EASA Quality Assurance Auditing - Understanding Trend Analysis of Compliance Data and Developing Effective Responses
Sofema Aviation Services (www.sassofia.com) takes a look “under the hood” of EASA Compliant Quality Auditing Derived Data.
Introduction
Effective Quality Management ensures that the organization's products and services are able to continue to meet internal company, client and all “Regulatory Requirements”.
Quality Assurance is the means by which the quality management process can be focused on providing confidence that all quality requirements will be fulfilled.
Aviation organizations should demonstrate compliance with regulatory requirements by:
a) Establishing and Maintaining a Quality Management System
b) Provision of status & feedback to the Accountable Manager
c) Continually Manage the Quality Assurance Audit Programme
Ongoing Quality Developments
Quality Assurance auditing can provide far more than a simple demonstration of regulatory compliance. Organizations which are able to both understand and interpret the data in a commercially positive way can generate a competitive advantage.
Consider the following Quality System elements which can together provide a Strong & Resilient Quality Driven Organisational System:
a) Provision of Quality Assurance Data to enable an Effective Management System
b) Support for the Development of Regulatory Compliant Policies, Procedures and Strategies
c) Ongoing Assessment of Operational Processes
d) Development of The Quality Management System including the establishment, initial development as well as management responsibilities
e) Oversight and Control of all OEM / TCH / STCH Manuals & Vendor Documents
f) Establishing an Effective Quality Assurance Record System
g) Oversight of Subcontractor and Service Providers
h) Provision of Audit Training for Quality Management System Personnel
i) Using the Quality System to measuring customer satisfaction (for internal and external )
j) Driving Organisational Change Based on Regulatory Driven Requirements
k) Monitoring the effectiveness of Corrective Action Mitigations
l) Supporting the Management Evaluation Process
Do we Audit for Organisational Success or Only Regulatory Compliance?
In many cases, the driver for a particular audit is the Quality Audit System Management Team who decide both what should be audited and how frequently to satisfy only regulatory compliance and not management objectives. This is clearly a missed opportunity, however without drive & guidance from the senior management team then it is an unfortunate inevitability.
The output of such audits provides status information regarding elements of organizational performance that are outside the specific concern of “Senior Management” whilst important (For Organisational Excellence & Improvement) aspects are left untouched by the Quality Audit Process.
Using Key Performance Indicators to drive metrics as well as detailed analysis of both corrective actions and implemented mitigations the following KPI’s can be developed.
Key Performance Indicators (KPI) Examples
○ Effectiveness of the Quality Management System QMS;
○ Effectiveness of the organization’s processes;
○ Number of major non-conformities from external audits;
○ Customer satisfaction measures & improvements;
○ Increasing the effectiveness of the production process;
○ Cost reduction improvement (including the cost of poor quality);
○ Meet or exceed compliance with regulatory and organizational obligations.
Further Guidance
Sofema Aviation Services (www.sassofia.com) and SofemaOnline (www.sofemaonline.com) are pleased to offer a range of EASA compliant regulatory training courses in support of MTOE Development and associated services. For details or inquiries please email office@sassofia.com or online@sassofia.com.
