Production Approval Procedures Manual

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    Production Approval Procedures Manual

    This is an internal CASA policy manual. It contains guidance material intended to assistCASA officers and delegates in carrying out their regulatory responsibilities and may be

    made available to the public for information purposes only.

    Copies of this manual are available from: http://casa.jsmcmillan.com.au/He/cat.

    Since this is an uncontrolled version of the manual which will not be updated by CASA, itshould not be relied upon for any regulatory purpose. The current manual can be viewed atany time via CASA's website at "www.casa.gov.au".

    You should always refer to the applicable provisions of the Civil Aviation Act, Civil AviationRegulations and the Civil Aviation Orders, rather than this manual, to ascertain therequirements of, and the obligations imposed by or under, the civil aviation legislation.

    Version 2.0: August 2004

    http://079r01.pdf/http://casa.jsmcmillan.com.au/He/cathttp://casa.jsmcmillan.com.au/He/cathttp://079r01.pdf/
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    Production Approval Procedures ManualTable of Contents

    Approved by Executive Manager, Aviation Safety Standards Version 2.0: August 2004

    ii

    2.2

    Production Certificate (PC)....................................................................................2-8

    2.2.1 Applicability Production Certificate............................................................2-82.2.2 PCs Issued for Fabrication In The Course of Maintenance..........................2-92.2.3 Responsibility for PCs..................................................................................2-92.2.4 Advising the Applicant................................................................................2-102.2.5 Preliminary Assessment Procedures .........................................................2-112.2.6 Testing Aircraft, Engines and Propellers....................................................2-192.2.7 PC Holder's Location(s) .............................................................................2-192.2.8 Responsibility for PC Management............................................................2-202.2.9 Assessment of an Applicants Suppliers ....................................................2-202.2.10 Summary of Distribution of Production Certification Documents................2-21

    2.3 Australian Parts Manufacturer Approval............................................................2-222.3.1 Applicability of Australian Parts Manufacturer Approval.............................2-222.3.2 Responsibility for Australian Parts Manufacturer Approval ........................2-232.3.3 Lodgement of an Application for an APMA ................................................2-232.3.4 CASA Engineering Assessment ................................................................2-242.3.5 Manufacturing Inspector Assessment........................................................2-292.3.6 APMA Approval .........................................................................................2-30

    2.4 Australian Technical Standard Order Authorisation (ATSOA) .........................2-332.4.1 Applicability ATSOA................................................................................2-332.4.2 Advising the Applicant................................................................................2-332.4.3 Lodgement of an Application .....................................................................2-342.4.4 ATSOA Issue Procedure............................................................................2-342.4.5 ATSOA Holder's Facility Location ..............................................................2-372.4.6 Approval of Materials and Processes.........................................................2-37

    3. Assessments.....................................................................................................................3-1 3.1 Assessment of an Applicant's Quality Systems for Manufacture......................3-1

    3.1.1 General Principles........................................................................................3-13.2 Assessment of an Applicants Suppliers .............................................................3-3

    3.2.1 Assessment of an Applicants Suppliers ......................................................3-33.2.2 Assessment .................................................................................................3-43.2.3 Stage 1 Quality System AssessmentDesk-top Review ............................3-43.2.4

    Stage 2 Quality System Assessment Quality System Evaluation ...........3-23

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    3.2.5 Stage 3 Quality System AssessmentManufacturer's CorrectiveAction.........................................................................................................3-24

    3.2.6 Manufacturers Service Documentation .....................................................3-243.2.7 Service Difficulty Reports...........................................................................3-243.2.8 Reporting of Failures, Malfunctions and Defects During Manufacture.......3-253.2.9 Manufacturers Maintenance Facility..........................................................3-253.2.10 Supplier Quality Control .............................................................................3-253.2.11 Engineering Drawings................................................................................3-263.2.12 Use of CASA Form 917 Authorised Release Certificate ............................3-263.2.13

    Use of CASA Form 917 for Unapproved Parts ..........................................3-27

    3.2.14 Export Airworthiness Approvals .................................................................3-27

    4. Inspections........................................................................................................................4-14.1 Conformity Inspections .........................................................................................4-1

    4.1.1 Introduction to Conformity Inspections.........................................................4-14.1.2 Conformity Inspections ................................................................................4-14.1.3 First Article Inspection..................................................................................4-34.1.4 Materials ......................................................................................................4-44.1.5 Processes and Processing ..........................................................................4-44.1.6 Automatic Production Processes .................................................................4-54.1.7 Non-destructive Inspection (NDI) Method Evaluation ..................................4-64.1.8 Critical and Major Characteristics ................................................................4-64.1.9 Workmanship...............................................................................................4-7 4.1.10 Adequacy of Drawings and Related Change Records.................................4-74.1.11 Adequacy of Inspection Records...................................................................4-74.1.12 Material Review Action ..................................................................................4-74.1.13 Software ........................................................................................................4-8

    4.1.14 Conformity Inspections of Test Articles .........................................................4-84.1.11 Structural Test Articles Aircraft .................................................................4-94.1.12 Flight Test ArticlesAircraft ........................................................................4-94.1.13 Endurance Test ArticlesEngines and Propellers ......................................4-9

    4.2 Final Inspection and Flight Test..........................................................................4-114.2.1 Applicability Final Inspection and Production Flight Test.......................4-114.2.2 Preliminary Ground Inspection...................................................................4-114.2.3 Final Ground Inspection.............................................................................4-114.2.4 Flight Inspection.........................................................................................4-12

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    Production Approval Procedures ManualTable of Contents

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    5. Sample Letters ..................................................................................................................5-15.1 Sample APMA Application Letter..........................................................................5-25.2 Sample CASA APMA Approval Letter...................................................................5-35.3 Sample CASA APMA Supplement without Licensing Agreement......................5-5

    5.3.1 Sample CASA APMA Supplement (Design Approval) Test andComputation ................................................................................................5-5

    5.4 Sample CASA APMA Supplement with Licensing Agreement ...........................5-65.4.1 Sample CASA APMA Supplement (Design Approval) Identicality ...............5-6

    5.5

    Sample Australian Parts Manufacturing Approval Supplement.........................5-7

    5.6 Sample CASA APMA Design Rejection Letter .....................................................5-85.7 Sample ATSO Authorisation Application and Statement of Conformance.......5-95.8 Sample ATSO Authorisation................................................................................5-105.9 Sample APIS Approval Letter..............................................................................5-12

    6. Definitions .........................................................................................................................6-1Revision History .................................................................................................................. RH-1List of Effective Pages ...............................................................................................................v

    Forms

    Form 724 Statement of Conformity

    Form 849 Production ApprovalApplication

    Form 882 Conformity Inspection Record

    Form 883 Production Approval Assessment Control Document

    Form 1248 Request for Conformity Inspection

    (Note: The above forms are only those available to the industry/public via the CASAWebsite. Forms and templates used internally are available to CASA staff only, viaCASAconnect, and are not listed here.)

