ML20206C377
| ML20206C377 | |
| Person / Time | |
|---|---|
| Site: | (NR-375-D-101-B, NR-375-D-102-S, NR-375-D-103-S, NR-375-D-104-S, SSD-98-83) |
| Issue date: | 02/01/1999 |
| From: | Compton E NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Burnet S ISOTOPEN MEBSYSTEME GMBH (ISOTOPE MEASURING SYSTEMS |
| Shared Package | |
| ML20206C365 | List: |
| References | |
| SSD, NUDOCS 9905030006 | |
| Download: ML20206C377 (2) | |
Text
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UNITED STATES j
j NUCLEAR REGULATORY COMMISSION p
WASHINGTON, o.C. 2066m1 February 1,1999 Susan Bumet President Isotone Measuring Systems (IMS), Inc.
108 Blue Ridge Drive Mars, PA 16046
Dear Ms. Bumet:
The U.S. Nuclear Regulatory Commission is in the process of reviewing all of IMS's device registration certificates based on findings of an inspection performed on August 25-27,1997, anri IMS's response dated February 27,1998. In order to update IMS's Quality Assurance Program for all of the registration certificates, please submit the following:
1.
A cc.nmitment that IMS GmbH (Germany) will maintain an ISO 9001 certified program.
2.
A commitment that IMS (USA) will maintain an ISO 9001 certified program for receipt inspection in the United States.
Please provide the requested information within thirty (30) days. If you have any questions, please contact me at (301) 415-5799 or John Lubinski at (301) 415-7868.
s Sincerely,
[A Eric Compton, Engineering Alde Material Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards 1
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i February 1,1999 Susan Burnet President Isotope Measuring Systems (IMS), Inc.
108 Blue Ridge Drive Mars, PA 16046
Dear Ms. Burnet:
The U.S. Nuclear Regulatory Commission is in the process of reviewing all of IMS's device registration certificates based on findings of an inspection performed on August 25-27,1997, and IMS's response dated February 27,1998. In order to update IMS's Quality Assurance Program for all of the registration certificates, please submit the following:
1.
A commitment that IMS GmbH (Germany) will maintain an ISO 9001 certified program, 2.
A commitment that IMS (USA) will maintain an ISO 9001 certified program for receipt i
inspection in the United States.
Please provide the requested information within thirty (30) days. If you have any questions, please contact me at (301) 415-5799 or John Lubinski at (301) 415-7868.
Sincerely, (orig. signed by)
Eric Compton, Engineering Aide Material Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards Distribution:
l IMNS r/f SSD-98-83 NE01 SSD File # NR-375-D-10X-X l
DOCUMENT NAME: H:\\ERIC\\ MISC \\lMS.LTR Ta receive a copp of this document, indcete in the toon: "C' = Copyrithout attachment / enclosure "E" = Copy with attachment / enclosure
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NAME ECompton JL JLubindi DATE 1/29/99 1/29/99 OFFICIAL RECORD COPY Yokook y
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r February 1,1999 Susan Burnet President Isotope Measuring Systems (IMS), Inc.
108 Blue Ridge Drive Mars, Pa 'd*D46
Dear Ms. Burnet:
o The U.S. Nuclear Regulatory Commission is in the process of reviewing all of IMS's device registration certificates based on findings of an inspection performed on August 25-27,1997, and IMS's response dated February 27,1998. In order to update IMS's Quality Assurance Program for all of the registration certificates, please submit the following:
1.
A commitment that IMS GmbH (Germany) will maintain an ISO 9001 certified program.
2.
A commitment that IMS (USA) will maintain an ISO 9001 certified program for receipt inspection in the United States.
Please provide the requesteJ lr. formation within thirty (30) days. If you have any questions, please contact rne at (301) 415-5790 or John Lubinski at (301) 415-7868.
