Meeting the Challenges of Aviation Compliance Auditing
A SofemaOnline Review (www.sofemaonline.com)
Compliance Auditing – Understanding the Process
Compliance Auditing is typically charged with meeting the challenge of ensuring that the organisation always remains fully compliant with both internal and external obligations.
In the complex environment delivered by EASA & GCAA, it is necessary to have a proactive approach to maintaining a full understanding of all regulatory obligations.
Compliance Auditing brings with it the daily challenge of ensuring that the organisation remains at all times fully compliant with both internal and external obligations.
It is essential to ensure robust and continuous oversight of all internal processes, and procedures. The various departments must continue to meet all applicable internal and EASA driven regulatory requirements.
Compliance Auditing looks at the effective management of the organisational controls to ensure continuous delivery of the Quality Control driven process. At all times the organisation should endeavour to comply with best practice and industry standards.
Quality Control Ownership
The business area owner (ultimately the nominated postholder) is directly responsible to ensure that the business remains compliant with the regulations (Quality Assurance should be the Safety Net).
Quality Assurance Activities
It is essential to ensure robust and continuous oversight of all internal processes, and procedures. The various departments must continue to meet all applicable internal and EASA/GCAA driven regulatory requirements.
In addition, a full audit program will be delivered across the entire business process including production elements and the complete supply chain.
Any issues which are raised as Corrective Action/Preventative Action (CAPA) need to be addressed by the business area owner in a timely and efficient manner. All documentation must be controlled within the framework of the organisation, with status and revision control managed and periodically audited for full compliance.
Obligations related to Compliance Auditing
The Audit Management, Control, and Oversight system should ensure that the established safety and quality procedures are fully complied with. In addition, to plan and deliver audits, review findings, perform root cause analysis and develop additional actions where necessary (under the specific control or guidance of the business area owner or post holder). In an effective Quality Management System QMS monitoring is a continuous process.
What does an effective EASA/GCAA Compliant Quality System Look like?
A successful Quality System requires a fully functioning closed loop system or process which typically delivers compliance oversight processes which provide for an effective environment for raising full awareness of discrepancies as well as an understanding of the appropriate remedial action or mitigation.
By making the best possible use of Information together with the visibility of measuring systems it should be possible to reduce the cost of compliance without compromising either the overall product quality or the organisational risk and exposure.
Any issues which are raised as Corrective Action/Preventative Action (CAPA) need to be addressed by the business area owner in a timely and efficient manner.
All documentation must be controlled within the framework of the organisation, with status and revision control managed and periodically audited for full compliance.
Delivering a Strong Compliance Audit Process Requires that:
a) The Audit Management, Control and Oversight system should ensure that the established safety and quality procedures are fully complied with
b) In addition to plan and deliver audits, review findings perform root cause analysis
c) Develop additional actions where necessary (under the specific control or guidance of the business area owner of post holder)
d) In an effective Quality Management System QMS monitoring is a continuous process
e) A successful Quality System requires a fully functioning closed loop system or process which typically delivers compliance oversight processes
f) To provide for an effective environment for raising full awareness of discrepancies as well as an understanding of the appropriate remedial action or mitigation
g) By making the best possible use of Information and visibility of measuring systems it should be possible to reduce the cost of compliance without compromising either the overall product quality or the organisational risk and exposure
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