• Shall include specific directions and limits for accuracy & precision
• Shall include guidance for remedial action when accuracy & precision limits are not met
• Normally provided in the manufacturer’s manuals
• Some compendial requirements exist for some specific laboratory instrumentation
• Performance checks (e.g. system suitability, daily balance performance checks) are NOT suitable substitutes for regularly scheduled calibrations
Each calibration & maintenance procedure should include the following:
–Identification of department responsible to perform the calibration or maintenance
–Step-by-step calibration instructions, reference to appropriate calibration procedures or instrument manuals
–Methods for preventive maintenance or reference to appropriate instrumentation manuals
–Calibration equipment used in the calibration (e.g. spectroscopy filters, voltmeters, digital thermometers, etc)
–Calibration parameter and tolerance ( ± )
Each calibration & maintenance procedure should include the following:
–Required environmental controls or conditions, where appropriate
–Provisions for adjustments, if needed
–Requirement for recording actual measurements before (“as found”) and after adjustment or preventive maintenance (“as left”)
Note: “as found” recordings are not required where routine performance checks are available to provide evidence indicating instrument is operating properly and is suitable for use
–Actions to be taken if instrumentation cannot be calibrated (e.g. contact appropriate service people, label and remove from service)
–A step to record all calibration & maintenance activities.