‘operational risk’ means the risk that deficiencies in information systems or internal processes, human error, management failures, or disruptions caused by external events or outsourced services will result in the reduction, deterioration or breakdown of services provided by a SIPS;

116. Stresses that the authorities of the Member States for the majority of transactions affected by error in shared management areas (e.g. agriculture and cohesion) had sufficient information to detect and correct the errors; therefore, once again requests the Member States to urgently reinforce the primary controls to address this unacceptably high level of mismanagement; moreover, calls on the Commission to shield the Union budget from the resulting risk of irregular payment by applying financial corrections in the event that such weaknesses in Member States' management and control systems ...[+++] are found; calls, therefore, on the Member States and the Commission once again to urgently reinforce first-level checks to address this unacceptably high level of mismanagement;

The Commission's proposal is confusing and could be clarified to confirm that the pharmacovigilance system should be used to collect information on all suspected adverse drug reactions - not just those occurring through misuse, abuse and medication errors.

The major problems that had emerged over the years since 1989 had been some dubious decision-making attributable perhaps to patronage appointments and the patronage appointment system in general, the lack of an effective error correction mechanism, and as of late, slow processing times at the IRB.

(13) Whereas nothing in this Directive should prevent a participant or a third party from exercising any right or claim resulting from the underlying transaction which they may have in law to recovery or restitution in respect of a transfer order which has entered a system, e.g. in case of fraud or technical error, as long as this leads neither to the unwinding of netting nor to the revocation of the transfer order in the system;

As is sometimes the case in isolated and regrettable instances, the correctional system's failures can be traced to human error where established policies and procedures that would protect the public are ignored or often misapplied.