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GM1 Annex I Definitions

ED Decision 2022/021/R

For the purpose of the Acceptable Means of Compliance (AMC) and Guidance Material (GM) to AnnexĀ I (PartĀ 21) to Regulation (EU)Ā NoĀ 748/2012, the following definitions apply:

Audit

It refers to a systematic, independent, and documented process for obtaining evidence and objectively evaluating it to determine the extent to which the requirements are complied with.

Note: audits may include inspections.

Assessment

In the context of management system performance monitoring, continuous improvement, and oversight, it refers to a planned and documented activity that is performed by competent personnel to evaluate and analyse the achieved level of performance and maturity in relation to the organisation’s policy and objectives.

Note: an assessment focuses on desirable outcomes and the overall performance, looking at the organisation as a whole. The main objective of the assessment is to identify the strengths and weaknesses to drive continual improvement.

Remark: for ā€˜risk assessment’, please refer to the definition below.

Certificate

It is any certificate, approval, licence, authorisation, attestation or other document that is issued as the outcome of the certification process, which attests compliance with the applicable requirements.

Competency

It is a combination of individual skills, practical and theoretical knowledge, attitude, training, and experience.

Correction

It is the action to eliminate detected non-compliance.

Corrective action

It is the action to eliminate or mitigate the root cause(s) and prevent the recurrence of existing detected non-compliance, or of any other undesirable condition or situation. Proper determination of the root cause(s) is crucial for defining effective corrective action to prevent reoccurrence.

Error

It is a person’s action or inaction that may lead to deviations from the accepted procedures or regulations.

Note: errors are often associated with occasions when a planned sequence of mental or physical activities either fails to achieve its intended outcome, or is not appropriate with regard to the intended outcome, and when results cannot be attributed purely to chance.

Fatigue

It is a physiological state of reduced mental or physical performance capability, resulting from sleep loss or extended wakefulness, circadian phase, or workload (mental and/or physical activity), which can impair a person’s alertness and ability to safely perform their tasks.

Hazard

It is a condition or an object with the potential to cause, or contribute to, an aircraft incident or accident.

Human factors (HF)

It is anything that affects human performance, which means principles that apply to aeronautical activities, and which seek safe interface between the human and other system components by proper consideration of human performance (ref. ICAOĀ DocĀ 10151 — Human Performance (HP) Manual for Regulators[7]).

Human performance (HP)

It refers to human capabilities and limitations that have an impact on the safety and efficiency of aeronautical activities (ref. ICAOĀ DocĀ 10151 — Human Performance (HP) Manual for Regulators[8]).

Inspection

In the context of compliance monitoring and oversight, it refers to an independent and documented conformity evaluation by observation and judgement, which is accompanied, as appropriate, by measurements, testing or gauging, in order to verify compliance with the applicable requirements.

Note: inspection may be part of an audit (e.g. product audit), but may also be conducted outside the normal audit plan; for example, to verify the closure of a particular finding.

ā€˜Just culture’

Ref. ArticleĀ 2 of RegulationĀ (EU) NoĀ 376/2014[9].

Near miss

It is an event in which an occurrence to be mandatorily reported according to Regulation (EU)Ā NoĀ 376/2014 was narrowly averted or avoided.

Example: a staff member, on rechecking their work at the end of a task, realises that one work card step was not properly carried out.

Organisational factor

It is a condition that affects the effectiveness of safety risk controls, and is related to the culture, policies, processes, resources, and the workplace of an organisation.

Oversight planning cycle

It refers to the time frame within which the areas of the approval and the processes that are identified through a risk assessment should be reviewed by the competent authority by means of audits and inspections.

Oversight programme

It refers to the detailed oversight schedule that defines the number of audits and other activities, including the scope and duration of each activity, as well as the details of product audits and locations, as appropriate, to be performed by the competent authority, and to the tentative time frame for performing each activity.

Preventive action

It is the action to eliminate the cause of potential non-compliance, or any other undesirable potential situation.

Risk assessment

It is an evaluation that is based on engineering and operational judgement and/or analysis methods in order to establish whether the achieved or perceived risk is acceptable or tolerable.

Safety culture

It is an enduring set of values, norms, attitudes, and practices within an organisation, which is concerned with minimising the exposure of the workforce and the general public to dangerous or hazardous conditions. In a positive safety culture, a shared concern for, commitment to, and accountability for, safety is promoted.

Safety risk

It refers to the predicted probability and severity of the consequences or outcomes of a hazard.

Safety training

It refers to dedicated training to support safety management policies and processes, including HF training.

NoteĀ 1: the main objective of the safety training programme is to ensure that personnel at all levels of the organisation maintain their competency to fulfil their roles safely. Safety training should, in particular, consider the safety knowledge that is derived from hazard identification and risk management processes, and forster a positive safety culture.

NoteĀ 2: safety management training refers to specific training for the staff that are involved in safety management functions in accordance with pointsĀ 21.A.139(c) and 21.A.239(c) of PartĀ 21.

Working days

It refers to days between, and including, Monday and Friday, except public holidays.




[7] ICAO Document 10151 ā€˜Manual on Human Performance (HP) for Regulators’, First Edition, 2021.

[8] Ibid.

[9] Regulation (EU) NoĀ 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18) (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0376&qid=1669377456448).