Staff Instruction. Aircraft Certification Inspection and Audit Procedures

Transcription

1 Staff Instruction Subject: Aircraft Certification Inspection and Audit Procedures Issuing Branch: Aircraft Certification Activity Area: Regulatory Standards SI No.: GEN-006 File No.: Issue No: 01 RDIMS No.: v9 Issue Date: TABLE OF CONTENTS 1.0 INTRODUCTION Purpose Applicability Description of Changes REFERENCES Reference Documents Cancelled Documents Definitions and Abbreviations BACKGROUND AIRCRAFT CERTIFICATION SPECIALTY/ELEMENT AREAS OF AUDIT Aircraft Certification Main Areas for Audits AUDIT SAMPLE DOCUMENTS CHECKLISTS DAO / AEO CONTACT OFFICE...9 APPENDIX 1 - INSPECTION AND AUDIT CHECKLISTS (DAO/AEO) Design Approval Procedures Manual (DAPM) Self-Audit System Airworthiness Control Committee (ACC) Personnel Authorized to Perform a Delegated Function Resource Library Certification Process Third Party Engineering Support DAO Software Audit Checklist Engineering Data Review (EDR) Records and Documentation Configuration Control (Design Drawings and Process Specification) Flight Test (FT) Support to Aircraft Maintenance and Manufacturing (M&M) TCCA Instructions for Continued Airworthiness (ICA)... 41

2 15. Post-Certification Activities (PCA) Airworthiness Directive & Service Bulletin (AD&SB) Airworthiness Directives/Service Bulletin Compliance Service Difficulties Reporting (SDR) APPENDIX 2 - INSPECTION CHECKLISTS DAR Previous Audit (PA) Engineering Procedures Manual (EPM) Exercise of Delegation (EoD) Resource Library (RL) Certification Process (CP) Third Party Engineering Support (TPES) Software Aspects (SA) Certification Data Review (CDR) Records and Documentation (R&D) Configuration Control (CC) Certification Test (CT) Flight Test (FT) Support to Aircraft Maintenance and Manufacturing (M&M) TCCA Instructions for Continued Airworthiness (ICA) Post-Certification Activities (PCA) Airworthiness Directive & Service Bulletin (AD&SB) APPENDIX 3 - DELEGATED PROJECTS TECHNICAL REVIEW CHECKLIST... 86

3 1.0 INTRODUCTION 1.1 Purpose (1) The purpose of this document is to provide additional policy specifics and procedures that pertain to inspection and audit activities. Its purpose is to ensure that inspection and audit activities are conducted in a standardized manner thus providing a level playing field for those organizations for which Aircraft Certification engineers hold oversight (surveillance, inspection and audit) responsibility. (2) Where applicable, material presented in this Staff Instruction (SI) is intended to supplement that provided in the Inspection and Audit Manual (IAM); where any conflict exists between information provided in this document and that set out in the IAM, the IAM will take precedence. 1.2 Applicability The procedures, checklists, forms and guidance material contained or referred to in this SI apply to the conduct of inspections and audits on the following Design Approval Organizations (DAO), Airworthiness Engineering Organizations (AEO) and Design Approval Representative (DAR). 1.3 Description of Changes This is a new issue. 2.0 REFERENCES 2.1 Reference Documents It is intended that the following reference materials be used in conjunction with this document: (a) (b) (c) (d) (e) (f) (g) (h) Part V. Subpart 11, of the Canadian Aviation Regulations (CAR) 511--Approval of the Type Design of an Aeronautical Product, Transport Canada Publication (TP) E Inspection and Audit Checklists (DAO/AEO); Chapter 505 of the Airworthiness Manual ()--Delegation of Authority; Chapter 513 of the --Approval of Modification and Repair Designs; Design Approval Procedures Manual (DAPM); Engineering Procedures Manual (EPM); Inspection and Audit Manual (IAM); and Operating Procedures Manual (OPM). 2.2 Cancelled Documents Not applicable. 2.3 Definitions and Abbreviations The following definitions and acronyms are used in this document: (a) Definitions: (i) Design Approval Organizations (DAO)--means the group of individuals in the employ of and nominated by the applicant (corporation) pursuant to subsections (c) and (d) and (c); (ii) Airworthiness Engineering Organizations (AEO)--means the group of individuals in the employ of and nominated by the applicant (corporation) pursuant to subsections (c) and (d) and (c); and of 91 SI GEN-006 Issue 01

