EASA Quality Audit Techniques – Considering the Basics Compliance Auditing

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Let’s consider the purpose and role of an EASA compliant Audit, and at the same time to consider how it differs from other types of Audit.

What the Audit is?

The Joint Airworthiness Authority (JAA) implemented and EASA continued the role of Quality Assurance (It should be noted that the one of the unique aspects of this role is the need to demonstrate independence from the function or activity).
A Quality Assurance Audit (Now referred to also as a Compliance Audit specifically looks at the organisations process and procedures with too primary objectives).
Firstly to demonstrate compliance with the regulatory requirements and secondly to demonstrate also compliance with the company procedures.

And what the Audit is not?

The audit does not consider best practice for example in the way that ISO9001-2015 will nor does it look at Performance or Customer Satisfaction - EASA Compliance Audits are essentially narrow in scope - it is intentional because the audit is in fact being performed on behalf of the regulatory authority - hence the role of the auditor required to be independent.

What is involved in the Compliance Audit?

Essentially it is a comparison with a “Standard” and any deviation from this standard is seen as “GAP” which translates to a finding and the need to develop a “corrective action” which should drive both an understanding of the “Root Cause” as well as appropriate remedial action.

So how do we do the audit?

It is a step by step process and the first thing to be considered is why we are auditing? It is a fundamental question which may at first seem obvious however often it is not the case and people seem to have the wrong idea.
To clarify we are not auditing to look for something wrong! We are in fact auditing to confirm satisfactory compliance with the “standard”. This is an important point and should focus the auditor on the need to validate the process and procedure and not to search for unnecessary trivia.

Asking Questions!

The key to a successful audit is being able to interview the auditee and to ask questions which provide a level of confidence regarding how the process or system is working. Together with the ability to process this information and make a comparison against the expected standard.

Things to Consider?
a) The Validity of the source information - the standard
b) The correct interpretation of this information
c) Visibility (evidence) that the activity is being carried out correctly in accordance with all requirements
d) That the oversight and management of the process is being correctly discharged, moreover that any training related to the process is also being carried out where required
e) That the Competence of all personal is appropriate for the task
f) All Facilities, Tooling & Equipment is appropriate for the task and correctly managed

What will we typically Find?

- Problems with the organisations procedures not reflecting correctly the standard
- Problems with Manpower, Competence, and Training
- Problems with the effectiveness of the Management Process

However please note it is important that the “Root Cause” of the finding is assigned to and determined by the auditee (It is not correct for the Compliance Auditor to determine other people’s root cause).
The Auditor still has to check and validate that the identified root cause is in fact correct and that the corrective action identified will likely do the job.

What are the different types of Compliance Audit?

Starting with the most straightforward we have:

1. Product Audit
Here we are looking at a finished product process or procedure and comparing against the standard expected.

2. Process Audit
Here we have a number of Products working together to deliver a Process – we are still talking about compliance but now we are typically showing compliance to a documented procedure.

3. System Audits
Again this is related to compliance however typically we have within a given system a number of processes which work together to provide an organisational solution to the objective.
And there is one more.

4. Surveillance Audits
All the above audits are typically planned in advance however there is one more compliance audit which is unplanned and it is called “surveillance auditing” - the strength in such an “ad hoc” approach is that it is quite often likely that we will discover non conformities which would not be found during a pre-planned audit.

For further information please see www.sofemaonline.com or email online@sassofia.com

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