ML20138A810
| ML20138A810 | |
| Person / Time | |
|---|---|
| Issue date: | 04/22/1997 |
| From: | NRC (Affiliation Not Assigned) |
| To: | |
| Shared Package | |
| ML20138A798 | List: |
| References | |
| REF-QA-99901313 99901313-97-01, 99901313-97-1, NUDOCS 9704280247 | |
| Download: ML20138A810 (14) | |
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U.S. NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR REACTOR REGULATION j Report No.: 99901313/97-01 Organization: SynTech Products Corporation 1 520 East Woodruff Avenue i Toledo, Ohio 43624 '
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Contact:
D. Moore, Quality Assurance Manager (419) 241-1215 Nuclear Industry Manufactures and supplies industrial cleaners, Activity: solvents, and other maintenance products such as penetrating oils, cutting fluid, gasket / paint strippers, etc., in bulk quantities or in aerosol Cans.
Dates: February 4-6, 1997 Inspectors: Stephen D. Alexander, Reactor Engineer (Team Leader)
Kamalakar R. Naidu, Senior Reactor Engineer Approved by: Gregory C. Cwalina, Chief Vendor Inspection Section Special Inspection Branch Division of Inspection and Support Programs Office of Nuclear Reactor Regulation Enclosure 1 :
9704280247 970422 PDR GA999 E*******
99901313 PDR ,
i 1 INSPECTION
SUMMARY
l During this inspection of SynTech Products Corporation, the NRC inspectors '
reviewed selected procurement documents, test certificates and other documents, examined products and storage facilities, and interviewed SynTech '
staff regarding the supply of industrial cleaning and maintenance products to NRC-licensed nuclear power plants. The inspection bases were Part 21 of Title 10 of the Code of Federal Reaulations (10 CFR Part 21) and Appendix B to 10 CFR Part 50.
Based on a SynTech purchase order (PO) to a licensee-operated testing laboratory for analysis of a SynTech product that invoked 10 CFR Part 50, Appendix B, and 10 CFR Part 21, SynTech may have supplied some of its products as basic components as defined in 10 CFR 21.3. However, the inspectors subsequently determined that SynTech products are not designed (developed) or manufactured under a 10 CFR Part 50, Appendix B, quality assurance (QA) program and SynTech has not supplied, nor does it currently supply its products as basic components. Although many of SynTech's nuclear plant :
customers required certificates of conformance (CoC) to their P0 requirements and a certified chemical contaminant analysis test report traceable to the batches or lots of the products supplied, the inspectors found no instances in which NRC licensees imposed nuclear-unique design or QA requirements on SynTech or invoked 10 CFR Part 21 in their procurement documents.
1 On the basis of a review of SynTech's commercial quality controls and review !
of independent analyses of SynTech products, the inspectors concluded that the contaminant content of SynTech products is variable enough to require batch- i or lot-traceable certified chemical contaminant analysis reports. -Such l reports would confirm that levels of undesirable substances such as halides, sulfur and heavy metals are within acceptable limits before using SynTech products on safety-related equipment or allowing them to come in contact with safety-related systems.
The inspectors also reviewed the circumstances surrounding SynTech's 1995 submission of what appeared to be a Detroit Edison (DE) Company chemical analysis report, but which reported data of indeterminate origin and cited a sample lot for which DE or its subsidiary, Utility Technical Services (UTS),
had no record of testing. Prior to the inspection, the information available to the inspectors suggested a fraudulent SynTech report. However, SynTech's explanation of the circumstances surrounding the creation of the report in its unusual form was plausible, if not conclusive, anu was supported by other information obtained by the inspectors. Although SynTech could not offer a satisfactory explanation for the report's not being effectively screened through management review before issue, the incident appeared to have been isolated. The inspectors could not conclusively determine that there was any deliberate intent to mislead the recipient of the report and found no evidence of a pattern of similar activity.
2 STATUS OF PREVIOUS INSPECTION FINDINGS This was the first NRC inspection of SynTech.
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3 INSPECTION FINDINGS AND OTHER COMMENTS 3.1 Commercial Ouality Controls / Chemical Contaminant Control
- a. Scope In order to evaluate SynTech commercial quality controls, particularly regarding control of chemical contaminants in SynTech products sold to NRC-licensed facilities, the inspectors toured the SynTech facility, interviewed personnel, examined raw materials and finished products in various forms and in various stages of preparation. Also examined were products awaiting shipment either to customers or subcontractor manufacturing or packaging facilities. The inspectors also reviewed numerous chemical analysis reports on the contaminant content of SynTech products as well as correspondence with the materials engineer at General Electric Nuclear Energy (GE NE) regarding I the eligibility of SynTech products for GE NE's " nuclear grade" designation. l
- b. Findinas and Observations SynTech manufactures several industrial cleaning and maintenance chemical products including the following which are used in nuclear power plants.
