Transcript MODULE B - PROCESS - C&S Tools

MODULE B - PROCESS
B1.
B2.
B3.
B4.
B5.
B6.
B7.
B8.
B9.
B10.
SUBMODULES
Organizational Structure
Standards Development: Roles and
Responsibilities
Conformity Assessment: Roles and
Responsibilities
Initiating Standards Projects
Consensus Process for Standards
Development
The Basics of Parliamentary Procedure
The Appeals Process
International Standards Development
ASME Conformity Assessment Programs
Performance Based Standards
REVISIONS
DATE SLIDE
11/22/10
ASME C&S Training Module B8
CHANGE
Changed “Codes and Standards Board of Directors” to
“Council on Standards and Certification” throughout.
1
B8. International Standards
Development
OBJECTIVES
This submodule will
– Describe the multiple paths to international
standardization.
ASME C&S Training Module B8
3
AGENDA
I.
II.
III.
IV.
V.
ASME International Standards
Normative References
U.S. National Adoption of ISO Standards
ISO Adoption of ASME Standards
ISO Standards Development
ASME C&S Training Module B8
4
I. ASME International Standards
ASME C&S Training Module B8
5
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
ASME C&S Training Module B8
6
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
ASME C&S Training Module B8
7
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
ASME C&S Training Module B8
8
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.
ASME C&S Training Module B8
9
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.
ASME C&S Training Module B8
10
II. Normative References
ASME C&S Training Module B8
11
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
ASME C&S Training Module B8
12
III. U.S. National Adoption of ISO Standards
ASME C&S Training Module B8
13
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
ASME C&S Training Module B8
14
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
ASME C&S Training Module B8
15
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
ASME C&S Training Module B8
16
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? _____
ASME C&S Training Module B8
17
IV. ISO Adoption of ASME Standards
ASME C&S Training Module B8
18
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.
ASME C&S Training Module B8
19
POP QUIZ #2
True or False. All standards recognized
and used internationally are ISO
Standards. _______
ASME C&S Training Module B8
20
V. ISO STANDARDS DEVELOPMENT
ASME C&S Training Module B8
21
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.
ASME C&S Training Module B8
22
ISO ORGANIZATION
Technical Management Board (TMB)
Technical Committee (TC)
Subcommittee
Working Group
ASME C&S Training Module B8
Ad Hoc Group
23
ISO ORGANIZATION
Technical Management Board
Technical Committee
Subcommittee
Working Group
Ad Hoc Group
ASME C&S Training Module B8
• Technical Management Board
(TMB)
– Manages ISO’s technical
activities and sets policy
– 12 member countries
• 4 permanent members
• 8 rotating members
24
ISO ORGANIZATION
Technical Management Board
Technical Committee
Subcommittee
Working Group
Ad Hoc Group
ISO has more
than 180
Technical
Committees
ASME C&S Training Module B8
• 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
25
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
ASME C&S Training Module B8
26
ISO ORGANIZATION
Technical Management Board
Technical Committee
Subcommittee
Working Group
Ad Hoc Group
ISO has close to
600
Subcommittees
ASME C&S Training Module B8
• Subcommittee
– Responsible for a specific
aspect of a TC’s
responsibility
– P and O members only*
– Parent TC appoints
Secretariat
*NOTE: A country’s
Subcommittee membership
category may differ from its
TC category.
27
ISO ORGANIZATION
Technical Management Board
Technical Committee
Subcommittee
Working Group
• Working Group/Ad Hoc
Group
– Formed for single project
– Collection of individually
appointed experts
Ad Hoc Group
ASME C&S Training Module B8
28
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
ASME C&S Training Module B8
29
OTHER ISO PUBLICATIONS
• Technical Report (TR)
– Provides information only
• Industry Technical Agreement (ITA)
– Results from international workshop
– Provides information only
ASME C&S Training Module B8
30
POP QUIZ #3
Consensus for approval of an ISO
Standard is developed by a _____
a.
b.
c.
d.
e.
Technical Management Board
Technical Committee
Subcommittee
Working Group
Ad Hoc Group
ASME C&S Training Module B8
31
POP QUIZ #4
(Extra Credit)
Which of the following ISO publications
define standards or norms? _____
a.
b.
c.
d.
e.
