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116 Part II: Metrology
It is important to note that any or all of the equipment needed to support calibration
processes may have its own calibration interval and, in fact, may be one of
the many pieces of equipment with its own calibration requirements.
Calibration Procedures
Part II.F.1
Calibration procedures are the step-by-step instructions that describe the calibration
process for a given piece of equipment. Such procedures are not normally
stored with the equipment while the equipment is installed for normal process
use; these procedures typically reside in the calibration laboratory.
Calibration procedures identify all process equipment models or configurations
to which the procedures apply. The procedures also provide important
safety warnings and identify any specifications for the calibration environment.
It is important to note that the calibration procedures are step-by step instructions,
not guidelines. Calibration technicians are not at liberty to deviate from the
instructions for any reason, unless that reason is a documented part of the process
equipment documentation and history for purposes of equipment traceability.
Calibration Environment Specifications
Calibration environment specifications describe the conditions under which calibrations
are to be performed. It is sometimes necessary to specify the conditions
under which calibrations are to be performed since certain types of process
equipment do not adequately perform under certain environmental conditions.
Calibration environment specifications commonly address cleanliness, temperature,
humidity, and vibration. However, there are many other factors that it may be
necessary to control in order to ensure that a valid calibration is completed.
Calibration Status Indicators
As a check and balance in case a calibration interval prompt is not effective, calibration
status indicators are used. Status indicators are color-coded stickers or
labels attached to equipment that provide information about calibration status.
Information included on the status indicators includes, but is not limited to, date
of the last calibration, date or operation cycle of next calibration, any modes of
operation or functions excluded from the last calibration, special comments, and
who performed the last calibration.
Calibration status indicators are prominently displayed on most equipment
to facilitate verification prior to use. Status indicators are also commonly attached to
equipment sealing assemblies, subassemblies, or components to ensure that
operators or technicians do not open the equipment to make any adjustments or
modifications. Where calibration status indicators are discovered to be broken
or compromised, the equipment is immediately removed and sent for calibration
in accordance with applicable standards.