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AIRWORTHINESSPROCEDURESMANUAL PART II Issue 2 Rev. 1 Chapter 5 July 2017 Page 1 of 32 CHAPTER 5 PRODUCTION ORGANISATION APPROVAL ( CAR 21 SUB PART G ) 1. Scope (21.B.5) Rule 133B provides for approval of an organization engaged in manufacture of an aircraft / component / item of equipment or part and CAR 21 Subpart G stipulates the requirements to be fulfilled by an organization desirous of seeking such approval. This chapter describes the administrative procedures which the Airworthiness Directorate officers shall follow when exercising their task and responsibility concerned with the issuance, maintenance, amendments, suspension and revocation of certificates, approvals and authorizations referred in CAR 21Sub Part G. 2. Obligations of DGCA (21.B.20) The Airworthiness Directorate of DGCA has been vested with the responsibility for the implementation of CAR 21 Section A Subpart F, G, H, I and P. 3. Requirements for DGCA (21.B.25) 3.1 Resources: 1. The number of staff deputed for approval of the Production organization shall be sufficient to perform the allocated tasks. 2. The Head of Regional office shall nominate a production organization approval team for each applicant or holder of a production organization approval to conduct all relevant tasks related to the Production Organization Approval as per CAR 21 Subpart G. 3.2 Qualification and training: All staff shall be appropriately qualified and have sufficient knowledge, experience and training to perform their allocated task. 4. Acceptance of Application 4.1 Applications made in accordance with CAR 21 for Production Organization Approval shall be assigned to an officer not below the rank of Dy. Director of Airworthiness. Form 50 shall be used for new applications and Form 51 shall be used by POA holders for applications for change to their approval.

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Page 1: 2. Chap.2 C of A OK164.100.60.133/manuals/APM/APM_Part 2 Chapter 5.pdfPART II AIRWORTHINESSPROCEDURESMANUAL Issue 2 Rev. 1 Chapter 5 Page July 2017 5 of 32 authenticated on the CA

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CHAPTER 5

PRODUCTION ORGANISATION APPROVAL ( CAR 21 SUB PART G )

1. Scope (21.B.5)

Rule 133B provides for approval of an organization engaged in manufacture of an aircraft /

component / item of equipment or part and CAR 21 Subpart G stipulates the requirements to be

fulfilled by an organization desirous of seeking such approval. This chapter describes the

administrative procedures which the Airworthiness Directorate officers shall follow when

exercising their task and responsibility concerned with the issuance, maintenance, amendments,

suspension and revocation of certificates, approvals and authorizations referred in CAR 21Sub Part

G.

2. Obligations of DGCA (21.B.20)

The Airworthiness Directorate of DGCA has been vested with the responsibility for the

implementation of CAR 21 Section A Subpart F, G, H, I and P.

3. Requirements for DGCA (21.B.25)

3.1 Resources:

1. The number of staff deputed for approval of the Production organization shall be

sufficient to perform the allocated tasks.

2. The Head of Regional office shall nominate a production organization approval team

for each applicant or holder of a production organization approval to conduct all

relevant tasks related to the Production Organization Approval as per CAR 21 Subpart

G.

3.2 Qualification and training:

All staff shall be appropriately qualified and have sufficient knowledge, experience and

training to perform their allocated task.

4. Acceptance of Application

4.1 Applications made in accordance with CAR 21 for Production Organization Approval shall

be assigned to an officer not below the rank of Dy. Director of Airworthiness. Form 50 shall

be used for new applications and Form 51 shall be used by POA holders for applications for

change to their approval.

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4.2 The officer concerned will scrutinize the applications for correctness and

completeness. Where incorrect or incomplete information is supplied, it shall be notified

to the applicant by a letter detailing the omissions and errors within Five (05) working days

from the date of receipt of the application.

4.3 Upon receipt of correct application, the officer concerned shall make a first check

on eligibility according to CAR 21 subpart G Para 21.133 and will determine how to proceed

with the application. When eligibility has been fully assessed, within 05 working days’ time

the officer concerned will inform the applicant, whether the application is accepted or not.

The eligible organization shall be informed of the planned technical investigation with the

tentative time frame.

4.4 A file shall be opened in the name of the organisation and applicable fees shall be

realized from the organization. In case of refusal of an application, the officer concerned

shall notify in writing to the applicant together with the reasons thereof, including a

reference to the provisions for appeal. In such case the fees collected shall be returned.

5. Determination of the POA team

5.1 After eligibility has been assessed and once principle acceptance is given, the regional

office shall establish an appropriate Investigation team and if required in consultation with

the Headquarters (Airworthiness Directorate). Officers from other Regional Offices having

necessary competence and previously accumulated experience may be involved while

constituting the Investigation team. The Director of Airworthiness will nominate a team

leader and members to carry out the investigation process. The composition and size of

the basic investigation team may consist of a Team Leader to manage and lead the approval

Team and if required, one or more in number. The size of the team may vary depending

upon:

(a) Size of the applicant organization;

(b) Complexity of the organization approval applied for;

(c) Number of sites covered by the approval;

(d) Nature of the services to be covered by the organization and its direct impact to

aviation safety.

5.2 Officers not forming part of the investigation team may participate in the investigation

as an observer, for acquiring on job training. For specific technical investigations the basic

team can call for assistance from appropriate technical experts from the industry but not

from the same organisation. Cost of hiring such technical experts shall be borne by the

applicant.

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6. Investigation Procedure for Initial Organization Approval (21.B.220)

The investigation process will be performed according to Section B of CAR 21 and its associated

Acceptable Means of Compliance (AMC) / Guidance Material (GM) and this procedure. Findings

made during the investigation process will be handled by the Team Leader in accordance with CAR

21 and its associated AMCs/ GMs. The Team Leader shall perform sufficient investigation activity

for an applicant or holder of a production organization approval to justify recommendation for the

issuance / amendment of such approval. The approval process shall consist of at least the following

elements/stages.

6.1 Acceptance of Nominated Post Holders

The nominated post holders shall be examined by the Team leader and accepted by

Director of Airworthiness within 05 days from the date of receipt of request of acceptance

of Post Holders The formal intimation regarding acceptance of post holders shall be

communicated to the applicant with advice to submit the Production Organization

Exposition, Procedure Manuals, Departmental Manuals including subcontractors quality

plan for acceptance. In case, any nominated post Holder is found not suitable, the applicant

shall be intimated with the reason of non-acceptance.

