Blog posts tagged in Quality Assurance

Comment by Steve Bentley CEO of www.sassofia.com 

Quality Assurance is considered as a subset of SMS. Is this correct? 

What does EASA Say? 

These key safety management processes are supported by a compliance monitoring function as an integral part of the management system for safety.

Most aviation safety regulations constitute generic safety risk controls established by the ‘regulator’. Therefore, ensuring effective compliance with the regulations during daily operations and independent monitoring of compliance are fundamental to any management system for safety.

The compliance monitoring function may, in addition, support the follow-up of safety risk mitigation actions.

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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.

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Let’s consider the difference between Assessment & Audit

Assessment

The evaluation process used to measure the performance or effectiveness of a system and its elements.

Our goal is to perform an assessment of the auditing process follow up to determine both the cost effectiveness and overall value to the business.

Audit

An EASA Audit is a systematic and independent examination to determine whether quality activities comply with external regulatory requirements and internal organisational specifications and whether these specifications are implemented effectively.

A primary indicator of a poor or failing system is repeat findings or findings which should be addressed at a lower level – for example the Competent Authority should not identify problems which are normally expected to be found within the internal Quality Assurance System audit process.

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How does the role the Quality Assurance (QA) Auditor differ within the EASA environment compared to say other aviation regulatory systems? (FAA for example?)

Well the first thing to consider is that the role of the Quality Assurance Auditor within the EASA system is quite specific in that it requires “Independence” This is not the case for example when you consider ISO 9001-2015.

9001: 2015 has removed the requirement for a single point of contact regarding the QMS replacing it with a new section on leadership to better emphasis a greater involvement from the leadership team. Compare with EASA where we have specific roles and responsibilities (Including Independent Compliance Manager (CM) and a clear understanding of who is managing each business objective, whilst still ultimately identifying the responsibility of the nominated persons.

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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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