21.A.245 Resources

HEAD OF THE DESIGN ORGANISATION

(a)The head of the design organisation (HDO) should:

(1)have sufficient knowledge and authority to be able to respond to the competent authority regarding major issues concerning the design organisation (DO) and the product design approval, and to carry out any necessary improvements;

(2)promote the safety policy that is specified in AMC1 21.A.239(c)(1); and

(3)demonstrate a Part 21 understanding that is sufficient to discharge the relevant responsibilities.

(b)The handbook that is submitted in accordance with point 21.A.243 should show that the HDO has the direct or functional responsibility for all the departments of the organisation which are responsible for the design of the product. If the departments responsible for design are functionally linked, the HDO still has the ultimate responsibility for compliance of the DO with Part 21. NOTE: When the HDO has no direct control on the resources necessary for the proper functioning of the design organisation, then a senior company manager should provide these resources. To confirm such commitment, the senior company manager should sign, along with the HDO, the binding statement (see AMC1 21.A.243(a), point (b)(20) and GM 21.A.265(b)).

NOMINATED MANAGERS

(a)The person or group of persons nominated in accordance with point 21.A.245(b) should represent the management structure of the organisation and be responsible for all the functions as specified in Part 21, Subpart J.

(b)The nominated managers should be identified (see GM1 21.A.243(d)).

(c)The responsibilities and the duties of each individual manager should be defined.

(d)The independent monitoring function should be independent from the design and airworthiness functions. As such, the chief of the independent monitoring function should not be at the same time one of the other persons that are referred to in point 21.A.245(b)(1) or (b)(3), except for the safety manager. If the same person is designated to manage both the independent monitoring function and safety-management-related processes and tasks, the head of the design organisation (HDO), in order to discharge their safety accountability, should ensure that sufficient resources are allocated to both functions, taking into account the size of the organisation, and the nature and complexity of its activities.

(e)Chief of the airworthiness function If more than one team, including their management, are designated for the airworthiness function as defined in point 21.A.239(d)(1)(i), the HDO should identify the person that acts as the unique focal point for the entire design organisation (DO), i.e. the ‘chief of the airworthiness function’. The need to designate more than one team may be triggered by the specific scope and volume of activity of the DO. For example: managing several lines of products (separate airworthiness representative per line of product); and division between initial and continued airworthiness activities. The tasks for which the chief of the airworthiness function should be responsible are presented in AMC1 21.A.239(d), point (c)(1)(iv).

(f)Chief of the independent monitoring function The role of the chief of the independent monitoring function should be to ensure that:

(1)the activities of the organisation are monitored for compliance with the applicable requirements and any additional requirements as established by the organisation, and that those activities are performed properly under the supervision of the nominated persons that are referred to in point 21.A.245(b);

(2)an audit plan is properly implemented, maintained, and continually reviewed and improved; and

(3)corrections and corrective action are requested, as necessary.

(g)Safety manager If more than one person is designated for the development, administration, and maintenance of effective safety management processes as defined in point 21.A.239(c)(2), the HDO should identify the ‘safety manager’ as the unique focal point. The role of the safety manager should be:

(1)to facilitate hazard identification, as well as risk assessment and management;

(2)to monitor the implementation of action taken to mitigate risks, as listed in the safety action plan, unless action follow-up is addressed by the independent monitoring function;

(3)to provide periodic reports on safety performance to the safety review board (the functions of the safety review board are defined in AMC1 21.A.239(c)(2));

(4)to ensure the maintenance of safety management documentation;

(5)to ensure that there is safety training available, and that it meets acceptable standards;

(6)to provide advice on safety matters; and

(7)to ensure the initiation and follow-up of internal investigations of occurrences.

DIRECT SUPERVISION OF THE AIRWORTHINESS FUNCTION BY THE HEAD OF THE DESIGN ORGANISATION To cope with unexpected circumstances, for a period of time, it is possible for the head of the design organisation (HDO) to directly supervise the airworthiness function activities. This period of time should be limited and should typically not exceed 6 months. Such a situation should be discussed with EASA and may be subject to certain limitations (e.g. only continued airworthiness activities may be allowed).

MANAGEMENT REPORTING LINES AND COMPETENCIES

(a)Managers that are nominated in accordance with point 21.A.245(b) should report directly to the HDO through either a hierarchical or a formal functional link.