6.2 Evaluation of Documentation (POE, Procedure Manuals, Departmental Manuals etc)

The POE and the associate Quality System shall be evaluated by the team leader in

accordance with Annexure VI. The detailed scrutiny of POE, associated procedure manuals

and Quality Systems shall be completed within 50 working days from date of receipt of

such manuals. If found satisfactory, the team leader shall recommend the same to Director

of Airworthiness for necessary Approval/Acceptance. The formal intimation of acceptance

shall be communicated to the applicant. In case any amendments in the draft manuals are

considered necessary, the same shall be intimated to the applicant.

6.3 Acceptance of Training Program as per approved POE and associated Quality System/

Procedure Manuals

The Team leader shall evaluate the training program for the personnel involved in the

Production Organization manufacturing process submitted by the applicant. The above

evaluation shall be completed within 10 days from the date of submission of the proposed

Training program. Formal acceptance of the Training program after necessary amendments

in consultation with the concerned Quality Manager shall be communicated to the

applicant.

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6.4 Acceptance of Customized Internal Audit Checklists

The customized audit checklist prepared in comparison with the requirements of approved

POE , procedures , Departmental manuals and Quality System shall be evaluated by and

accepted by the Team Leader within 10 working days from the date of submission of the

Checklists after required amendments, if considered necessary in consultation with Quality

Manager.

6.5 Evaluation and Acceptance of Internal Audit Report

The Evaluation and Acceptance of internal audit report submitted by the applicant shall be

completed within 05 working days from the date of submission of the report. If any

clarification is required the same shall be sought from the Quality Manager.

6.6 Acceptance of CAR Compliance Report

The Evaluation and Acceptance of CAR Compliance Report submitted by the applicant shall

be completed within 05 working days from the date of submission of the report. If any

clarification is required the same shall be sought from the Quality Manager.

6.7 Auditing

The Team Leader shall inform the organization for Inspection plan by the DGCA Team

within 10 working days after acceptance of CAR compliance report

Subsequently audit team shall carry out physical verification of availability of necessary

organizational infrastructure in terms of suitable accommodation, manufacturing facility,

competent manpower and adherence to the documented quality system. During

the inspection of the production organization, Annexure VI may be used for verification

purpose. The inspection process shall be completed within 25 working days from the date

of receipt of CAR compliance report.

6.8 Findings (21.B.225)

During the audit or by any other means, if any objective evidence is found by the

investigation team showing noncompliance with the applicable requirements of Section A

of CAR 21 , the same shall be classified in accordance with CAR 21.A .158(a) and recorded

on the form 56. The discrepancies noted shall be communicated to the Quality

Manager for appropriate corrective and preventive action.

6.9 Follow – up of corrective action

Upon receipt of the action taken report, the audit team members shall assess the action

taken for its adequacy and acceptance. The acceptance of the action taken shall be

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authenticated on the CA form 2001. The audit team members may carry out follow up

inspection, If considered necessary.

If the organization fails to comply the above discrepancies, the same may be

communicated to the applicant and a copy to Headquarters.

6.10 Recommendation for issuance of approval

When the full investigation for compliance of the applicant with CAR 21 has been

satisfactorily determined, the following documents shall be put up to the Director of

Airworthiness of the concerned regional office for necessary approval of the Production

Organization.

(a) The completed DGCA form 56 (all 5 sections). Wherever possible the phone and fax

number and email address of the organisation shall be provided. (Completed and

signed by the Team Leader and all Team Members);

(b) Notes of the final POA Team meeting with the applicant including

recommendations and significant findings together with appropriate

conclusions and corrective actions;

(c) The Approved Production Organization Exposition.

(d) Accepted Form 4.

(e) Consistency of the Form 50 with the Form 56 and the Production Organization

Exposition;

(f) The continued surveillance plan by the Regional Office /Sub regional Office.

Note: In case the investigation team has been constituted without an officer from

the concerned Region / Sub region, a member nominated by the team leader shall

review the documents.

The DAW of the region concerned shall countersign the form 56 when satisfied with the

review of paragraph 6.10 (a) to (f) and having assured that records will be maintained. The

DAW shall also verify that the continued surveillance plan covers all elements of the Quality

System. The Head of the Regional Office shall notify Headquarters of any major delays,

serious problems or rejection of key staff members of the applicant during the investigation

process.

6.11 Issuing the Organization Approval Certificate (21.B.230)

The investigation team leader shall prepare the Form 55 and submit to DAW of the

concerned Region along with countersigned form 56 (all parts). When satisfied with the

above recommendation package the DAW shall sign the DGCA Form 55 approval

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certificate. The approval shall be issued for a duration not exceeding one year and valid till

31st December of that calendar year.

The DAW will forward the original signed DGCA Form 55 to the organisation with a copy to

the Sub-regional office (if applicable) and Headquarters.

6.12 Record keeping (21.B.260)

The DAW will establish a system to maintain records of all documents generated and

received during the approval process and the subsequent continued surveillance

process. The DGCA Form 56, copy of the form 55 and the continued surveillance plan shall

be retained under the allocated DGCA approval number. Specific reference will be made

to the next date that the form 56 recommendation is due. Designated Officer of

Headquarters will update the approvals database with the above information. The DAW of

the Region will maintain a register of all Organisation Approvals issued by the region in

accordance with CAR 21 giving the following details:

(a) Approval number

(b) Name of organisation

(c) Address

(d) Scope of approval

6.13 Changes within the Approved Production Organization (21.B.240)

6.13.1 Any proposed significant changes as listed in CAR 21A.147 or CAR 21A.148 and its

AMC shall be processed by the respective Regional / Sub regional offices and

investigated. All significant changes as detailed in the above referred CARs require

a form 51. The Sub regional offices shall forward a copy of all form 51s to the DAW

of the Region for processing in accordance with paragraph 4 of this chapter

(application acceptance process). The application for a change should include the

relevant fees. The Sub regional office will confirm receipt of payment to the DAW

of the Region. The Team Leader will determine the extent of any subsequent review

according to the extent of proposed changes to the Organization and/or its

Exposition and shall carry out necessary actions.

6.13.2 The Sub Regional offices shall inform the DAW of the Region of all cases where the

organization wishes to operate in accordance with CAR21A.147 (b). When the

investigation for the change has been satisfactorily completed, the dealing officer

of the Regional/Sub Regional office shall carry out a review of any applicable

documents detailed in paragraph 6.1 and 6.2 pertaining to the change. When a

change to the certificate is required, paragraph 6.2- to 4.11 shall be used.

