U.S./Europe International Aviation Safety Conference By: Martin Thieringer – TCCA, Roger Simon –...
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Transcript of U.S./Europe International Aviation Safety Conference By: Martin Thieringer – TCCA, Roger Simon –...
U.S./Europe International Aviation Safety Conference
By: Martin Thieringer – TCCA, Roger Simon – EASA, Scott Geddie – FAA
Date: June 4, 2008
“Global Safety Management: Revolution or Evolution”
Reconciling Organizational Privileges
and Aviation Authority Responsibilities
Practical Challenges in Global SMS Implementation
Reconciling Organizational Privileges and Aviation Authority Responsibilities 2June 4, 2008
2
Topics• Formation of the Joint Cooperation Team on
Approved Design Organizations
• Authority Updates on Approved Design Organization Programs:– EASA Design Organization Approval (DOA) – TCCA Accredited Design Organization (ADO)– FAA Certified Design Organization (CDO)– Similarities and Differences
• Sample Joint Cooperation Team Issues:– SMS and Design Organizations– Accountability Framework– Authority Involvement– Suppliers and Specialty Service Suppliers
Reconciling Organizational Privileges and Aviation Authority Responsibilities 3June 4, 2008
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Joint Cooperation Team on Approved Design Organizations
• Chartered by the FAA/EASA/TCCA Certification Management Team (CMT) in November 2007
• Purpose: To create a forum for sharing ideas and plans regarding development and expansion of each authorities approved design organization programs.
Reconciling Organizational Privileges and Aviation Authority Responsibilities 4June 4, 2008
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Scope• Knowledge Sharing
– Understanding of each authority’s approach in developing and recognizing approved design organizations
– Identify similarities and differences– Lessons learned
• Areas of Collaboration– Areas where programs can be harmonized – Areas where common terminology, guidance and
regulatory language can be used
Reconciling Organizational Privileges and Aviation Authority Responsibilities 5June 4, 2008
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Scope (cont.)• Global implications
– Impact of each authority’s approach on partner authorities
– Areas that will require international acceptance by partner authorities
• Share timelines and schedules
Reconciling Organizational Privileges and Aviation Authority Responsibilities 6June 4, 2008
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Authority Updates on Design Organization Programs
Reconciling Organizational Privileges and Aviation Authority Responsibilities 7June 4, 2008
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EASA Design Organization Approval (DOA) Program
Reconciling Organizational Privileges and Aviation Authority Responsibilities 8June 4, 2008
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The EASA DOA
• " qualified framework " for:– Aviation design– Compliance demonstration with applicable
requirements– Discharge of responsibilities
• set the basis for:– EASA acceptance of statements– Approvals, for certain cases
Reconciling Organizational Privileges and Aviation Authority Responsibilities 9June 4, 2008
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In other terms:
• Means to recognise the capability of a design organisation
AND• Foundation for the exercise of privileges
The EASA DOA
Reconciling Organizational Privileges and Aviation Authority Responsibilities 10June 4, 2008
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Organisation, • with the necessary management• allocation of responsibilities• procedures • and resources
necessary for the accomplishment of the activities defined in the scope of DOA
Qualified framework
The EASA DOA
Reconciling Organizational Privileges and Aviation Authority Responsibilities 11June 4, 2008
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AND...• A system that monitors the performance of
the organisation and ensures that the need for effective corrective action is identified and carried out.
Qualified framework
The EASA DOA
Reconciling Organizational Privileges and Aviation Authority Responsibilities 12June 4, 2008
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Resp
on
sib
ilities
(21A
.265)
A Design Assurance System (21A.239)
A Handbook
(21A.243)
Terms of Approval
(21A.251 + 21A.263)
The RIGHT PEOPLE,in the RIGHT PLACES,
with the RIGHT MEANS(21A.243 + 21A.245)
The EASA DOA
Reconciling Organizational Privileges and Aviation Authority Responsibilities 13June 4, 2008
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J DOA
PART PARTPART
PRODUCT
Type
Certificate STC
Others...
