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1 | October 24, 2014 | © 2014 Curtiss-Wright
Nuclear Division
Steris Notice of Nonconformance
Marie Nemier
2 | October 24, 2014 | © Curtiss-Wright
Presentation Summary
Overview of NRC Non-conformance 99901445/2014-201-01 to Steris
QualTech NP response to notification from Steris
Actions has QualTech NP taken
Industry Task Force
Description of products impacted
Path forward
3 | October 24, 2014 | © Curtiss-Wright
NRC Non-conformance 99901445/2014-201-01
• From April 1 to April 3, 2014, the U.S. Nuclear Regulatory
Commission (NRC) staff conducted an inspection at the
Steris Isomedix (Steris) facility in Whippany, NJ.
• This inspection specifically evaluated Steris’s control
over radiation testing services associated with the
equipment qualification testing of nuclear safety-related
components.
• The NRC issued Non-conformance 99901445/2014-201-01
on May 15, 2014.
4 | October 24, 2014 | © Curtiss-Wright
NRC Non-conformance 99901445/2014-201-01
• Steris failed to account for all uncertainties in the
process as related to the irradiation of nuclear
components such as density of other product placed into
the irradiation chamber, source decay, and location
within the irradiation chamber.
• As a consequence, the actual radiation dose applied to
nuclear components could be less than what was
requested by Steris’s customers.
5 | October 24, 2014 | © Curtiss-Wright
QualTech NP Response to Notification
• QualTech NP received notification on June 23, 2014.
• The nonconformance impacts three QualTech NP
facilities:
• Huntsville, AL (formerly EGS & Scientech)
• Cincinnati, OH (formerly Farwell & Hendricks & Trentec)
• Newmarket, ON Canada (formerly NPSI Amidyne)
• Condition Report C14-559 was opened to track and
document QualTech NP’s investigation of the problem.
6 | October 24, 2014 | © Curtiss-Wright
QualTech NP Response to Notification
• Notified Rusty Dekleine – Curtiss Wright (CW) Nuclear
Division Corporate QA Director
• Verified that all CW Nuclear companies were notified
• QualTech NP was assigned as the lead for CW to contact
industry leadership to suggest that an industry group be
formed to respond to the nonconformance uniformly
• QualTech NP contacted John White, Chair of IEEE
Subcommittee 2 on Qualification
7 | October 24, 2014 | © Curtiss-Wright
Industry Task Force
• Task Force was formed in late July 2014 and several
conference calls were held in August and September.
• Task Force includes members from utilities,
manufacturers, NUGEQ, NEI and EQ test labs.
• Goal of the Task Force is to provide a unified &
consistent response to the Nonconformance.
• Industry Task Force met at the Steris facility on
September 23, 2014.
8 | October 24, 2014 | © Curtiss-Wright
Industry Task Force
• General Topics for Discussion 1. An overview of how nuclear test specimens are irradiated at
the facility, how the total received dose is determined, what procedures are applied to the irradiation process
2. Explanation of Industry Perspective
3. A general discussion on the relationship between the dose rate variability that is described in the Part 21 and dosimeter system uncertainty
4. Scope and timing of changes that occurred in 2003 and why process conditions cannot be recreated prior to 2003
5. How to quantify or provide a reasonable bounding value for the dose rate variability prior to 2003
6. Assurance of complete and accurate information going forward
9 | October 24, 2014 | © Curtiss-Wright
QualTech NP Products Potentially Impacted
• QualTech NP has been using Steris as a vendor for
irradiation services for over 20 years
• Steris was used to support EQ test programs for a variety
of projects
• Supply of dedicated parts to utilities
• Examples: Molded case circuit breakers, switches, relays,
valves, motor starters & contactors
• EQ test programs for various manufacturers or utilities
• QualTech NP products
• Trentec airlock seals
• EGS electrical connection products (limited impact)
10 | October 24, 2014 | © Curtiss-Wright
QualTech NP Products Potentially Impacted
Geographic Impact
• Products and services have been supplied to:
• All US reactors
• US DOE sites
• Korea
• Canada
• Europe
• China
11 | October 24, 2014 | © Curtiss-Wright
Path Forward
• Continue to participate on Industry Task Force
• Upon release of Steris position paper, evaluate impact on
QualTech NP EQ programs and notify customers as
needed
• Participate on working group to determine path forward
to avoid future occurrences
• Apply lessons learned to EQ programs going forward
• Determine if any changes or improvements need to be
made to EQ procedures
• Inform and train employees
12 | October 24, 2014 | © Curtiss-Wright
www.qualtechnp.cwfc.com
Marie Nemier
Director of Operations-EQ/CGD
513.528.7900 ext.2137