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    Production Approval Procedures ManualList of Effective Pages

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    v

    List of Effective Pages

    PartNo. ofPages

    VersionDate ofIssue

    Cover and verso 2 2.0 08/2004

    Table of Contents List of Effective Pages and Abbreviations 6 2.0 08/2004

    1. Introduction to Production Approval Procedures 16 2.0 08/2004

    2. Assessment and Issue of Approvals 38 2.0 08/20043. Assessments 28 2.0 08/2004

    4. Inspections 14 2.0 08/2004

    5. Sample Letters 12 2.0 08/2004

    6. Definitions 4 2.0 08/2004

    Revision History 2 2.0 08/2004

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    Production Approval Procedures ManualList of Abbreviations

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    List of Abbreviations

    Abbreviations

    AC Advisory Circular

    AD Airworthiness Directive

    APIS Approved Production Inspection System

    APMA Australian Parts Manufacturer Approval

    ARC Authorised Release Certificate

    ARN Aviation Reference Number

    ASCD Aviation Safety Compliance Division

    ATSOA Australian Technical Standard Order AuthorisationAWE Airworthiness Engineer

    CoA Certificate of Airworthiness

    ESS Engineering Support Section

    FIS Fabrication Inspection System

    FITCOM Fabrication in the Course of Maintenance

    IPC Illustrated Parts Catalogue

    MI Manufacturing Inspector

    MRB Materials Review Board

    NAA National Airworthiness Authority

    PAH Production Approval Holder

    PA Production Approval

    PC Production Certificate

    PCB Production Certification Board

    PLR Production Limitation Record

    PO Project Officer

    RMU Record Management Unit

    SB Service Bulletin

    SDR Service Difficulty Report

    STC Supplementary Type Certificate

    TC Type Certificate

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    Production Approval Procedures Manual1. Introduction to Production Approval Procedures1.1 About this Manual

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    1. Introduction to Production Approval Procedures

    1.1 About this Manual

    1.1.1 Review of this Manual

    Production Approval Manual Review Team

    This Production Approval Procedures Manual will be reviewed as required and within 12months of issue or review. The Production Approval Manual Review Team will comprise:

    q Executive Sponsor Executive Manager, Aviation Safety Standards

    q Technical Sponsor Head of Airworthiness Standards

    q Chair Central Office Manufacturing Specialist

    q Two Airworthiness Engineers

    q Three Manufacturing Inspectors

    q Administrative Support.

    Recommending Changes to the Manual

    If any information in this manual needs to be amended or new information added, notifythe technical sponsor. Use Form 476 Manual Amendment Request, when making

    suggestions, including additional sheets if necessary.

    Definitions

    See 6. Definitions.

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    Production Approval Procedures Manual1. Introduction to Production Approval Procedures1.1 About this Manual

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    1.1.2 Purpose and Scope of the Manual

    Purpose

    CASR

    Part 21

    The purpose of this manual is to provide CASA staff with procedures for assessingapplications for Production Approvals (PAs) under CASR Part 21 and for issuing thoseCASA approvals.

    Scope

    CASR

    Part 21

    This manual applies to PAs under Part 21 including but not limited to the following:

    CASR Part

    21. Subparts

    F,G, K, O,

    and Q

    CASR Part21.305(e)

    q Production under Type Certificate (TC) (CASR Part 21 Subpart F)

    q Production Certificate (PC) (CASR Part 21 Subpart G)

    q Australian Parts Manufacturer Approval (APMA) (CASR Part 21 Subpart K)

    q Australian Technical Standard Order Authorisation (ATSOA) (CASR Part 21Subpart O)

    q Identification of Aircraft and Aeronautical Products (CASR Part 21 Subpart Q)

    q Other approvals under CASR 21.305(e).

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    Production Approval Procedures Manual1. Introduction to Production Approval Procedures1.2 Regulatory Framework

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    1.2 Regulatory Framework

    1.2.1 Background

    An outline of the background to this manual is as follows:

    CASR Part

    21

    CAR 30

    CASR Part

    21

    a. Version 1 of this manual was introduced in May 2000 to address manufactureunder CASR Part 21 and for transition from previous approvals issued underregulation 30 of CAR 1988.

    b. CASRPart 21 provisions were developed with the intent of reflecting thecorresponding provisions in US FAR Part 21, but only where these wereappropriate to Australian requirements.

    c. The result has been regulations that harmonise with international best practicewhile at the same time meeting Australia's obligations as a contracting state tothe ICAO Convention.

    d. Audit of manufacturing approvals is conducted under CASAs surveillanceprocedures.

    e. Amendment 2.0 is introduced to clarify procedures in the light of experiencegained since the introduction of CASR Part 21.

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    Production Approval Procedures Manual1. Introduction to Production Approval Procedures1.2 Regulatory Framework

    Approved by Executive Manager, Aviation Safety Standards Version 2.0: August 2004

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    Civil Aviation Safety Regulations Part 21 Subpart K

    CASR Part

    21. Subpart

    K,

    Subpart K prescribes the requirements for issue of an Australian Parts ManufacturerApproval. This approval requires the establishment of a Fabrication Inspection System(FIS) in addition to design approval.

    Civil Aviation Safety Regulations Part 21 Subpart O

    CASR Part

    21. Subpart

    O.

    Subpart O prescribes the requirements for issue of an Australian Technical StandardOrder Authorisation. This approval is both a design and production approval.