Sincerely, (orig, signed by)
Eric Compton, Engineering Aide Material Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards Distribution:
IMNS r/f SSD-98-83 NE01 SSD File # NR-375-D-10X-X
! DOCUMENT NAME: H:\\ERIC\\ MISC \\lMS.LTR Ti receive a copy of this document, indicate in the box: 'C' = Copygithout attachment / enclosure
- E' = Copo eth attachmentJenclosure
- N* = No copy OFFICE MSB lJi MSB JtpA l8 NAME ECompton fc JLubindi DATE 1/29/99 1/29/99 OFFICIAL RECORD COPY Pf 03 0 cro G -'
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i February 1,1999 Susan Burnet President Isotope Measurir.;; Fystems (IMS), Inc.
108 Blue Ridge Drive Mars, PA 16046
Dear Ms. Burnet:
The U.S. Nuclear Regulatory Commission is in the process of reviewing all of IMS's device registration certificates based on findings of an inspection performed on August 25-27,1997, and IMS's response dated February 27,1998. In order to update IMS's Quality Assurance Program for all of the registration certificates, please submit the following:
1.
A commitment that IMS GmbH (Germany) will maintain an ISO 9001 certified program.
2.
A commitment that IMS (USA) will maintain an ISO 9001 certified program for receipt inspection in the United States.
Please provide the requested information within thirty (30) days. If you have any questions, please contact me at (301) 415-5799 or John Lubinski at (301) 415-7868.
Sincerely, (orig,signedby)
Eric Compton, Engineering Aide Material Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards Qistribution:
IMNS r/f SSD-98-83 NE01 SSD File # NR-375-D-10X-X DOCUMENT NAME: H:\\ERIC\\ MISC \\lMS.LTR Ta receive e copy of this document. Indicate in tt,e boa: 'C" = Copyytthout ottachment/ enclosure "F" = Copy with attachment / enclosure
'N' = No copy OFFICE MSB C MSB fte#
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I NAME ECompton f21 JLubin!Uti DATE 1/29/99 1/29/99 I
OFFICIAL RECORD COPY l
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February 27,1998 U S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D.C. 20555 RE: Reply to A Notice Of Violation (Notice)
Dear Mr. Frank Costello.
We are responding to your notice dated December 8,1997. We appreciate the deadline extenaion granted by Mr. John R McGrath During rnestings on September 28,1903 with Messrs Steven Baggett and Duuglas Broaddus, we discussed our device registrations and the IMS QA Program We confirmed I
that the QA program descnbed in the license was IMS GmbH's Everyone present at this I
meeting concurred that the QA program submitted with the Model 5301 Dev ce Registration application belonged to IMS G_mbH (Germany), and not IMS Inc Since the revisions to 10 CFR Part 20, we have conducted annual audits of our radiation safety program Our company and IMS GmbH are now ISO 9001 certified and annual l
audits are conducted. The QA program described in our license and device registrations will continue under the control of IMS GmbH. IMS Inc will continue to conduct the ISO annual I
audit as presenbed in IMS inc' ISO 9001 QA program Sincerely,
)
Susan K Bumet President, IMS Inc l
cc:
Regional Administrator, Region i Francis M. Costello, Chief Nuclear Materials Safety Branch 3 Division of Nuclear Matenals Safety U.S. NRC Region 1 475 Allendale Road King of Prussia, PA 19406-1415 l
Susan Engelhardt, Engelhardt & Associated l
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Fcbruary 27,1998 U S. Nuclear Regulatory Commission ATTN; Document Control Desk Washington, D.C. 20555 l
RE: Reply to A Notice Of Violation (Notice)
Dear Mr. Frank Costello:
l We are responding to your notice dated December 8,1997 We appreciate the deadline extension granted by Mr. John R. McGrath Our response (wntten statement of explanation!
is presented as four separate items as requested in the notice item 1: Basis for Contesting Violation
[ 1MS inc contests the notice of violation, which states that IMS Inc has not perform audits as required by IMS IncJs OA program IMS Inc contests the violation because the QA program in question does not belong to IMS Inc (the device distnbutor). but instead belongs to IMS GmbH (the device manufacturer)
Dunng our 1992 Sept. 23 meeting with Messrs Baggett and Broaddus of the US NRC (Washington, DC) wo discussed the QA program Mr Baggett noted that IMS incJs predecessor in the USA (AEG) did not duplicate the IMS GmbH QA program in the USA Mr. Baggett observed that it would not be necessary for IMS Inc to implement this OA j
program in the USA. Specifically, Mr. Baggett stated that "Now you can rely more heavily on IMS'(IMS GmbH in Germany) QA program and just do a receipt inspection in this country."
