ML20133F081
| ML20133F081 | |
| Person / Time | |
|---|---|
| Issue date: | 10/04/1985 |
| From: | Zech G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Stohr J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| References | |
| REF-QA-99900003 RII-84-A-0172, RII-84-A-172, NUDOCS 8510100114 | |
| Download: ML20133F081 (2) | |
Text
. -
/
'o
' UNITED STATES
~g NUCLEAR REGULATORY COMMISSION o
g 8
WASHINGTON, D. C. 20655 s..../
e' October 4, 1985 MEMORANDUM FOR:
J. Philip Stohr Director Division of Radiation Safety and Safeguards Region II FROM:
Gary G. Zech, Chief Vendor Program Branch Division of Quality Assurance, Vendor and Technical Training Center Programs Office of Inspection and Enforcement
SUBJECT:
GE WILMINGTON INSPECTION REPORT (99900003/85-01)
Reference:
Case No. RII-84-A-0172
'The enclosed inspection report (Enclosure 2) discusses the results of the Vendor Program Branch (VPB) inspection conducted at the GE Wilmington, North Carolina, facility during the week of June 24, 1985. This inspection was a
conducted in response to Region II's request that the VP8 review thirteen allegations. The allegations reviewed during this inspection were:
(Region II's allegation number) 84-0172-001-V1B through 84-0172-009-V18, 84-0172-019-V1B, j
j 84-0172-020, 84-0172-021, 84-0172-022, and three additional allegations (IA, 2A, and 3A) were identified and reviewed by VPB inspectors. This memorandum provides information to close out the allegations. The allegations reviewed and their associated findings are discussed in Enclosure 1.
Additional VPB inspection effort is not planned concerning these allegations. Should you have any uestions with respect to the inspection, please contact Mr. R. L. Cilimberg FTS492-9042).
Two additional aspects of the report.should be noted. The first is the conclusion that while items of nonconformance were identified, items of noncompliance were not identified. The inspectors reviewed GE's license (No. SNM-1097, renewed June 29,1984) prior to conducting the inspection. Following the inspection, additional reviews were conducted by ELD and other members of the IE staff to determine whether or not the inspection findings constituted violations of legally binding requirements. The conclusion of these reviews was that no items of noncompliance had been identified. However, the inspection findings were deter-mined to constitute items of nonconformance. The procedures reviewed and analyses observed during tha-subject inspection were focused upon and limited to those discussed in the report. These procedures and analyses were determined not to involve nuclear criticality safety, protection of the environment or radiation safety. Therefore, the findings were classified as items of nonconformance.
4 h03
J. Phi. lip Stohr October 4, 1985 The second concerns attitudes related to procedural adherence and adequacy of
(-
procedures. As discussed in the report, the inspectors determined that GE personnel, including supervisors and senior technicians, were aware that procedures were not being followed and were inadequate. The acceptance of this " method of operation" by GE personnel may Le a factor in determining the cause and significance of other inspection findings not necessarily limited to the chemet laboratory.
OmetNAL SIGNED SY:
GARY G. ZECH Gary G. Zech, Chief Vendor Program Branch Division of Quality Assurance, Vendor and Technical Training Center Programs Office of Inspection and Enforcement
Enclosures:
1.
Summary of Inspection Findings 2.
Inspection Report #99900003/85-01 dated August 26, 1985 DISTRIBUTION: w/o Enclosure 1 A S 016 VPB Reading DQAVT Reading JWCraig RCilimberg RBurch, RII l
d
. V [\\yJ C VPB:DQAVT' C/VPE:DQAVT PB:DQAVT RCilimbers: sam fWCraig h
9/.10 /85 9/y:/85 9
/85
/
'o UNITED STATES NUCLEAR REGULATORY COMMISSION o
WASHINGTON, D. C. 20555
/
August 26, 1985
. Docket No. 99900003/85-01 General Electric Company Wilmington Manufacturing Facility ATTN: Mr. E. A. Lees General Manager Post Office Box 780 Wilmington, North Carolina 28402 Gentlemen:
This refers to the inspection conducted by Messrs. R. L. Cilimberg, J. W.
Craig, and D. Meikrantz of this office on June 24-28, 1985, of your facility at Wilmington, North Carolina, and to the discussions of our findings with Mr. W. McMahon and members of your staff at the conclusion of the inspection.
This inspection was made in response to allegations concerning possible deficiencies in your Quality Assurance (QA) Program. Areas examined during the inspection and our findings are discussed in the enclosed report. Within these areas, the inspection consisted of an examination of procedures and representative records, interviews with personnel, and observations by the inspectors.
