As a part of a study that aims to evaluate and improve the labelling of containers for injectable drugs, Failure Mode and Effects Analysis (FMEA) was applied to the label reading process. Implementing a FMEA on a small-scale cognitive process involved various challenges including difficulties in representing the process, defining the failure modes, causes and effects, developing the rating scales for criticality, and rating the criticality of the failure modes. The failure modes were rated via two focus groups of healthcare professionals. The results highlight complexities and potential pitfalls with applying FMEA to the label reading process.