1. STANDARDS OVERVIEW Wednesday, April 30, 2015 KAREN RECZEK, STANDARDS COORDINATION OFFICE, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY karen.reczek@nist.gov 1

2. Today’s Discussion  Part 1: Standards Overview  Part 2: Standards and the OSAC 2

3. Definitions of a Standard Common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices. (NTTAA of 1995 and OMB Circular A-119 of 1998) Market-driven technical specification for a product, service, person, process or system with which compliance is voluntary. (Anonymous) 3

4. Types of Standards documentary (technical) standards physical (measurement) standards Certified reference material to aid with calibration of measurements Specific requirements for the operation of a laboratory related to management system and competence 4

5. The U.S. Standards System The U.S. standards system is voluntary, decentralized, sector and market driven and is, sometimes, competitive and duplicative. The system relies on cooperation and communication among: Industry Private sector standards organizations Stakeholders Government 5

6. Other Terms for Standards  Best practice  Guide  Guideline  Guidance  Specification  De facto standard  Code 6

7. Codes are Special Standards Building Code Example: Used in the design, build and compliance process to construct safe, sustainable, affordable and resilient structures. Prevents disaster occurrence and manages disaster impact - minimizes the risk and effects. 7

8. Notional Forensic Science Code of Practice A standard that ties lab practices, crime scene investigation and other forensic services to: the use of standards and guidelines on the OSAC Registries laboratory accreditation personnel competencies 8

9. Federal Standards Policy The National Technology Transfer and Advancement Act (NTTAA), and the Office of Management and Budget Circular A119: Establishes a preference for federal agency use of voluntary consensus standards over government standards Encourages federal participation in standards development Authorizes the National Institute of Standards and Technology to coordinate conformity assessment activities of the agencies working with state and local government and the private sector http://www.whitehouse.gov/omb/circulars_a119/ 9

10. Key Concepts in Voluntary Consensus Standards Development Openness All stakeholders may participate; no single interest may dominate Transparency Records/ processes open and publicly available Due Process Appeals mechanism Consensus Decisions more than majority but not unanimity 10 OpennessTransparency Consensus Due Process

11. Standards Development Life Cycle 11

12. Standards Developing Organizations (SDOs) – Who are they?  Professional Societies whose members seek to advance their professions, and also develop standards  Trade Associations promote their industry's products, and also develop standards  International Standards Organizations – Country member based organization like the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) 12

13. Relevant Forensic Science SDOs 13

14. STANDARDS AND THE OSAC Wednesday, April 30, 2015 KAREN RECZEK, CHAIR, QUALITY INFRASTRUCTURE COMMITTEE (QIC) 14

15. OSAC Standards Processes  One process for OSAC Registry Approval Adoption of a published document  Two processes for the development of standards and guidelines 1.Working with an SDO 2.OSAC Canvass method 15

16. OSAC Core Principles Openness ◦Public notice of intent ◦Public meetings ◦Public comment period Balance ◦Diverse interests represented ◦Lack of dominance Consensus ◦Due process including appeals ◦Ensure consideration of all views, proposals and objections and endeavor to reconcile them ◦Document opposing views or abstentions and process to adjudicate ◦Make decisions based on available information and documentation Harmonization ◦Adoption of existing standards ◦Identification of gaps and needs ◦Reduce duplication and inconsistencies 16

17. American National Standards Institute (ANSI) ANSI Essential Requirements Documented procedures Audits to ensure processes are followed Available guidance documents Balance Lack of dominance OSAC will build off of ANSI members’ procedures for development and coordination of standards 17

18. OSAC Registry Approval – Adoption of a published document 18

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21. Registry Approval 1.Subcommittee recommends document for approval 2.SAC reviews and votes to approve/disapprove moving forward in process 3.If approved, SAC notifies public and RCs of “intent to place document on a Registry” 4.SAC receives comments from public and RCs (30 days) and reviews 5.SAC votes to approve/disapprove inclusion on the Registry 6.If approved by SAC goes to FSSB for vote to approve/disapprove on the Registry 7.If approved by FSSB, QIC updates online Registry listing 21

22. Standards Development – Working with and SDO 22

23. Standards Development – Working with an SDO 1.Subcommittee recommends working with an SDO on needed standard/guideline 2.SAC reviews and votes to approve/disapprove moving standard development forward in external SDO process 3.If approved, SAC notifies public and RCs of “intent to develop a document with ABC SDO” 4.SAC receives comments from public and RCs (30 days); Subcommittee / Task Group adjudicates comments and sends back to SAC for review 5.SAC votes to approve/disprove Subcommittee going forward 6.If approved, Subcommittee/TG works with SDO to draft and ballot a standard through to final publication using SDO’s process 23

24. Canvass Method for Creating a Consensus Body Canvass is the method by which we find participants to develop a consensus body Any stakeholder is invited to attend. By stakeholder that includes those who are known to be, or have indicated that they are or would be, directly and materially affected by X standard OSAC must define interest categories appropriate to the development of forensic science standards The most important thing about building a consensus body is achieving balance of diverse interests No one single interest can dominate Size is not prescribed and is based on what is necessary to achieve balance 24

25. Standards Developing – OSAC Canvass Method 25

26. Standards Development – OSAC Canvass Method 1.Subcommittee recommends canvassing method to develop a needed standard/guideline 2.SAC reviews and votes to approve/disapprove moving forward in canvass process 3.If approved, SAC notifies public and RCs of “intent to develop a standard and call for interested consensus body participants.” 4.SAC receives comments from public and RCs (30 days); Subcommittee / Task Group adjudicates comments and sends back to SAC for review 5.SAC votes to approve/disapprove Subcommittee/TG going forward 26

27. Standards Development – OSAC Canvass Method (Continued) 6. If approved, Subcommittee/TG selects a balanced consensus body to draft and/or ballot a standard and public comment 7. TG adjudicates comments from public and repeats process with consensus body if any changes are made 8. Once approved by the consensus body, the document is final 9. Subcommittee votes to send finalized document forward to the SAC to begin the Registry Approval Process 27

28. Next Steps  OSAC Subcommittees will begin to recommend existing documents to the SAC for approval onto the OSAC Registries (May 2015)  QIC will continue to work on documenting the procedure for working with an SDO so that OSAC Subcommittees and Task Groups can begin developing new documents in conjunction with an existing SDO (June/July 2015)  QIC will finalize interest categories and formal procedures for the OSAC Canvass method including the formation of a consensus body, voting, comments adjudication and a process for appeals (July/August 2015) 28

29. Questions? 29

30. Thank you! KAREN RECZEK, STANDARDS COORDINATION OFFICE, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY karen.reczek@nist.gov 30