SynTech supplies these products in aerosol cans, in bulk containers, or both:
Easy Tap: Cutting and tapping fluid (aerosol and squeeze bottles)
Parts Kleen: Solvent and degreaser (aerosol and bulk containers)
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N-Grade: Gasket and paint stripper (aerosol) l N0C: (Non-organic Cleaner) All purpose cleaner Rust Buster II: Penetrating oil Titanic C: All purpose floor cleaner (bulk)
Touch It Up: All purpose cleaner (aerosol and bulk)
SynTech manufactures (blends) a batch of a product supplied in bulk from raw materials or receives finished product in bulk form from one of its suppliers or contract manufacturers. It then sends a sample of that numbered batch to a subcontractor laboratory, currently Philadelphia Electric Company's (PECO Energy's) Wayne, Pennsylvania, laboratory, for chemical analysis to determine if the levels of total halogens / halides, sulfur, and other undesirable elements, mostly heavy metals (e.g., As, Bi, Sn, Pb, Hg, etc.), are within specified acceptance levels. For products in aerosol cans, the finished products are sent in bulk form to a SynTech subcontractor for packaging in the aerosol cans. Samples from numbered lots of aerosol cans (which are supposed !
to be filled from one batch of bulk product) are also sent to PEC0's laboratory for analysis. SynTech has samples of aerosol can lots analyzed l after repackaging because SynTech has found that the packaging process or cans themselves may introduce some of the contaminants of concern.
Batches or lots of products routinely sold to nuclear plants as well as other customers that are awaiting results of chemical analysis are stored in a locked cage designated the " Commercial Quality" area with QA hold tags or 3
labels affixed. If the results of the chemical analysis indicate that the levels of the contaminants of concern are within acceptable limits, the batches of chemicals are released for shipment to nuclear power plants. If the levels are above the acceptance limits, the products are removed from the
" Commercial Quality Area" and stored in general storage for sale to non-nuclear facilities.
As discussed in correspondence with and from GE NE's materials engineer, SynTech established the acceptance limits to maintain a " nuclear grade" rating in accordance with GE NE Material Specification D50YP12 and Appendix A of NEDE-31295P, GE's "BWR Operator's Manual for Materials and Processes," June, 1986. However, individual licensees sometimes specify their own limits, either explicitly or by reference to a material standard or specification (e.g., those of the American Society for Testing and Materials (ASTM)). For nuclear customers, SynTech stated that it checks that the batch / lot analysis report indicates the customer's specific limits are met before shipping the product unless specifically requested otherwise by the customer. Review of '
numerous lot analysis reports on file at SynTech indicated that the amounts of contaminants or undesirable substances such as halides, sulfur, and heavy metals (e.g., mercury, bismuth, arsenic, lead, tin, etc.) are somewhat variable, sometimes being marginal or even exceeding GE NE nuclear grade or customer-specific limits.
SynTech brought two such instances to the inspectors' attention. In one case, SynTech had discovered that tin was leaching out of aerosol cans into the product. This was corrected by SynTech requiring their aerosol can packaging subcontractor henceforth to use cans with a non-metallic coating inside.
Subsequent analysis reports indicated that this measure corrected the problem and did not introduce additional problems such as adding halides. In the other instance, the NRC licensee, Philadelphia Electric Company (PEco) requested that SynTech ship a batch of product for which the analysis results ,
had not yet been obtained because it was PEco's laboratory that was currently performing the contaminant analyses for SynTech. As Murphy's Law would have it, sure enough, this particular batch of the product contained excessive sulfur and was of course captured and sent back to SynTech. Shipping records reviewed by the inspectors confirmed this and also indicated that, as stated I
by SynTech, it routinely provides copies of the batch / lot chemical analysis test reports to nuclear customers whether or not they are required.
In the Commercial Quality Area, the inspectors noted information on the tags affixed to 55-gallon drums containing Titanic C, N0C, and Parts Kleen, and a tag affixed to a box containing Part Kleen aerosol cans, and reviewed the documents associated with their manufacture. The inspectors observed that the access to this storage area was controlled with a lock and key.