4 (b) (iii) Design Approval Representative (DAR)--means a delegate is an individual who is appointed to act independently on behalf of the Minister to find compliance of regulatory requirements and issue Limited Supplementary Type Certificates and Repair Design Certificates as detailed in CAR/ 513 and 505 C. (iv) Third Party--means an organization or individual, involved with the auditee, in the design manufacture or provision of parts, components or materials supplied to the auditee for incorporation into the type design of the auditee s aeronautical product(s) (e.g., design organization, approved manufacturing organization, subcontractors, suppliers, etc.). Acronyms: (i) Activity Reporting and Standard System (ARASS) (ii) Aircraft Certification Policy Letter (ACPL) (iii) Aircraft Certification Staff Instruction (ACSI) (iv) Airworthiness Control Committee (ACC) (v) Airworthiness Directives (AD) (vi) Airworthiness Directive & Service Bulletin (AD& SB) (vii) Airworthiness Engineering Organizations (AEO) (viii) Airworthiness Manual () (ix) Canadian Aviation Regulations (CAR) (x) Certification Data Review (CDR) (xi) Certification Process (CP) (xii) Certification Test (CT) (xiii) Changed Product Rule (CPR) (xiv) Configuration Control (CC) (xv) Convening Authority (CA) (xvi) Commercial Air Service Standards (CASS) (xvii) Design Approval Organization (DAO) (xviii) Design Approval Representative (DAR) (xix) Design Approval Procedures Manual (DAPM) (xx) Designated Engineer (DE) (xxi) Engineering Data Review (EDR) (xxii) Engineering Procedures Manual (EPM) (xxiii) Exercise of Delegation (EoD) (xxiv) Engineering Test and Witnessing (ET) (xxv) Flight Test and Witnessing (FT) (xxvi) Inspection and Audit Manual (IAM) (xxvii) Instructions for Continued Airworthiness (ICA) (xxviii) Leave and Extra Duty (LEX) (xxix) Aircraft Maintenance and Manufacturing (M&M) TCCA (xxx) Material Review Board (MRB) (xxxi) National Aeronautical Product Approval Information System (NAPA) (xxxii) Operating Procedures Manual (OPM) (xxxiii) Policy Letter (PL) (xxxiv) Post-Certification Activities (PCA) (xxxv) Previous Audit (PA) of 91 SI GEN-006 Issue 01

5 (xxxvi) Records and Documentation (R&D) (xxxvii) Resource Library (RL) (xxxviii) Service Bulletin (SB) (xxxix) Service Difficulties Reporting (SDR) (xl) (xli) (xlii) (xliii) 3.0 BACKGROUND Software Aspects (SA) Staff Instruction (SI) Third Party Engineering Support (TPES) Transport Canada Civil Aviation (TCCA) (1) Aircraft Certification inspection and audit activities confirm for TCCA that a Canadian civil aviation document holder is conducting their business in compliance with regulatory requirements. (2) A company receives its approval on the basis that the documentation, submitted for TCCA approval, meets regulatory requirements. For the company to receive TCCA approval, company control manuals (i.e., Design Approval Procedures Manual, Engineering Procedures Manual, Operating Procedures Manual, etc.) must clearly explain how the organization intends to meet the requirements of the standards and regulations under which the company will be operating. The manuals are reviewed to ensure that the means of achieving compliance with regulatory requirements is referenced and documented by process. (3) Once approved, the company control manuals form important standards to which the organization will be evaluated. If for any reason, procedures or processes specified in a manual are inadequate or are not being complied with by company personnel, such deficiencies must be brought to the attention of the company for rectification. Moreover, non-compliance with other regulatory requirements must also be brought to the attention of the company. Where a non-compliance/nonconformance is identified during an inspection or audit, a finding will be assigned citing examples of the deficiencies. Corrective action and follow-up will be conducted in accordance with the process specified in the IAM. (4) Checklists, forms and material presented or referred to in this document are designed to provide auditors with guidance information in an effort to accurately assess an organization s level of compliance with regulatory requirements. Checklists may be general in nature or refer to more specialized forms or other guidance material. Auditors may also supplement these checklists with information contained in other authoritative publications as required. 4.0 AIRCRAFT CERTIFICATION SPECIALTY/ELEMENT AREAS OF AUDIT 4.1 Aircraft Certification Main Areas for Audits (1) Delegation of Authority (Reference Chapter 505 of the ); (2) Design Approval Procedures Manual (Reference Chapter 505 of the ) and DAPM/EPM); (3) Certification Process; (4) Post-Certification Activities and (5) Third Party Operations. (6) Each area may be further divided into its systemic functional areas. For example, the Certification Process will include Type Certification Data Review, Type Design Drawings and Specifications Control, Type Certification Approval Records, and Documentation. (7) Approaching the organization by systemic functional area permits an organized, more focused approach to the activity, which will aid in the organization s overall assessment. The systemic functional areas will include smaller elements consisting of procedural and technical aspects. For example, Type Certification Data Review should include the following items: (a) The correct certification basis; of 91 SI GEN-006 Issue 01

6 (b) (c) (d) The review of all affected areas; Acceptable means of compliance; and Data substantiation compliance. (8) For the oversight of a Design Approval Delegate, the functional areas should include the following items: (a) (b) (c) (d) (e) Issuance of LSTCs and RDCs; Findings of Compliance; Flight Authority recommendations; Production of design data; and Production of substantiating data. (9) The fundamental areas of a delegation for DAO/AEO/DAR may be limited to some or a combination of the following functional specialties: (a) (b) Engineering: (i) (ii) (iii) (iv) (v) (vi) Flight Test: (i) (ii) Aircraft Structures Powerplants and Emissions Fuel and Hydro Mechanical Systems Avionics and Electrical Systems Occupant Safety and Environmental Systems Software Pilot Analyst (10) The Element area checklists and their use are discussed in more details in Checklists DAO/AEO. 5.0 AUDIT (1) The following procedures are found in the IAM and should be considered when initiating an audit. (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) Classification and Type; Audit Planning; Audit Phases; Notification Audit Management; Notification Auditee; Audit Plan; Audit Budget. Overtime Procedures During an Audit; Pre-Audit Meeting; Physical Audit; Post-Audit; Audit Follow-up; and Audit Report Review of 91 SI GEN-006 Issue 01

