Our glossary for guidance - Letter O

Overall Administration Effectiveness.

Formula: OAE = OEE*OSE

A observation is at least one non-compliance with a part of a management system requirement. An observation is not in itself a situation that causes significant doubt about the ability of the audited organisation's management system to achieve its intended objectives.

Overall Equipment Effectiveness (OEE).
Formula: OEE = Availability*Performance*Quality

Original Equipment Manufacturer.

Is the result of conception, at all stages of development, embryo and foetus, premature and full term neonates, child and adult.

[Definition according to MDCG 2020-16 rev.1 No. 2]

Devices placed on the market according to the medical devices Directives or the in vitro diagnostic medical devices Directive before the date of application of the MDR and IVDR or placed on the market before the Directives entered into force.

[Definition according to MDCG 2021-13 rev.1 Terminology]

Manufacturing concept WITHOUT WIP: the product is passed individually from one workstation to the next to save resources.

Operational indicators monitor efficiency (process indicators), e.g. throughput times, utilisation rates,...

The ordinate is the vertical orientation of a coordinate system.

Mnemonic: "The ordinate goes up and the abscissa goes the other way".

Overall Service Effectiveness

Outgoing goods inspection is the inspection of the finished and semi-finished products according to the defined specification.