Advisory Circular (AC) No. 561-001

Implementation Procedures for Canadian Aviation Regulation Part V - Subpart 61

Issuing Office: Aircraft Maintenance and Manufacturing
Activity Area: Qualifying AC No.: 561-001
File No.: 5015-11-0 Issue No.: 01
RDIMS No.: 1984415-V1 Effective Date: 2006-09-05

1.0  INTRODUCTION

This Advisory Circular (AC) describes an acceptable means, but not the only means of demonstrating compliance with regulations and standards. This AC in and of itself does not change, create, amend or permit deviations from regulatory requirements nor does it establish minimum standards. The applicant may elect to follow an alternate method, which must be acceptable to Transport Canada.

1.1  Purpose

The purpose of this Advisory Circular is to provide information to existing Transport Canada (TC) approved manufacturer certificate holders, who are required to implement the new Canadian Aviation Regulation (CAR) Part V, Subpart 61, regulatory requirements and the corresponding Standard (STD) 561. This guide is also intended to provide assistance for any new applicants seeking a TC Part V, Subpart 61, manufacturing approval.

1.2  Applicability

This document is applicable to Transport Canada Civil Aviation personnel and industry.

1.3  Description of Changes

N/A

2.0  REFERENCES

2.1  Reference Documents

It is intended that the following reference materials be used in conjunction with this document:

  1. Part V, Subpart 61 of the Canadian Aviation Regulations, Manufacture of Aeronautical Products; dated November 21, 2005, (copy attached as Appendix F);

  2. Standard 561, Standard for Approved Manufacturers; (copy attached as Appendix G); and

  3. Maintenance & Manufacturing Policy Letter 17, Alternate Means of Compliance to AWM 561, Original issue, dated May 29, 2003.

2.2  Cancelled Documents

Aircraft Maintenance & Manufacturing Policy Letter 17, Alternate Means of Compliance to AWM 561, will be cancelled when CAR 561 becomes effective.

2.3  Definitions and Abbreviations

The following definitions and abbreviations are used in this document:

  1. Quality Program Manual (QPM) means the manual required by CAR 561.07(1).

  2. Principal Manufacturing/Maintenance Inspector (PMI) refers to the inspector assigned oversight responsibilities for a particular manufacturing organization.

3.0  BACKGROUND

  1. New regulatory requirements for TC approved manufacturer certificate holders will come into effect on December 1, 2007. This document was developed to provide a proactive approach for the implementation of these new requirements. This document will provide the necessary information to manufacturing organizations wishing to adopt the proposed new manufacturing CAR & STD before they come into effect. This document will also be used by TC Civil Aviation Safety Inspectors to standardize the application, review, and approval processes.

  2. Presently, manufacturers of aeronautical products are approved in accordance with Chapter 561 of the Airworthiness Manual (AWM) or in accordance with the alternate means of compliance to AWM 561, which is contained in Aircraft Maintenance & Manufacturing Policy Letter (MPL) #17. Currently, MPL 17 contains Notices of Proposed Amendment (NPA) 1998-140 for CAR Part V, Subpart 61 and 1998-141 for STD 561, as recommended by the Part V Technical Committee members of the Civil Aviation Regulatory Advisory Committee (CARAC).

  3. As a result, manufacturer organizations that have already been approved by TC in accordance with MPL 17 will require less change to their Quality Program Manual (QPM) to meet the new requirements of CAR Part V, Subpart 61 & STD 561, versus an organization that had been approved by TC in accordance with AWM 561. However, TC approvals issued in accordance with MPL 17 will still require a review, and QPM amendment, to ensure that all the new CAR Part V, Subpart 61 and STD 561 requirements have been met. Manufacturer organizations approved in accordance with AWM 561, who have not adopted the provisions contained in MPL 17, will require a more significant QPM review and amendment to incorporate the new regulatory requirements.

  4. By producing this Implementation Procedures document, Transport Canada is offering manufacturer certificate holders a means to be fully compliant with the new regulations and standards on the date they come into effect. As such, Transport Canada will concentrate its resources to address the needs of those organizations that transition to the new requirements in accordance with this Advisory Circular. Organizations who choose to delay addressing the new requirements until after the effective date (Dec 1/07) may be subject to certificate action.

4.0  CONVERSION/IMPLEMENTATION PROCEDURES FOR APPROVED MANUFACTURERS

To confirm a manufacturer certificate holder's level of compliance with the new CAR & STD, TC has implemented a National Manufacturer Recertification program. Implementation of this program has been scheduled in two (2) phases.

  1. Review of the current TC approved QPM against the new CAR and STD and identification by the manufacturer certificate holder of the non-compliant areas followed by the submission of an acceptable Corrective Action Plan (CAP) and/or compliance program, Dec 1/06;

  2. Recertification of compliant manufacturers by Transport Canada, Dec 1/07.

5.0  MANUFACTURER RECERTIFICATION

  1. The manufacturer certificate holder will:

    1. Complete the applicable Quality Program Manual - Review Document (Appendix C or D) by identifying where the policies and procedures of their existing QPM differ with the new regulation and standard. This review will include applicable documents incorporated by reference.

    2. Develop an acceptable corrective action plan and/or compliance program detailing the methods that will be implemented to establish/ensure compliance with the new standard and establish completion dates for all areas/issues identified through the review process. The CAP should include a proposed QPM amendment to address the areas identified in item (a) as well as the submission of progress report(s) as agreed to with the Principal Manufacturing/Maintenance Inspector.

    3. Fully implement the corrective action plan by December 1, 2007.

  2. The Manufacturer Certificate holder will submit the information/documentation generated per items (a) and (b) above, to their TC Principal Manufacturing/Maintenance Inspector (PMI) for review on or before December 1, 2006. Submission by this date will ensure timely review and approval by Transport Canada.

6.0  TRANSPORT CANADA RESPONSIBILITIES

Upon receipt, TC will review each submission to determine its acceptance and will provide written acknowledgment that the proposed amendment/implementation program is satisfactory, or indicate where changes are required. Target compliance dates will be established by agreement with TC including submission of a progress report(s).

7.0  TRANSPORT CANADA ON-SITE ACTIVITIES

  1. To determine the manufacturer's implementation progress and level of compliance with CAR Part V, Subpart 61 and STD 561, TC may conduct on-site review activities of the organization's quality program. The scheduling of these activities will be determined by the applicable TC PMI and each organization shall be notified accordingly.

  2. When the manufacturers Corrective Action Plan (Appendix A) has been fully implemented, the manufacturers Certificate of Approval will be reissued (on or before December 1, 2007), to reflect compliance with CAR Part V, Subpart 61 & STD 561. Manufacturer certificate holders should ensure that the information provided on their new Certificate of Approval and Approval Limitation Record is correct.

8.0  NEW ENTRANTS

  1. This Implementation Procedures document is intended to transition organizations that hold a Manufacturer Certificate of Approval to the new manufacturing regulations and standards. While it is not mandatory, organizations that apply for a Manufacturer Certificate of Approval during this transition phase are encouraged to adopt the new CAR 561 and Standards.

  2. New applicants that adopt the new regulations and standards as the basis for their approval will be issued a Certificate of Approval in accordance with Airworthiness Manual 561. A replacement Certificate of Approval will be issued approximately four to six weeks before the new regulations come into force. Their original certificate will cease to be in force as of December 1, 2007, and will be returned to the applicable Transport Canada Centre.

    Information Note:

    The Transport Canada program used to issue a Certificate of Approval will be adjusted to reflect CAR Part V, Subpart 61 and STD 561 in October 2007. Once this adjustment has taken place, the program will no longer issue a Certificate of Approval in accordance with Airworthiness Manual 561.

  3. New applicants who choose not to adopt the new regulations and standards and adopt the existing Airworthiness Manual 561 or the provisions of MPL 17 as the basis for their approval will be issued a Certificate of Approval. They will also be issued a Notice of Suspension with an effective date of December 1, 2007, as their certificate will cease to be in force on that date.

    Information Note:

    New manufacturer organizations that have not met the conditions for approval beyond the date of adjustment of the program per the Information Note above will loose the opportunity to be approved in accordance with AWM 561 or the provisions of MPL 17. Approval in accordance with CAR 561 will be the only available option.

9.0 CONTACT OFFICE

For more information please contact:
Aircraft Maintenance & Manufacturing (AARP)
Phone: 613-952-7974
Facsimile: 613-952-3298

Original signed by,

D.B. Sherritt
Director, Standards
Civil Aviation

Appendix A - Actions, Documents, Timetable

  1. To allow manufacturing organizations and Transport Canada personnel sufficient time to review, amend, implement and approve documentation and programs required by the new regulations and standards, the following timetable is recommended;

    1. On or before December 1, 2006, the manufacturer shall;

      1. complete Appendix C or D as applicable (QPM Review Document) to identify those areas in the QPM that do not comply with the new regulations and standards;

      2. develop a Corrective Action Plan (CAP) and/or compliance program to address the areas of non compliance identified in item a) that will include;

        1. a proposed QPM amendment and,

        2. a timetable to implement those programs that are required but not currently in place.

