Parasailing And Parasailing And Consensus Standards Consensus Standards ASTM International ASTM International Investigation & Information Exchange Investigation & Information Exchange for Standards in the Parasailing Industry for Standards in the Parasailing Industry Organizational Meeting Organizational Meeting – – XX January 2012 XX January 2012 ASTM has a proven industry partnership for elevating safety and ASTM has a proven industry partnership for elevating safety and performance in the recreational and consumer product sectors thr performance in the recreational and consumer product sectors thr ough ough industry industry - - derived consensus standards derived consensus standards … … timely, cost effectively, openly timely, cost effectively, openly
Transcript
Parasailing And Parasailing And
Consensus StandardsConsensus Standards
ASTM International ASTM International Investigation & Information ExchangeInvestigation & Information Exchange
for Standards in the Parasailing Industryfor Standards in the Parasailing IndustryOrganizational Meeting Organizational Meeting –– XX January 2012XX January 2012
ASTM has a proven industry partnership for elevating safety and ASTM has a proven industry partnership for elevating safety and performance in the recreational and consumer product sectors thrperformance in the recreational and consumer product sectors through ough industryindustry--derived consensus standardsderived consensus standards……timely, cost effectively, openlytimely, cost effectively, openly
Presentation ObjectivePresentation Objective
To help this forum formulate an understanding of:To help this forum formulate an understanding of:-- What consensus standards are;What consensus standards are;-- How they are applied in a regulated industry;How they are applied in a regulated industry;-- The industry cost and contribution involved with The industry cost and contribution involved with
standardization; standardization; -- Standards that might be needed;Standards that might be needed;-- ASTMASTM’’ s experience in consumer products and s experience in consumer products and
recreational industries, and in regulated sectors.recreational industries, and in regulated sectors.
Presentation OutlinePresentation Outline
1)1) About consensus standardsAbout consensus standards
2)2) About ASTM InternationalAbout ASTM International
3)3) Standardization for the Standardization for the parasailing industryparasailing industry
About Consensus StandardsAbout Consensus Standards
What are consensus standards and how are they used?What are consensus standards and how are they used?
What is a Standard?What is a Standard?
“A standard is a common language that promotes the flow of goods between buyer and seller and protects the general welfare.”
Example Industries:� Medical Devices� Metals, Alloys, Composites� Aviation� Environment Site Assessment� Petroleum Products & Lubricants� Consumer Products
It can be:� 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
Types of StandardsTypes of Standards
•• Company StandardCompany Standard•• Consensus among the employees of an organization.Consensus among the employees of an organization.
•• Consortium StandardConsortium Standard•• Consensus among a small group of organizations; usually likeConsensus among a small group of organizations; usually like--minded minded
companies forced to undertake an activity that is beyond the rescompanies forced to undertake an activity that is beyond the resources of ources of any one member.any one member.
•• Industry StandardIndustry Standard•• Consensus among the many companies within an association or Consensus among the many companies within an association or
professional society.professional society.
•• Government StandardGovernment Standard•• May reflect many degrees of consensus. Some are written by indivMay reflect many degrees of consensus. Some are written by individuals iduals
within government agencies, sometimes developed in the private swithin government agencies, sometimes developed in the private sector ector and then adopted by reference as mandatory.and then adopted by reference as mandatory.
•• Voluntary Consensus StandardVoluntary Consensus Standard•• Consensus is developed by representatives of all sectors that haConsensus is developed by representatives of all sectors that have an ve an
interest in the use of the standard. These sectors can include pinterest in the use of the standard. These sectors can include producers, roducers, users, and those having a general interest (government and/or acusers, and those having a general interest (government and/or academia), ademia), as well as ultimate consumers. Consensus standards, with their bas well as ultimate consumers. Consensus standards, with their broad road input, are considered by many as the most technically sound and input, are considered by many as the most technically sound and credible credible documents. They are often used as the basis for commercial and documents. They are often used as the basis for commercial and regulatory action.regulatory action.