    Civil Aviation Safety Regulations Part 21 Subpart Q

    CASR Part

    21. Subpart

    Q

    Subpart Q prescribes the requirements for part identification and marking.

    Civil Aviation Safety Regulations 21.305 (e)

    CASR Part

    21.305(e)Section 21.305(e) authorises approval of items not otherwise covered by other approvalmechanisms.

    Civil Aviation Safety Regulations Part 201

    CASR Part

    201

    Part 201 prescribes the appointment of authorised persons.

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    Production Approval Procedures Manual1. Introduction to Production Approval Procedures1.3 Responsibility for Production Approval

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    1.3 Responsibility for Production Approval

    1.3.1 Staff Responsibilities

    Executive Sponsor

    The Executive Sponsor has responsibility for the overall control of this manual.

    Technical Sponsor

    The Technical Sponsor assumes technical responsibility for this manual and manages itsdevelopment through to completion, or its amendment as and when required, in

    accordance with the Manual of Controlled Documents.

    Managers

    Managers ensure that CASA staff correctly implement the procedures in this manual.

    CASA Officers

    CASA officers are to:

    q Adhere to the procedures in this manual

    q Bring to the notice of the Sponsor the need for amendments to the manual, inaccordance with the instructions for Recommending Changes to the Manual.

    CASA Project Officer

    The Head of the Engineering Support Section (ESS) appoints a Project Officer (PO) for aparticular production approval, who ensures that the production approval application isassessed effectively and that all aspects of the approval are complete and in accordancewith this manual. When satisfied, the Project Officer recommends the issue of theapproval.

    The PO for PC and APIS applications will be a Manufacturing Inspector (MI). The PO whoevaluates the APMA and ATSOA applications will be an Airworthiness Engineer (AWE).

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    Production Approval Procedures Manual1. Introduction to Production Approval Procedures1.4 Production Approval Process

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    1.4 Production Approval Process

    1.4.1 Production Approval Flowchart

    Receive application

    Set up project files

    Acknowledge application

    ESS assigns a ProjectOfficer

    Is this thefacility's firstapproval?

    Is there a majorchange in the facility's

    procedures?

    Establish PC board if theapplication is for a PC

    Review data for compliance

    Do procedurescomply?

    Notify applicant to reviseprocedures

    Conduct onsite evaluation/audit of QC system

    Doesapplicant follow

    approvedprocedures?

    Is PC boardinvolved?

    Convene PC board

    Hasapplicant met allrequirements?

    Issue the approval

    Initial advice to applicant

    Complete files andenter approval details

    on CASA Internetdatabase

    Notify applicant totake corrective action

    Notify applicant totake corrective action

    No

    Yes

    No

    No

    Yes

    No

    Yes

    Yes

    No

    Yes

    No

    Yes

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    Production Approval Procedures Manual1. Introduction to Production Approval Procedures1.5 Processing Inquiries and Applications for Production Approvals

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    1.5 Processing Inquiries and Applications for Production Approvals

    1.5.1 Advice Provided by CASA for General Enquiries

    AC21.14,

    21.16,

    21.20,

    21.27,

    21.601

    When people make inquiries about production approvals, provide them with relevantadvice and request that they read the appropriate Advisory Circular (AC) for the particularapproval, including:

    q AC 21.14 Production Certificates

    q AC 21.16 Australian Parts Manufacturer Approval

    q AC 21.20 Production Under TC

    q AC 21.27 Manufacturing Approval Overview.

    q AC 21.601 ATSOA (Yet to be issued)

    Should the person wish to proceed, advise that a formal written application to CASA isrequired before the application can be processed. Enquirers must be advised that costrecovery procedures are applicable.

    Regardless of which production approval is sought, it should be stressed to the applicantthat it is the applicants responsibility to demonstrate conforming products and parts. It isa CASA responsibility to find that conforming parts have been demonstrated as a basis forissue of the approval sought. A non-conformed proof-of-concept product is not a basis forCASA assessment and subsequent approval.

    CASR 21.325

    The CASA officer should advise the applicant of the advantages of obtaining a PC. Theadvantages of being a PC holder, compared to production under a TC only, include thefollowing:

    q No requirement to submit a Statement of Conformity to CASA, for each conformedproduct

    q Reduced CASA involvement, relative to conformity inspections

    q An Authorised Person within the Approved Production Inspection System (APIS) willbe able to issue airworthiness certificates and approvals for completed productswithout reliance on CASA inspections

    q The issue of export approvals for small aircraft without assembly or flight test (CASR21.325).

    s

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    1.5.2 On Receipt of an Application

    Administrative Procedures

    1. All correspondence is to be recorded and controlled in accordance with RecordManagement Unit (RMU) guidelines.

    2. All actions to be properly documented and filed as appropriate.

    3. All other administrative processes to be in accordance with local ESS internalprocedures.

    Cost Recovery Procedures

    The cost recovery procedures for production approvals are similar to those described inthe Type Certification Procedures Manual.

    Engineering Manager

    The Engineering Manager or Team Leader is to monitor the progress of the application. Ifit becomes evident that the application will not be processed within the normal timeframe,ensure that the applicant is notified accordingly.

    Project Officer

    1. RaiseForm 883 Production Approval Assessment Control Documentand place it onthe appropriate file.

    2. Check thatForm 849 Production Approval Applicationand covering letter arecomplete and on file.

    3. Check the LARP database for any current enforcement actions pending or proceedingin relation to the applicant or whether any exclusion periods have been imposed.Refer any of these to the Office of Legal Counsel for advice.

    4. Prepare a cost-recovery estimate within 7 days.

    5. Forward the file with the attached cost-recovery details to Administration.

    6. Liaise with Central Office personnel, as applicable, to advise them of the applicationand, if the application is for an APIS or PC, to arrange the establishment of aProduction Certification Board (PCB). Refer to 1.6.1Production Certification Board.The ESS and Central Office managers will allocate resources.

    !

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    7. Send the applicant a letter of acknowledgment when notified that the applicant has

    accepted the estimate for service and/or the prescribed fee has been paid.

    If a PCB is required, pre-PCB (CASA) and pre-PCB (applicant) meetings may now beconvened (refer to 1.6.1 Production Certification Board), to prepare both CASAofficers involved in the assessment and the applicant for the requirements of theassessment. A PCB is required for Class 1 items, and may be required for otheritems, at the discretion of the Head of ESS, depending upon the complexity andinvestigations required.

