Check-off logs for routine equipment maintenance.
The regulatory requirement for appropriate routine instrument maintenance documentation is approached by laboratories in numerous ways. Standard operating procedures (SOPs) may refer to maintenance listed in instrument manuals, may indicate "periodic" performance of an action, or may indicate specific tasks to be performed at certain frequencies. The Quality Assurance Unit (QAU) task of assuring the performance of these indicated maintenance tasks can be extremely laborious if these records are merged with other analysis records. Further, the lack of written maintenance schedules often leads to omission of infrequently performed tasks. We recommend creation of routine maintenance check-off logs for instruments with tasks grouped by frequency of expected performance. Usage of such logs should result in better laboratory compliance with SOPs and the compliance can be readily monitored by QAU or by regulatory agencies.
Brewster
M A
MA
Biotechnical Services, Inc., North Little Rock, AR 72116-7059, USA.
Carver
P H
PH
Randolph
B
B
D004282:Documentation / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D005161:Facility Regulation and Control; D005568:Forms and Records Control / Q000379:methods*; D007221:Industry; D007753:Laboratories / Q000458:organization & administration*; D008283:Maintenance / Q000458:organization & administration*; D011786:Quality Control