Blog posts tagged in Assurance

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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Please consider that just because a product meets for example compliance with ISO 9001-2015 objectives does not automatically mean it is safe. (Just as not having an accident can be taken as meaning that we will not have an accident in the future.)

In reality the key aspect becomes our ability to measure risk and exposure. Quality systems audits consider gaps related to compliance with both external regulations and internal organisational process and procedures.

Quality Assurance and Risk Assessment

The first point to make is that the term “risk” subjective whereas the role of an EASA regulatory driven audit is to assess compliance with a standard not an opinion so this creates a challenge.

So when a discrepancy is identified it creates a number of questions

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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.

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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.

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