7 6.0 SAMPLE DOCUMENTS (1) Sample documents to aid Auditors plan, conduct, report and conclude the audit process. This material relates to the combined audit process and is easily tailored to other activities such as specialty, special purpose audits or routine inspections. These documents are found in the IAM: (a) Confirmation Request Form ; (b) Conformation Request Tracking Form ; (c) Corrective Action Form (1 page) ; (d) Corrective Action Form (2 pages) ; (e) Finding Form ; (f) Parallel Finding Form ; (g) Parallel Observation Form ; and (h) Evidence Log (2) The forms listed above can also be found at the following web site: (a) (b) Intranet: Internet: CHECKLISTS DAO / AEO (1) Inspection and audit checklists have been developed to provide a systematic approach to the inspection of an organization various element areas. The checklists are designed to guide auditors through specific items within the element area. Questions contained within the checklist(s) are intended to provoke or stimulate analysis of the element considering the performance-based nature of our regulations. Normally, each question contains a reference(s) to applicable regulatory requirements for the auditor s convenience. Where an operator fails to comply with requirements, they will be considered in non-compliance, which will necessitate corrective action. (2) This SI is made available to any organization or operator; it is hoped that they will make use of the material presented in this document as they evaluate their systems for effectiveness and compliance with regulatory requirements. It is anticipated that companies will further develop checklists and materials that pertain to processes and procedures described in their company manuals. (a) Audit checklists will be: (b) (i) (ii) (iii) (iv) (v) Used in the inspection of a process, procedure or program; amended to reflect the current revision of the applicable regulation or standard; supplemented to include processes specified in the appropriate control manual; completed or have areas that are not completed so annotated; and signed and dated by the team member responsible for that specialty area or specialty area sub-group. The following specialty areas have checklists developed, which cater to Aircraft Certification functional responsibilities: of 91 SI GEN-006 Issue 01

8 Certificate Holder / Canadian Aviation Regulation Checklist Reference Design Approval Procedures Manual ( Chapter 505) 1 Self-Audit System ( 505) 2 Airworthiness Control Committee (ACC) (ACSI 45 & 46) 3 Personnel Authorized to Perform a Delegated Function ( 505) 4 Resource Library ( 505, SI GEN-003) 5 Certification Process ( 511) 6 Third Party Engineering Support ( 505) 7 Software Aspects of Aircraft Certification (DAPM/EPM) 8 Certification Data Review ( 511 & 513) 9 Type Certification Approval Records and Documentation ( 505, 511 & ) Type Design Drawings and Specifications Control ( 505, 511 & 513) 11 Engineering Test and Witnessing ( 511, 513 and ACPL 33) 12 Flight Testing ( 511, 513, 516 and SI ) 13 Designated Engineer (DE) Support to Maintenance and Manufacturing 14 Instructions for Continued Airworthiness ( 523/ & 527/ & 533/535.4) Post Certification Activities ( 513) 16 Airworthiness Directives/Service Bulletin Compliance (CAR 593) 17 Service Difficulty Reporting (CAR 591 Service Difficulty Reporting) 18 Information Note: Even though guidance materials such ACSI and ACPLs are referenced in this list; Findings of noncompliance can only be written against the CAR//DAPM/EPM etc as explained in section 5.9. (3) Checklists. Inspection checklists, forms and other guidance materials will guide auditors through the inspection process of a particular element area. Regardless of the purpose for the inspection (routine, annual inspection, special purpose audit) the checklists, forms and guidance materials are to be used as indicated. This ensures that all inspections are conducted in a uniform manner and that the results of the activity are appropriately documented. (4) Specific Checklists. Certain element area checklists or guidance documents provide a level of detail that is suitable for completing certification activities. The checklist or guidance document may, when completed, ensure a complete review of that particular aspect or characteristic of a company. Often, these checklists aid or assist auditors (and operators who use the checklists during their certification activities) to interpret regulatory requirements in a standardized manner. (5) Checklist Amendment. Checklist(s) will be revised as required. Amendments are published as complete Parts of 91 SI GEN-006 Issue 01

9 8.0 CONTACT OFFICE For more information please contact: Policy Standards Coordinator (AARDH/P) Phone: (613) Facsimile: (613) Original signed by Martin Thieringer for Gilles Morin Chief, Regulatory Standards Aircraft Certification Branch of 91 SI GEN-006 Issue 01

10 1. Design Approval Procedures Manual (DAPM) APPENDIX 1 - INSPECTION AND AUDIT CHECKLISTS (DAO/AEO) N/C = Not Checked 1 Does the DAPM contain the address of the ordinary place of business of the DAO? (a)/ 107(a) 2 Does the DAPM contain a statement of purpose? 3 Does the DAPM contain a statement of commitment to provide to the DAO the resources required for effective performance of its duties? (b)/ 107(b) (c)(1)/ 107(c)(1) 4 Does the DAPM contain a statement of commitment to grant to the DAO the authority necessary to effectively perform the delegated functions? (c)(2)/ 107(c)(2) 5 Does the DAPM contain a statement of commitment to ensure that the DAO staff remains knowledgeable in their technical specialty with respect to airworthiness standards and procedures? (c)(3)/ 107(c)(3) 6 Does the DAPM contain a description of the DAO and associated lines of responsibility? 7 Does the DAPM contain a description of the functions, which the DAO is authorized to perform? (d)/ 107(d) (e)/ 107(e) of 91 SI GEN-006 Issue 01