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6.14 Production without POA

Cases pertaining to grant of permission to organizations for manufacturing product, part

and appliance shall be dealt in accordance with CAR 21 Subpart F and Chapter 5 A of this

manual.

6.15 Production organizations not covered in CAR 21 shall be approved in line with CAR section

2 Series F part XIV.

7. Continued Surveillance (21.B.235)

7.1 A continued surveillance plan shall be developed by a nominated field officer taking into

consideration follow up of corrective actions and acceptance by the DAW of the Region as

per CAR 21 Sub Part G and its associated AMC&GM and records on part 2 to the DGCA form

56. The continued surveillance plan shall cover entire area of activity of the organization

and shall be communicated to the organization by the designated Team Leader.

7.2 The Team Leader assigned to perform the continued surveillance will process all findings

and notify the DAW of the Region who will inform Headquarters immediately regarding

any Level 1 finding made against the POA holder along with details of action taken by the

office. In case of a Level 1 finding the DAW of the Region will review the finding and take

appropriate action. The findings shall also be communicated to the concerned organization

for taking necessary rectification action within the specified time limit.

8. Continued Validity

8.1 The continuation of approval shall be monitored in accordance with the continued

surveillance plan.

DGCA form 56 (Part 1-5) recommendation must be completed at least every 24 months.

Officer assigned with the responsibility of overseeing the activities of the organization

concerned must carry out a quality review of the form 56 and countersign the form. The

designated officer shall submit / forward the form 56 to the Head of the Regional

Airworthiness office (Not below the rank of DDAW) for continuation of the approval every

12 months along with the completed surveillance plan. Where the recommendation for

continuation of the approval certificate is accepted, Director of Airworthiness shall notify

the approved production organization and DGCA Headquarters. Designated officer of

Headquarters shall update the approvals database with all the relevant information.

8.2 Any negative decision by the Regional/Sub Regional Office shall be taken in

consultation with Headquarters. The approval holder will be notified by letter and copy to

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the DAW of the region (if applicable) / Headquarters (Airworthiness Directorate), detailing

the suspension or revocation of the POA by the Head of the concerned office. The letter

will specify the reference to the provisions for appeal by the POA holder.

8.3 In extenuating circumstances the 12 month audit cycle period may be extended by the

Regional / sub-regional office concerned with approval of Headquarters. This is subject to

verification by other means that the systems are functioning within the POA holder’s

organization.

9. Production Organization Exposition (POE) Amendments

The Organization should submit each proposed amendment to POE to the concerned Regional

office / sub regional office for approval. The designated field officer shall examine the proposed

amendments and on being satisfied that the amendments meet the current requirements of CAR

21 and approval shall be intimated in writing to the organization.

10. Additional Provisions

10.1 Reporting System

10.1.1 CAR 21A.3 (b) and 21A.165 (f) detail the Production Organization Approval holders

responsibilities regarding reporting to DGCA. The Regional / Sub-Regional Offices

shall process the reports in association with the Aeronautical Engineering Division

at DGCA Headquarters. The form and manner for such reports shall be as laid down

in the organization’s procedures as contained in the Production Organisation

Exposition of the POA holder.

10.2 Panel of Experts

10.2.1 A Panel of Experts (PE) which comprises specialists with extensive technical

knowledge and experience necessary for approval of production organizations as

established by DGCA.

10.2.2 The PE specialists shall advise on technical certification principles and technical

interpretation of the implementing rules of the Basic Regulation, technical

standardization and technical training ensuring appropriate technical certification

knowledge within DGCA. They may also act as team members, provided there is no

conflict of interest. In such cases they shall abstain from participating in the

deliberations of the PE. The Government of India rules on the subject shall be

applicable to the PE.

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10.3 Resolution of Disagreements

10.3.1 Every effort shall be made to resolve all kind of disagreements concerning issues between

DGCA and the Approval Holder/Applicant at the lowest possible level. The investigation

team will be the primary decision maker in the process under the supervision of its team

leader. The DAW of the Region shall have the ability and power to take the first decisions

to the largest possible extent. If the Approval Holder/ Applicant do not agree with the

Investigating Team decision, the Head of the office as a first step, and the DAW of the

region, will try to reach a mutually acceptable resolution. If an agreement still cannot be

reached, the matter will be brought to the Airworthiness Directorate at Headquarters who

will take a decision thereto. If further escalation is necessary the final decision will be made

by the DGCA following consultation with the panel of experts. In this case the Applicant

shall have the right to be heard by the PE. The opinion of the PE will be communicated to

the Applicant together with the final decision.

10.4 Involvement of the Legal Service

10.4.1 The DAW (Headquarters) may consult the Directorate of Information and

Regulation of DGCA at the earliest possible stage;

(a) Before the adoption of a negative decision taken during the approval process which

is subject to appeal according to Indian Aircraft Rules, 1937 Rule no. 3B or this

internal working procedure;

(b) when an applicant or certificate holder requests that a disagreement be

formally handled and the DAW (Headquarters) should consult the Directorate of

Information and Regulation of DGCA at the earliest possible stage;

(c) When there is a disagreement with the applicant or certificate holder on a

significant decision affecting the result of the approval process;

(d) In any other case when deemed necessary.

11. Limitation, Suspension and Revocation (21.B.245)

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11.1 A Production Organization Approval shall be limited, suspended or revoked by the DGCA if

the certificate becomes invalid under the conditions specified in CAR-21, or fails to comply

with the DGCA fees and charges Regulation.

11.2 The DAW of the regional office shall notify the holder of a Production Organization

Approval in writing about this suspension or revocation including the reasons thereof and

the right to appeal against this decision.

11.3 An enforcement action must be taken in accordance with Sub rule (10) of Rule 133B

and the Enforcement Manual.

12. Communication and Publication

Significant decisions affecting the result of the approval procedure shall be communicated by

DGCA to the applicant in writing. The status of approval shall be updated in the DGCA website by

DAW (Headquarters).

13. Confidentiality of Documents

All documents and information received and held by DGCA related to the approval procedure

which originates from the Approval Holder/Applicant or a third party shall not be made public

without the consent of the Approval Holder/Applicant.

ANNEXURE -I

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Application for Production Organization Approval under CAR21, Subpart G Form CA-50

DGC A 1. Registered name and address of the organization.

