In order to show compliance with 18.104.22.168, an AMO should establish its quality system in accordance with the instruction and information contained in the following paragraphs.
The terms used in the context of the requirement for an AMO’s quality system have the following meaning:
Accountable Manager. The person acceptable to the Authority who has corporate authority for ensuring that all maintenance activities can be financed and carried out to the standard required by the Authority, and any additional requirements defined by the AMO.
Quality assurance. Quality assurance, as distinguished from quality control, involves activities in the business, systems, and technical audit areas. A set of predetermined, systemic actions which are required to provide adequate confidence that a product or service satisfies quality requirements.
1.2 Quality Policy.
1.2.1 An AMO shall establish a formal, written quality policy statement that is a commitment by the accountable manager as to what the quality system is intended to achieve. The quality policy should reflect the achievement and continued compliance with the [Model Regulations] together with any additional standards specified by the AMO.
1.2.2 The accountable manager is an essential part of the AMO management organisation. The term “accountable manager” is intended to mean the Chief Executive/President/Managing Director/ General Manager, etc. of the AMO, who by virtue of his or her position has overall responsibility (including financial) for managing the organisation.
1.2.3 The accountable manager will have overall responsibility for the AMO quality system, including the frequency, format and structure of the internal management evaluation activities as prescribed in paragraph 3.9 below.
1.3 Purpose of the Quality System.
1.3.1 The quality system should enable the AMO to monitor compliance with these [Model Regulations], the AMO’s manual system, and any other standards specified by the AMO, or the Authority, to ensure safe operations and airworthy aircraft.
1.4 Quality Manager.
1.4.1 The function of the quality manager to monitor compliance with, and the adequacy of, procedures required to ensure safe operational practices and airworthy aircraft as required by these [Model Regulations] may be carried out by more than one person by means of different, but complementary, quality assurance programmes.
1.4.2 The primary role of the quality manager is to verify, by monitoring activity in the field of, maintenance, that the standards required by the Authority, and any additional requirements defined by the AMO, are being carried out under the supervision of the relevant required management personnel.
1.4.3 The quality manager should be responsible for ensuring that the quality assurance programme is properly established, implemented and maintained.
1.4.4 The quality manager should:
Report to the accountable manager;
Not be one of the required management personnel; and
Have access to all parts of the AMO’s, and as necessary, any sub-contractor’s organisation.
1.4.5 In the case of small/very small AMO, the posts of the Accountable Manager and quality manager may be combined.
2.0 Quality System.
2.1.1 The AMO’s quality system should ensure compliance with and adequacy of operational and maintenance activities requirements, standards, and procedures.
2.1.2 The AMO should specify the basic structure of the quality system applicable to the operation.
2.1.3 The quality system should be structured according to the size and complexity of the organisation to be monitored.
2.2.1 As a minimum, the quality system should address the following:
The provisions of these [Model Regulations];
The AMO’s additional standards and operating practices;
The AMO’s quality policy;
The AMO’s organisational structure;
Responsibility for the development, establishment and management of the quality system;
Documentation, including manuals, reports and records;
The required financial, material and human resources;
2.2.2 The quality system should include a feedback system to the accountable manager to ensure that corrective actions are both identified and promptly addressed. The feedback system should also specify who is required to rectify discrepancies and non-compliance in each particular case, and the procedure to be followed if corrective action is not completed within an appropriate timescale.
2.3 Relevant Documentation.
2.3.1 Relevant documentation includes the relevant part of the operator’s manual system.
2.3.2 In addition, relevant document should include the following:
Specified maintenance standards;
A description of the organisation;
The allocation of duties and responsibilities;
Operational procedures to ensure regulatory compliance;
Accident prevention and flight safety programme;
The quality assurance programme, reflecting:
Schedule of the monitoring process;
Follow-up and corrective action procedures;
The training syllabus; and
3.0 Quality assurance programme.
3.1.1 The quality assurance programme should include all planned and systematic actions necessary to provide confidence that all maintenance is conducted in accordance with all applicable requirements, standards and l procedures.
3.1.2 When establishing a quality assurance programme, consideration should be given to at least the following:
Monitoring and corrective action;
3.2 Quality Inspection.
3.2.1 The primary purpose of a quality inspection is to observe a particular event/action/document, etc. in order to verify whether established procedures and requirements are followed during the accomplishment of that event and whether the required standard is achieved.
3.2.2 Typical subject areas for quality inspections are:
Facilities size and segregation;
Staff numbers and man-hour plan
Qualifying certifying staff;
Records of certifying staff;
Issue of authorisations
Equipment control and calibration;
Approved data held;
Modified maintenance data;
Data up to date;
Release document contents;
Details on work documents;
Operator’s copy of release;
Reporting unairworthy findings;
Clear work orders;
Procedures per AMO Procedures Manual;
Suppliers and subcontractors;
Acceptance of parts;
Parts control in stores;
Use of tools;
Control of repairs;
Aircraft Maintenance Programme completion;
Airworthiness directive control;
Control of alterations;
Control of working documents;
Base maintenance defects;
Defective parts to stores;
Parts to outside contractors;
Computer maintenance systems;
Line maintenance control parts;
Line servicing control;
Line defect control;
Aircraft Technical Log – Maintenance Records section completion;
Pool and loan parts;
Return defective parts to base;
Product maintenance exemption control;
Procedures deviation control;
Special services control (NDI);
Contractors working teams;
Privileges and locations control;
Control of changes.