How Standards are UsedHow Standards are Used
•• Developed voluntarily and used voluntarilyDeveloped voluntarily and used voluntarily
•• A costA cost--saving means to communicate between saving means to communicate between materials/service suppliers and consumers to establish a materials/service suppliers and consumers to establish a baseline for safety and practicality in design, practice, baseline for safety and practicality in design, practice, operation and for conformity assessment activitiesoperation and for conformity assessment activities
•• Cited in a contractCited in a contract
•• Government agencies reference them in codes, certification, Government agencies reference them in codes, certification, regulations, and laws (US: P.L. 104regulations, and laws (US: P.L. 104--113)113)–– ASTM International standards are used as the basis for national ASTM International standards are used as the basis for national
standards, globallystandards, globally
•• Used by thousands of individuals/companies/agencies Used by thousands of individuals/companies/agencies around the world to declare conformance/compliance, around the world to declare conformance/compliance, coordinate research, and convey material/product coordinate research, and convey material/product specifications and best practicesspecifications and best practices
Standards as ToolsStandards as Tools
•• AID in design, manufacturing, AID in design, manufacturing, performance, operation and performance, operation and maintenancemaintenance
•• ADVANCE safety, health, qualityADVANCE safety, health, quality•• INCREASE public interest, product INCREASE public interest, product
certainty, and information availabilitycertainty, and information availability•• TRANSFER technology to the TRANSFER technology to the
marketplace via standards, handbooks, marketplace via standards, handbooks, manuals, and trainingmanuals, and training
•• PASSPORTS to the global marketPASSPORTS to the global market•• UPDATED at any time to reflect better UPDATED at any time to reflect better
practices and latest technologiespractices and latest technologies
Illustrating Standards UseIllustrating Standards Use
Illustrating Standards UseIllustrating Standards Use
Illustrating Standards UseIllustrating Standards Use
Illustrating Standards UseIllustrating Standards Use
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 …
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…
GUIDANCE FOR THE PREPARATION OF PREMARKET NOTIFICATIONS (510(k)s) FOR CEMENTED, SEMI-CONSTRAINED TOTAL KNEE PROSTHESES
Illustrating Standards UseIllustrating Standards Use
About ASTM InternationalAbout ASTM International
IIIIAbout ASTM InternationalAbout ASTM International
113 years of experience as an open 113 years of experience as an open forum for standards development and forum for standards development and delivery, and as a source for technical delivery, and as a source for technical support services in the form of certifications, trainings, support services in the form of certifications, trainings, certificates, proficiency testing, and more.certificates, proficiency testing, and more.
…… is to be the foremost developer and provider is to be the foremost developer and provider of consensus standards, related technical of consensus standards, related technical information, and services having globally information, and services having globally recognized quality and market relevance. recognized quality and market relevance.
The ASTM International The ASTM International
Standards Process and ProductsStandards Process and Products
�� Developing consensus standards for materials products, systems aDeveloping consensus standards for materials products, systems and nd services worldwide through direct member participationservices worldwide through direct member participation
�� 141 technical committees; 12,000 standards141 technical committees; 12,000 standards�� ASTM standards reflect current technology; are continually revisASTM standards reflect current technology; are continually reviseded�� Approximately 35,000 members from 135 countries participate on AApproximately 35,000 members from 135 countries participate on ASTM STM
committees; Users from 175 countriescommittees; Users from 175 countries�� Over 5,100 ASTM standards form the basis for national standards Over 5,100 ASTM standards form the basis for national standards by reference by reference
in regulation in over 75 countries.in regulation in over 75 countries.�� In contracts, on drawings, in regulations, in company specificatIn contracts, on drawings, in regulations, in company specifications, in ions, in RFPsRFPs..
�� Certification and certificate servicesCertification and certificate services�� Technical and professional trainingTechnical and professional training�� Proficiency testingProficiency testing�� Contract management, Contract management, intralaboratoryintralaboratorystudy, and other programsstudy, and other programs
Why ASTM International?Why ASTM International?