2. Trade name(if different):

3. Locations for which the approval is applied for:

4. Brief summary of proposed activities at the item 3 addresses

a) General

b) Scope of approval

c) Nature of privileges

5. Description of organisation

6. Links/arrangements with design approval holder(s)/ Design organization(s)where different from1.

7. Approximate number of staff engaged or intended to be engaged in the activities

8. Position and name of the accountable manager

Date: Signature of Accountable Manager

Note:

1. Applicants for Production Organization Approval (POA) under CAR 21, Subpart G, will be charged as

2. The fees for renewal of POA shall be fifty percent of that of the new POA as above.

3. Completion Instructions

Block 1: The name of the organization must be entered as stated in the register of the Indian Companies

Registration Office. For the initial application a copy of the entry in the register of the Indian

Companies Registration Office must be provided to the DGCA.

Block 2: State the trade name by which the organization is known to the public if different from the

information given in Block 1. The use of a logo may be indicated in this Block.

Block 3: State all locations for which the approval is applied for. Only those locations must be stated that

are directly under the control of the legal entity stated in Block 1.

Block 4: This Block must include further details of the activities under the approval for the addresses

indicated in Block 4. The Block “General” must include overall information, while the Block “Scope

of approval” must address the scope of work and products/categories following t he principles laid

down in the GM 21.151. The Block “nature of privileges” must indicate the requested privileges as

defined in 21.163(b)-(d). For an application for renewal state “N/A”.

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Block 5: This Block must state a summary of the organization with reference to the outline of the production

organization exposition, including the organizational structure, functions and responsibilities. The

nomination of the responsible managers in accordance with

Block 6: The information entered here is essential for the evaluation of eligibility of the application. Therefore

special attention must be given concerning the completion of this Block either

directly or by reference to supporting documentation in relation to the requirements of

21.A.133(b) and (c) and the AMC to 21.A.133(b) and (c).

Block 7: The information to be entered here must reflect the number of staff, or in case of an initial approval the intended number of staff, for the complete activities to be covered by the approval and therefore must include also any associated administrative staff.

Block 8: State the position and name of the accountable manager.

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ANNEXURE– II

Application for significant changes or variation of scope and terms of Production Organization Approval under CAR21, Subpart G

Form CA - 51

DGC A 1. Name and address of the POA holder:

2. Approval reference number:

3. Locations for which changes in the terms of approval are requested:

4. Brief summary of proposed changes to the activities at the item 3 addresses

a) General:

b) Scope of approval:

c) Nature of privileges:

5. Description of organizational changes:

6. Position and name of the accountable manager or nominee:

Date: Signature of Accountable Manager

Filling Instructions

Block 1: The name must be entered as written on the current approval certificate. Where a change in the name is to be announced

state the old name and address here, while using Block 5 for the information about the new name and address. The

change of name and/or address must be supported by evidence, e.g. by a copy of the entry in the register of commerce.

Block 2: State the current approval reference number.

Block 3: State the locations for which changes in the terms of approval are requested or state “N/A” if no change is to be

anticipated here.

Block 4: This Block must include further details for the variation of the scope of approval for the addresses indicated in Block 3.

The Block “General” must include overall information for the change (including changes e.g. in workforce, facilities etc.),

while the Block “Scope of approval” must address the change in the scope of work and products/categories following the

principles laid down in the GM 21A.151. The Block “nature of privileges” must indicate a change in the privileges as

defined in 21A.163(b)-(d). State “N/A” if no change is anticipated here.

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Block 5: This Block must state the changes to the organisation as defined in the current production organisation exposition,

including changes the organisational structure, functions and responsibilities. This Block must therefore also be used to

indicate a change in the accountable manager in accordance with 21A.145(c)(1) or a change in the nomination of the

responsible managers in accordance with 21A.145(c)(2). A change in the nomination of responsible managers must be

accompanied by the corresponding CA Form 4. State “N/A” if no change is anticipated here.

Block 6: State the position and name of the Accountable Manager here. Where there is a change in the nomination of the

Accountable Manager, the information must refer to the nominee for this position. State “N/A” if no change is anticipated

here.

In case of an application for a change of the Accountable Manager the CA Form 51 must be signed by the new nominee for this position. In

all other cases the CA Form 51 must be signed by the Accountable Manager.

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ANNEXURE– III POA Certificate of Approval-Sheet A Form CA - 55

DGCA APPROVAL CERTIFICATE Reference: DGCA.G.XXXX

Pursuant to the Indian Regulations in force and subject to the conditions specified below, DGCA here by certifies

Company Name & Address as a

PRODUCTIONORGANISATION approved according toCar21,Subpart G

CONDITIONS: 1. The approval is limited to that specified in the enclosed Terms of Approval; and 2. This approval requires compliance with the procedures specified in the Production Organization Exposition; and 3.This approval is valid whilst the approved production organization remains incompliance with

Car21,Subpart G.

Date of original issue: Date of this issue:

Signed : For DGCA:

POA Certificate of Approval-Sheet B DGCA Terms of Approval TA:DGCA.G.XXXX This document is part of Production Organization Approval Number DGCA.G.XXXX issued to Company name:

Section1.SCOPEOFWORK:

PRODUCTIONOFPRODUCTS/CATEGORIES

For details and limitations refer to the Production Organization Exposition,

Section2.LOCATIONS: Section3.PRIVILEGES:

The Production Organization is entitled to exercise, with in its Terms of Approval and in accordance with the procedures of its Production Organization Exposition, the privileges set forth in 21.163.Subject to the following:

Prior to approval of the design of the product a FormCA-1 may be issued only for conformity purposes.

A Statement of Conformity may not be issued for an on approved aircraft.

Maintenance may be performed, until compliance with maintenance regulations is required, in accordance with the Production Organization Exposition Section xxx.

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ANNEXURE -IV

DIRECTORATE GENERAL OF CIVILAVIATION

FORM 21-56

Part1of 5

Page1of 1

RECOMMENDATION REPORT IN SUPPORT OF CAR-21 SUBPART G APPROVAL ISSUE/ RENEWAL/CONTINUATION/VARIATION

PART1: BASIC DETAILS OF THE ASSESSMENT

Name of the Organization :

Approval Reference :

Address(es)of the facilities surveyed :

Main CAR-21 Subpart G activities at facilities surveyed :

Date (s) of survey:

Names and positions of the organization’s Senior Management attended during survey:

Name of DGCA officer :

Office :

Form 21-56completiondate :

Note: If it is determined that recommendation for issue/renewal/continuation/variation of Approval cannot be made because of non-compliance with CAR-21Subpart G, the reasons for non-compliance need to be identified in PART4 of the report. A copy of PART1 and PART4 ,or at least the information included in the reports, must be given to the organization to ensure that the organization, in failing to obtain CAR-21SubpartG Approval, even if only temporarily, has the same information as is on the files of the DGCA.

