Parasailing And Consensus Standards ASTM International Investigation & Information Exchange for Standards in the Parasailing Industry Organizational Meeting – 12 January 2012
ASTM has a proven industry partnership for elevating safety and performance in the recreational and consumer product sectors through industry-derived consensus standards…timely, cost effectively, openly © ASTM International. All Rights Reserved.
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To help this forum formulate an understanding of: - What consensus standards are; - How they are applied in a regulated industry; - The industry cost and contribution involved with standardization; - Standards that might be needed; - ASTM’s experience in consumer products and recreational industries, and in regulated sectors.
Presentation Objective
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3) Standardization for the parasailing industry
2) About ASTM International
1) About consensus standards
Presentation Outline
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What are consensus standards and how are they used?
I About Consensus Standards
About Consensus Standards
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Medical Devices Metals, Alloys, Composites Aviation Environment Site Assessment Petroleum Products & Lubricants Consumer Products
Example Industries:
“A standard is a common language that promotes the flow of goods between buyer and seller and protects the general welfare.”
An e-file / piece of paper A method of testing, a practice for an operation, a classification system… An interlaboratory study to support a method An adjunct material such as a reference radiographs or detailed charts The basis for industry training and development Provided in handbook form or as specialized compilations of companion standards
It can be:
What is a Standard?
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interest in the use of the standard. These sectors can include producers, users, and those having a general interest (government and/or academia), as well as ultimate consumers. Consensus standards, with their broad input, are considered by many as the most technically sound and credible documents. They are often used as the basis for commercial and regulatory action.
• Consensus is developed by representatives of all sectors that have an
• Voluntary Consensus Standard
within government agencies, sometimes developed in the private sector and then adopted by reference as mandatory.
• May reflect many degrees of consensus. Some are written by individuals
• Government Standard
professional society.
• Consensus among the many companies within an association or
• Industry Standard
companies forced to undertake an activity that is beyond the resources of any one member.
• Consensus among a small group of organizations; usually like-minded
• Consortium Standard
• Consensus among the employees of an organization.
• Company Standard
Types of Standards
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• Used by thousands of individuals/companies/agencies around the world to declare conformance/compliance, coordinate research, and convey material/product specifications and best practices
– ASTM International standards are used as the basis for national standards, globally
• Developed voluntarily and used voluntarily • A cost-saving means to communicate between materials/service suppliers and consumers to establish a baseline for safety and practicality in design, practice, operation and for conformity assessment activities • Cited in a contract • Government agencies reference them in codes, certification, regulations, and laws (US: P.L. 104-113)
How Standards are Used
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performance, operation and maintenance ADVANCE safety, health, quality INCREASE public interest, product certainty, and information availability TRANSFER technology to the marketplace via standards, handbooks, manuals, and training PASSPORTS to the global market UPDATED at any time to reflect better practices and latest technologies
• AID in design, manufacturing,
Standards as Tools
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Illustrating Standards Use
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Illustrating Standards Use
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Illustrating Standards Use
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Illustrating Standards Use
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ASTM Standard F-1223 provides a standard test method for evaluating constraint… it may be used for comparison purposes to commercially available total knee prostheses. Alternatively, constraint may be measured using a worst case analysis of the anterior, posterior, medial, lateral and rotational tibiofemoral shearing forces…
H. Materials Provide the voluntary standards to which the materials used in each component of the device conform. Most of the materials used in legally marketed or predicate knee prostheses conform to an American Society for Testing and Materials (ASTM) … standard for implant usage. If not, then data must be provided demonstrating the material's biocompatability. In addition, information about the processes and effects of any additional manufacturing techniques…must be provided….Range of Motion and Constraint Data on the expected range of motion for the device should include all modes of rotation …
GUIDANCE F OR TH E PRE PAR ATION OF PRE M AR KE T N OTIFICATIONS (510(k)s) FOR CEM E NTED, SEM I-CONS TR AINE D TOTAL K NEE PR OSTH ES ES
Illustrating Standards Use
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113 years of experience as an open forum for standards development and delivery, and as a source for technical support services in the form of certifications, trainings, certificates, proficiency testing, and more.
II About ASTM International
About ASTM International
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… is to be the foremost developer and provider of consensus standards, related technical information, and services having globally recognized quality and market relevance.