    8. If the application does not require the establishment of a PCB, proceed as for thepreliminary assessment only.

    Administration Officer

    1. Complete the cost recovery documentation in accordance with the FinancialProcedures Manual.

    2. Return the file to the Project Officer.

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    1.6 Production Certification Board (PCB)

    1.6.1 Production Certification Board Description

    A Production Certification Board (PCB) is a CASA panel established for the purpose offacilitating the assessment of a production approval

    PCBs should be convened for initial production approvals covered by production under TCor Production Certificate, or when entire facilities have been relocated or are to be addedto the production approval. PCBs should not be convened for the addition of new modelsto the production approval or for relocation of a portion of a facility, unless significantchanges in production technology or processes apply. In these instances, follow theprocedures in Chapter 2.

    s

    1.6.2 PCB Membership

    The PCB will include a Chairperson nominated by the ESS manager, the Project Officerand any other nominated specialists. These members will assist in evaluating theapplicant's production, engineering, flight test procedures, and other related functions.The Project Officer may be, or act as, the Chairperson of the PCB and will coordinateactivity through the Head of ESS.

    s

    1.6.3 PCB Member Responsibilities

    PCB Chairperson

    The PCB chairperson is responsible for:

    q Assigning board members, as deemed appropriate for the particular product, andnotifying members of the pending PCB schedule in sufficient time to permit adequateplanning and preparation

    q Notifying the applicant of the PCB schedule

    q Selecting a representative number of the applicant's supplier facilities for evaluation todetermine whether or not the applicant's quality system provides for satisfactorysupplier control

    q Conducting pre/post-PCB meetings with CASA officers and/or the applicant

    q Reviewing and analysing the PCB findings and ensuring that appropriate correctiveactions have been or will be taken by the applicant

    q Completing, signing, and distributing the PCB minutes.

    !

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    Project Officer

    The Project Officer is responsible, using administrative assistance as appropriate, for:

    q Establishing schedules

    q Making arrangements for meeting rooms

    q Obtaining sufficient copies of quality system data

    q Making all other arrangements necessary for convening and conducting the PCB inthe most expeditious manner

    q Ensuring that all agreed-upon corrective actions have been taken by the applicant

    q Preparing the minutes of the PCB.

    Certification Specialists

    The Certification Specialists are responsible for:

    CASR

    21.127,

    21.128,

    21.129,

    21.143(1)(c)

    q Evaluating and approving the applicant's production engine/propeller test procedures,as required by CASR 21.143(1)(c), 21.127, 21.128 or 21.129

    q Evaluating and approving the applicant's flight test procedures and check-off lists as

    required by CASR 21.143(1)(c)

    q Reporting and making recommendations to the Project Officer (rather than makingdirect communication with the applicant).

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    1.6.4 Conduct of the PCB

    A PCB is generally conducted as follows:

    q Initial CASA personnel meeting

    q Pre-PCB meeting

    q PCB meetings

    q Review of the PCB process and conduct.

    Initial CASA Planning Meeting

    A meeting of CASA personnel is held to plan the preliminary assessment, ESS Officerecommendations, and related correspondence between CASA and the applicant. Thismeeting is also used to plan the PCB schedule for subsequent meetings; and establish

    agenda items for the pre-PCB meetings.!

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    Pre PCB Meeting

    A Pre-PCB meeting may be held with the applicant's representatives upon receipt of theproduction approval application. This meeting should include the Chairperson and anyother specialist as necessary. The purpose of this meeting is to advise the applicant ofthe purpose of the CASA PCB and of CASA's evaluation plans.

    CASR

    21.125,

    21.135,

    21.137

    Inform the applicant that the PCB is a fact-finding body convened to determine whether ornot the applicant is in compliance with CASR 21.125 or 21.135 and, that in making thisdetermination, the PCB will thoroughly evaluate the applicants quality system, data,organisation and production facilities. It is at this point that the Chairperson determineswhether or not the location of the applicants facilities poses an undue burden on CASA,

    as specified in CASR 21.137.

    PCB Assessment of Applications

    Following the pre-PCB meeting with the applicant, the PCB evaluates the applicant'squality system data and performs an on-site evaluation of the applicant's quality system,organisation production facility and suppliers, as appropriate.

    PCB Meetings

    PCB meetings attended by all board participants are conducted as needed to discuss and

    evaluate each unsatisfactory condition and related recommendation submitted by eachmember. All unsatisfactory conditions are recorded as findings on Form 883 ProductionApproval Assessment Control Document. A final meeting, attended by all PCB membersand representatives of the applicant, is held to advise the applicant of the PCB findings.Each unsatisfactory condition and recommendation should be presented and brieflydiscussed.

    Corrective Action

    In those instances where a product is being produced under a TC, the PCB must requestthat the applicant commence immediate corrective action on those items that directly

    involve the product and related quality practices. A reasonable time may be allowed forcorrecting deficiencies in the quality system data. However, the applicant must be advisedthat the PCB cannot recommend that an approval be issued until all applicable regulationsare complied with and the ESS Office has evaluated all corrective actions and found themto be satisfactory.

    Formal Confirmation

    The applicant must also be advised that the applicant will receive an official letterconfirming the verbal presentation of the list of unsatisfactory conditions andrecommendations. This formal notification should be prepared and signed by the PCB

    Chairperson, within ten working days of the final meeting with the manufacturer.!

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    Violations

    CASR

    Part 21

    Subpart F

    If the applicant is manufacturing a product under a TC, and any of the unsatisfactoryconditions are determined to be violations of CASR Part 21, Subpart F, appropriateenforcement actions should be initiated by the ESS Office.

    Final Phase of the PCB

    The final phase of a PCB is the evaluation by the ESS Office of the corrective action takenby the applicant. The results of any re-inspection should be reported to the Chairpersonof the PCB and, if satisfied, the Chairperson will make a recommendation to the ESSManager and sign off on Form 883 Production Approval Assessment Control Document.