During the inspection a number of allegations were substantiated, and the NRC inspectors determined that the implementation of your QA program failed to meet commitments made to the NRC. These failures include the failure to follow procedures, inadequate procedures, failure to ensure that test results are properly identified, and failure to properly identify instrument calibration data. As discussed in the enclosed report, although the NRC recognizes that the results of the analyses were within the accuracy limits of the analytical methods used, we are concerned that technicians routinely do not follow procedures and, in some instances, cannot follow the procedures as written. The use of inadequate procedures and the established practice of not following procedures was known by personnel at the Wilmington facility and corrective action was not initiated. The specific findings and references to the pertinent requirements are identified in the enclosures to this letter.
Please provide us within 30 days from the date of this letter a written state-ment containing:
(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. Consideration may be given to extending your response time for good cause shown.
b VV
Genera'l Electric Company Wilmington Manufacturing Facility August 26, 1985 The responses requested by this letter are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
In accordance with 10 CFR 2.790 of the Commission's regulations, a copy of this letter and the enclosed inspection report will be placed in the NRC's Public Document Room.
Should you have any questions concerning this inspection, we will be pleased to discuss them with you.
Sincere 4
k i
Gary ech, Chief Vendor Program Branch Division of Quality Assurance, Vendor and Technical Training Center Programs Office of Inspection and Enforcement
Enclosures:
1.
Appendix A-Notice of Nonconformance 2.
Inspection Report No. 99900003/85-01 j
.,7
--m.
E APPENDIX A General Electric Company Wilmington Manufacturing Facility Wilmington, North Carolina Docket No. 99900003/85-01 NOTICE OF NONCONFORMANCE During an inspection conducted June 24-28, 1985, the implementation of the Quality Assurance (QA) Program at General Electric's Wilmington Manufacturing Facility was reviewed. The Quality Assurance (QA) Program requirements are discussed in GE's Nuclear Energy Business Operations BWR Qualif; Assurance Program Descriptien, NED0-11209-04A, Revision 5.
This program, which has been reviewed and approved by the Nuclear Regulatory Commission, includes activities associated with the fabrication of fuel bundles, channels and fuel assembly components manufactured at the Wilmington facility.
Based on the results of this inspection, it appears that certain activities at the GE manufacturing facility were not conducted in accordance with comitments made to the NRC.
These items are listed below.
1.
Section 10, NED0-11209-04A, Revision 4, dated December 31, 1982,
" Inspection," requires, in part, that inspection of materials be performed in accordance with established procedures or instructions.
Section 12, NED0-11209-04A, Revision 4, " Control of Measuring and Test Equipment," requires, in part, that calibration of test equipment be performed at specified intervals.
Wilmington Manufacturing Department (WMD), Chemet Laboratory Station Control Document Book W-5, " Nitrogen In UO,, And Metallics," SCP No. 208, Revision 3, dated May 24, 1983, Section 1.0, requires that calibration curves be verified once per year or when required by calibration verification.
Contrary to the above, activities were not conducted in accordance with established procedures in that analyses conducted during the time period October 12, 1984, to November 1, 1984, to determine wet iron test results were calculated using outdated calibration values.
2.
Section 12, NED0-11209-04A, Revision 5, dated March 1, 1985, " Control of Measuring and Test Equipment," requires, in part, that items of test equipment be uniquely identified for traceability to their calibration test data.
Contrary to the above, items of test equipment are not uniquely identified to provide traceability to calibration test data in that both Beckman (DU-5) test instruments in the Chemet laboratory are labeled 201, and all wet iron test results entered in the computerized data system were identified as having been performed using instrument 201.
g2%1g
~
r
.. _ _ __ _ _- 1 2-3.
Section 12, NED0-11209-04A, Revision 5. " Control of Measuring and Test Equipment," requires, in part, that instruments be of the proper type to verify conformance to established requirements, and that items of
. test equipment be uniquely identified for traceability to their calibration test data.
SCP No. 202, " Wet Iron," Revision 5, dated May 3, 1984, requires that calibration curve data be posted in the yellow work station book.
Contrary to the above, the calibration curve contained in the yellow work station book for the Beckman instrument was dated January 7, 1981, and was based upon calibration tests performed using a Beckman Model 25 instrument.
The Beckman instruments currently used in the Chemet laboratory are both model DU-5.
F 4.
Section 10. NED0-11209-04A, Revision 5 " Inspection," requires, in part, that inspection of materials be defined and executed in accordance with established procedures or instructions.
GE Analytical Test Method No. 1.2.9.4, Revision 4, dated July 12, 1984,
" Determination of Iron in Uranium 0xide and Uranyl Nitrate Solutions,"
requires in Step 7.7 that sample volumes be 200 ml.