ASTM International’s Primary Objective
Certification and certificate services Technical and professional training Proficiency testing Contract management, intralaboratory study, and other programs
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141 technical committees; 12,000 standards ASTM standards reflect current technology; are continually revised Approximately 35,000 members from 135 countries participate on ASTM committees; Users from 175 countries Over 5,100 ASTM standards form the basis for national standards by reference in regulation in over 75 countries. In contracts, on drawings, in regulations, in company specifications, in RFPs.
Developing consensus standards for materials products, systems and services worldwide through direct member participation
The ASTM International Standards Process and Products
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No project costs
Regional Offices: USA, China, UK, Mexico
Compliance with the WTO TBT Agreement
Global market relevance
Research institutions and laboratories
societies • Professionals and consultants • Financial organizations • Academia •
• Product manufacturers • Regulatory agencies • Associations • Professional
Common sense approach, driven by stakeholders, in a neutral and balanced forum
Extensive support infrastructure and staff assistance
Information development and delivery made uncomplicated
Private and public sector cooperation
Consensus-based procedures
A proven and practical system
Why ASTM International?
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Assisting with verification of compliance
Certification Services
200 global points of resale and electronic flexibility of products / XML
Delivery of technical information
Full administrative and strategic support through staff management, editorial/graphics assistance, meetings management, customized web infrastructure
Development of technical formation
Specifically designed to support the development and delivery of technical information – making it “uncomplicated”
ASTM’s Infrastructure
• • • • • • • • • • • •
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A01 on Steel, Stainless Steel and Related Alloys Main Committee B07 on Light Metals and Alloys C16 on Thermal Insulation Subcommittee Subcommittee Subcommittee D01 on Paint .01 .02 .03 D02 on Petroleum Products and Lubricants D20 on Plastics Task Task E28 on Mechanical Testing Group 1 Group 2 F04 on Medical and Surgical Materials and Devices F15 on Consumer Products F37 on Light Sport Aircraft F38 on Unmanned Aircraft Systems G01 on Corrosion of Metals
Examples
141 Technical Committees
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Committees form to address industry subjects, with subcommittees addressing specialized subsets Approved Standards Achieve Separate Subcommittee and Main Committee Approvals, as well as a Society Review and “Internal Audit”
ASTM’s Balloting Process
ASTM
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Summary: Classification of members, and the assignment of official votes, ensures balance.
Balance: There are no more producer official voters than non-producer official voters. This ensures the development of unbiased, technically sound documents.
Official Vote: Every member gets to return a position on a balloted document, and every such return must be considered equally. Official votes are assigned to individuals, and authorizes them to vote on the resolution of conflicts related to ballot returns. The rules for official votes: (a) Only 1 member from a given entity (i.e.: company) may have an official vote. (b) There can be no more producer official voters than non-producer official voters.
Classification: Members are classified as producers, users, or general interest participants, in terms how they are affected by standardization.
Technical committees are “classified” and “balanced.”
Producer
User & General Interest
ASTM’s Balloting Process
COMPANY_NAME L-3 Communications Oak Ridge National Laboratory National Research Council of Canada Middle Tennessee State University NASA Middle Tennessee State University National Aerospace Laboratory NLR Civil Aviation Authority CZ Sensenich Wood Propeller US Coast Guard AeroViroment Inc Civil Aviation Authority - UK Federal Aviation Adminstration Federal Aviation Adminstration Transport Canada AAI TEXTRON SYSTEMS NIST NASA - Goddard Federal Aviation Adminstration Aerovironment Raytheon Company Raytheon Company
CLASS VOTE NV RSN CITY PROD Yes San Diego GEN Yes Huntsville GEN Yes Ottawa GEN No REDUN INT Murfreesboro GEN Yes Wallops Island PROD Yes Murfreesboro PROD Yes Amsterdam GEN No REQ NO VTE Prague 6 PROD Yes Plant City USER Yes Washington PROD No REDUN INT Simi Valley GEN Yes Gatwick Airport South GEN No REDUN INT Kansis City GEN Yes Kansis City GEN No REDUN INT Ottawa PROD Yes Hunt Valley GEN No REDUN INT Gaithersburgh PROD No REDUN INT Wallops Island GEN No REDUN INT Washington PROD Yes Pasadena PROD No WAIT Arlington PROD No REDUN INT Lutherville
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Example roster from committee F38 on Unmanned Aircraft Systems, Sept. 2011
NAME Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member Valued Member
STATE COUNTRY CA United States AL United States Canada TN United States VA United States TN United States Netherlands Czech Republic FL United States DC United States CA United States United Kingdom MO United States MO United States Canada MD United States MD United States VA United States DC United States CA United States VA United States MD United States
An example of how classification and official voting are tracked to maintain balance
Classification and Voting Status
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Committee F37 on LSA developed 16 standards in 20 months
artists, up-front/back end editors, managers, templates and collaboration tools
ASTM supports with meetings management, online meetings and calls, graphic
retention of expertise, regulatory integration under Public Law