It was agreed that the QA program would belong to IMS GmbH, and not to IMS Inc It was specifically agreed that IMS Inc., like AEG before it, would have an inspection program (i e,
the IMS Inc. Radiation Safety Checklist) item 2: Corrective Actions Taken
~
No
- corrective" actions were necessary, as no violation occurred Since the revisions to 10 CFR Part 20, however, we have conducted annual audits of our radiation safety program l
Our company and IMS GmbH are now ISO 9001 certif!ed and scheduled audits are conducted. The QA program desenbed in our license and device registrations will continue under the control of IMS GmbH. IMS Inc. will continue to conduct the ISO annual audit as prescribed in IMS inc' ISO 9001 QA program j
ltem 3: Future Corrective Actions Planned IMS Inc. has no plans for additional corrective actions item 4: Date When Full Compliance Will be Achieved To the best of our knowledge, IMS Inc has been in full compl:ance since beginning operations in 1992. We will endeavor to remain in full compliance now and in the future We request that the notice of violation be made null and void, and that the NRC will make it clear in the public record that IMS Inc has committed no violations of its license agreement with the NRC
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Sincerely, George Bumet, VI RSO and General Manager, IMS inc.
cc.
Susan Engelhardt Engelhardt & Associates Petra Klein IMS GmbH Alec Shaw IMS Ltd l
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l December 8, 1997 Docket No. 030-32807 License No. 37-28767-01 Susan Burnet President isotope Measuring Systems, Inc.
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108 Blue Ridge Drive Mars, PA 16046
SUBJECT:
INSPECTION NO. 030-32807/97-001
Dear Ms. Burnet:
On August 25-27,1997, John McGrath and Sheri Arredondo of this office and Brian Smith of the NRC Office of Nuclear Materials Safety and Safeguards, conducted a special safety inspection aJ the above location of activities authorized by the above listed NRC license. The inspection was an examination of your licensed activities as they relate to radiation safety and to compliance with the Commission's regulations and the license conditions. The inspection consisted of observations by the inspector, interviews with personnel, and a selective examination of representative records. The findings of the inspection were discussed with you at the conclusion of the inspection.
During the telephone conversation between you and M Smith on November 13, 1997, you discussed the need for clarification 'f the rb 'stration certificates for the
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Model 5301 tube thickness gauge and the Mo el 5221 rofile thickness gauge as well 1
as clarification of your Quality Assurance Prog
- m. In r sponse to this letter, please provide an update on the information you state that ou would provide to Mr. Smith on these matters.
Based on the results of this inspection, it appears that some of your activities were not conducted in full compliance with NRC requirements. A Notice of Violation is enclosed and categorizes each violation by severity levelin accordance with the
" General Statement of Policy and Procedure for NRC Enforcement Actions,"
(Enforcement Policy), NUREG 1600. You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the
/
l NRC will determine whether further NRC enforcement action is necessary to ensure J
compliance with NRC regulatory requirements.
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RETURN ORIGINAL TO h40024 REGION I OFFICIAL RECORD COPY ll ll Illi l llIll ll heaaquay _ _3n
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S. Burnet '
Isotope Measuring Systems, Inc.
In accordance with Section 2.790 of NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and your reply will be placed in the Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the l
PDR without redaction. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public. The responses directed by this letter and the accompanying Notico 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.
Your cooperation with us is appreciated.
