ED Decision 2014/025/R
OVERSIGHT DECLARED ORGANISATIONS
(a) When determining the oversight programme of organisations having declared their activity, the competent authority should make a selection of operators to be inspected/audited based on the elements specified in ARO.GEN.305(d).
(b) For each selected operator an inspection is a sample inspection of the pre-defined inspection criteria on the basis of key risk elements and the applicable requirements.
(c) The results of past oversight activities should include information from approval activities, e.g. SPA or from other survey programmes such as ACAM.
(d) The oversight programme should also include a certain percentage of unannounced inspections.
(e) The oversight programme should be developed on a yearly basis. All operators should be considered for inclusion into the programme not later than 12 months after the date of the first declaration received. At least one inspection should be performed within each 48-month cycle starting with the date of the first declaration received.
(f) Additional audit/inspections to specific operators may be included in the oversight programme on the basis of the assessment of associated risks carried out within the occurrences reporting scheme(s).
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