11 N/C = Not Checked 8 Does the DAPM contain a description of the airworthiness control system utilized for (f)/ determining the adequacy of technical data 107(f) approved by the DAO? 9 Does the DAPM contain a description of the system used by the applicant for auditing the performance of the DAO? 10 Does the DAPM contain a description of the record keeping system? 11 Does the DAPM contain the name and title of the person appointed to provide the function described in subsections (d) and (d) - (the person whose functions include the responsibility for the activities of the DAO)? 12 Does the DAPM contain the names, titles and specimen signatures of persons nominated pursuant to subsections (e) and (e)? 13 Does the DAPM contain a description of the procedures used to control revisions to the DAPM? (g)/ 107(g) (h)/ 107(h) (i)/ 107(i) (j)/ 107(j) (k)/ 107(k) 14 Are all revisions to the DAPM reviewed and authorized in-house prior to submission to TC for approval? Are procedures adequate to control the DAPM revision? (k)/ 107(k) 15 Are the DAPM revision procedures being followed? DAPM of 91 SI GEN-006 Issue 01

12 N/C = Not Checked 16 Does the DAPM contain a "record of revisions" page, which shall include the identification of (l)/ each revised item, page, date and the signature 107(l) of the person approving the change on behalf of the Minister? 17 Does the manual contain any information inconsistent with TCCA Civil Aviation Regulations, Standards, Advisory and Policy? / Do all DAPM holders keep their copies up to date with TC-approved amendments? DAPM 19 Are up-to-date resumes included in the DAPM? (a)/ 109(a) 20 Are documents incorporated by referenced included in the DAPM? / Does the DAPM contain any other information, which in the opinion of the Minister, is necessary? 22 Does the DAPM have procedures described to address the Changed Product Rule? / of 91 SI GEN-006 Issue 01

13 N/C = Not Checked 23 Do the procedures described in the DAPM satisfy the requirements of the CAR 511/513.14? /107 Function Summary (Design Approval Procedures Manual): Items Completed By: Date: of 91 SI GEN-006 Issue 01

14 2. Self-Audit System Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Is there an adequate procedure describing the quality assurance program which describe the self-audit system? (g)/ 107(g) 2 Are self-audits conducted in accordance with the DAPM? 3 Does the individual responsible for managing the quality assurance program have the necessary authority and organizational freedom? (g)/ 107(g) (3)/ 109 (3) 4 Does the quality assurance program provide for planned and systemic self-audits of the specified Delegated activities per an acceptable frequency basis? 5 Does the quality assurance program describe the assignment of personnel having appropriate qualifications and training to conduct audits? (g)/ 107(g) (g)/ 107(g) 6 Do the quality assurance program procedures ensure that critical engineering tasks and the technical adequacy of the substantiating data are performed correctly? 7 Does the internal audit program include the engineering activities of the external third parties? 8 Does the Delegate maintain adequate audit records? 9 Is the Corrective Action Plan resulting from an internal audit being followed up? (g)/ 107(g) (g)/ 107(g) (g)/ 107(g) (g)/ 107(g) of 91 SI GEN-006 Issue 01

15 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 10 Are corrective actions implemented with a timescale commensurate with the seriousness of the finding, its extent and frequency of occurrence? (g)/ 107(g) 11 Are the results of the self-audits brought to the attention of the person responsible for the Delegate activities or before the Airworthiness Control Committee? 12 Through the implementation of the self-audits and within the quality assurance program, does the Airworthiness Control Committee or the person responsible for the Delegate activities, facilitate and promote a culture of continuous improvement? Function Summary (Self-Audit System): (g)/ 107(g) (g)/ 107(g) Items Completed by: Date: of 91 SI GEN-006 Issue 01

16 3. Airworthiness Control Committee (ACC) Information Note: For additional guidance material refer to ACSI 45 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Does the Terms of Reference for the Airworthiness Control Committee (ACC) described in the DAPM cover such items as its membership, responsibilities, privileges, frequency of meetings, decision process and records? (f)/ 107(f) 2 Has the ACC met on a regular frequency? (f)/ 107(f) 3 Are minutes kept for all ACC meetings? (f)/ 107(f) 4 Is the ACC providing leadership direction to the DAO? (f)/ 107(f) 5 Is the ACC fulfilling its responsibilities? (f)/ 107(f) 6 Are Core Designated Engineers attending ACC Meetings? 7 Are the findings due to the inadequacy of the established procedures? (f)/ 107(f) (f)/ 107(f) of 91 SI GEN-006 Issue 01

17 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked Function Summary (Airworthiness Control Committee (ACC)): Items Completed by: Date: of 91 SI GEN-006 Issue 01