        Information Note:

        It is recommended that the CAP include progress reporting points to ensure implementation of new programs remains on schedule for completion no later than December 1, 2007. 

        Information Note:


        There is no requirement for the QPM amendment to be submitted or approved by December 1, 2006. The amendment can be approved when compliance is demonstrated in the same manner as any other amendment. It is recommended that a QPM amendment be submitted as soon as possible to ensure sufficient time for review and approval. Approval of the amendment in advance of the “in force” date of the new regulations will not invalidate the Certificate of Approval issued under AWM 561.

      3. Manufacturer to submit the above documents (A) & (B) to their Transport Canada PMI for review and acceptance.

        Information Note:

        The purpose of the submission is for Transport Canada and the affected organization to agree on the proposed implementation schedule, provide for timely approval of the QPM amendment (as applicable) and be in a position for recertification no later than December

    2. Progress Report(s)
      As agreed between the manufacturing organization and the Transport Canada PMI.

    3. December 1, 2007: Full implementation of the corrective action plan must be completed no later than this date.

  2. A new Manufacturer Certificate of Approval will be issued when compliance with the new regulations and standards has been demonstrated. Replacement certificates should be available approximately four to six weeks before the new regulations come into force.

  3. Organizations who adopt the above timetable and follow their corrective action plan will be in a position for recertification on or before December 1, 2007. Organizations who choose to address the implementation of the new regulations and standards with little or no advance notice to Transport Canada may not be recertified in time to avoid certificate action.

APPENDIX B - Regulatory Reference Table: CAR 561 - STD 561 – MPL 17 and Airworthiness Manual 561

CAR 561 Standard 561 MPL 17 Airworthiness Manual 561
561.01 - Interpretation 561.01 - Reserved Interpretation  561.101 General
561.02 - Application 561.02 - Application Condition .01 - Application 561.103 Eligibility
561.113 Entitlement
    Condition .02 – Manufacturer Certificate Privilege 561.105 Aeronautical Products
561.115 Privileges
561.03 – Manufacturer Certificate – Application, Issuance and Amendment 561.03 – Manufacturer Certificate – Application, Issuance and Amendment Condition .03 – Manufacturer / Application or Amendment
Condition .04 – Issuance of Manufacturer Certificate
561.117 Responsibilities of an Approved Manufacturer
561.201 General
561.203 Application for Approval
561.205 Granting Approval
561.207 Approval Limitations
Note: Regulations relating to the Accountable Executive for manufacturers will be added to CAR 106.01 at a later date.   Condition .05 – Accountable Executive No reference in AWM 561
561.04 - Management Personnel 561.04 - Management Personnel Condition .06 – Management Personnel 561.109 Quality Program
561.05 - Resources 561.05 - Resources Condition .07 – Resources 561.111 Inspection Personnel
561.107 Manufacturing Facilities
561.06 – Facilities Located in a Foreign State 561.06 – (Reserved) Condition .08 – Facilities Outside Canada 561.107 Manufacturing Facilities
561.07 - Manual 561.07 - Manual Condition .09 – Manual 561.109 Quality Program
561.08 – Production Control System 561.08 – Production Control System Condition .10 – Production System 561.109 Quality Program
561.09 – Quality Assurance Program 561.09 – Quality Assurance Program Condition .11 – Quality Audit System 561.109 Quality Program
561.10 – Statement of Conformity 561.10 - Statement of Conformity Condition .12 – Statement of Conformity 561.301 General
561.303 Airworthiness Certification - General
561.305 Certification - Aircraft
561.307 Certification - Aeronautical Products other than Complete Aircraft
561.309 Certification for Export
561.11 - Training Program 561.11 - Training Program Condition .13 – Training Program 561.111 Inspection Personnel
561.12 – Personnel Records 561.12 – (Reserved) Condition .14 – Personnel Records 561.209 Approval of Manufacturer's Personnel
561.13 - Control of Suppliers 561.13 - Control of Suppliers Condition .15 – Control of Suppliers 561.117 Responsibilities of an Approved Manufacturer
561.14 – Aeronautical Product Records 561.14 – Aeronautical Product Records Condition .16 – Aeronautical Product Records 561.119 Record Retention
561.15 – Service Difficulty Reporting 561.15 – (Reserved) Condition .17 Service Difficulty Reporting No reference in AWM 561
561.16 – Cessation of Manufacturing 561.16 – (Reserved)   561.207 Approval Limitations
  Appendix A – Authorized Release Certificate Schedule I  
  Appendix B – Sample Statement of Conformity Schedule II  

APPENDIX C - Quality Program Manual (QPM) - Review Document CAR/STD 561 To AWM 561

The review process:

The following steps may be helpful in getting started but are not meant to be considered as the only acceptable method.

  1. Make several blank copies of the review document.

  2. Read the regulatory material relating to the topic area under review thoroughly.

  3. Review all the material in your manual against the requirements in the applicable regulation and standard, make an accurate assessment of its compliance, and record your findings in the comments column. This step is critical to the process. The intent of this document is to assist and speed up the approval process.

  4. Once you have completed your manual review and identified the areas that you feel do not comply, prepare an amendment to your QPM to address those items/issues that are not in compliance.

The information per item 3 should be submitted on or before December 1, 2006 to your Transport Canada Principal Manufacturing/Maintenance Inspector (PMI). Please refer to Appendix A, Information Note, regarding the submission of QPM amendments.

Information Note:

These documents are designed to provide a simple, accurate and user-friendly method for determining the level of compliance with the STD.  Each numbered block contains a title segment, which has been referenced directly to the required standard.   Within each block is a short description of the desired content and, where possible, a direct quote from the applicable regulation or standard. Each block also has a list of pertinent sections of the regulation and standard that must be read to determine if the manual under review does in fact, comply.

Quality Program Manual (QPM) - Review Document CAR & STD 561 to AWM 561

Reference to
CAR/STD
561
Item Title Previous standard references:
AWM 561
March, 2000
Refer to CAR/STD 561 for specific regulatory requirements
Additional information that should be included in the QPM
Manufacturer Comments
CAR 561.04(1) Management Personnel AWM 561.109(b) The person appointed by the certificate holder shall be specified in the Quality Manual.  
CAR 561.04(6) Management of Specific Activities AWM 561.109(d) (1)(ii) The person appointed may assign responsibility for the management of specific activities, systems or programs to other persons, provided that the assignments and the scope of the assigned responsibilities are specified in the manual.  
CAR 561.07(1) Manual AWM 561.109(d) (1) The holder of a manufacturer certificate shall establish, maintain and require the use of a manual.  
STD 561.07(1)(a) Manual Certification Statement and Approval Page AWM 561.109(d) (1)(i)

AWM 561.205(c)
… the manual shall contain a certification statement signed by the accountable executive confirming that the manual and any incorporated documents reflect the certificate holder's means of ensuring compliance
… the manual shall contain a section reserved for ministerial approval
 
STD 561.07(1)(b) Identification of Certificate Holder   … the quality manual shall contain…
the approval number of the certificate holder
the legal name and or registered trade name of the certificate holder, which the organization does business
the mailing address where different from the manufacturing site address
 
STD 561.07 Quality Manual Contents
STD 561.07(1)(c) Table of Contents AMA 561/4 … the quality manual shall contain a table of contents  
STD 561.07(1)(d) List of Effective pages   … a means of identifying each page of the manual, in the form of a list of effective pages (LEP), with each page numbered and either dated or marked with a revision number  
STD 561.07(1)(e) Issuance and Control of amendments, distribution & compliance   … the manual shall contain a process for issuance and control of amendments, including a description of the distribution procedures
… a reference to the list stating the title of each person who holds a copy of the manual
… a description of the system used to ensure compliance with the requirements of subsection 561.07 (8) of the CARs
 
STD 561.07(1)(f) Organization AWM 561.109(d) (1)(ii)
AMA 561/4
… a brief description of the organization including approximate size, geographic location and basic layout of the facilities  
STD 561.07(1)(g) Scope of work   … a description of the scope of work that is intended to be performed at each facility  
STD 561.07(1)(h) Management functions
Org. Chart
AWM 561.109(d) (1)(ii)
AWM 561.203(b)(2)
AMA 561/4
… where management functions have been assigned
the name or title of any person to whom functions have been assigned
a description of the functions that have been assigned to each person
where necessary for clarity, a chart depicting the distribution of functions
 
STD 561.07(1)(i) Control of data AWM 561.119(a) … a description of the system to obtain and preserve pertinent regulatory, design and other technical data, and procedures to ensure they are kept up to date  
STD 561.07(1)(j) Control of product conformity AWM 561.109(a)
AWM 561.117(b)
… a description of the controls used to ensure that the product conforms to its type design  
STD 561.07(1)(k) Control of suppliers AWM 561.107 … a description of the methods for evaluating and controlling suppliers  
STD 561.07(1)(l) Identification and traceability of product AWM
561.109 (d)(1)(iv)
… a description of the methods used to identify and trace the aeronautical products during all stages of the manufacturing process and up to delivery of the product  
STD 561.07(1)(m) Production control AWM 561.109(d) … a description of the production control system which includes the requirements set out in section 561.08 of this standard  
STD 561.07(1)(n) Quality audit system AWM
561.109(d)(2)
… a description of the quality audit system which includes methods of audit, identification and analysis of probable root cause and contributory causes of deficiencies identified in audit results, corrective action follow-up and record keeping  
STD 561.07(1)(o) Control of authorized persons AWM 561.111
AWM 561.115
AWM 561.209
… a description of the policies and procedures for;
authorizing persons to sign statements of conformity
identifying those persons
identifying the product or range of products they are authorized to certify, and
controlling the stamp issued to each person
 
