ML20206C369
| ML20206C369 | |
| Person / Time | |
|---|---|
| Issue date: | 04/29/1999 |
| 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 9905030004 | |
| Download: ML20206C369 (3) | |
Text
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t UNITED STATES l
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20066-0001 April 29, 1999 Susan K. Burnet President Isciope Measuring Systems (IMS), Inc.
108 Blue Ridge Drive Mars, PA 16046
Dear Ms. Burnet:
We have reviewed your facsimile dated April 12,1999, regarding your quality assurance and quality control (OA/OC) program.
Due to increased use of ISO-9000 certification, the NRC now allows applicants to submit commitments regarding their ISO-9001 certification in lieu of submitting QA/OC procedures to l
meet the Quality Assurance and Quality Control requirements for a Sealed Source and Device (SSD) review. However, an alternate program, as specified in your facsimile, will not be acceptable without an evaluation by the NRC to satisfy the OA/OC requirements for an SSD review. Should either IMS (USA) or IMS (Germany) terminate its ISO-9001 OA/OC program, you must notify the NRC immediately and submit an amendment request providing a replacement program for evaluation.
Based on the commitment to ISO-9001 certification, we conclude isotope Measuring Systems, Inc. Quality Assurance Program is acceptable for licensing purposes. However, IMS will need to provide copies of ISO-9001 certification, verifying the ISO-9001 standard, for both IMS (USA) and IMS (Germany). Copies will be placed on file, in lieu of QA/OC procedures. No changes to the registration certificates that IMS holds are necessary at this time.
Please be advised that you must manufacture and distribute products in accordance with the statements and representations contained in your applications, with enclosures thereto, and the j
information set out in your registration certificates. As a general rule, you must request and obtain an amendment to the certificate before you make changer, or modifications to the information submitted to obtain the certificate.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
i Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
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If you have any questions, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415-7904.
I Sincerely, Eric B. Compton, Engineering Aide l
Materials Safety and inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards cc 1:
SKimberley, LFDCB FCostello, DNMS, RG-1 4
i I
i 1
Distribution:
IMNS r/f SSD-98-83 NE0 d SSD File # NR-375-D-10X-X DOCUMENT NAME: H:\\ERIC\\COMPLTR\\NR375XXX. CMP i
Ta veceive a coat of this document,Indcate in the box: *C" = Copy without attachment / enclosure
'E' = Copy with attachment / enclosure
'N' = No copy OFFICE MSIB lC.MSlB u l(>
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l NAME-ECompton 7C JJankovich/ If
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DATE 04/Sf/99 04/.2Y/99 b V OFFICIAL RECORD COPY
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t WASHINGTON, D.C. 20666 4 001 C4W
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April 29, 1999 o
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i Susan K. Burnet l
President Isotope Measuring Systems (IMS), Inc.
108 Blue Ridge Drive Mars, PA 16046
Dear Ms. Burnet:
We have reviewed your facs mile dated April 12,1999, regarding your quality assurance and quality control (OA/OC) program.
Due to increated use of ISO-9000 certification, the NRC now allows applicants to submit commitments regarding their ISO-9001 certification in lieu of submitting OA/QC procedures to meet the Quality Assurance and Quality Control requirements for a Sealed Source and Device (SSD) review. However, an alternate program, as specified in your facsimile, will not be acceptable without an evaluation by the NRC to satisfy the OA/OC requirements for an SSD review. Should either IMS (USA) or IMS (Germany) terminate its ISO-9001 OA/OC program, you must notify the NRC immediately and submit an amendment request providing a replacement program for evaluation.
Based on the commitment to ISO-9001 certification, we conclude Isotope Measuring Systems, Inc. Quality Assurance Program is acceptable for licensing purposes. However, IMS will need to provide copies of ISO-9001 certification, verifying the ISO-9001 standard, for both IMS (USA) and IMS (Germany). Copies will be placed on file, in lieu of OA/OC procedures. No changes to the registration certifi::ates that IMS holds are necessary at this time, Please be advised that you must manufacture and distribute products in accordance with the statements and representations contained in your applications, with enclosures thereto, and the information set out in your registration certificates. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR l
Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
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e if you have any questions, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415 7904.
Sincerely, k
Eric B. Compton, Engineering Aide Materials Safety and Inspection Branch '
Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards cc1:
SKimberley, LFDCS FCostello, DNMS, RG-1 1
1 1
Distribution:
IMNS r/f SSD-98-83 NE0 d l
SSD File # NR-375-D-10X-X DOCUMENT NAME: H:\\ERIC\\COMPLTR\\NR375XXX. CMP Tm receive e sepy of this document,Indcase in the boar *C' = Copy without ettechment/ enclosure
- E' = Copy with attachment / enclosure
- N* = No copy OFFICE MSIB lC -MSIB u l(>
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NAME ECompton 1'C JJankovich/P DATE 04/ 2f/99 04/Jf/99 V V OFFICIAL RECORD COPY l
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April 29, 1999 Susan K. Burnet President isotope Measuring Systems (IMS), Inc.