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DIRECTORATE GENERAL OF CIVIL AVIATION

FORM 21-56

Part2of 5 Page 1of 7

RECOMMENDATION REPORT IN SUPPORT OF CAR-21 SUBPART G APPROVAL ISSUE/ RENEWAL/ CONTINUATION/ VARIATION

CAR21 SUBPART G COMPLIANCE Name of the organization :

Approval of organization :

Approval Reference :

Survey reference :

Note A:This form has been complied according to those paragraphs of CAR –21 Subpart G which are relevant to an organization trying to demonstrate compliance

Note B : The right hand part of each box must be completed with one of three indicators:

1. A tick (√) which means compliance. 2. NR which means the requirement is Not Relevant to the activity at the address surveyed (the

Reason for NR should be stated in PART 4 of the report, unless the reason is obvious). 3. A number relating to a comment which must be recorded in PART 4 of the report.

CAR 21.33 Eligibility

The DGCA will only accept an application for a production organization approval if -

(a) The DGCA agrees that, for a defined scope of work ,such an approval is appropriate for the purpose

of showing conformity with a specific design; and

(b) The applicant holds or has applied for an approval of such a design, or the applicant has a suitable arrangement with the applicant for or holder of an approval of such a design which ensures satisfactory co-ordination between production and design or possess design data obtained through a license agreement.

CAR 21.134 Application

Each application for a Production Organization Approval must be made in a form and manner acceptable to the DGCA, and must include an outline of the information required by CAR 21.143 and the Terms of Approval requested to be issued under CAR21.151.

CAR 21.139 Quality System (a) The production organization shall demonstrate that it has established and can maintain a quality

system. The quality system must be documented. This quality system shall be such as to enable the

organization to ensure that each product, part or appliance produced by the organization or by its

partners, or supplied from or sub contracted to outside parties, conforms to the applicable design data

and is in condition for safe operation, and thus exercise the privileges set for in CAR21.163.

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DIRECTORATE GENERAL OF CIVILAVIATION

FORM 21- 56 Part2of 5

Page2of 7

(b) The quality system must include:

(1) As applicable with in the scope of approval, control procedures for those elements shown below; and

a) ____ Document issue, approval or change.

b) ____Vendor and sub-contractor assessment, audit and control

c) ____Verification that incoming products, parts, materials, and equipment, including

items supplied new or used by buyers of products, are as specified in the applicable design

data.

d) ____Identification and traceability

e) ____Manufacturing processes

f) ____Inspection and testing, including production flight tests.

g) ____Calibration of tools, jigs and test equipment

h) ____ Non-conforming item control

i) ____Airworthiness co-ordination with the applicant/holder of a design approval

j) ____Records completion and retention

k) ____Personnel competence and qualification

l) ____Issue of airworthiness certifications

m) ____Handling, storage and packing

n) ____Internal quality audits and resulting corrective actins

o) ____Work within the Terms of Approval performed at any location other than the approved

facilities.

p) ____Work carried out after completion of production but prior to delivery, to maintain

the aircraft in a condition for safe operation

q) ____issue of permit to fly and approval of associated flight conditions.

r) ____The control procedures need to include specific provisions for any critical parts.

:

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DIRECTORATE GENERAL OF CIVIL AVIATION

FORM 21-56 Part2of 5 Page3of 7

(2) An independent quality assurance function to monitor compliance with, and adequacy of, the documented procedures of the quality system. This monitoring must include a feedback system to the person or group of persons specified in CAR 21.145(c)(2) and ultimately to the manager specifiedinCAR21.145(c)(1)to ensure, as necessary, corrective action. CAR 21.143 Expositions (a) The organization must furnish to the DGCA a production organization Exposition providing the information listed in Appendix A to CAR21(see part3of this Form) (b) The Production Organization Exposition must be amended as necessary to remain an up-to-date description of the organization ,and copies of amendments must be supplied to the DGCA CAR 21.145 Approval requirements The production organization must show ,on the basis of the information submitted in accordance with CAR 21.143, that- (a) with regard to general approval requirements, facilities, working conditions, equipment and

tools, processes and associated materials, personnel numbers and competence, and general organization are adequate to discharge responsibilities under CAR21.165 ____________________

(b) with regard to all necessary airworthiness, noise, fuel venting and exhaust emissions data (1) The production organization is in receipt of all necessary airworthiness data from the holder

Of or applicant for the approval of the Type Design, as appropriate to determine conformity with the applicable design data.

(2) The production organization has a procedure to ensure that airworthiness; noise, fuel venting

and exhaust emissions data are correctly incorporated in its production data. (3) Such data are kept upto date and made available to all personnel who need access to such data to perform their duties.

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DIRECTORATE GENERAL OF CIVIL AVIATION

FORM 21-56 Part2of 5 Page4of 7

SURVEY REFERENCE:

CAR 21.145 Approval Requirements(cont’d)

( C ) with regard to management and staff

(1) A manager accountable to the DGCA, has been nominated, with responsibility with in the Organization to ensure that all production is performed to the required standards and that the Production organization is continuously in compliance with the data and procedures identified in the Exposition.

(2) A manager or group of managers has been nominated to ensure that the organization is in

compliance with the requirements of this Subpart, and are identified, together with the extent of their authority. In this respect such person(s) must ultimately be responsible to the manager identified in sub-paragraph (c) (1) of this paragraph. The knowledge, background and experience of the managers nominated must be appropriate to discharge their responsibilities.

(3) Staff at all levels have been given appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective co-ordination within the production organization is respect of airworthiness noise, fuel venting and exhaust emission data matters.

(d) with regard to certifying staff, authorised by the production organisation to sign the documents issued under point 21.A.163 under the scope or terms of approval:

(1) The knowledge, background, (including other functions in the organisation), and experience of

the certifying staff must be appropriate to discharge their allocated responsibilities.

(2) The production organization maintains a record of all certifying staff which must include details of their authorization.

