SofemaOnline.com (SOL) offers EASA-compliant online regulatory training including Part 21 for CAMO

So what are the challenges to delivering an effective Compliance System within our Part M CAMO? Financial/Organizational/Manpower/Commercial/Contracted & Subcontracted Service Providers?

Consider the relationship with Part 21 Subpart G & J organizations - The relationship is fundamentally Contract - which means that in each case the organization is responsible for self-manage. Our role is to ensure oversight and diligent behavior.

To start by considering a major difference between a Quality Assurance System that is fully compliant with EASA requirements and one which is for example compliant with ISO 9000 2008 or ISO 9000 2015. That difference is simply that the EASA-compliant system focuses on Compliance and not performance.

This is one of the reasons that the title of the Quality Manager has been changed. (In the case of “OPS” other business areas to follow!)

In the EASA system, the quality manager is referred to as the Compliance Manager (CM) (His or her essential function within the EASA-approved organization.)

The Compliance that the CM seeks to validate is with respect to 2 specific areas.

The first is that the organization must be able to show full compliance with EASA and other relevant requirements together with all external regulatory obligations which are placed on the organization.

The second is that the Organization must be able to demonstrate compliance with its own internal procedures and processes moreover these should all demonstrate full compliance with the regulations and be documented in a clear and unambiguous way.

So now we know that the scope and focus of our audit is compliance, we can start to consider what type of compliance audits we may perform.

Audit Type 1 - Demonstration that all regulatory requirements may be found to be correctly documented within the organizational system.
This type of audit can be done from your desk for an internal audit and may be the appropriate level of audit for oversight of a Part 21 Organization. To validate and to perform a gap analysis against the specific regulation and what is transcribed within the relevant procedure.

Audit Type 2 - Demonstration that all organizational procedures are being followed correctly.
This type of audit can be performed in a variety of ways.
a) By looking at the entire system for a given business objective - This is known as a System Audit and will typically appear horizontally across the business flow.
b) By looking at a particular segment or process for a given element or aspect within the System this is known as a Process Audit - This audit tends to be deeper and more narrow in its scope and may appear more as a vertical audit.

Have questions about our programs, need more information, or want to learn about our exclusive special offers? We’re here to help! Reach out to us at team@sassofia.com, and one of our friendly experts will get back to you promptly. Let us guide you in finding the perfect training solution tailored to your needs!