recirculation, process oversight and management, liability, brand recognition and
Significant long-term considerations: publishing, distribution, maintenance and
building / industry & gaps analysis) and authoring high priority documents
Complexity of the job and urgency of needs Time devoted by members & utilization of informational technologies Most committees meet about twice a year; members cover in-kind New activities can experience a higher resource burn starting-up (activity
Timing & Resources for Standards Development
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– A participant receiving a certificate through the program has participated in a learning event or series of events designed to educate or train individuals to achieve specified learning outcomes within a defined scope. The participant shall be verified to have successfully completed all program requisites including, but not limited to, a test to evaluate learner attainment. Certificates have a specified period of validity
• ASTM Personnel Certificate Program
– Personnel certified through the program have prerequisite levels of relevant education and/or experience as deemed appropriate by industry standards; have passed an objective examination that is either written, oral, practical, or observational; participate in approved continuing education activities to maintain their professional competencies; and have agreed to adhere to an industry code of conduct. Once certified, personnel are recertified on a periodic basis.
• ASTM Personnel Certification Program
systems, and services) and personnel for industries that desire an independent third party demonstration of compliance to standards and/or are facing regulatory pressures to prove compliance to standards.
• The ASTM Certification Program covers products (material, products,
Beyond Standards – ASTM International Certification & Certificates
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– Aid to technical committees with heightening the quality of ASTM test methods by assisting development of precision statements backed by high quality laboratory data.
• Intralaboratory Study Program (ILS)
– Statistical quality assurance programs enabling laboratories to assess their performance in conducting test methods within their own laboratories when their data are compared against other laboratories that participate.
• Proficiency Testing Programs (PTP)
– Management support for grants, research projects and other related activities intended to enhance the quality and timeliness of ASTM products and services.
• Contract and Project Management Services (CPMS)
– Continuing technical education programs (1 to 3 day) for industry and government that are intensive, focused, and offer practical training on the standards that most impact the industry.
• Technical and Professional Training Courses (TPT)
Beyond Standards – ASTM International Technical and Professional Training & More
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From 2010 Financials Annual Budget of $42 Million Operating Revenues of $54 Million Revenue Sources:
Miscellaneous = 3%
Training = 6%
Proficiency Test Program = 12%
Administrative Fees = 8%
Interest = 6%
Publications = 65%
ASTM Business Model
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A discussion of standardization and the standards that may be needed
III Standardization for the Parasailing Industry
About Standardization for Parasailing
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- Within existing committee - New committee or other activity
Marketing and Promotion Organizational Meeting Activity Startup
- Cross section of industry participants - Conserve resources - Confirm a need for the activity - Agreement to look at the issue with the broader industry
Planning Meeting
- Activity requested - Industry researched - Discussions with industry, associations and regulators
Research and Request
Process of Activity Organization
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- Operational safety - Guidelines/practices for training and continued education - Materials/equipment design and maintenance - Other human factors and materials/equipment considerations
to support safety and reliability across a continuum of needs:
The industry might want a systemic approach; a set of standards
- Series of failures / to prevent failures - Underwriting needs / Risk mitigation - Regulatory pressures - Consumer demand - Capture baselines - Industry established need to communicate, improve quality, enhance safety
When is the right time for standardization?
Standardization Timing
More flexibility and timeliness with standards referenced by regulation than by regulation alone
•
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– Collective expertise and consensus input
Regulations identify “what to do”; standards identify “how to do it”
– Numerous government references
FAA and USCG – strong history of utilizing PL 104-113 to develop a mutually beneficial partnership with industry for standards to support regulatory frameworks
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The “ASTM Advantage” in Regulated Space…
Standards and Regulation
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- CFR Part 23 for GA vs. F2245 for LSA > 178 pages vs. 29 pages > The right standard for a level of safety appropriate for the aircraft type and intended function > Global recognition of the standards - Certification/Certificate services considered to support industry declarations
Case Study: Light Sport Aircraft (LSA)
Standards and Regulation
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Crew training & human factors consideration
Operations protocols & component performance
System design and reliability
Build System Reliability And a Safety Case
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– Safe practices by the individuals responsible for employing the system & training for consumers of the system; crew & passenger oriented
Pilot & Maintenance Qualifications?
