MODULE B - PROCESS - ASME · 2010-11-19 · MODULE B - PROCESS SUBMODULES B1. Organizational...
Transcript of MODULE B - PROCESS - ASME · 2010-11-19 · MODULE B - PROCESS SUBMODULES B1. Organizational...
MODULE B - PROCESS
SUBMODULESB1. Organizational StructureB2. Standards Development: Roles and
ResponsibilitiesB3. Conformity Assessment: Roles and
ResponsibilitiesB4. Initiating Standards ProjectsB5. Consensus Process for Standards
DevelopmentB6. The Basics of Parliamentary ProcedureB7. The Appeals ProcessB8. International Standards DevelopmentB9. ASME Conformity Assessment ProgramsB10. Performance Based Standards
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REVISIONS
CHANGESLIDEDATEChanged “Codes and Standards Board of Directors” to “Council on Standards and Certification” throughout.
11/22/10
B8. International Standards Development
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OBJECTIVES
This submodule will– Describe the multiple paths to international
standardization.
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AGENDA
I. ASME International StandardsII. Normative ReferencesIII. U.S. National Adoption of ISO StandardsIV. ISO Adoption of ASME StandardsV. ISO Standards Development
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I. ASME International Standards
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WHAT MAKES A STANDARD “INTERNATIONAL”?
• Criteria– A development process characterized by openness,
transparency, international participation and due process (WTO principles)
– A record of success in meeting or a potential to meet global marketplace and public safety needs
– The ability to maintain technical relevance
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INTERNATIONAL STANDARDIZATION
• ASME develops standards intended to meet needs of industries and governments on global basis
• ASME standards developed under process that meets WTO principles for international standards development
• To address global relevance, an ASME committee may take various approaches, including:– development of performance based and prescriptive
standards as means of compliance with regulations or essential safety requirements;
– normative or informative references to non-ASME international, regional, or national standards; and
– national adoptions of non-ASME international standards
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ASME INTERNATIONAL STANDARDS
• Some ASME codes and standards in international use– Boiler and Pressure Vessel Code (over 100 countries)– B31 Piping Codes– B16 Standards on Valves, Flanges, Fittings and
Gaskets– Bioprocessing Equipment Standard
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ASME INTERNATIONAL STANDARDS
• International Participation– Enhances international acceptance and use– Delegate position on ASME Committees
• Represents recognized group of interested parties (e.g., individuals from a jurisdiction, professional society, trade organization, users group)
• Represented group reviews/comments on work of committee or submits proposals
• Group works in own country, in native language. • Delegate on standards committee has first consideration
voting privilege on standards actions.
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ASME International Standards
• International Participation – Alternative Models– B31.3 (Process Piping) International Review Group
• Member of organization involved with process piping outside U.S. and Canada
• Review and comment on balloted proposals• Advise committee of desirable changes to B31.3
– BPE (Bioprocessing Equipment) European Subcommittee• Review and comment on balloted proposals• Evaluates issues of concern for European industry
– BPV (Boilers and Pressure Vessels) International Interest Review Group (IIRG)
• Review and comment on balloted proposals• Representatives of national agencies that have accepted at
least one section of ASME BPV Code as means of meeting regulatory requirements.
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II. Normative References
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NORMATIVE REFERENCES
• Approach– Incorporate normative reference to ASME Standard in ISO
Standard
• Example– B31.3 Process Piping Code referenced in
ISO 15649:2001, Petroleum and natural gas industries – Piping
• Advantages– Maintain control of technical content– No need to exert the sometimes extensive effort in creating new
standard– Users can continue to use familiar requirements
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III. U.S. National Adoption of ISO Standards
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U.S. NATIONAL ADOPTION
• Definition– Adoption of ISO standard as American National
standard
• Reasons for U.S. national adoption– No ASME standard exists– ISO standard is the industry recognized standard
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U.S. NATIONAL ADOPTION
• Procedure– Process ISO standard in accordance with ASME
and ANSI procedures.– Withdraw or modify existing ASME standard.– Notes:
• ANSI procedures allow for..– Identical adoption (and expedited approval)– Modified adoption
• ASME procedures require– Approval by appropriate Board and Council on Standards
and Certification
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MODIFIED U.S. NATIONAL ADOPTION
• Approaches and rationales– Process modified U.S. national adoption; add
special U.S. requirements in appendix• Best when U.S. standard requires additions
but no changes to ISO standard• Allows multinational companies to use same
standards document both inside and outside U.S.
– Process modified U.S. national adoption• When ISO standard needs technical changes
for U.S. use
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POP QUIZ #1
A new ISO standard covering an area already covered in the U.S. by an existing ASME standard has rapidly become the standard of preference in much of the industry. The new standard does not address a couple of issues important in the U.S., but otherwise meets all U.S. needs.