The EASA DOA
Reconciling Organizational Privileges and Aviation Authority Responsibilities 14June 4, 2008
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• EASA investigation to verify:– Compliance with all applicable Part 21 requirements– Adherence to approved system
Audits PracticeComplianceChecklist
Part 21/AMC/GM
Handbook/Procedures
The EASA DOA
Reconciling Organizational Privileges and Aviation Authority Responsibilities 15June 4, 2008
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• Implementation started before EASA (first DOA issued in 1996)
• Currently ~235 organisations approved, including:
– All TC Holders (exceptions for balloons, airships and sailplanes)
– STC Holders
– Companies with scope limited to minor changes or repairs
• Discussions for further development on-going
The EASA DOA
Reconciling Organizational Privileges and Aviation Authority Responsibilities 16June 4, 2008
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TCCA Accredited Design Organization (ADO) Program
Reconciling Organizational Privileges and Aviation Authority Responsibilities 17June 4, 2008
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TCCA Accredited Design Organization (ADO)
• Holders of Transport Canada issued operation certificates are required to implement a safety management system (SMS).
• SMS will be applicable to design organizations (year 2010+).
• However, existing TCCA delegation system does not provide for:– integration of SMS into design activities;– the accreditation of design organization; and– clear aircraft certification accountability framework.
Reconciling Organizational Privileges and Aviation Authority Responsibilities 18June 4, 2008
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TCCA ADO “operating certificate” for design organizations
• A distinct vehicle is needed to recognize design organizations knowledge and technical capabilities.
• Best approach is to build on existing expertise gained by 20+ years of delegation principles while clarifying the roles and responsibilities of all stakeholders.
• “Accreditation” is believed to be the best tool to enable the introduction of a “operating certificate” for design organizations.
Reconciling Organizational Privileges and Aviation Authority Responsibilities 19June 4, 2008
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TCCA ADO – What it means…
• TCCA is building a system that will recognize the knowledge and technical capabilities of design organizations – Accredited Design Organization (ADO).
• Fundamentally, any person may apply for a design approval provided the applicant meets knowledge and technical capability requirements which are function of design approval sought, category of aeronautical product and “criticality” or “risk severity”.
Reconciling Organizational Privileges and Aviation Authority Responsibilities 20June 4, 2008
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TCCA ADO – the ABC’s …• A: ADO will…
– make determinations of compliance for every applicable airworthiness requirements; and
– issue a single declaration of compliance for the design approval sought.
• B: TCCA will…– make a single finding of compliance;– conduct Project Surveillance through its Level of
Involvement (LOI);– conduct System Oversight through SMS
implementation.
• C: A design approval will be issued.
Reconciling Organizational Privileges and Aviation Authority Responsibilities 21June 4, 2008
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TCCA ADO – some features…
• ADO may use subcontractor(s) AND is 100% responsible for all compliance determinations for the design approval sought.
• ADO must have a design assurance system.
• ADO will be scalable to fit an individual to small, medium, large design organizations.
• Intent is aligned with EASA’s DOA and FAA’s CDO.
Reconciling Organizational Privileges and Aviation Authority Responsibilities 22June 4, 2008
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TCCA ADO (the benefits…)
• TCCA’s level of confidence in design organizations holding an ADO certificate would provide for their declarations of compliance to be accepted by the Minister without further verification subject to appropriate TCCA surveillance*.
* Project surveillance (LOI) and System Oversight (SMS)
Reconciling Organizational Privileges and Aviation Authority Responsibilities 23June 4, 2008
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FAA Certified Design Organization (CDO) Program
Reconciling Organizational Privileges and Aviation Authority Responsibilities 24June 4, 2008
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CDO Authorizing Statute
• U.S. Congress created the program in 2003 -- Vision 100-Century of Aviation Reauthorization Act
• Allows FAA Administrator to rely on certifications of compliance by a CDO when making a “finding” to issue a type certificate
• FAA has proposed changes to extend implementation date from 2010 to 2013, and to encompass production
Reconciling Organizational Privileges and Aviation Authority Responsibilities 25June 4, 2008
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CDO Aviation Rulemaking Committee (ARC)
• Chartered in May 2005 for two year period– Membership
• 15 from industry and industry associations• 5 from FAA• 1 from TCCA
– ARC was free to make any recommendations including those that might require additional statutory changes
• ARC report submitted to FAA last week– Recommends CDO for TC, STC, PMA and TSOA
holders– Includes a proposed NPRM
Reconciling Organizational Privileges and Aviation Authority Responsibilities 26June 4, 2008
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Principles and Attributes
• Not a delegation – certificate-based privileges
• Must be a design approval holder
• US must be State of Design
• CDO makes all ‘determinations of compliance’
Reconciling Organizational Privileges and Aviation Authority Responsibilities 27June 4, 2008
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Principles and Attributes (cont.)
