Quality Considerations within an EASA Part 21 G Organisation

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Sofema Online (SOL) www.sofemaonline.com considers the specific tasks which require a QC input to ensure the production process integrity.

Introduction

With effect from 7th March 2023 EASA Part 21G - 21.A.139 Quality System is being renamed 21.A.139 Production Management System, however the functional requirements which can be considered as Quality Control Activities essentially remain the same.

Consider the following elements which are required to support the production planning process:

» 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;

o How Delivered? Managed Standards / Effective Oversight, Management & Supervision / Documentation Control / Competence / Effectiveness of Tooling & Equipment

» Establish, implement and maintain, as appropriate, within the scope of the approval, control procedures for:

o Document issue, approval, or change;

• How Delivered? Relationship with DOA

o Vendor and subcontractor assessment audit and control;

• How Delivered? Vendor Audit (QA) – Vendor Control (QC)

o 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;

• How Delivered? First Article & Conformity Inspection

o Identification and traceability;

• How Delivered? Compliance with EASA Part 21 Subpart Q – Control & Records Retention

o Manufacturing processes;

• How Delivered? Documented Process & Procedures Compliant with DOAH Instructions

o Inspection and testing, including production flight tests;

• How Delivered? In Process Testing, Functional & Conformity Testing

o The calibration of tools, jigs, and test equipment;

• How Delivered? Internal Calibration Lab? / External Specialised – Control & Oversight

o Non-conforming item control;

• How Delivered? Concession Management / Rework

o Airworthiness coordination with the applicant for, or holder of, the design approval;

• How Delivered? POA / DOA Arrangement – Interface and Co-ordination including investigations

o The completion and retention of records;

• How Delivered? Records Management, Control & Retention

o The competence and qualifications of personnel;

• How Delivered? Management of Staff including certification staff – Competence Assessment – Skills Development & Training

o The issue of airworthiness release documents;

• How Delivered? Issue of EASA Form 1 Process & Authorised Signatories

o Handling, storage, and packing;

• How Delivered? Compliance with Standards (Documented) AS 300 – Training, ESDS procedures if applicable

o Internal quality audits and the resulting corrective actions;

• How Delivered? Typically delivered through independent audit (QA)

o Work within the terms of approval performed at any location other than the approved facilities;

• How Delivered? Control and oversight of the scope of approval and Ad-Hoc Process & Procedures

o Work performed after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;

• How Delivered? EASA Form 52 (Aircraft Statement of Conformity) or the EASA Form 53 (Certificate of Release to Service)

o The issue of a permit to fly and approval of the associated flight conditions;

• How Delivered? Process Document for Management Control & Oversight

o Include specific provisions in the control procedures for any critical parts.

• How Delivered? Process Document for Management Control & Oversight

Next Steps

Sofema Aviation Services www.sassofia.com & Sofema Online www.sofemaonline.com provide Part 21 and CS 25 Training as Classroom, Webinar, and Online Courses – for additional details please email team@sassofia.com

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