TCCA-JAA Generic Arrangement on Certification under JAR-21 Subpart N
Appendix B
TYPE CERTIFICATION OF IMPORTED PRODUCTS
(TCCA/JAA TYPE VALIDATION PRINCIPLES)
1. Introduction
1.1 This document addresses the concepts under which the authorities will operate during type validation projects relating to:
- How the validation items (VI) will be established by the validating authority (VA).
- What involvement the VA will have in the review of the methods of compliance (MOC) accepted by the certificating authority (CA).
- How and by whom the compliance determinations will be made to the validation requirements.
1.2 The VA has sovereign authority over the certification process and compliance findings within its country. The validation principles are not intended, in any way, to diminish the authority's responsibilities or future right to type design information, but are intended to define how the rights of the authority would be routinely exercised. It is agreed that if there are overwhelming reasons to go outside these defined principles, such reasons will be technically explained by the VA in every instance.
2. Definitions
2.1 Certificating Authority: The airworthiness authority of the state of the type certificate holder. Also referred to as the exporting authority.
JAA Note: Where the certificating authority is a member authority of the JAA, JAA procedures will be applied.
2.2 Compliance Determination: The determination, by either the CA or the VA, that identified certification requirements have been complied with by the applicant.
2.3 Compliance Findings: The official act by which the responsible authority makes a legal determination of compliance with identified airworthiness requirements. The finding may be based, in part, on compliance determinations made by another airworthiness authority under a bilateral agreement, or similar country-to-country legal arrangements.
2.4 Non-Significant Regulatory Difference: Regulations where the CAR/AWM and the JAR requirements are different, but are not classified as SRDs.
2.5 Significant Regulatory Difference: Regulations where the CAR/AWM and JAR requirements are substantively different and may result in type design changes (including approved manuals) to meet the requirements of the VA different from the design and operation approved by the CA.
2.6 Validating Authority: The TCCA for import into Canada, or a member state of the JAA, for import into a state of a JAA member authority, when using the applicable JAA procedures. Also referred to as the importing authority.
3. Vision
3.1 The vision of all validation projects is:
"A simple process based on mutual authority trust, which leads to design acceptance in compliance with the validating authority's safety regulations." This process requires effective communication between all parties on all matters related to the validation process.
3.2 The expectation is that, with only a few exceptions, the determinations of compliance with the VA's validation basis would be made by the CA, as delegated by the VA. The VA is able to make findings of compliance, without further showing, based upon statements of compliance by the CA, on the basis of bilateral airworthiness, or bilateral aviation safety, agreements.
3.3 The authorities recognize the benefits to aviation safety of efficiently run validation programs. These programs provide an opportunity for assessment of significant safety features, in accordance with the concepts in this document. This will enable and facilitate the mutual recognition of the work of the authorities and the long term cooperation and effectiveness of the authorities and the manufacturers.
3.4 It is the VA's prerogative to issue a type certificate without any investigation of compliance, relying solely on the compliance statements of the CA.
4. Applicability
4.1 These principles define the normal conduct of both the certificating and validating authorities during a type validation program.
4.2 These principles apply to validation projects on engines, propellers, airplanes, and helicopters.
4.3 These principles apply to both type validation and amended type validation programs, carried out either concurrently or sequentially.
5. The Use of Significant Regulatory Differences (SRD)
5.1 The SRD are unique to a particular amendment-pair of regulations. An amendment-pair is defined as a particular JAR amendment number and a comparable CAR/AWM amendment number.
5.2 The SRD for the current regulations will be updated as the CAR/AWM and JAR regulation amendments change. Pending full harmonization, there will be a current set of SRD, as well as other SRD that have been generated for other amendment-pairs in the past.
5.3 Once a particular set of SRD is generated for a particular amendment-pair of regulations, that set of SRD will be published and should be used for all validation projects where the regulatory basis consists of that amendment-pair.