    PCB Conclusion

    CASR

    21.123,

    21.135

    The ESS Office will formally advise the applicant in writing, as soon as practicable, thatbased on a demonstrated compliance with CASR 21.123 or 21.135, an approval will beissued. Conversely, if compliance has not been demonstrated, the applicant will beformally advised that an approval will not be issued, and a statement of reasons must beadvised to the applicant.

    s

    1.6.5 PCB Records

    The Project Officer shall prepare the PCB minutes for the signature of the Chairperson.The minutes should contain a concise record of the entire PCB proceedings, including thenames and titles of all participants. All correspondence and forms relating to the PCB,including letters to the applicant, the applicants replies, etc, are considered to be part ofthe minutes and should be attached as appendices.

    Once accepted by the Chairman, the PCB minutes should be distributed as follows:

    q Original to the applicants file

    q One copy to Certification Support Services Sectionq Copies to the members of the PCB.

    s

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    2. Assessment and Issue of Approvals

    2.1 Approved Production Inspection SystemProduction under a TC

    2.1.1 Applicability Approved Production Inspection System

    CASR

    Part 21,

    Subpart F

    This section provides guidance on the assessment and issue of an Approved ProductionInspection System (APIS), under CASR Part 21, Subpart F. It applies to a holder orlicensee of a TC who wants to manufacture complete aircraft, aircraft engines orpropellers and parts thereof under an APIS prior to obtaining a Production Certificate(PC).

    Additional guidance is contained in AC 21.20 and AC 21.27.AC21.20,21.27

    Applicants should be aware that CASA considers an APIS an interim production stage,and they should be encouraged to achieve a PC for their activities. This is because, fromthe date of issue of the Type Certificate (TC) and prior to the issue of an APIS, CASAprovides the resources to determine whether the product, and parts manufactured by theapplicant, conform to the type design and are in a condition for safe operation.

    Because there is a six-month deadline from date of issue of a TC to the time when anapplicant must have an APIS in place, the applicant should signal his or her intention toproduce duplicates at the start of the type certification process.

    The regulations require the APIS holder to have process specifications, materials review

    records, test procedures and flight check forms that are acceptable to CASA, and theapplicant should have started developing these data concurrently with other data relevantto type certification requirements.

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    2.1.2 Responsibility

    Subsequent to the date of issue of the TC and prior to the issue of an APIS (or PC), CASAhas full responsibility for determining whether the product and parts thereof conform to thetype design and are in a condition for safe operation.

    The ESS is responsible for managing all aspects of progression to an APIS or PC and forthe relevant surveillance activities once an APIS or PC has been issued.

    The Project Officer performs detailed inspections of all incoming materials (at the source,if necessary), installations, operations, processes, detail parts, sub-assemblies and

    completed products. These inspections must be documented as prescribed in section 4.1Conformity Inspections, so that there is a complete inspection record for eachproduct/part.

    The ESS Office maintains the complete inspection record of each product/part thereof.

    s

    2.1.3 Procedure for APIS Issue

    Preliminary Assessment Procedures

    CASR 21.123 An applicant for an APIS must show compliance with CASR 21.123.

    This preliminary assessment consists of an evaluation of the applicants:

    q Production inspection system data

    q Facilities, equipment, processes, personnel, control of suppliers, stores, etc, to ensurethat they are adequate for the purpose.

    The assessment of the data will require a number of visits to the applicants facilities andsuppliers, as necessary; to evaluate and confirm that the procedures provide control forthe conformity of detail parts, sub-assemblies and completed products. In other words,the Project Officer must evaluate the adequacy of the quality system by personallyobserving the control of each stage of production, and all supporting functions such asdocument control.

    In the preliminary assessment, use the appropriate sections of this manual to assess:

    q Suppliers

    q Supplier control

    q All quality systems.

    !

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    Project Officer

    1. Make arrangements to conduct the preliminary assessment only after the applicanthas accepted the CASA estimate of costs and has the capability to comply with theregulatory requirements.

    2. Assess the applicant's quality system assisted by specialists, as required.

    3. Carry out the assessment concurrently with conformity inspections of first articles priorto the issue of an APIS. That is, assess the applicants inspection system foradequacy on a progressive basis.

    4. As parts of the system are found to meet the regulatory requirements: Maintain a record of those portions of the system considered satisfactory on Form

    883 Production Approval Assessment Control Document

    Reduce conformity inspections to spot-checks for articles covered by those partsof the system found satisfactory

    Place increasing emphasis on securing corrective actions on the parts of thesystem where procedural discrepancies or nonconformities are found, or wherethe system is found to be inadequate, as recorded on Form 883 ProductionApproval Assessment Control Document.

    Assessing the Applicant's Progress

    Project Officer

    1. Periodically assess the applicant's progress in obtaining approval of the APIS.

    CASR

    21.123(1)(c)

    2. If it appears that the applicant may not be eligible for the APIS by the deadline date(six-month period specified in CASR 21.123(1)(c)), advise the applicant in writing ofall known deficiencies. Also, caution the applicant that after the deadline date, CASAwill not issue any airworthiness certificates or any other approvals unless anextension of the time period is authorised by the delegate.

    Keep the delegate informed if such a situation becomes inevitable.

    CASR

    21.123(3)

    3. Extension of six-month period: An application for extension of the six-monthperiod must take into consideration the impact the extension would have on CASAstaff, resources and safety.

    CASR21.123(3) allows CASA to grant an extension when there are unusual orextenuating circumstances which would preclude the establishment of an APIS withinthe six-month limitation.

    4. Forward requests for extension, together with a detailed summary of the ESS Officeinspections and assessment results during the six-month period to the delegate.

    !

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    Revision of an APIS Approval Letter

    If, subsequent to the issue of the original letter, the manufacturer applies to add anothertype-certificated product or a new model to the manufacturer's APIS, the ESS Manager orteam leader must appoint a Project Officer to evaluate any required changes to the APISresulting from new technology change to the facilities and staff.

    Project Officer

    1. If the change is considered to be significant, you may re-convene the APIS Board tomake the determination, and process the application in accordance with this section.

