GM-ELA No 4 to 21.A.131 Scope – Explanation of terms used in AMC-ELA    

CAA ORS9 Decision No. 1

‘A method needs to be practised’.

When AMC-ELA applies the principle that ‘a method needs to be practised’, it means that the applicant can show what is actually done in order to comply with a requirement in a practical but systematic way. The applicant is not expected to have an excessively detailed documented procedure. As a baseline, documented procedures for such ‘practised methods’ can be limited to a declaration of the principles that are considered within the practised method. For example, a declaration such as ‘Document control is ensured by the workflow management as part of the IT-based Document Management System (DMS)’, may be provided. This is acceptable when evidence is provided by work results, by the demonstration of satisfactory conduct during surveillance activities, or by similar means. When the actions that are continuously performed show that they do not satisfy the needs of the AMC, a more detailed and documented procedure may need to be implemented to rectify the situation.

‘Delegation of tasks and responsibilities’

AMC-ELA differentiates between the delegation of tasks and the delegation of responsibilities. For small and simple organisations, the delegation of responsibilities to specific and separate organisational positions can create overly burdensome administrative processes that do not reflect the operational reality. The AMC-ELA accepts that tasks can be delegated, while the responsibility formally remains with the delegator. This can increase efficiency, and it offers the possibility for the applicant to simplify procedures. A typical example is when the accountable manager delegates tasks, while keeping the responsibility associated with these tasks. If this situation is identified with respect to the individual requirements, this may significantly reduce the effort required for documentation, and it allows streamlined methods to be practised.

‘Consolidated team’

AMC-ELA makes reference to companies working in a ‘consolidated team’, mainly in relation to coordination between the design and production activities. Companies are considered to be working in consolidated teams if the following criteria apply:

— Even when a consolidated team spans across different legal entities, it acts as one organisation;

— A consolidated team is expected to work within one consolidated setup, and under one management, so that a free flow of information is inherently ensured;

— In a consolidated team, functions are not duplicated, so the same person(s) takes care of both the production and design aspects of any one function;

— Responsibilities are defined at the level of the person or the position, not at the level of the legal entity;

— Within consolidated teams, adequate coordination is expected to be present through ‘practised methods’, without any further written definitions of responsibilities beyond those elements that are explicitly described within AMC-ELA.