EASA Part 21G Independent Monitoring Function - Considerations Related to Role & Purpose
Sofema Online (SOL) www.sofemaonline.com considers the change introduced into Part 21 subpart G effective from March 2023.
Introduction
EASA has clarified that effective 7th March 2023 (2-year transition for existing organisations) a design or production organisation shall have a management system made of two elements:
» The safety management element and the design assurance (in case of design organisations) or quality element (in case of production organisations).
» As regards the safety management element, the role of the key safety personnel should not be limited to the execution of the safety policy but should be broader.
» The duplication of requirements, such as the documentation already provided in point 21.A.143 or 21.A.243, was considered to be unnecessary.
» To aid understanding and clarification in regard to the text concerning independent monitoring. The text has been improved to clarify that the scope is to monitor the compliance of the organisation with the relevant requirements and the compliance with, and adequacy of, the production or design management system.
OLD Text - An independent quality assurance function to monitor compliance with, and adequacy of, the documented procedures of the quality system. This monitoring shall include a feedback system to the person or group of persons referred to in point 21.A.145(c)(2) and ultimately to the manager referred to in point 21.A.145(c)(1) to ensure, as necessary, corrective action.
NEW Text ‘21.A.139 Production management system
(e) 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.
Note - 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
Independent Monitoring of Compliance & Adequacy - AMC1 21.A.139(f)
» The function that carries out independent monitoring of the compliance and adequacy of the documented procedures of the production management system should ensure that:
o The activities of the organisation are monitored for their adequacy and compliance with the applicable requirements and with any additional requirements as established by the organisation, and that these activities are carried out properly under the supervision of the nominated persons referred to in point 21.A.145(c)(2);
o An objective review of the complete set of production-management-related activities is provided through independent audits;
o The independence of an audit is established by always ensuring that audits and inspections are carried out by personnel who are not responsible for the function, procedure or products that they audit or inspect;
o An audit plan is established to show when and how often the activities required by Part 21 will be audited;
o The audit cycle is determined through a risk assessment agreed by the competent authority and that does not exceed the applicable audit planning cycle according to point 21.B.222. That determination should consider at least:
- The criticality of the items checked during the audit; and
- The safety performance of the organisation, including any previous findings and root causes;
o When a non-compliance is found, the root cause(s) and contributing factor(s) are identified and corrective actions are defined.
o The feedback part of the compliance monitoring function should define who is required to address any non-compliance in each particular case, and the procedure to be followed if the corrective action is not completed within the defined time frame;
o The compliance monitoring function that ensures the aspects above performs the planned continuing and systematic evaluations or audits of the factors that affect the conformity (and, where required, the safe operation) of the products, parts or appliances to the applicable design. This evaluation should include all the elements of the production management system in order to demonstrate compliance with Part 21.
Note - Adequacy of procedures means that the production management system, through the use of the procedures as set forth defined, is capable of meeting the conformity objectives identified in point 21.A.139(d)(1)(a).
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
