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Part V - Standard 561 - Approved Manufacturers

Content last revised: 2009/12/01

APPENDICES A, B

(2007/12/01; previous version)

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.

(amended 2007/12/01)

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 modification under section 571.06 of the CARs, including repairs approved under a Repair Design Approval (RDA) and modifications approved under a Supplemental Type Certificate (STC).
(amended 2009/12/01; previous version)

(ii) The making of aeronautical products as part of a repair or modification is a maintenance activity, and is controlled by section 571.06 of the CARs. This applies regardless of the means of design approval. The person signing the release shall 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 shall 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, as well as designs approved by the relevant foreign airworthiness authority.
(amended 2009/12/01; previous version)

(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.

(iii) 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 & 561.16 Reserved