�� A proven and practical systemA proven and practical system�� ConsensusConsensus--based proceduresbased procedures
�� Private and public sector cooperationPrivate and public sector cooperation
�� Information development and delivery made uncomplicatedInformation development and delivery made uncomplicated�� Extensive support infrastructure and staff assistanceExtensive support infrastructure and staff assistance
�� Common sense approach, driven by stakeholders, in a neutral and Common sense approach, driven by stakeholders, in a neutral and balanced forumbalanced forum
•• Product manufacturers Product manufacturers •• Regulatory agencies Regulatory agencies •• Associations Associations •• Professional Professional
societies societies •• Professionals and consultants Professionals and consultants •• Financial organizations Financial organizations •• Academia Academia ••
Research institutions and laboratoriesResearch institutions and laboratories
�� Global market relevanceGlobal market relevance�� Compliance with the WTO TBT AgreementCompliance with the WTO TBT Agreement
�� Regional Offices: USA, China, UK, MexicoRegional Offices: USA, China, UK, Mexico
�� No project costsNo project costs
ASTMASTM’’s Infrastructures Infrastructure
Specifically designed to support the development and delivery ofSpecifically designed to support the development and delivery oftechnical information technical information –– making it making it ““ uncomplicateduncomplicated””
�� Development of technical formationDevelopment of technical formationFull administrative and strategic support through staff Full administrative and strategic support through staff management, editorial/graphics assistance, meetings management, editorial/graphics assistance, meetings management, customized web infrastructuremanagement, customized web infrastructure
�� Delivery of technical informationDelivery of technical information200 global points of resale and electronic flexibility of 200 global points of resale and electronic flexibility of products / XMLproducts / XML
�� Certification ServicesCertification ServicesAssisting with verification of complianceAssisting with verification of compliance
141 Technical Committees141 Technical Committees
ExamplesExamples•• A01 on Steel, Stainless Steel and Related AlloysA01 on Steel, Stainless Steel and Related Alloys
•• B07 on Light Metals and AlloysB07 on Light Metals and Alloys
•• C16 on Thermal InsulationC16 on Thermal Insulation
•• D01 on PaintD01 on Paint
•• D02 on Petroleum Products and LubricantsD02 on Petroleum Products and Lubricants
•• D20 on PlasticsD20 on Plastics
•• E28 on Mechanical TestingE28 on Mechanical Testing
•• F04 on Medical and Surgical Materials and DevicesF04 on Medical and Surgical Materials and Devices
•• F15 on Consumer ProductsF15 on Consumer Products
•• F37 on Light Sport AircraftF37 on Light Sport Aircraft
•• F38 on Unmanned Aircraft SystemsF38 on Unmanned Aircraft Systems
•• G01 on Corrosion of MetalsG01 on Corrosion of Metals
Main Committee
Subcommittee.01
Subcommittee.02
Subcommittee.03
Task Group 1
Task Group 2
ASTMASTM’’s Balloting Process s Balloting Process
�� Committees form to address Committees form to address industry subjects, with industry subjects, with subcommittees addressing subcommittees addressing specialized subsetsspecialized subsets
�� Approved Standards Achieve Approved Standards Achieve Separate Subcommittee and Main Separate Subcommittee and Main Committee Approvals, as well as Committee Approvals, as well as a Society Review and a Society Review and ““ Internal Internal AuditAudit””
Technical committees are “classified” and “balanced.”
Classification: Members are classified as producers, users, or general interestparticipants, in terms how they are affected by standardization.
Official Vote: Every member gets to return a position on a balloted document, and every such return must be considered equally. Official votesare 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.
Balance: There are no more producerofficial votersthan non-producerofficial voters. This ensures the development of unbiased, technically sound documents.
Summary: Classification of members, and the assignment of official votes, ensures balance.
