DOE Nuclear Regulatory Framework and Comparisons of

Nuclear & Aerospace Quality Requirements

Gustave (Bud) DanielsonDuli C. AgarwalU.S. Department of Energy

NASA Quality Leadership Forum

March 20, 2013

Purpose

Describe DOE Nuclear Regulatory Framework

DOE and SAE Counterfeit Prevention Requirements

ASME NQA Committee’s Current Projects

Discuss Nuclear and Aerospace Quality Assurance

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U.S Department of EnergyOrganizational Chart

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Office of the SecretaryDr. Steven Chu, Secretary

Daniel B. PonemanDeputy Secretary

Melvin G. Williams Jr.Associate Deputy Secretary

DEPARTMENT OF ENERGY

Office of the Under Secretary for Nuclear Security

Thomas P.D’ AgostinoUnder Secretary for

Nuclear Security

Health, Safety and Security

July 2012

DOE Mission

SCIENCE & INNOVATION

ENERGY NUCLEAR SAFETY AND SECURITY

MANAGEMENT AND OPERATIONAL EXCELLENCE

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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.

DOE Quality Assurance Framework

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

DOE Order 414.1D, Quality Assurance (Nuclear and non-nuclear Facilities)– 10 QA Criteria– Suspect/Counterfeit Items (SC/I)– Nuclear Safety Software– National & International Standards

DOE G 414.1-2B, Quality Assurance Program Guide

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DOE S/CI Prevention

DOE Order 414.1D, Attachment 3, Suspect/Counterfeit Items Prevention– Program, responsibilities, inspection, control– Once adopted, civil/criminal/contract penalties for non

compliance DOE O 232.2, Occurrence Reporting and Processing of

Operations Information International Atomic Energy Agency IAEA-TECDOC-1169 DOE Awareness Training Manual, 2007 DOE Order 221.1A,Reporting Fraud Waste & Abuse to the

Office of the Inspector General

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Why is SC/I Prevention Important to DOE?

Pretreatment Facility

Pretreatment Facility

Analytical LaboratoryAnalytical Laboratory

Low-Activity Waste FacilityLow-Activity

Waste Facility

High-Level Waste

High-Level Waste

Balance of Facilities

Balance of Facilities

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Low-Activity Waste VitrificationFacility

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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DOE Issues and Challenges

DOE has a mature program (2004). “S/CI Focus Group” formed to avoid complacency and address new S/CI risks, tactics, sources

Existing programs may need to adapt– Expand focus: mechanical & hardware to electronics – New Government wide initiatives– Federal Acquisition Regulations changes– NDAA 2012/13– Common reporting system– Update training– New standards and technologies

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Suspect/Counterfeit and Defective Items

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DOE & SAE AS5553A S/CI Requirements

Similarities Formal planning, implementation and documentation

– DOE “Quality Assurance Program” includes S/CI process – AS5553A Fraudulent/Counterfeit EEE Parts “Control Plan”

under an SAE AS9100C “Quality Management System”.

Tailored approach to S/CI prevention– DOE “graded approach”– AS5553A “risk assessment”

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Similarities (Continued)

Training

Reference outside guidance– DOE references an IAEA standard for implementing DOE

S/CIs requirements in nuclear industry– SAE references various government and industry

standards including military (MIL) standards and ANSI standards.

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Comparison Example

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DOE O 414.1D Attachment 3 SAE AS5553A Comment

2 c - The QAP requires training and informing managers, supervisors, and workers on S/CI processes and controls (including prevention, detection, and disposition of S/CIs).

4.1.1 -Personnel Training

Meets Fully. Both DOE O 414.1D and SAE AS5553A require training on S/CI prevention.

Recommendation: None.

DOE & SAE AS5553A Differences

DOE requirements not found in the SAE standard:

Engineering involvement in procurement specifications, inspection, testing, maintenance, replacement, equipment modification, and safety/non-safety applications.

Trending analysis and review of lessons learned to improve S/CI prevention process.

Cost-benefit impact to support engineering evaluations of installed items.

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DOE Requirements not found in SAE standard:

Report occurrences– Prime contractors, via an internal system – DOE shares certain reports to GIDEP

Research information– DOE S/CI website references prior to purchase and installation

Evaluate storage areas for “legacy” and/or installed S/CIs

Evaluate safety and non-safety applications

Differences(Continued)

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SAE requirements not found in DOE Order:

Maximize parts availability– Authentic, originally designed and/or qualified parts throughout

product’s life cycle, including management of parts obsolescence.

Detailed purchasing process– Including procurement specifications, contract and approach.

Supply chain history and traceability – Documented evidence of EEE parts’

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Differences(Continued)

SAE requirements not found in DOE Order:

Product assurance of purchased and returned EEE parts

Material control of scrap or surplus EEE parts or assemblies

Detailed implementation appendices for parts availability, purchasing process, supply chain traceability, examples of procurement contract, product assurance, and material control

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Differences(Continued)

Comparison Example

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DOE O 414.1D Attachment 3 SAE AS5553A Comment

2 f - The QAP requires engineering evaluations to be used in the disposition of identified S/CIs installed in safety applications/systems or in applications that create potential hazards. Evaluations must consider potential risks to the environment, the public and workers along with a cost/benefit impact, and a schedule for replacement (if required).

No corresponding requirements in SAE AS5553A.

No Similar Requirement. SAE AS5553A does not specify the use of engineering to evaluate the disposition of identified S/CIs installed in safety applications/systems as well as conducting cost/benefit impacts and a schedule of replacement.

Recommendation: Include DOE requirements on engineering evaluations, cost/benefit analysis, and replacement schedule for previously installed S/CIs.

ASME “NQA” Committee

ASME Committee on Nuclear Quality Assurance

ASME NQA-1-2012, Quality Assurance Requirements for Nuclear Facility Applications

NQA-1 has comparisons with:– DOE 10 CFR 830 & Order 414.1– ISO 9001-2008– IAEA GS-R-3 (in collaboration with IAEA)– SAE???

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NQA S/CI Projects

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

Work is in progress

Target publication in the 2014 Edition

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Conclusions

Potential outcomes from understanding compatibility of nuclear & aerospace requirements.– Provide a basis for evaluating a suppliers and contractors’ S/CI

program that is compliant with DOE or SAE requirements– Suppliers and Contractors can use as a tool for self assessment– Facilitate expansion of supplier base– Increase confidence in transferability of supplier S/CI programs– Support upcoming FAR changes for S/CI reporting across

agencies

Groundwork for NQA + SAE collaborative project

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Thank you for your time and attention!!

Questions?

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Contact Information

Bud Danielson DOE Chief of Nuclear Safety StaffASME Committee on Nuclear Quality Assurance, Vice Chair Phone: 301-903-2954Email: bud.danielson@hq.doe.gov

Duli AgarwalDOE Office of Quality AssuranceASME NQA Subcommittee on Applications, Vice Chair Phone: 301-903-3919Email: duli.agarwal@hq.doe.gov

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