STD 561.07(1)(p) Control of inspection, measuring and test equipment AWM 561.109(d)(3)(iv) … a description of the policies and procedures to control inspection, measuring and test equipment traceable to applicable Canadian or international standards  
STD 561.07(1)(q) Control of non-conforming products AWM
561.109 (d)(2)
… a description of the system for the identification and control of non-conforming products along with the determination of corrective actions to be taken  
STD 561.07(1)(r) Training program AWM 561.111 … a description of the training program required by section 561.11 of the CARs  
STD 561.07(1)(s) Personnel records   … a description of the methods used to establish and maintain personnel records required by section 561.12 of the CARs  
STD 561.07(1)(t) Product records AWM
561.119(a)(b)
… a description of the methods used to establish and maintain product records required by section 561.14 of the CARs  
STD 561.07(1)(u) Control and recording of defects, malfunctions, & failure data AWM
561.109(d)(3)
… a description of the policies and procedures to control the collection, evaluation and reporting defects, malfunctions and failure data pursuant to section 561.15 of the CARs  
STD 561.07(2) Control of other activities   … documented procedures governing other activities other than those approved pursuant to Subpart 61 of Part V of the CARS, provided the structure of the manual makes clear which parts of the manual are intended to meet the requirements of Subpart 61 of Part V  
CAR 561.08 Production Control System
CAR 561.08(1) Production Control System AWM
561.109 (d)(2)
… the production control system shall consist of systems and procedures set out in section 561.08 of Standard 561 to ensure that aeronautical products comply with the regulations throughout the manufacturing process  
STD 561.08(a) Process Controls AWM
561.109 (d)(2)
… shall include process controls during the production stage to ensure that processes are performed under controlled conditions and include documented instruction, workmanship criteria, data, suitable equipment and competent personnel  
STD 561.08(b) Inspection and Testing Procedures AWM
561.109(d)(3)
… inspection and testing procedures, including receiving, in-process through final inspection, testing and flight operations including production flight tests, to ensure that all manufacturing and inspection tasks have been completed as planned and documented.
The system shall include written instructions for product verification that
establishes where, throughout the production process, inspections will be performed, including those required at suppliers facilities
identify the nature of the inspections to be performed
establish final inspection procedures for a completed product, including
in the case of an aircraft, flight operations including the flight test procedures and checklists
in the case of an engine, variable pitch propeller or component, procedures to ensure that all required functional tests have been performed
 
STD 561.08(c) Control of Inspection, Measuring and Test Equipment AWM
561.109(d)(3)(iv)
… a system to ensure that inspection, measuring and test equipment is calibrated prior to use or at the intervals recommended by the equipment manufacturer, and the calibration is traceable to applicable Canadian or internationally recognized primary standards  
STD 561.08(d) Identification and control of non-conforming product AWM 561.109(d) …a system for the identification and control of non-conforming product along with the determination of corrective actions to be taken  
STD 561.08(e) Control of product AWM
561.109(d)(3)
AWM
561.111
…a system to track and record inspection and test status of products as they progress through the manufacturing process and the identity of the persons who confirm product compliance at each stage  
STD 561.08(f) Corrective action AWM
561.109(d)(2)
… a system of corrective action for systemic deficiencies found during audits conducted under section 561.09 of the CARs.  
CAR 561.09 Quality Assurance Program
CAR 561.09(1) Quality Assurance Program AWM 561.109(a) … the holder of a manufacturer certificate shall, establish and maintain a quality assurance program, which is independent of the production control system and meets the requirements specified in section 561.09 of Standard 561  
STD 561.09(1) Changes to Quality Assurance Program AWM 561.109(b) … the quality assurance program shall be responsive to any changes within the organization that could affect compliance with the manual or the scope of privileges of the manufacturer      certificate and addresses the need for amendments resulting from such changes  
STD 561.09(2) Audit System AWM 561.109(d)(2) … shall include an audit system which employs sufficiently detained checklists or equivalent methods which include the elements listed under subsection 561.09 (3) of the CARs  
CAR 561.09(3)(a) Initial Audit   … an initial audit, within 12 months after the day on which the manufacturer certificate is issued, that covers all aspects of the manufacturer's activities  
CAR 561.09(3)(b) Subsequent Audits AWM 561.109(d)(2) … subsequent audits conducted at the intervals set out in the quality manual  
STD 561.09(3) Audit Frequency   … audits conducted under section 561.09 of the CARs may be conducted on a progressive or segmented basis, provided that the entire organizational system is verified within the applicable interval  
CAR 561.09(3)(c) Recording of non-compliance   … a record of each occurrence of compliance or non-compliance found during an audit  
CAR 561.09(3)(d) Audit finding communication   … procedures for ensuring that each finding of an audit is communicated to them  
CAR 561.09(3)(e) Follow - up   … follow-up procedures for ensuring that corrective actions are effective  
CAR 561.09(3)(f) Recording of Findings   … a system for recording the findings of initial and periodic audits, corrective actions and follow-ups  
STD 561.10(1) Statement of Conformity AWM 561.111 … a system to authorize persons to sign a statement of conformity that identifies the individuals by name, together with the product or range of products they are authorized to certify, and where a stamp is used, the stamp number assigned.  
CAR 561.11(a)(b) Training Program   … establish and maintain a training program that includes initial training, update training and any other training set out in section 561.11 of Standard 561
… ensure that persons who are authorized to perform or supervise the performance of any function required under this Subpart are trained applicable to that function
 
STD
561.11(1)(d)(2)
Training Program AWM 561.111(a)(b) … provisions to ensure that persons authorized to sign statements of conformity have demonstrated an appropriate level of knowledge and experience and understand their responsibilities
… until such time as the quality assurance program indicates that a different interval is appropriate, the initial cycle for update training is not to exceed three years.
 
CAR 561.12(1) Personnel Records   … the manufacturer certificate holder shall establish and maintain a personnel record for each employee
which includes all of the employee's qualifications
and all authorizations to sign a statement of conformity
 
CAR 561.13 Control of Suppliers
CAR 561.13(1)(a) Control of Suppliers AWM 561.107
AWM 561.117
… the holder of a manufacturer certificate who contracts work to a supplier shall have a written agreement with the supplier which specifies the work to be performed by the supplier and provides that the Minister may have access to and inspect the suppliers facilities and records to ensure compliance  
CAR 561.13(1)(b) Evaluation of Suppliers AWM 561.107 … policies and procedures to ensure that contracted suppliers have been evaluated by the manufacturer certificate holder  
CAR 561.13(1)(c) Supervision of work done by suppliers AWM
561.109 (d)(3)(i)
AWM 561.117
… policies and procedures to ensure that any work done by the contracted supplier is done under the certificate holder's supervision and is subject to the quality assurance program set out in section 561.09 of the CARs  
CAR 561.13(1)(d) Evaluation of Supplier capabilities AWM 561.107
AWM 561.117
… policies and procedures to ensure that the supplier's capability to perform the contracted work is evaluated and monitored  
CAR 561.13(1)(e) Control of Supplier product conformity AWM 561.117 … policies and procedures to ensure the aeronautical product conform to its type design  
CAR 561.13(2) Control of Supplier Statement of conformity   … policies and procedures to ensure that suppliers who hold a manufacturing certificate or equivalent document issued by a foreign state, that the issuance of the supplier's own statement of conformity meets the requirements of CAR 561.13 (1) (c) thru (e)  
CAR 561.13(3) Control of subcontract work by suppliers   …policies and procedures to ensure that no supplier who performs work for the holder of a manufacturer certificate holder, subcontracts the work to any other supplier without having obtained the written consent of the prime manufacturer certificate holder  
CAR 561.14(1) Aeronautical Product Records AWM 561.119 … establish and maintain records for each aeronautical product manufactured under a manufacturing certificate, including those specified in section 561.14 of Standard 561  
STD 561.14(1) Aeronautical Product Records AWM 561.119 … each record required to be maintained for an aeronautical product pursuant to section 561.14 of the CARs includes records in respect of activities applicable to production inspection and testing performed to determine conformity rework to correct non-conforming products production ground and flight tests and release certification  
STD 561.14(2) Aeronautical Product Records AWM 561.119 … a record keeping system that relies upon hard copy records, includes provisions to ensure that they are kept in a secure location to prevent loss or deterioration  
STD 561.14(3) Aeronautical Product Records AWM 561.119 … a record keeping system that relies upon electronic storage media, includes provisions to ensure that:
entries are subject to approval by an authorized person prior to saving the record
the system provides that if changes to established records become necessary, they are made in such a manner that the reason for the change and the identity of the person making the change are also recorded, and the original information remains available back up copies are made and kept in a secure location to prevent loss of data in the case of a system malfunction
printed copies are made available to the Minister upon request
 
CAR 561.15 Service Difficulty Reporting STD 591.01 The holder of a manufacturer certificate shall report, in accordance with section 591.01, any service difficulty related to the aeronautical product being manufactured.
STD 591.01;
(3) A Service Difficulty Report (SDR) is to be submitted to Transport Canada for each occurrence of a reportable service difficulty on a "one SDR per event" basis.
(4) An SDR is to be submitted for each occurrence of a suspected unapproved part on a "one SDR per event" basis.
(5) An SDR is to be submitted to Transport Canada within 3 working days from the time the service difficulty was first discovered.
 
