PFMEA DEVELOPMENT

quality engineering services

SERVICE AREA:

IMEG was hired by a marking and coding equipment manufacturer to conduct a Process Failure Mode and Effects Analysis (PFMEA) for several key manufacturing processes. This engagement was followed by the creation of detailed Control Plans to enhance operational reliability and quality compliance.

THE PROBLEM

Low process yields were negatively impacting overall production efficiency
Inconsistent or missing process control methods, with few or no formal systems in place
Difficulty tracing upstream failure modes that contributed to poor downstream process yields
Outdated, incomplete, or undocumented quality procedures
Immediate need to analyze, evaluate, and modernize process documentation

THE PLAN

IMEG partnered with cross-functional teams to execute a comprehensive PFMEA project plan that included:

Developing PFMEAs for critical processes across multiple production flows
Reviewing and analyzing existing process documentation, work instructions, and quality records to identify failure modes and process risks
Categorizing failure causes such as tool misalignment, handling errors, and incorrect part usage
Performing detailed walk-throughs of Process Work Instructions to uncover gaps in compliance and execution
Auditing product and process specifications for traceability and conformity
Conducting real-time process observations to validate actual repeatability and identify variability
Assigning Risk Priority Numbers (RPN) based on Severity, Occurrence, and Detection scores
Facilitating cross-functional collaboration with Quality, Operations, and Design Engineering teams to prioritize corrective actions

pfmea consulting

quality documentation services

THE RESULTS

Developed complete PFMEA documentation for seven high-impact process flows
Created a structured list of Recommended Actions to improve process stability and increase operating efficiency
Generated an actionable list of risk mitigation tasks based on calculated RPNs
Identified gaps in work instructions, including: