TABLE OF CONTENTS General Changes..................................................................................................................................i Chapter I.........................................................................................................................................................1 General FMEA Guidelines................................................................................................................1 Introduction................................................................................................................................................2 FMEA Process....................................................................................................................................2 Purpose of Manual..................................................................................................................................3 Scope of Manual.....................................................................................................................................4 Impact on Organization and Management..................................................................................................4 FMEA Explained........................................................................................................................................5 Follow-up and Continuous Improvement...................................................................................................6 Chapter II........................................................................................................................................................7 Overview of FMEA Strategy, Planning and Implementation.............................................................7 Introduction................................................................................................................................................8 Basic Structure...........................................................................................................................................8 Approach....................................................................................................................................................8 Identify the Team...................................................................................................................................9 Define the Scope...................................................................................................................................10 Define the Customer.............................................................................................................................11 Indentify Functions, Requirements, and Specifications.......................................................................11 Identify Potential Failure Modes..........................................................................................................12 Identify Potential Effects......................................................................................................................12 Identify Potential Causes......................................................................................................................12 Identify Controls...................................................................................................................................13 Identifying and Assessing Risk............................................................................................................13 Recommended Actions and Results.....................................................................................................13 Management Responsibility.....................................................................................................................14 Chapter III....................................................................................................................................................15 DFMEA Design Failure Mode and Effects Analysis.......................................................................15 Introduction..............................................................................................................................................16 Customer Defined.................................................................................................................................16 Team Approach....................................................................................................................................17 Manufacturing, Assembly and Serviceability Considerations..............................................................17 Development of a Design FMEA.............................................................................................................18 Prerequisites.........................................................................................................................................18 Block (Boundary) Diagrams.............................................................................................................18 Parameter (P) Diagrams....................................................................................................................21 Functional Requirements..................................................................................................................22 Other Tools and Information Resources...........................................................................................22 Example DFMEA.................................................................................................................................25 Header of the Design FMEA Form (fields A-H)..............................................................................25 Body of the DFMEA Form (fields a – n)..........................................................................................29 Maintaining DFMEAs..........................................................................................................................64 Leveraging DFMEAs...........................................................................................................................65 Linkages...............................................................................................................................................65 Design Verification Plan & Report (DVP&R).................................................................................66 PFMEA.............................................................................................................................................66 Chapter IV....................................................................................................................................................67 PFMEA Process Failure Mode and Effects Analysis.......................................................................67 Introduction..............................................................................................................................................68 Customer Defined.................................................................................................................................69 Team Approach....................................................................................................................................69 Design Considerations..........................................................................................................................69 Development of a Process FMEA............................................................................................................70