– Safe employment of the system, the airspace and ground environment among other crafts & systems; procedure/ performance oriented
Operations Standards?
– Safe design, construction, test, modification, & inspection of the individual component, craft, or system; hardware oriented
Airworthiness Standards?
System Considerations From F38 on Unmanned Aircraft Systems
Approaches to Standardization
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– Do we need or want standards? – Can standards assist by providing continual stepping-stones to move best practices and products forward; to assist with the safety concerns of regulators? – Can standardization help vet what we currently think are best practices? – Discussion on needed standards precedes activity; what standards currently exist that might apply? – Discussion on notional standards needs…
Gap Analysis
Immediate Standards Needs?
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Inspections Life Expectancy Relationship between line and type of chute Current state = different lines, sizes, strengths, etc – consistency = critical – Cordage Institute = relevant (impact of introduction of bow line knot) – Effect of line strength on vessel, break strength of tow line (30 mph = threshold?) – Possible use of weak link (shear pin)
– – – –
• Tow Lines
Potential Standards Topics
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– Inspection (annual) to include replacement time? Service schedule? Instruction? Service life of chute? – Material degradation / identification of weaknesses – Replacement requirements & repair instructions
• Should factor regular use vs. disuse
– Made to a standard they have developed – Are the materials identical to those used within skydiving industry/military? – Assembled chutes sent to customer. Responsibility for inspection on owner of chute? Labeling: maximum wind speed (relative vs. actual), minimum & maximum weight capacity, etc. – Standard specification for the design & construction (traceability of?) of a parasailing parachute. – Standard practice for the continued inspection, maintenance, repair, storage, cleaning, and airworthiness of parasailing parachutes.
• Chutes
Potential Standards Topics
• Situation-specific
Training Minimum flight time (operators) Continuing education Operator qualifications Emergency procedures/drills
Materials Maintenance Inspection (frequency and type of – operator as well as annual) Repair
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– – – –
• Ropes/Shrouds (of Chutes)
– Minimum insurance levels
– – – – –
• Human Factors
Potential Standards Topics
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– Standard practice for design (safety requirements?) and performance of a universal parasailing harness – Harness material and strength (testing?) – Inspections (daily + annual) – Waist-mounted (preferred) vs. shoulder-mounted – Effect of salt (other elements?) on material – Stitching patterns, thread requirements – Webbing requirements (single vs. double) – Securing mechanism (material, D-rings, mechanical devices) – Ability to release the participant
• Harness
Potential Standards Topics
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assembly, tow line Evaluation of conditions (weather) Correct fitting of harness Properly fitted life jacket (and related equipment) Proper selection of chute Maximum weight per chute Maximum # of parasailers on a single chute Monitoring of conditions (weather) Selection of participants, pre-flight briefing
• Inspection of equipment (daily vs. trip) to include propulsion, winch
– Standard practice for the safe operation of a parasail activity – Pre-launch activities
• Operation
– Materials, maintenance, inspection, repair – Capacity (1, 2, 3 individuals) – Chair
to focus on # of passengers)
• Tandem/Triple Bar (multi-passenger bar/equipment – not
Potential Standards Topics
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– Post activity • Inspection • Storage and repair of life jackets, chutes, harnesses, etc. • Documentation/logs of activity • Daily check sheet
• • • •
obstacles Monitoring of sea conditions Monitoring of altitude Monitoring forward movement of boat (situational awareness) Monitoring of conditions (weather)
(Operation, continued) – During the activity • Proximity to shore, vessels, docks, aircraft (banner), other
Potential Standards Topics
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– Standard practice for vessel maintenance for continued seaworthiness for parasailing activity (checklist?) – Post-activity (every morning? Every night? Both?) – Rinsing of equipment – Inspection/repair – Storage – Apparatus & gear connected to it • Winch • Eyelets & cleats
• Vessel Maintenance
Potential Standards Topics
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