18 4. Personnel Authorized to Perform a Delegated Function Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Is there an up to date and accurate list of designated engineer in the DAPM? 2 Are the designated engineers receiving appropriate technical training to remain current with their duties? (c)/ 117(c) (a)/ 109(a) 3 Are the Designated Engineers holding a position on the DAO staff with sufficient authority to ensure that designs meet the applicable airworthiness requirements? 4 Are the Designated Engineers aware of the governing documents and of the limitations stated in the DAPM, the Letter of Authorization for their delegated functions within the DAO? 5 Are the Designated Engineers using established analytical methods, test methods when performing adequate accuracy of calculations as part of their delegated functions? 6 Are the Designated Engineers aware of their limitations and what documentation must be approved by the Regional Transport Canada office or Headquarters? 7 Is the basis of certification properly determined by the designated engineers to ensure that the design change installed continues to comply with its original basis of certification? 505,409(b)(4)/ 109(b)(4) (a)/ 117(a) (b)(4)/ 109(b)(4) (b)(4)/ 109(b)(4) (b)(4)/ 109(b)(4) of 91 SI GEN-006 Issue 01

19 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 8 Has each person nominated to become a Designated Engineer satisfied the eligibility criteria prior to becoming a designated engineer? (a)/ (109)(a) 9 Have designated engineers acted outside their approved specialty or limitations or is there evidence of unqualified personnel exercising a delegated function? 10 Is the relationship between the Designated Engineer and Transport Canada counterpart(s) adequate? 11 Does each designated engineer use both the DE and DAO numbers in conjunction with their signature on all documents signed on behalf of the Minister? 12 Have the designated engineers completed the Transport Canada Engineering Specialty Course or an equivalent course acceptable to Transport Canada? 13 Have the Delegates had training in the Changed Product Rule implementation procedures as described in the DAPM? 14 Have the Delegates completed the Changed Product Rule Course offered by Transport Canada or a similar course recognized by TC? (a)/ 115(a) (b)(4)/ 109(b)(4) (b)(4)/ 109(b)(4) (b)(3)/ 109(b)(3) (b)(3)/ 109(b)(3) (b)(3)/ 109(b)(3) 15 Is there objective proof for each Designated Engineer regarding their qualifications? EPM/DAPM of 91 SI GEN-006 Issue 01

20 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked Function Summary (Personnel Authorized to Perform a Delegated Function): Items Completed by: Date: of 91 SI GEN-006 Issue 01

21 5. Resource Library NC = Not Checked 1 Does the organization follow the policies and procedures for technical publications as described in the DAPM? 2 Is the individual responsible for keeping publications current aware of his/her responsibilities? 3 Does the company have technical and regulatory manuals available for the scope of work performed? 4 How are the vendor and partner technical and engineering manuals handled? 5 Are the manuals current, i.e. are the amendments up to date? 6 Is there a system in place to ensure the required regulatory documents are identified and acquired? 7 Does the DAO make available to engineering staff, properly amended and up-to-date legislation, standards, advisories and related literature appropriate to their functions? 8 Do the Designated Engineers have ready access to properly amend and up-to-date legislation, standards, advisories and related literature appropriate to their functions? 9 Is there objective evidence that the DAPM/EPM procedures are not being followed? 10 Are the findings due to the inadequacy of the procedures? (b)/ 117(b) (e)/ 103(e) (b)/ 117(b) (b)/ 117(b) (b)/ 117(b) (b)/ 117(b) (b)/ 117(b) (b)/ 117(b) EPM/DAPM EPM/DAPM of 91 SI GEN-006 Issue 01

22 NC = Not Checked Function Summary (Resource Library): Items Completed by: Date: of 91 SI GEN-006 Issue 01

23 6. Certification Process Information Note: For additional guidance refer to AC Type Certification Procedure for Canadian Aeronautical Products. Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Does the organization follow the policies and procedures for certification process as DAPM/ EPM described in the DAPM? 2 How are findings of compliance on behalf of DAPM/ EPM Foreign Authorities handled? 3 Are technical issue papers appropriately raised and adequately resolved prior to Certificate Issue? 4 Have all findings of compliance been made prior to Certificate issue? 5 Do the signatories to the General Compliance Program have delegated authority for the areas they have taken responsibility for? 6 Following Certificate Issue, how are changes (major and minor) in design handled and approved? 7 Is the submitted documentation required prior to Certificate issuance adequate (i.e. MDL, FMS, ICAs etc.)? 8 Is there a procedure for defining whether the design change is a minor or major one as part of post certification activities? 9 Is the appropriate type of data (I.e. specified, acceptable and/or approved) used to support the design change (minor or major)? 10 Is the submitted application documentation adequate in covering standards in place, special conditions, noise and emission standards, exemptions and equivalent safety? 11 Is a compliance Program or Statement of Compliance signed off before the Approval Document issuance? DAPM/ EPM DAPM/ EPM DAPM/ EPM DAPM/EPM DAPM/ EPM CAR / DAPM/EPM of 91 SI GEN-006 Issue 01

24 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 12 Are required data submitted within the time DAPM/EPM frame specified in the DAPM? 13 Are the Initial, Intermediate and Final Type Board Meetings adequately conducted including closure of actions items? 14 Is the submitted documentation required prior to Certificate of Airworthiness issuance adequate i.e. Maintenance Manual, Overhaul Manual for Engines, Logbook, and Conformity Inspection? 15 Is there objective evidence that the established procedures are not being followed? 16 Are the findings due to the inadequacy of the established procedures? EPM/DAPM EPM/DAPM EPM/DAPM EPM/DAPM Function Summary (Certification Process) Items Completed by: Date: of 91 SI GEN-006 Issue 01

