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.

Sofema Aviation Services (www.sassofia.com) takes a look “under the hood” of EASA Compliant Quality Auditing Derived Data. 

Introduction

Effective Quality Management ensures that the organization's products and services are able to continue to meet internal company, client and all “Regulatory Requirements”.
Quality Assurance is the means by which the quality management process can be focused on providing confidence that all quality requirements will be fulfilled.

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.

Sofema Aviation Services www.sassofia.com looks at the challenges of using Compliance Audit Techniques to determine the effectiveness of a “supplier”

What do we Mean by Third Party when we talk about auditing?

Means that the organisation is “Stand Alone” or “Stand Apart”. So effectively we are connected to the Organisation for business purposes, however, we cannot exert direct control.

This is an important consideration because in some cases the where the relationship is sub-contractual the “Contracting Organisation” is held accountable for the diligence and acceptable delivery including standards, management oversight and the effective control of competence.

SOL (www.sofemaonline.com) looks at Measuring the Effectiveness of the Aviation Organisation’s QC Management 

QC Belongs to Production

As an Introduction and to share as a common understanding within the EASA system that Quality Assurance QA is independent & QC is essentially embodied within the production process.

Please consider the following elements:

So there are essentially 2 elements to this presentation:

a) Considering the Role of Quality Assurance means What does an EASA Quality Assurance Do?
b) Maximising the Return on the Investment (Which Investment? - Essentially the Investment the Organisation makes to deliver the role of Quality Assurance)

Considering the QA - QC connection

One interpretation defines QC as “to check, test, or verify by evidence or experiments” and assurance being defined as “confidence of delivery” (maybe too narrow for our needs).

A Discussion Paper by Steve Bentley Group CEO of Sofema Aviation Services www.sassofia.com

Clearing up the Basic Stuff

SMS is not QMS by another name they are both separate and both significantly important QMS together with Quality Assurance (QA) strives to deliver a fully compliant product or process, whereas SMS considers the risk associated with any & all business risks. SMS is both subjective & forward looking. A fully functioning Safety Management System contributes to the viability of the organisation by addressing safety risk.

SMS should focus on real-time performance monitoring and reporting together with effective data analysis – a major challenge being to consider how to capture the required data across the business in a valid way.

How to deliver Performance Audits?

One example concerns a process or concept which is known as Total Quality Management (TQM), if TQM is effectively embedded within the organisation it can play a significant role and serve as a driving force to improve performance.

As with all effective business processes it requires ownership and a timeline to deliver.

If the organisation system process is to be improved, then that system must be understood in terms of all key elements:

Considering the relationship between Aviation Quality and Aviation Safety, together with the relationship between Quality Assurance Auditing and Safety Assurance Auditing in Aviation

Often it is apparent there is some confusion between the specific functions of the two different undertakings namely a quality assurance management system and that of a safety assurance management system.

So consider that Quality is essentially looking at compliance, and Safety is looking at Risk.
In essence Quality Assurance is determining gaps based on non compliance with either the regulatory requirements or organisational requirements.

Steven Bentley MD of Sofema Aviation Services believes it is time to recognise QAS as a component of our organisations' SMS.

Where Should an EASA Compliant Quality Assurance System “Sit” in relation to the Organisations SMS?

Introduction

Historically (and growing up in the workplace through the 1970’s I can attest to the fact) there was no formal Quality Assurance within European Aviation Operations.

Of course we had Quality Control and the Role of Flight Operations Director and within Maintenance the Role of “Chief Inspector”.

As the Joint Airworthiness Authority’s influence grew the concept of an independent assessment of conformity became the acceptable way of demonstrating compliance.

A discussion paper by Steve Bentley MD of SAS (www.sassofia.com)

So what is the Fundamental Mistake?

Essentially it is to "believe" that there is a similarity between ISO & EASA – there is not! Sure, Quality is Quality but make no mistake – EASA is all about compliance.

Even the Quality Assurance Manager has received a name change "makeover" He or She, is now called the Compliance Manager (CM).

What Does EASA Expect?

There are actually two expectations:

Considering the Fundamental EASA QA/ QC Relationship

The Quality Manager (Compliance Manager) is responsible for the independent assessment of compliance – not to loose sight that this process is additional and should be considered as a Safety Net rather than a primary method of ensuring compliance.

The Continuing Airworthiness Manager (CAM) is responsible for the QC Activities related to the compliances which are validated during the ACAM process.

Building on this understanding means that an effective oversight of an effective process will focus on the physical management, delivery and maintenance of competence within the system of control.

The Regulatory Point of View

Related to Auditor Experience

If you are new to auditing or you have limited experience then the challenge of performing an audit can be quite daunting. It is not at all unusual to feel like a fish out of water (so to speak).
The best way to approach this is to be professional in our approach – to understand the audit subject and to use the knowledge of the auditee to our advantage.

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.

SofemaOnline is developing a portfolio of online training courses written by professionals with many years of experience.

Here we look at techniques to support an effective Aviation Quality Assurance Audit and the way we ask questions during an audit, to enable us to take the maximum benefit from the responses we receive.

For the most effective outcome the Auditor should remain in control of the process from start to finish. The auditor has (or should have) the full attention of the Auditee and must ensure that you understand the responsibility to obtain the information necessary to make the correct determinations.

So how are we going to ask questions, in such a way that we quickly get to the substance of what we are trying to audit?
Although we ask questions of each other all day long we seldom consider which technique works best and how we may improve our questioning skills.

There can be two reasons to implement a Quality Assurance System. The first is that it is a required mandatory process to ensure compliance with all regulatory and organisational requirements. The second is that we have an opportunity to use the QA process to support the companies objectives to effectively manage the business in the most efficient way.

A commitment to Quality can become intrinsic within the organization whereby Quality becomes the driver rather than allowing Compliance to become the driver – Compliance should be assumed as a given rather than a target.

If a regulatory audit throws up a non compliance then it is also an indication of a Quality Assurance system shortfall as this is where the non compliance should have been identified. To move to a higher level requires the company to develop effective and compliant business processes which are acceptable to the post holders and business area managers and can at the same time be supported by all employees.