When assessing a non-conformity, one should also take into consideration the amount of risk associated with the problem.
Risk in this context may be defined as a future event that may result in loss or injury (negative patient outcome). It is the combination of the probability of occurrence of harm and the severity of the harm caused by the non-conformity. The degree of corrective/preventive action taken to eliminate NCEs must be appropriate to the amount of risk that is incurred by the problem.