What action might ASME take to update its U.S. standard in a way that meets the needs of both domestic and multi-national companies? _____
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IV. ISO Adoption of ASME Standards
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SUBMISSION OF ASME STANDARDS TO ISO
• Rationale – Make the ASME standard recognized more internationally– The ISO Technical Committee has a stronger technical base
• Requirements – Obtain approval of
• Consensus committee• Appropriate Board • Council on Standards and Certification
– Submit as New Work Item proposal– Use ISO format (ISO template)– NOTE: With this option the U.S. would lose control over the
technical content in the resulting ISO standard.
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POP QUIZ #2
True or False. All standards recognized and used internationally are ISO Standards. _______
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V. ISO STANDARDS DEVELOPMENT
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INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
• Purpose– To facilitate the internationalization and unification of
standards and related activities• Membership
– 140 countries, each represented by a national standards body, each with one vote
– ANSI is the U.S. member body• Official languages
– English, French, Russian• Outputs
– International standards, technical reports, etc.
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ISO ORGANIZATION
Technical Management Board (TMB)
Technical Committee (TC)
Subcommittee
Working Group Ad Hoc Group
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ISO ORGANIZATION
• Technical Management Board (TMB)– Manages ISO’s technical
activities and sets policy– 12 member countries
• 4 permanent members• 8 rotating members
Technical Management Board
Technical Committee
Subcommittee
Working Group Ad Hoc Group
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ISO ORGANIZATION
• Technical Committee (TC)– Responsible for a
particular technical area, e.g Pipe Fittings
– Membership: all countries• P = Participating (must
vote)• O = Observer (may vote)• L = Liaison (no vote)
– TMB appoints a national body to provide Chair and Secretariat
ISO has more than 180
Technical Committees
Technical Management Board
Technical Committee
Subcommittee
Working Group Ad Hoc Group
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THE TC SECRETARIAT
• Responsibilities– Provides administrative and technical support to
the committee in accordance with ISO Directives• Examples: meeting arrangements, agendas,
letter ballots – Works closely with ISO Central Secretariat– Must remain strictly neutral in its dealings
NOTE: ASME is Secretariat for TC 5/SC 10 on Flanges; and TC 96/SC 6 on Mobile Cranes
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ISO ORGANIZATION
• Subcommittee– Responsible for a specific
aspect of a TC’sresponsibility
– P and O members only*– Parent TC appoints
Secretariat
*NOTE: A country’sSubcommittee membershipcategory may differ from itsTC category.
ISO has close to 600
Subcommittees
Technical Management Board
Technical Committee
Subcommittee
Working Group Ad Hoc Group
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ISO ORGANIZATION
• Working Group/Ad Hoc Group– Formed for single project– Collection of individually
appointed experts
Technical Management Board
Technical Committee
Subcommittee
Working Group Ad Hoc Group
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ISO NORMATIVE PUBLICATIONS
• International Standard– Requires approval of 2/3 of P-members with less
than 1/4 of voting members dissenting– Five year review cycle
• Technical Specification (TS) – Requires only 2/3 of P-members– Three year review cycle
• Publicly Available Specification (PAS) – Requires only a simple majority– Three year review cycle
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OTHER ISO PUBLICATIONS
• Technical Report (TR)– Provides information only
• Industry Technical Agreement (ITA)– Results from international workshop– Provides information only
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POP QUIZ #3
a. Technical Management Board b. Technical Committeec. Subcommitteed. Working Groupe. Ad Hoc Group
Consensus for approval of an ISO Standard is developed by a _____
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POP QUIZ #4(Extra Credit)
a. International Standard b. Industry Technical Agreementc. Publicly Available Specificationd. Technical Reporte. Technical Specification
Which of the following ISO publications define standards or norms? _____
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ISO STANDARDS DEVELOPMENT
• Stages of Development Process1. Proposal2. Preparatory 3. Committee 4. Enquiry5. Approval 6. Publication
(cont’d)
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New Work
(NP)
Vote by TC or SC ACCEPTED
ISO STANDARDS DEVELOPMENT
• Development process1. Proposal
New Work Item
Proposal (NP)
(cont’d)
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Submitted to Parent
TC/SC
ISO STANDARDS DEVELOPMENT
• Development process (cont’d)2. Preparatory
Working Draft (WD)
Proposal Drafted
New Work
(NP)ACCEPTED
(cont’d)
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Draft International
Standard(DIS)
TC or SC Comments or Letter
Ballot
ISO STANDARDS DEVELOPMENT
• Development process (cont’d)3. Committee
Committee Draft (CD)
Submitted to Parent
TC/SC
(cont’d)
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ISO STANDARDS DEVELOPMENT
• Development process (cont’d)4. Enquiry
Final Draft International
Standard (FDIS)
Letter Ballot
Draft International
Standard (DIS)
(cont’d)
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ISO STANDARDS DEVELOPMENT
• Development process (cont’d)5. Approval
Final Draft International
Standard (FDIS)
Yes/No Vote
International Standard
(IS)
(cont’d)
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ISO STANDARDS DEVELOPMENT
• Development process (cont’d)
Standard Published
Yes/No Vote
5. Approval 6. Publication
Final Draft International
Standard (FDIS)
International Standard
(IS)
(cont’d)
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POP QUIZ #5
The document used to propose a standards action to an ISO Technical Committee is called a _____.
