Sofema Aviation Services (SAS) considers the role of Quality & Safety within the Part 21 Production Management System.
EASA Part 21G Quality & Safety – Introduction
21.A.139 Production management system [applicable from 7 March 2023 – Regulation (EU) 2022/201]
The production organisation shall establish, implement and maintain a production management system that includes:
- A safety management element, and
- A quality management element, with
- Clearly defined accountability, and
- Lines of responsibility throughout the organisation.
The production management system shall:
- Correspond to the size of the organisation, and
- To the nature and complexity of its activities (Taking into account the hazards and associated risks inherent in those activities),
- Be established, implemented, and maintained under the direct accountability of a single manager appointed pursuant to point 21.A.145(c)(1) (accountable manager).
Safety Management System
As part of the safety management element of the production management system, the production organisation shall:
- Establish, implement, and maintain a safety policy and the corresponding related safety objectives;
- Appoint key safety personnel in accordance with point 21.A.145(c)(2);
- Establish, implement, and maintain a safety risk management process to
o Identify safety hazards entailed by its aviation activities,
o Evaluate them and manage associated risks,
o Including taking actions to mitigate the risks and verify their effectiveness;
- Establish, implement, and maintain a safety assurance process that includes:
o The measurement and monitoring of the organisation’s safety performance;
o The management of changes in accordance with point 21.A.147;
o The principles for the continuous improvement of the safety management element;
- Promote safety in the organisation through:
o Training and education;
o Communication;
- Establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to the continuous improvement of safety.
Quality Management
As part of the quality management element of the production management system, the production organisation shall:
- Ensure that each product, part or appliance produced by the organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in condition for safe operation, thus enabling the exercise of the privileges set out in point 21.A.163;
- Establish, implement and maintain, as appropriate, within the scope of the approval, control procedures for:
o Document issue, approval or change;
o Vendor and subcontractor assessment audit and control;
- verifying that incoming products, parts, materials and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;
- Identification and traceability;
- Manufacturing processes;
- Inspection and testing, including production flight tests;
- The calibration of tools, jigs, and test equipment;
- Non-conforming item control;
- Airworthiness coordination with the applicant for, or holder of, the design approval;
- The completion and retention of records;
- The competence and qualifications of personnel;
- The issue of airworthiness release documents;
- Handling, storage and packing;
- Internal quality audits and the resulting corrective actions;
- Work within the terms of approval performed at any location other than the approved facilities;
- Work performed after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;
- the issue of a permit to fly and approval of the associated flight conditions;
- Include specific provisions in the control procedures for any critical parts.
Independent Compliance (Quality Assurance)
- The production organisation shall establish, as part of the production management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as compliance with and adequacy of the production management system.
- Monitoring shall include feedback to the person or group of persons referred to in point 21.A.145(c)(2) and
- to the manager referred to in point 21.A.145(c)(1) to ensure, where necessary, the implementation of corrective action.
Integration with other approvals
If the production organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the production management system may be integrated with that required under the additional certificate(s) held.
Next Steps
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