108 Blue Ridge Drive Mars, PA 16046
Dear Ms. Burnet:
We have reviewed your facsimile datec 3pril 12,1999, regarding your quality assurance and quality control (OA/OC) program.
Due to increased use of ISO-9000 certification, the NRC now allows applicants to submit commitments regarding their ISO-9001 certification in heu of submitting QA/QC procedures to meet the Quality Assurance and Quality Control requirements for a Sealed Source and Device (SSD) review. However, an alternate program, as specned in your facsimile, will not be acceptable without an evaluation by the NRC to satisfy the OA/OC requirements for an SSD review. Should either IMS (USA) or IMS (Germany) terminate its ISO-9001 QA/QC program, you must notify the NRC immediately and submit an amendment request providing a replacement program for evaluation.
Based on the commitment to ISO-9001 certification, we conclude isotope Measuring Systems, Inc. Quality Assurance Program is acceptable for licensing purposes. However, IMS will need to provide copies of ISO-9001 certification, verifying the ISO-9001 standard, for both IMS (USA) and IMS (Germany). Copies will be placed on file, in lieu of QA/OC procedures. No changes to the registration certificates that IMS holds are necessary at this time.
Please be advised that you must manufacture and distribute products in accordance with the statements and representations contained in your applications, with enclosures thereto, and the information set out in your registration certificates. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Ye" we obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
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if you have any questbns, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415-7904.
Sincerely, i
Eric B. Compton, Engineering Aide Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards 1
cc1:
SKimberley, LFDCB FCostello, DNMS, RG-1 1
Distribution:
IMNS r/f SSD 98-83 NE0 d SSD File # NR-375-D-10X-X DOCUMENT NAME: H:\\ERIC\\COMPLTR\\NR375XXX. CMP Ta mesive e copy of this document, Indcate in the bos:
"C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure
- N* = No copy OFFICE MSIB lC M SIB u l()
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l NAME ECompton TC JJankovichhl/-
DATE 04/.2f/99 04/ X /99 V V OFFICIAL RECORD COPY 3
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WASHINGTON, D.C. 20555 0001 April 29, 1999 MEMORANDUM TO:
Francis M. Costello, Chief Nuclear Materlats Safety Branch 3 Division of Nuclear Materials Safety Region I FROM:
Eric B. Compton, Engineering Alde Materials Safety and inspection Branc A
Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards
SUBJECT:
FOLLOW-UP OF ISSUES CONCERNING REGISTRATION CERTIFICATES FOR ISOTOPE MEASURING SYSTEMS, INC.,
RAISED DURING INSPE0 TION REPORT NO. 030-32807/97-001 On August 25-27,1997, John McGrath and Sheri Arredondo of your office, and Brian Smith of the NRC Office of Nuclear Materials Safety and Safeguards, conducted a special safety inspection at Isotope Measuring Systems, (IMS) Inc of Mars, PA (License No. 37-28767-01).
The inspection report (No. 030-32807/97-001) concluded with a number of recommended actions. This memorandum provides resolution to the inspection findings regarding the SSDs.
IMS has been issued registration certificates NR-375-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 linea in steel mills to measure the thickness of materials. Several comments were raised, during the inspection, in regards to the registration certificates. As a result, the Materials Safety and Inspection Branch has reexamined the registration certificates and contacted the licensee. Based on our review, we have determined that no changes to the registration certificates that IMS holds are necessary at this time, as discussed below.
Inspection findina re:"Manufacturina. Distribution. Installation. and Servicino" (c. 2)
=
In response to IMS termination of its general distribution license, the inspection team recommended that the registration for the Model 5221 Series profile thickness gauge to be amended to indicate that the device is to be distributed only as a specifically-licensed device.
The Model 5221 Series profile thickness gauge had previously been reviewed by the NRC and found appropriate for use by both persons specifically and generally licensed by the NRC or Agreement State. The basis of the approvals contained in the sealed source and device review have not changed. Therefore, we feel that there is no reason to amend the certificate. Under the current license, IMS is only authorized at this time to distribute the Model 5221 Series profile thickness gauge to specific licensees.
f6.Td3Ud0.5 p,p
r How3v:r, tha units distribut d e:rli:r und:r g:n:rallicense are still acceptable for use under a general license (i.e. generally licensed gauges in service are not recalled).
