ML16039A269
| ML16039A269 | |
| Person / Time | |
|---|---|
| Site: | Oconee, Point Beach, Cooper, Susquehanna, Brunswick, FitzPatrick  |
| Issue date: | 02/03/2016 |
| From: | Alexandra Smith Nutherm International |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| Download: ML16039A269 (4) | |
Text
02/03/2016 U.S. Nuclear Regulatory Commission Operations Center Event Report Pa*e 1 Part 21 (PAR)
Event #
50359 Rep Org: NUTHERM INTERNATIONAL, INC Notification Date / Time: 08/01/2014 15:16 (EDT)
Supplier: NUTHERM INTERNATIONAL, INC Event Date / Time: 08/01/2014 (CDT)
Last Modification: 02/03/2016 Region:
3 Docket #:
City: MOUNT VERNON Agreement State:
Yes County:
License #:
State: IL NRC Notified by: ADRIENNE SMITH Notifications:
SILAS KENNEDY R1DO HQ Ops Officer: JEFF ROTTON GEORGE HOPPER R2DO Emergency Class: NON EMERGENCY CHRISTINE LIPA R3DO 10 CFR Section:
VIVIAN CAMPBELL.
R4DO 21.21 (a)(2)
INTERIM EVAL OF DEVIATION PART 21 GROUP EMAIL POTENTIAL ISSUE REGARDING INCORRECT INDUSTRIAL IRRADIATION DOSE The following information was received via facsimile:
Nutherm International, Inc. was notified by Steris Isomedix Services that the applied radiation dose reported on their Component Irradiation Certificates did not account for all uncertainties involved (i.e. density of unrelated products in carriers, off-carrier location within the irradiator and Cobalt-60 source decay). This issue was originally identified as part of NRC Inspection Report No. 99901445/2014-201.
"Nutherm International, Inc. is conducting an evaluation to determine whether a defect as defined by 10 CFR Part 21 exists. The impact of this failure to account for all uncertainties will be evaluated for all projects that required
- data from any sample irradiated by this supplier.
"At the conclusion of the evaluation, any customer impacted by this issue will be notified and the U.S. Nuclear Regulatory Commission will be notified in accordance with the requirements of 10 CFR Part 21.21.
"If you have any questions regarding this issue please do not hesitate to contact Adrienne Smith, Quality Assurance Manager at 618-244-6000, adrienne~smith@nutherm.com."
The supplier will update this report when the evaluation is complete. This event report was originally received by the NRC Operations Center on 08/01/2014
- *
- UPDATE AT 1727 ON 8/31/2015 FROM THOMAS STERBIS TO MARK ABRAMOVITZ * *
- The following information was received via fax:
02/03/2016 U.S. Nuclear Re*ulato* Commission Operations Center Event Report Pa*e 2
'Nutherm has identified one customer where there is a potential impact to the conclusions of the equipment qualification that Nutherm does not have the capability to perform further evaluations to determine if a defect exists.
"Nutherm International,-Inc. performed equipment qualification testing for SOR, Inc., Lenexa, KS under SOR, Inc.
Purchase Order number 166984 which included irradiation performed by Steris Isomedix. Based on the location of the sample during the irradiation and the total variability for this location provided by Steris Isomnedix, Nutherm has verified that the test specimens received a minimum irradiation dose that meets the customer's TID requirement but does not meet the customer's TID requirement with the 10 percent IEEE 323 margin.
"In accordance with the requirements of 10 CFR Part 21.21, SOR Inc. has been notified regarding this issue to allow them to evaluate this deviation or failure to comply."
Notified the R4DO (Werner), NMSS Events Resource (via e-mail), and the Part-21 Group (via e-mail)
- ** UPDATE FROM NUTHERM INTERNATIONAL, INC. AT 1658 EST ON 2/3/16 **
- The following information is summarized from the information received from Nutherm International, Inc. via fax:
Nutherm has completed their evaluation of past equipment qualifications and identified that the following U.S.
facilities may be impacted: Cooper Nuclear Plant, Oconee Station, J.A. Fitzpatrick Station, Point Beach Nuclear, Brunswick Nuclear, Susquehanna Nuclear and Electric Power Research Institute.
Nutherm has notified the affected facilities.
Notified RI DO (Rogge), R2D.O (Musser), R30O (Kozak), R4DO (Pick) and the Part 21 group via email.
