Quality Assurance Manual
Quality Assurance Manual
Dokument: QAM
Revision: d00
Duck Tape
Generated
QM
Duck Duckling
Approved
AM
Revision Log
Rev. Description Date
00 complies with AMC-ELA to 21.G as on the day of issue 2017-05-24
1. General......................................................................................................................... 3
2. Organisational Aspects................................................................................................. 3
2.1. Scope and Approval ..........................................................................................................3
2.1.1. Organisational Context ...............................................................................................................3
2.1.2. Approval and Conditions ............................................................................................................3
2.2. Resources .........................................................................................................................4
2.2.1. Organisation, Staff and Roles .....................................................................................................4
2.2.2. Certifying Staff ............................................................................................................................5
2.2.3. Infrastructure...............................................................................................................................5
2.3. Changes to the QAM .........................................................................................................5
2.4. Monitoring of the Quality System .......................................................................................6
2.5. Authority Oversight ............................................................................................................6
2.5.1. Investigations ..............................................................................................................................6
2.5.2. Findings ......................................................................................................................................6
3. Quality System ............................................................................................................. 7
3.1. Control of Documented Information ...................................................................................7
3.2. Supplier Control ................................................................................................................7
3.3. Incoming Goods Inspection ...............................................................................................8
3.4. Identification and Traceability ............................................................................................8
3.5. Manufacturing Processes and Production Planning ..........................................................8
3.5.1. Critical Parts and Special Processes..........................................................................................9
3.6. Inspection and Testing ......................................................................................................9
3.6.1. Quality Assurance Records (QAR) .............................................................................................9
3.7. Calibration of Jigs and Tools ...........................................................................................10
3.8. Nonconforming Item Control............................................................................................10
3.9. Airworthiness Release Documents ..................................................................................10
3.10. Handling, Storage and Packing....................................................................................10
3.11. Maintenance of Completed Products ...........................................................................11
3.12. Factory Acceptance Test Flights ..................................................................................11
Document Management .................................................................................................... 13
Normative References .............................................................................................................................13
Associated Documents ............................................................................................................................13
Literature ..................................................................................................................................................13
Terms and Definitions ..............................................................................................................................13
Abbreviations ...........................................................................................................................................13
2. Organisational Aspects
2.1. Scope and Approval
2.2. Resources
Administration
Accounting
Office of Metal
Airworthiness Shipping
Production
Assembly
Associated staff is identified in Appendix I to this QAM. The Accountable Manager (AM) is
in addition identified to the relevant CA using EASA Form 4.
On the basis of the limited size and complexity of the undertaking, all delegation of duties
leaves the responsibility with the AM. All interaction with the authority is coordinated
through the AM.
It is in the responsibility of the AM to ensure adequate resources with respect to number
and qualification. Adequacy is continuously monitored by the AM as part of regular quality
meetings and lessons learned sessions, supported by review of logged working hours.
2.2.3. Infrastructure
21.A.139(b)1.(xv); 21.A.145(a);
The major place of activity where the products are completed and checked out is:
Ducktale 1,
007 Ducks Ford
EASA-Land
It is in the responsibility of the AM to ensure adequate infrastructure with respect to applied
technologies and production rate. Adequacy is continuously monitored by the AM as part
of regular quality meetings and lessons learned sessions, supported by review of recurring
quality issues and observed non-conformities.
When conducting work by PO staff but at a different location than normally used,
measures are taken to ensure an equivalent quality of the work result. This includes con-
sideration of the critical environmental parameters for the work to be provided, ensuring
adequate tooling comparable to the one used in regular production, and ensuring equiva-
lent inspection possibilities.
2.5.1. Investigations
21.A.157;
The manufacturer agrees to cooperate with CA during its investigations at the location of
the manufacturer, and gives the necessary access to facilities, staff and information rele-
vant to demonstrate conformity of the product to the approved Type Design.
Authority investigation will be based upon the assessment of products produced under the
approved scope, and will verify conformity with the type design and condition for safe oper-
ation. Monitoring, witnessing, checks, flight and ground tests may become part of the in-
vestigation when non-conformities to the Type Design are identified that have the potential
to endanger safe operation of the product.
Investigations are only extended to subcontractors or suppliers in those cases, where the
approved Type Design requires to exercise direct supplier supervision, performance as-
sessment and extension of quality assurance methods due to the nature of the involved
processes and lacking detectability of critical aspects after receipt of a part.
2.5.2. Findings
21.A.158(a), (b), (c);
The CA may raise findings in case of non-conformities to the Type Design are identified
that have the potential to endanger safe operation of the product. Depending on the sever-
ity of the identified situation, the CA will classify these findings as Level 1, 2 or 3.
An uncontrolled non-compliance with applicable design data is a non-compliance that:
- cannot be discovered through systematic analysis; or
- prevents identification of affected products, parts, appliances, or material.
3. Quality System
21.A.139(a);
ASTM F2972-14, 4.1; 4.3; 4.3.1; 4.3.2;
The Quality (Assurance) System defines the key workflows that are required to ensure
conformity of delivered products to the applicable design data and a condition of the prod-
uct that allows safe operation.
The Quality System defines key responsibilities for the determination of conformity with the
applicable design data.
Notwithstanding his responsibility, the AM delegates the duties of definition, implementa-
tion and maintenance of the QS to QM. AM charges Quality Management and Certfying
Staff with the implementation of the Quality Assurance System, thus together forming the
Quality Assurance Administration.
Definition of the elements of the QS is done within this manual, by declaration of the princi-
ples applied. As suitable, details may be enhanced by flow charts for individual activities,
outside of the formal manual. The affected section of the company is responsible to ensure
that this detailing meets the commitment provided here.
Normative References
Annex I of the Commission Regulation (EU) 748/2012 (Part 21), as amended by Regulations (EU) Nr.
7/2013, 69/2014, 2015/1039
Sections: Subpart G
ASTM F2971-14
Sections: All sections
Associated Documents
- none -
Literature
Annex I of the Commission Regulation (EU) 748/2012 (Part 21), as amended by Regulations (EU) Nr.
7/2013, 69/2014, 2015/1039
Sections: AMC-ELA to Subpart G
Abbreviations
AM Accountable Manager
AMC Acceptable Means of Compliance
CA Competent Authority
CS Certifying Staff
DMS Document Management System
ERP Enterprise Resource Management
FC Flight Conditions
FTOM Flight Test Operations Manual
FTP Flight Test Plan
FTP Flight Test Plan
ICA Instructions for Continued Airworthiness
LA Light Aircraft
LSA Light-Sport Aircraft
MRB Materials Review Board
PO Production Organisation
POA Production Organisation Approval
POE Production Organisation Exposition
PtF Permit to Fly
QAM Quality Assurance Manual
QAR Quality Assurance Record
QM Quality Management