CAR 561.16 Cessation of Manufacturing AWM 561.207 The holder of a manufacturer certificate shall notify the Minister in writing of the permanent cessation of the manufacture of an aeronautical product specified in the manufacturer certificate within 30 days after cessation.  

APPENDIX D - Quality Program Manual (QPM) - Review Document
CAR/STD 561 To MPL 17

The review process:

The following steps may be helpful in getting started but are not meant to be considered as the only acceptable method.

  1. Make several blank copies of the review document.

  2. Read the regulatory material relating to the topic area under review thoroughly.

  3. Review all the material in your manual against the requirements in the applicable regulation and standard, make an accurate assessment of its compliance, and record your findings in the comments column. This step is critical to the process. The intent of this document is to assist and speed up the approval process.

  4. Once you have completed your manual review and identified the areas that you feel do not comply, prepare an amendment to your QPM to address those items/issues that are not in compliance.

The information per item 3 should be submitted on or before December 1, 2006 to your Transport Canada Principal Manufacturing/Maintenance Inspector (PMI). Please refer to Appendix A, Information Note, regarding the submission of QPM amendments.

Information Note:

These documents are designed to provide a simple, accurate and user-friendly method for determining the level of compliance with the STD. Each numbered block contains a title segment, which has been referenced directly to the required standard. Within each block is a short description of the desired content and, where possible, a direct quote from the applicable regulation or standard. Each block also has a list of pertinent sections of the regulation and standard that must be read to determine if the manual under review does in fact, comply.

Quality Program Manual (QM) - Review Document
CAR & STD 561 to MPL 17

Reference to
CAR/STD 561
1 Dec. 2007
Item Title Reference to MPL 17
May 29 2003
Refer To STD 561 for specific regulatory requirements
Additional information that should be included in the QPM
Manufacturer Comments
CAR 561.04(1) Management Personnel Condition .06(1) The person appointed by the certificate holder shall be specified in the Quality Manual.  
CAR 561.04(6) Management of Specific Activities Condition .06(5) The person appointed may assign responsibility for the management of specific activities, systems or programs to other persons, provided that the assignments and the scope of the assigned responsibilities are specified in the manual.  
CAR 561.07(1) Manual Condition .09(10) The holder of a manufacturer certificate shall establish, maintain and require the use of a manual.  
STD 561.07 (1)(a) Manual Certification Statement and Approval Page Condition .09(1)(a) … the manual shall contain a certification statement signed by the accountable executive confirming that the manual and any incorporated documents reflect the certificate holder's means of ensuring compliance
… the manual shall contain a section reserved for ministerial approval
 
STD 561.07 (1)(b) Identification of Certificate Holder Condition .09(1)(b) … the quality manual shall contain…
the approval number of the certificate holder
the legal name and or registered trade name of the certificate holder, which the organization does business
the mailing address where different from the manufacturing site address
 

STD 561.07

Quality Manual Contents
STD 561.07 (1)(c) Table of Contents Condition .09(1)(c) … the quality manual shall contain a table of contents  
STD 561.07 (1)(d) List of Effective pages Condition .09(1)(d) … a means of identifying each page of the manual, in the form of a list of effective pages (LEP), with each page numbered and either dated or marked with a revision number  
STD 561.07 (1)(e) Issuance and Control of amendments, distribution & compliance Condition .09(1)(e) … the manual shall contain a process for issuance and control of amendments, including a description of the distribution procedures
… a reference to the list stating the title of each person who holds a copy of the manual
… a description of the system used to ensure compliance with the requirements of subsection 561.07 (8) of the CARs
 
STD 561.07 (1)(f) Organization
Org. Chart
Condition .09(1)(f) … a brief description of the organization (Org. Chart) including approximate size, geographic location and basic layout of the facilities  
STD 561.07 (1)(g) Scope of work Condition .09(1)(g) … a description of the scope of work that is intended to be performed at each facility  
STD 561.07 (1)(h) Management functions Condition .09(1)(h) … where management functions have been assigned
the name or title of any person to whom functions have been assigned
a description of the functions that have been assigned to each person
where necessary for clarity, a chart depicting the distribution of functions
 
STD 561.07 (1)(i) Control of data Condition .09(1)(i) … a description of the system to obtain and preserve pertinent regulatory, design and other technical data, and procedures to ensure they are kept up to date  
STD 561.07 (1)(j) Control of product conformity Condition .09(1)(j) … a description of the controls used to ensure that the product conforms to its type design  
STD 561.07 (1)(k) Control of suppliers Condition .09(1)(k) … a description of the methods for evaluating and controlling suppliers  
STD 561.07 (1)(l) Identification and traceability of product Condition .09(1)(l) … a description of the methods used to identify and trace the aeronautical products during all stages of the manufacturing process and up to delivery of the product  
STD 561.07 (1)(m) Production control Condition .09(1)(m) … a description of the production control system which includes the requirements set out in section 561.08 of this standard  
STD 561.07 (1)(n) Quality audit system Condition .09(1)(n) … a description of the quality audit system which includes methods of audit, identification and analysis of probable root cause and contributory causes of deficiencies identified in audit results, corrective action follow-up and record keeping  
STD 561.07 (1)(o) Control of authorized persons Condition .09(1)(o) … a description of the policies and procedures for;
authorizing persons to sign statements of conformity
identifying those persons
identifying the product or range of products they are authorized to certify, and
controlling the stamp issued to each person
 
STD 561.07 (1)(p) Control of inspection, measuring and test equipment Condition .09(1)(p) … a description of the policies and procedures to control inspection, measuring and test equipment traceable to applicable Canadian or international standards  
STD 561.07 (1)(q) Control of non-conforming products Condition .09(1)(r) … a description of the system for the identification and control of non-conforming products along with the determination of corrective actions to be taken  
STD 561.07 (1)(r) Training program Condition .09(1)(s) … a description of the training program required by section 561.11 of the CARs  
STD 561.07 (1)(s) Personnel records Condition .09(1)(t) … a description of the methods used to establish and maintain personnel records required by section 561.12 of the CARs  
STD 561.07 (1)(t) Product records Condition .09(1)(u) … a description of the methods used to establish and maintain product records required by section 561.14 of the CARs  
STD 561.07 (1)(u) Control and recording of defects, malfunctions, & failure data Condition .09(1)(v) … a description of the policies and procedures to control the collection, evaluation and reporting defects, malfunctions and failure data pursuant to section 561.15 of the CARs  
STD 561.07(2) Control of other activities   … documented procedures governing other activities other than those approved pursuant to Subpart 61 of Part V of the CARS, provided the structure of the manual makes clear which parts of the manual are intended to meet the requirements of Subpart 61 of Part V  

CAR 561.08

Production Control System
CAR 561.08(1) Production Control System Condition .10(1) … the production control system shall consist of systems and procedures set out in section 561.08 of Standard 561 to ensure that aeronautical products comply with the regulations throughout the manufacturing process  
STD 561.08(a) Process Controls Condition .10(1)(a) … shall include process controls during the production stage to ensure that processes are performed under controlled conditions and include documented instruction, workmanship criteria, data, suitable equipment and competent personnel  
STD 561.08(b) Inspection and Testing Procedures Condition .10(1)(b)
(i)(ii) & (iii)
… inspection and testing procedures, including receiving, in-process through final inspection, testing and flight operations including production flight tests, to ensure that all manufacturing and inspection tasks have been completed as planned and documented.
The system shall include written instructions for product verification that
establishes where, throughout the production process, inspections will be performed, including those required at suppliers facilities
identify the nature of the inspections to be performed
establish final inspection procedures for a completed product, including
in the case of an aircraft, flight operations including the flight test procedures and checklists
in the case of an engine, variable pitch propeller or component, procedures to ensure that all required functional tests have been performed
 