(9 02/03/2016 1:56 PM 000320615PM14154847068
-÷ 13018165151 D01 501 S* 11th fle Moint Wnzu, IL 62 RhwoaS.824l 6
Faui&2414. 1 Februay 3,2016 U.S. Nuclear Reuatr Commnission washngon,,IC 20555.0001 Anttiour Document Control Desk
Subject:
Fnal Updateon Ptnta 10 CFRPat 21 Issue Tzunit n dutra InflationDose Refercue: 1) LaterThua Sterbis toNRC datedS&'12014-EveatNo. 50359 -Log Number 2014-56-(00 Potenia Issue Reutn Incorrnc Industril Radiaton Dose
- 2) Industy Gukidan Position Paper: Repodngt the 2014 Stals 10CFR Part 21, IEEEFNUGEQ, Revisio 0, dated June 2015
- 3) Lae Thu Stbito NRC dae 8t31t2015 - Event No. 50359-Log Nwnbr" 2014-56-01 Nudheam Internaional, Inc. was notified by STERIS lsomedix Services, Whppn, New Jersey that the applied radiation dose reore on their Component Irradiation Certifcates did not accoimt for elU uncerainties involved (iAe. density of unreated product in carriers, off-carrier location within the irrdiator and Cobalt-60 sonrc decay). This issue was originaly identified as part of NRC Inspection Reor No.
99901445i2014-201.
Nuthcnn notified the NRC in Reeec 1) above thatl Nuthemn would conduct an evaluation ofall past equipment qualifications performed by Nuthemn to detemine, on a case by case basis, ifany customer is impcte by this issue. This evahluaion is now complete.
In addition to the customer identified in Reeec 3), Nutherrn les idntfedother custonmer whee thr is a potetal impact tothe conclusionsof the equipmentqualification. Ntherm does not have the capability to perform fluer evaluations to deemineif fa defect exists.
The cutmonmer were identified as follows:
Nebraska Public Power District - Cooper Nuclear Station Duke Energy-Oconee Station EeryNucea~r-Fitquric Station NextEra Point Beach - NextEra Energy Point Beach Nuclear Progress Enrg - Brunswick Nuclear Plant PGS Enrique Maria Hienro S.L. - C.N. Cofiuntes Taint Energy, LLW - Susquehamna Nuclear Station Electric Powe Research Institute In all case wham a customer identified a minimum iraiton dose, the dose received nut th custoe' TB) eurm ent but did not meet the customer's TID requirement with the 10% IEEE 323 margin.
(]) 02/03/2016 1:56 PM D020/0615PM14154847068 413018165151 Page, 2 Feblruay3, 2016 hI accordance with the requirements of 10CFR Part 21-.21 these customeas have been notified regarding this issue to ailow them to evaluat this deviation or failure to comply.
Nuien has complete*d its re'view of ail potantiafy imace work and considers thi issue closed with regrdto thePart2l review.
If you have any questions regardin this issue please do not hesitat to contact Adrienne Smith, Quality Assurance Manager at 613-244-6000 x3034, adrienne..snith~nutlwrn.com.
Sincerely, NUTHERM INTERNATIONAL, lIne.
WB/ab
02/03/2016 U.S. Nuclear Regulatory Commission Operations Center Event Report Pa*e 1 Part 21 (PAR)
Event #
50359 Rep Org: NUTHERM INTERNATIONAL, INC Notification Date / Time: 08/01/2014 15:16 (EDT)
Supplier: NUTHERM INTERNATIONAL, INC Event Date / Time: 08/01/2014 (CDT)
Last Modification: 02/03/2016 Region:
3 Docket #:
City: MOUNT VERNON Agreement State:
Yes County:
License #:
State: IL NRC Notified by: ADRIENNE SMITH Notifications:
SILAS KENNEDY R1DO HQ Ops Officer: JEFF ROTTON GEORGE HOPPER R2DO Emergency Class: NON EMERGENCY CHRISTINE LIPA R3DO 10 CFR Section:
VIVIAN CAMPBELL.
R4DO 21.21 (a)(2)
INTERIM EVAL OF DEVIATION PART 21 GROUP EMAIL POTENTIAL ISSUE REGARDING INCORRECT INDUSTRIAL IRRADIATION DOSE The following information was received via facsimile:
Nutherm International, Inc. was notified by Steris Isomedix Services that the applied radiation dose reported on their Component Irradiation Certificates did not account for all uncertainties involved (i.e. density of unrelated products in carriers, off-carrier location within the irradiator and Cobalt-60 source decay). This issue was originally identified as part of NRC Inspection Report No. 99901445/2014-201.
"Nutherm International, Inc. is conducting an evaluation to determine whether a defect as defined by 10 CFR Part 21 exists. The impact of this failure to account for all uncertainties will be evaluated for all projects that required
- data from any sample irradiated by this supplier.
"At the conclusion of the evaluation, any customer impacted by this issue will be notified and the U.S. Nuclear Regulatory Commission will be notified in accordance with the requirements of 10 CFR Part 21.21.
"If you have any questions regarding this issue please do not hesitate to contact Adrienne Smith, Quality Assurance Manager at 618-244-6000, adrienne~smith@nutherm.com."
