1. Quality Assurance Policy in DOE Debbie Rosano Director, Office of Quality Assurance (AU-33) September 14, 2015 Presented to: 2015 Analytical Services Program Workshop

2. Office of Environment, Health, Safety and Security AU Organizational Chart

3. Office of Environment, Health, Safety and Security AU-30

4. 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.

5. 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

6. 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

7. 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

8. 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

9. 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.

10. Office of Environment, Health, Safety and Security DOE Document Hierarchy Policy DOE Polic y Requirements Rules/Orders/Notices Guidance Implementation Guides Technical Standards DOE 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

11. 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

12. Office of Environment, Health, Safety and Security Questions

13. Office of Environment, Health, Safety and Security Contact Information Debbie Rosano Director, Office of Quality Assurance (301) 903-8177 Debbie.Rosano@hq.doe.gov