Sofema Aviation Services (SAS) www.sassofia.com considers the process and the steps which need to be taken by an organisation receiving EASA Regulatory findings.
Introduction
To satisfy the obligations of an organisation related to the continuance of an EASA third country approval. The organisation should recognise the following
1/ It is the responsibility of the Business Area Owner / Nominated Post Holder to ensure that all process and procedures are fully compliant with EASA requirements (Consider this as a QC role)
2/ Separately it is the responsibility of the Compliance Manager to independently assess that the organisation ensures full compliance with all external regulatory requirements as well as internal organisational requirements.
Why Do we see findings from EASA?
- Because both Item 1/ and Item 2/ above have failed (failed is the correct term to use) – any findings should be considered seriously – Multiple findings are an indicator of major organisational problems which need to be addressed to maintain the authority and scope of the issued approval
- EASA therefore correctly expects to understand
>> Why the organisation failed
>> What steps are taken to ensure that it will not happen again
- Such a process should be an internal investigation overseen by the AM who holds ultimate responsibility. – The investigation will identify Root Causes and Contributing Causes
Organisation Action on Receipt of Finding
On receipt of an EASA Finding the first action is to formally accept the finding (or findings – all should be mentioned using the EASA reference No) as valid
– This should take the form of an official communication recognising the finding and advise that a corrective action plan has been created
Corrective Action Plan
The corrective action plan should outline the following. (example)
To address accepted multiple findings (formal reference should be made to the finding No’s) XXXXX (The organisation) has put in place the following:
(a) To implement a training Plan to Ensure all EASA Part 145 receive the required training in accordance with PART 145 Regulatory requirements and EASA third Country additional requirements.
(b) To implement an MOE re-write specifically to address all findings as well as to ensure compliance with Regulation EU 2021/1963
(c) To provide a Detailed Response for each finding identifying Root Cause (s) (RCA’s) Contributing Causes (CC’s)
(d) To implement in the case of each finding a Corrective Action (CA) and Preventative Action (PA) to ensure that the identified Discrepancy will not re-occur
The above items (a) to (c) together with the specific acceptance should be communicated to EASA
To finish with the following statement – The organisation understands and accepts the obligation to complete the above task by XXXXX (state date) and will continue to update EASA as required and on completion of the Corrective Action Plan (CAP) actions.
Addressing Each Finding
For each finding it will be necessary to determine the following (simply showing it is fixed is not sufficient – must also show RCA / CC / CA / PA
1/ What are the root causes of the finding (EASA expects the organisation to identify the fundamental reason or reasons for the discrepancy)
2/ Also necessary – what are the Contributing Factors
3/ What is the corrective action taken to address the discrepancy (this is typically an immediate fix)
4/ What steps are taken to address the potential of re-occurrence to ensure that it does not re-occur.
350 Findings and corrective actions; observations
Regulation (EU) 2021/1963
(a) The competent authority shall have a system in place to analyse findings for their safety significance.
(b) A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the organisation’s certificate including the terms of approval, which lowers safety or seriously endangers flight safety.
- Level 1 findings shall also include:
(1) any failure to grant the competent authority access to the organisation’s facilities referred to in point 145.A.140 during normal operating hours and after two written requests;
(2) obtaining the organisation certificate or maintaining its validity by falsification of the submitted documentary evidence;
(3) any evidence of malpractice or fraudulent use of the organisation certificate;
(4) the lack of an accountable manager.
(c) A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the organisation’s certificate including the terms of approval, which is not classified as a level 1 finding.
(d) When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance identified.
- If a level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.
(1) If there are any level 1 findings, the competent authority shall take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, it shall take action to revoke the certificate or to limit or suspend it in whole or in part, depending on the extent of the level 1 finding, until successful corrective action has been taken by the organisation.
(2) If there are any level 2 findings, the competent authority shall:
(i) grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months.
The period shall commence from the date of the written communication of the finding to the organisation requesting corrective action to address the non-compliance identified.
At the end of that period, and subject to the nature of the finding, the competent authority may extend the 3-month period provided that a corrective action plan has been agreed with the competent authority;
(ii) assess the corrective action plan and implementation plan proposed by the organisation, and if the assessment concludes that they are sufficient to address the non-compliance, accept them.
(3) If the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to level 1 and action shall be taken as laid down in point (d)(1).
(4) The competent authority shall record all the findings that it has raised or that have been communicated to it in accordance with point (e) and, where applicable, the enforcement measures it has applied, as well as all corrective actions and the dates of the action closures for all the findings.
(e) Without prejudice to any additional enforcement measures, when an authority performing the oversight tasks pursuant to point 145.B.300(d) identifies any non-compliance with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts by an organisation certified by the competent authority of another Member State or the Agency, it shall inform that competent authority and provide an indication of the level of the finding.
(f) The competent authority may issue observations for any of the following cases not requiring level 1 or level 2 findings:
(1) for any item whose performance has been assessed to be ineffective;
(2) when it has been identified that an item has the potential to cause a non-compliance under points (b) or (c);
(3) when suggestions or improvements are of interest for the overall safety performance of the organisation.
The observations issued under this point shall be communicated in writing to the organisation and recorded by the competent authority.
Next Steps
Follow this link to our Library to find & Download related documents for Free.
Please see details here EASA Compliant Aviation Quality Assurance Senior and Lead Auditor with VO
Please visit the website www.sofemaonline.com or email team@sassofia.com with questions or comments
Tags:
(RCA’s) Contributing Causes (CC’s), Action Plan, AM, Business Area Owner, Contributing Causes, Contributing Factors, Corrective Action (CA), Corrective Action Plan, EASA Part 145, EASA Regulatory findings, EASA Third Country Organisation, Nominated Post Holder, Preventative Action (PA), Regulation (EU) 2021/1963, Root Causes, SAS blogs, SAS Library
