What Does EASA Expect within a Quality System which covers EASA Part M?

This document considers the roles and responsibilities within the Part M environment. Please note that when EASA refers to the Quality System it is considering both the role of Quality Control QC and Quality Assurance QA.

M.A.712 Quality system Regulations

(a) To ensure that the approved continuing airworthiness management organisation continues to meet the requirements of this Subpart, it shall establish a quality system and designate a quality manager to monitor compliance with, and the adequacy of, procedures required to ensure airworthy aircraft. Compliance monitoring shall include a feedback system to the accountable manager to ensure corrective action as necessary.

(b) The quality system shall monitor activities carried out under Section A, Subpart G of this Annex (Part-M). It shall at least include the following functions:

1. monitoring that all activities carried out under Section A, Subpart G of this Annex (Part M) are being performed in accordance with the approved procedures, and;

2. monitoring that all contracted maintenance is carried out in accordance with the contract, and;

3. monitoring the continued compliance with the requirements of this Part.

Consider that there is a difference between the term monitoring and auditing – monitoring implies an ongoing oversight of a given process and auditing is a “sample” measured against a set of criteria or a standard.

(c) The records of these activities shall be stored for at least two years.

(d) Where the approved continuing airworthiness management organisation is approved in accordance with another Part, the quality system may be combined with that required by the other Part.

This means for example that an operator could combine the Quality Management of the Operations Environment with that of the Part M and or Part 145 environment.

(e) For licenced air carriers in accordance with Regulation (EC) No 1008/2008 the M.A. Subpart G quality system shall be an integrated part of the operator's quality system.

This requirement identifies that need to have a single “common” quality system although of course it is possible to have multiple quality managers.

(f) In the case of a small organisation not managing the continuing airworthiness of aircraft used by licenced air carriers in accordance with Regulation (EC) No 1008/2008, the quality system may be replaced by regular organisational reviews subject to the approval of the competent authority, except when the organisation issues airworthiness review certificates for aircraft above 2730 kg MTOM other than balloons.

In the case where there is no quality system, the organisation shall not contract continuing airworthiness management tasks to other parties.

AMC M.A.712(a) Quality system

1.Procedures should be held current such that they reflect best practice within the organisation. It is the responsibility of all employees to report any difficulties with the procedures via their organisation’s internal occurrence reporting mechanisms.

Please note the reference to procedures refers not just to Quality Procedures but to all organisational procedures which together support the effective delivery of the business process

2. All procedures, and changes to the procedures, should be verified and validated before use where practicable.

 Procedures are “owned by the business area leaders and ultimately the “nominated person” within a particular business area.

3. The feedback part of the system should address who is required to rectify any non-compliance in each particular case and the procedure to be followed if rectification is not completed within appropriate timescales.

The procedure should lead to the accountable manager specified in M.A.706.

The accountable manager within the EASA system is directly responsible to ensure financing of any aspect of the business which directly contributes to the showing of compliance with regulatory requirements.

Also consider that non-compliance identified during a quality audit is an indication of a potential business area issue which also needs to be addressed – to consider the why (5 whys)

4. The independent quality audit reports referenced in AMC M.A.712(b) should be sent to the relevant department for rectification action giving target rectification dates.

Rectification dates should be discussed with such department before the quality department or nominated quality auditor confirms such dates in the report.

The relevant department is required to rectify findings and inform the quality manager or the quality auditor of such rectification.

Please Note it is important that any findings are understood by the relevant department “owner “ and agreed. A lack of agreement would lead to the involvement of either the Nominated Person or AM to ensure an acceptable resolution (we cannot INFLICT findings they should be accepted )

5. 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.

So the term regular in the above context is meant to mean at least twice per year, ideally follow up 3 monthly status meetings would add considerable “value” and keep the process moving in the right direction.

AMC M.A.712(b) Quality System

1. The primary objectives of the quality system are to enable the CAMO to ensure airworthy aircraft and to remain in compliance with the Part-M 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 CAMO ability to carry out continuing airworthiness management to the required standards.

Ref the mention of a “Standard” in fact all compliance audits are referenced to a standard and the need to be able to demonstrate that the procedure, process, activity or product remains fully compliant.

 It includes some product sampling as this is the end result of the process.

4. The independent audit represents an objective overview of the complete continuing airworthiness management related activities.

It is intended to complement the M.A.902 requirement for an airworthiness review to be satisfied that all aircraft managed by the organisation remain airworthy.

Note that this essentially requires an independent review of all elements which together form the airworthiness review. How is this evidenced in your organisation?

5. The independent audit should ensure that all aspects of M.A. Subpart G compliance are checked annually, including all the sub-contracted activities, and may be carried out as a complete single exercise or subdivided over the annual period in accordance with a scheduled plan.

More is usually better as it allows for a progressive delivery of the program with the likelihood of a smaller but more frequent level of findings

Note the “all aspects” element has been modified in the case of Reg 965/2013 Operations Quality System to allow for a more effective approach which is related to the level of findings.

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 year 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 the annual interval for the particular procedure.

Provided that there are no safety related findings, the audit time periods specified in this AMC may be increased by up to 100% subject to agreement by the competent authority.

6. Where the organisation has more than one location approved the quality system should describe how these are integrated into the system and include a plan to audit each location every year.

7. 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.

 8. 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.

9. An organisation should establish a quality plan acceptable to the competent authority to show when and how often the activities as required by M.A. Subpart G will be audited.

The audit Plan is usually presented on an annual basis and is updated based on the need to perform additional audits.

AMC M.A.712(f) Quality system A small organisation is considered to be an organisation with up to 5 full-time staff (including all M.A.706 personnel) or equivalent proportional number when using part-time staff.

The complexity of the organisation, combination of aircraft and aircraft types, the utilisation of the aircraft and the number of approved locations of the organisations should also be considered before replacing the quality system by an organisational review.

Appendix XIII to this AMC should be used to manage the organisational reviews.

The following activities should not be considered as subcontracting and, as a consequence, they may be performed without a quality system, although they need to be described in the continuing airworthiness management exposition and be approved by the competent authority:

- Subscription to a technical publisher that provides maintenance data (Aircraft Maintenance Manuals, Illustrated Parts Catalogues, Service Bulletins, etc.), which may be applicable to a wide range of aircraft.

These data may include maintenance schedules recommended by different manufacturers that can be afterwards used by the continuing airworthiness management organisation in order to produce customised maintenance programmes.

- Contracting the use of a software tool for the management of continuing airworthiness data and records, under the following conditions (in addition to M.A.714(d) and (e)):

- If the tool is used by several organisations, each organisation should have access to its own data only.

 - Introduction of data can only be performed by personnel of the continuing airworthiness management organisation.

 - The data can be retrieved at any time.