Sincerely, R Y//
L Francis M. Costello, Chief Nuclear Materials Safety Branch 3 i
Division of Nuclear Materials Safety Docket No.: 030-32807 License No.: 37-28767-01
Enclosure:
Notice of Violation cc w/ enclosure:
Commonwealth of Pennsylvania l
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I OFFICIAL RECORD COPY
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5 S. Burnet Isotope Measuring Systems, Inc.-
Distribution; w/enct PUBLIC Nuclear Safety Information Center (NSIC) j Region i Dacket Room (w/ concurrences)
D. J. Holody, RI l
S. Baggett, NMSS B. Smith, NMSS i
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DOCUMENT NAME: R:\\WPS\\MLDL\\L3728767.01 To r.c.sv.. copy or thi. 4.com.nt. indic.i. in in. b.: c - copy wro tt.ch/.nci r - copy w/.ti.ch/.nci
- N* - No copy OFFICE DNMS/Ri N
DNMS/RI DNMS/RI,,,
NAME Arredondo @
McGrath p(O Costello$t\\"
DATE 12/03/97 V'
12/3/97
- p 1 2/.3/97 12/ /97 OFFICIAL RECORD COPY
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1 NOTICE OF VIOLATION isotope Measuring Systems, Inc.
Docket No. 030-32807 Mars, PA 10046 License No. 37-28767-01 During an NRC inspection conducted on August 25-27,1997, a violation of NRC requirements was identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG 1600, the violation is listed below:
cense Condition No.17 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures ntained in a letter dated July 24,1992.
Item G 7. of the letter dated July 24,1992 requires that annual audits be performed by personnel not having direct responsibilities with the area being audited.
Contrary to the above, as of August 27,1997, the licensee did not conduct annual audits.
This is a Severity Level IV violation 'Jupplement VI).
Pursuant to the provisions of 10 CFR 2.201, Isotope Measuring Systems, Inc. is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDRhithout redaction. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR. and provide the legal basis to support your request for withholding the information from the public.
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Notice of Violation If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
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NOTICE OF VIOLATION Isotope Measuring Systems, Inc.
Docket No. 030-32807 Mars, PA 16046 License No. 37-28767-01 During an NRC inspection conducted on August 25-27, 1997, a violation of NRC requirements was ideritified. In accordance with the " General Statement of Policy and Procedure for NRC Enf-cement Actions," (Enforcement Policy), NUREG 1600, the violation is listed below.
License Condition No.17 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in a letter dated July 24,1992.
Item G.7. of the letter dated July 24,1992 requires that annual audits be performed by personnel not having direct responsibilities with the area being audited.
Contrary to the above, as of August 27,1997, the licensee did not conduct annual audits.
This is a Severity Level IV violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Isotope Measuring Systems, Inc. is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a " Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response, if an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. However, if you find it necessary to include such information, you should clearly indicate the specific l
information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.
OFFICIAL RECORD COPY
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,s Notice of Violation If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
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OFFICIAL RECORD COPY
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l U.S. NUCLEAR REGULATORY COMMISSION REGION l Docket No.
030-32807 License No.
37-28767-01 l
Registration No.
NR-375-D-101-8, NR-375-D-102-S, NR-375-D-103-S, and NR-375-D-104-S Report No.
030-32807/97-001 Licensee:
Isotope Measuring Systems, Inc.
i Location:
108 Blue Ridge Drive Mars, Pennsylvania 16046 Dates:
Au ust 25-27,1997
! !3! 7 Inspectors:
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S. Arredondo Health Physicist, Region I
[d/7,2
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J). AcGrath senior Health P ysicist, Region I ic J. McGrath for-
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l B. Smith, Health Physicist Office of Nuclear Material Safety and Safeguards, Headquarters Approved by:
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F/ Costello Chief, Nuclear Materials Safety Branch 3 nGC.l ( 91l}!.LS Wd6.vd ;
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2 EXECUTIVE SUMMAP,Y lsotope Measuring Systems, Inc.
NRC inspection Report 030-32807/97-001 This special announced inspection included a review of the organization and scope of program, one customer site visit, review of the distribution, installation, and servicing of specifically and generally licensed devices, and review of the quality assurance program.
Oraanization and Inspection Scope The licensee possesses two NRC licenses, which authorize the installation, relocation, servicing and distribution of specifically and generally licensed nuclear gauging devices. The scope of the inspection included review of the authorized licensed activities stated above with emphasis on distribution of devices in accordance with their registration certificates.
i Customer Site Visit The inspection included a review of one customer that uses a gauging device in tubular mill applications. The inspectors observed that the nuclear gauging device had been manufactured, distributed, installed, and serviced by the licensee. However, through discussions with the customer and the licensee, it was determined that the registration certificate for the Model 5301 16 tube thickness gauge needs to be amended to clarify the limitation in the registration certificate f conceming the use of the Model CDC.PE2 sealed source.
