My company manufactures a blood-based infusion product that is currently undergoing its clinical phase in trials, so it is common for errors to occur along the process which are then handled under a risk-based approach. One such approach in which risk is handled in my company is to categorize the most common types of errors throughout the clinical phase, such as errors regarding labeling, calculations, transcription, entry errors, mishandling, etc. These risk factors are then plotted along with their frequency of occurrence to show which parts of the manufacturing process need analysis and mitigation. For example, if technicians makes too many calculation errors during any or all parts of a process, then the risk management department will assign a verifier to double-check the calculations before the batch record is passed onto the next process. This is essential because the sooner an error is addressed, the less harm there will be later on for the error to propagate into.

According to the Bonezone article posted, a part of risk-based decision making can be to apply the technique of FMEA (Failure Modes and Effect Analysis) which analyzes risk by making worst-case scenario assumptions about a device to determine which aspects of its design require changes. In order to evaluate the safety and integrity of a device, FMEA must take into account factors such as each component in a device failing, a subsystem or sub-function within the device failing, improper usage of the device, or any negative impact from the device that can result from a loss of power. Knowing this, what design changes can be derived from examining the likelihood of a power failure of an external electromagnetic bone-healing device? What about the improper usage of a blood-glucose reader? Are there any other official risk-management techniques that are known to effectively mitigate risk?

Reference:
Gagliard, John et al, “Design Controls, Design Verification and Validation” (2010) MidWest Process Innovation