi-ies that were not controlled.
(i.e., a tape measure) is a " commercial d. ice' as stated in NQA-1 and calibration is not requirest 1.
Ilowever, Westerman used a torque tester that did not have a current calibration sticker to Furthermore. the tolerances specified in ANSI calibra e torque wrenches. Specifically, the torque tester used for calibrating torque N14.1, LMUS specificatior,. and drawings for the w rencnes, ased in 48G cylinder assembly, had a calibration sticker indicating that it was fabncation ofcylinders do not require" precision-l last calibrated July 1992, and that it was due for calibration July 1993. In addition, the asurmg equipment. Therefore, no action by i
torque tester manual recommended calibration at least every 6 months.
Westerman is required.
j s
i 2.
Westerman did not control measuring equipment used in the fabrication of 48Gs.
Specifically, Westerman's QC Manual, Section 8, " Calibration," does not address the f
control of measuring equipment used in the fabrication process. Uncontrolled measurmg
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equipment was used to locc:e the cylinder nameplate on the cylinder head, the mounting holes in the cylinder heads (for the valves and plugs), the depth of the couplings used m
' the cylinder heads (for the valves and plugs), and the location of the stiffening rings around the c)linder shell.
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i The corrective actions described in this Table are actions being t:. ken by Westerman to address the specific examples of the cited violation. These act nns are not j
commitments on USEcs behalf. USEC will verify the completion of these corrective actions through future audits.
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J
Table 1
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Action Taken by Westermian to Address Violation Exa:mples Cited Violation Exanspies Corrective Actions Taken or BeingiTaken by Westeresan
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=
L 10 CFR 71.137 " Audits" states: "De licerisce shall carry out a comprehensive system of planned rnd USEC's response to the cited violation addresses this
,miodic audits to verify compliance with all aspects of the qua!ity assurance program and to determine issue.
the effectiveness of the program."
Ilowever, LMUS' audit of Westerman (PGD-97-003) dated March Il-12,1997 was not sufTiciently cor.,prehen<ive. Specifically, In PGD-97-003 LMUS states: "He supplier audit was performed to determine & technical and quality capabilities of Westerman Companies to meet or exceed the requirements of... UEO-1041, Rt.v.1, Radioactive Material Packaging and Transp.mation Quality Assurance Program." His document. UEO-104I, is the NRC approved QA program Furthermore.
PGD-97-003 states: " Westerman Companies psesces a quality assurarKe progiam that effectively i
meets or exceeds the intent of NQA-I-1989, the QAP, ANSI N14.1-1990, and the FTQAP and will be placed on the Approved Suppliers List." Ilowever, Westennan's QA program did not meet or exceed l
NQA-t-1989, ANSI N14.1 1990. or the " Radioactive Material Packaging and Transportation Quality Assurance Program "
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i
)
He corrective actions described in this Table are actions being taken by Westerman to address the specific examples of the cited violation. These actions are not commitments on USEC's behalf. USEC will verify the completion of these corrective actions through future audits.
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1 ENCL,OSUllE 2 LIST OF COMhilThiENTS 1.
PGDP and PORTS are reviewing past audit reports of suppliers placed on the ASI, to evaluate i
the comprehensiveness of the audit as a result of the NRC findings of Westerman. This action is expected to be completed by February 16,1998. If this review indicates that a comprehensive audit was not performed, the vendor will be removed from the ASL until a comprehensive audit i
is cenducted.
2.
Procedure UE3-QA-QS1071 will be revised to provide better guidance regarding auditing the implementation aspects of a vendor's QA program. This action is expected to be completed by March 2,1998.
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3.
Following the completion of the above corrective actions, USEC will perform a re audit of Westerman.
W E21 r,