One of the products, Titanic C floor cleaner, was manufactured on February 28, 1996, and stored in a 55-gallon drum. A tag attached to this drum identified the product as belonging to Lot 095, and Batch 1089. The batch manufacturing sheet for Lot 095, dated February 28, 1996, indicated the various ingredients that were used to manufacture this lot of Titanic C. The SynTech QA manager stated that all this material was stored in an area designated for commercial quality products. The inspectors observed some of the ingredients used in the 4
manufacture of Titanic C stored in their original bags in the Commercial Quality Area. SynTech issued P0 15201 on February 4, 1997, to PECO Energy, its current independent testing laboratory, to analyze a sample of Lot 095 for
- contaminant content including halogens, sulfur and heavy metals.
The tag attached to a 55-gallon drum of N0C (non-organic cleaner) was marked Lot NOC 01, Batch 10994. The tag indicated that a sample of the contents of the drum had been tested. SynTech received certification on October 3, 1996, that the levels of halogens, sulfur and heavy metals were within the acceptable limits.
A 5S-gallon drum of Lot 0408942 of Parts Kleen, blended for SynTech by Chem Central in Toledo had a hold tag attached to it indicating that it was awaiting the results of chemical analysis of a sample of it that had been sent to one of SynTech's contract laboratories for chemical analysis. The laboratory report, dated August 23, 1994, indicated the content of halogens, sulfur and heavy metals were within the usual prescribed limits, but the hold tag was left on so that the report would be checked against specific customer requirements prior to shipment.
A hold tag was attached to a pallet of 90 cases of Parts Kleen aerosol cans, Lot 6m30, in the commercial quality area packaged for SynTech by American Jetway of Detroit, Michigan. The hold tag indicated that SynTech had sent one can of Lot No. 6m30 to the PECO Energy laboratory for chemical analysis.
The inspectors reviewed the documents on a shipment of I dozen aerosol cans of Touch It Up for Niagara Mohawk Power Company's Nine Mile Point site. The documents included a SynTech CoC that certified that the contents were from Lot #4K31 which conformed to Specification 15586/94-004215, and the halides, sulphur and heavy metals were within acceptable limits. SynTech's certification was based on a certified laboratory report providing the chemical contaminant analysis results,
- c. Conclusions SynTech has implemented commercial quality controls to provide reasonable assurance that its products shipped to NRC-licensed facilities typically contain less than the maximum acceptable levels of chemical contaminants of concern. SynTech had established measures to routinely control the release of products to nuclear plant customers pending receipt of certified chemical contaminant analysis reports from SynTech's contract laboratory. According to SynTech, this had become their standard practice, regardless of whether such reports were required by a particular customer. No further concerns were identified in this area.
3.2 Review of Procurement Documents.
- a. Scope The inspectors reviewed SynTech customer procurement document files to determine if NRC-licensees had imposed the requirements of 10 CFR 50, Appendix B, or 10 CFR Part 21 on SynTech, i.e., if licensees had treated 5
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SynTech products as basic components. In addition, the inspectors examined
- selected files of SynTech procurement documents to determine if SynTech had
- passed these requirements to its suppliers of materials and services.
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- b. Observation and Findinas Prior to the inspection, the inspectors had obtained a copy of SynTech P0 No.
10022, dated January 28, 1993, and a letter accompanying a sample of Lot A050-303 of " Touch-It-Up" to a subsidiary of Detroit Edison (DE), Utility Technical Services (UTS), which stated that " Appendix B and Part 21 apply, 10 CFR 50" (sic). This suggested that SynTech may have supplied some of its products to nuclear power plants as basic components as defined in 10 CFR 21.3. According '
to SynTech and documents on file at SynTech, when this P0 was issued, SynTech had been contracting DE's Technical and Engineering Services laboratory for several years to perform the contaminant analyses on its products being shipped to nuclear plants. However, the DF lab reports, notably in the form of letters on DE letterhead, had covered multiple products and multiple samples. The inspectors found three such reports in SynTech's files, dated March 26, 1990, December 6, 1990, and January 15, 1992. In addition, there had historically been significant time delays in obtaining results from DE.