STD 561.08(c) Control of Inspection, Measuring and Test Equipment Condition .10(1)(c) … a system to ensure that inspection, measuring and test equipment is calibrated prior to use or at the intervals recommended by the equipment manufacturer, and the calibration is traceable to applicable Canadian or internationally recognized primary standards  
STD 561.08(d) Identification and control of non-conforming product Condition .10(1)(e) …a system for the identification and control of non-conforming product along with the determination of corrective actions to be taken  
STD 561.08(e) Control of product Condition .10(1)(f) …a system to track and record inspection and test status of products as they progress through the manufacturing process and the identity of the persons who confirm product compliance at each stage  
STD 561.08(f) Corrective action Condition .10(1)(g) … a system of corrective action for systemic deficiencies found during audits conducted under section 561.09 of the CARs.  
CAR 561.09 Quality Assurance Program
CAR 561.09(1) Quality Assurance Program Condition .11(1) … the holder of a manufacturer certificate shall, establish and maintain a quality assurance program, which is independent of the production control system and meets the requirements specified in section 561.09 of Standard 561  
STD 561.09(1) Changes to Quality Assurance Program Condition .11(1) … the quality assurance program shall be responsive to any changes within the organization that could affect compliance with the manual or the scope of privileges of the manufacturer      certificate and addresses the need for amendments resulting from such changes  
STD 561.09(2) Audit System Condition .11(1) … shall include an audit system which employs sufficiently detained checklists or equivalent methods which include the elements listed under subsection 561.09 (3) of the CARs  
CAR 561.09 (3)(a) Initial Audit Condition .11(1)(a)
See Note
… an initial audit, within 12 months after the day on which the manufacturer certificate is issued, that covers all aspects of the manufacturer's activities
Note: refer to paragraph on Supplementary Information
 
CAR 561.09 (3)(b) Subsequent Audits Condition .11(1)(b)
See Note
… subsequent audits conducted at the intervals set out in the quality manual
Note: refer to paragraph on Supplementary Information
 
STD 561.09(3) Audit Frequency See Note … audits conducted under section 561.09 of the CARs may be conducted on a progressive or segmented basis, provided that the entire organizational system is verified within the applicable interval
Note: refer to paragraph on Supplementary Information
 
CAR 561.09 (3)(c) Recording of non-compliance Condition .11(1)(c)
See Note
… a record of each occurrence of compliance or non-compliance found during an audit
Note: refer to paragraph on Supplementary Information
 
CAR 561.09 (3)(d) Audit finding communication Condition .11(1)(e)
See Note
… procedures for ensuring that each finding of an audit is communicated to them
Note: refer to paragraph on Supplementary Information
 
CAR 561.09 (3)(e) Follow - up Condition .11(1)(f)
See Note
… follow-up procedures for ensuring that corrective actions are effective
Note: refer to paragraph on Supplementary Information
 
CAR 561.09 (3)(f) Recording of Findings Condition .11(1)(g)
See Note
… a system for recording the findings of initial and periodic audits, corrective actions and follow-ups
Note: refer to paragraph on Supplementary Information
 
STD 561.10 (1) Statement of Conformity Condition .12(1) … a system to authorize persons to sign a statement of conformity that identifies the individuals by name, together with the product or range of products they are authorized to certify, and where a stamp is used, the stamp number assigned.  
CAR 561.11(a) Training Program Condition .13(a) … establish and maintain a training program that includes initial training, update training and any other training set out in section 561.11 of Standard 561  
STD 561.11 (1)(d) Training Program Condition .13(1)(d) … provisions to ensure that persons authorized to sign statements of conformity have demonstrated an appropriate level of knowledge and experience and understand their responsibilities  
CAR 561.12(1) Personnel Records Condition .14(1) … the manufacturer certificate holder shall establish and maintain a personnel record for each employee
which includes all of the employee's qualifications
and all authorizations to sign a statement of conformity
 
CAR 561.13 Control of Suppliers
CAR 561.13 (1)(a) Control of Suppliers Condition .15 (1)
(a) & (b)
… the holder of a manufacturer certificate who contracts work to a supplier shall have a written agreement with the supplier which specifies the work to be performed by the supplier and provides that the Minister may have access to and inspect the suppliers facilities and records to ensure compliance  
CAR 561.13 (1)(b) Evaluation of Suppliers Condition .15(1)(c)(i) … policies and procedures to ensure that contracted suppliers have been evaluated by the manufacturer certificate holder  
CAR 561.13 (1)(c) Supervision of work done by suppliers Condition .15(1)(c)(ii) … policies and procedures to ensure that any work done by the contracted supplier is done under the certificate holder's supervision and is subject to the quality assurance program set out in section 561.09 of the CARs  
CAR 561.13 (1)(d) Evaluation of Supplier capabilities Condition .15(1)(c)(iii) … policies and procedures to ensure that the supplier's capability to perform the contracted work is evaluated and monitored  
CAR 561.13 (1)(e) Control of Supplier product conformity Condition .15(1)(c)(iv) … policies and procedures to ensure the aeronautical product conform to its type design  
CAR 561.13 (2) Control of Supplier Statement of conformity Condition .15(2) … policies and procedures to ensure that suppliers who hold a manufacturing certificate or equivalent document issued by a foreign state, that the issuance of the supplier's own statement of conformity meets the requirements of CAR 561.13 (1) (c) thru (e)  
CAR 561.13(3) Control of subcontract work by suppliers Condition .15(3) …policies and procedures to ensure that no supplier who performs work for the holder of a manufacturer certificate holder, subcontracts the work to any other supplier without having obtained the written consent of the prime manufacturer certificate holder  
CAR 561.14(1) Aeronautical Product Records Condition .16(a) … establish and maintain records for each aeronautical product manufactured under a manufacturing certificate, including those specified in section 561.14 of Standard 561  
STD 561.14(1) Aeronautical Product Records Condition .16(1) … each record required to be maintained for an aeronautical product pursuant to section 561.14 of the CARs includes records in respect of
activities applicable to production
inspection and testing performed to determine conformity
rework to correct non-conforming products
production ground and flight tests and
release certification
 
STD 561.14(2) Aeronautical Product Records Condition .16(2) … a record keeping system that relies upon hard copy records, includes provisions to ensure that they are kept in a secure location to prevent loss or deterioration  
STD 561.14(3) Aeronautical Product Records Condition .16(3) … a record keeping system that relies upon electronic storage media, includes provisions to ensure that:
entries are subject to approval by an authorized person prior to saving the record;
the system provides that if changes to established records become necessary, they are made in such a manner that the reason for the change and the identity of the person making the change are also recorded, and the original information remains available;
back up copies are made and kept in a secure location to prevent loss of data in the case of a system malfunction
printed copies are made available to the Minister upon request
 
CAR 561.15 Service Difficulty Reporting Condition. 17
(STD 591.01)
The certificate holder shall report to the Minister any service difficulty related to any aeronautical products being manufactured, in accordance with Subpart 91.  
CAR 561.16 Cessation of Manufacturing Condition. 04(9) The certificate holder shall notify the Minister, in writing, within 30 days after the permanent cessation of the manufacture of an aeronautical product specified in the manufacturer certificate.  

Appendix E - QPM Approval Page

Each QPM must include a statement of compliance and a space for Transport Canada to indicate approval. The following are examples of acceptable wording that may be used for both these statements. The actual wording adopted for the statement of compliance will depend on the manual format adopted by the organization and the certificate holder's preference. However, when the manual contains both approved and unapproved material, or when it contains material in support of more than one certificate, organizations are advised to clearly identify which parts of the manual comply with which requirements. Failure to do this could result in any future enforcement action having an affect on unrelated activities.

One way to achieve this level of control is to keep the Manufacturer Organization, Distributor or AMO related information in separate sections, with information that is applicable to all activities of the company in a common introductory section. The common section can also contain the applicable statements of compliance and approval for all sections. Regardless of the system adopted by the organization, the wording used for the Transport Canada approval block must always state the purpose (i.e. Manufacturer, Distributor or AMO, etc.) for which the manual is approved.

Sample Statement of Compliance

Company compliance statement:

This manual, and any incorporated documents, reflects this organization's means of compliance with Canadian Aviation Regulations as required by CAR 561.07 and associated Standards. In cases of conflict between company policy and the regulatory requirements, the regulatory requirements shall prevail. All incorporated documents identified herein and every amendment thereto, shall meet the requirements established in this manual. The policies and procedures outlined in this manual and in all incorporated documents identified herein must be strictly adhered to at all times.

Signature of Certificate Holder:

_______________________________________________________

Print name ____________________________ Date: ____________

Transport Canada Approval

This manual is approved as meeting the requirements for a Manufacturer Organization pursuant to CAR/STD 561.

_______________________________________________________
For the Minister of Transport

Date: __________________________________________________

Appendix F - CAR Part V, Subpart 61

Information Note:
The following copy of CAR 561 was taken from Canada Gazette II dated November 21, 2005 and added here for information purposes only.

Interpretation

561.01 In this Subpart,

"design approval" means a type certificate, a supplemental type certificate, a foreign document that is equivalent to a type certificate or a supplemental type certificate and a Technical Standard Order design approval issued by the civil aviation authority of a foreign state; (approbation de conception)

"manual" means the manual established under section 561.07; (manuel)
"Standard 561" means Standard 561 - Standard for Approved Manufacturers. (norme 561)

Application

561.02 This Subpart applies in respect of the manufacture of an aeronautical product in respect of which a design approval has been issued but does not apply in respect of

(a) maintenance;

(b) the manufacture of standard parts;

(c) the manufacture of commercial parts; or

(d) the manufacture of parts during a repair or modification under subsection 571.06(4).