Manufacturina. Distribution. Installation, and Servicina i
The licensee appears to be distributing gauges which are in compliance with the registration I
certificates. However, the registration certificate for the Model 5221, Series profile thickness 10 (
i gauges needs to be amended to indicate that the device is distri6iJted as a specifically-licensed f device.
Quality Assurance and Control Proarams (OA Proaram) 4 The licensee is not fully implementing the OA program provided to NRC as part of its license and device registration applications in that it has not conducted 'ts required audit program.
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REPORT DETAILS
- i. Organization and Scope a.
Oraanization and Inspection Scope isotope Measuring Systems (IMS) currently possesses one NRC license. License No.
37-28767-01 authorizes possession of americium-241 and cesium-137 sealed sources incident to the distribution of IMS's nuclear gauging devices. This license also authorizes i
installation, relocation, and servicing of these devices.6MS recently terminated their license authorizing the distribution of these uges to general licensees) IMS also has been issued registration certificates NR-D-101-B (Model 5221 Series), NR-375-D-102 S (Model 5245-XX Series), NR-375-D 103-S (Model 5301), and NR-375-D-104-S (Model 5321). These gauging devices are mounted on processing lines in steel mills to measure the thickness of materials.
The scope of the inspection included review of the authorized licensed activities stated above with emphasis on distribution of devices in accordance with their registration certificates.
b.
Observations and Findinas i
.The licensee's gauging systems are manufactured in Germany by isotope' Measuring i
Systems GMBH (IMS GMBH). To date,13 of these devices have been distributed. The licensee currently distributes all of their devices under their specific distribution license.
The devices are shipped from Germany directly to the customer and are installed by a representative from IMS. Amersham (IL) installs the sources into the source housings and then transports the loaded source housings to the customer's location.
c.
Conclusions Licensed activities are conducted in accordance with their license.
II. Customer Site Visit a.
Inspection Scope On Tuesday, August 26,1997, the inspectors visited ARMCO Inc., Sawnill Tubular Division (Sawhill), in Sharon, PA. Sawhill has an IMS Model 5301 tube thickness gauge installed and in operation. Sawhill manufactures steel pipe of varying lengths, diameters, and thicknesses. The device is operated by an individual located in a control room approximately 25 feet away. This is a specifically licensed device that was installed in
- 1994, b.
Observations and Findinas The inspectors were able to observe the device in operation. The inspectors also observed the device baing calibrated. For calibration, the device is retracted from the I
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process line, a calibration is performed, and the device is returned to the process line.
Due to the process line being in operation and the high temperatures caused by the steel pipe, the inspectors were not able to inepect the device very closely. In addition, due the high temperatures, a water blanket (steel, filled with circulating water) is installed around the device obstructing the view of the device.
During device calibration, the waming lights were observed to operate appropriately.
Three labels, as described in the registration certificate for the Model 5301, were observed on the back of the device (facing away from the operator). These labels were difficult to read from the location where the inspectors were located (catwalk) due to the distance and the thick black dust which had built up on the labels. The wording could not i
be checked against that in the registration certificate.
Radiation levels near the device (outside the water shield) were approximately 1 mR/hr.
Radiation levels on the catwalk approximately 20 feet away were indistinguishable from background.
The registration certificate for the Model 5301 tube thickness gauge limits the use of the l O
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Amersham Model CDC.PE2 cesium ch'oride sealed source to applications where a measurement of tube eccentricity is essential. The source used in the Sawhill gauge is the Model CDC.PE2. Through discussions with IMS, it was determined that tube eccentricity is not the critical factor for the.use of this source, but rather the determination of tube or device movement. The device calculates the eccentricity, but the theory behind the calculation'uses the assumption that the tube is eccentric, and when it calculates an out of tolerance eccentricity, a warning is sent to the operator that the tube is out of position. According to IMS, a source other than the Model CDC.PE2 could be used, but the air gap would have to be doubled and the source strength quadrupted.
