Wednesday April 30 2015 Karen Reczek Standards coordination office national institute of standards and technology karenreczeknistgov 1 Todays Discussion Part 1 Standards Overview Part 2 Standards and the OSAC ID: 202201
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STANDARDS OVERVIEW
Wednesday, April 30, 2015
Karen Reczek, Standards coordination office, national institute of standards and technologykaren.reczek@nist.gov
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Today’s Discussion
Part 1: Standards Overview
Part 2: Standards and the OSAC2Slide3
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)
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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
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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
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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 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 standardsEncourages 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
DevelopmentOpenness
All stakeholders may participate; no single interest may dominateTransparency Records/ processes open and publicly available
Due Process
Appeals mechanism
Consensus
Decisions more than majority but not unanimity
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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 OSAC
Wednesday, 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
Working with an SDOOSAC Canvass method
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OSAC Core Principles
OpennessPublic notice of intent
Public meetingsPublic comment periodBalance Diverse interests representedLack 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 RequirementsDocumented procedures
Audits to ensure processes are followedAvailable guidance documentsBalance 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 Approval
Subcommittee recommends document for approval
SAC reviews and votes to approve/disapprove moving forward in processIf approved, SAC notifies public and RCs of “intent to place document on a Registry”SAC receives comments from public and RCs (30 days) and reviews
SAC votes to approve/disapprove inclusion on the Registry
If approved by SAC goes to FSSB for vote to approve/disapprove on the Registry
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
Subcommittee recommends working with an SDO on needed standard/guidelineSAC reviews and votes to approve/disapprove moving standard development forward in external SDO processIf approved, SAC notifies public and RCs of “intent to develop a document with ABC SDO”
SAC receives comments from public and RCs (30 days); Subcommittee / Task Group adjudicates comments and sends back to SAC for review
SAC votes to approve/disprove Subcommittee going forward
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 standardOSAC 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
Subcommittee recommends canvassing method to develop a needed standard/guidelineSAC reviews and votes to approve/disapprove moving forward in canvass processIf approved, SAC notifies public and RCs of “intent to develop a standard and call for interested consensus body participants.”
SAC receives comments from public and RCs (30 days
); Subcommittee / Task Group adjudicates comments and sends back to SAC for review
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 comment7. TG adjudicates comments from public and repeats process with consensus body if any changes are made8. Once approved by the consensus body, the document is
final9. 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 technology
karen.reczek@nist.gov
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