The planning phase supports the definition of the product content (systems, subsystems, and components) that requires analysis. Participants will receive example criteria and modifiable templates they can use to evaluate any product to determine the DFMEA / FMECA scope and cross-functional team. The following are elements of Step One:

• Define the “Voice of the Customer” (Requirements)
• Define Product (System, Subsystem, Component, etc.)
• Define Current Issues (e.g., Field, Test, Supplier Issues)
• Define DFMEA/FMECA Plan - (Design Risk Level / Novelty)
• Define and Train the Team

The preparation phase makes the design and design requirements visible. Included are modifiable templates and examples that organizations can use to ensure internal and external stakeholders have a road map to develop a robust design without any hidden requirements. The following are elements of Step Two:

• Define Usage Profile (e.g., Environment)
• Define Product and Interfaces (Boundary Diagrams)
• Define Functions
• Define P-Diagram
• Define Current DVP (Design Verification Plan)
• Define known Guidelines and Best Practices
• Define review process to proceed to analysis phase

The assessment phase provides a step-by-step process for the relevant engineer and FMEA Team to complete assessment of the design. Various technical reviews require different experts that can uncover hidden design deficiencies. The linkage and collaboration with the interfacing processes will yield a robust design. The following are elements of Step Three:

• Preparation information provides the FMEA foundation for DFMEA (Mechanical, Electric Software) or FMECA
• Level of analysis (Item/Element) is defined based on system, subsystem, or component
• Functions and requirements are assigned for each element of analysis
• Failure modes, effects, and causes are defined for each element of analysis
• Prevention and Detection controls (Guidelines, Best Practices, etc.) are defined with input from DVP

Note: The following interfacing technical reviews support the technical risk analysis phase:
• Monitoring and Systems Response (MSR)
• Design Reviews Input
• Fault Tree Analysis Input
• Design for Manufacturing and Assembly Input
• Survivability analysis input
• Process Integration (PFD, PFMEA, PCP, etc.)
• Design Verification Plan (DVP)
• Management Review and Approval to Proceed

Based on the type of analysis, DFMEA or FMECA, associated risk calculations will be completed. The following are elements of Step Four:

• Risk Calculation (Ranking)
• Definition of Critical/Special Characteristics

DFMEA has little value unless the recommended actions are fully executed and decisions are made based on actions results and reassessment of risk. The following are elements of Step Five:

• Actions and Actions Results
• Reassessment of Risk
• Confirm Supplier Actions Results
• Confirm Process Integration
• Cross-functional Team and Management Review

It is recommended the responsible engineer (or team) or a third-party complete an audit of the DFMEA or FMECA. The results of the DFMEA or FMECA and the audit should be shared with the organization and the customer or appropriate suppliers. The following are elements of Step Six:

• DVP Updated
• Audit of the DFMEA or FMECA and Process
• Results of DFMEA or FMECA and Audit feedback to organization
• Results of DFMEA or FMECA feedback to customers and suppliers
• Development or update of lessons learned, guidelines and best practices
• Celebrate with the team!