Altematively, a source with equivalent strength could be used, but only with the use of optical diodes to measure tube movement. However, this method would increase the cost of the device significantly. IMS stated that the Model CDC.PE2 sealed source would be used in most applications of this device, c.
Conclusions The Model 5301 tube thickness gauge installed at Sawhill appears to have been distributed in accordance with the IMS license and the device appears to be in compliance with the registration certificate. The limitation in the registration certificate conceming the use of the Model CDC.PE2 sealed source needs to be clarified.
Ill. Manufacturing, Distribution, installation, and Servicing a.
Inspection Scope l
The team inspected some sparo parts manufactured by IMS GMBH and other companies, as well as the engineering drawings used by IMS to manufacture the devices.
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5 The inspectors discussed IMS's procedures for distribution, installation, and repair of gauges. The inspectors reviewed a number of the licensee's field service reports for the following customers: Alcoa, Davenport, Iowa; ARMCO Inc., Sawhill Tubu'ar Division, Sharon, Pennsylvania; Nucor, Crawfordsville, Indiana; and Logan Aluminum, Kentucky.
b.
Observations and Findinos i
The engineering drawings for several devices that were distributed were compared to the respective registration certificates. The results of these reviews are listed below:
1.
The engineering drawings for the Model 5245-01 profile thickness gauge were compared. The engineering drawings for the source housing were not included, but the overall drawing for the C-frame was included. The dimensions as listed in l
the registration certificate matched those in the drawing.
2.
The engineering drawings for five Model 5221 Series profile thickness gauges were compared. The engineering drawings for the source housings were not included, but the overall drawing for the C-frames and the number of source housings were included. The registration certificate did not include information (C-frame dimensions, air gap, and number of source housings) on the Model 5221-01, which was distributed to Ormet Aluminum in Hannibal, OH. [The registration certificate contains this'information on Models 5221-02,5221-03, 5221-04,5221-05, and 5221-5121.] However, the information on the Model 5221-01 matches that as listed in the registration certificate for the model 5221-
- 02. The information on the Model 5221-02 listed in the aegistration certificate is as a generally licensed device when IMS states that the device was incorrect. The registration certificate states that Model 5221-03 was distributed a specifically licensed device. The information for Models 5221-04 and 5221-05 was as listed in the registration certificate.
I The spare parts measured by the inspectors were within tolerance when compared to the engineering drawings provided for the registration certificate. Examples of parts that were measured include the end plates of the shutter, spring cover plate, and the shutter barrel drive flange. Four measurements of each part were taken with the licensee's Mitutoyo calipers and were compared to the original drawings.
Most of the service reports reviewed by the inspectors indicated no problems with the operation of the gauges.
c.
Conclusions The licensee appears to be c!!stributing gauges which are in comp!iance with the registration certificates. The registration certificate for the Model 5221 Series profile thickness gauges needs to be amended to reflect the devices distributed.
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6 IV. Quality Assurance and Control Programs (OA Program) a.
Inspection Scope The team inspected IMS's implementation of its quality assurance and control program.
The inspectors were able to locate the quality assurance program commitments as documented in the license file and for Models 5245-XX Series and 5221 Series as provided in the device applications for registration.
b.
Observations and Findinos The quality assurance program committed to in the 'MS license is very general in nature and contains very few details. It appears that the majority of the actions will be performed by IMS GMBH in Germany, c
The following is a summary of the IMS quality assurance program es described by IMS:
A.
Prior to a device being shipped to a customer, engineering drawings are provided to the customer and to IMS by iMS GMBH. These drawings are compared against the drawings submitted for the device registration. If a change has been made to a safety significant component, the d6vice will be modified to meet the specifications in the registration certificate.' NS states that there have never been any deviations from the specificationr,in the registration certificate identified during this review. This is the only methoc' e x IMS to identify changes made to the devices; IMS GMBH does not inform !.M Ichanger to the devices.
B.
