Page 124 - Safety Risk Management for Medical Devices

Risk Analysis Techniques 103

Figure 12.13 When End Effect and Failure Mode are the same.

12.7 PROCESS FAILURE MODES AND EFFECTS ANALYSIS
A process is a sequence of tasks that are organized to produce a product, or provide a
service. PFMEA is a structured approach to identify weaknesses in process design, and
assign criticality levels to each step in a process. PFMEA is a powerful prevention
tool, since it does not wait for defects to occur, but rather anticipates them and imple-
ments countermeasures ahead of time.
For risk management, Process refers typically to manufacturing process, but could
also include other processes such as service, repair, maintenance, and installation. For
the balance of this section, the focus will be on manufacturing, but you can substitute
any process that could have an impact on the safety of a medical device.
The PFMEA focuses on these questions:
• How can the process fail to deliver a product/part built to its specifications?
• What is the degree of criticality of a process step in producing a product/
part that does not meet specifications?

Process Failure Modes with undesirable outcomes are mitigated via various means
such as design or process changes. As a matter of practicality, the Failure Modes are
prioritized so that the highest criticality Failure Modes are addressed first.