Note: IMS must maintain the commitments contained in its application and supporting documentation referencing the registration certificate (e.g. Quality Assurance, labeling, etc.) which affect units distributed under its earlier general distribution license.
Inspection findina re: " Customer Site Visit" (c. 2)
The inspection team had recommended that the registration certificate for the Model 5301 tube thickness gauge be amended to clarify the limitation concerning the use of the Amersham Model CDC.PE2 cesium chloride sealed source. The registration certificate limits the use of this source to applications where a measurement of tube eccentricity is essential.
Through its discussion with IMS, the inspection team reported IMS had stated that the tube eccentricity is not the critical factor for use of this source; rather eccentricity must be accounted for in the determination of tube or device movement. Since, the registration certificate addresses the issue of eccentricity, our review did not indicate a need for further clarification by amending the registration certificate.
Insoection findina re:" Observations and Findinas" (item b. o. 6)
The inspection team had reported that IMS possesses a very general quality assurance and quality control program that contains very few details.
In response, IMS (USA) has committed that it will maintain an ISO 9001 certified program for receipt inspection in the United States. Furthermore, IMS (USA) has stated that IMS (Germany) will maintain an ISO 9001 certified program or an alternative program. Due to increased use of ISO 9000 certification, the NRC now allows applicants to submit commitments regarding their ISO 9001 certification in lieu of submitting OA/OC procedures to meet the OA/OC requirements for an SSD review.
However, should either IMS (USA) or IMS (Germany) terminate its ISO 9001 QA/OC program, IMS (USA) must notify the NRC immediately and submit an amendment request providing a replacement program for evaluation.
We have requested IMS in a letter dated April 29,1999, to provide a copy of its ISO 9001 certification for the file.
Distribution:
IMNS r/f SSD-98-83 NE0h SSD File # NR-375-D-XXX-X DOCUMENT NAME: H:\\ERIC\\ MISC \\lMS.MEM Ta receive a copr of this document. Indicato in the boa: 'C' = Copy without attachment / enclosure T = Copy with attachment / enclosure
- N* = No copy OFFICE MSIB C MSIB
\\3t C/
l l
NAME ECompton K Jankovich A N DATE 04/ 3 /99 04//b/99 W \\
OFFICIAL RECORD COPY
AIR-573-b-l65-S 1
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UNITED STATES g
g NUCLEAR REGULATORY COMMISSION g
WASHINGTON, D.C. 20555 0001 o
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e April 29, 1999 Susan K. Burnet President Isotope Measuring Systems (IMS), Inc.
108 Blue Ridge Drive Mars, PA 16046
Dear Ms. Burnet:
i We have reviewed your facsimile dated April 12,1999, regarding your quality assurance and quality control (OA/OC) program.
Due to increased use of ISO-9000 certification, the NRC now allows applicants to submit commitments regarding their ISO-9001 certification in lieu of submitting OA/OC procedures to meet the Quality Assurance and Quality Control requirements for a Sealed Source and Device (SSD) review. However, an alternate program, as spec:fied in your facsimile, will not be acceptable without an evaluation by the NRC to satisfy the OA/OC requirements for an SSD review. Should either IMS (USA) or IMS (Germany) terminate its ISO-9001 OA/OC program, you must notify the NRC immediately and submit an amendment request providing a replacement program for evaluation.
Based on the commitment to ISO-9001 certification, we conclude isotope Measuring Systems, Inc. Juality Assurance Program is acceptable for licensing purposes. However, IMS will need to provide copies of ISO 9001 certification, verifying the ISO 9001 standard, for both IMS (USA) and IMS (Germany). Copies will be placed on file, in lieu of QA/OC procedures. No changes to the registration certificates that IMS holds are necessary at this time.
Please be advised that you must manufacture and distribute products in accordance with the statements and representations contained in your applications, with enclosures thereto, and the information set out in your registration certificates. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be sub,'ect to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
i
r
^ -
If you have any questions, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415-7904.
Sincerely, k
I Eric B. Compton, Engineering Alde Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety j
And Safeguards ccI:
SKimberley, LFDCB FCostello, DNMS, RG-1 Distribution:
IMNS r/f SSD-98-83 NE0 d SSD File # NR-375-D-10X-X l
DOCUMENT NAME: H:\\ERIC\\COMPLTR\\NR375XXX. CMP l
T.
es. py e tw. 4.c
. wee. w dem c. copy wiinoui.et.cnm.ntioncio.or.
