Process development is critical for organizations to remain competitive, satisfy customers’ needs, and meet regulatory requirements.

However, developing a process is not an easy task and requires careful consideration of all potential risks and hazards that could affect its performance. This is where Process Failure Mode and Effects Analysis (PFMEA) comes in handy.

PFMEA is a systematic and proactive approach to identify and analyze potential risks and failure modes that could occur in a process. The PFMEA process involves a cross-functional team that evaluates the process, identifies potential failure modes, and evaluates the severity, occurrence, and detectability of each failure mode. Based on these evaluations, the team develops and implements action plans to prevent or mitigate the effects of potential failures.

The Process Failure Mode and Effect Analysis (aka PFMEA) is a popular risk assessment tool to prevent risks associated with a manufacturing process.

Begun in the 1940s by the U.S. Army, failure modes and effects analysis is a step-by-step approach for identifying all possible failures in a design, manufacturing or assembly process, product or service. It is a common process analysis tool.

A few different types of FMEA analyses exist, such as:

• Functional
• Design
• Process

Sometimes FMEA is extended to FMECA (failure mode, effects, and criticality analysis) to indicate that criticality analysis is performed too.

In modern organizations it is important that Manufacturing Engineers know how to manage the tool, from process design to process optimization.

In this course, the practitioner will learn the importance of the Process Failure Mode and Effect Analysis, aka PFMEA, how it is structured and how it must be used.