The risk referred to, in this case, is the risk to the patient. But this risk may come from many places. There are several possible sources of risk and thus error during production. As seen below, each area has its own possible source of error and thus it becomes a risk to the patient. It must be determined which risk or possible error poses a substantial risk and this needs to be corrected or prevented from occurring. Several organizations have published risk management programs (eg, ISPE Risk-Mapp) to address these risk areas. Table 7.2 below outlines some of the general risk types that need to be considered.
With the above list of general risks one needs to start determining the outcome of each if the risk were to present itself. Table 7.3 shows some points to consider when determining if a risk is real, and how to address the risk. Some references on risk analysis, and risk handling are found (PAT5 (Process Analytical Technology), ICH6 [Q8, Q9, Q10], QSIT7 (Quality Systems Inspections Technique), The Quality System Approach (GMPs for the 21st Century)8).