• A CDO can extend its system into its suppliers allowing them to make ‘compliance determinations’
• CDO intended to encompass continued airworthiness of legacy products
• FAA relies on CDO ‘statement of compliance’ when issuing a certificate or design approval
Reconciling Organizational Privileges and Aviation Authority Responsibilities 28June 4, 2008
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Principles and Attributes (cont.)• Compliance by process rather than by the
action of a few individuals at the end of a program
• CDO requires – – Compliance Assurance System– Quality Management System– Safety Management System– Culture of Compliance
• FAA approved procedures manual required
CAS QMS
SMS
Reconciling Organizational Privileges and Aviation Authority Responsibilities 29June 4, 2008
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FAA Level of Involvement
• Establish cert basis, approve alternate means of compliance, issue exemptions
• After that, FAA involvement in any program will consist of oversight and audit of the CDO operation
• FAA may, at any time, and for any reason conduct any certificate oversight it deems appropriate
• Delegation retained to issue certificates
Reconciling Organizational Privileges and Aviation Authority Responsibilities 30June 4, 2008
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SMS/QMS (Company)
SMS (FAA)
Air Agency
Repair
CDO Concept Model
TCSTC
AW
FA
A A
dm
inis
tra
tor
Approved Data
Approved Parts Production “Finding”
Design “Finding”
PC
Production
CDO
Design
Reconciling Organizational Privileges and Aviation Authority Responsibilities 31June 4, 2008
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Benefits• Recognizes a design organization’s system,
processes, and capabilities• Safety Management System (SMS) in place• A catalyst to promote further maturity of the
‘safety cultures’ within FAA and industry• Allows FAA to re-focus its resources on:
– areas of highest safety risk– developing clear policy and guidance for industry– enhanced role as compliance educator, coach
Reconciling Organizational Privileges and Aviation Authority Responsibilities 32June 4, 2008
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Benefits (cont.)• The creation of “eligible” data• Reinforces industry’s responsibility for
compliance• Industry has greater control over its project
costs and schedules• Suppliers can be integrated into the process• CDO procedures manual replaces FAA Type
Certification Order
Reconciling Organizational Privileges and Aviation Authority Responsibilities 33June 4, 2008
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Similarities and Differences Between DOA, ADO and CDO
Reconciling Organizational Privileges and Aviation Authority Responsibilities 34June 4, 2008
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Similarities
Applicant’s System
Product Compliance
• Greater focus on process management and system oversight
• Design Organizations responsible for all compliance determinations
• Authority performs project and system oversight
• Routine projects require little authority involvement
• Suppliers can be incorporated with proper oversight
Moving to…
Agency
Reconciling Organizational Privileges and Aviation Authority Responsibilities 35June 4, 2008
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Differences
Item EASA
DOA
TCCA
ADO
FAA
CDO
Acts as agent for other applicants Yes Yes No
Contains provisions to include production
No No Yes
Applicant must be an organization Yes No Yes
Declarations of compliance must be accepted by the authority
No Yes No
Must be located in country/union No Yes Yes
Reconciling Organizational Privileges and Aviation Authority Responsibilities 36June 4, 2008
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Sample Issues Being Addressed by the Joint Cooperation Team
Reconciling Organizational Privileges and Aviation Authority Responsibilities 37June 4, 2008
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SMS and Design Organizations• TCCA
– SMS is overarching (mandated by regulation)– Design Assurance elements will complement the SMS
requirements
• FAA– SMS is overarching– Single seamless system likely, but SMS, QMS and Design
Assurance requirements are separate
• EASA– New requirement for Management Systems will be the new
basis for organisation approvals to which DOA requirements will be added
– Introduces risk based approach to DOA activities and manner in which agency conducts oversight
Reconciling Organizational Privileges and Aviation Authority Responsibilities 38June 4, 2008
38
SMS and Design Organizations
• Things to consider going forward– ICAO requirements– The relationship between Safety Management,
Quality Management, and Design Assurance– Scalability– SMS regulations and oversight– Interface points between the authority and the SMS
of an approved design organization – Alignment of design organization SMS requirements
with other SMS facets of the company
Reconciling Organizational Privileges and Aviation Authority Responsibilities 39June 4, 2008
