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STANDARDS OVERVIEWWednesday, April 30, 2015

KAREN RECZEK, STANDARDS COORDINATION OFFICE, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

karen.reczek@nist .gov

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Today’s Discussion Part 1: Standards Overview

Part 2: Standards and the OSAC

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Definitions of a StandardCommon 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)

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Types of Standardsdocumentary (technical)

standardsphysical (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

The U.S. Standards SystemThe 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

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

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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.

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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

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Federal Standards PolicyThe 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/

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Key Concepts in Voluntary Consensus Standards Development

OpennessAll stakeholders may participate; no single interest may dominate

TransparencyRecords/ processes open and publicly available

Due Process Appeals mechanism

ConsensusDecisions more than majority but not unanimity

Openness

Transparency

Consensus

Due Process

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Standards Development Life Cycle

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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)

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Relevant Forensic Science SDOs

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STANDARDS AND THE OSACWednesday, April 30, 2015

KAREN RECZEK, CHAIR, QUALITY INFRASTRUCTURE COMMITTEE (QIC)

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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 SDO2. OSAC Canvass method

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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

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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

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OSAC Registry Approval – Adoption of a published document

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Registry Approval1. 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

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Standards Development – Working with and SDO

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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

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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

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Standards Developing – OSAC Canvass Method

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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

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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

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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)

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Questions?

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Thank you!KAREN RECZEK, STANDARDS COORDINATION OFFICE,

NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGYkaren . reczek@nis t .gov