The following key attributes should be observed (mindful of the risk significance addressed in the previous question):
-
clearly identify the process being assessed and what it is attempting to achieve, ie what the harm/risk is and what the impact could be on the patient
-
be based on systematic identification of possible risk modes e.g. as per Failure Mode and Effects Analysis (FMEA)
-
take full ac of current scientific knowledge
-
be facilitated by people with experience in the risk assessment process and the process being
risk assessed
-
use factual evidence supported by expert assessment to reach conclusions
-
do not include any unjustified assumptions
-
identify all reasonably expected risks – simply and clearly along with a factual assessment and
mitigation where required
-
be documented to an appropriate level and controlled/approved
-
ultimately be linked to the protection of the patient
-
should contain objective risk reduction plans.
