Vienna, Austria September 9, 2014

Duli C. Agarwal, PE Office of Quality Assurance (AU-33)

U.S. Department of Energy Chair, NQA-1 Subcommittee on Applications

Duli.Agarwal@hq.doe.gov

DOE Nuclear Suspect/Counterfeit Item Framework

DOE Suspect/Counterfeit Item (S/CI) Framework Overview

• DOE Organization and Mission

• DOE Nuclear Facility Portfolio

• DOE Quality Assurance (QA) Requirements

• DOE Counterfeit Item Prevention Program

• DOE issues and challenges related to counterfeit item prevention

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U.S. Department of Energy

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DOE Mission

SCIENCE & INNOVATION

ENERGY NUCLEAR SAFETY & SECURITY

MANAGEMENT &

OPERATIONAL EXCELLENCE

Catalyze the timely, material, and efficient transformation of the Nation’s energy system and secure U.S. leadership in clean energy technologies.

Maintain a vibrant U.S. effort in science and engineering as a cornerstone of our economic prosperity with clear leadership in strategic areas.

Enhance nuclear security through defense, nonproliferation, and environmental efforts.

Establish an operational and adaptable framework that combines the best wisdom of all Department stakeholders to maximize mission success.

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Environmental Management (EM)

~108 facilities ~$20 billion new projects

NNSA

~72 facilities

~$15–20 billion new projects

Chief of Nuclear Safety

Chief of Defense Nuclear Safety

Nuclear Energy (NE) ~20 facilities

Chief of Nuclear Safety

Science ~18 facilities

Nuclear Facility Portfolio

Under Secretary for

Energy & Science

Under Secretary for

Nuclear Security

Under Secretary for

Management & Performance

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• Fuel Cycle R&D

• Nuclear Fuel Disposition R&D

• Uranium Management & Policy

Deputy Asst. Secretary for

Science and Technology Innovation

Nuclear Energy (NE) R&D Portfolio

Assistant Secretary for

Nuclear Energy

Deputy Asst. Secretary for

Nuclear Reactor Technologies

Deputy Asst. Secretary for

Fuel Cycle Technologies

• Advanced Simulation

• Innovative Nuclear Research

• LWR Technologies

• Advanced Reactor Technologies

• Space & Defense

Power Systems

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• 10 CFR Part 830, Nuclear Safety Management (QA & Safety Basis)

– 10 QA Criteria

– Use voluntary consensus standards

– Integrate the quality assurance criteria with the safety management system

• DOE Order 414.1D, Quality Assurance (Nuclear & Non-Nuclear Facilities)

– 10 QA Criteria

– Suspect/Counterfeit Items (S/CI)

– Nuclear Safety Software

– Use of National and International Standards

• DOE G 414.1-2B, Quality Assurance Program Guide

– Provides enhanced understanding on the 10 QA Criteria, and Graded Approach/Application

Quality Assurance Regulatory Framework

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S/CI Requirements

• DOE Order 414.1D, Attachment 3, Suspect/Counterfeit Items Prevention

– Program, responsibilities, inspection, control

– Once adopted, civil/criminal/contract penalties for noncompliance

• DOE O 232.2, Occurrence Reporting and Processing of Operations Information

• DOE Awareness Training Manual, 2007

• DOE Order 221.1A, Reporting Fraud Waste & Abuse to the Office of the Inspector General

• IAEA-TECDOC-1169, Managing suspect and counterfeit items in the nuclear industry (This is guidance and not a requirement)

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Suspect/Counterfeit Item Framework

Pretreatment Facility

Analytical Laboratory

Low-Activity Waste Facility

High-Level Waste

Balance of Facilities

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Why is S/CI Prevention Important to DOE?

Waste Treatment Plant – currently under construction

Mixes low-activity rad-waste in glass

70% Construction Complete

Low-Activity Waste Facility exterior

Low-Activity Waste carbon bed adsorber

Low-Activity Waste transfer tunnel

Overhead pipe racks for steam and glass formers

200-ton Low-Activity Waste melter

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Low-Activity Waste Vitrification Facility

• Prevention and detection of Suspect/Counterfeit Items in the DOE supply chain. In 2012, DOE formed S/CI Focus Group to address new S/CI risks, tactics, and sources.

• Reporting of S/CI. U.S. Federal Agencies formed a task group to determine if revisions are needed to address S/CI.

• Implementation of the Commercial Grade Dedication Process requirements. The Quality Council will work with EFCOG to develop a methodology with examples (15–20 examples, i.e., diesel generator).

• Purchasing Practices. National Defense Authorization Act (NDAA) revision emphasizes purchase from Original Component Manufactures or authorized distributors.

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S/CI Issues and Challenges

• DOE established requirements for preventing counterfeit items in 2004. The S/CI Focus Group is working to identify improvements and avoid complacency to address new S/CI risks.

• Existing programs may need to adapt the following:

Expand focus: mechanical and hardware to electronics

New Government-wide initiatives

FAR Part 46 proposal to expand reporting of nonconforming items to include S/CI and require higher-level contract quality requirements.

NDAA 2012/13

Update DOE training

New standards and technologies

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S/CI Initiatives for Improvement

External S/CI Efforts Impacting DOE

2011

*TPD – Task Planning Document

2013

Documented history of DOE’s S/CI awareness and initiatives

≈1989–2010 NDAA 2012 is enacted

December 2011

DOE Quality Council forms S/CI Focus Group

January 2012

Quality Council approves S/CI

Prevention TPD*

April 2012

FAR Case 2012-032

August 2012

FAR Case 2013-002

October 2012

1989

The White House forms an interagency S/CI Initiative

2011

HSS Quality Council

2012 JAN

DEC APR OCT AUG

JAN

2014

IAEA TECDOC-1169

Revision

June 2014

NDAA 2013 is enacted

January 2013

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Example of S/CI at a DOE site

• Reporting Criteria: 4C(3) – Discovery of any defective item or material, other than a suspect/counterfeit item or material, in any application whose failure could result in a loss of safety function, or present a hazard to public or worker health and safety. (DOE O 232.2 requirement)

• The scaffold tube end fitting failed internal to the tubing and showed no external signs of damage, cracking, or corrosion. The metallic face of the break was significantly discolored over the vast majority of the surface. The pole was stenciled in black as being made in China for STEPUP Scaffolding. Random scaffold poles with similar markings were cut to expose the end fitting and several of the castings were found to be out of round and/or cracked.

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Example S/CI ORPS Report

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Example S/CI ORPS Report

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Example S/CI ORPS Report

NQA Committee S/CI Projects for NQA-1

• The NQA Committee approved a project to develop requirements for the prevention of suspect, counterfeit, and fraudulent items.

• The Part III guidance inclusion is expected to be published in the NQA-1 2014 edition

• The committee is also looking to include Part II requirements into NQA-1, but it is in the preliminary stages.

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• DOE has a complex and wide ranging mission.

• DOE has a large Nuclear Facility Portfolio, including R&D facilities.

• DOE has requirements enforcing S/CI prevention in the supply chain.

• There are continuous efforts to improve through the S/CI prevention program by participating with consensus standard bodies such as ASME, IAEA, and other U.S. Federal agencies, such as NRC, etc.

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Summary

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