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w - no copy OFFICE MSIB lC MSIB u l()
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NAME ECompton TC JJank_ovich/ IJF DATE 04/Sf/99 04/JY/99 V V OFFICIAL RECORD COPY L.
c A/K-375-D- /O 3-S e C'o g \\
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UNITED STATES NUCLEAR REGULATORY COMMISSION f
WASHINGTON, D.C. 2055H001
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April 29, 1999 MEMORANDUM TO:
Francis M. Costello, Chief Nuclear Materials Safety Branch 3 Division of Nuclear Materials Safety Region I FROM:
Eric B. Compton, Engineering Alde Materials Safety and inspection Branc A
q Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards
SUBJECT:
FOLLOW-UP OF ISSUES CONCERNING REGISTRATION CERTIFICATES FOR ISOTOPE MEASURING SYSTEMS,INC.,
RAISED DURING INSPECTION REPORT NO. 030-32807/97-001 On August 25-27,1997, John McGrath and Sheri Arredondo of your office, and Brian Smith of the NRC Office of Nuclear Materials Safety and Safeguards, conducted a special safety inspection at Isotope Measuring Systems, (IMS) Inc of Mars, PA (License No. 37-28767-01).
The inspection report (No. 030-32807/97-001) concluded with a number of recomtnended actions. This memorandum provides resolution to the inspection findings regarding the SSDs.
IMS has been issued registration certificates NR 375-D-1018 (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. Several comments were raised, during the inspection, in regards to the registration certificates. As a result, the Materials Safety and Inspection Branch has reexamined the registration certificates and contacted the licensee. Based on our review, we have determined that no changes to the registration certificates that IMS holds are necessary at this time, as discussed below.
Insoection findino re:'Hanufacturino. Distribution. Installation. and Servicina" (c. 2) in response to IMS termination of its general distribution license, the inspection team recommended that the registration for the Model 5221 Series profile thickness gauge to be amended to indicate that the device is to be distributed only as a specifically-licensed l
device.
I c
The Model 5221 Series profile thickness gauge had previously been reviewed by the NRC and found appropriate for use by both persons specifically and generally licensed j
l by the NRC or Agreement State. The basis of the approvals contained in the sealed source and device review have not changed. Therefore, we feel that there is no reason to amend the certificate. Under the current license, IMS is only authorized at this time to distribute the Model 5221 Series profile thickness gauge to specific licensees.
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j
7 6
i How:v:r, the units distributed earlier under general license are still acceptable for use under a general license (i.e. generally licensed gauges in service are not recalled).
Note: IMS must maintain the commitments contained in its application and supporting documentation referencing the registration certificate (e.g. Quality Assurance, labeling, etc.) which affect units distributed under its earlier general distribution license.
l l
Inspection findino re:" Customer Site Visit" (c. 2) l The inspection team had recommended that the registration certificate for the Model 5301 tube thickness gauge be amended to clarify the limitation concerning the use of the Amersham Model CDC.PE2 cesium chloride sealed source. The registration l
certificate limits the use of this source to applications where a measurement of tube eccentricity is essential.
Through its discussion with IMS, the inspection team reported IMS had stated that the tube eccentricity is not the critical factor for use of this source; rather eccentricity must be accounted for in the determination of tube or device movement. Since, the registration certificate addresses the issue of eccentricity, our review did not indicate a need for further clarification by amending the registration certificate.
Insoection findino re:" Observations and Findinos" (ltem b. o. 6)
The inspection team had reported that IMS possesses a very general quality assurance and quality control program that contains very few details.
i in response, IMS (USA) has committed that it will maintain an ISO 9001 certified i
program for receipt inspection in the United States. Furthermore, IMS (USA) has stated that IMS (Germany) will maintain an ISO 9001 certified program or an alternative program. Due to increased use of ISO 9000 certification, the NRC now allows j
applicants to submit commitments regarding their ISO 9001 certification in lieu of i
submitting OA/OC procedures to meet the OA/OC requirements for an SSD review.
i However, should either IMS (USA) or IMS (Germany) terminate its ISO 9001 OA/OC program, IMS (USA) must notify the NRC immediately and submit an amendment request providing a replacement program for evaluation.
l We have requested IMS in a letter dated April 29,1999, to provide a copy of its ISO 9001 certification for the file.
Distribution:
IMNS r/f SSD-98-83 NE0h SSD File # NR-375-D-XXX-X DOCUMENT NAME: H:\\ERIC\\ MISC \\lMS.MEM T, receive a copt of this docuenent. Indcare in the box?
- C* = Copy without attachment / enclosure
'E' = Copy with attachment /endosure
'N' = No copy OFFICE MSIB C MSIB
\\3dW l
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NAME ECompton ff Jankevich A N DATE 04/E/99 04//b/99 W \\
OFFICIAL RECORD COPY
N A - S '75-D- / O H'-S f,
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UNITED STATES 3
j NUCLEAR REGULATORY COMMISSION g
WASHINGTON, D.C. 20555 4 001
\\.....#
i April 29, 1999 Susan K. Burnet President Isotope Measuring Systems (IMS), Inc.