Producer
User&
General InterestASTM
ASTMASTM’’s Balloting Process s Balloting Process
NAME COMPANY_NAME CLASS VOTE NV RSN CITY STATE COUNTRYValued Member L-3 Communications PROD Yes San Diego CA United StatesValued Member Oak Ridge National Laboratory GEN Yes Huntsville AL United StatesValued Member National Research Council of Canada GEN Yes Ottawa CanadaValued Member Middle Tennessee State University GEN No REDUN INT Murfreesboro TN United StatesValued Member NASA GEN Yes Wallops Island VA United StatesValued Member Middle Tennessee State University PROD Yes Murfreesboro TN United StatesValued Member National Aerospace Laboratory NLR PROD Yes Amsterdam NetherlandsValued Member Civil Aviation Authority CZ GEN No REQ NO VTE Prague 6 Czech RepublicValued Member Sensenich Wood Propeller PROD Yes Plant City FL United StatesValued Member US Coast Guard USER Yes Washington DC United StatesValued Member AeroViroment Inc PROD No REDUN INT Simi Valley CA United StatesValued Member Civil Aviation Authority - UK GEN Yes Gatwick Airport South United KingdomValued Member Federal Aviation Adminstration GEN No REDUN INT Kansis City MO United StatesValued Member Federal Aviation Adminstration GEN Yes Kansis City MO United StatesValued Member Transport Canada GEN No REDUN INT Ottawa CanadaValued Member AAI TEXTRON SYSTEMS PROD Yes Hunt Valley MD United StatesValued Member NIST GEN No REDUN INT Gaithersburgh MD United StatesValued Member NASA - Goddard PROD No REDUN INT Wallops Island VA United StatesValued Member Federal Aviation Adminstration GEN No REDUN INT Washington DC United StatesValued Member Aerovironment PROD Yes Pasadena CA United StatesValued Member Raytheon Company PROD No WAIT Arlington VA United StatesValued Member Raytheon Company PROD No REDUN INT Lutherville MD United States
Classification and Voting Status Classification and Voting Status
An example of how classification and official voting are trackedAn example of how classification and official voting are trackedto to maintain balancemaintain balance
Example roster from committee F38 on Unmanned Aircraft Systems, Example roster from committee F38 on Unmanned Aircraft Systems, Sept. 2011Sept. 2011
Timing & Resources for Standards Timing & Resources for Standards
DevelopmentDevelopment
�� Complexity of the job and urgency of needsComplexity of the job and urgency of needs
�� Time devoted by members & utilization of informational technologTime devoted by members & utilization of informational technologiesies
�� Most committees meet about twice a year; members cover inMost committees meet about twice a year; members cover in--kindkind
�� New activities can experience a higher resource burn startingNew activities can experience a higher resource burn starting--up (activity up (activity
building / industry & gaps analysis) and authoring high priobuilding / industry & gaps analysis) and authoring high priority documentsrity documents
�� Significant longSignificant long--term considerations: publishing, distribution, maintenance and term considerations: publishing, distribution, maintenance and
recirculation, process oversight and management, liability, recirculation, process oversight and management, liability, brand recognition and brand recognition and
retention of expertise, regulatory integration under Public retention of expertise, regulatory integration under Public Law Law
�� ASTM supports with meetings management, online meetings and callASTM supports with meetings management, online meetings and calls, graphic s, graphic
artists, upartists, up--front/back end editors, managers, templates and collaboration tofront/back end editors, managers, templates and collaboration toolsols
�� Committee F37 on LSA developed 16 standards in 20 monthsCommittee F37 on LSA developed 16 standards in 20 months
Beyond Standards Beyond Standards –– ASTM International ASTM International
•• The ASTM Certification Program covers productsThe ASTM Certification Program covers products (material, products, 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.
•• ASTM Personnel Certification ProgramASTM Personnel Certification 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 Certificate ProgramASTM Personnel Certificate Program– 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
Beyond Standards Beyond Standards –– ASTM International ASTM International
Technical and Professional Training & MoreTechnical and Professional Training & More
•• Technical and Professional Training Courses (TPT)Technical and Professional Training Courses (TPT)– 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.
•• Contract and Project Management Services (CPMS)Contract and Project Management Services (CPMS)– Management support for grants, research projects and other related
activities intended to enhance the quality and timeliness of ASTM products and services.
•• Proficiency Testing Programs (PTP)Proficiency Testing Programs (PTP)– 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.
•• IntralaboratoryIntralaboratoryStudy Program (ILS)Study Program (ILS)– Aid to technical committees with heightening the quality of ASTM test
methods by assisting development of precision statements backed by high quality laboratory data.
