AMC1 ORA.GEN.200(a)(6) Management system

ED Decision 2012/007/R

COMPLIANCE MONITORING - GENERAL

(a) Compliance monitoring

The implementation and use of a compliance monitoring function should enable the organisation to monitor compliance with the relevant requirements of this Part and other applicable Parts.

(1) The organisation should specify the basic structure of the compliance monitoring function applicable to the activities conducted.

(2) The compliance monitoring function should be structured according to the size of the organisation and the complexity of the activities to be monitored.

(b) Organisations should monitor compliance with the procedures they have designed to ensure safe activities. In doing so, they should as a minimum, and where appropriate, monitor:

(1) privileges of the organisation;

(2) manuals, logs, and records;

(3) training standards;

(4) management system procedures and manuals.

(c) Organisational set up

(1) To ensure that the organisation continues to meet the requirements of this Part and other applicable Parts, the accountable manager should designate a compliance monitoring manager. The role of the compliance monitoring manager is to ensure that the activities of the organisation are monitored for compliance with the applicable regulatory requirements , and any additional requirements as established by the organisation, and that these activities are being carried out properly under the supervision of the relevant head of functional area.

(2) The compliance monitoring manager should be responsible for ensuring that the compliance monitoring programme is properly implemented, maintained and continually reviewed and improved.

(3) The compliance monitoring manager should:

(i) have direct access to the accountable manager;

(ii) not be one of the other persons referred to in ORA.GEN.210(b);

(iii) be able to demonstrate relevant knowledge, background and appropriate experience related to the activities of the organisation; including knowledge and experience in compliance monitoring; and

(iv) have access to all parts of the organisation, and as necessary, any contracted organisation.

(4) In the case of a non-complex organisation, this task may be exercised by the accountable manager provided he/she has demonstrated having the related competence as defined in (c)(3)(iii).

(5) In the case the same person acts as compliance monitoring manager and as safety manager, the accountable manager, with regards to his/her direct accountability for safety, 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.

(6) The independence of the compliance monitoring function should be established by ensuring that audits and inspections are carried out by personnel not responsible for the function, procedure or products being audited.

(d) Compliance monitoring documentation

(1) Relevant documentation should include the relevant part(s) of the organisation’s management system documentation.

(2) In addition, relevant documentation should also include the following:

(i) terminology;

(ii) specified activity standards;

(iii) a description of the organisation;

(iv) the allocation of duties and responsibilities;

(v) procedures to ensure regulatory compliance;

(vi) the compliance monitoring programme, reflecting:

(A) schedule of the monitoring programme;

(B) audit procedures;

(C) reporting procedures;

(D) follow-up and corrective action procedures; and

(E) recording system.

(vii) the training syllabus referred to in (e)(2);

(viii) document control.

(e) Training

(1) Correct and thorough training is essential to optimise compliance in every organisation. In order to achieve significant outcomes of such training, the organisation should ensure that all personnel understand the objectives as laid down in the organisation’s management system documentation.

(2) Those responsible for managing the compliance monitoring function should receive training on this task. Such training should cover the requirements of compliance monitoring, manuals and procedures related to the task, audit techniques, reporting and recording.

(3) Time should be provided to train all personnel involved in compliance management and for briefing the remainder of the personnel.

(4) The allocation of time and resources should be governed by the volume and complexity of the activities concerned.