3.2.3 Typical methods for quality inspections for maintenance include:
Product sampling - the part inspection of a representative sample of the aircraft fleet;
Defect sampling - the monitoring of defect rectification performance;
Concession sampling - the monitoring of any concession to not carry out maintenance on time;
3.3.1 An audit is a systematic and independent comparison of the way in which an operation is being conducted against the way in which the published operational procedures say it should be conducted.
3.3.2 Audits should include at least the following quality procedures and processes:
A statement explaining the scope of the audit;
Planning and preparation;
Gathering and recording evidence; and
Analysis of the evidence.
3.3.3 Techniques that contribute to an effective audit are:
Interviews or discussions with personnel;
A review of published documents;
The examination of an adequate sample of records;
The witnessing of the activities that make up the operation; and
The preservation of documents and the recording of observations.
3.4.1 An AMO should decide, depending upon the complexity of the organisation, whether to make use of a dedicated audit team or a single auditor. In any event, the auditor or audit team should have relevant maintenance experience.
3.4.2 The responsibilities of the auditors should be clearly defined in the relevant documentation.
3.5 Auditor’s Independence.
3.5.1 Auditors should not have any day-to-day involvement in the area of the maintenance activity that is to be audited. An AMO may, in addition to using the services of full-time dedicated personnel belonging to a separate quality department, undertake the monitoring of specific areas or activities by the use of part-time auditors. An AMO whose structure and size does not justify the establishment of full-time auditors, may undertake the audit function by the use of part-time personnel from within its own organisation or from an external source under the terms of an agreement acceptable to the Authority. In all cases the AMO should develop suitable procedures to ensure that persons directly responsible for the activities to be audited are not selected as part of the auditing team. Where external auditors are used, it is essential that any external specialist is familiar with the type of operation and/or maintenance conducted by the operator.
3.5.2 The AMO’s quality assurance programme should identify the persons within the company who have the experience, responsibility and authority to:
Perform quality inspections and audits as part of ongoing quality assurance;
Identify and record any concerns or findings, and the evidence necessary to substantiate such concerns or findings;
Initiate or recommend solutions to concerns or findings through designated reporting channels;
Verify the implementation of solutions within specific timescales;
Report directly to the quality manager.
3.6 Audit Scope.
3.6.1 AMOs are required to monitor compliance with the operational and maintenance procedures they have designed to ensure safe operations, airworthy aircraft and the serviceability of both operational and safety equipment. In doing so they should as a minimum, and where appropriate, monitor:
Plans and company objectives;
AMO certification (AMO/Operations specifications)
Manuals, logs, and records;
Duty time limitations, rest requirements, and scheduling;
Maintenance programmes and continued airworthiness;
Airworthiness directives management;
3.7 Audit Scheduling.
3.7.1 A quality assurance programme should include a defined audit schedule and a periodic review cycle area by area. The schedule should be flexible, and allow unscheduled audits when trends are identified. Follow-up audits should be scheduled when necessary to verify that corrective action was carried out and that it was effective.
3.7.2 An AMO should establish a schedule of audits to be completed during a specified calendar period. All aspects of the operation should be reviewed within every 12-month period in accordance with the programme unless an extension to the audit period is accepted as explained below. An AMO may increase the frequency of audits at its discretion but should not decrease the frequency without the agreement of the Authority. Audit frequency should not be decreased beyond a 24-month period interval.
3.7.3 When an AMO defines the audit schedule, significant changes to the management, organisation, operation, or technologies should be considered as well as changes to the regulatory requirements.
3.8 Monitoring and Corrective Action.
3.8.1 The aim of monitoring within the quality system is primarily to investigate and judge its effectiveness and thereby to ensure that defined policy and maintenance standards are continuously complied with. Monitoring activity is based upon quality inspections, audits, corrective action and follow-up. The AMO should establish and publish a quality procedure to monitor regulatory compliance on a continuing basis. This monitoring activity should be aimed at eliminating the causes of unsatisfactory performance.
3.8.2. Any non-compliance identified as a result of monitoring should be communicated to the manager responsible for taking corrective action or, if appropriate, the accountable manager. Such non-compliance should be recorded, for the purpose of further investigation, in order to determine the cause and to enable the recommendation of appropriate corrective action.
3.8.3 The quality assurance programme should include procedures to ensure that corrective actions are taken in response to findings. These quality procedures should monitor such actions to verify their effectiveness and that they have been completed. Organisational responsibility and accountability for the implementation of corrective action resides with the department cited in the report identifying the finding. The accountable manager will have the ultimate responsibility for resourcing the corrective active action and ensuring, through the quality manager, that the corrective action has re-established compliance with the standard required by the Authority, and any additional requirements defined by the operator.
