Blog posts tagged in Compliance

To deliver effective EASA compliance audits it is necessary to pay attention to a number of key areas which are identified below for discussion purposes.

a) Maintaining Objectivity
b) Sample Size
c) Value of Finding Raised
d) Operator’s Authority on Area of Audit

Maintaining Objectivity

Objectivity requires both perspective and balance on the part of the auditor. We should also pay attention to the fundamental reason we are carrying out the audit.

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Introduction

The essential purpose of an EASA compliance audit is to support the maintenance of the regulatory approval.

Quality Assurance Compliance Audits are a systematic and independent comparison of the way the system process or objective is met. Using the observations made during this audit, as “objective evidence” a comparison is thus made against the standard, generating non-conformities or corrective actions in the event of any discrepancy.

The audits should be documented with a checklist which shows the details of the audit standard or audit criteria which is being applied to the audit.

Note 1 Quality Assurance Audits are Prescriptive in as much as they are always referenced against a standard – means compliant.

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Why should we wish to measure the performance of our Compliance Audit Process?

Essentially for 2 reasons

1/ The first is that we have an organisational obligation to ensure both regulatory and organisation compliance and of course there is a cost for this – so the question becomes is the organisation receiving value for money?

2/ The second is because there is a cost associated lets call it a return on investment – if we invest more will we return more- without a measure we will not be able to understand this.

The Internal Audit function was predominantly existing as a mandatory process to ensure and demonstrate compliance is also able to focus on improving business performance and add value by supporting strategic business objectives.

Management communication of the various shortfalls related to the audit findings should be strong and consistent and to be demonstrated to have a contributory impact on a culture of compliance within an organization

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With the exception of EASA Part 21 Subpart J "Design Organisation Approval" which as will be aware is managed directly by EASA the process for all other approvals (Air Carrier – Part 145 / Part M / Part 147 / Part 21 Subpart G POE / ATO) essentially works as follows

Achieving Regulatory Approval (Simplified)

1/ The organisation demonstrates to the Competent Authority (CA) that they satisfy the pre-requisites to be granted the requested approval

Documentation / Facilities / Manpower / Competence / Finance / Oversight

2/ The Accountable Manager of the Approved Organisation signs a statement to confirm his or her responsibility related to ensure sufficient finance is available to maintain full compliance

3/ The Organisation must set up a process (Independent Quality Assurance) to ensure continuous compliance

4/ The CA periodically assess the organisation for continuous compliance and raises findings for any non – compliance (Level 1 or 2 as appropriate)

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As an EASA approved organisation Aviation Postholder, your primary responsibility is to ensure full compliance of your business area with all regulatory requirements externally as well as all organizational requirements internally. Other challenges faced by both the EASA approved organisation Aviation Postholders and Senior Aviation Business Leaders involve effectively managing your team and developing effective strategies to optimize performance whilst maintaining standards.

In order to effectively manage aviation standards it is essential to both document and communicate clearly all expected objectives, challenges, and team goals. The level of communication must ensure that this is confirmed and understood.

EASA Approved Organisation Postholder Quality Control Obligations

The starting point is to put in place the most effective Quality Control processes because it is necessary not only to ensure compliance but also to promote efficiency wherever possible in the work place. This in turn brings the growing need to measure the effectiveness of the processes and people you are managing. Increasingly, the focus will be orientated towards integrated management standards. This is why it is required to develop a process approach with embedded quality principles.

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EASAOnline is pleased to discuss the role of the EASA Quality Assurance Auditor. Quality Auditors will be found in all organisations which work under the umbrella of the European Aviation Safety Agency (EASA), including Airlines, Airports, and Maintenance Organizations.

Considering the Nature of Audits

When we talk about audits we are generally talking about the need to ensure compliance. Regulatory audits are essentially compliance audits where we are looking to compare the actual with the expected. The expected typically being compliance either with EASA or another regulatory body.

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What is it all about?

A compliance audit essentially looks for conformance to a set of rules or standards – the rules may be external (regulations) or internal, process and procedures driven.
Certain areas of business, (in aviation these are many) can be described as high risk. For these activities audits play a significant role to establish ongoing conformity with company processes and procedures.


What are compliance audits?
Compliance audits are designed to give assurance that activities have been performed properly and they are, of course, reactive. Compliance audits also tend to be binary - they either pass or fail. It is also fair to say that the compliance audit in fact requires a lower level of auditor competence. Why? Because it is essentially rules driven which means that there is a removal of subjective ambiguity. This audit is presented typically as a completed checklist of observed conditions at the time when it takes place.

Tagged in: Audit Compliance EASA
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An effective Aviation Safety Management System (SMS) provides the industry with a key driver to manage the various organisational elements, which when managed in an effective way can support the prevention of incidents and accidents.

The crux of implementing an effective safety management system (SMS) is not just in defining it, but also in effectively implementing it. This really is the major challenge – ask yourself how your organisation measures the effectiveness of your SMS.

The Accountable Manager (AM) of the organization is ultimately responsible and accountable for Safety. The AM MUST understand the risk of not having an effective SMS in place for his organization. The key to a job well done is to see the SMS not merely as a compliance-driven requirement but as an opportunity to drive improvement both in terms of Safety and also in terms of organisational effectiveness which can save significant expenditure in the long run.

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As you become familiar with this process you will start to understand that there are two options and a challenge to consider:

Option 1 - To develop an EASA Compliant Auditing Program which ensure compliance with the regulatory objectives.

Option 2 - To develop an Organisation Auditing Program which ensures compliance with the regulatory objectives but goes on to set and meet further organisational objectives which provide a far wider and deeper understanding of the organisational exposures.

Tagged in: Audit Compliance EASA
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The following details the Specific role of the Compliance Manager in a combined Quality System (OPS +145)

1) Be responsible for establishing, documenting, developing and managing the Compliance System and for ensuring that it continues to comply with regulatory requirements and to meet the needs of the business.

2) Ensure that all quality related policies and procedures detailed in the Operations, Quality and Company Exposition manuals are adhered to and carry out an ongoing review of the adequacy and effectiveness of Compliance System procedures.

3) Maintain and keep current all Compliance Audit and inspection records for review at any time by the Competent authority and other external bodies as appropriate.

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We are very pleased to announce the availability of our latest training which provides for an opportunity to update regarding the Role of the Aviation Quality System within the European Aviation Safety Agency “EASA” Environment.

The Aviation Quality Compliance System should be at the heart of the operation, fully functioning and visible within every department and element of the organization.

This course delivers a comprehensive understanding of all elements of an Aviation Compliance led Quality Management System (QMS). An effective Compliance Management Process can help to support the organization in the most meaningful and tangible way. Organizations which can deliver the most effective quality audit system, together with an efficient process to follow up with all identified issues in a practical way, can excel in the delivery of their core products and services.

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