12 Calibration verification of performance and qualification of equipment

12 calibration verification of performance and

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conditions indicated. 12. Calibration, verification of performance and qualification of equipment, instruments and other devices 12.1 Each item of equipment, instrument or other device used for testing, verification and/or calibration should, when practicable, be uniquely identified. 12.2 All equipment, instruments and other devices (e.g. volumetric glassware and automatic dispensers) requiring calibration should be labelled, coded or otherwise identified to indicate the status of calibration and the date when recalibration is due. 12.3 Laboratory equipment should undergo design qualification, installation qualification, operation qualification and performance qualification (for definitions of these terms see the Glossary) ( 11 ). Depending on the function and operation of the instrument, the design qualification of a commercially available standard instrument may be omitted as the installation qualification, operational qualification and performance qualification may be considered to be a sufficient indicator of its suitable design. 12.4 As applicable, the performance of equipment should be verified at appropriate intervals according to a plan established by the laboratory. 12.5 Measuring equipment should be regularly calibrated according to a plan established by the laboratory ( 11 ). 12.6 Specific procedures should be established for each type of measuring equipment, taking into account the type of equipment, the extent of use and supplier’s recommendations. For example: pH meters are verified with standard certified buffer solutions before use;
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107 balances are to be checked daily using internal calibration and regularly using suitable test weights, and requalification should be performed annually using certified reference weights. 12.7 Only authorized personnel should operate equipment, instruments and devices. Up-to-date SOPs on the use, maintenance, verification, qualification and calibration of equipment, instruments and devices (including any relevant manuals provided by the manufacturer) should be readily available for use by the appropriate laboratory personnel together with a schedule of the dates on which verification and/or calibration is due. 12.8 Records should be kept of each item of equipment, instrument or other device used to perform testing, verification and/or calibration. The records should include at least the following: (a) the identity of the equipment, instrument or other device; (b) the manufacturer’s name and the equipment model, serial number or other unique identification; (c) the qualification, verification and/or calibration required; (d) the current location, where appropriate; (e) the equipment manufacturer’s instructions, if available, or an indication of their location; (f) the dates, results and copies of reports, verifications and certificates of all calibrations, adjustments, acceptance criteria and the due date of the next qualification, verification and/or calibration; (g) the maintenance carried out to date and the maintenance plan; and (h) a history of any damage, malfunction, modification or repair.
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