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?
- The predefined expectation is the ability to find data from a publication or lab meeting. Hence, the process owner (or any dedicated person) could take a presentation from the last lab meeting and focus on one figure with results from an experiment. The person performing the spot check will then try to find the raw data and understand different stages of the experiment as well as the analysis. The guiding principle might be to be able to understand the experiment to a degree that another researcher could perform it. If that is possible, the spot check was successful and if that is not possible, the researcher documenting the experiment could receive another training on documentation. There is no need to document such spot checks but the requirement to do them.
- 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.