(a) The organisation shall establish a safety and quality policy for the organisation to be included in the exposition under point 145.A.70.
AMC 145.A.65(a) Safety and quality policy
The safety and quality policy should as a minimum include a statement committing the organisation to:
— Recognise safety as a prime consideration at all times.
— Apply Human factors principles.
— Encourage personnel to report maintenance related errors/incidents.
— Recognise that compliance with procedures, quality standards, safety standards and regulations is the duty of all personnel.
— Recognise the need for all personnel to cooperate with the quality auditors.
145.A.65(b) Organisational procedures
(b) The organisation shall establish procedures agreed by the competent authority taking into account human factors and human performance to ensure good maintenance practices and compliance with the applicable requirements established in 145.A.25 to 145.A.95. The procedures under this point shall:
1. ensure that a clear work order or contract has been agreed between the organisation and the organisation requesting maintenance to clearly establish the maintenance to be carried out so that aircraft and components may be released to service in accordance with 145.A.50; and,
GM 145.A.65(b)(1) Maintenance contract
Appendix XI to AMC M.A.708(c) or Appendix IV to AMC1 CAMO.A.315(c) provide guidance on the elements that need to be considered for the maintenance contract between the CAMO and the maintenance organisation. The Part-145 organisation should take into account these elements to ensure that a clear contract or work order has been concluded before providing maintenance services.
2. cover all aspects of carrying out maintenance, including the provision and control of specialised services and lay down the standards to which the organisation intends to work.
AMC 145.A.65(b)(2) Specialised servises
Specialised services include any specialised activity, such as, but not limited to non-destructive testing requiring particular skills and/or qualification. 145.A.30(f) covers the qualification of personnel but, in addition, there is a need to establish maintenance procedures that cover the control of any specialised process.
AMC 145.A.65(b) Maintenance procedures
1. Maintenance procedures should be held current such that they reflect best practice within the organisation. It is the responsibility of all organisation’s employees to report any differences via their organisation’s internal occurrence reporting mechanisms.
2. All procedures, and changes to those procedures, should be verified and validated before use where practicable.
3. All technical procedures should be designed and presented in accordance with good human factors principles.
145.A.65(c) Quality system
(c) The organisation shall establish a quality system that includes the following:
1. Independent audits in order to monitor compliance with required aircraft/aircraft component standards and adequacy of the procedures to ensure that such procedures invoke good maintenance practices and airworthy aircraft/aircraft components. In the smallest organisations the independent audit part of the quality system may be contracted to another organisation approved under this Part or a person with appropriate technical knowledge and proven satisfactory audit experience; and
AMC 145.A.65(c)(1) Independent quality system
1. The primary objectives of the quality system are to enable the organisation to ensure that it can deliver a safe product and that organisation remains in compliance with the requirements.
2. An essential element of the quality system is the independent audit.
3. The independent audit is an objective process of routine sample checks of all aspects of the organisation’s ability to carry out all maintenance to the required standards and includes some product sampling as this is the end result of the maintenance process. It represents an objective overview of the complete maintenance related activities and is intended to complement the 145.A.50(a) requirement for certifying staff to be satisfied that all required maintenance has been properly carried out before issue of the certificate of release to service. Independent audits should include a percentage of random audits carried out on a sample basis when maintenance is being carried out. This means some audits during the night for those organisations that work at night.
4. Except as specified in sub-paragraphs 7 and 9, the independent audit should ensure that all aspects of Part-145 compliance are checked every 12 months and may be carried out as a complete single exercise or subdivided over the 12 month period in accordance with a scheduled plan. The independent audit does not require each procedure to be checked against each product line when it can be shown that the particular procedure is common to more than one product line and the procedure has been checked every 12 months without resultant findings. Where findings have been identified, the particular procedure should be rechecked against other product lines until the findings have been rectified after which the independent audit procedure may revert back to 12 monthly for the particular procedure.
5. Except as specified otherwise in subparagraphs 7, the independent audit should sample check one product on each product line every 12 months as a demonstration of the effectiveness of maintenance procedures compliance. It is recommended that procedures and product audits be combined by selecting a specific product example, such as an aircraft or engine or instrument and sample checking all the procedures and requirements associated with the specific product example to ensure that the end result should be an airworthy product.
For the purpose of the independent audit, a product line includes any product under an Appendix II approval class rating as specified in the approval schedule issued to the particular organisation.
It therefore follows for example that a maintenance organisation approved under Part-145 with a capability to maintain aircraft, repair engines, brakes and autopilots would need to carry out four complete audit sample checks each year except as specified otherwise in subparagraphs 5, 7 or 9.