25 7. Third Party Engineering Support Information Note: Third party means an organization or individual, involved with the auditee, in the design manufacture or provision of parts, components or materials supplied to the auditee for incorporation into the type design of the auditee s aeronautical product(s) (e.g., design organization, approved manufacturing organization, subcontractors, suppliers, etc.). (See section 2.3 Definitions) Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Does the DAPM describe Designated Engineer responsibility for third party engineering (m)/ Yes No support? 107(m)/ 2 Does the Delegate verify data produced by third party that is used to make a finding of compliance? EPM/DAPM EPM/DAPM 3 How does the Delegate control design where a third party has responsibility to ensure a system of design traceability which permits the design process to be clearly followed from the Delegate design input through to the third party design output? 4 How does the Designated Engineer ensure that compliance documentation produced by a third party are complete and accurate? 5 Are the third party compliance reports submitted in time for adequate review by the Designated Engineers and prior to Certificate issuance? 6 Does the DAPM describe Designated Engineer responsibility for projects involving multiple delegates? 7 Is there objective evidence that the established procedures are not being followed? 8 Are the findings due to the inadequacy of the established procedures? EPM/DAPM EPM/DAPM EPM/DAPM EPM/DAPM EPM/DAPM EPM/DAPM of 91 SI GEN-006 Issue 01

26 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked Function Summary (Third Party Engineering Support) Items Completed By: Date: of 91 SI GEN-006 Issue 01

27 8. DAO Software Audit Checklist Information Note: These questions are based on DO-178B/ DAPM/AMOC related to Software acceptable to TCCA. Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked G-1 Does the DAPM contain or refer to standards for the development of airborne software? G-2 Is the documentation sufficient to clearly define the work accomplished and determine compliance? DAPM/EPM Procedures Manual DAPM/EPM Procedures Manual G-3 Are there areas of the standards that are already identified by the applicant as requiring an update? G-4 Are there areas of the standards already identified as not generating enough or appropriate evidence/documentation? G-5 Is evidence of observance to standards systematically generated and kept for further reference/assessment? G-6 How does the applicant make sure that third parties (partners, suppliers, sub-contractors) standards comply with DO-178B, to the same extent as the applicant s standards? DAPM/EPM Procedures Manual DAPM/EPM Procedures Manual DAPM/EPM Procedures Manual DAPM/EPM Procedures Manual Item Handling Software Changes References SC-1 Are there procedures for the DAO to make sure that the standards of the Design partners; suppliers; subcontractors etc., comply with the relevant standards such as DO 178 B to the same extent as the DAO s standards DAPM/EPM Procedures Manual of 91 SI GEN-006 Issue 01

28 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked SC-2 Is there a procedure requiring a review of the system safety analysis to determine whether the certification basis of the software baseline is still applicable? DAPM/EPM Procedures Manual SC-3 Is there a procedure requiring a software change planning process, including software quality assurance aspects? DAPM/EPM Procedures Manual SC-4 SC-5 Is there a procedure describing how to handle airborne software changes? Is there a procedure describing how to assess the impact of a software change? If so, is the procedure systematically used and is its usage documented? DAPM/EPM DAPM/EPM Procedures Manual SC-6 Is there a procedure describing how to assess the amount of verification required to certify changed software? If so, is the procedure systematically used and is its usage documented? DAPM/EPM Procedures Manual SC-7 Have these procedures (relating to change impact and verification of changed software) been assessed for compliance with DO-178B? DAPM/EPM Procedures Manual SC-8 Is there a procedure describing how certification liaison with Transport Canada must be achieved in each step of the software change process? DAPM/EPM Procedures Manual of 91 SI GEN-006 Issue 01

29 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked SC-9 Does the organization have an effective procedure for identifying all products that have been altered (affected) as a result of a software change (post-certification)? DAPM/EPM Procedures Manual SC-10 Is there a procedure providing traceability of hardware and software part numbers to the approved configuration? DAPM/EPM Procedures Manual Item CM-1 Configuration Management References Are there sufficient documentation records to ensure proper configuration control (i.e. identification and marking, control return to service, baseline software and other pertinent information) for all software? DAPM/EPM Item Software Problem Reporting System References PR-1 PR-2 Is there a procedure to report, assess, track and resolve software problems? Are there procedures or internal guidelines regarding the applicant s involvement in third parties (partners, suppliers, sub-contractors) problem reporting and change control processes? DAPM/EPM Procedures Manual DAPM/EPM Procedures Manual QA-1 Is there a procedure describing the software quality assurance process to obtain assurance that the DO-178B software quality assurance objectives (or equivalent) are met for all projects involving airborne software? DAPM/EPM Procedures Manual of 91 SI GEN-006 Issue 01

30 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked QA-2 Are there procedures for the DAO to ensure that the standards of the Design partners, suppliers, subcontractors etc., comply with the DO 178 B SQA objectives (or equivalent )? DAPM/EPM Procedures Manual Function Summary (DAO Audit Checklist Software) Items Completed by: Date: of 91 SI GEN-006 Issue 01

