AMC-ELA No 1 to 21.A.139(b)(1) Quality system – Control procedures
CAA ORS9 Decision No. 1
Note: This AMC-ELA is numbered in accordance with the numbering of the subparagraphs of point 21.A.139(b)(1).
These minimum means are considered to be acceptable unless repeated non-conformities show otherwise. The quality system should contain, as applicable, the following structured information that may be provided and embedded in various documents and systems.
(i) Information is provided that shows how control procedures for the issuing, approval, or change of documents are organised and practised. This information also specifies to which documents it is applicable. A practised method describes how the use of invalid or superseded information in production is prevented.
(ii) A practised method describes how and when the assessment and surveillance of any vendors and subcontractors are carried out. This information explains how this is controlled. The assessment and surveillance of vendors and subcontractors are only required in cases where the methods identified in (iii) below or in other production control mechanisms are not able to detect non-conformities with the applicable design data.
(iii) 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 can be achieved by one or more of the following practised methods:
— inspections of incoming articles;
— assessment and surveillance of vendors and subcontractors;
— other production control mechanisms that are able to detect non-conformities with the applicable design data.
(iv) Information is provided to show that procedures are practised that ensure the identification and traceability of parts and material in stock, in completed parts or in parts in process. Where the applicable design data specifies that parts require specific individual traceability, these parts are identified and records are kept.
(v) Information is provided for the procedures of the manufacturing process for:
— specific manufacturing process information as required in the applicable design data; and/or
— complementary procedures established by the production organisation.
Practised methods that use standard manufacturing processes do not require specific documentation.
If strict adherence to a manufacturing process is required in order to ensure that safety-critical product characteristics are met, this is specified in the manufacturing procedure.
(vi) Information is provided on the scope and sampling rate of production inspections and testing that, as a minimum, covers the inspection and testing that is defined as part of the applicable design data. If needed, it is complemented by inspections and testing as defined by the production organisation.
Information is provided for the flight test plan and flight conditions defined for the purpose of production acceptance flight tests, when applicable.
(vii) Information is provided on the tools, jigs and test equipment on which verification or calibration is performed and recorded. A statement that all other production tooling is controlled via practised methods is acceptable.
(viii) General practised methods are described that prevent the release of non-conforming products and their parts that would have an impact on the safe operation of the aircraft. Non- conformities are recorded in order to control the quality system.
(ix) General practised methods are described for adequate airworthiness coordination with the applicant for, or the holder of, the design approval. The documented DO/PO arrangement is used to define responsibilities.
(x) Information is provided about which production records are kept, and how completed records are kept in an adequately protected environment.
(xi) Information is provided that shows what the required competences and qualifications are for certifying staff, and how records on the certifying staff are kept.
(xii) Information is provided on the procedures to issue airworthiness release documents by the:
— identification of the persons permitted to issue airworthiness release documents; and
— identification of the relevant forms, and instructions for filling in the forms.
(xiii) Information is provided on the handling, storage and packaging methods that are adequate if:
— inappropriate handling, storage or packaging could lead to damage or deterioration;
— standard inspections prior to the use of the component would not detect defects; and
— such damage or deterioration would endanger the airworthiness of a component or a part.
(xiv) Information is provided on how internal quality audits and the resulting corrective action procedure are covered by practised surveillance mechanisms that allow the organisation to verify the efficiency of all the elements of the quality system as per this listing.
(xv) Work conducted in places other than the ‘major place of activity’ and the premises specified in the POE should be approved by the accountable manager, who must ensure that the critical process parameters for the work conducted, such as the light, temperature, humidity, etc., and adequate tooling, are identified and considered. Work conducted at such a location cannot be of a kind that would be performed at a ‘major place of activity’. The information on this kind of work is considered to be a change to the production approval, and it requires approval.
(xvi) Work carried out after the completion of the product, but prior to its delivery, is conducted according to the same definitions and procedures and by the same staff as are relevant for the regular production process. It is the responsibility of the accountable manager to ensure the adherence to this requirement.
(xvii) A workflow is defined that shows how to issue flight conditions and permits to fly (PtFs) for the purpose of the production flight testing of new production aircraft. When the flight test plan, the completed flight conditions and Forms 18a and 20b for the purpose of conducting the flight tests are provided as part of the approved type design, the workflow can be limited to:
— making the required entries in those documents (i.e. the reference to the individual aircraft S/N and the configuration);
— verification that the product configuration conforms with the definitions provided within the flight conditions document (which may be an integral part of the type inspection as part of the production workflow); and
— the issuing of the documents.
As part of the workflow, it should be defined that the production organisation can only issue flight conditions and PtFs for this case, and as long as this flight test plan and flight conditions can be fully adhered to.
When the production organisation issues flight conditions and PtFs for a purpose other than the production flight testing of new production aircraft, a flight test operations manual (FTOM) needs to be put in place, which should define the relevant workflows.
For companies that work as one consolidated team, it is sufficient to have one set of flight test procedures that have been established on the basis of an FTOM within either the design or the production organisation.