    2. If an APIS Board is not required, a Project Officer may carry out an assessment, issuethe revised APIS approval letter and request the manufacturer to return the originalapproval letter to the ESS Office

    ESS Admin Officer

    1. Mark the returned APIS approval letter "superseded" and retain it in the ESS Officefiles.

    s

    2.1.5 TC Holder's/TC Licensee's Responsibility under CASR Part 21, Subpart F

    CASR Part

    21,

    Subpart F,

    21.130.

    Manufacturers producing aircraft, aircraft engines or propellers under a Type CertificateOnly (CASR Part 21, Subpart F) are required to submit to CASA a Statement ofConformity (Form 724) for each completed aircraft, aircraft engine or propeller. TheStatement of Conformity is required before aircraft produced only under a Type Certificatecan be issued with a Certificate of Airworthiness or, in the case of engines and propellers,before an Authorised Release Certificate can be issued. The Statement of Conformitysubmitted by the manufacturer is a certification that the product conforms to its typedesign and is in a condition for safe operation. See form 724, the Statement of

    Conformity required by CASR 21.130.

    CASR 21.125 Subsequent to the issue of an APIS, the TC holder/licensee is additionally responsible formaintaining the APIS in accordance with CASR 21.125 to ensure that each productconforms to the type design and is in a condition for safe operation. The manufacturermust also comply with any terms or conditions as prescribed in the APIS approval letter.

    CASR 21.003 A TC holder/licensee is responsible for reporting any failures, malfunctions, and defectsas required by CASR 21.003.

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    2.1.6 APIS Holders Facility Location

    An APIS holder's manufacturing complex may consist of a principal facility and associatefacilities using the same quality system approved by CASA for the particular typecertificated product(s).

    The APIS is issued to the principal manufacturing facility that controls the quality of theproduct(s) for which the approval was granted. The principal facility and associate facilityaddresses are listed on the APIS. A post office box address is not acceptable for a facilitybecause the actual location must be identified. However, post office boxes may be usedas postal addresses for correspondence.

    When CASA surveillance is required at an associate facility located outside thegeographical area of the ESS Office controlling the APIS, the ESS Manager may arrangefor surveillance in accordance with the procedures contained in the SurveillanceProcedures Manual.

    When an APIS holder moves the principal manufacturing facility to a new location theAPIS is no longer effective.

    When the APIS holder moves an associate facility or adds a new plant, the ESS Officemust be notified of the changes. Before the new plant or moved facility is approved for

    production it must be subjected to a satisfactory audit or be assessed by an APIS Board ifthe change is significant.

    The APIS must be amended to reflect this change.

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    2.1.7 Assessment of an Applicants Suppliers

    See 3.2 Assessment of an Applicants Suppliersfor supplier evaluation procedures.

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    2.2 Production Certificate (PC)

    2.2.1 Applicability Production Certificate

    CASR Part

    21,

    Subpart G

    This section provides guidance on the assessment and issue of a Production Certificate(PC) when an applicant complies with CASR Part 21 Subpart G.

    AC21.14 Additional guidance is contained in AC 21.14.

    CASR

    21.135,

    The following persons may be issued with a PC when CASA finds, after examination ofsupporting data, inspection of the organisation and production facilities, that the applicanthas complied with CASR 21.135:

    21.021

    21.029

    q The holder/licensee of a CASR 21.021/21.029 TC

    q The holder/licensee of a Supplementary Type Certificate (STC)

    q The holder of a PC who wishes to apply for an STC, may include the productionapproval for the STC on the PLR.

    Note: STC holders who only desire to produce the modification parts/kit shouldapply for an Australian Parts Manufacturer Approval (APMA).

    CASR21.025,

    21.031

    q

    The holder/licensee of a CASR 21.025 TC, when the TC issue was based onsubmission by the TC applicant and CASA approval of the type design data requiredby CASR 21.031

    CASR 21.133

    (2B)

    q The holder of a PC issued for the fabrication of components specific to a particularaircraft undergoing maintenance in accordance with CASR 21.133 (2B).

    A PC may not be issued to:

    CASR

    21.027, Part

    21,Subpart C

    q The holder of a TC issued under CASR 21.027, or CASR Part 21, Subpart C(provisional TC)

    q An organisation whose manufacturing facilities are located outside Australian territory,

    unless it has been determined that such location(s) would place no undue burden onCASA.

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    2.2.4 Advising the Applicant

    As part of the assessment, CASA must ensure that the PC applicant understands that theholder of a PC is responsible for:

    q Maintaining the quality system in accordance with the regulations, data andprocedures approved for the PC

    q Ensuring conformity with the Type Design or Product Design, as applicable, andcondition for safe operation of each completed product or part

    CASR 21.147q Notifying CASA of any changes to the quality system in writing to the responsible

    CASA ESS Office that may affect the inspection, conformity, or airworthiness of the

    product or partCASR 21.147 requires the holder of a PC to notify CASAimmediately. These changes include:

    Relocation of a part of a facility or addition to existing facilities

    Discontinuing production for an extended period of time for other than normalreasons such as scheduled holidays

    Resumption of production after discontinuance

    Significant curtailment/resumption of production operations

    Significant reduction/reassignment of quality system personnel

    Changes or revisions to quality system data and related procedures

    CASR 21

    Subpart Q

    q Marking products in accordance with the requirements of the regulations (CASR 21Subpart Q) and approved design data

    CASR 21.003q Reporting all failures, malfunctions, and defects as required by CASR 21.003.

    Project Officer

    1. Advise the applicant that:

    AC21.14

    CASR Part

    21,Subpart

    G

    AC21.27,

    a. AC21.14 provides an acceptable means of compliance with CASR Part 21,Subpart G. Where an applicant proposes to use a different means of complianceto that published in the AC, the delegate will assess this and the applicantadvised accordingly.

    b. The data required to be submitted is described in appendix 1 of AC 21.27.

    2. A title must be provided for the quality system manual for positive identification. Inaddition, a revision page or similar control is required to ensure that the originalapproval date and the date of each revision is recorded. A number or letter, and dateof the revision must identify each revision.

    CASR 21.143 3. Where an applicant has existing quality control procedures for other purposes, theapplicant must identify those parts that comprise the quality system that show

    compliance with CASR 21.143.

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    2.2.5 Preliminary Assessment Procedures

    AC21.14 The application Form 849 Production Approval - Applicationis recorded at the ESS officeis accordance with local procedures.