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Accountability FrameworkApplicants have a regulatory obligation to:
Use means of compliance acceptable to the Authority Show that their designs are compliant
Design Approval Holders have an obligation to: Maintain compliant designs with no unsafe features
Authorities promote Aviation Safety by… Issuing regulations Specifying the certification basis Providing guidance regarding acceptable means of compliance Overseeing compliance Taking enforcement actions as necessary Issuing certificates and approvals; and Mandating corrective action as necessary
Reconciling Organizational Privileges and Aviation Authority Responsibilities 40June 4, 2008
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Accountability Framework• TCCA
– Framework originated with TCCA– Provides the foundation of stakeholder responsibilities– Serves as the basis for any program undertaken
• FAA– Slight deviation from TCCA version– CDO ARC included it in proposed NPRM
• EASA– Will evaluate TCCA version, taking into account
responsibilities allocated by community laws
Reconciling Organizational Privileges and Aviation Authority Responsibilities 41June 4, 2008
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Accountability Framework
• Things to consider going forward– Working toward a common definition– Impact of individual country laws, regulations, or
agency polices, in defining our views of the Accountability Framework
– Significant implications, if any, resulting from our differences
Reconciling Organizational Privileges and Aviation Authority Responsibilities 42June 4, 2008
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Post CertComplianceConcept
• Ongoing system oversight based on risk management indicators
Pro
ject
Sys
tem
• COS
• Issue Certificate
• Trend monitoring
• Post-project reviews
• Determine cert basis
• Special conditions
• Exemptions
• Project shadowing/oversight
Authority Involvement
Reconciling Organizational Privileges and Aviation Authority Responsibilities 43June 4, 2008
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Authority Involvement• Topic:
– To what extend the Authority is involved in product certification?
• Two main domains: – Obligations (e.g., development of cert basis, means of
compliance, issue certificates…)– Involvement in compliance determination (witnessing
of tests, verification activities…)
• Discussion on impact of CDO/ADO/DOA on involvement in compliance determination
Reconciling Organizational Privileges and Aviation Authority Responsibilities 44June 4, 2008
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Authority Involvement
• Things to consider going forward– Impact of individual country laws, regulations, or
agency polices, on our view of LOI– Significant implications, if any, resulting from our
differences
Reconciling Organizational Privileges and Aviation Authority Responsibilities 45June 4, 2008
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Suppliers• EASA
– Integration of suppliers in DOA already defined– Chartered working group to investigate granting sub-
tier DOA to suppliers• Limited scope of privileges• Concept exists under production system for POA• Prime has ultimate responsibility for continued
airworthiness
• TCCA/FAA– ADO/CDO can extend its system into suppliers
allowing them to make ‘compliance determinations’– No plan to introduce sub-ADO/CDO for suppliers
Reconciling Organizational Privileges and Aviation Authority Responsibilities 46June 4, 2008
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Specialty Service Suppliers
• Consideration of authority recognition of suppliers of specialized services to the aviation industry– Have unique expertise and testing capability– Supply to multiple applicants
• Examples – Flammability labs– Materials labs– Environmental and HIRF/Lightning test facilities
Reconciling Organizational Privileges and Aviation Authority Responsibilities 47June 4, 2008
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Specialty Service Suppliers• EASA
– Open to possibility of recognizing suppliers of specialty services
– Sub-tier DOA would be applicable, if specialty service supplier has the capability to make compliance determinations
• TCCA/FAA– Open to possibility of recognizing suppliers of
specialty services (e.g. test laboratories)– No plan to introduce sub-ADO/CDO for any
suppliers
Reconciling Organizational Privileges and Aviation Authority Responsibilities 48June 4, 2008
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Suppliers• Things to consider going forward:
– International implications– Competition driving need to ensure a ‘level playing field’– Impact on safety– Alignment with Accountability Framework– Establishing a basis in regulation– Authorities/Industry role in Oversight– Responsibility for compliance– What is the resulting product – ‘compliance
determination’, ‘recognized data’ or something else? – Establishing standards and requirements
Reconciling Organizational Privileges and Aviation Authority Responsibilities 49June 4, 2008
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Questions?