Page 116 - UK Regulation Part 21 Initial Airworthiness Annex I (consolidated) March 2022

PART 21 - INITIAL AIRWORTHINESS (ANNEX I)

(x) records completion and retention;
(xi) personnel competence and qualification;
(xii) issue of airworthiness release documents;
(xiii) handling, storage and packing;
(xiv) internal quality audits and resulting corrective actions;
(xv) work within the terms of approval performed at any location other than the
approved facilities;
(xvi) work carried out after completion of production but prior to delivery, to
maintain the aircraft in a condition for safe operation;
(xvii) issue of permit to fly and approval of associated flight conditions.
The control procedures need to include specific provisions for any critical parts.
2. An independent quality assurance function to monitor compliance with, and
adequacy of, the documented procedures of the quality system. This monitoring
shall include a feedback system to the person or group of persons referred to in
point 21.A.145(c)(2) and ultimately to the manager referred to in point 21.A.145(c)(1)
to ensure, as necessary, corrective action.
21.A.139(a) GM1 Quality System
The quality system is an organisational structure with responsibilities, procedures, processes, and
resources which implement a management function to determine and enforce quality principles.
The quality system should be documented in such a way that the documentation can be made easily
available to personnel who need to use the material for performing their normal duties, in particular:
- procedures, instructions, data to cover the issues of 21.A.139(b)(1) are available in a
written form,
- distribution of relevant procedures to offices/persons is made in a controlled manner,
- procedures which identify persons responsible for the prescribed actions are established,
- the updating process is clearly described.
The manager responsible for ensuring that the quality system is implemented and maintained should
be identified.
The CAA will verify on the basis of the exposition and by appropriate investigations that the production
organisation has established and can maintain their documented quality system.
21.A.139(a) GM1-ELA Quality system
The focus of the quality system is on the key workflows that are indispensable to ensure conformity to
the relevant parameters of the applicable design data. The quality system should include elements to
determine that there is conformity to the relevant parameters of the applicable design data and, if
applicable, the production process definitions. The quality system should mitigate any repetitive
nonconformities found in products or spare parts.
The production organisation should demonstrate that it has established, and will maintain, a quality
system via integration or by making use of one of the following, as applicable:
1. a valid ISO 9001 certificate;
2. a valid EN 9100 certificate;
3. compliance with ASTM F2972 for organisations that have only the production of CS-LSA
aircraft in their scope of approval; or
4. an individual quality system that meets all the definitions of the full set of AMC-ELA.
It should be ensured that the existing quality system covers all the aspects defined in 21.A.139(a).
The quality system should be documented in such a way that the documentation can be made easily
available to any personnel who need to use the material to perform their duties.
21.A.139(a) GM2 Quality System – Conformity of supplied parts or appliances
The POA holder is responsible for determining and applying acceptance standards for physical
condition, configuration status and conformity of supplied products, parts or appliances, whether to be
used in production or delivered to customers as spare parts. This responsibility also includes BFE
(Buyer Furnished Equipment) items.
To discharge this responsibility the quality system needs an organisational structure and procedures
to adequately control suppliers. Elements of the quality system for the control of suppliers may be
performed by other parties provided that the conditions of AMC No 1 or No 2 to 21.A.139(b)(1)(ii) are
met.
Control can be based upon use of the following techniques (as appropriate to the system or product
orientation necessary to ensure conformity):
- qualification and auditing of supplier’s quality system,
- evaluation of supplier capability in performing all manufacturing activities, inspections and
tests necessary to establish conformity of parts or appliances to type design,
- first article inspection, including destruction if necessary, to verify that the article conforms
to the applicable data for new production line or new supplier,
- incoming inspections and tests of supplied parts or appliances that can be satisfactorily
inspected on receipt,
- identification of incoming documentation and data relevant to the showing of conformity to
be included in the certification documents,
- a vendor rating system which gives confidence in the performance and reliability of this
supplier,
- any additional work, tests or inspection which may be needed for parts or appliances
which are to be delivered as spare parts and which are not subjected to the checks
normally provided by subsequent production or inspection stages.
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