The Role of Regulatory Compliance - Considerations regarding The Involvement of the Competent Authority in your Organisational Decision-Making Process.
Thought Leadership by Steve Bentley CEO of Sofema Aviation Services (SAS) www.sassofia.com
– What is the Role of EASA in my Organisational Decision Making?
– Can I use an online training platform for the delivery of EASA Part 66 Module 9 & Module 10 for Component Workshop Certifying Staff?
Background – Organisation's view of the need for compliance.
Some Organisations – let's call them to tick the box organizations – focus on collecting all the necessary pieces of paper to show they are compliant.
Other Organisations – recognize the role of demonstrating compliance but focus on managing competence to ensure the organization is able to deliver to the highest & most profitable standard
Which is your organization?
Introduction – Where do Regulations Sit in the Organisations Environment?
Some Organisations lead and some organizations are happy to be led
– Fundamentally you need to decide where you sit in this story but consider an important point.
Compliance with the regulations is a STEP on the journey and not the destination.
What does this mean?
– Quite simply it means that aviation organizations are in business to deliver a product or service – with efficiency, effectiveness, compliance, and safety as well as profit key all elements of this process.
What is the Regulatory Authorities View of Organisational Engagement with the above elements?
Quite simple it is prescriptive compliance - one of the reasons EASA required Competent Authorities to cease issue level 3 findings – “observations” where specifically disallowed because it is not correct for the Competent Authority to involve in Business Decisions
– it is either correct or not – and if not provide a finding against a standard/criteria
What is the role of EASA User Guides?
EASA Serves the role of Competent Authority for Third Country Approval Holders including EASA Part 145. To provide the industry with guidance EASA produces a number of documents which are called user guides
In the case of EASA Part 145, the reference document is - Foreign Part-145 approvals - Components, engines, and APU certifying staff UG.CAO.00126-003 (Note – the current revision is dated Oct 2015)
The EASA Regulatory Environment Consists of
– Implementing Rules – High-Level Regulation – issued by the European Commission (based on EASA Opinions)
– Acceptable Means of Compliance (AMC) – issued by EASA (based on EASA Decisions)
– Guidance Material – additional explanatory material regarding how to comply with AMC
– Certification Specification (equivalent to AMC Material) – Used in Support of Part 21 Objectives
Do I have to comply with AMC Requirements – The short answer is yes – the longer answer is that a possibility exists to develop an Alternate Means of Compliance (AMOC) – but this will have to be authorized by your Competent Authority and Registered and accepted by EASA
Do I have to comply with GM – In theory no, however in practice if you choose to ignore Guidance Material you should have evidence of an Analysis & Risk Assessment to show that your deviation is equal to or of higher value than the GM (rationally there is usually no business advantage of deviating – but multiple downsides – So the path of least resistance is to show full compliance
So what is the authority of the User Guide?
In fact, they are something of an orphan in as much as they are produced by EASA, but only in the role of “competent authority” for Third Countries, as such they should not exceed in scope or intent the IR/AMC/GM as provided by EASA in its role of “Manager” of the Regulatory Environment.
For its Part EASA as the competent authority producing “User Guides” should ensure the best practice and standards which they aspire to through the user guides are also to be found within EASA core material which is not always the case! (Such a Conflict does not in fact benefit our Industry)
Essentially the user guide is a “Best Practice” and as with GM above the path of least resistance is to show full compliance, however, this is not always achievable in an effective way within the business framework and it is in such situations that alternative solutions can be considered
For example to undertake online training in respect of Part 66 Module 9 & Part 66 Module 10 for Third Country Certifying Staff including Component Certifying Staff.
The Potential role of Online Training & Specific Comments concerning - UG.CAO_.00126-Components-engines-and-APU-certifying-staff.pdf
1.3.3.2. Human factor and aviation legislation training.
When selecting a non-EASA Part-147 AMTO to provide the Human Factor training and/or Aviation Legislation, the maintenance organization quality department shall be in a position to demonstrate as a minimum that:
– The course is carried out according to a detailed syllabus including the level of training as per EASA Part66 Module 9 and/or 10 as applicable (the duration of the course need to be specified to demonstrate the adequacy to cover all subjects);
Note – EASA Requires and justifiably so – The Quality Department to take proactive control of the process (This is all about managing competence!)
If an Organisations Quality System takes a back seat and asks EASA is XYZ ok – they are trying to out-source their management & oversight responsibility to EASA
– For Reasons Already Mentioned Involving EASA in your Management Does not work – Take Control!
– Manage the Competence of Your Staff in an Effective Way means fully documented & fully auditable
– Treat the User Guide as a Guide, not as a Legal Document – which can never be deviated.
– If you use Online Training Manage the Environment, Validate through Audit the material, Ensure the Delegate meets your expectations through examination & interview
Sofema has 2 types of customers – those that take control and implement online training using Sofemaonline.com Training Platform and those that create problems for themselves by trying to involve external regulators in their decision-making process.
(Note HF / EWIS & FTS regulatory-compliant training has been delivered online for more than 7 years throughout Europe for literally 100’s of companies – so it is not possible for EASA to say online training is not acceptable in a controlled situation for Third Country Component Maintenance Organisation)
How can the above criteria be demonstrated if online training is used?
The acceptance of this course whether delivered in the classroom / Webinar / Online is the responsibility of the receiving organization and forms part of the management of competence of the certifying staff.
Steps to take for the Organisation to manage its training obligations using “online training”
– The Quality Manager should audit the course to ensure it complies with all objectives.
– A course delivered at Level 2 will meet this objective - A general knowledge of the theoretical and practical aspects of the subject and an ability to apply that knowledge.
– It is ultimately the responsibility of the Quality Manager to ensure that the content of this training is fully compliant with the organisational requirement to meet EASA Part 145 Requirements
Concerning the following - The Qualification criteria for instructors is defined;
Note There is no Instructor for “online training” Therefore this item becomes “Not Applicable” for Online Training - Whilst this is relevant in the classroom
In the case of Online Training the 145 Organisations Quality Manager “Must” assumes responsibility to ensure standards.
– For online delivery, the Quality Manager should ensure the student fully engages with the material
– This can be ensured by mandated supervised online access to the material,
– Supervised completion of the examination together with
– Competence assessment to ensure satisfactory completion.
All Fully Documented & Auditable
Final Comment The relevant user guide is out of date (over 5 years old) Many third Country Organisations have satisfied the obligation for Module 9 & Module 10 using www.sofemaoline.com online training
So clearly there is a need is for the organization to take control and challenge the EASA surveyor in the event the online solution is “blocked” ensure this is put in writing by the survey so there are grounds to challenge – (but please ensure your validation & oversight is 100% effective before entering into any dispute)
Sofema Aviation Services is pleased to support the Industry to achieve both a fair deal and responsible regulatory oversight.
Please email team@sassofia.com with any comments or questions
