TRAINEE - World Health Organization

Chapter 2 • GLP Training Manual TRAINEES
Early warning that equipment is malfunctioning is important. The checking interval
should be assigned to assure this, but the use of alarms will often assist in this, particularly
if the problem occurs at a time when the staff is not present in the laboratory.
Documentation
The planning of routine maintenance mentioned above should be documented in
such a way that users of the equipment can ensure that it has been adequately maintained
and is not outside its service interval. A “sticker” attached to equipment, or provision
of a clear service plan, may do this.
Records of equipment calibration, checking and maintenance demonstrate that the
laboratories SOPs have been followed and that equipment used in any study was adequate
for the job and was delivering to its specification.
The records should also demonstrate that the required action was taken as a result
of the checks that had been made.
Records should show that that all relevant staff knew about, and took, appropriate
action when parameters went out of acceptable limits.
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