International Standard
Industry Technical Agreement
Publicly Available Specification
Technical Report
Technical Specification
ASME C&S Training Module B8
32
ISO STANDARDS DEVELOPMENT
•
Stages of Development Process
1. Proposal
2. Preparatory
3. Committee
4. Enquiry
5. Approval
6. Publication
(cont’d)
ASME C&S Training Module B8
33
ISO STANDARDS DEVELOPMENT
• Development process
1. Proposal
New Work
Item
Proposal
(NP)
New Work
Vote by TC
or SC
(NP)
(cont’d)
ASME C&S Training Module B8
34
ISO STANDARDS DEVELOPMENT
• Development process (cont’d)
2. Preparatory
New Work
(NP)
Proposal
Drafted
Working
Draft
(WD)
Submitted
to Parent
TC/SC
(cont’d)
ASME C&S Training Module B8
35
ISO STANDARDS DEVELOPMENT
• Development process (cont’d)
3. Committee
Submitted
to Parent
TC/SC
Committee
Draft
(CD)
TC or SC
Comments
or Letter
Ballot
Draft
International
Standard
(DIS)
(cont’d)
ASME C&S Training Module B8
36
ISO STANDARDS DEVELOPMENT
• Development process (cont’d)
4. Enquiry
Draft
International
Standard
(DIS)
Letter
Ballot
Final Draft
International
Standard
(FDIS)
(cont’d)
ASME C&S Training Module B8
37
ISO STANDARDS DEVELOPMENT
• Development process (cont’d)
5. Approval
Final Draft
International
Standard
(FDIS)
Yes/No
Vote
International
Standard
(IS)
(cont’d)
ASME C&S Training Module B8
38
ISO STANDARDS DEVELOPMENT
• Development process (cont’d)
5. Approval
Final Draft
International
Standard
(FDIS)
Yes/No
Vote
6. Publication
International
Standard
(IS)
Standard
Published
(cont’d)
ASME C&S Training Module B8
39
POP QUIZ #5
The document used to propose a standards
action to an ISO Technical Committee is
called a _____.
ASME C&S Training Module B8
40
FAST TRACK DEVELOPMENT
• Development process
1. Proposal
New Work
Item
Proposal
(NP)
Existing
Standard
Vote by
TC or SC
Existing
Standard
(Draft
International
Standard)
ACCEPTED FOR
FAST TRACK
(cont’d)
ASME C&S Training Module B8
41
FAST TRACK DEVELOPMENT
• Development process (cont’d)
4. Enquiry
Existing
Standard
Letter
Ballot
(Draft
International
Standard)
5. Approval
Final Draft
International
Standard
(FDIS)
Yes/No
Vote
International
Standard
(IS)
ACCEPTED FOR
FAST TRACK
ASME C&S Training Module B8
42
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
ASME C&S Training Module B8
43
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
ASME C&S Training Module B8
44
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)
ASME C&S Training Module B8
45
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
ASME C&S Training Module B8
46
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
ASME C&S Training Module B8
47
TAG PROCEDURES
• Basic concepts
– Openness
– One member, one vote
– Balance
– All negatives considered
– Appeals process
ASME C&S Training Module B8
48
POP QUIZ #6
Which of the following apply? U.S. Technical
Advisory Groups administered by ASME
shall:
a.
b.
c.
d.
Be balanced
Be a Standards Committee
Have a scope the same as the ISO activity
Be accredited by ANSI
ASME C&S Training Module B8
49
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
ASME C&S Training Module B8
50
SUBMITTING A U.S. POSITION
• Step 2: Submitting the position to ISO
Technical
Advisory
Group
(TAG)
TAG
Position
ASME C&S Training Module B8
ANSI
U.S.
Ballot
ISO
Secretariat
51
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.
ASME C&S Training Module B8
52
SUMMARY
I.
II.
III.
IV.
V.
ASME International Standards
Normative References
U.S. National Adoption of ISO Standards
ISO Adoption of ASME Standards
ISO Standards Development
ASME C&S Training Module B8
53
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%20
Activities/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
ASME C&S Training Module B8
54