5.4 In a particular validation project, especially for derivative products, the amendment-pair of regulations that form the certification and validation basis may not have a set of SRD. In that case, the VA team will work during Phase II of the validation project (See 8.3) to identify the SRD for the amendment-pair of regulations that comprise the certification and validation basis of the product. The team must begin their work by referring to the SRD that correspond to an amendment-pair of regulations that is closest to those of the product certification and validation basis.
5.5 All regulatory interpretive material must be included with the SRD. For the JAA, the Advisory Circular-Joint (ACJ), Advisory Material Joint (AMJ), and Temporary Guidance Material (TGM) may contain regulatory interpretive material. For the TCCA, the regulatory interpretive material is found in the CAR standards as information notes or in the Airworthiness Manual Advisory (AMA).
5.6 Once the project-specific SRD are developed they must be approved by the appropriate Directors within the TCCA and the Regulation and Certification Directors within the JAA.
6. Validation Items (VI)
6.1 Validation items define the normal scope of involvement of the VA. The basic principle behind the VI is that the VA will not review compliance determinations by the CA to the CA regulations except in identified cases within the areas defined by the VI.
6.2 Validation Items consist of:
6.2.1 Significant Regulatory Differences (SRD)
6.2.2 Validation Items Specific to an Individual Project (VI(P))
6.2.3 Validation Items Identified in the Validation Process (VI(I))
VI = SRD + VI(P) + VI(I)
6.3 VI(P) consist of those items that are unique to the particular validation project and are established solely to address that uniqueness. VI(P) items under 6.3.1, 6.3.2, 6.3.3, and 6.3.4 may result in special conditions. All VI(P) are identified in issue papers and certification review items (CRI). The VI(P) consist of items that address:
6.3.1 New Technology — This is technology that is new to the TCCA or the JAA as a whole, not just new to the VA team members. For instance, if technology used by the applicant were new to the validation team but not the VA itself, it would not be considered a VI(P). It would be the VA responsibility to make sure the VA team members were properly educated on the technology, VA regulations, and MOC.
6.3.2 Novel Applications of Existing Technology — This is where a particular technology is being used in a manner that causes the precepts of the technology to be questioned. Novel again applies to the TCCA or JAA as a whole, not just the VA team members - as discussed above. This does not mean that existing technology being applied for the first time to a particular product line is automatically novel.
6.3.3 The Product Use is Unconventional — This is where a product is being used for a purpose for which it was previously not designed.
6.3.4 Unsafe Condition — The product contains design features where experience with other products in service has shown an unsafe condition might occur in that product, even though compliance with the regulations in the validation basis can be demonstrated. Unsafe is measured with respect to the overall level of safety intended by the product validation basis.
Note: This principle of "unsafe condition" should not be used to upgrade the level of safety of the product unless the VA has mandated, or will immediately mandate, in accordance with its own regulation, that upgraded safety to products with similar design features for which it is responsible.
6.3.5 New Rule Interpretations or MOC for the Existing Rules by the CA that are different from those already agreed to between the CA and the VA.
6.3.6 Exemptions — These are exemptions from issued CA or VA regulations. The VA may wish to understand the exemptions allowed by the CA to the CA's rules.
6.3.7 Equivalent Safety Findings — Again, these are to both the CA and the VA regulations, as above for exemptions.
6.4 VI(I) consist of those items that are identified by the validation team during its familiarization and validation of the product as justified by the VA team and endorsed by the VA management. These might include potential VI(I) identified in paragraph 8.2.3. VI(I) are identified in issue papers and CRI.
7. The Validation Basis
7.1 Compliance with the VA certification basis for the product will be based on compliance with: the certification basis of the CA, plus the SRD for the particular amendment-pair of regulations, plus any exemptions and special conditions issued by the VA.
7.2 Operational requirements with design impacts should be identified by the VA up front in the program so they may be included in the validation program.
7.3 Once the validation basis has been established by the VA, it will remain unchanged except when unsafe conditions arise, design changes are made that affect the certification basis, or when the applicant elects to comply with later amendments.
