EASA Regulatory Requirements for a Compliant Quality System

All EASA Approvals typically provide an independent Quality Assurance Function (EASA Part 21J requires a design assurance system)

The next comment is to consider the EASA “take” on QA & QC (A Quality System Contains Both). QC is embedded in every aspect and element of the Production Process.

The primary objective of an EASA Compliant Quality Auditing is to ensure both external and internal compliance with regulatory and organisational procedures.

We have a number of secondary objectives which are typically organisationally driven rather than EASA driven. (Never the less such elements provide for an indication of the intent and effectiveness of the organisation.)

An example of a secondary objective would be a demonstration of continuous improvement – which would mean a reduction in findings over time for a consistent level of auditing activity.

EASA advises they require the following from the Operator

“The operator must implement and maintain a management system to ensure compliance with these essential requirements for operations and aim for continuous improvement of this system.”

We can reasonably consider this as a read across for all held approvals.

How to Deliver Continuous Improvement?

1. Management Team Behaviour

The support of an organization’s Management Team is usually cited as a major contributor to the success of any continuous improvement initiative.
Evidenced by:
a) Demonstrating Support both general and Specific
b) Providing Guidance
c) Ensure adequate resources and follow up

2. Proactive Behaviour and Attitude to Positive Change

- Willing to invest time and effort to achieve a required change
- Focus on long term solution not just dealing with the immediate issue
- Addressing the Root Cause of a problem in a meaningful way
- Work smarter not harder!

3. Focus Focus and Focus

It is of the utmost importance to ensure sufficient momentum to ensure the changes are not forgotten and we are able to deliver successful continuous improvement programs.
We must understand that any improvement is most likely to succeed if it is developed into a long-term practice that needs to permeate everything an organization does.

4. Looking more towards the Horizon

a) Move the focus out from monthly or quarterly targets
b) Develop an appropriate mind set regarding long term objectives
c) Be able to accept “some” short term pain where there is a long term potential benefit

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For details please see www.sassofia.com & www.sofemaonline.com or email office@sassofia.com or online@sassofia.com