SynTech stated that at about the same time that DE's Technical and Engineering l Services laboratory was put under the new DE subsidiary organization, UTS, i SynTech was advised by the QA manager at UTS that if SynTech invoked 10 CFR ;
Part 50, Appendix B, and Part 21 in the P0, then UTS would be able to perform i the analyses expeditiously in addition to the added benefits of a certified 1 analysis report for one lot of one product at a time. Although in translating '
these unfamiliar requirements, SynTech cited them incorrectly, the inspectors observed that subsequently, UTS test reports were for one lot of one product each and contained the statement "the work was performed in accordance with the Technical and Engineering Services quality assurance program." The inspectors identified no other instances in which SynTech had invoked 10 CFR Part 21 or imposed 10 CFR Part 50, Appendix B, on any of its suppliers or subcontractors.
The inspectors reviewed P0s issued to SynTech by several NRC licensees including Boston Edison Company, Centerior Services Company, Niagara Mohawk Company, Detroit Edison Company, Consumers Power Company, and Commonwealth Edison Company between 1992 and 1996 for the supply of various quantities of different SynTech products. Although many of SynTech's nuclear plant customers required CoCs to their P0 requirements or a certified chemical contaminant analysis test report, traceable to the batches or lots of the products supplied, the inspectors found no instances in which NRC-licensees !
had imposed nuclear-unique QA requirements on SynTech or had invoked 10 CFR Part 21 in their procurement documents to SynTech.
In addition, the inspectors determined through information obtained from some licensees that they typically procure SynTech products as commercial grade material, although some handle them under their augmented quality programs in order to maintain certain controls, such as requiring analyses for contaminant ,
exclusion, when they are used in maintenance of safety-related systems and equipment.
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i Finally, during discussions with SynTech personnel and review of procedures and records, the inspectors also determined that SynTech had established a i commercial quality program, but did not have a 10 CFR Part 50, Appendix B, !
quality assurance program. SynTech was not familiar with the requirements of 10 CFR Part 50, Appendix B, and 10 CFR Part 21. (
j c. Conclusion ;
j The inspectors concluded that SynTech's commercial quality program does not, ;
i nor was it intended to meet Appendix B QA requirements. Therefore, the ,
i inspectors concluded that SynTech products have not and are not being designed j or manufactured under a 10 CFR Part 50, Appendix B, quality assurance program.
i Further, SynTech products have no nuclear-unique design requirements, they are i used in non-nuclear applications and they may be purchased on the basis of l .
SynTech's published product descriptions. Therefore, SynTech products meet j the definitions of comercial grade items in 10 CFR 21.3 for both 10 CFR Part 50 licensees and non-Part 50 licensees, and are not procured or supplied as j basic components.
3.3 Ouestionable SynTech Analysis Report and CoC
- a. Scope i
q In preparation for this inspection, the inspector reviewed documentation i provided by UTS and Consumers Power Company (CPCo) at Palisades relevant to j the circumstances surrounding SynTech's submission to Consumers Power Company (CPCo), Palisades' licensee, of what appeared to be a DE chemical analysis
- report, dated May 15, 1995, that was not issued by DE. Although SynTech did j not have a copy of this report in its files at the time of the NRC inspection, the inspectors had reviewed a copy along with other SynTech-related documen-tation obtained prior to this inspection. During this inspection, SynTech i brought this issue to the attention of the inspectors before being asked about ;
it specifically. The inspectors reviewed relevant documentation on file at
- SynTech and interviewed SynTech personnel on this issue.
l b. Observations and Findinas i b.1 Report Anomalies The report exhibited several anomalies, most notably that, although it l appeared to have been printed on DE letterhead or stationery, unlike the
{ genuine DE reports that SynTech had on file, this report contained results of
- analysk of only one lot of only one product, specifically Lot 761-055 of j SynTech N-Grade Gasket Remover and Paint Stripper. The report was in the form
- of a letter that was typed on what initially appeared to be DE letterhead, and
} contained a signature block indicating the name of the analyst who had signed
- the previous DE reports, but his signature itself was not presett on the J report in question. In addition, the report provided data for a sample lot for which UTS stated it had no record of testing.
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l t b.2 The Palisades Response !