108 Blue Ridge Drive Mars, PA 16046
Dear Ms. Burnet:
We have reviewed your facsimile dated April 12,1999, regarding your quality assurance and quality control (OA/QC) program.
Due to increased use of ISO 9000 certification, the NRC now allows applicants to submit commitments regarding their ISO-9001 certification in lieu of submitting OA/OC procedures to meet the Quality Assurance and Quality Control requirements for a Sealed Source and Device (SSD) review. However, an alternate program, as specified in your facsimile, will not be acceptable without an evaluation by the NRC to satisfy the OA/OC requirements for an SSD review. Should either IMS (USA) or IMS (Germany) terminate its ISO-9001 OA/OC program, you must notify the NRC immediately and submit an amendment request providing a replacement program for evaluation.
Based on the commitment to ISO-9001 certification., we conclude isotope Measuring Systems, Inc. Quality Assurance Program is acceptable for licensing purposes. However, IMS will need to provide copies of ISO-9001 certification, verifying the ISO-9001 standard, for both IMS (USA) and IMS (Germany). Copies will be placed on file, in lieu of OA/OC procedures. No changes to the registration certificates that IMS holds are necessary at this time.
Please be advised that you must manufacture and distribute products in accordance with the statements and representations contained in your applications, with enclosures thereto, and the information set out in your registration certificates. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
l
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If sou have any questions, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415-7904.
Sincerely, Eric B. Compton, Engineering Aide Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards ccI:
SKimberley, LFDCB FCostello, DNMS, RG-1 Distribution:
iMNS r/f SSD-98-83 NE0 d SSD File # NR-375-D-10X-X DOCUMENT NAME: H:\\ERIC\\COMPLTR\\NR375XXX. CMP T* receive e copy of this document, Indicate in the tem: "C" = Copy without attachment / enclosure
- E" = Copy with attachrnent/ enclosure
- N' = No copy OFFICE MSIB C.MSIB
()
l l
u NAME ECompton 76-JJankovich/}l)F DATE 04/Jf/99 04/J#/99 V V OFFICIAL RECORD COPY
A/R-375-D- /0%S
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p erc UNITED STATES NUCLEAR REGULATORY COMMISSION f
WASHINGTON, D.C. 20555 0001
%..... #o April 29, 1999 MEMORANDUM TO:
Francis M. Costello, Chief Nuclear Materials Safety Branch 3 Division of Nuclear Materials Safety Region i FROM:
Eric B. Compton, Engineering Aide
.h Materials Safety and Inspection Branc M
Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards
SUBJECT:
FOLLOW UP OF ISSUES CONCERNING REGISTRATION CERTIFICATES FOR ISOTOPE MEASURING SYSTEMS, INC.,
RAISED DURING INSPECTION REPORT NO. 030-32807/97-001 I
On August 25-27,1997, John McGrath and Sheri Arredondo of your office, and Brian Smith of i
the NRC Office of Nuclear Materials Safety and Safeguards, conducted a special safety inspection at isotope Measuring Systems, (IMS) inc of Mars, PA (License No. 37-28767-01).
The inspection report (No. 030-32807/97-001) concluded with a number of recommended actions. This memorandum provides resolution to the inspection findings regarding the SSDs.
i IMS has been issued registration certificates NR-375-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. Several comments were raised, during the inspection, in regards to the registration certificates. As a result, the Materials Safety and Inspection Branch has reexamined the registration certificates and contacted the licensee. Based on our review, we have determined that no changes to the registration certificates that IMS holds are necessary at this time, as discussed below.
insoection findino re: "Manuf acturino. Distribution. Installation. and Servicino" (c. 2) in response to IMS termination of its general distribution license, the inspection team recommended that the registration for the Model 5221 Series profile thickness gauge to be amended to indicate that the device is to be distributed only as a specifically-licensed device.
The Model 5221 Series profile thickness gauge had previously been reviewed by the NRC and found appropriate for use by both rersons specifically and generally licensed by the NRC or Agreement State. The basis of the approvals contained in the sealed source and device review have not changed. Therefore, we feel that there is no reason to amend the certificate. Under the current license, IMS is only authorized at this time to distribute the Model 5221 Series profile thickness gauge to specific licensees.
Qi9tobO3 7ff
I-t l0 Howev r, the units distributed earlier under general license are still acceptable for use l
under a general license (i.e. generally licensed gauges in service are not recalled).
