Advanced Aviation Quality Assurance Audit Techniques

A SofemaOnline Review (www.sofemaonline.com)

Introduction

Compliance Auditing looks at the effective management of the organisational controls to ensure continuous delivery of the Quality Control driven process. However, we must not lose sight of the fact that at all times the organisation should endeavour to comply with best practice and industry standards.

Being able to support an in-depth understanding of non-conformities in your organisation is part of the mission.

Being able to clearly explain the exposure to your organisations business area owners and post holders is an essential attribute of an effective Quality Assurance Auditor.

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 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.

The Role of the Audit and How to dig a little deeper?

The role of the audit provides for a basic tool which enables the assessment and determination of both effective implementation and conformity in compliance with all related requirements.

To take the audit to a higher “advanced level” requires the evaluation (against a standard) of the effectiveness of the Quality Management System (QMS) and all Quality Control (QC) processes to achieve the organisation's objectives.

Consider the following - To achieve conformity without organisational effectiveness does not promote a strong organisation.

Without full regulatory conformity, the organisation will be exposed (regardless of the effectiveness of the product or process).

So our primary objective is to ensure conformity within a strong & effective organisation.

In the complex environment delivered by EASA, it is necessary to have a proactive approach to maintaining a full understanding of all regulatory obligations.

EASA - GCAA / ISO Comparison

What’s in an ISO Audit Program?

We should start by comparing the difference of focus between an ISO Audit Program and EASA Audit Program.
Related to ISO the audit program typically contains 3 primary elements:

a) Compliance
b) Risk Management
c) Continuous Improvement 

What’s in an EASA-GCAA Audit Program?

Related to the audit program essentially the audit focuses on a single element:

a) Compliance

Within an EASA Audit environment, the primary objective is to ensure compliance. Both externally with the regulatory requirements and internally with organisational requirements. Whilst mention is made within the regulations regarding Continuous Improvement it is not supported by any significant related EASA “Acceptable Means of Compliance” (AMC) or “Guidance Material” (GM) documentation.

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/ GCAA driven regulatory requirements.

Note considering Risk Management

EASA requires an active Risk Management environment however this is typically found within the Safety Management System (SMS).

Advance Audit Questions which should form the basis of the Audit Interview/Discussions.

a) Is the process documented understood and correctly defined in accordance with regulatory requirements?
b) What would cause the procedure/process to be changed?
c) Are all relevant responsibilities associated with the process assigned?
d) Are all stakeholders impacted by the process competent for the role they perform – how is this managed and measured?
e) Are the processes adequately managed and maintained?
f) How is the effectiveness of the process measured? (Does it achieve the required and desired results?)
g) Is there training associated with the procedure? If yes how is it assessed and managed?
h) How often is the organization analysing associated data? (Is the periodicity effective?)
i) Is the organisation able to implement change based on the information being analysed?

Ongoing objectives within an effective QMS include the following:

a) The ability to demonstrate on continuous basis conformity of the QMS to the required standard (EASA plus?)
b) The need to show in details full process definition including all process elements inputs and outputs
c) A method whereby the validity of any process is identified
d) The management of the competence of any person who reviews and assesses any data
e) The development of a process to manage the definition of targets and evidence that such targets are met – Key Performance Indicators (KPI)
f) A method whereby any identified discrepancies can be formally rectified to include analysis of the root cause together with the development of appropriate responses

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