Upon receipt of the product, Palisades conducted its own analyses on a sample from Lot 761-055, as is their routine practice, but obtained unacceptable l results, most notably excessive chlorides. This prompted Palisades ;
Procurement Engineering to obtained SynTech's CoC and the attached analysis i report for comparison. Although the report was on what appeared to be DE letterhead, the procurement engineer involved stated that she did not notice ,
that t.he report was not in the usual format because normally only receiving :
seet < hem and they didn't identify that as an anomaly. Nevertheless, due to j the significantly differing results, Palisades procurement engineering called the remed analyst at DE/UTS in order to resolve the differences. She also telefaxed to the analyst a copy of the report.
l The Palisades procurement engineer further stated that she later contacted the !
QA Manager at SynTech who reportedly told her that the report was a mistake by :
a new person. The SynTech QA manager also reportedly requested that Palisades send back all the product and the original Coc. Palisades informed the inspectors that they did this except for the one Lot 761-055 can from which the CP'o sample was taken. !
l With respect to 10 CFR Part 21 evaluation, the Palisades procurement engineer ,
explained to the NRC inspector that UTS had told her that they would make any '
reports required to the NRC; therefore CPCo did not evaluate the deviation '
under Part 21 procedures (a) because of this assurance from DE/UTS, (b) because the products were not considered basic components, and (c) because 4 CPCo had never used this batch in Palisades. Previous batches used, she ;
stated, would have been verified satisfactory or rejected.
b.3 The UTS Reply According to an August 24, 1995, handwritten memo to Palisades from the DE/UTS analyst named in the report, written in response to Palisades' call and fax, j DE did not issue that report. The memo also stated that the report was not in the standard format of current UTS reports in that it did not have a report '
number or supervisory signatures, and if " nuclear related," was missing a traveller number and QA review signatures. However, the inspectors noted that the memo did not mention the fact that DE had provided similar reports (although covering multiple products and lots) on its letterhead until 1993.
t b.4 UTS Correspondence with SynTech !
t In an August 29, 1995, letter to SynTech in response to the apparent !
unauthorized use of DE letterhead, and after a reported telephone conveysation I between a UTS QA representative and a SynTech sales representative, UTS !
demanded that SynTech stop using DE stationery, inform UTS of every instance in which SynTech had published product analysis results on DE stationery, and '
inform all its affected customers that DE did not perform the analyses. i Again, there was no mention of the earlier reports DE had provided SynTech on !
DE letterhead before the establishment of UTS. i
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4 b.5 SynTech Reply to UTS l
! The inspectors also reviewed a copy of a SynTech letter, also dated August 29, 1995, from the SynTech QA director, addressed to the UTS QA representative, in reply to the UTS letter of the same date, that denied any possession or use of 1 DE stationery. However, this letter also did not clearly answer the UTS l questions. Its explanation of the circumstances surrounding the issuance of
- the report in question was vague and still did not explain how SynTech would
, have had legitimate possession of DE letterhead, not blank stationery.
j b.6 UTS Contact with NRC
- In February 1996, in response to the inspector's inquiries to DE and UTS, a
! UTS QA representative informed the inspector that a SynTech sales
- representative had stated to him (in the telephone conversation mentioned i above prior to issuance of the UTS August 29, 1995, letter) that SynTech had s
' " routinely reported results of chemical analyses of its products to licensees and others on Detroit Edison letterhead." This statement was construed by UTS as an admission by SynTech. In addition, to compound the misunderstanding, l
during this reported conversation, the SynTech sales representative allegedly could not recall, wher. asked by UTS, how SynTech came into possession of DE i stationery, b.7 NRC Review at SynTech When the NRC inspectors first learned of this issue, the inspectors were not aware of the DE letterhead reports on file at SynTech and the UTS QA representative did not mention them. However, in light of the DE reports and other documents reviewed by the inspectors at SynTech, the telephone conversation statement attributed by UTS to SynTech's sales representative (confirmed during the inspection), was consistent with the circumstances.
During this inspection, the SynTech sales representative stated that he had admitted at the time of the reported telephone conversation that he could not offer a satisfactory explanation for the issuance of the analysis report in question (a) on what appeared to be DE letterhead during a period when UTS had taken over analysis of SynTech product:, and (b) reported results on a lot of N-grade that neither UTS, nor apparently DE, had a record of analyzing. He stated that his remark about routinely issuing reports on DE letterhead was made in an effort to explain to the UTS QA representative how SynTech came to have possession of DE letterhead. However he failed to make it clear that the letterhead to which he was referring was what the DE reports had been printed on, not blank DE stationery. SynTech stated during this inspection that it never had blank DE stationery. Nevertheless, the unclear explanation provided by.the SynTech Sales representative, interpreted by UTS as an admission by SynTech, served to confirm UTS's suspicion that SynTech was routinely sending out fraudulent reports on DE letterhead (presumably using blank DE stationery), thus prompting UTS's August 29, 1995, letter. The inspectors found no evidence to suggest that SynTech had done more than send a single report on what appeared to be DE letterhead, and apparently only to Palisades on the one occ.asion in question.