The supplier will update this report when the evaluation is complete. This event report was originally received by the NRC Operations Center on 08/01/2014
- *
- UPDATE AT 1727 ON 8/31/2015 FROM THOMAS STERBIS TO MARK ABRAMOVITZ * *
- The following information was received via fax:
02/03/2016 U.S. Nuclear Re*ulato* Commission Operations Center Event Report Pa*e 2
'Nutherm has identified one customer where there is a potential impact to the conclusions of the equipment qualification that Nutherm does not have the capability to perform further evaluations to determine if a defect exists.
"Nutherm International,-Inc. performed equipment qualification testing for SOR, Inc., Lenexa, KS under SOR, Inc.
Purchase Order number 166984 which included irradiation performed by Steris Isomedix. Based on the location of the sample during the irradiation and the total variability for this location provided by Steris Isomnedix, Nutherm has verified that the test specimens received a minimum irradiation dose that meets the customer's TID requirement but does not meet the customer's TID requirement with the 10 percent IEEE 323 margin.
"In accordance with the requirements of 10 CFR Part 21.21, SOR Inc. has been notified regarding this issue to allow them to evaluate this deviation or failure to comply."
Notified the R4DO (Werner), NMSS Events Resource (via e-mail), and the Part-21 Group (via e-mail)
- ** UPDATE FROM NUTHERM INTERNATIONAL, INC. AT 1658 EST ON 2/3/16 **
- The following information is summarized from the information received from Nutherm International, Inc. via fax:
Nutherm has completed their evaluation of past equipment qualifications and identified that the following U.S.
facilities may be impacted: Cooper Nuclear Plant, Oconee Station, J.A. Fitzpatrick Station, Point Beach Nuclear, Brunswick Nuclear, Susquehanna Nuclear and Electric Power Research Institute.
Nutherm has notified the affected facilities.
Notified RI DO (Rogge), R2D.O (Musser), R30O (Kozak), R4DO (Pick) and the Part 21 group via email.
(9 02/03/2016 1:56 PM 000320615PM14154847068
-÷ 13018165151 D01 501 S* 11th fle Moint Wnzu, IL 62 RhwoaS.824l 6
Faui&2414. 1 Februay 3,2016 U.S. Nuclear Reuatr Commnission washngon,,IC 20555.0001 Anttiour Document Control Desk
Subject:
Fnal Updateon Ptnta 10 CFRPat 21 Issue Tzunit n dutra InflationDose Refercue: 1) LaterThua Sterbis toNRC datedS&'12014-EveatNo. 50359 -Log Number 2014-56-(00 Potenia Issue Reutn Incorrnc Industril Radiaton Dose
- 2) Industy Gukidan Position Paper: Repodngt the 2014 Stals 10CFR Part 21, IEEEFNUGEQ, Revisio 0, dated June 2015
- 3) Lae Thu Stbito NRC dae 8t31t2015 - Event No. 50359-Log Nwnbr" 2014-56-01 Nudheam Internaional, Inc. was notified by STERIS lsomedix Services, Whppn, New Jersey that the applied radiation dose reore on their Component Irradiation Certifcates did not accoimt for elU uncerainties involved (iAe. density of unreated product in carriers, off-carrier location within the irrdiator and Cobalt-60 sonrc decay). This issue was originaly identified as part of NRC Inspection Reor No.
99901445i2014-201.
Nuthcnn notified the NRC in Reeec 1) above thatl Nuthemn would conduct an evaluation ofall past equipment qualifications performed by Nuthemn to detemine, on a case by case basis, ifany customer is impcte by this issue. This evahluaion is now complete.
In addition to the customer identified in Reeec 3), Nutherrn les idntfedother custonmer whee thr is a potetal impact tothe conclusionsof the equipmentqualification. Ntherm does not have the capability to perform fluer evaluations to deemineif fa defect exists.
The cutmonmer were identified as follows:
Nebraska Public Power District - Cooper Nuclear Station Duke Energy-Oconee Station EeryNucea~r-Fitquric Station NextEra Point Beach - NextEra Energy Point Beach Nuclear Progress Enrg - Brunswick Nuclear Plant PGS Enrique Maria Hienro S.L. - C.N. Cofiuntes Taint Energy, LLW - Susquehamna Nuclear Station Electric Powe Research Institute In all case wham a customer identified a minimum iraiton dose, the dose received nut th custoe' TB) eurm ent but did not meet the customer's TID requirement with the 10% IEEE 323 margin.
(]) 02/03/2016 1:56 PM D020/0615PM14154847068 413018165151 Page, 2 Feblruay3, 2016 hI accordance with the requirements of 10CFR Part 21-.21 these customeas have been notified regarding this issue to ailow them to evaluat this deviation or failure to comply.
Nuien has complete*d its re'view of ail potantiafy imace work and considers thi issue closed with regrdto thePart2l review.
If you have any questions regardin this issue please do not hesitat to contact Adrienne Smith, Quality Assurance Manager at 613-244-6000 x3034, adrienne..snith~nutlwrn.com.
Sincerely, NUTHERM INTERNATIONAL, lIne.
WB/ab