Calibration and Operation Instruction (COI) No. 203, Revision 1 dated June 3, 1985, " Waste Water Analyses," requires that Steps 4.5.1.2 through 4.5.1.5 be repeated for sample analyses.
~
Contrary to the above, procedures were not adequately defined in that
-(1) Analytical Test Method No.1.2.9.4 reflects analysis performed using a Brinkman instrument, however, this procedure is also conducted using a Beckman instrument which requires a 100 m1 sample volume; and (2) COI No. 203 Step 4.3 contains references to nonexistent " Steps 4.5.1.2 through 4.5.1.5."
5.
Section 5. NED0-11209-04A, Revision 5, " Instructions, Procedures, and Drawings," requires, in part, that activities affecting quality be delineated, accomplished, and controlled by procedures and instructions.
Step 7.8 of GE Analytical Test Method No. 1.2.9.4, Revision 4, requires that technicians wait 30-45 minutes prior to measuring absorbance of samples.
Contrary to the above, during the inspection, the inspectors observed that technicians did not wait 30-45 minutes prior to measuring absorbance of samples. No wait period was observed by the technicians prior to measuring absorbance.
6.
Section 5, NED0-11209-04A, Revision 5 " Instructions, Procedures, and Drawings " requires, in part, that activities affecting quality be delineated, accomplished, and controlled by procedures and instructions.
-i-e v-
,i-m nw-,
--e------
- -. -. ~.., - -
.--ey-.-v.+-o
-ne.----w.w e.-me-.-s----..y-,oc,.,,-w.,,-ew
.w,--.-.-
~,<wyww*-
e-mwm+-
^
3-i 1
Step 7.7 of GE Analytical Test Method No. 1.2.9.4, Revision 4, requires dilution to 200 ml with mix solution.
Calibration and Operating Instruction No. 203, Revision 1, dated June 3, 1985, " Waste Water Analyses," Step 4.3 " Sample Analysis" refer-ences(althoughincorrectly) Step 4.3.1.2.
Step 4.3.1.2 requires that a 25 ml blank be prepared for subsequent absorbance measurement.
Contrary to the above, during the inspection, the inspectors observed that (1) technicians diluted to a 100 ml volume of mix solution instead of the 200 ml specified; and (2) technicians did not use a 25 ml blank during sample analysis.
7.
Section 5, NED0-11209-04A, Revision 5. " Instructions, Procedures, and Drawings," requires, in part, that activities affecting quality be delineated.. accomplished, and controlled by procedures and instructions.
Section 4.4.5 of GE Practices and Procedures No. 30-33, Revision 6, dated April 22, 1985, requires, in part, that corrections be made per approved methods including as a minimum, a single line through the incorrect entry so that it may still be read with the date and signature such that it is traceable to the person who made the change.
Contrary to the above, Chemet laboratory personnel used white-out on data forms rather than drawing a single line through incorrect data entries. White-out was used on the form to record " Rad Waste Composites
& Miscellaneous Liquid Waste," CL.238, Revision 0, dated March 4, 1981, and on entries on page 3 of the " Rad Safety Book for PRM-43."
i j
-*---r-y 4-wr,---,--w-m-- - -p.-c-.r.
e s.
r -----
--we--,- - - ----
,1y.
,e-,,--,.-w.
-wr
--.---m-w---,.r-,
m--
I ORGANIZATION:
GENERAL ELECTRIC WILMINGTON MANUFACTURING FACILITY WILMINGTON, NORTH CAROLINA REPORT INSPECTION INSPECTION NO.: 99900003/85-01 DATE(S):
6/24-28/85 ON-SITE HOURS:
129 CORRESPONDENCE ADDRESS: General Electric Company Wilmington Manufacturing Facility ATTN: Mr. E. A. Lees, General Manager Post Office Box 780 Wilmington, North Carolina 28402 ORGANIZATIONAL CONTACT: Mr. C. W. Doyle, Manager Quality Audits & Customer Service TELEPHONE NUMBER:
(919)343-5874 PRINCIPAL PRODUCT: Nuclear Fuel Assemblies and Core Hardware NUCLEAR INDUSTRY ACTIVITY: Major nuclear fuel and BWR core hardware for GE designed reactors and fuel pellet fabrication for B&W cores.
bI b
ll A
/
j E//6[f[
ASSIGNED INSPECTOR:
R. L. C1Timberg, Speyal Projects Inspection
' Date Section(SPIS)
OTHERINSPECTOR(S):
J. W. Craig, SPIS.
D.
krantz EG&G APPROVED BY:
/fo/IF6 1
' bhn W. Craig, Chief, S q, Vendor Program Branch
' Date INSPECTION BASES AND SCOPE:
A.