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As mentioned above, the inspectors found three reports on DE letterhead that had been sent to SynTech by DE, during the period before the formation of UTS, when DE's Technical and Engineering Services group had been the name of the organization whose laboratory was performing contaminant analyses of SynTech products. The reports, dated in 1990 and 1992, were all signed by the analyst whose name, but not his signature, appeared on the report in question. The inspectors noted that none of the analysis reports from DE on file at SynTech contained results of analysis of N-grade, and the UTS report on file at SynTech that did contain N-grade analysis results was for lot 761-193, not lot 761-055 as in the SynTech report to Palisades.
Review of associated records during this inspection confirmed that SynTech had in fact routinely reported its product test results to its customers simply by l forwarding copies of the DE reports which included results for the products and lots being shipped, among others. UTS had also stated that it had never given SynTech permission to use its stationery, letterhead, name or logo, but the inspectors found no evidence that either DE or UTS had evar prohibited SynTech from forwarding DE or UTS analysis results to SynTech customers on the original reports. UTS also confirmed the inspectors' findings at SynTech that, although the UTS laboratory had performed a number of analyses for SynT2ch on its products over the last two years, the lot listed on the apparently fraudulent report was never analyzed by UTS.
b.8 SynTech Internal Investigation and Explanation Presumably in anticipation of questions about this issue by the inspectors, SynTech disclosed the issue of the questionable report to the inspectors and offered their explanation of the circumstances. SynTech stated that in response to the August 29, 1995, letter from UTS, it had conducted an internal investigation to establish the facts and circumstances surrounding the issuance of the report in question. On the basis of the results of this investigation, SynTech developed the following explanation: At the time the report in question was sent to Palisades, May 1995, SynTech was using UTS to perform its product contaminant analysis for nuclear customers. However, on this particular occasion, in response to an order from Palisades for some of the N-Grade Gasket Remover and Paint Stripper (hereinafter referred to as "N-Grade"), SynTech discovered that it did not have a UTS analysis report on file l for the lot of N-grade it had in stock, Lot 761-055. SynTech stated that upon l informing Palisades of this fact, Palisades agreed to accept so-called
" typical" results for this order, because they would be testing a sample of the received product themselves anyway. Therefore, according to SynTech, )
instructions were given to a clerk (who was reportedly new at the time and who j is no longer with the company) to prepare a report for Palisades of typical i contaminant analysis results for N-Grade Lot 761-055. SynTech explained (and produced examples from their files in support of the explanation) that after sending out DE reports with multiple product and lot results on them, it had become their practice for a while to scan into their computer the letter reports from DE. The reports could then be conveniently eatted to produce customized reports containing only the data for the product and lot being shipped under the report and the accompanying CoC. The rationale was that this practice would result in fewer, if any, transcription errors, less 10 l
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1 l confusion, and admittedly, would not disclose unnecessarily the few results
! not pertinent to the shipment being certified that did not meet contaminant
- specifications.
i During this inspection, the inspectors examined some of these edited reports i j
' and found that they were printed out on plain paper and in a font not '
resembling the font of the original DE letters, but some were left partially in the form of letters from one of SynTech's contractor laboratories addressed
} either to the SynTech QA Manager or to the SynTech sales representative who <
l was involved, depending on the vintage. The inspectors pointed out to SynTech that while it would _have been appropriate to quote the results of the product 4
and lot of interest from the test report and/or to refer to the report or even '
to attach a copy, it was not appropriate to edit the original report to }
! isolate the desired set of results, yet leave it partially in the form of a i i letter report to SynTech which would result in a document that was
! fundamentally misleading as to its origin, if not the content. SynTech .
j agreed, but stated that they had discontinued this practice entirely when their investigation to determine how the report in question could have been )
i produced revealed that the scanning and editing practice was a significant ,
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contributing factor. ;
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SynTech stated that as nearly as they were able to determine, the clerk who 1 had been told to produce a report for the Palisades N-grade order in question ;
citing typical results for this product had called up an old DE report that I had been scanned into the computer to obtain the results of analysis of a ;
- previous lot of the same product. However, instead of using the report (not '
{ scanned) provide by UTS in 1992 of Lot 761-193 of N-Grade that SynTech had on j
file, the clerk reportedly deleted the data for products not being shipped, l
, leaving only the N-grade data and then edited the date of the report and the j lot number to read May 15, 1995 and Lot 761-055 that was being shipped. !
