EASA Compliant Quality Assurance Assessment of Remedial Action follow up and Measures of Effectiveness

Let’s consider the difference between Assessment & Audit

Assessment

The evaluation process used to measure the performance or effectiveness of a system and its elements.

Our goal is to perform an assessment of the auditing process follow up to determine both the cost effectiveness and overall value to the business.

Audit

An EASA Audit is a systematic and independent examination to determine whether quality activities comply with external regulatory requirements and internal organisational specifications and whether these specifications are implemented effectively.

A primary indicator of a poor or failing system is repeat findings or findings which should be addressed at a lower level – for example the Competent Authority should not identify problems which are normally expected to be found within the internal Quality Assurance System audit process.

Let's now consider some of the areas where we may see exposures.

Weakness of the Quality Assurance Procedures QAP or Standard Operating Procedures (SOP’s) in detail the procedures inadequately explain how the controls in data generation and mechanisms to perform reviews are managed.

Any finding related to noncompliance must be addressed in an agreed and acceptable way, however in the real world competing priorities, financial and budget limitations and other factors may distract managers from addressing the root cause and taking appropriate actions to mitigate the risk.

Clearly a positive attitude towards early and effective closure of any corrective action requests is a positive demonstration of engagement.

As part of the Quality Assurance (QA) processes – Follow up activities will include a validation that not only has the management implemented the action, but that it has addressed adequately the initial issue.

How to mitigate exposures related to remedial action.

The benefits of a comprehensive approach to the management of quality are significant. By utilising the best Quality Assurance process to identify non-conformities and for the Business area owner with responsibility for Quality Control to fully engage with the root-cause analysis to identify the problems and develop appropriate mitigations and strategies to eliminate these problems.

Benefits of an effective remedial action include:

A motivated team who not only understands the purpose of active engagement but fully embrace it.

The opportunity to minimise waste within the process or system.

Examples of indicators include:

Current vs. planned costs.

Current vs. planned schedule timeline achievements in percentage terms.

Trend information related to the fulfillment of activities aggregating completion of various projects to understand trend information (What is significant here is the trend of the deviation. Is it getting better or worse?)

Sofema Aviation Services www.sassofia.com (SAS) and our Partner SofemaOnline www.sofemaonline.com (SOL) offer both classroom based and online regulatory training course compliant with EASA Regulations. For additional details please see the websites or email office@sassofia.com or online@sassofia.com