Methods to Assess the Effectiveness of an EASA-Compliant Quality Assurance System
Sofema Online (SOL) www.sofemaonline.com considers oversight fundamentals related to the assessment of an EASA Compliant Quality Assurance System (QAS) / Compliance Management System (CMS)
Introduction – Oversight activities based on looking at how the organisation looks at itself
The Accountable Manager within the EASA system is directly responsible to ensure financing of any aspect of the business which directly contributes to the showing of compliance with regulatory requirements.
>> Also, consider that non-compliance identified during a quality audit is an indication of a potential business area issue which also needs to be addressed – to consider the why (5 whys).
>> To assess the effectiveness of a QAS, data must be collected and analyzed. This data can come from a variety of sources, such as audits, inspections, and safety reports. Analysis can be time-consuming and requires a certain level of expertise.
Required change implementation can be challenging, as it may require changes to existing procedures and policies, as well as retraining employees.
Challenges to Effective Assessment of Compliance Management System (CMS)
The Assessment of a CMS is a Complex Process that requires a significant amount of time and resources.
The following are some of the challenges that must be overcome to ensure an effective assessment Consider the following key elements:
>> The QAS must be in compliance with all applicable regulations and guidelines set forth by EASA. This includes not only the QAS itself but also all other procedures and policies related to safety.
>> All aspects of the QAS must be properly documented. This documentation should include policies, procedures, training materials, and audit reports. Proper documentation is essential for ensuring that the QAS is consistent and can be easily audited.
>> Regular audits must be conducted to ensure that the QAS is functioning as intended.
Consider The Following Key Features:
>> Performance of internal audits to identify any non-conformities, as well as the effectiveness of the implementation of any corrective actions to address such non-conformities.
>> Oversight of the management review activities to assess process effectiveness, identify areas for improvement, and make necessary changes.
>> Establishing KPIs to measure the effectiveness of the QAS.
o Examples of KPIs include the number of non-conformities identified.
o Time is taken to implement corrective actions.
o Solution effectiveness and internal satisfaction levels.
>> Review of the root cause analysis processes related to non-conformities to assess the effectiveness of the identification of underlying causes and mitigation / corrective actions taken to prevent a recurrence.
>> How is the process of continuous improvement managed? Assess the evidence of a successful process with a focus on the last 24 months' improvements implemented.
Next Steps
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