The planning phase supports the definition of required manufacturing and assembly operations associated with the new or modified product content (systems, subsystems, and components) that requires analysis. Participants will receive example criteria and modifiable templates they can use to evaluate any process to determine the PFMEA scope and cross-functional team. The following are elements of the Step One:

⦁ Define the “Voice of the Customer” (Requirements)
⦁ Define Operations that require analysis based on new or modified product
⦁ Define Current Issues (e.g., Field, Test, Internal Manufacturing and Assembly Issues, Supplier Issues)
⦁ Define PFMEA Plan (PFD, PFMEA, PCP requirements)
⦁ Define and Train the Team

The preparation phase makes the process visible by completing a detailed PFD that includes definition of Product and Process Characteristics associated with each operation step. The training provides modifiable templates and examples that they can use to ensure internal and external stakeholders have a road map to develop a robust process without any hidden factory steps. The following are elements of Step Two:

• Define process layout at required levels (system, subsystem, component)
• Define Current PFD, PFMEA, Control Plans, Work Instructions
• Define the Outputs of each operation (Functions - Product Characteristics)
• Define the Inputs of each operation (Process Characteristics)
• Define known Guidelines and Best Practices for new or modified operations

Note: The engineer and manager (FMEA expert as needed) ensure the correct preparation is complete to engage the cross-functional team in an organized technical review of the manufacturing and assembly processes

The assessment phase provides a step-by-step process for the relevant engineer (or team) to complete assessment of their manufacturing and assembly processes. The training material provides modifiable templates and examples organizations can use to complete PFD’s, PFMEA’s, and PCP’s. The following are elements of Step Three:

• Using the PFD to define the PFMEA structure
• Using the PFD to define the function and requirement for each operation in the PFMEA
• Using the PFD to support defining PFMEA Potential Failure Modes
• Using the PFD to support defining PFMEA Potential Causes
• Defining all Failure modes, effects and causes for each operation
• Controls defined for each potential failure mode and potential cause
• On-going proficiency assessment by FMEA Expert

The engineer (or team) utilizes the PFD to initiate the PFMEA. Technical process reviews will uncover hidden process deficiencies and define process controls that will yield a robust manufacturing and assembly process. The following are elements of Step Four:

• Design and Process Reviews input
• Linkage with DFMEA input to define process risk
• Linkage with DFM/A input to define process risk
• PFMEA Risk Calculation (Ranking)
• Definition of Critical/Special Characteristics
• Define Verification Plan updates to prevent product defects in the customer hands
• Actions Defined to address risk
• Management Review and Approval to Proceed

This training connects the output of PFD, PFMEA and PCP methodologies. The processes would have little value if all actions were not completed and there was not verification the manufacturing and assembly processes produced the product to defined requirements. The following are elements of Step Five:

• Actions defined
• Re-assess Risk based on Actions Results
• Supplier Risk Assessment
• Cross-functional Team and Management Review

After it has been determined the design will meet requirements, it is recommended the engineer share the learnings with the organization. It is also recommended engineers work with their suppliers to ensure they have completed DFMEA analysis to the same detailed level as defined in this process. If your supplier fails you fail! The following are elements of Step Six:

• Control Plans Developed
• Audit of the PFD, PFMEA and PCP
• Results of Audit reviewed with the organization
• Results of PFD, PFMEA, and PCP reviewed with customers and suppliers
• PFD, PFMEA, and PCP locked for change control and traceability
• Development or update of lessons learned, guidelines and best practices
• Celebrate with the team!