8. The Validation Process
8.1 General
8.1.1 In the paragraphs below, different phases of a validation project are discussed. The events that begin and end each phase are identified. Certain technical disciplines on a validation team may be at different phases of the validation project, depending on the progress of their efforts. There is no need for any technical discipline to hold up its validation efforts to wait for those that are not as far along.
8.1.2 Upon identification of the VI and agreement to the MOC, the expectation is that all determinations of compliance, except for defined subjects limited to VI, would be delegated to the CA.
8.1.3 When an activity is carried out by the CA on behalf of the VA, that activity may be carried out by the CA or under the legally constituted System of the CA.
8.1.4 The VA will not review any of the determinations made by the CA to rules that are outside of the set of regulations defined by the VI.
8.1.5 The TCCA and the JAA agree that management will closely follow the validation programs. Every effort must be made to resolve all certification impasses between the VA and CA teams as the program progresses, at the lowest possible level. Only where necessary, impasses should be expeditiously elevated to consecutively higher levels of management within the VA and the CA until resolution has been obtained or the appeal process has run its course. The objective is to not delay the applicant's certification program while the authorities are resolving their issues.
8.1.6 The concepts discussed below are summarized in the table in the Appendix.
8.2 Phase I - General Familiarization
8.2.1 This phase begins when the type certification application is received by the validating authority. In this meeting the time schedule will be established for the validation process.
8.2.2 The objective of this meeting is to enable the VA to receive an overview briefing of the project. The purpose of this briefing is to acquire sufficient information for the VA to establish the appropriate technical disciplines, size of the team, and guidance for the follow-on technical validation team. This should maximize the effectiveness of any follow-on meetings. The meeting is expected to last no more than about two days.
8.2.3 At the initial meeting, the VA should identify potential VI(I) that meet the following criteria, for further discussion in the familiarization phase. These potential VI(I) should be published and periodically updated by the VA so they may be commonly known by all applicants.
8.2.3.1 Regulations where variations in methods of compliance resulting from different design philosophies used in the industry may affect design and operation, and the acceptability of these variations cannot be solved by the harmonization process without limiting the applicant's prerogative to propose a method of compliance; or
8.2.3.2 New VA rules where there is no past experience with their application to a product, they have an important impact on the whole product or a critical feature, and engineering judgment is required to establish compliance.
8.2.4 This phase ends with the establishment of the validation technical team.
8.3 Phase II - Technical Familiarization
8.3.1 The objective of this phase is technical familiarization with the project by the VA and the establishment of the initial validation basis and the initial VI.
8.3.2 This phase begins with the scheduling of a familiarization meeting, unless the product is a derivative and the changes from previously validated designs do not warrant the briefing.
8.3.3 The VA should receive a thorough familiarization briefing on a new certification program in order to fully understand the product design and any unique or novel design features. This information will be used to establish the validation basis for the project. It will also serve the purpose of educating the VA so it may appropriately deal with continued operational safety issues within its country.
8.3.4 The briefing should be conducted jointly by the CA and the applicant.
8.3.5 The CA should identify its certification basis and an overview of any significant compliance findings already established.
8.3.6 Of prime importance is the presentation of the MOC used, or to be used, for regulations that significantly contribute to the airworthiness of the product, such as fatigue, static strength, software validation and verification, basic loads, lightning, etc.
8.3.7 The CA will thoroughly brief the VA on all exemptions and special conditions issued by the CA to ensure they are fully understood by the VA.
8.3.8 The objective of the briefing is to convey information to the VA. In-depth discussion or debate of the material is to be done, if needed, during Phase III of the project. The VA should ask clarifying questions and have dialogue as necessary to properly understand the material presented.
8.3.9 It is expected that all VA functional areas would be represented at the briefing so that the familiarization briefing takes place only once. It is recognized that once information is received, the size of the actual VA team involved in the type validation may be reduced. For instance, if there are no significant systems issues, the VA team may not have a full-time systems member.