BASES:
10 CFR 50, Appendix B and 10 CFR 21.
B.
SCOPE: This inspection was made in response to allegations concerning possible deficiencies in the implementation of the General Electric Quality Assurance Program at the Wilmington, North Carolina facility.
PLANT SITE APPLICABILITY:
BWR facilities and Babcock and Wilcox facilities with fuel supplied by GE.
1
ORGANIZATION: GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WILMINGTON. NORTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 2 of 13 A.
VIOLATIONS:
None.
B.
NONCONFORMANCES:
1.
Contrary to Section 10. " Inspection," and Section 12 " Control of Measuring And Test Equipment," of NEDO 11209-04A, Revision 4, dated December 31, 1982, and GE SCP No. 208, Revision 3, dated May 24, 1983, analyses conducted during the time period October 12, 1984, to November 1, 1984, were not conducted in accordance with established procedures in that wet iron test results were calculated using outdated calibration values.
2.
Contrary to Section 12, " Control of Measuring and Test Equipment,"
of NED011209-04A, Revision 5, dated March 1,1985, items of measuring and test equipment are not suitably, nor uniquely identified to provide traceability to calibration test data in that both Beckman instruments in the Chemet laboratory were labeled 201, and all wet iron test results entered in the computerized data system were identified as having been performed using instrument 201.
3.
Contrary to Section 12 " Control of Measuring and Testing Equipment,"
NE00-11209-04A, Revision 5, and GE SCP No. 202, " Wet Iron," Revision 5, dated May 3,1984, the calibration curves contained in the yellow work station book for the Beckman instrument were dated January 7, 1981, based upon calibration tests performed using a Beckman Model 25 instrument. The Beckman instruments currently used in the Chemet laboratory are both model DU-5.
4.
Contrary to Section 10, " Inspection," NED0-11209-04A, Revision 5, procedures for examinations and measurements were not adequately defined, in that, GE Analytical Test Method No.1.2.9.4, Revision 4, dated July 12, 1984, Step 7.7 requires sample volumes to be 200 ml, and COI 203, Revision 1, dated June 3, 1985, Step 4.3 contains references to nonexistent steps 4.5.1.2 through 4.5.1.5.
5.
Contraty to Section 5, " Instructions, Procedures and Drawings,"
NED0-11?09-04A, Revision 5, and Step 7.8 of GE Analytical Test Method Na 1.2.9.4, Revision 4, technicians did not wait 30-45 minutes prior to measuring absorbance of samples.
6.
Contrary to Section 5, " Instructions, Procedures and Drawings," NED0-11209-04A, Revision 5, Step 7.7 of GE Analytical Test Method No.
1.2.9.4, Revision 4, and Step 4.3.1.2 of GE COI No. 203, Revision 1,
_._-_.,___._.m.,
0 ORGANIZATION: GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WilMTNRTON. N0 ?TH rAR01 INA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 3 of 13 (1) technicians diluted to a 100 m1 volume of mix solution instead of the 200 ml specified, and (2). technicians did not prepare a 25 ml blank.
7.
Contrary to Section 5, " Instructions, Procedures and Drawings,"
NEDO-11209-04A, Revision 5, and Section 4.4.5 of GE Practices and Procedures No. 30-33, Revision 5, dated April 22, 1985, Chemet laboratory personnel used white-out on data forms rather than drawing a single line through incorrect data entries.
C.
UNRESOLVED ITEMS:
None.
D.
STATUS OF PREVIOUS INSPECTION FINDINGS:
(0 pen) Nonconformance (84-01): Contrary to Criterion V of 10 CFR 50, Appendix B, and GE Quality Control Operator Requirements (QCOR) 14.1.4, complete tubeshell corrosion improvement heat treat analog temperature recordings (strip charts) are not being obtained for all tubeshells.
This item was not reviewed during this inspection.
E.
OTHER FINDINGS OR COMMENTS:
1.
Entrance and Exit Meetings GE management representatives were informed of the scope of the inspection during the entrance meeting.
The inspection findings and observations were summarized during the exit meeting on June 28, 1985..
2.
Measuring and Test Instruments The inspectors reviewed procedures and practices related to the control of measuring and test instruments used in the wet laboratory including calibration curve data and computer programs.
Findings are discussed below. The procedures reviewed are discussed in subsequent sections of the report.
a.
The first finding involves the use of the Brinkman 801 colorimeter (Brinkman) which was placed in operation in early 1984. The first calibration curve for the Brinkman was dated February 8, 1984, and exhibited a slope of 517.009 i
and an intercept of -4.020.