Manufacturer Certificate - Application, Issuance and Amendment

561.03 (1) An applicant for the issuance or amendment of a manufacturer certificate respecting an aeronautical product shall submit an application to the Minister that includes the documents specified in section 561.03 of Standard 561.

(2) An applicant for the issuance or amendment of a manufacturer certificate respecting an aeronautical product shall

(a) be the holder of, or applicant for, a design approval for that aeronautical product; or

(b) have written authorization from the holder of a design approval to manufacture that aeronautical product.

(3) An applicant for the issuance or amendment of a manufacturer certificate respecting an aeronautical product shall demonstrate that they have access to all present and future design data, process specifications and other related information necessary for the continuing airworthiness of the aeronautical product.

(4) The Minister shall issue or amend a manufacturer certificate authorizing an applicant to manufacture the aeronautical products set out in the manufacturer certificate if the applicant meets the requirements of this Subpart.

(5) A manufacturer certificate may authorize the manufacture of a limited number of an aeronautical product where

(a) an applicant has made an application for a design approval for that aeronautical product but it has not yet been issued; or

(b)an applicant is about to enter into a license agreement with the holder of the design approval for that aeronautical product.

(6) Unless an expiry date is specified in the manufacturer certificate issued under subsection (4), the certificate shall remain in effect until it is surrendered by the manufacturer or suspended or cancelled.

(7) A manufacturer certificate is not transferable.

(8) Except as provided in section 561.06, the final assembly facilities for an aeronautical product specified in a manufacturer certificate shall be located in Canada.

Management Personnel

561.04 (1) The holder of a manufacturer certificate shall

(a) appoint a person to be responsible for all the activities performed under this Subpart and specified in the manual;

(b) ensure that the person appointed has acquired experience in the areas of responsibility set out in subsection 561.04(1) of Standard 561; and

(c) ensure that the person appointed demonstrates to the Minister, within 30 days after their appointment, knowledge of the topics set out in subsection 561.04(2) of Standard 561.

(2) The Minister shall conduct an interview, in accordance with subsection 561.04(3) of Standard 561, to assess the appointed person's knowledge of the topics referred to in paragraph (1)(c).

(3) The Minister shall notify the person appointed of the results of the assessment and, if applicable, identify any deficiencies in their knowledge of the topics within ten days after the interview.

(4) A person who, at the time this section comes into force, is already performing the functions referred to in paragraph (1)(a) may be appointed under that paragraph without meeting the requirements of paragraphs (1)(b) and (c).

(5) The holder of a manufacturer certificate shall provide the person appointed with the authority and the financial and human resources necessary to ensure that the requirements of this Subpart are met.

(6) The person appointed may assign responsibility for the management of specific activities, systems or programs required by this Subpart to other persons, provided that the assignments and the scope of the assigned responsibilities are specified in the manual.

(7) The holder of a manufacturer certificate shall ensure that no person is appointed under paragraph (1)(a) or remains responsible for the activities referred to in that paragraph if, at the time of their appointment or during their tenure, they have a record of conviction for

(a) an offence under section 7.3 of the Act; or

(b) two or more offences in respect of section 561.10 of these Regulations, not arising from a single occurrence.

Resources

561.05 The holder of a manufacturer certificate shall have, and ensure that any supplier referred to in section 561.13 has, the financial and human resources necessary for the manufacture and inspection of any aeronautical product specified in the manufacturer certificate, including those specified in section 561.05 of Standard 561.

Facilities Located in a Foreign State

561.06 If an arrangement exists between Canada and a foreign state concerning the manufacture of an aeronautical product, the holder of a manufacturer certificate may be authorized to perform their activities under the certificate in facilities located in that foreign state if the holder

(a) submits a written application to that effect to the Minister;

(b) gives, by a written agreement, an undertaking to the Minister to ensure that the Minister has access to those facilities to verify that the performance of the activities complies with the requirements of the Act and these Regulations, as if those facilities were located in Canada; and

(c) undertakes to pay the expenses referred to in paragraphs 104.04(1)(a) and (b) incurred by the Department of Transport under paragraph (b).

Manual

561.07 (1)The holder of a manufacturer certificate shall establish, maintain and require the use of a manual that must include the information set out in section 561.07 of Standard 561 and that sets out policies and procedures respecting the construction and inspection of the aeronautical products specified in the manufacturer certificate.

(2) Subject to subsection (4), the person appointed under paragraph 561.04(1)(a) shall ensure that any person who performs work under a manufacturer certificate complies with the manual.

(3) Subject to subsection (4), any person who performs work under a manufacturer certificate shall comply with the manual.

(4) Subject to the following conditions, the holder of a manufacturer certificate and any person who performs work under a manufacturer certificate may temporarily be authorized to use alternative policies and procedures to comply with subsections (2) and (3):

(a) they have determined that, as a result of unforeseen or temporary circumstances, compliance with the manual would be impossible or unreasonable;

(b) they believe on reasonable grounds that the safety of the aeronautical product can be achieved by complying with the alternative policies and procedures;

(c) they have notified the Minister in writing; and

(d) the Minister has notified them in writing that they can use those alternative policies and procedures.

(5) The holder of a manufacturer certificate shall submit the manual and any subsequent amendment to the Minister for approval.

(6) The Minister shall approve the manual and any subsequent amendment if they meet the requirements of this Subpart and Standard 561.

(7) If the manual no longer meets the requirements of this Subpart or Standard 561, the holder of a manufacturer certificate shall

(a) submit an amendment to the manual for the Minister's approval; or

(b) amend the manual immediately if instructed to do so by the Minister.

(8) The person who has been assigned the responsibility under subsection 561.04(6) shall amend each copy of the manual within 30 days after receiving the Minister's approval of an amendment to it.

(9) A manual may incorporate other documents by reference if it includes policies and procedures to control the incorporated material.

(10) The person appointed under paragraph 561.04(1)(a) shall ensure that any part of the manual or incorporated document that is relevant to the work to be performed is made available to each person who performs that work.

Production Control System

561.08 (1) The holder of a manufacturer certificate shall establish and maintain a production control system that consists of systems and procedures set out in section 561.08 of Standard 561 to ensure that aeronautical products comply with these Regulations throughout the manufacturing process.

(2) The production control system shall be under the control of

(a) the person appointed under paragraph 561.04(1)(a); or

(b) a person assigned the responsibility for the management of the production control system under subsection 561.04(6).

(3) The person referred to in subsection (2) who has control of the production control system shall ensure that the activities carried out under the manufacturer certificate for which they have been assigned responsibility are in compliance with this Subpart.

Quality Assurance Program

561.09 (1)The holder of a manufacturer certificate shall, in order to ensure that all aspects of the activities carried out under the manufacturer certificate continue to comply with these Regulations, establish and maintain a quality assurance program, independent of the production control system, that

(a) is under the sole control of

(i) the person appointed under paragraph 561.04(1)(a), or

(ii) a person assigned the responsibility for the management of the quality assurance program under subsection 561.04(6); and

(b) meets the requirements specified in section 561.09 of Standard 561.

(2) The person referred to in paragraph (1)(a) shall ensure that records related to the findings from the quality assurance program are distributed to the appropriate manager for corrective action and follow-up in accordance with the procedures specified in the manual.

(3) The person referred to in paragraph (1)(a) shall establish and maintain an audit system that consists of

(a) an initial audit, within 12 months after the day on which the manufacturer certificate is issued, that covers all aspects of the manufacturer's activities;

(b) subsequent audits conducted at the intervals set out in the manual;

(c) a record of each occurrence of compliance or non-compliance found during an audit referred to in paragraph (a) or (b);

(d)procedures for ensuring that each finding of an audit is communicated to them;

(e) follow-up procedures for ensuring that corrective actions are effective; and

(f) a system for recording the findings of initial and periodic audits, corrective actions and follow-ups.

(4) The records required under paragraph (3)(f) shall be retained for the greater of

(a) two audit cycles; and

(b) two years.

(5)The quality assurance program duties related to specific tasks or activities shall be performed by persons who are not responsible for and have not been involved in the performance of the tasks or activities being audited.

Statement of Conformity

561.10 (1) No person shall sign a statement of conformity in respect of an aeronautical product unless

(a) the statement contains the elements referred to in section 561.10 of Standard 561;

(b) the person has been authorized to do so by the person in control of the production control system;

(c) the aeronautical product is specified in the manufacturer certificate; and

(d) the aeronautical product has been manufactured in accordance with this Subpart.

(2) No person shall authorize a person to sign, on behalf of the holder of a manufacturer certificate, a statement of conformity unless the person being authorized has complied with the policies and procedures set out in the manual and has successfully completed the training required under section 561.11.

Training Program

561.11 The holder of a manufacturer certificate shall

(a) establish and maintain a training program that includes the initial training, updating and any other training set out in section 561.11 of Standard 561 to ensure continued qualification that is appropriate to the function to be performed or supervised; and

(b) ensure that persons who are authorized to perform or supervise the performance of any function required under this Subpart are trained in respect of the parts of the policies and procedures of the holder of the manufacturer certificate and the parts of these Regulations applicable to that function.

