The purpose of this procedure is to define the methods used to ensure that the monitoring and measuring equipment is appropriately calibrated and fit for use.
This procedure applies to all monitoring and measuring devices held by EBME Department.
Monitoring and Measuring equipment - Any measuring device used for the verification or validation of the service provided by the Department in the form of monitoring and measuring devices or validation software.
The Department manager may nominate a representative from their staff to carry out this process. However it is the responsibility of the Quality Assurance Manager to ensure that all monitoring and measuring equipment meets the requirements of this procedure.
The staff representative will ensure that a list of all monitoring and measuring devices used by the EBME Department is maintained on the equipment management database. This is updated to record any new equipment added and also items withdrawn from service or subject to limitation due to condition. Equipment that is considered not in need of calibration will also be recorded on this list. The equipment in need of calibration will be annotated 'B'. Equipment not needing calibration will annotated 'C'.. The majority of monitoring and measuring devices will be calibrated by an external organisation on the 'list of approved suppliers'. Records will be maintained in chronological order for all category 'B' equipment. All new items of test, monitoring, and measurement equipment will be recorded on the equipment management database.
A nominated staff representative is responsible for maintaining the accuracy of measuring and monitoring and measuring devices in a manner traceable to National Standards. Some minor pieces of test and measuring equipment may be calibrated in house. Where this is the case, acceptable master equipment will be used. All measuring equipment other than that calibrated in-house is calibrated by organisations that supply an appropriate certificate of calibration. These checks are undertaken to demonstrate accuracy traceable to National Standards, the staff representative will record equipment sent away for calibration and include a contact document with the equipment to the manufacturer/calibration authority.
Certificates are obtained for all external checks and maintained by the nominated representative.
The Department will use master instruments if calibrating other instruments in-house. Certificates of Calibration are held for these items against recognised standards.
The nominated representative will arrange for the calibration of all standard measuring instruments at a frequency appropriate to the degree of usage of each item of equipment. This frequency is determined by the Quality Assurance Manager and can be amended if subsequent calibration checks reveal that the level of accuracy is not affected.
The Quality Assurance Manager will perform regular checks for any damage or wear of items in regular use, although these checks may not be recorded.
Records are maintained for all measuring and inspection equipment, also any externally supplied calibration certificates and in-house calibration checks performed by the EBME Department.
Control of Equipment
All items of monitoring and measuring devices are normally located in the workshop that is maintained under normal environmental conditions. Equipment may not be used or removed from the designated areas unless authorised by the EBME Manager. Where manufacturers handbooks are not available a work instruction will give details of the method used for any internal checks and calibrations. The EBME Manager will also issue firm instructions to all personnel to prevent unauthorised adjustments to equipment that would invalidate the calibration setting.
Non-Conformity of Equipment
The control procedures have been designed to prevent the issue or use of monitoring and measuring devices that do not conform to the required standard of accuracy.
In the event that calibration non-conformity of inspection, measuring or monitoring and measuring devices is found, this is immediately reported to the Quality Assurance Manager. He then assesses the validity of previous inspection results verified with the faulty equipment.
The status of all monitoring and measuring devices will be identified by an appropriate label.