The second calibration curve for the Brinkman was dated October 12, 1984, and exhibited a slope of 506.881 and an intercept of -1.310.
The inspectors reviewed i
I
ORGANIZATION: GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WILMINGTON. NO RTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 4 of 13 worksheets used by technicians to perform the wet iron analysis during the time period of February 1984-April 1985. These worksheets include calibration data used during the analysis.
Based upon this review, the inspectors determined that the analyses performed by technicians from October 12, 1984, to November 1, 1984, were conducted using outdated calibration data.
The wrong slope and intercept values were being used during this two week period.
The inspectors also reviewed the variation between the slope and intercept values for the calibration curve dated February 8, 1984, and values for the calibration curve dated October 12, 1984:
11%. The accuracy of Analytical Test Method 1.2.9.4, Revision 4, dated July 12, 1984, for the wet iron analysis, as stated in this procedure, is 5%. The inspectors determined that while the test results obtained during the October 12-November 1, 1984, time period were derived using outdated calibration data, these test results were within the specified accuracy of the test method and therefore, these test results are acceptable.
Nonconformance Item B.1 was identified in this area.
b.
The second item involves computer programs used in the Chemet (wet) laboratory.
The inspectors determined that the computer programs used to calculate test results are not formally controlled / revised. No records are kept which indicate the type or date a change is made to the program and there is no mechanism in place to ensure that laboratory personnel are informed of changes made to these computer programs.
The inspectors reviewed test results stored in the laboratory's computerized data system (LMCS) to determine when the Brinkman was used to conduct tests during the past two years. This data indicated that only one instrument, identified as 201, had been used.
Based upon a review of the computer program (WETFEO, Step 1720),theinspectorsdeterminedthatall test results entered into the computerized data system were identified as having been performed by instrument 201.
In fact, three different instruments were used to perform the analyses. As discussed above, the review of worksheets indicated that three different instruments are used in the wet laboratory (one Brinkman and two Beckman instruments).
Nonconformance Item B.2 was identified in this area.
ORGANIZATIONr GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WILMINGTON. NORTH CAROLINA REPORT INSPECTION NO.:
99900003/85-01 RESULTS:
PAGE 5 of 13 The inspectors observed that the laboratory program incorporates various standards which are pro' cessed along with test samples from the manufacturing process. These standards are entered into the computer and pass a statistical evaluation prior to computer acceptance of test sample results. The processing and release of test sample results is controlled by computer software.
If the sample results do not meet the statistical requirements entered into the computer, they are not released, c.
The third item involves the control of measuring and test instruments used in the. wet laboratory with respect to calibration curves and instrument identification. The calibration curve for the Brinkman instrument used during wet iron analysis was identified as "PC 801 colorimeter" and dated October 12, 1984.
An instrument serial number or other identification number was not used which could uniquely identify the instrument.
There are two Beckman DUS instruments used in the laboratory both are identified as "201."
The calibration curve used during nitrogen analyses has two calibration lines. One line is identified as "Beckman 201= Blue" the other is identified as "Beckman 202= Red." While the values given for the slope of these curves are the same (661), the intercept values are different:
201 (-10.7) and 202 (-10.2). These curves are dated January 7, 1981. An instrument serial number or other identification number was not included on the calibration curves to uniquely-identify the instrument to which each curve was applicable.
Finally, the calibrat' ion curve for the Beckman instruments used during wet iron analysis was identified as "Beckman Model 25" and dated 1/7/81. There are no Beckman model 25 instruments currently used in the wet laboratory.
Nonconformance Item B.2 and B.3 were identified in this area.
3.
Procedure Review Various procedures used to perform / support analyses in the wet laboratory were reviewed. These include Station Control Plan (SCP) instructions, Calibration and Operation Instructions (C0I), Analytical Test Methods (CM&S) and Quality Notices (QN).
As discussed in Item 4 below the inspectors also observed technicians performing the analyses associated with these procedures.
ORGANIZATION: GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILTTY WILMINGTON. NORTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
I, PAGE 6 of 13
\\
[
a.
The inspectors reviewed several procedures concerning wet iron' analysis.
(1) QN No. F-G-1295, Revision 0, dated April 17, 1984,
" Documentation of Qualification Data for Dipping Probe Colorimeter," was reviewed.
This QN documents the quali-fication data for the Brinkman instrument for use during wet iron analysis, was approved April 17, 1984 and references CM&S 1.2.9.4.
The "LMCS Analyzer No." data was not entered on the qualification tag sheet.