ASTM Business ModelASTM Business Model
From 2010 FinancialsFrom 2010 Financials
Annual Budget of $42 MillionAnnual Budget of $42 Million
Operating Revenues of $54 MillionOperating Revenues of $54 Million
Revenue Sources:Revenue Sources:
Publications = 65%
Interest = 6%
Administrative Fees = 8%
Proficiency Test Program = 12%
Training = 6%
Miscellaneous = 3%
About Standardization for ParasailingAbout Standardization for Parasailing
IIIIIIStandardization for the Parasailing IndustryStandardization for the Parasailing Industry
A discussion of standardization and the standards that A discussion of standardization and the standards that may be neededmay be needed
�� Research and RequestResearch and Request- Activity requestedActivity requested-- Industry researchedIndustry researched-- Discussions with industry, associations and regulatorsDiscussions with industry, associations and regulators
�� Planning MeetingPlanning Meeting-- Cross section of industry participantsCross section of industry participants-- Conserve resourcesConserve resources-- Confirm a need for the activityConfirm a need for the activity-- Agreement to look at the issue with the broader industry Agreement to look at the issue with the broader industry
�� Marketing and PromotionMarketing and Promotion�� Organizational MeetingOrganizational Meeting�� Activity StartupActivity Startup
-- Within existing committeeWithin existing committee-- New committee or other activityNew committee or other activity
Process of Activity OrganizationProcess of Activity Organization
�� When is the right time for standardization?When is the right time for standardization?-- Series of failures / to prevent failures Series of failures / to prevent failures -- Underwriting needs / Risk mitigationUnderwriting needs / Risk mitigation-- Regulatory pressuresRegulatory pressures-- Consumer demandConsumer demand-- Capture baselinesCapture baselines-- Industry established need to communicate, improve quality, enhaIndustry established need to communicate, improve quality, enhance safetynce safety
�� The industry might want a systemic approach; a set of standards The industry might want a systemic approach; a set of standards to support safety and reliability across a continuum of needs:to support safety and reliability across a continuum of needs:
-- Operational safetyOperational safety-- Guidelines/practices for training and continued educationGuidelines/practices for training and continued education-- Materials/equipment design and maintenanceMaterials/equipment design and maintenance-- Other human factors and materials/equipment considerationsOther human factors and materials/equipment considerations
Standardization TimingStandardization Timing
Standards and RegulationStandards and Regulation
The The ““ ASTM AdvantageASTM Advantage”” in Regulated in Regulated SpaceSpace……
• FAA and USCG – strong history of utilizing PL 104-113 to develop a mutually beneficial partnership with industry for standards to support regulatory frameworks– Numerous government references
• Regulations identify “what to do”; standards identify “how to do it”
• More flexibility and timeliness with standards referenced by regulation than by regulation alone– Collective expertise and consensus input
Standards and RegulationStandards and Regulation
-- CFR Part 23 for GA vs. F2245 for LSACFR Part 23 for GA vs. F2245 for LSA> 178 pages vs. 29 pages> 178 pages vs. 29 pages> The right standard for a level of safety appropriate > The right standard for a level of safety appropriate
for the aircraft type and intended functionfor the aircraft type and intended function> Global recognition of the standards> Global recognition of the standards
-- Certification/Certificate services considered to support Certification/Certificate services considered to support industry declarations industry declarations
Case Study: Light Sport Aircraft (LSA)Case Study: Light Sport Aircraft (LSA)
Approaches to StandardizationApproaches to Standardization
• Harness– 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
• Tandem/Triple Bar (multi-passenger bar/equipment – not to focus on # of passengers)– Materials, maintenance, inspection, repair– Capacity (1, 2, 3 individuals)– Chair
• Operation– Standard practice for the safe operation of a parasail activity– Pre-launch activities
• Inspection of equipment (daily vs. trip) to include propulsion, winch 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
• Proximity to shore, vessels, docks, aircraft (banner), other obstacles
• Monitoring of sea conditions• Monitoring of altitude• Monitoring forward movement of boat (situational awareness)• Monitoring of conditions (weather)
– Post activity• Inspection• Storage and repair of life jackets, chutes, harnesses, etc.• Documentation/logs of activity• Daily check sheet
Daniel A. Schultz, MSDaniel A. Schultz, MSASTM InternationalASTM InternationalDirector, Operations DevelopmentDirector, Operations Development+1 610+1 610--832832--97169716