(3) Certifying staff are provided with evidence of the scope of their authorization.

CAR 21.147 Changes to the Approved Production Organization

(a) After the issue of a Production Organization Approval, each change to the approved production

organization that is significant to the showing of conformity or to the airworthiness of the product, part or appliance, particularly changes to the quality system, must be approved by the DGCA. A proposal for such a change must be notified as soon as practical and the production organization must show, as far as possible before the implementation of the change, to the satisfaction of the DGCA that it will continue to comply with requirements of this Subpart G.

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SURVEY REFERENCE: CAR 21.147 Changes to the Approved Production Organization

(b) The DGCA may prescribe the conditions under which a Subpart G approved production organization may

operate during such changes unless the DGCA determines that the approval should be suspended. CAR 21.148 Changes in location

A change in the location of the manufacturing facilities of the approved production organization must be regarded as a change of significance to the organization which must therefore comply with CAR21.147

CAR 21.149 Transferability

Except for a change in ownership, which must be regarded as a change of significance, and must therefore complywithCAR21.147, a Production Organization Approval is not transferable.

CAR 21.151 Terms of approval

The Terms of Approval identify the scope of work, the products and /or the categories of parts and appliances for which the holder is entitled to exercise the privileges definedinCAR21.163. Terms of approval are issued as part of a Production Organization Approval.

CAR 21.153 Changes to the terms of approval

Application for a change to the Terms of Approval must be made in a form and manner acceptable to the DGCA. The applicant must comply with the applicable requirements of this Subpart G.

CAR 21.157 Investigations

A Production Organization Approval shall make arrangements that allow the DGCA to make any investigations, including investigations of partners and/or sub-contractors, necessary to determine compliance with the applicable requirements of this Subpart G.

CAR 21.163 Privileges

Pursuant to the terms of approval issued under point 21.A.135, the holder of a Production Organization Approval may, with in his Terms of Approval issued under CAR21.135

(a) Perform production activities under CAR 21 Sub Part G

( b) In the case of complete aircraft and upon presentation of a Statement of Conformity, to obtain an aircraft

certificate of airworthiness, Standard or Export.

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SURVEY REFERENCE:

(c) In the case of other products, parts or appliances issue Authorised Release Certificates (DGCA Form

21-1 )without further showing.

(d) Maintain a new aircraft that it has produced and issue a certificate of release to service in respect of that maintenance.

CAR 21.165 Obligation of Holder

The holder of a Production Organization Approval shall –

(a) Ensure that the production organization Exposition furnished in accordance with CAR 21.143 and the documents to which it refers, are used as basic working documents with in the Organization.

(b) Maintain the production organization in conformity with the data and procedures approved for the

Production Organization Approval.

(c) Determine that each completed aircraft conforms to the type design and is in condition for safe

operation prior to submitting Statements of Conformity to the DGCA or

-Determine that other products, parts or appliances are completed and conform to the approved design data and are in condition for safe operation before issuing DGCA Form 21-1 to certify airworthiness, or additionally in case of engines, determine according to data provided by the engine type-certificate holder that each completed engine is in compliance with the applicable emissions requirements as defined in point 21.A.18(b), current at the date of manufacture of the engine, to certify emissions compliance; or

- Determine that other products, parts or appliances conform to the applicable data before issuing

DGCA Form 21-1as a conformity Certificate

(d) Record all details of work carried out in a form acceptable to the DGCA

( e ) establish and maintain an internal occurrence reporting system in the interest of safety, to enable the

collection and assessment of occurrence reports in order to identify adverse trends or to address deficiencies, and to extract reportable occurrences. This system shall include evaluation of relevant information relating to occurrences and the promulgation of related information;

______________________________________ (f) (1) Report to the holder of the Type Certificate or Design Approval, all cases where products, parts or

appliances have been released by the production organization and subsequently identified to have deviations from the applicable design data, and investigate with the holder of the Type Certificate or Design Approval to identify those deviations which could lead to an unsafe condition

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(2) Report to the DGCA, the deviations identified according to sub-paragraph (f)(1) of this paragraph. Such reports must be made in a form and manner acceptable to the DGCA according to CAR21.3 (b)(2).

(3) Where the Production Organization Approval holder is acting as a supplier to another production organization, report also to that other organization all cases where it has released products, parts or appliances to that organisation and subsequently identified them to have possible deviations from the applicable design data;

(g) Provide assistance to the holder of the Type Certificate or Design Approval in dealing with any continuing

airworthiness actions that are related to the products, parts or appliances that have been produced.

(h) establish an archiving system incorporating requirements to its partners, suppliers and sub-contractors, ensuring conservation of the data used to justify conformity of the products, parts or appliances, to be held at the disposal of the DGCA and to be retained in order to provide the information necessary to ensure the continuing airworthiness of the products ,parts or appliances.

(i) Where, under his Terms of Approval, he issues a certificate of release to service, determine that each completed aircraft has been subjected to the necessary maintenance and is in condition for safe operation, prior to issuing the certificate.

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DIRECTORATE GENERAL OF CIVIL AVIATION

FORM 21-56

Part3 of 5 Page1of 1

RECOMMENDATION REPORT IN SUPPORT OF CAR-21 SUBPART G ISSUE/RENEWAL/CONTINUATION / VARIATION

CAR-21 SUBPART G EXPOSITION COMPLIANCE

Name of the Organization :

Approval of organization :

Approval Reference : Survey reference : Note A: Each box must be completed with of three indicators:

1. a tick(я which means of compliance. 2. NR which means the requirement is NOT RELEVANT to the activity at the address surveyed. (The reason for

NR should be stated in PART4 of the report, unless the reason is obvious) 3. a number relating to a comment which must be recorded in PART4 of the report.

Note B: The exposition may be complied in any subject order as long as all applicable subjects are covered.

Note C: If the organization holds another CAR approval requiring an exposition or handbook it is acceptable to use this

index as a supplement to the existing exposition or handbook and to cross-refer each subject to the position in the existing exposition or handbook.

Production Organization Exposition: Revision Status: (Content as required by CAR21.143(a)-Appendix Ato CAR-21)

(a) A statement signed by the accountable manager confirming that the production organization exposition

and any associated manuals which define the approved organization’s compliance with this Subpart will be complied with a tall times.

