Measuring the Effectiveness of an EASA Compliant Quality System
An essential element of any system is to be able measure the effectiveness of the various processes which are involved in delivering the overall product.
The Quality System consists of 2 distinct parts:
a) The Quality Control Processes – Embedded in all production areas
b) The Quality Audit Processes – An independent way of assessing point a) above
By measuring the effectiveness of both parts of the company’s quality system (QA & QC) we will be able to provide a detailed status of the strength of the Quality Management System (QMS) as well as to provide a detailed understanding which will facilitate management planning and development.
Step 1 - Organisation & Regulatory Review
The process starts with a review of the organizational QMS policy together with a detailed gap analysis to assess full compliance with all regulatory obligations.
Understanding the policy, recognises that compliance with EASA is in fact minimum compliance and it is quite possible for organisations to go further and deeper in delivering system effectiveness.
Step 2 - Organisational Internal Compliance
Having established regulatory compliance a further measure for assessing the strength of QMS is to employ a formal “internal” compliance audit process which will be set against an expected organisational standard.
The effectiveness of any audit is of course heavily dependent on the competency of the auditor, however to also consider that any external regulatory driven audit should not show many discrepancies if our “in house” system is doing a good job.
The number of findings across all audits is also a “coarse” measure of effectiveness.
Note Regarding Trend Awareness
However, note that it is not just numbers which matter it is a trend showing a reducing level of findings, as well as confirmation of effective closure of the finding (root cause plays a big part here).
Step 3 - In Detail Expectations
A detailed assessment of the audit program showing a wide program including multiple system and product audits. (Little and often always being more productive)
Another measure of the effectiveness of the QMS relates to the willingness of the employees to engage with and report into the system.
Many employees are lacking in knowledge regarding the purpose of the Quality Assurance System and are even suspicious of its function.
Fully engaged employees will work with the Quality System and provide strength and resilience, much however will depend on the culture of the organisation as well as the top down leadership.
Step 4 - Building an Outcome
An inspection of the formal management review will also provide indications regarding the effectiveness of the QMS Typical contents of the management review will include a summary of all internal and external audits with an overview of the status of major findings.
How the organisation has dealt with the major findings provide a key measure which can be utilised as part of the assessment.
The Engagement of the QMS with external agencies is a key measure, in particular with respect to the management of any Mandatory Occurrence Reports (MOR’s) or any other mandatory reports, in each case satisfactory closure is a key indicator to ensure in each case the appropriate action has been taken.
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