(2) COI 209, Revision 1, dated January 18, 1985, Operating of 2
Brinkman 801 Colorimeter, was reviewed. This procedure l-contains the steps placing the Brinkman instrument in-service including Step 5.0, Direct Computer Input. Prior to the'Brinkman being removed from the laboratory durint this inspection, data from the Brinkman could be entered into a computer (Hewlett Packard 87XM) by two methods.
The first is the manual mode in which the technician manually enters the Brinkman reading into the computer.
The second is an automatic mode in which the Brinkman reading is entered directly into the computer when a function key on the computer is p essed.
(3) CM&S 1.2.9.4, Revis' on 4, dated July 12, 1984, " Determination i
of Iron In Uranium Oxide and Uranyl Nitrate Solutions," was reviewed. =This CM&S discusses the wet iron analysis method and contains the steps for calibration curve preparation 4
(Section 6.0) and steps to analyze samples (Section 7.0).
This procedure was revised to reflect the use of the l
Brinkman when this instrument was placed in-service. While Step 7.7 requires that solutions be diluted to 200'ml, no i
reference is made to indicate that a 100 ml solution is S
used with the Beckman instrument. A note in Step 7.8 l
references the difference in sample size to be used during the analysis.
Nonconformance Items B.4 and B.6 were identified in this area.
i (4)
SCP 202, Revision 5, dated May 3, 1984, " Wet Iron,"
l discusses acceptance limits, standard or method, frequency and actions to be taken if results are outside limits associated with wet iron analysis.
Step 2.0 specifies that l
a U0 standard be prepared with the first group of samples 7
I to be analyzed and a second standard with the second set of l
samples.
Step 3.0 requires that an fron standard be 1
(j.)
kf
I ORGANIZATION: GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WilMINGTON. NORTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 7 of 13 analyzed after every 15th sample (unknown) if there are more than 15 unknowns analyzed durin~g a shift.
SCP 202, Step 4.0, also discusses the use of the Brinkman and Beckman instruments. Step 7.0 of SCP 202 requires that calibration be performed annually and that the calibration curve data be posted in the yellow work station book.
b.
The procedures related to ammonia and nitrogen analysis were reviewed.
(1) COI 203, Revision 1, dated June 3, 1985, " Waste Water Analyses," contains the procedures used for. fluoride, ammonia and nitrate analysis. Section 2.0, Scope, of this procedure states that samples submitted for quality safeguards and/or environmental measurements are not within the scope of this procedure.
Section 4.2, of COI 203, contains the procedure for ammonia analysis and references CM&S method 1.2.14.1.
Steps 4.2.1, 4.2.2, and 4.2.3 of COI 203 require a sample volume of 100 m1, as do Steps 6.1, 6.2, and 6.3 of CM&S 1.2.14.1.
Ne'ther procedure COI 203 or CM&S 1.2.14.1 notes that a different sample size may be required depending upon the instrument used (Brinkman vs. Beckman).
Both procedures specify that samples are to be diluted "to the mark" of the 100 m1 flask.
Step 4.3, Nitrate, of COI 203 discusses analysis associated with the generation of a calibration curve. The first subsection of Step 4.3 is labeled 4.5.1 not 4.3.1; Step 4.3.2.2 refers to nonexistent Steps 4.5.1.2 through 4.5.1.5.
Nonconformance Item B.4 was identified in this area.
)
l (2) CM&S 1.2.14.1 Revision 4, dated January 1, 1981, Determination of Nitrogen In Zirconium, Zircaloy, and Uranium Dioxide With or Without Gadolinia Additive-A Spectrophotometric Measurement, contains the procedures used for nitrogen analysis.
Step 3.2 states that a Beckman l
model 24 spectrophotometer or its equivalent is adequate for this analysis which may be performed on either zirconium or uranium base specimens. Also, Note 11.1 indicates that different spectrophotometers may be used to perform this analysis.
0
-)
ORGANIZATION:
GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WILMINGTON. NO RTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 8 of 13
-(3) SCP 208, Revision 3, dated May 24, 1983, discusses procedural requirements fo'r calibration curves and l
curve verification for determining nitrogen in uranium dioxide and metallics. Step 1.0 requires that calibration s
curve verification be performed annually or who required i
by reading standards of known concentrations. Step 4.0 specifies that standard solutions (knowns) must be run before and after sample solutions (unknowns) and that values of standard solutions be within control limits.
4.
Quality Assurance Audit Reviews The inspectors reviewed Internal Quality Audit Control Logs for 1983, 1984, and 1985 and selected audit reports, the current audit schedule and several Practices and Procedures (PP).