(b) The title(s)and names of managers accepted by the DGCA in accordance with CAR21.145(c)(2)

(c) The duties and responsibilities of the manager(s) as required by CAR21.145(c)(3) including matters on

which they may deal directly with the DGCA on behalf of the Organization

(d) An organizational chart showing associated chains of responsibility of the managers as required by

CAR21.145(c) (1) and (c)(2)

(e) A list of certifying staff.

[Note: a separate document may be referenced]

(f) A general description of man-power-resources

(g) A general description of the facilities located at each address specified in the production organization’s certificate of approval

(h) A general description of the production organization’s scope of work relevant to the Terms of

Approval

(i) The procedure for the notification of Organizational changes to the DGCA

(j) The amendment procedure for the production organization exposition

(k) A description of the quality system and the procedures as required by CAR21.139(b)(1)

(l) A list of those out side parties referred to in CAR21.139(a) [Note: a separate document may be

referenced]

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DIRECTORATE GENERAL OF CIVIL AVIATION

FORM 21-56

Part4 of 5 Page1of 1

RECOMMENDATION REPORT IN SUPPORT OF CAR-21 SUBPART G APPROVAL ISSUE /RENEWAL/ CONTINUATION /VARIATION

FINDINGS ON CAR-21 SUBPART G (COMPLIANCE STATUS)

Name of the Organization :Approval Reference : Survey reference:

Note A: Each finding must be identified by number and the number must cross-refer to the same number in a box in Part 2or3 of the

CAR-21 Subpart G Survey Report.

Note B: As stated in Part 1 any comments recorded in this Part should be copied to the organization surveyed together with Part1

. Note C: In case of a partial clearance of a finding with some outstanding action remaining, this action has to be identified.

No Finding Level Outstanding

Action

Clearance

Date Rep Ref

NAME &SIGNATURE OFSURVEYOR : Date :

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DIRECTORATE GENERAL OF CIVIL AVIATION

FORM 21-56

Part5of 5 Page1of 1

RECOMMENDATION REPORT IN SUPPORT OF CAR- 21 SUBPARTG APPROVAL ISSUE /RENEWAL /CONTINUATION /VARIATION

CAR–21 SUBPART G APPROVAL RECOMMENDATION

Name of the Organization:

Approval Reference :

Survey Reference:

Recommendation for issue/renewal/variation of approval: The following CAR-21 Subpart G Terms of approval are recommended for the above organization at the address (es specified inPart1 of this report:

Or

Recommendation for continuation of existing approval:

It is recommended that the CAR-21 Subpart G Terms of Approval identified in DGCA Form21-55 referenced be continued.

Name of DGCA Officer making recommendation: Signature of the

DGCA Officer : DGCA Regional

Office : Date :

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ANNEXURE- V

Check List for Contents of Production Organization Exposition

Name of the Organization :

Contact Person & Phone No.:

POE Title & reference :

Reviewing Officer & Date of Review:

Document Identification and reference:

Name of the organization and Address:

PART I

• Statement signed by the Accountable Manager confirming the compliance with the CAR and other

regulations -Counter signature.

• list of title(s) and names of managers accepted by the DGCA in accordance with CAR 21.145(c)(2).

• Duties and responsibilities of the manager(s) as required by CAR 21.145 (c)(3) including the authority and

co-ordination with its various departments and design organization.

• Organizational chart indicating the chain of responsibility of the managers as required by CAR 21.145(c)(1)

and (c)(2) is available. Check whether all responsible managers directly report to Accountable Manager or

have direct access to him.

• List of certifying staff. ( Not to include inspection personnel)

• Manpower resource requirement anr training requirements described in the manual including the

manner of compliance with the same.

• General description of the facilities located at each address specified in the production organization’s

certificate of approval covered in the Manual. Check that the manual describe the facilities and

equipment at each location.

• Terms of Approval is specified for each scope of work being carried out.

• Procedure for the notification of Organizational changes to the DGCA is described

• Accountable Manager

Responsible Managers

Facility & Location

• Scope of work

• Amendment procedures for the POE and occasions for amendment

• Check for any changes in organization. Is the chart updated & same is communicated and prior to

notifying changes to POE , acceptance of the changes by DGCA had been obtained. `

• Check that the procedures and periodicity / situation requiring amendment to the POE & QS are

explained.

• Check whether holders of this manual keep their copies up to date with approved amendments.

• Description of the quality system and the procedures are relevant to the scope of approval as required by

CAR 21.139(b)(1).

• Check that the function of independent Quality Assurance System described.

• Availability of list of outside parties as referred in CAR 21.139(a).

• Check that the manual contain/cross refers to the list of sub-contractors / outside parties and bought out

item suppliers and products supplied by them.

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PART II

Document control

• Classification of documents, originator/ issue, distribution / control requirements / procedures are

defined in the quality system

• Document preparation, review and approval procedure

• Procedure for distribution of document

• Procedure for confirming the action taken by the recipient of the document-in addition to normal action,

check updation of training syllabus if applicable.

• Dissemination of information to personnel concerned ( in each case )

• Release of Standard of Preparation

• Release of design data and control procedures

• Preparation and upkeep of manufacturing document and process sheets/ inspection standards

• List of document released by the department & distribution list in respect of each document.

• Maintenance of master copy, identification of control copy / reference.

• Procedure to communicate error / ambiguity noted in the manufacturing document to the approving

authority

• Check for the Stamping of obsolete copies and retention by originating department for future reference.

• Removal and destruction of obsolete documents and maintenance of evidence

• Requirement for periodical review of the documents have been established

• Availability of copies of all the documents (Internal / External documents ) at one location – Quality

Engineering

Vendors and sub-contractor assessment audit and control stores

Vendor

• Vendors classification and their evaluation criteria have been established

• Vendor assessment forms & audit report are available and approved

• Vendors monitoring & control criteria had been established

• Approved Vendors list and products that can be procured are maintained

• Documents to be supplied and packing requirements have been identified

• Procedure to notify the deficiency noted in the supplied item have been established.

Sub contract

• Organization’s Quality standards/ plan for each type of work had been established and organizations are

audited against the standard

• Quality plan specifies the infrastructure, drawings & materials equipment, quality control measures,

manufacturing procedure and documentation, inspection and certification requirements, personnel

competence, record to be delivered / retained, Archiving, handling and packing requirements,

• Issue & withdrawal of drawings & specifications control -Vendors/Sub-contractors

• Requirement of approval of subcontractor including first article inspection have been established

• Sub contractor approval procedures have been established.