6. The sample check of a product means to witness any relevant testing and visually inspect the product and associated documentation. The sample check should not involve repeat disassembly or testing unless the sample check identifies findings requiring such action.
7. Except as specified otherwise in sub-paragraph 9, where the smallest organisation, that is an organisation with a maximum of 10 personnel actively engaged in maintenance, chooses to contract the independent audit element of the quality system in accordance with 145.A.65(c)(1) it is conditional on the audit being carried out twice in every 12 month period.
8. Except as specified otherwise in sub-paragraph 9, where the organisation has line stations listed as per 145.A.75(d) the quality system should describe how these are integrated into the system and include a plan to audit each listed line station at a frequency consistent with the extent of flight activity at the particular line station. Except as specified otherwise in sub-paragraph 9 the maximum period between audits of a particular line station should not exceed 24 months.
9. Except as specified otherwise in sub-paragraph 5, the competent authority may agree to increase any of the audit time periods specified in this AMC 145.A.65(c)(1) by up to 100% provided that there are no safety related findings and subject to being satisfied that the organisation has a good record of rectifying findings in a timely manner.
10. A report should be raised each time an audit is carried out describing what was checked and the resulting findings against applicable requirements, procedures and products.
11. The independence of the audit should be established by always ensuring that audits are carried out by personnel not responsible for the function, procedure or products being checked. It therefore follows that a large maintenance organisation approved under Part-145, being an organisation with more than about 500 maintenance staff should have a dedicated quality audit group whose sole function is to conduct audits, raise finding reports and follow up to check that findings are being rectified. For the medium sized maintenance organisation approved under Part-145, being an organisation with less than about 500 maintenance staff, it is acceptable to use competent personnel from one section/department not responsible for the production function, procedure or product to audit the section/department that is responsible subject to the overall planning and implementation being under the control of the quality manager. Organisations with a maximum of 10 maintenance staff actively engaged in carrying out maintenance may contract the independent audit element of the quality system to another organisation or a qualified and competent person approved by the competent authority.
GM 145.A.65(c)(1) Working audit plan
1. The purpose of this GM is to give guidance on just one acceptable working audit plan to meet part of the needs of 145.A.65(c)1. There is any number of other acceptable working audit plans.
2. The proposed plan lists the subject matter that should be covered by the audit and attempts to indicate applicability in the various types of workshops and aircraft facilities. The list should therefore be tailored for the particular situation and more than one list may be necessary. Each list should be shown against a timetable to indicate when the particular item is scheduled for audit and when the audit was completed.
Note 1: ‘if appl.’ means ‘if applicable or relevant’.
Note 2: In the case of line stations, all line stations should be audited at the frequency agreed with the competent authority within the limits of AMC 145.A.65(c)(1).
GM1 145.A.65(c)(1) and 145.B.30 The use of information and communication technologies (ICT) for performing remote audits
This GM provides technical guidance on the use of remote information and communication technologies (ICT) to support:
— competent authorities when overseeing regulated organisations;
— regulated organisations when conducting internal audits / monitoring compliance of their organisation with the relevant requirements, and when evaluating vendors, suppliers and subcontractors.
In the context of this GM:
— ‘remote audit’ means an audit that is performed with the use of any real-time video and audio communication tools instead of the physical presence of the auditor on-site; the specificities of each type of approval need to be considered in addition to the general overview (described below) when applying the ‘remote audit’ concept;
— ‘auditing entity’ means the competent authority or organisation that performs the remote audit;
— ‘auditee’ meansthe entity being audited/inspected (or the entity audited/inspected by the auditing entity via a remote audit);
It is the responsibility of the auditing entity to assess whether the use of remote ICT constitutes a suitable alternative to the physical presence of an auditor on-site in accordance with the applicable requirements.
The conduct of a remote audit
The auditing entity that decides to conduct a remote audit should describe the remote audit process in its documented procedures and should consider at least the following elements:
— The methodology for the use of remote ICT is sufficiently flexible and non-prescriptive in nature to optimise the conventional audit process.
— Adequate controls are defined and are in place to avoid abuses that could compromise the integrity of the audit process.
— Measures to ensure that the security and confidentiality are maintained throughout the audit activities (data protection and intellectual property of the organisation also need to be safeguarded).
Examples of the use of remote ICT during audits may include but are not limited to:
— meetings by means of teleconference facilities, including audio, video and data sharing;
— assessment of documents and records by means of remote access, in real time;
— recording, in real time during the process, of evidence to document the results of the audit, including non-conformities, by means of exchange of emails or documents, instant pictures, video or/and audio recordings;
— visual (livestream video) and audio access to facilities, stores, equipment, tools, processes, operations, etc.