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Vote by TC or SC
Existing Standard
(Draft International
Standard)ACCEPTED FOR
FAST TRACK
FAST TRACK DEVELOPMENT
• Development process
New Work Item
Proposal (NP)
1. Proposal
Existing Standard
(cont’d)
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Yes/No Vote
5. Approval
International Standard
(IS)Letter Ballot
Final DraftInternational
Standard (FDIS)
FAST TRACK DEVELOPMENT
• Development process (cont’d)
4. Enquiry
Existing Standard
(Draft International
Standard)ACCEPTED FOR
FAST TRACK
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TECHNICAL ADVISORY GROUP (TAG)
• Role– The means by which U.S. participates in ISO
Technical Committees– Responsible for a specific technical area
• ANSI accredits TAG• Scope of TAG typically matches that of a specific
ISO committee or subcommittee– Prepares the U.S. position on issues– Represents U.S. at committee meetings
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TECHNICAL ADVISORY GROUP (TAG)
• Specific Responsibilities– Determines the U.S. position on
• ISO drafts out for ballot• ISO Technical Committee agenda items
– Designates U.S. delegations– Initiates and approves U.S. proposals to TC for new
work– Recommends the TAG membership
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TECHNICAL ADVISORY GROUP (TAG)
• Membership
– Open to all U.S. national interested parties (companies, technical and trade organizations, government agencies and individuals)
– Balanced (no single interest category has majority)
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TAG ADMINISTRATION
• TAG Administrator– Organization is accredited by ANSI to administer a
TAG – Provides Chairman and administrative services in
accordance with ANSI and ISO procedures
• TAG Secretary– TAG Administrator “staff”– Duties include meeting arrangements and minutes,
agendas, letter ballots, etc.– For ASME TAG, an ASME staff person
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TAG PROCEDURES
• Requirements– Must be based on ANSI Model Operating Procedures– May include changes and additions– Possible additions:
• ASME categories of interest• Things to consider when thinking of hosting an
ISO meeting• Generic Procedures for ASME-administered TAG’s
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TAG PROCEDURES
• Basic concepts– Openness– One member, one vote– Balance– All negatives considered– Appeals process
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POP QUIZ #6
a. Be balancedb. Be a Standards Committeec. Have a scope the same as the ISO activityd. Be accredited by ANSI
Which of the following apply? U.S. Technical Advisory Groups administered by ASME shall:
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SUBMITTING A U.S. POSITION
• Step 1: Determining the consensus position – Option 1 (2 ballots needed)
• Draft sent to TAG for ballot• Consolidated position prepared• Consolidated position balloted
– Option 2 (1 ballot needed)• Draft sent to TAG for comment• Project Team prepares proposed position• Proposed position balloted
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SUBMITTING A U.S. POSITION
• Step 2: Submitting the position to ISO
Technical Advisory
Group(TAG)
ISO SecretariatANSI
TAG Position
U.S. Ballot
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EFFECTIVE ISO PARTICIPATION
• Guidelines/Considerations– Begin participation in early stages of draft
development.– Consider being a Convener.– Study the ISO Directives (procedures).– Know how to use the ISO Template.– Review ANSI’s Guide for U.S. Delegates to ISO
Meetings.
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SUMMARY
I. ASME International StandardsII. Normative ReferencesIII. U.S. National Adoption of ISO StandardsIV. ISO Adoption of ASME StandardsV. ISO Standards Development
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REFERENCES
– Codes and Standards Policy CSP-4, International Standardization• http://cstools.asme.org/csconnect/CommitteePages.cfm?
Committee=A01000000&Action=7609– Operating Procedures for ASME Administered U.S. Technical Advisory
Groups for ISO Activities• http://cstools.asme.org/csconnect/pdf/CommitteFiles/21386.pdf
– ANSI Procedures for U.S. Participation in the International Standards Activities of the ISO
• http://public.ansi.org/ansionline/Documents/Standards%20Activities/International%20Standardization/ISO/intl0504.doc
– ANSI Guide for U.S. Delegates to IEC and ISO Meetings*– ISO Directives*– ISO Templates*– Vienna Agreement*
* Available on C&S Web site at http://www.asme.org/Codes/About/Links/Links_Codes_Standards.cfm