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• Subcontractor monitoring requirements / procedure have been established -Subcontractor rating based

on quality of the parts, deviations, rejection and audit findings (excluding commercial aspects and

delivery schedule)

• Inspection requirements of subcontractor manufactured items have been established

• Inspection requirements after receipt of the part from sub-contractor and experience requirements of

personnel engaged in the activity

• Procedure to deal with non-conformances / deviations noted have been established

• Contract made with the sub-contractor provides for investigation by DGCA staff

Verification of incoming products, parts, materials, and equipment

• Acceptance criteria for Vendors supplied items have been established (Matrix form of by way of grouping)

-Raw material, std parts, bought out items etc.

• Inspection requirements after receipt of the part from sub-contractor (Matrix form of by way of grouping)

• Procedure to deal with non-conformances / deviations noted during receipt have been established

• Competency of personnel inspecting Vendors supplied items have been established

• Competency of personnel inspecting sub-contractor supplied items have been established

Identification and traceability

• Identification requirements with respect to the design standard have been established during all stages of

manufacturing

• Process of traceability with respect to design data, material source, manufacturing document, personnel

involved in manufacturing / inspection and machine and tools used have been established

• Flow chart explaining identification method adopted has been depicted.

Manufacturing process

• Configuration control procedure is documented.

• General manufacturing procedure, documents used for manufacture and purpose have been established.

• Check whether the manual describe the procedures used to perform the work.

• Check whether the manual identify the standards observed in the performance of work.

• Working environment for each type of activity had been defined

• Requirements and procedure for maintenance of manufacturing facilities have been established

Inspection and testing including production test flight

• Inspection requirements of the product from the raw material stage onwards to finished product have

been defined along with the standards to be followed

• Check whether the manual describe the method used to ensure that authorized personnel adopt an

acceptable method to indicate adherence to the manufacturing and inspection requirements.

Calibration of Tools, jigs and test equipment

• Acceptance procedure for each category of tools /equipment / gauges have been established

• Check whether calibration standards, inspection and maintenance requirements for tools, equipment and

instruments have been established

• Maintenance of master list of tools / equipment / gauges / instruments and monitoring of calibration and

inspection status have been established.

• Rework / rejection criteria for tools / gauges have been established.

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• Calibration and maintenance records upkeep procedure is defined

• Control procedures to avoid issuance / use of tools / equipment / gauges not conforming to standards for

use during manufacture and inspection

Non-conforming item control

• Identification of nonconformance items and extent of deviation

• Recording and classification of non-conformances

• Classification of deviations & Procedure to deal with non-conformance

• Analysis of non-conformances and preventive action

• Notifying the Airworthiness authorities regarding the manufacturing defects

Airworthiness co-ordination with the applicant /holder of design approval

• Release of design data and changes to the product

• Referral procedure to design organization / approved designers with respect to manufacturing problems /

defects.

Note: -Spot disposition by approved designer without proper analysis of snag not acceptable

• Disposal procedure of manufacturing problems / defects by the design organization / approved designers

and follow up action.

• Collection of in-service failures, malfunction / defects by manufacturing organization and notification to

the Type Design approval holder

• Analysis and investigation of failures, malfunction / defects.

• Notification of solutions to the aircraft operators / product users

• Procedure to deal with non-conformances noted on sub-contracted (Including design) items

Record completion and retention

• Location wise documents used

• Procedure to confirm completion of manufacturing / established procedure

• Periodicity of retention of completed manufacturing / inspection documents

• Procedure to identify / archive and access control

• Minimum standards for storage area of manufacturing documents

• Computerized document retention procedure and backup system

Personnel competence and qualification

• Requirements for approval of various group of post holders, inspection and certifying personnel in terms

of education, experience, medical standards, training, on job training and assessment procedure

• Identification of approved personnel

• Duties and responsibilities for approved personnel

• Monitoring of standard of work of personnel and renewal of approval

• Record keeping of details of approved personnel

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Issue of Airworthiness certification

• Certification requirements during various stages of manufacturing have been defined

• Procedure for identification of certification status of the part / item have been established

• Requirements for issuance of Airworthiness certification

• Procedure to issue Authorized Release certificate and Aircraft statement of conformity have been

established.

Handling, storage and packing

• Packing requirements for each group of materials, components of aircraft have been established

• Storage conditions for various types of materials and aircraft components have been established

• Handling requirements of materials and component during all stages of manufacturing and at stores have

been defined.

• Note: the above procedures should include sub-contract / vendor supplied items also.

Internal Quality Audit and resulting corrective actions

• Quality audit plan for the entire organization, sub-contractors and Vendors has been documented

• Elaborate audit check list for each functional aspect (with cross reference to the requirement / standards

/ procedure of the organization) have been prepared and cross referred in the document.

• Qualification, Experience, training, on job training requirement, assessment and approval procedure of

auditing personnel have been defined.

• Procedure to use audit check list, recording on non-conformances, classification of non-conformances

and communicating to responsible personnel have been documented.

• Assessment of deficiencies for root cause and Manner of communicating corrective action by responsible

managers

• Acceptance of corrective / preventive action by the Manger responsible for quality assurance

• Procedure to maintain statistics of area wise non-conformances. Review of non-conformances by the

Accountable manager

• Procedure to communicate findings of internal audit to the Airworthiness Authorities

• System to implement various regulatory requirements including CAR

Work within the Terms of Approval performed at locations other than the approved facility

• Details of work carried out at other location

• Requirements of the organization for the outside facility

• Management and administration of applicable elements of Quality system at the remote location

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Work carried out after completion of production but prior to delivery, to maintain theaircraft in a condition for

safe operation

• Extent of maintenance work required to be performed

• Release of work scope of maintenance

• Accomplishment of maintenance work and certification

• Aircraft / Component Release to service procedures.

• Recording of defects and rectification of defects

• Maintenance of Aircraft records

• Monitoring of maintenance programme

• Accomplishment of modifications & service bulletins and certification

• Requirements for approval of maintenance and certifying personnel in terms of education, experience,

medical standards, training, on job training and assessment procedure

The Organization’s Procedure should be a tamper proof close loop system providing traceability ( Personnel,

equipment and Literature / document ) at all stages. The procedure should address the following aspects:

What should be done?

When should the procedure be used?

Where should the procedure be used ?

Why should you follow the procedure ?

Who should follow the procedure ?

How the work should be performed ?

The Procedure should require generating evidence to indicate that documented procedure had been followed.

Provide cross reference to appropriate document with para number.

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