Personnel Records

561.12 (1) The holder of a manufacturer certificate shall establish and maintain a personnel record for each employee of the manufacturer and retain each record for at least three years after the end of their employment.
(2) A personnel record may be in paper or electronic form and shall include all of the employee's qualifications, all authorizations to sign a statement of conformity pursuant to section 561.10 and a description of the training referred to in section 561.11.
(3) The holder of a manufacturer certificate shall ensure that a copy of any record required by this section is provided to the employee referred to in the record on the completion of each training activity or the granting of an authorization to sign a statement of conformity under section 561.10.

Control of Suppliers

561.13 (1) The holder of a manufacturer certificate who contracts work to a supplier shall ensure that

(a) a written agreement with the supplier specifies the work to be performed by the supplier and provides that the Minister may have access to and inspect the supplier's facilities and records to ensure compliance with this Subpart;

(b) work is contracted only to suppliers that have been evaluated in accordance with the policies and procedures set out in the manual;

(c) work is done under the holder's supervision and is subject to the quality assurance program set out in section 561.09;

(d) the supplier's capability to perform the contracted work is evaluated and monitored; and

(e) the aeronautical product conforms to its approved design.

(2) If a supplier holds, in respect of an aeronautical product, a manufacturer certificate or an equivalent document issued by a foreign state with which Canada has an airworthiness agreement or similar arrangement, the issuance of the supplier's own statement of conformity in respect of that product is considered as meeting the requirements of paragraphs (1)(c) to (e).

(3) No supplier who performs work for a holder of a manufacturer certificate under this Subpart shall subcontract the work to another supplier without having first obtained the written consent of the holder of a manufacturer certificate.

Aeronautical Product Records

561.14 (1) The holder of a manufacturer certificate shall establish and maintain records for each aeronautical product manufactured under a manufacturer certificate, including those specified in section 561.14 of Standard 561.

(2) The holder of a manufacturer certificate shall ensure that product records are kept for at least three years after the day on which the statement of conformity was signed.

Service Difficulty Reporting

561.15 The holder of a manufacturer certificate shall report, in accordance with section 591.01, any service difficulty related to the aeronautical product being manufactured.

Cessation of Manufacturing

561.16 The holder of a manufacturer certificate shall notify the Minister in writing of the permanent cessation of the manufacture of an aeronautical product specified in the manufacturer certificate within 30 days after cessation.

Appendix G - Standard (STD) 561

Information Note:

The following copy of Standard 561 was taken from Notice of Proposed Amendment 1998-141 and added here for information purposes only. This Standard may be subject to change before final publication.

Preamble

This amendment replaces the former Chapter 561 of the Airworthiness Manual.

This new standard titled Standard for Approved Manufacturers has been developed in line with the overall Canadian Aviation Regulations (CARs) system, and sets out the requirements and procedures to follow pursuant to Subpart 61 of Part V of the Regulations, for the issuance and continued validity of a manufacturer certificate by the Minister with respect to the manufacture of aeronautical products referred to in Subpart 61 of Part V of the Regulations.

561.01 [reserved]

561.02 Application

Information Notes:

(i) Standard 561 is applicable to the manufacture of aeronautical products in respect of which a design approval has been issued with the exceptions noted under section 561.02 of the CARs, i.e.: standard or commercial parts, and any parts made during a repair or modifications under subsection 571.06(4), including repairs approved under a Repair Design Certificate (RDC) and modifications approved under a Supplemental Type Certificate (STC) or Limited Supplemental Type Certificate (LSTC).

(ii) The making of aeronautical products as part of a repair or modification is a maintenance activity, and is controlled by subsection 571.06(4) of the CARs. This applies regardless of the means of design approval. The person signing the release must have access to the applicable design data. The maintenance release covers the entire task, including the manufacture of the aeronautical product.

(iii) Where aeronautical products such as STC kits are manufactured for installation by another person, the aeronautical products must be accompanied by a statement of conformity issued under the control of the holder of a manufacturer certificate pursuant to Subpart 61 of Part V of the CARs.

561.03 Manufacturer Certificate – Application, Issuance and Amendment

(1) An application made pursuant to section 561.03 of the CARs consists of a letter to the Minister and a copy of the proposed manual required by section 561.07 of the CARs.

(2) In addition to the letter of application and manual required under subsection (1), the applicant submits to the Minister, where applicable, a copy of the authorization from the holder of the applicable Canadian design approval or equivalent foreign design approval to manufacture the aeronautical products referred to in the application.

(3) The applicant submits to the Minister, upon request by the Minister, any other documents supporting the application.

Information Notes:

(i) Subsection 561.03(2) of the CARs specifies that an applicant be the holder of the applicable design approval or be in possession of an agreement with the design approval holder. The expression “design approval” covers designs approved by the Minister under Subparts 511 and 513 of the CARs, as well as equivalent designs approved by a relevant foreign airworthiness authority.

(ii) As indicated in subsection 561.03(5) of the CARs, an applicant may apply for and be granted a manufacturer approval while still in the process of obtaining the design approval for the product or obtaining a licensing agreement for the aeronautical product concerned. However, the statement of conformity required by section 561.10 of the CARs must not be signed until the design has been approved or the licensing agreement has been secured.

If a manufacturer's facilities are at more than one location, including other countries pursuant to section 561.06 of the CARs, all locations may be included under one approval.

561.04 Management Personnel

(1) Except as provided in subsection 561.04(4) of the CARs, the person appointed under paragraph 561.04(1)(a) of the CARs meets the following standards of competence:

(a) in the case of an organization approved for the manufacture of aircraft or aircraft engines, has acquired a minimum of six years experience in the performance or direct supervision of technical activities of a similar complexity to those undertaken by the organization, three years of which have been in a supervisory capacity; and

(b) in the case of an organization approved for the manufacture of aeronautical products other than aircraft or aircraft engines, has acquired a minimum of three years experience in the performance or direct supervision of technical activities of similar complexity to those undertaken by the organization.

(2) Except as provided in subsection 561.04(4) of the CARs, within 30 days following the appointment, the person appointed demonstrates, during an interview to be conducted in accordance with subsections 561.04(2) and (3) of the CARs, knowledge of the following topics as they relate to the manufacturer's approved policies:

(a) the duties and responsibilities of the appointed position;

(b) the duties of persons who have been assigned functional responsibilities;

(c) the responsibilities of the holder of the manufacturer certificate, including responsibilities for work that has been contracted out;

(d) the responsibilities of persons authorized to sign statements of conformity pursuant to section 561.10 of the CARs;

(e) the functions of production control system and quality assurance program referred to in sections 561.08 and 561.09 of the CARs;

(f) the record keeping requirements;

(g) the identification of acceptable reference data;

(h) parts control and traceability; and

(i) the control of non-conforming parts and materials.

(3) Within the scope of the interview, the minister :

(a) records the questions and responses relating to each interview conducted under subsection (2);

(b) immediately informs the person interviewed of the results verbally upon conclusion of the interview; and

(c) provides written notification of the results of the interview and, if applicable, also provides a summary identifying those areas requiring further development to the person interviewed and the holder of the manufacturer certificate within 10 days as required by subsection 561.04(3) of the CARs.

Information Notes:

(i) Subsection 561.04(5) of the CARs requires the holder of a manufacturer certificate to provide the person appointed with the financial and human resources necessary to ensure compliance with Subpart 61 of Part V of the CARs and Standard 561. These should include the resources to identify quality problems and to initiate corrective actions to ensure compliance with the conditions of the manufacturer approval.

(ii) The person appointed may be the Accountable Executive, provided they meet the requirements of this section.

561.05 Resources

The following include the financial and human resources required pursuant to section 561.05 of the CARs:

(a) reasonable facilities;

(b) applicable production and inspection equipment;

(c) competent personnel;

(d) applicable regulatory and design documentation; and

(e) pertinent manufacturing process specifications.

