Recently, I went on a trip to a nice hotel with a swimming pool. Upon arrival, standing in the modern room with a nice view into the countryside, I realized with pain that I didn’t pack my swimming suite. One can say that this is actually rather silly since everybody knows packing lists when preparing for a journey to reduce the risk of forgetting essentials, like the swimming suite in this case.
Why do I mention this story in this newsletter? Well, one could draw a parallel to the biomedical research world: working in a lab is just like a journey for which one should be prepared. And this preparation should also include measures to reduce certain risks, which are naturally present or appear in the complex lab environment.
In fact, such measures are described in quality management systems and may refer to “risk assessment” or “Corrective and Preventive Actions”. The EQIPD quality system also includes a risk assessment and describes its three levels HERE:
- Alterations from recommended practices
- Inherent risk of key processes
- Changes in the environment
Even though it does sound more abstract than remembering a swimming suit when going on holidays, EQIPD offers an easy implementation of risk assessment measures into laboratory practice.
The first level, “alterations from recommended practices” asks that the person overseeing the EQIPD quality system (process owner) double checks regularly (usually once per year, defined by the group) whether all recommendations of the EQIPD QS are followed, since deviations might cause a risk. This regular risk assessment is actually part of the self-assessment and can be documented in the self-assessment template (HERE) as part of Core Requirement 15.
The second level refers to the key processes of the experiment itself. It simply asks that every researcher performing an experiment briefly assesses whether there are any risks leading to a biased research outcome, risks of forgetting something essential or risks of running into avoidable trouble (e.g. a planned holiday). This second level is crucial to increase research rigor and EQIPD provides a template in form of a risk assessment summary, which is integrated into the study protocol (shown HERE).
The third level is about assessing any associated risks connected to changes in the lab environment and just like the first level, will be the responsibility of the process owner. These changes can, for example, be a new freezer in the lab (is it connected to a warning system?), a new student (was he/she properly trained?) or a lab relocation. EQIPD also provides templates HERE for such risk assessments.
In any case, for my next trip I certainly use my old (!) packaging list, which I had created years ago but forgot about. I hope that this little risk assessment will avoid the disappointment of not being able to enjoy the swimming pool in the future.
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