SynTech stated that they were not able to find the original report from which l the "typicals" presumably were taken so the origin or correctness of the data
- could not be verified. Then, SynTech explained, and as is apparent when i examining the report, for an unknown reason, the clerk did not edit out the DE
' logo that appeared in the upper left hand corner of the page. The logo i
consisted of printed words in a stylized version of a bold block letter font and it had been scanned as part of the document by the optical character j recognition (OCR) software being used by SynTech as part of the text of the j letter instead of as a graphic, in a font as close to the one scanned as the j software could reproduce. Upon close examination, the inspectors were able to j see that in fact, what had appeared to UTS_and CPCo to be DE letterhead, was a computer reproduced facsimile of the logo that had reportedly been on the j stationery on which the original report (similar to ones seen by the j inspectors in SynTech's files) had been written. Close examination of the
! letters revealed that the reproduced font differed slightly from the actual DE logo in the thickness, spacing and proportions of the letters, the alignment
! of the words, and in particular, in the form of the letter "t" as it appeared
- in the word " Detroit" in the name and address of DE in the logo. In the 0 . actual DE logo, the stylized "t" is not fully crossed. In the custom DE font, the cross of the "t" extends from the vertical part only to the right, not to the left as on a conventional "t." This feature, once noticed was evident on all the actual DE reports on file. Whereas, the scanned document, exhibited a 11
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$ similar font, but, as previously stated with slightly differently formed and aligned letters and with normal t's on which the cross piece extended fully from the left to the right sides. This information tended to support SynTech's explanation of how the report in question had been produced. Also, SynTech assured the inspectors that although it no longer had the scanning software used so that could not demonstrate the effect, it was named and described as readily available so that the NRC could test SynTech's explanation.
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Nevertheless, SynTech was not able to offer a satisfactory explanation of why the scanneu and incorrectly edited report was sent out in that form and not at least edited to the extent that others had been. Even the error of a new clerk would not explain why supervisors had not caught the error. SynTech could only postulate that in their haste to fill the order and deliver the paperwork quickly in response to customer pressure, they had failed to adequately review all the submitted documentation, including the accompanying CoC letter which also referenced the lot number instead of stating that the l accompanying results were supposed to be typical.
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c. Conclusion
Prior to the inspection, the information available to the inspectors, as discussed above, suggested a fraudulent SynTech report. However, SynTech's explanation of the circumstances surrounding the creation of the report in its unusual form, was plausible, if not conclusive, and was supported by other information obtained by the inspectors. Although SynTech could not offer a
- satisafactory explanation for the report's not being effectively screened through management review prior to issue, the incident appeared to have been isolated. The inspectors could not conclusively determine that there was any deliberate intent to mislead the recipient of the report and found no evidence of a pattern of similar activity.
3.4 Procurement Status and Chemical Analysis Results
- a. Scope To determine the validity of SynTech reported contaminant content of Lot No.
761-055 (as well as other products), and the consistency of contaminant content in SynTech products, the inspectors interviewed analysts at two of SynTech's former contract laboratories, both NRC licensee subsidiaries, had the results evaluated by the NRC Chemical Engineering and Materials Branch, reviewed numerous analysis reports on SynTech products and reviewed the nuclear-grade evaluation of SynTech products by GE NE Materials Engineering.
- b. Observations and Findinas During a telephone conversation on July 15, 1996, between the inspector and a representative of Consumers Power (CPCo), Palisades Procurement Engineering, the Palisades procurement engineer stated that Syntech Products are treated under CPCo's consumables program as Augmented Quality items because SynTech is not a qualified / approved supplier. CPCo had, for a number of years, purchased 12
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i the product in question ("N-Grade Gasket Remover and Paint Stripper -
Certified Non-Chlorinated, Clinging Gel") among other SynTech products as non-safety-related. However, because the products are used on safety-related plant components, CPCo said it always independently tested a sample of each lot / batch in its own Trail Street Labs (owned by CPCo) to verify the product meets CPCo's safety-related or Category A requirements. For consumables used for cleaning, etc., even though they are not allowed to remain in safety-
' related systems, CPCo conservatively prefers not to allow any undesirable substances (e.g., fluorides, chlorides, sulfides, heavy metals, etc.) to come in contact with safety-related metals. Therefore, a sample of each received i lot is routinely sent to the CPCo lab by the Palisades receiving department for analysis. In September of 1995, CPCo's Trail St. Labs obtained results reported as " total chloride"[ sic] of 10,492 ppm on the sample of lot 761-055.