Note: IMS must maintain the commitments contained in its application and supporting documentation referencing the registration certificate (e.g. Quality Assurance, labeling, l
etc.) which affect units distributed under its earlier general distribution license.
l Inspection findina re:" Customer Site Visit" (o 2)
=
The inspection team had recommended that the registration certificate for the Model 5301 tube thickness gauge be amended to clarify the limitation concerning the use of -
the Amersham Model CDC.PE2 cesium chloride sealed source. The registration certificate limits the use of this source to applications where a measurement of tube eccentricity is essential.
Through its discussion with IMS, the inspection team reported IMS had stated that the tube eccentricity is not the critical factor for use of this source; rather eccentricity must be accounted for in the determination of tube or device movement. Since, the registration certificate addresses the issue of eccentricity, our review did not indicate a need for further clarification by amending the registration certificate.
i Inspection findino re:" Observations and Findinas" (ltem b. o. 6)
The inspection team had reported that IMS possesses a very general quality assurance and quality control program that contains very few details.
In response, IMS (USA) has committed that it will maintain an ISO 9001 certified program for receipt inspection in the United States. Furthermore, IMS (USA) has stated that IMS (Germany) will maintain an ISO 9001 certified program or an alternative program. Due to increased use of ISO 9000 certification, the NRC now allows applicants to submit commitments regarding their ISO 9001 certification in lieu of submitting OA/OC procedures to meet the OA/OC requirements for an SSD review.
However, should either IMS (USA) or IMS (Germany) terminate its ISO 9001 QA/OC program, IMS (USA) must notify the NRC immediately and submit an amendment request providing a replacement program for evaluation.
We have requested IMS in a letter dated April 29,1999, to provide a copy of its ISO 9001 certification for the file.
Distri' ution:
o IMNS r/f SSD-98-83 NE0h SSD File # NR-375-D-XXX-X l
( DOCUMENT NAME: H:\\ERIC\\ MISC \\lMS.MEM
! Ta receive e copr of this document, indcate in the bon: *C" - Copy without attachmentlanctosure
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NAME ECompton K Jankovich A(W DATE 04/3f/99 04//b/99 W \\
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PAGE1 letC FORM 567 U. S. NUCLEAR REGUI.ATORY COMMISSION ises)
REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION f
BfSTRUCTIONS: Send tNs request AND a copy of all related letters /appimations and drowings to: The Sealed Source Safety Section, ATTN: CNef, OWFN Mail Stop 6 H3. Change tne License Tracidng System milestone to 19 and seeign to reviewer code I-5.
4 NOTE: Retain a copy of tNs request with the applicehon and background files.
REQUESTER REGION / LOCATION:
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TYPE OF ACTION REQUESTED (Check as appropriate)
APPUCANTS NAME SOURCE REVIEW AMENDMENT OF (134 n Aef REGISTRATION SHEET w_
Mall CONTROL NUMBER (S)
DEVICE REVIEW LETTER /APPUCATON DATE UCENSE NUMBER (S)
CUSTOM REVIEW Jo y 2lue K,cigo 3c.vc n, M S, f'# 7 & W A FOR 8888 USE ONLY REUIEWER MODEL NUMBERS NUMBER ASSONED
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l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (90)
DEVICE (98)
NEW NJW NEW NEW AMENDMENT AMENDMENT AMENDMENT AMENDMF'dT LICENSING ACTION REQUIRED 'F KNOWN NO p r t.ts neuvintA
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TOTAL NUMBER OF NOTES REVIEW HOURS g/o g c gffcd 3.5.5,5
- 4 iAikA/enj NUMBER OF DEFICIENCY LETTERS NW' b' NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY j NEW REGISTRATION -
J PRODUCT INACTIVE -
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NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY T7PE OF FEE FEE CATEGORY 9C 9D kbM l9A U 9B AMOUNT RECEIVED CHECK NUMBER MATANN UPDATED
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'3 December 8, 1997 1
Docket No. 030-32807 License No. 37-28767-01 Susan Burnet j
President j
lsotcpe Measuring Systems, Inc.
108 Blue Ridge Drive Mars, PA 16046
SUBJECT:
INSPECTION NO. 030-32807/97-001 Dear f/
Durnet:
~
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 at the above location of activities authorized by the above Llisted NRC license. The inspection was an axamination 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 c the inspection.
j
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During the telephone conversation between you nd M Smith on November 13, i
s 1997, you discussed the need for clarification f the r'5 'stration certificates for the Model 5301 tube thickness gauge and the Mo el 5221 rofile thickness gauge as well 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
/
NRC will determine whether further NRC enforcement action is necessary to ensure tJ compliance with NRC regulatory requirements.