561.06 [reserved]

561.07 Manual

(1) The manual required to be established and maintained pursuant to subsection 561.07(1) of the CARs includes the following:

(a) a section reserved for ministerial approval and a certification statement signed by the accountable executive confirming that the manual and any incorporated documents identified therein reflect the certificate holder's means of ensuring compliance with Subpart 61 of Part V of the CARs and Standard 561, and instructing the staff to comply with the policies and procedures therein;

(b) the manufacturer's approval number as shown on the manufacturer certificate issued by the Minister under section 561.03 of the CARs or provision to record that number, including the following information:

(i) the legal name of the certificate holder and, where that name is not the name under which the organization does business, its registered trade name, and

(ii) the mailing address where different from the manufacturing site address;

(c) a table of contents;

(d) a means of identifying each page of the manual that has been submitted for approval, in the form of a list of effective pages, with each page numbered and either dated or marked with a revision number; alternatively, in the case of electronic manuals, an equivalent means of ensuring that the manual is complete and up to date;

(e) the process for issuance and control of amendments, including a description of the amendment distribution procedures and a reference to the list stating the title of each person who holds a copy of the manual, and the system used to ensure compliance with the requirements of subsection 561.07(8) of the CARs;

(f) a brief description of the organization including the approximate size, geographic location and basic layout of the facilities;

(g) a description of the scope of work that is intended to be performed at each facility;

(h) where management functions have been assigned pursuant to subsection 561.04(6) of the CARs:

(i) the name or title of any person to whom functions have been assigned,

(ii) a description of the functions that have been assigned to each person, and

(iii) where necessary for clarity, a chart depicting the distribution of functions;

(i) a description of the system to obtain and preserve pertinent regulatory, design and other technical data, and procedures to ensure they are kept up to date;

(j) a description of the controls used to ensure that the product conforms to its type design;

(k) a description of the methods for evaluating and controlling suppliers;

(l) a description of the methods used to identify and trace the aeronautical products during all stages of the manufacturing process and up to delivery of the product;

(m) a description of the production control system which includes the requirements set out in section 561.08 of this standard;

(n) a description of the quality audit system which includes methods of audit, identification and analysis of probable root cause and contributory causes of deficiencies identified in audit results, corrective action follow-up and record keeping;

(o) a description of the policies and procedures for:

(i) authorizing persons to sign statements of conformity,

(ii) identifying those persons,

(iii) identifying the product or range of products they are authorized to certify, and

(iv) controlling the stamp issued to each person, where applicable;

(p) a description of the policies and procedures to control inspection, measuring and test equipment traceable to applicable Canadian or international standards in accordance with section 561.08 of this standard;

(q) a description of the system for the identification and control of non-conforming products along with the determination of corrective actions to be taken in accordance with section 561.08 of this standard;

(r) a description of the training program required by section 561.11 of the CARs;

(s) a description of the methods used to establish and maintain personnel records required by section 561.12 of the CARs;

(t) a description of the methods used to establish and maintain product records required by section 561.14 of the CARs; and

(u) a description of the policies and procedures to control the collection, evaluation and reporting of defects, malfunctions and failure data pursuant to section 561.15 of the CARs.

(2) Where the holder of a manufacturer certificate also holds other approvals, or conducts activities other than those approved pursuant to Subpart 61 of Part V of the CARs, the documented procedures governing those activities may be contained in the manual required by section 561.07 of the CARs, provided the structure of the manual makes clear which parts are intended to meet Subpart 61 of Part V of the CARs and Standard 561, and which are not.

Information Notes:

(i) Subsection (2) addresses instances where the content of the manual, required by Subpart 61 of Part V of the CARs, will be identical to the content of the manuals required to support other certificates. However, certain material will be required specifically for Subpart 61. In these cases, the certificate holder may provide cross-references that list each manual's requirements with reference to where the requirements are met within his approved manuals to support other certificates. In the process of granting his approval under these circumstances, the Minister will indicate which parts of the manuals are approved and for what purpose,( i.e. under what part of the regulations the approval is being granted). It is in the certificate holder's interest to ensure that material specifically required to support one particular certificate is separately identified to distinguish it from material of common interest. Deficiencies in material not so identified will have a direct bearing on all approvals held.

(ii) In emergency situations, the provisions of subsection 561.07(4) of the CARs provide a means for authorizing the use of temporary alternative policies and procedures to comply with the manual. It provides a means of authorizing the manufacturer to conduct specific activities outside the applicable policies and procedures contained in the approved manual. This can occur for any number of reasons. However, authorization may be granted only where the certificate holder reasonably demonstrates that an equivalent level of safety is maintained.

561.08 Production Control System

The production control system required by section 561.08 of the CARs includes the following:

(a) process controls during the production stage to ensure that processes are performed under controlled conditions and include documented instruction, workmanship criteria, data, suitable equipment and competent personnel;

(b) inspection and testing procedures, including receiving, in-process through final inspection, testing and flight operations including production flight tests, to ensure that all manufacturing and inspection tasks have been completed as planned and documented. The system includes written instructions for product verification that:

(i) establish where, throughout the production process, inspections will be performed, including those required at suppliers' facilities,

(ii) identify the nature of the inspections to be performed, and

(iii) establish final inspection procedures for a completed product, including:

(A) in the case of an aircraft, flight operations including the flight test procedures and checklists, and

(B) in the case of an engine, variable pitch propeller or component, procedures to ensure that all required functional tests have been performed;

(c) a system to ensure that inspection, measuring and test equipment is calibrated prior to use or at the intervals recommended by the equipment manufacturer, and the calibration is traceable to applicable Canadian or internationally recognized primary standards;

(d) a system for the identification and control of non-conforming product along with the determination of corrective actions to be taken;

(e) a system to track and record inspection and test status of products as they progress through the manufacturing process and the identity of the persons who confirm product compliance at each stage; and

(f) a system of corrective action for systemic deficiencies found during audits conducted under section 561.09 of the CARs.

561.09 Quality Assurance Program

(1) The quality assurance program required by section 561.09 of the CARs is

(a) responsive to any changes within the organization that could affect compliance with the manual or the scope of privileges of the manufacturer certificate; and

(b) addresses the need for amendments resulting from such changes.

(2) In order to identify and address all functions controlled by the manual, the audit system employs sufficiently detailed audit checklists or equivalent methods, having regard to the complexity of the activities of the holder of a manufacturer certificate, and more specifically, the audit system includes the elements listed under subsection 561.09(3) of the CARs.

(3) The audits required under section 561.09 of the CARs may be conducted on a progressive or segmented basis, provided that the entire organizational system is verified within the applicable interval.

561.10 Statement of Conformity

(1) The system required to authorize persons to sign statement of conformity identifies the individuals by name, together with the product or range of products they are authorized to certify, and where a stamp is used, the stamp number assigned.

(2) Duly signed statements of conformity confirm that the products certified:

(a) were produced in accordance with the policies and procedures identified in the organization's Manual;

(b) conform to the applicable type design; and

(c) are in condition for safe operation, subject to any conditions identified on the statement of conformity.

(3) Statements of conformity consist of the following, or a similarly worded, statement: “The [reference to product] identified above, except as otherwise specified in [reference to any exceptions or remarks] has been manufactured in conformity to approved design data and is in condition for safe operation”.

Information Note:

The phrase "similarly worded statement" is intended to ensure that an error in wording will not invalidate the statement of conformity. It will also allow for manufacturers who produce aeronautical products under contract to foreign organizations operating under the rules of other countries with which Canada has agreements. This statement may be omitted on documents intended for internal use within the manufacturing organization if the manual includes procedures that indicate when a signature in a given block of a company document constitutes a statement of conformity pursuant to section 561.10 of the CARs.

(4) Statements of conformity include the identification of the signatory, the name of the manufacturer and manufacturing approval number.

(5) In the case of aeronautical products other than complete aircraft, the statement of conformity may be made on an Authorized Release Certificate completed in accordance with Appendix A.

6) In the case of aircraft, the certification is based on a Statement of Conformity Document that meets the requirements set out in Appendix B.

Information Note:

Persons not directly employed by the approved manufacturer certificate holder may be authorized to sign a statement of conformity in accordance with section 561.10 of the CARs, provided the applicable policies and procedures are set out in the manual.

561.11 Training Program

(1) The training program required to be established and maintained pursuant to section 561.11 of the CARs includes the following:

(a) initial training to ensure that all persons authorized to perform or supervise the performance of functions under the Subpart are aware of their technical, administrative, and regulatory responsibilities;

(b) update training to ensure that these persons remain competent and are made aware of any change to their area of responsibility;

(c) additional training, where shown to be necessary by a finding made under the quality assurance program or required due to changes in the CARs, Standard 561, or company procedures; and

(d) provisions to ensure that persons authorized to sign statements of conformity have demonstrated an appropriate level of knowledge and experience and understand their responsibilities.

(2) Until such time as the quality assurance program required by section 561.09 of the CARs indicates that a different interval is appropriate, the initial cycle for update training is not to exceed three years.

561.12 [reserved]

561.13 Control of Suppliers

Information Note:

Where the parts supplied are standard or commercial parts, the certificate holder's control may be limited to incoming inspection and test.

561.14 Aeronautical Product Records

(1) Each record required to be maintained for an aeronautical product pursuant to section 561.14 of the CARs includes records in respect of:

(a) activities applicable to production;

(b) inspection and testing performed to determine conformity;

(c) rework to correct non-conforming products;

(d) production ground and flight tests if applicable; and

(e) release certification.

(2) A record keeping system that relies upon hard copy records, includes provisions to ensure that they are kept in a secure location to prevent loss or deterioration.

(3) A record keeping system that relies upon electronic storage media, includes provisions to ensure that:

(a) entries are subject to approval by an authorized person prior to saving the record;

(b) the system provides that if changes to established records become necessary, they are made in such a manner that the reason for the change and the identity of the person making the change are also recorded, and the original information remains available;

(c) back up copies are made and kept in a secure location to prevent loss of data in the case of a system malfunction; and

(d) printed copies are made available to the Minister upon request.

561.15 and 561.16 [reserved]

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