This was significantly higher than the 120 ppm "C1" [ sic] results reported on the May 15, 1995 SynTech report in question. In accordance with CPCo procedures, the issue was then referred to Procurement Engineering for resolution.
On August 6,1996, the inspector talked to a chemist at CPCo's Trail Street Labs, about the analysis report provided by SynTech to Palisades of Lot No.
761-055 of its "N-Grade" solvent / cleaner and gasket remover. Discussed were the differences between her lab's analysis cf the product, and the SynTech reported results, which differed widely as discussed previously. She confirmed the inspector's concern that the SynTech results of heavy metal analysis may be questionable because many of the heavy metals (e.g., As, Bi, Pb, Sn, At, Hg, etc.) were reported by SynTech on the order of <1 to <5 ppm, whereas, CPCo's analyses of these same elements were reported typically as <50 or <100 ppm because of the minimum sensitivity of the analyses. At the time, !
the inspector was concerned that unless SynTech (or its contract laboratories) i had more sensitive instruments and processes for analyzing for these elements, the SynTech-reported results may have been below what is typically achievable, and would therefore, be questionable.
During this inspection, however, the inspectors found comparable results on i another lot of the same product in a test report by UTS. Also, the report was reviewed by the NRC's Chemical Engineering and Materials Branch who stated that the SynTech-reported results were not below the sensitivity of the more sophisticated techniques in common use in the industry.
- During subseqcent conversations with the analyst at UTS who had signed the old DE reports to SynTech and also the analyst who had performed the analyses for
. UTS, they indicated that results of analyses could vary widely depending on analytical method used if only minimums are being reported due to minimum sensitivity or detectable qualities. Also, for halides, sulfur, it is necessary to know whether the analysis was for total amounts or leachable amounts. If being analyzed for " total" content, chlorinated or fluorinated compounds will release large quantities of halides when certain analytical methods are employed.
j The second conversation the inspector had with the CPCo chemist at the Trail Street Labs confirmed that her analysis was for total chlorides, yielding 10,492 ppm, indicating that the product contained chlorinated compound (s). On 13
2
- August 29, 1996, the Palisades p' ..
- urement engineer fa::ed the NRC copies of
- previous reports of analyses of synTech products done by the CPCo lab for themselves and said they would iocate the records of analyses they used to do
, for SynTech several years ago, just as UTS had done until recently. The :
)
J inspectors found some of these old (pre DE) CPCo reports on file at SynTech.
- c. Conclusion i
On the basis of the information from the UTS and CPCo labcratories, the NRC Chemical Engineering and Materials Branch review, the GF dE nuclear-grade evaluation, and the analysis reports reviewed, the inspectors concluded that although N-Grade, Lot 761-055, contained excessive chloride, even for total (vice leachable) content, the results of the other substances analyzed for were consistent with the other analyses of N-Grade. The inspectors further concluded that the SynTech reported results, although their specific origin was indeterminate, appeared tc be typical of N-Grade and were consistent with the capabilities of the analytical methods used.
However, on the basis of review of many SynTech produca analysis reports and ,
review of GE NE Materials Engineering recommendations in their nuclear-grade '
evaluation, the inspectors concluded that the contaminant content of SynTech products is variable enough such that " typical" analyses are not useful. ,
{
Therefore, the practice of most of SynTech's nuclear customers to require !
batch-traceable or lot-traceable certified chemical contaminant analysis :
reports is prudent. Such reports would ensure that levels of undesirable !
substances such as halides, sulfur and heavy metals are within acceptable i limits.
- 4. PERSONS CONTACTED I
- +J. Leslie, President
+M. Bramson, Executive Vice President
- +D. Moore, Quality Assurance Manager J. Broderick, Sales T. Mosier, Assistant QC Coordinator
+ Attended the entrance meeting on February 4, 1997.
Attended the exit meeting on February 6, 1997.
l 1
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