An agreement between the auditing entity and the auditee should be established when planning a remote audit, which should include the following:
— determining the platform for hosting the audit;
— granting security and/or profile access to the auditor(s);
— testing platform compatibility between the auditing entity and the auditee prior to the audit;
— considering the use of webcams, cameras, drones, etc. when the physical evaluation of an event (product, part, process, etc.) is desired or is necessary;
— establishing an audit plan which will identify how remote ICT will be used and the extent of their use for the audit purposes to optimise their effectiveness and efficiency while maintaining the integrity of the audit process;
— if necessary, time zone acknowledgement and management to coordinate reasonable and mutually agreeable convening times;
— a documented statement of the auditee that they shall ensure full cooperation and provision of the actual and valid data as requested, including ensuring any supplier or subcontractor cooperation, if needed; and
— data protection aspects.
The following equipment and set-up elements should be considered:
— the suitability of video resolution, fidelity, and field of view for the verification being conducted;
— the need for multiple cameras, imaging systems, or microphones, and whether the person that performs the verification can switch between them, or direct them to be switched and has the possibility to stop the process, ask a question, move the equipment, etc.;
— the controllability of viewing direction, zoom, and lighting;
— the appropriateness of audio fidelity for the evaluation being conducted; and
— real-time and uninterrupted communication between the person(s) participating to the remote audit from both locations (on-site and remotely).
When using remote ICT, the auditing entity and the other persons involved (e.g. drone pilots, technical experts) should have the competence and ability to understand and utilise the remote ICT tools employed to achieve the desired results of the audit(s)/assessment(s). The auditing entity should also be aware of the risks and opportunities of the remote ICT used and the impacts they may have on the validity and objectivity of the information gathered.
Audit reports and related records should indicate the extent to which remote ICT have been used in conducting remote audits and the effectiveness of remote ICT in achieving the audit objectives, including any item that has not been able to be completely reviewed.
2. A quality feedback reporting system to the person or group of persons specified in point 145.A.30(b) and ultimately to the accountable manager that ensures proper and timely corrective action is taken in response to reports resulting from the independent audits established to meet point (1).
AMC 145.A.65(c)(2) Feedback system
1. An essential element of the quality system is the quality feedback system.
2. The quality feedback system may not be contracted to outside persons. The principal function of the quality feedback system is to ensure that all findings resulting from the independent quality audits of the organisation are properly investigated and corrected in a timely manner and to enable the accountable manager to be kept informed of any safety issues and the extent of compliance with Part-145.
3. The independent quality audit reports referenced in AMC 145.A.65(c)(1) sub-paragraph 10 should be sent to the relevant department(s) for rectification action giving target rectification dates. Rectification dates should be discussed with such department(s) before the quality department or nominated quality auditor confirms such dates in the report. The relevant department(s) are required by 145.A.65(c)(2) to rectify findings and inform the quality department or nominated quality auditor of such rectification.
4. The accountable manager should hold regular meetings with staff to check progress on rectification except that in the large organisations such meetings may be delegated on a day to day basis to the quality manager subject to the accountable manager meeting at least twice per year with the senior staff involved to review the overall performance and receiving at least a half yearly summary report on findings of non-compliance.
5. All records pertaining to the independent quality audit and the quality feedback system should be retained for at least 2 years after the date of clearance of the finding to which they refer or for such periods as to support changes to the AMC 145.A.65(c)(1) sub-paragraph 9 audit time periods, whichever is the longer.
Does the Part-145 or Part-CAO quality system need to be subject to monitoring?
Yes, the quality system is part of the activities of the Part-145 organisation and therefore it should be monitored. Point 145.A.65 (c) or CAO.A.100 (b) (1) requires that the quality system monitors that the activities are (being) performed in accordance with the approved procedures. The quality system procedures are included within these approved procedures. This implies that quality system must be subject to audits and the Part-145 or Part-CAO organisation audit programme/plan needs to reflect this. Besides that, the audits of the quality system shall satisfy the requirement of independent audits. This is further explained in AMC 145.A.65(c)(1) point 11: the independence of the audits should be established by always ensuring that audits are carried out by personnel not responsible for the functions, procedures or products being checked. So, the quality manager cannot audit the quality system in terms of independence of the audit. For Part-CAO this subject is explained in AMC1 CAO.A.100(b). Therefore, to audit the quality system, it is acceptable to: use competent personnel from a different section/department in the same organisation not responsible for the quality function/procedure, or, contract the independent audit element of the quality system to another organisation or a qualified competent person. The way the quality system is going to be audited has to be described in the MOE or CAE and approved by the competent authority.