A spot check is a focused review of a selection of experimental records, reports, procedures or lab environment at random or scheduled timepoints against predefined expectations and performance standards.
For a spot check, records / data / experiments may be selected randomly to see how well the RU is doing by finding answers to questions such as:
- how easy is it to retrieve and reconstruct the data?
- are study protocols completed prior to the start of experiments?
- have data been generated in an unbiased fashion?
- have all results been reported?
Spot checks are typically conducted by a Process owner or someone to whom this task is delegated. EQIPD does not require that the research unit maintains documentation on spot checks conducted and leaves it up to the Process owner and the research unit to decide how often spot checks are conducted, how the outcome is evaluated, discussed, reported or followed up. Some research units opt to build key performance indicators that quantify the outcome of the spot checks of key processes.
If a research unit undergoes an internal or external assessment, the assessors may also conduct spot checks to evaluate the overall performance and to identify processes or specific examples for an in-depth discussion with the research unit.