31 9. Engineering Data Review (EDR) Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Is compliance with the design standards of Relevant Airworthiness maintained? CAR// Standards 2 Is the documentation sufficient to clearly define the work accomplished and determine compliance? 3 Are all airworthiness requirements appropriate to a specific modification and repair specified in the pertinent Compliance Program? 4 Has compliance been demonstrated by an acceptable means? / (1)(g) / (1)(b) / (1)(c) 5 Does the Designated Engineer have authority in his letter of authorization for making a finding of compliance? 6 Does the Designated Engineer understand the substantiation used to support findings of compliance? 7 Are the means / method by which compliance is shown against applicable airworthiness requirements clearly demonstrated and identified in the Compliance Program? 8 Are special design and certification considerations applicable to a given modification/repair being addressed? 9 Where applicable, were additional technical conditions addressed? 10 How are the manufacturing, maintenance and continuous airworthiness considerations handled in the design process? 11 Was sufficient time and resources provided to the Designated Engineer for his review in support of making findings of compliance? / (c)/ (c) / (1)(c) (4)(b)/ (b) DAPM DAPM of 91 SI GEN-006 Issue 01

32 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 12 Is there objective evidence DAPM procedures DAPM are always followed? 13 Are the findings due to the inadequacy of the established procedures? DAPM Function Summary (Engineering Data Review EDR) Items Completed By: Date: of 91 SI GEN-006 Issue 01

33 10 Records and Documentation Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Are established procedures followed to record and control a technical data file for each (a)/ aeronautical product including drawings, 121(a) photographs, specifications, instructions, reports and any applicable SB/AD/SDR necessary for the approval of the design? 2 Does the DAO have an effective system for identifying by make, model, and manufacturer's serial number those products that have been altered using design data held by the DAO? 3 Does the DAO retain all files or have written approval for disposal of such file? 4 Does the DAO control the certification approval records and documentation as described in the DAPM? 5 Is the individual responsible for keeping records current aware of his or her responsibilities? 6 Is there a procedure to establish a correlation between the configuration, which is presented in the engineering reports, the configuration which is ground/flight tested and the approved design as detailed in the Type Certificate Data Sheets/ STC/LSTC/RDC? 7 Are the records of analyses and tests that were conducted that the aeronautical product is in compliance with the applicable standards in accordance with the 511/513 complete and available to the minister? (b)/ 421(b) (c)/ 121(c) DAPM DAPM / / of 91 SI GEN-006 Issue 01

34 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 8 Are procedures being followed to transmit DAPM/EPM engineering data as described in DAPM? 9 Does the organization control the certification approval records and documentation as described in the DAPM? 10 Is there objective evidence that the established procedures are not being followed? 11 Are the findings due to the inadequacy of the established procedures? DAPM/EPM DAPM/EPM DAPM/EPM Function Summary (Records and Documentation) Items Completed By: Date: of 91 SI GEN-006 Issue 01

35 11. Configuration Control (Design Drawings and Process Specification) Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Does the organization control design configurations drawings and process specifications as described in the DAPM? 2 Are established procedures followed to control the assignment of drawing numbers, registration of drawings, maintenance of a drawing logbook, issuance, filing and disposal of drawings and specifications necessary for the approval of the design? (l) and (3) & DAPM/EPM (l) and (3) & DAPM/EPM 3 Is there a procedure describing the list of drawings and specifications necessary to define the configuration of certified design? 4 Is there a procedure for the control of preliminary, experimental or draft drawings and process specs? 5 Are there adequate procedures to handle the approval and control of process specifications? 6 Are there adequate procedures to handle the approval and control of Engineering Change Notice? 7 Is there objective evidence that the established procedures are not being followed? 8 Are the findings due to the inadequacy of the established procedures? (l) and (3) & DAPM/EPM (l) and (3) & DAPM/EPM (l) and (3) & DAPM/EPM (l) and (3) & DAPM/EPM (l) and (3) & DAPM/EPM (l) and (3) & DAPM/EPM of 91 SI GEN-006 Issue 01

36 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked Function Summary (Configuration Control) Items Completed By: Date: of 91 SI GEN-006 Issue 01

37 12. Flight Test (FT) N/C = Not Checked 1 Does the DAR ensure proper flight test qualitative and quantitative assessments are made using a properly configured a/c equipped with adequate instrumentation & recording capability for the intended test? 2 Is there a procedure for confirming that the aircraft has been flown previously by the applicant's test pilot in the configuration to be flown prior to the first TCCA flight? / EPM / EPM 3 Does the DAR make appropriate liaison with Regional Office on the scope and extend of flight test programs as well as acceptable means of compliance? 4 Does the DAR validate the engineering analytical tools used as part of the flight-testing activities? 5 Are the uncertainties from the test and measuring equipment and uncertainties in the engineering/design analysis taking into consideration in acquiring the data necessary to substantiate and complete an approval? 6 Does the applicant have specific procedures and requirements regarding safety equipment during flight-testing? 7 Is a sufficiently detailed test plan accepted by TCCA prior to conducting the test? / EPM / EPM / EPM / EPM / EPM 8 Are test articles shown to conform with the configuration as identified in TCCA accepted Test Plan through conformity inspection? / EPM 9 Is a flight permit obtained prior to conducting the test flight? / EPM of 91 SI GEN-006 Issue 01

38 10 N/C = Not Checked Other Function Summary (Flight Test) Items Completed By: Date: of 91 SI GEN-006 Issue 01

