Process FMEA Example

What This Document Contains

This Process FMEA analyzes potential failure modes at every manufacturing step identified in the Process Flow Diagram. For each operation, the AI identified what could go wrong (failure mode), what the impact would be (effect), what would cause it (cause), and how the current process detects or prevents it (controls). Severity, Occurrence, and Detection ratings produce a Risk Priority Number (RPN) for each failure mode. High-RPN items include recommended actions with responsible owners and target completion dates. The PFMEA follows the industry-standard PFMEA methodology.

• Industry-standard PFMEA methodology
• Failure modes, effects, and causes for every process step
• Severity, Occurrence, and Detection ratings with RPN scoring
• Recommended actions for high-risk failure modes
• Responsibility assignments and target dates
• Characteristics traced from the Process Flow Diagram
• Current prevention and detection controls documented
• Special characteristics linked to Control Plan controls