Brewster M A, Carver P H, Randolph B
Biotechnical Services, Inc., North Little Rock, AR 72116-7059, USA.
Qual Assur. 1995 Dec;4(4):332-5.
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.
实验室以多种方式满足对适当的常规仪器维护文件的监管要求。标准操作规程（SOP）可能会提及仪器手册中列出的维护内容，可能会指明某项操作的“定期”执行，或者可能会指明在特定频率下要执行的特定任务。如果这些记录与其他分析记录合并，质量保证部门（QAU）确保执行这些指定维护任务的工作将极其繁琐。此外，缺乏书面维护计划往往会导致不常执行的任务被遗漏。我们建议为仪器创建常规维护检查日志，将任务按预期执行频率分组。使用此类日志应能使实验室更好地遵守SOP，并且QAU或监管机构可以很容易地监测到这种合规情况。
