ED Decision 2026/006/R
MANAGEMENT OF A MAJOR MODIFICATION WITHOUT PRIOR APPROVAL
(a) When the organisation operating the FSTD implements a major modification in accordance with point ORA.FSTD.110(b)(2), it should clearly define lines of responsibility for the implementation of the modification.
(b) The procedure referred to in point ORA.FSTD.110(b)(2) should be part of the organisation’s management system and include at the least all the following:
(1) the modification without prior approval should be part of the configuration control management of the organisation;
(2) the depth of the acceptance tests should be adapted to the nature of the modification and the impact on the qualified FSTD;
(3) the assigned personnel for internal acceptance of the modification should be suitably trained and qualified;
(4) the competent authority should be informed of the modification with the declaration of compliance as referred to in AMC1 ORA.FSTD.110(c)(4);
(5) the modification should be accurately documented and archived in accordance with point ORA.FSTD.240 and should be available on request by the competent authority.
(c) The personnel assigned to perform internal acceptance tests as referred to in point (b)(3) should possess the following qualification:
(1) knowledge and relevant experience in the areas appropriate to their role and in the areas impacted by the modification;
(2) proven record of managing similar major modifications to the scope and complexity of the modification being undertaken;
(3) experience in verification of modifications, including, but not limited to, test reports, engineering analysis, QTG tests and calibration records;
(4) experience in validation of modifications, including, but not limited to, pilot evaluations, subject matter expert assessments and validation reports.
[applicable from 30 April 2028 — ED Decision 2026/006/R]
AMC1 ORA.FSTD.110(b)(2) requires organisations implementing major modifications without prior approval to define responsibilities and include acceptance test depth, personnel qualifications, and configuration control in,
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