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HETURN ORIGlHAL TO a40024 REGION I OFFICIAL RECORD COPY 4 w % % 3ff ll ll I.lli. lill.11.1 ll anp oww
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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 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 Notice 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, d
//2-Francis M. Costello, Chief Nuclear Materials Safety Branch 3 Division of Nuclear Materials Safety Docket No.: 030-32807 License No.: 37-28767-01
Enclosure:
Notice of Violation cc w/ enclosure:
Commonwealth of Pennsylvania OFF!CIAL RECORD COPY
9 l
S. Burnet Isotope Measuring Systems, Inc Distribution: w/enct PUBLIC Nucles-Safety Information Center (NSIC)
Region : Cocket Room (w/ concurrences)
D. J. Holody, Rl S. Baggett, NMSS B. Smith, NMSS DOCUMENT NAME: R:\\WPS\\MLDL\\L3728767.01 To receive e copy of this document, Indicate in the bos: 'C' = Copy w/o ettech/enci
- E' = Copy w/ sttach/enci
- N' = No copy OFFICE DNMS/RI N
DNMS/RI DNMS/RI l
NAME Arredondo @
McGrath Ql\\n Costello3VA DATE 12/03/97 V8 12/3/97
- ff1 2/.3/97 12/ /97 OFFICIAL RECORD COPY
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 identified. In accordance with the " General Staternent of Policy and l-Procedure for NRC Enforcement Actions," (Enforcement Policy),- NUREG 1600, the violation is listed below:
L License Condition Nc.17 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures l
contained in a letter dated July 24,1992.
l 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.
l-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 Regulatoy 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 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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[.i Notico 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 financialinformation). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
- .,l NOTICE OF VIOLATION isotope Measuring Systems, Inc. -
Docket No. 030-32807 Mars, PA 16046 License No. 37-28767-01 l-l 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:
l l
License Condition No.17 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures l
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 i
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 l
letter transmitting this Notice of Violation (Notice). This reply should be clearly l
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 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 putilic.
i OFFICIAL RECORD COPY I
h)&
W 'HS
.g.
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 financialinformation). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
OFFICIAL RECORD COPY l
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U.S. NUCLEAR REGULATORY COMMISSION REGION I Docket No.
030-32807 License No.
37 28767-01 Registration No.
NR-375-D-101-B, NR-375-D-102-S, NR-375-D-103-S, and l
NR-375-D-104-S l
l Report No.
030-32807/97-001 Licensee:
Isotope Measuring Systems, Inc.
Location:
108 Blue Ridge Drive Mars, Pennsylvania 16046 Dates:
Au ust 25-27,1997 Inspectors:
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S. Arredondo Health Physicist, Region I
. }/vf/T/,[
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/.jMcGrath 5enior Health Pflysicist, Region I
'l n bJ McGrath for
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/Y vB. Smith, Health Physicist Office of Nuclear Material Safety and Safeguards, Headquarters Approved by:
8 N ' E.e /_
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F/ Costello Chief, Nuclear Materials Safety Branch 3 Bt!TU d n,W!!?.LTO S'd(;..6ved t
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EXECUTIVE
SUMMARY
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.
Oroanization 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.
Customer Site Visit The inspection included a review of one customer that uses a gauging device in tubular mill I
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 tube thickness gauge needs to be amended to clarify the limitation in the registration certificate conceming the use of the Model CDC.PE2 sealed source.
a Manufacturina. Distribution. Installation, and Servicina The licensee appears to be distributing gauges which are in compliance with the registration certificates. However, the registration certificate for the Model 5221 Series profile thickness gauges needs to be amended to indicate that the device is distributed as a specifically-licensed device.
Quality Assurance and Control Procrams (OA Proaram)
The licensee is not fully implementing the QA program provided to NRC as part of its license and device registration applications in that'it has not conducted its required audit program.
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REPORT DETAILS l
- 1. Organization and Scope Oroanization and inspection Scope a.
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 installation, relocation, and servicing of these devices. IMS recently terminated their license authorizing the distribution of these gauges to general licensees. IMS also has been issued registration certificates NR-396-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 Findinos The licensee's gauging systems are manufactured in Germany by Isotope ^ Measuring 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 i
Licensed activities are conducted in accordance with their license.
- 11. Customer Site Visit a.
Inspection Scope On Tuesday, August 26,1997, the inspectors visited ARMCO Inc., Sawhill 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 t
The inspectors were able to observe the device in operation. The inspectors also
)
observed the device being calibrated. For calibration, the device is retracted from the L
e'%
5 The inspectors discussed IMS's procedures for distribution, installation, and re; gauges. The inspectors reviewed a number of the licensee's field service repe following customers: Alcoa, Davenport, lovx ARMCO Inc., Sawhill Tubular Di Sharon, Pennsylvania; Nucor, Crawfordsville, Indiana; and Logan Aluminum, '
b.
