March 26, 2018

sasadmin

Measuring the effectiveness of your company’s quality system should be an essential element of the management of your overall quality management system strategy. 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.

Having established regulatory compliance a further measure for assessing the strength of QMS is to employ a formal ā€œinternalā€ 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 ā€œin houseā€ system is doing a good job.

The number of findings across all audits is also a ā€œcoarseā€ measure of effectiveness. 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)

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.

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 (MORā€™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.

Sofema Aviation Services www.sassofia.com (SAS) and our partner SofemaOnline www.sofemaonline.com (SOL) offer both classroom based and online regulatory training course compliant with EASA Regulations. For additional details please see the websites or email office@sassofia.com or online@sassofia.com

 

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EASA Compliant Quality System