IMEG was hired by a marking and coding equipment manufacturer to perform Process Failure Mode and Effect Analyses for their key manufacturing processes. This project was followed up with development of Control Plans.
THE PROBLEM
Low process yields affecting customer’s operating efficiency
Low confidence in existing process control methods, none established in some cases
Inability to determine upstream root causes affecting downstream process yields
Urgent need to analyze, evaluate and update existing process documentation
THE PLAN
Develop PFMEAs for key processes across all production flows
Understand and analyze product and process documentation to identify potential failure modes and their potential effects
Document and categorize causes/mechanisms of failure, such as tool failure, human error, incorrect part usage, etc.
Analyze existing Process Work Instructions on a step-by-step basis to identify gaps
Evaluate product and process specifications and determine whether they are being followed/tracked
Conduct real-world process observations to validate process adherence and repeatability
Based on analysis performed, create PFMEA documents:
Assign ‘Severity’, ‘Occurrence’ and ‘Detection’ ratings to each failure mode
Conduct cross-functional reviews with Process, Quality, Operations and Design teams
THE RESULTS
Developed PFMEA documentation for seven process flows in total
Pulled together a list of Recommended Actions to be taken to improve process control and operating efficiency
Compiled list of action items based on Risk Prioritization Numbers (RPN)
Determined that process work instructions needed:
Major updates including removal of obsolete methods, improving description clarity, and adding visual references
Initiated projects aimed to mitigate failure modes related to high RPN ratings
