The Role of the Aviation Quality System within the European Aviation Safety Agency “EASA”

Sofema Online (SOL) www.sofemaonline.com considers the fundamental elements related to an EASA compliant Quality Assurance (Compliance System)

Introduction

Consider the following role definitions and responsibilities :

» First that the Accountable Manager is responsible for the Quality System which includes both elements of Quality Control and Quality Assurance;

» Second The Quality Assurance Manager (Compliance Manager CM) is responsible for the auditing of all Compliance related elements of the organization system.

Organisational Compliance

When we speak about Organisational Compliance we are talking about compliance with all external regulatory requirements together with the internal obligations driven by all “internal” company documentation, manuals and procedures.

The Compliance Manager (CM) is required to head up the independent process for performing gap analysis (auditing for conformity) of the organisation's documentation systems and processes.

Any finding becomes a “discrepancy” and generates the need for “corrective action”

About Quality Control

Quality Control is typically the responsibility of the individual post holders and business area owners.

Quality Control is delivered through the development of regulatory compliant organisational processes and procedures which are followed by suitably trained and competent organisational staff.

Important Note - Independently all QC processes should be audited by the QA process.

EASA Compliant Organisations Responsibility

The organization has an inherent obligation to ensure compliance and this is further enfranchised by the obligation of the Accountable Manager “AM” to sign a statement accepting responsibility for the organization to remain in compliance with all mentioned requirements.

Concerning the Role of the Accountable Manager

The Accountable Manager is not required to be a specialist in the way that the Post Holders are required to demonstrate specific background knowledge experience and competence to the regulator before being allowed to commence “Post Holder” Duties.

Do not forget a Key Role of the NPH is to “Protect’ the AM

So we can share the understanding that one of the roles of the Post Holder is to protect the Accountable Manager by ensuring that all required compliances are satisfied in respect of each relevant business area.

Concerning Findings

Any identified deficiencies should be brought to the attention of the Accountable manager in the most appropriate way, if necessary with the support of the Quality and Safety Manager.

The regulatory authority will perform “oversight” audits of the organization, it should be understood that the purpose of these audits is entirely different to the needs of the organization.

About the Competent Authority (CA) – Regulatory Authority

The regulatory authority is of course not part of the organisations QC or QA process and independently assesses what they wish when they wish. It should be said that lack of awareness not identified by the regulatory does not exonerate the organization anyway from compliance.

Further Considerations – What does it all mean!

It is a fact that anything omitted in terms of oversight by the regulator due to time manpower or other constraints will not be missed by agencies such as the National Transportation Safety Board NTSB or Aircraft Accident Investigation Board AAIB.

The Compliance Manager (CM)  is also responsible to “Protect” the Accountable Manager by ensuring that all significant organisational non-conformities are brought to the attention of the AM.

Once we accept the above we can focus on the importance of the CM.  - To finish with two comments:

» The first is that if the QM fails to identify organization non-conformity he has let down the AM.

» The second is that if the regulatory find an organizational deficiency it is possibly an indication of two deficiencies.

Further Considerations

If we understand that the organization has been identified as non-compliant it becomes apparent that the independent Compliance Audit System has failed to identify the shortfall

This is an indication of potential weakness within our organisation's oversight system.

Bottom Line - We could sum up and say the following:

An effective aviation quality and compliance system should generate few if any non-conformities during regulatory audits.

Both Safety Management and Quality Control are the responsibility of the individual post holders and business area owners.

Quality Control is delivered through the development of regulatory compliant organizational procedures which are followed by suitably trained and competent organizational staff. Independently all QC processes should be audited by the QA process.

Safety Management is delivered through the identification and measurement of Risk together with the development of appropriate mitigations.

Next Steps

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