    ESS Administration Officer

    1. On receipt of the application, issue a letter of acknowledgment.

    2. Provide an estimate of costs for assessment of the application in accordance withCASA cost-recovery procedures, advising the applicant that CASA cannot proceed

    with the assessment until his or her payment/acceptance, in writing, of the estimate ofcosts.

    Preliminary Assessment

    Project Officer

    1. Plan for the establishment of the PCB and a pre-PCB meeting with the applicant sothat the meetings can proceed on payment/acceptance of the estimate of costs.

    2. Before the preliminary assessment, convene a pre-PCB meeting, if necessary.

    3. After acceptance of the estimate of costs make arrangements to commence thepreliminary assessment. This assessment consists of an evaluation of the applicant's:

    Quality system data

    Facilities, equipment, processes, personnel, control of suppliers, stores, etc, toensure that they are adequate for the purpose.

    The assessment of the quality system data may require a number of visits to theapplicants facilities and suppliers as necessary, to evaluate and confirm that theprocedures are in fact adequate to control the conformity of detail parts, sub-assemblies and completed products. The MI must evaluate the adequacy of the

    quality system by personally observing the control of each stage of production and allsupporting functions.

    Establishing the PCB and Holding Meetings of the PCB

    Project Officer

    Establish the PCB and meet, as appropriate, in accordance with the procedures in1.6.1 Production Certification Board (PCB) Description.

    !

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    Notifying the Applicant

    On completion of the preliminary assessment, formally notify the applicant of anycorrective actions needed. Further advise the applicant that these items only representCASAs preliminary findings and that additional requests for corrective actions can beanticipated as a result of subsequent findings of the PCB, future routine audits andsurveillance activities.

    Issuing the PC and Production Limitation Record (PLR)

    The PC and PLR certificates are prepared using the CASA templates for the Production

    Certificate (Form 737) and the Production Limitation Record (PLR) (Form 002). (Thetemplates are available on CASA's Intranet).

    PCs and PLRs are printed on the official CASA certificate quality paper No 401CERTIFICATE PAGE 1 LOGO & BORDER (refer to the McMillan catalogue on theCASA Intranet for supply). See sample Production Approval Templateson page 2-15(Production Certificate) and page 2-16 (Production Limitation Record).

    When issued, the original PC and PLR are given to the applicant. Copies of the PC andPLR are kept on the project file and on the master folders of PCs and PLRs issued oramended. The details of the PC and PLR are entered on the PC and PLR Register held

    as a shared drive in the Certification Support Services (CSS) Section. Electronic copiesare also held on the shared drive.

    ESS Office

    CASR

    Part 21

    1. When the PCB has determined and documented that the manufacturer's qualitysystem and procedures comply with CASR Part 21, prepare the PC and PLR,together with a draft letter of approval for the signature of the appropriate delegate.

    When preparing the PLR, list:

    The TC number or Design Data Reference of each product authorised for

    production The model numbers and the date on which production was authorised

    Any limitations (eg limitation to parts only).

    Note: When a PC is issued and based on a licensing agreement for a specificperiod of time, the PC must terminate on the same date. The approvalletter to the applicant must refer to this date.

    !

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    Additions to the PLR

    If a PC holder wants to add a new TC, or a new model or new parts, the holder must applyin the same manner as for the original issue.

    ESS Office

    1. Normally it is not necessary to establish a PCB. However, in place of the PCB,conduct an audit to the extent necessary to determine whether the quality controlsystem is adequate or has been appropriately changed to ensure positive control ofthe product/parts to be added to the PLR.

    However, if changes to the quality control system are substantial, establish andconvene a PCB to make the determination.

    2. If the revisions to the PLR are to include new products/models, prepare and issue therevised PLR, together with a draft approval letter for the delegates signature.

    3. After the PLR has been approved and signed by the delegate, forward the revisedPLR to the applicant with a request to return the superseded PLR to the ESS Office.

    Deletions to the PLR

    Responsible ESS Office

    1. Where production of a type-certificated product has been discontinued, and more thanone TC is listed on the PLR, the following applies:

    a. If neither the complete product nor spare parts are being produced, delete thediscontinued product or model from the PLR.

    b. If production of the complete product has ceased, but spare parts are still beingproduced, revise the PLR to reflect this:

    CASR 21.147 Ensure that the manufacturer remains in compliance with CASR 21.147 and

    continue to advise CASA of any changes in the organisation, systems,procedures or processes

    Continue surveillance, in accordance with established procedures, of thosefacilities that are still active, paying particular attention to determine whether:

    CASR Part

    21,Subpart

    G

    The quality control data adequately covers the remaining procedures andprocesses involved

    The PC holder continues to comply with the requirements of CASR Part 21,Subpart G.

    2. The revised PLR supersedes all previous issues of the PLR and is now the currentapproval for production.

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    STC Modifications Incorporated by the PC Holder

    There are two means available:

    q The TC holder may apply to CASA to have the STC entered on the TC. The PCholder as either the TC holder or licensee of the TC may then incorporate the STCduring production; or

    q The PC holder may apply to CASA to have the STC entered on the PLR.

    The production inspection system must be revised to address the incorporation of the STCduring production.

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    Sample Production Approval Templates

    Sample Production Certificate

    CIVIL AVIATION SAFETY REGULATIONS 1998

    Production Certificate

    Number PC-123456

    In accordance with regulation 21.134 of the Civil Aviation SafetyRegulations 1998, this certificate including the associated

    production limitation record(s) authorises:

    Planemaker Aircraft Pty Ltd

    ABN 91 123 456 789

    to manufacture

    Class 1 Products

    at the following manufacturing facilities:

    2A Industrial Place

    Werribee, Victoria 3030

    This certificate terminates on: 15/06/2004This certificate is subject to the condition that the holder must notify CASAin writing of any change to the business address of the holder.

    (signed)

    A. G. Citizen

    Date Issued: 15/06/2003 Delegate of CASA

    Original Issue: 22/05/2002

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    Sample Production Limitation Record

    Production Limitation Record

    The holder of Production Certificate No. PC-123456may produce:

    Aircraft and Parts

    manufactured in accordance with the following design data.

