Quality Assurance Policy in DOE

Debbie Rosano Director, Office of Quality Assurance (AU-33)September 14, 2015

Presented to: 2015 Analytical Services Program

Workshop

Office of Environment, Health, Safety and Security

AU Organizational Chart

Office of Environment, Health, Safety and Security

AU-30

Office of Environment, Health, Safety and Security

AU-33 Mission

• Establishes and maintains QA and technical standards policies, requirements, and guidance for the Department

• Serves as DOE's corporate resource to ensure that products and services meet or exceed the Department’s quality objectives.

• Provide assistance to Departmental elements and contractors in the interpretation and implementation of DOE QA and technical standards requirements.

Office of Environment, Health, Safety and Security

QA Topical Areas • Software QA including Safety Software

• Suspect/Counterfeit Items– IAEA TECH DOC 1169 “Managing Suspect and Counterfeit Items in

Nuclear Facilities and Activities”

• Commercial Grade Dedication (CGD)

• High Efficiency Particulate Air Filters (HEPA)– FTF– DOE-STD- 3020 and DOE-STD-3025

• DOE Technical Standards including Functional Area Qualification Standards

Office of Environment, Health, Safety and Security

Activities

• Assistance with Assessments/Audits in QA topical areas

• Maintenance of QA policy and associated guides

• Participation in voluntary consensus standards bodies (ASME, IAEA, ASCE, AISC)

• Participate in DOECAP Audits

Office of Environment, Health, Safety and Security

DOE Order 414.1D

• Update and Revise Order – Update definitions, responsibilities (creation of AU and

EA)– Explore potential to add environmental QA area

• Associated Guides– DOE G 414.1-1C – Management and Independent

Assessment Guide– DOE G 414.1-2B – Quality Assurance Program Guide– DOE G 414.1-4 – Safety Software Guide

Office of Environment, Health, Safety and Security

Quality Council

• Establishing the DOE Quality Council– Federal and Contractor employees from HQ, Field, DOE Laboratories

• Purpose: To improve the Department’s QA posture by promoting communication, consistency, and collaboration across the DOE-complex

• Role for the Council is to assist the DOE in:– Identifying cross-cutting QA issues– Evaluating effectiveness of lessons learned and identify common

trends– Recommend QA notifications via alerts and bulletins– Provide input to QA policy developers

Office of Environment, Health, Safety and Security

DOE Technical Standards Program (TSP)

Purpose of the Program:

• Implements Public Law 104-113 and OMB A-119 through DOE TSP and DOE Order 252.1A, Technical Standards Program.

• Provides infrastructure for employing Voluntary Consensus Standards (VCSs), when applicable, and for developing internal DOE Technical Standards when necessary.

• DOE Technical Standards: - Internally developed DOE Technical Standards are written/processed ONLY if

VCSs are not available or do not apply to DOE.

- DOE needs are so specialized that, in some cases, the information required goes beyond what a VCS is capable of providing in a timely manner.

- VCSs sometimes represent compromises on technical requirements that DOE cannot accept.

Office of Environment, Health, Safety and Security

DOE Document Hierarchy

PolicyDOE Policy

RequirementsRules/Orders/Notices

GuidanceImplementation Guides

Technical StandardsDOE Standards, DOE Handbooks and DOE

Specifications

Technical Standards serve as the foundation of the DOE document hierarchy and facilitate implementation of DOE policy and requirements

Departmental Directives System

Technical Standards Program

Office of Environment, Health, Safety and Security

New DOE Technical Standard

• AU-21 led the development of a new technical standard

• “Requirements for Proficiency Testing and Evaluation of Environmental Analytical Laboratories”

• Provides requirements for proficiency testing samples that meet DOE’s expectations for a proficiency evaluation program

• Roundtable discussion will follow this presentation

Office of Environment, Health, Safety and Security

Questions

Office of Environment, Health, Safety and Security

Contact Information

Debbie Rosano Director, Office of Quality Assurance(301) 903-8177Debbie.Rosano@hq.doe.gov