(b)All prospective members of the design management staff and staff that is nominated in accordance with point 21.A.245(b) should:

(1)be assessed for their competency, qualifications, and capabilities that are related to their intended duties;

(2)be able to demonstrate their knowledge of, and compliance with, the design management organisation procedures that are applicable to their tasks; and

(3)be able to demonstrate an understanding of the safety management principles, as well as human factors (HF) issues and human performance (HP) issues that are related to their tasks.

(c)The chief of the airworthiness function should be able to demonstrate relevant knowledge, background, and appropriate experience that are related to the product certification and continued airworthiness, including knowledge of, and experience in, managing the design assurance system.

(d)The chief of the independent monitoring function should be able to demonstrate relevant knowledge, background, and appropriate experience that are related to the activities of the organisation, including knowledge of, and experience in, independent system monitoring.

(e)The competency of the person that assumes (or the persons that assume) the function of the safety manager should include, but not be limited to, the following:

(1)knowledge of the International Civil Aviation Organization (ICAO) standards and EU requirements for safety management;

(2)an understanding of management systems, including compliance monitoring systems;

(3)an understanding of risk management;

(4)an understanding of safety investigation techniques;

(5)an understanding of HF, including HP and limitations;

(6)an understanding of a positive safety culture and of its promotion; and

(7)operational experience related to the activities of the organisation.

STAFF, FACILITIES, AND COORDINATION

(a)General The handbook that is submitted in accordance with point 21.A.243 should show that sufficient skilled personnel are available, and that suitable technical and organisational provisions are made for carrying out the type investigation that is defined in GM1 21.A.239(d), point (b)(3).

(b)Personnel The organisation should show that the personnel that is available to comply with point 21.A.245(e)(1) are able, based on their special qualifications and numbers, to provide assurance of the design or modification of a product, as well as of the compilation and verification of all the data that is needed to meet the applicable type certification basis, operational suitability data (OSD) certification basis, and environmental protection requirements, while taking into account the state of the art and new experience. The organisation should have a system in place to plan the availability of staff to ensure that the organisation has sufficient appropriately qualified staff to plan, perform, supervise, inspect, and monitor the organisation’s activities in accordance with the organisation’s terms of approval.

(c)Technical The organisation should have access to:

(1)workshops and production facilities that are suitable for manufacturing prototype models and test specimens; and

(2)accommodation and test facilities that are suitable for carrying out the tests and measurements that are needed to demonstrate compliance with the type certification basis, OSD certification basis, and environmental protection requirements; the test facilities may be subject to additional technical conditions that are related to the nature of the tests performed.

(d)Organisation The handbook that is submitted in accordance with point 21.A.243 should show that:

(1)the responsibilities for all the tasks that are related to the certification process are assigned in such a way that gaps in authority are excluded;

(2)the responsibility for a number of tasks as in point (d)(1) may be assigned to one person, especially in cases of simple projects; and

(3)coordination between technical departments and the persons in charge of the system monitoring that is required by point 21.A.239(e) is established:

(i)to ensure the quick and efficient reporting and resolution of difficulties that are encountered using the handbook and associated procedures;

(ii)to maintain the design management system; and

(iii)to optimise auditing activities.

(e)Competency and training

(1)The organisation should establish and control the competency of the staff that is involved in the activities of the organisation, as detailed in the organisation’s terms of approval, in accordance with documented procedures. In addition to the necessary expertise that is related to the job function, the competency of the staff should include an understanding of safety management and human factors (HF) principles, which is appropriate to the staff member’s function and responsibilities in the organisation.

(2)To assist in the assessment of competency and to perform the analysis of the training needs, job (job family) descriptions are recommended, which should contain sufficient criteria to enable the required competency assessment throughout the duration of the employment/contract.

(3)The organisation should develop a procedure that describes the process for assessing the competency of the staff. The procedure should specify:

(i)the staff that are responsible for that process;

(ii)the means and methods for the initial assessment;

(iii)the means and methods for the continuous control of the competency of the personnel, including feedback on their performance;

(iv)the action to be taken if the assessment is not satisfactory; and

(v)how to record assessment results.

(4)Adequate initial and recurrent training should be provided in relation to the job function to ensure that staff remain competent. This training should be adapted based on experience that is gained within the organisation (for safety training, refer also to AMC1 21.A.239(c)(5)(i)).

(5)The organisation should record the training that is provided as described in point (e)(4).