The device is shipped directly to the customers Iccation and is installed by an IMS representative. This individual also installs tne source housing. The source housing has the source loaded by Amersham (IL) in accordance with engineering drawings provided by IMS. There are no specific measurements or 7 pfd Ig determinations of rnaterials of construction made to verify that the device that is J
shipped is the same that is registered. IMS does fill out a checklist that has one ghG block for conformance with the registration certificate, however, due to the lack of further detailin the checklist, it is unclear what is confirmed. A copy of the checklist is retained by IMS. IMS also performs radiation surveys around the source housing. These results are compared to expected values to determine if the shielding required is present in the source housing.
C.
IMS keeps an inventory of spare parts of safety significant components. These parts are provided by IMS GMBH and other suppliers approved by IMS GMBH.
When the parts are received, they are checked against the purchase order for appropriate model numbers and quantity. A visual check is also performed to identify any damaged parts.
IMS GMBH (Germany) has been ISO 9001 certified and recently had their program amended to include IMS and Isotope Measuring Systems, Limited (United Kingdom).
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7 Conclusions it appears that the licensee is not fully implementing the QA program provided to NRC as part of its license and device registration applications. The inspectors noted the following violation:
Section G.7. of the licensee's quality assurance program requires annual audits by an individual not normally involved in the OA program. IMS indicated that they have not performed such audits.
A V. Management Meetings The inspectors presented the inspection results to the company president at the
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conclusion of the inspection. The inspectors discussed the one general area of noncompliance and the amendments needed to the registration cortificates. The licensee acknowledged the findings presented and indicated that corrective action would be taken.
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8 PARTIAL LIST OF PERSONS CONTACTED George Bumet Radiation Safety Officer Susan Bumet, President.
Susan Englehardt, Consultant, Engelhardt & Associates, Inc.
Harley Tennant, Manager-Engineering Services, ARMCO Inc.
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i *4 PAGE1 NRC FORM 567 U. S. NUCLEAR REGUL4 TORY COMMISSION D83) -
/.
REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all related lotta.s/applicatsons and drawirigs to: The Semied Source Safety Section, ATTN: Chief, OWFN Malf Stop 6 H3. Change the License Tracking System milesta to 19 and assign to reviewer code I-5.
NOTE: Retain a copy of this request with the apNication and backgrout m.
REQUESTER EGION/ LOCATION:
I7o -/,i es
/7/d C a/' M a bvMW 7/7d-l ll Ill IV V
HQ C LFDCB TELEF50NE NUMlsER
- ) ATE /
/
l TYPE OF ACTION REQUESTED (Check as appropriate)
APPLICANT'S NAME SOURCE REVIEW AMENDMENT OF b < / 34 <>
f /1 e J.
REGISTRATION SHEET
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MCJL CONTROL NUMBER (S)
DEVICE REVIEW NUMBER (S)
LETTER / APPLICATION DATE LICENSE NUMBER (S)
CUSTOM REVIEW COMMENTS k.j
. h ub ja y Blac p
nulc, 84 14oY4 FOR SSSS USE ONLY REUIEWER MODEL NUMBERS NUMBER ASSIGNED c.D) A h v fl}E) f)l'! $
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DQTE RECEIVED DATE ASSIGNED DATE TO FEES Y
[
Yh2Rf@$
J ff "V
b TYPE OF ACTION (Indicate the number of each type)
/
/
l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (90)
DEVICE (9B)
NEW NEW NEW NEW AMENDMENT 2AhlENDMENT AMENDMENT
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AMENDMENT j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED j OTHER (Specify)
TOTAL NUMBER OF NOTES REVIEW HOURS gg gg 333, A, n, f, a v.a NUMBER OF DEFICIENCY LETTERS O i ed'C kl' NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY
- j NEW REGISTRATION -
J PRODUCT INACTIVE -
NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILUNG FOR FEE USE ONLY YYPE OF FEE FEE CATEGORY 9C U 9D
]9A U 98 CMOUNT RECEtVED CHECK NUMBER MATANN UPDATED AS REQUIRED l
i j MATSYS UPDATED DATE OF CHECK LOG AS REQUIRED GPPROVED BY DATE RETURN DATE I
i COMMENTS i
Ne_. t.
'N SSSS USE ONLY-SUSPENSE COPY I
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