Observations and Findinos The engineering drawings for several devices that were distributed were cor respective registration certificates. The results of these reviews are listed t 1.
The engineering drawings for the Model 5245-01 profile thickness compared. The engineering drawings for the source housing were but the overall cirawing for the C-frame was included. The diment the registration certificate matched those in the drawing.
i 2.
The engineeang drawings for five Model 5221 Series profile thic were compared. The engineering drawings for the source hour included, but the overall drawing for the C-frames and the num housings were included. The registration certificate did not int (C-frame dimensions, air gap, and number of source housing <
5221-01, which was distrib./ d to Ormet Aluminum in Hannit registration certificate contains this'information on Models SF
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5221-04,5221-05, and 5{21-5121.] However, the informat!<
5221-01 matches that as listed in the registration certificate j
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- 02. The information on the Model 5221-02 listed in the reg incorrect. The registration certificate states that Model 527 j
as a generally licensed device when IMS states that the d a specifically licensed device. The information for Modelt was as listed in the registration certificate.
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The spare parts measured by the inspectors were within tolerat i
engineering drawings provided for the registration certificate. I were measured include the end plates of the shutter, spring er barrel drive flange. Four measurements of each part were te Mitutoyo calipers and were compared to the original drawing <
Most of the service reports reviewed by the inspectors indic-operation of the gauges.
q c.
Conclusions q
The licensee appears to be distributing gauges which arr 1
registration certificates. The registration certificate for th thickness gauges needs to be amended to reflect the dr
4 process line, a calibration is performed, and the device is retumed 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 inspect 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.
1 Three labels, as described in the registration certificate for the Model 5301, were j
observed on the back of the device (facing away from the operator). These labels were i
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 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 Amersham Model CDC.PE2 cesium chloride 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 uces 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 quadrup!ed.
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 j
be used in most applications of this device.
c.
Conclusions The Model 5301 tube thickness gauge installed at Sawhill appears to have been i
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.
111. Manufacturing, Distribution, installation, and Servicing a.
Inspection Scope l
The team inspected some spare parts manufactured by IMS GMBH and other companies, as well as the engineering drawings used by IME to manufacture the devices.
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The inspectors discussed IMS's procedures for distribution, installation, and repair of i
gauges. The inspectors reviewed a number of tha licensee's field service reports for the following customers: Alcoa, Davenport, Iowa; ARMCO inc., Sawhill Tubular Division, Sharon, Pennsylvania; Nucor, Crawfordsville, Indiana; and Logan Aluminum, Kentucky.
I b.
Observations and Findinas l
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 I
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 the registration certificate matched those in the drawing.
2.
The engineering drawings for five Model 5221 Series profile thickne',s gauges were compared. The engineering drawings for the source housirgs 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 cf 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 registration certificate is incorrect. The registration certificate states that Model 5221-03 was distributed as a generally licensed device when IMS states that the device was distributed as a specifically licensed device. The information for Models 5221-04 and 5221-05 was as listed in the registration certificate.
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 l'censee appears to be distributing gauges which are ir. compliance with the registration cert!ficates. 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 (QA Program) a.
Insoection 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 registrat;vn.
b.
Observations and Findinas The quality assurance program committed to in the IMS 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.
The following is a summary of the IMS quality assurance program as described by IMS:
A.
Prior to a devico 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 device will be modified to meet the specifications in the registration certificate; IMS states that there have never j
been any deviations from the specifications in the registration certificate identified during this review. This is the only method for IMS to identify changes made to the devices; IMS GMBH does not inform IMS of changes to the devices.
B.
The device is shipped directly to the customers location and is installed by an IMS representative. This individual also installs the 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 determinations of rnaterials of construction made to verify that the device that is shipped is the same that is registered. IMS does fill out a checklist that has one block for conformance with the registration certificate, however, due to the lack of further detail in 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 performt.d to 1
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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r-i Conclusions 1
It apperrs 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 i
by an individual not normally involved in the QA program. IMS indicated that they nave not pe formed such audits.
V. Management Meetings The inspectors presented the inspection resuits to the company president at the conclusion of the inspection. The inspectors discussed the one general area of noncompliance and the amendments needed to the registration certificates. The licensee acknowledged the findings presented and indicated that corrective action would be taken.
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8 PARTIAL LIST OF PERSONS CONTACTED l
George Burnet, Radiation Safety Officer Susan Burnet, Prerident i
Susan Englehard', Consultant, Engelhardt & Associates, Inc.
j Harley Tennant, i.Snager - Engineering Services, ARMCO Inc.
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