39 13. Support to Aircraft Maintenance and Manufacturing (M&M) TCCA Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 1 Is there an adequate procedure for establishing the DAR support to the Maintenance and Manufacturing? 2 Are the procedures used to transmit engineering information in support of the Maintenance and Manufacturing as described in the DAPM? DAPM/EPM DAPM/EPM 3 Are there adequate procedures to address the involvement of DAR in the Material Review Board (MRB) process when approved data is required as part of the appropriate action to be taken on product non-conformance from the engineering and design requirements? 4 Is there evidence that the feedback from the field is being considered into improving the engineering and design process to prevent the recurrence of non-conformance by reviewing engineering analysis and prediction previously done? 5 Is there evidence of engineering investigation, in timely manner, of all non-conformance material found during maintenance and manufacturing activities? 6 Is there evidence of records of causes, trends, summaries of corrective actions taken in order to initiate, implement product improvements and to ensure the effectiveness as part of the MRB? 7 Are rejected parts/materials tagged, identified and quarantined to prevent inadvertent use or installation? DAPM/EPM DAPM/EPM DAPM/EPM DAPM/EPM DAPM/EPM of 91 SI GEN-006 Issue 01

40 Item Description References N/A = Not Applicable, Fdg = Finding, PF = Parallel Finding, N/C = Not Checked 8 Are parts/materials considered scrap properly identified and/or disposed of? DAPM/EPM 9 Other Function Summary (Aircraft Maintenance and Manufacturing) Items Completed By: Date: of 91 SI GEN-006 Issue 01

41 14. Instructions for Continued Airworthiness (ICA) N/C = Not Checked 1 Is there a procedure to describe the process for the preparation of ICA? 52X Is there a procedure for the development of the Airworthiness Limitations as a part of the Instruction of Continued Airworthiness? 52X Is there a procedure for the development and approval of the initial maintenance requirement? DAPM/EPM 4 Does each ICA contain all required elements? 52X Is there a procedure for the development of maintenance inspection/checks associated with system safety assessment process of the final design? 6 Is there a procedure to describe how changes to the Instructions for Continued Airworthiness will be accepted by TCCA? DAPM/EPM DAPM/EPM 7 Is there a procedure to ensure that the format of the manuals, which are part of the ICA, will be provided in a practical arrangement? 52X Is there a procedure to ensure that TCCA accepted ICA and changes to ICA are distributed to affected operators? Other of 91 SI GEN-006 Issue 01

42 N/C = Not Checked Function Summary (Instructions for Continued Airworthiness) Items Completed By: Date: of 91 SI GEN-006 Issue 01

43 15. Post-Certification Activities (PCA) NC = Not Checked 1 Is there a procedure for handling design changes EPM as part of post certification activities for approval reissue requirement? 2 Does the DAR follow the policies and procedures for post certification process as described in EPM? Is the basis of certification for post certification activities documented? 4 Is there a procedure for defining whether the design change is a minor or major one as part of the PCA? 5 Following Certificate Issuance, how are design changes (major and minor) handled and approved? 6 Is the appropriate type of data (i.e. specified, acceptable and/or approved) used to support the PCA design change? 7 Is a Compliance Program and AE-100 signed off before the Approval Document re-issuance? EPM EPM CAR AWN EPM 8 Other of 91 SI GEN-006 Issue 01

44 NC = Not Checked Function Summary (Post-Certification Activities) Items Completed By: Date: of 91 SI GEN-006 Issue 01

45 16. Airworthiness Directive & Service Bulletin (AD&SB) N/C = Not Checked 1 Does the EPM contain a procedure to handle the processing of AD & SB? CAR 593/ EPM 2 Does the DAR follow the policies and procedures for handling AD & SB as described in EPM? EPM 3 Are the airworthiness and reliability aspects taken into account? 4 Are AD and SB procedures for justification and authorization followed as outlined in the EPM? 5 Is the process for handling exemptions, AMOC, foreign AD defined in the EPM and followed? 6 Is there a system to ensure a voluntary compliance program to correct design deficiency? 7 When an AD is issued and it relates to a design change approved by the DAR, does the DAR submit appropriate data for approval to TCCA? CAR App H CAR App H / EPM CAR App H/ EPM CAR App H CAR When an AD is issued and it relates to a design change approved by the DAR, does the DAR, upon approval, make available the descriptive data covering the changes to all operators of product affected by the AD? CAR Are AD and SB accomplishments recorded and/or followed up as described in the EPM? EPM 10 Does the DAR submit service difficulty reports (SDRs) as described in the EPM? CAR / EPM of 91 SI GEN-006 Issue 01

46 N/C = Not Checked 11 Does the DAR data collection system for defects, malfunctions and failures follow the procedures in the EPM? CAR /EPM 12 Is the DAR knowledgeable about the SDR procedure to be followed? EPM 13 Is the individual responsible for reporting SDRs to TCCA familiar with reporting procedure? CAR /EPM 14 Are the reports forwarded within the required time frames? 15 Is there evidence that some SDRs are not being forwarded? CAR (2) /EPM CAR /EPM 16 Are SDRs records maintained as described in the EPM? 17 Are the proper forms (e.g. form or equivalent) used for reportable occurrences? 18 Is there evidence that reports of difficulties or occurrences are being duplicated? CAR /EPM CAR /EPM CAR /EPM 19 Other of 91 SI GEN-006 Issue 01