EASA Audit Considerations - Assessment of Remedial Action follow up and Measures of Effectiveness

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What are we Trying to Verify?

An Audit will typically generate several findings, and whilst the first step is usually to take an immediate “short-term” action, the important business is ensuring the fundamental cause or “root cause” is addressed – the challenge is that this is far from easy!

Essentially, we are seeking evidence that the cause or “causes” of the problem have either been removed or mitigated acceptably. (It is not always possible to completely fix the issue and sometimes the best outcome we can hope for is a reduction of the causes.)

Essential Evidence for Verification

The key to effective verification is objective & factual evidence. Evidence may be visual observations or documentary-based. How much evidence to close a finding depends on the nature and magnitude of the problem. The important note here is to focus on a scalable response that ensures the verification matches the significance of the actions taken.

Sampling Examples (Size appropriate to the nature of the initial event)

a) Records of completion - post-change implementation
b) Client or customer feedback following rectifications or amendments
c) Walk the procedure following the change to test for effectiveness
d) Interview employees to test their knowledge following changes in the training process program or procedure
e) Review the contents of the amended Training Program - How is it measured for effectiveness
f) Review Training records to ensure that the modified training has been received

Dealing with the Challenges

Mutually agree the verification audit visit and ensure that you keep the auditee “onside” - means providing an open verification with clear objectives, factually and always remaining professional and independent.

Consider the possibility that corrective actions fail to deliver!

The most common reasons for this are:

a) The proposed mitigations didn't work
b) Lack of full implementation of the proposed solution
c) Corrective action focused on the problem's symptoms instead of its causes

Meeting Root Cause Objectives of a Finding

The single biggest reason for corrective action's lack of success is when the auditee only focuses on symptoms instead of true causes.

Actions taken must address the root as well as the contributory causes, this includes modification to process and procedures documentation to ensure the correct reflection of all elements of the fundamental cause of the finding.

The effectiveness of some corrective actions may require a measurement or monitoring of the audited process. In this case, the closure will take place following the analysis of the data.

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