8.3.10 This phase ends with the establishment of the initial validation basis and initial validation items.
8.4 Phase III - Determining VA Involvement
8.4.1 The objective of this phase is to specifically identify the amount of delegation of compliance determinations by the VA to the CA and identify those findings that the VA wishes to make for itself.
8.4.2 This phase begins with the first technical team meeting following the establishment of the validation basis and initial VI.
8.4.3 The practice of authorities making joint determinations of compliance for any one specific requirement should be avoided unless there is a justifiable benefit.
8.4.4 Where compliance to the validation basis has been delegated to the CA, compliance documents representing those determinations should only be requested by the VA in the spirit of preparing itself for continued operational safety issues. They should not be requested to review the compliance determinations of the CA.
8.4.5 This phase ends with the issuance of a document that identifies which authority is to make compliance determinations with the regulations within the VI.
8.5 Phase IV - Compliance Determinations
8.5.1 This phase is where the actual compliance determinations are made by either the CA or the VA.
8.5.2 This phase begins immediately after the establishment of compliance responsibility.
8.5.4 This phase ends with the issuance of the type certificate by the VA.
9. Methods of Compliance
9.1 Where there is no precedent, i.e. for new technology, novel applications of existing technology or MOC, novel MOC, or product use is unconventional, the VA will work closely with the CA and the applicant during Phase II of the program to establish an acceptable validation basis and MOC.
9.2 Once a MOC for a given rule has been accepted by the VA on any program with the CA, the expectation is that the VA will accept that MOC in the future as long as the assumptions made in the MOC are applicable. An exception is where an MOC has been determined not to be sufficient. This determination must be discussed between the VA and the CA.
9.3 When the VA determines there is a need to evaluate or review a MOC with the CA and the applicant, in accordance with the concepts in this document, the VA will confine its evaluation or review to the general, overall methodology to be used by the applicant, including assumptions, boundary conditions, and critical parameters of that methodology that are essential to the technical adequacy of the MOC. Details in the form of test plans, test parameters and other MOC steps should be left up to the CA to further define and approve.
10. Compliance Statements
10.1 On the basis of the agreement on certification under JAR-21 Subpart N between the [NAA] and the TCCA, the below statement is to be given by the TCCA (exporting authority) to the [NAA] (importing authority) at the end of the validation project so that the [NAA] may issue the type certificate.
"With the determinations of compliance made by the [NAA] and summarized in {Letter or document} dated {Date}, the TCCA certifies that the {Specific product type and model} complies with the [NAA] validation basis as identified in {Certification Review Item A-1 or issue paper G-1} dated {Date}."
10.2 Note that this statement requires the [NAA] to list all compliance findings it has made in a letter or report to the TCCA.
11. Consequences of Existence of Non-SRDs for the Application of this Document
11.1 For non-SRDs, until the non-SRDs between the JARs and the CAR/AWMs have been harmonized, there is a need for a compliance statement from the CA relative to these VA regulations.
11.2 The non-SRDs are unique to a particular amendment-pair of regulations. An amendment-pair is defined as a particular JAR amendment number and a comparable CAR/AWM amendment number.
11.3 The non-SRDs will be listed in a Certification Review Item (CRI) or Issue Paper (IP) that will be provided to the VA team by the VA management.
11.4 This CRI/IP must be referred to in CRI A-1 and IP G-1, respectively.
11.5 The determination of compliance against all non-SRDs outside the VIs will be made by the CA.
Appendix
Summary of Validation Phases
Project Phase | Objective | Beginning | Ending |
---|---|---|---|
Phase I | General familiarization | Receipt of application by VA | Establishment of validation team |
Phase II | Technical familiarization | Familiarization briefing | Establishment of initial validation basis and initial VI |
Phase III | Establishing the scope of delegation to the CA | Technical compliance discussions | Document defining which authority is to make which determinations |
Phase IV | Compliance determinations | Establishment of compliance authority | Issuance of VA type certificate |