Consider that all Amendments to the MOE should be approved by the Regulatory Authority, moreover for any major changes the approval should be sought before implementing the change.
For minor changes arrangements may be agreed which allow small changes of a limited effect on a process or procedure to be effected with the knowledge of the regulator (but without the specific approval).
Nevertheless such change or amendment would still be identified and approved by the quality Manager. It must be clearly understood by all stakeholders exactly how the Exposition is “managed” and the distinction between those parts under the control of the company and those parts for which amendments are required to receive prior Regulatory approval.
Usually within the organisation the Quality Manager is identified as the person with the responsibility for amending the Exposition.
A typical text would be as follows:
“The Quality Manager is responsible for the monitoring and amendment of the Exposition, including associated procedures manuals, and the submission of proposed amendments to the CAA. “
Note that this does not in any way identify the Quality Manager as responsible for the actual content “text” (this is normal, correct & ensures the independence of the audit process).
Now consider the potential sources of proposed amendments within the organisation
Any desire or requirement to change an MOE procedure could be driven by:
a) Major changes to the nominated staff
b) A wish to change (improve or optimise an existing procedure)
c) Driven by an event (accident or incident)
d) As a result of an audit finding or even observation
Sitting below the exposition are a number of “lower order” documents, constituting the total Exposition. This includes interdepartmental procedures, but often does not include the lowest level of procedure which could be considered as local procedures.
In the case of the existence of multiple procedural documents it is best practice to provide a summary of documents comprising the complete Exposition and “extended” Exposition. Provision of such information is ideally presented as both a descriptive text together with a diagrammatic illustration to show all interrelations.
The MOE often controls the capability list and in this case the status of the capability list is actively monitored through the MOE itself. On other occasions the capability list is managed via an agreed procedure which operates outside of the capability list.
The origin of a proposed amendment to the MOE may come from any part of the organisation. It is an essential requirement that all proposed changes are continuously monitored and assessed to ensure compliance with Part 145 requirements by the Quality Manger.
Regarding the submission of Amendments
It is typical in most organisations for the Quality Manager to be identified as the focal point of MOE amendment submissions. In addition the Regulatory Authority (CAA) will usually only accept such amendments from the agreed source
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