    Design Data Model or Parts Date ProductionAuthorised

    VA999 Airhawk 132B 1 December 2003ASR028SY ACME R12 12 December 2003

    Conditions and Limitations:

    None.

    (Signed)

    12/12/2003 A. G. Citizen

    Date Issued:(dd/mm/yyyy)

    Delegate of CASA

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    Sample Production Certificatefor Fabrication in the Course of Maintenance

    CIVIL AVIATION SAFETY REGULATIONS 1998

    Production Certificate

    Number PC-123456-1

    In accordance with regulation 21.134 of the Civil Aviation SafetyRegulations 1998, this certificate including the associatedproduction limitation record(s) authorises:

    Planemaker Aircraft Pty Ltd

    ABN 91 123 456 789

    to fabricate

    Class III Products

    at the following manufacturing facilities:

    2A Industrial PlaceWerribee, Victoria 3030

    This certificate terminates on: 15/06/2004This certificate is subject to the condition that the holder must notify CASAin writing of any change to the business address of the holder.

    (signed)

    A. G. Citizen

    Date Issued: 15/06/2003 Delegate of CASA

    Original Issue: 22/05/2002

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    Sample Production Certificatefor Fabrication in the Course of Maintenance

    Production Limitation Record

    The holder of Production Certificate No. PC-123456-1mayproduce:

    Class III Products

    manufactured in accordance with the following design data.

    Design Data Module or PartsDate Production

    Authorised1 December 200312 December 2003

    Design dataapproved by CASAor a CASR 201.001Authorised Person,specific to anindividual aircraft

    Sheet metal parts as defined by thedesign data

    Conditions and Limitations:

    Limited to the fabrication and supply of parts to be consumed in the course of maintenance(FITCOM), for the supply to:

    a maintenance organisation

    an owner/operator of the aircraft.

    (Signed)

    12/12/2003 A. G. Citizen

    Date Issued:(dd/mm/yyyy)

    Delegate of CASA

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    2.2.10 Summary of Distribution of Production Certification Documents

    The Project Officer is to distribute the PC documents as indicated below.

    Application for PC, CASA Form 849

    q Original retained by the ESS Office, together with:

    Copies of the applicants legal identity

    Licensing agreement(s)

    Documented quality control system when approved.

    Prepared PC, PLR and Draft Letter of Approval

    q The ESS Office prepares these documents after the satisfactory completion of theassessment, completion and acceptance of the PCB findings, and approval of thequality system data. The Project Officer forwards the documents to the delegate.

    Approved PC, PLR and Draft Letter of Approval

    The delegate when satisfied signs and forwards:

    q The originals to the applicant

    q Copies to the Project Officer for filing.

    Request for Amendment to the Production Certificate

    CASR 21.153 The applicant is to submit the Production Approval Application form (Form 849). An ESSProject Officer will assess the application for amendment in accordance with theseprocedures for revised PC and for its compliance with CASR 21.153.

    The PC and PLR will be re-issued to reflect the amendment.

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    2.3 Australian Parts Manufacturer Approval

    2.3.1 Applicability of Australian Parts Manufacturer Approval

    CASR Part

    21,Subpart

    K,21.303

    This section covers the assessment and issue of an Australian Parts ManufacturerApproval (APMA) for replacement and modification parts for installation on a typecertificated product, in accordance with CASR Part 21, Subpart K, regulation 21.303.

    Note: AN APMA is not issued for production of parts for installation on non-typecertificated aircraft or products.

    The section provides guidance for CASA to be satisfied that the applicant has showncompliance with airworthiness requirements on the basis of tests and computations, or incertain cases, on the basis of identicality.

    CASR 21.303 CASR 21.303 requires that any person producing replacement or modification parts forsale for installation on a type-certificated product must obtain an APMA. An APMA mustbe obtained for replacement or modification parts for an STC if they are not beingproduced under a PC.

    CASA does not approve manufacturing inspection procedures, materials or specialprocesses such as heat treatment, plating, shot peening etc. If such processes are

    required in the manufacture of parts, the APMA approved data will specify therequirement.

    Note: The part or parts for a STC, which carry or carries a one-time only limitation,may be manufactured under maintenance approval for the one aircraftinvolved.

    CASR

    21.303(2)(e)Note: Standard parts conforming to an established industry or Australian

    specificationeg, AN bolts and nuts are not eligible for an APMA(CASR 21.303(2)(e)).

    Imported Products

    CASR

    21.502,

    21.502A

    If, in producing a part under an APMA, imported parts are to be used, they must beimported parts in accordance with CASR 21.502 and 21.502A.

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    2.3.2 Responsibility for Australian Parts Manufacturer Approval

    Applicant

    The applicant must show that the design meets the applicable airworthiness standards.The applicant shows compliance in two ways:

    q The applicant demonstrates that the design of the part is identical to the design of apart covered under a TC or STC; or

    q The applicant demonstrates through tests and/or computations that the design of thepart meets the airworthiness requirements applicable to the product on which the partis installed. The applicant must assure that no interference with mating or adjacent

    hardware occurs and that the part performs its intended function.

    Applicants intending to demonstrate that the design is identical must produce evidence ofany licensing agreement held with original equipment manufacturer or STC holder.

    CASR

    21.303(11),

    The applicant must establish and maintain a Fabrication Inspection System (FIS) thatmeets the requirements of CASR 21.303(11).

    Assigned Engineer and Manufacturing Inspector

    CASR

    21.303(3)The assigned AWE assesses the design data, any test reports and computations for

    compliance with the applicable airworthiness requirements CASR 21.303 (3).

    CASR 21.303 The MI assesses the APMA applicants facilities, process, documentation and fabricationinspection system for compliance with the airworthiness requirements CASR 21.303.

    s2.3.3 Lodgement of an Application for an APMA

    Applicants should be advised to submit an application for an APMA in a letter completewith Form 849Production Approval Applicationto the Manager, ESS.

    CASR 21.303 The suggested format of the application and a list of required attachments are shown in5.1Sample APMA Application Letterin Chapter 5 Sample Letters. The applicant mustcomply with CASR 21.303.

    Note: The applicant must have produced conforming parts in support of theapplication. A non-conformed proof-of-concept part is not a basis for CASAassessment and subsequent approval.