Guidance Document - American Association of Tissue Banks

the upper and lower limit capabilities of a specific instrument relative to areferenced standard), and would specify the tolerances within which a specificpiece of equipment could be expected to hold, as measured against a referencedknown standard. “Precision” is the ability of an instrument to consistentlyreproduce those accuracy requirements; or the number of significant digits towhich a value has been reliably measured.Q8. In section (e) Records, it’s required that records of recent maintenance,cleaning, sanitizing, calibration, and other activities shall be available “ateach piece of equipment”… Is this to be interpreted that all documentationof preventive maintenance and calibration must be physically kept at eachpiece of equipment?A8. No. This does not necessarily mean that all preventative maintenance andcalibration records must be physically kept directly with each piece of equipment.It may be appropriate for an establishment to implement a method of identifying thecurrent preventative maintenance and/or calibration status of each piece ofequipment. It should be clear and obvious to the operator, prior to each use of theequipment that the equipment is in a state of preventative maintenance and/orcalibration and may be confidently and safely used.Page 42 of 44