PP 30-13, Revision 8, dated March 29, 1984, Internal Quality Audit Program, describes the audit program to be conducted at the jWilmington facility. This PP defines program requirements,
" ~ responsibilities, and implementation of the internal audit program. The following PPs were also reviewed:
PP 70-09, Corrective Action Request, Revision 9, dated November 20, 1983 PP 70-32, Qualification of Q.C Inspection, Examination & Test Personnel, Revision 10, dated January 24, 1985 PP 70-35, QA In-Process Corrective Action Program, Revision 8, dated July 3, 1984 PP 70-39, Lab Procedure Development and Qualification, Revision 5, dated March 27, 1984 I
The following audit reports, associated findings and corrective action records were also reviewed:
WMD No. 2, February 1, 1983 WMD No. 7, September 22, 1983 WMD No. 5, September 21, 1984 WMD No. 9, January 17, 1985 Quality Assurance & Reliability Operation (QA&RO) (Q 8303),
dated May 13, 1983, conducted by GE San Jose Special Audit WMD No.'SP1, dated October 15, 1984 QA&R0(Q8409),datedNovember 27, 1984 No items of nonconformance were identified in this area.
ORGANIZATION: GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WILMINGTON. NO RTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 9 of 13 5.
Observation of Analysis The inspectors observed several technicians performing selected analyses.
The following findings were identified:
a.
The first analysis observed by the inspectors was the wet iron analysis. Step 7.8 of CM&S 1.2.9.4R4 requires that after Step 7.7 (dilute to 200 ml) the technician wait 30-45 minutes and then measure absorbance. This time period allows the chemicals to react (color development) so that an accurate iron measurement can be made. A wait period is necessary in the procedure since uranium in the solution slows down color development.
The inspectors observed that technicians did not wait between Steps 7.7 and 7.8, rather they immediately measured absorbance after sample dilution.
The inspectors discussed failure to follow the procedure with several technicians and supervisors.
One explanation of the meaning of this procedure given to the inspectors was that all samples had to be measured within 30-45 minutes after completing Step 7.7.
The inspectors discussed the meaning and purpose of these steps with technicians and supervisors. Based upon observations and discussions the inspectors determined that Step 7.8 of CM&S 1.2.9.4R4, is routinely not followed, and that supervisors were aware that the procedure was not being followed.
1 Nonconformance Item B.5 was identified in this area.
b.
The second analysis observed by the inspector was the nitrate analysis.
Step 4.3 of COI 203 is the nitrate determination
-procedure used for waste water analysis.
Step 4.3.1.2 requires that deionized water (DI water) be added to each solution to make the volume in each vial equal to 25 ml. This includes a 25 Step 4.3, Nitrate.) p is in the calibration curve portion of ml blank.
(This ste The intent of Step 4.3.2, Sample Analysis, is to require that Step 4.3.1.2 through 4.3.1.5 be repeated during sample analysis.
(See Item 3.b.1 above.)
The inspectors observed that during sample analysis that a 25 ml blank was not prepared. A blank reading was made by adding the DI water directly to the Beckman 1 cm cell.
This was discussed with technicians. The inspectors determined that this was general practice when performing Step 4.3 of COI 203. The inspectors also observed that
h 1
ORGANIZATION: GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY Wil MTNGTON. NO RTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 10 of 13 technicians properly followed Step 4.3.1.4 which' requires that a wait of 10 minutes not t'o exceed 20 minutes be allowed for color development prior to measuring sample absorbance.
Honconformance Item B.6 was identified in this area.
c.
The third analysis observed by the inspectors was the ammonia analysis.
Step 4.2 of COI 203 contains the procedure for annonia determination used when analysis is performed on waste water samples. The technicians used a 100 ml flask for samples as specified in Step 4.2.1.
The procedure was followed and the absorbance measured using the Beckman.
The inspectors observed that absorbance readings from the blank samples were subtracted from each sample reading as required by Step 4.2.4.
6.
Other Comments / Findings a.
As discussed in preceding sections, the technicians and supervisors were aware of many of the procedural inadequacies identified during the inspection.
Further, based upon discussions with supervisory personnel the inspectors determined
.that the strict adherence to laboratory procedures is not a routine laboratory practice in the wet laboratory.
b.
The inspectors observed' that white-out was used to revise readings on two different documents. The first instance involved the " Rad Waste Composites & Miscellaneous Liquid Waste," CL238, Revision 0, issue date March 4, 1981.
White-out was used on sample entries No. 677340, 677334, and 677333. The second instance involved " Rad Safety Book for PRM-4B," (located in the wet laboratory supervisor's office). White-out was used on page 3.
Additionally, the entries for January 28, 1985, were entered in the following sequence:
1300 hrs., 1000 hrs.,
then 1700 hrs.