3.8.4 Corrective action. Subsequent to the quality inspection/audit, the AMO should establish:
The seriousness of any findings and any need for immediate corrective action;
The origin of the finding;
What corrective actions are required to ensure that the non-compliance does not recur;
A schedule for corrective action;
The identification of individuals or departments responsible for implementing corrective action;
Allocation of resources by the accountable manager, where appropriate
3.8.5 The quality manager should:
Verify that corrective action is taken by the manager responsible in response to any finding of non-compliance;
Verify the corrective action includes the elements outlined in paragraph 3.8.4 above;
Monitor the implementation and completion of corrective action’
Provide management with an independent assessment of corrective action; implementation and completion;
Evaluate the effectiveness of corrective action through follow-up process.
3.9 Management Evaluation.
3.9.1 A management evaluation is a comprehensive, systematic, documented review by the management of the quality system, policies and procedures, and should consider:
The results of quality inspections, audits and any other indicators;
The overall effectiveness of the management organisation in achieving stated objectives.
3.9.2 A management should identify and correct trends, and prevent, where possible, future non-conformities. Conclusions and recommendations made as a result of an evaluation should be submitted in writing to the responsible manager for action. The responsible manager should be an individual who has the authority to resolve issues and take action.
3.9.3 The accountable manager should decide upon the frequency, format and structure of internal management evaluation activities.
3.10.1 Accurate, complete and readily accessible records documenting the results of the quality assurance programme should be maintained by the AMO. Records are essential data to enable an operator to analyse and determine the root causes of non-conformity, so that areas of non-compliance can be identified and addressed.
3.10.2 The following records should be retained for a period of 5 years:
Quality inspection and audit reports;
Responses to findings;
Corrective action reports;
Follow-up and closure reports; and
Management evaluation reports.
4.0 Quality Assurance Responsibility for Sub-Contractors.
4.1.1 AMOs may decide to sub-contract out certain activities to external agencies for the provision of services related to areas such as:
4.1.2 The ultimate responsibility for the product or service provided by the sub-contractor always remains with the AMO. A written agreement should exist between the AMO and the sub-contractor clearly defining the safety related services and quality to be provided. The sub-contractor’s safety related activities relevant to the agreement should be included in the AMO’s quality assurance programme.
4.1.3 The AMO should ensure that the sub-contractor has the necessary authorisation/approval when required and commands the resources and competence to undertake the task.
5.0. Quality System Training.
5.1.1 An AMO should establish effective, well-planned and resourced quality related briefing for all personnel.
5.1.2 Those responsible for managing the quality system should receive training covering:
An introduction to the concept of the quality system;
The concept of quality assurance;
Reporting and recording; and
The way in which the quality system will function in the company
5.1.3 Time should be provided to train every individual involved in quality management and for briefing the remainder of the employees. The allocation of time and resources should be governed by the size and complexity of the AMO.
5.2 Sources of Training.
5.2.1 Quality management courses are available from the various [National] or International Standards Institutions, and an AMO should consider whether to offer such courses to those likely to be involved in the management of quality systems. AMO’s with sufficient appropriately qualified staff should consider whether to carry out in-house training.
6.0 Organisations with 20 or Less Full-Time Employees.
6.1.1 The requirement to establish and document a quality system and to employ a quality manager applies to all AMOs. References to large and small operators elsewhere in these [Model Regulations] are governed by aircraft capacity (i.e. more or less than 20 seats) and by mass (i.e. greater or less than 10 tonnes maximum take-off mass). Such terminology is not relevant when considering the scale of an operation and the quality system required. In the context of quality systems therefore, operators should be categorised according to the number of full time staff employees.
6.2 Scale of Operation.
6.2.1 AMOs who employ 5 or less full time staff are considered to be “very small” while those employing between 6 and 20 full time employees are regarded as “small” operators as far as quality systems are concerned. Full-time in this context means employed for not less than 35 hours per week excluding vacation periods.
6.2.2 Complex quality systems could be inappropriate for small or very small operators and the clerical effort required to draw up manuals and quality procedures for a complex system may stretch their resources. It is therefore accepted that such operators should tailor their quality systems to suit the size and complexity of their operation and allocate resources accordingly.
6.3 Quality System for Small/Very Small AMOs.
6.3.1 For small and very small AMOs it may be appropriate to develop a quality assurance programme that employs a checklist. The checklist should have a supporting schedule that requires completion of all checklist items within a specified timescale, together with a statement acknowledging completion of a periodic review by top management. An occasional independent overview of the checklist content and achievement of the quality assurance should be undertaken.
6.3.2 The “small” AMO may decide to use internal or external auditors or a combination of the two. In these circumstances it would be acceptable for external specialists and or qualified organisations to perform the quality audits on behalf of the quality manager.
6.3.3 If the independent quality audit function is being conducted by external auditors, the audit schedule should be shown in the relevant documentation.
6.3.4 Whatever arrangements are made, the operator retains the ultimate responsibility for the quality system and especially the completion and follow-up of corrective actions.
JAR 145, Section 2, Appendix 4 and Appendix 5
JAR OPS 1: AMC to JAR OPS 1.035 and AMC and IEM to 1.900
JAR OPS 3: AMC to JAR OPS 3.035 and AMC and IEM to 3.900