Nonconformance Item B.7 was identified in this area.
c.
The inspectors reviewed the training requirements / program for laboratory technicians in addition to observing technicians perform analyses. The method of training /
qualification used in the laboratory is on-the-job training (0JT). The technicians qualify to perform various analyses by actually performing an analysis
1 ORGANIZATION: GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WILMINGTON. NORTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 11 of 13' while being observed. This " practical test" is performed after a period of 0JT.
Based upon observations of the general conduct of laboratory practices, observation of technicians performing specific analyses, and discussions with the technicians, the inspectors concluded that the technicians were adequately trained and capable of performing laboratory analyses.
However, technicians do not routinely rotate assignments to maintain proficiency for each analysis they are qualified to perform. Rather, extended periods of time may pass between performance of the same analysis.
d.
The inspectors determined that the pH test buffer solutions are not routinely changed.
Regular changing of test buffers is a common laboratory practice to prevent chemical contamination of the buffer solutions and/or other samples.
F.
PERSONS CONTACTED
- T. P. Winslow, GE
- R. I. Parnell, GE
- E. A. Schaefer, GE
- C. M. Vaughan, GE
- L. A. Sheely, GE
- W. W. McMahon, GE
- J. H. Liberman, GE
- C. W. Doyle, GE P. Hann, GE P. Jasinski, GE M. Thompson, GE R. Brown, GE A. Kosci, GE L. Brown, GE W. Baker, GE C. Ogle, GE W. Ruff, GE
- Denotes people attending exit meeting
I n
ORGANIZATION:
GENERAL ELECTRIC COMPANY-WILMINGTON MANUFACTUR:NG FACILITY WILMINGTON. NO RTH CAROLINA PEPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 12 of 13 G.
ADDITIONAL DOCUMENTS REVIEWED 1.
Specification, No. A50YP12, Rev. 33, dated May 31, 1984, Uranium 0xide Fuel Pellets 2.
QSAR No. 80.04, Rev. 7, dated July 26, 1984, Certification of Chemet Lab Test Personnel.
3.
QSAR, No. 150.01, Rev. 6, dated February 28, 1985, Training and Qualification of QA Internal Audit Personnel.
4.
QSAR, No. 150.02, Rev. 6, dated October 3, 1985, QA Audits.
5.
QSAR, No. 130.06, Rev. 6, dated April 10, 1984, Chemet Lab Records Retention.
6.
QSAR, No. 60.03m Rev. 8, dated January 8, 1985, Nonconforming Measurement & Test Equipment.
7.
PR0 (PP), No. 70-32, Rev. 10, dated January 24, 1985, Qualification of QC Inspection, Examination & Test Personnel.
8.
Procedure (PP), No. 140-9, Rev. 3, dated Januaiy 10, 1985, SNMC Measurement Training and Qua.lification.
9.
Procedure (PP), No. 30-28, Rev. 11, dated June 20, 1985, Product Quality Records.
10.
Procedure (PP), No. 30-33. Rev. 6, dated April 22, 1985, QA Records Legibility.
11.
Procedure (PP), No. 70-39, Rev. 5, dated March 27, 1984, Lab Procedure Development and Qualification.
12.
Procedure (PP), No. 30-13, Rev. 8, dated March 29, 1984, Internal Quality Audit Program.
13.
Procedure (PP), No. 70-09, Rev. 9, dated November 21, 1983, Corrective Action Request.
14.
Procedure (PP), No. 70-35, Rev. 8, dated July 3, 1984, QA In-Process Corrective Action Program.
- 15. Analytical Test Method, No.1.2.9.4, Rev. 4, dated July 12,1984, Determination of Iron in UO and Uranyl Nitrate Solutions.
2
ORGANIZATION:
GENERAL ELECTRIC COMPANY WILMINGTON MANUFACTURING FACILITY WILMINGTON. NORTH CAROLINA REPORT INSPECTION NO.: 99900003/85-01 RESULTS:
PAGE 13 of 13
- 16. Analytical Test Method, No. 1.2.14.1, Rev. 4, dated July 1, 1981, Determination of N in Zr, Zircaloy & U0 Gadolinia Additive - A Spectrophotometri, with or without 2
t Measurement.
- 17. Station Control Plan, No. 202, Rev. 5, dated May 3, 1984, Wet Iron (Section 7 - Calibration).
t
- 18. Station Control Plan, No. 208, Rev. 3, dated May 24, 1983, Nitrogen in UO and Metallics (Section 10 - Calibration / Year).
2 I
,._,,,.--.,,,,--.---..,.-..,_...---.--......-----..-n-
, -. ~ -
--