,FMEA Steps,1Define the scope for the FMEA 2Identify team members, customer, and knowledge experts 3Develop roles and responsibilities for team members 4Study the product / process / service 5Develop rating scales for Severity, Occurrence, and Detection 6Brainstorm failure modes, known and potential 7List the effects, causes, and current controls for each failure mode 8Assign ratings for Severity, Occurrence, and Detection 9Calculate RPN 10Decide on a threshold RPN 11Prioritize based on RPN and severity, or as required by the customer 12Identify corrective actions 13Implement and verify effectiveness of corrective action 14Complete the documentation,1Define the scope for the FMEA Define the boundaries within which the product, process, or service will be studied, identifying the operating assumptions, current conditions, and constraints if any. Example 1: Conduct a Process FMEA on PCB manufacturing line 1, starting with operation 10 and ending with operation 250. The assumption is that design of parts is correct, and no shortages The line is setup as shown in process flow drawing # 809901 Example 2:Conduct Design FMEA on the pressure relief valve (Part #JJJKKK) for potential failures under extreme operating conditions Assume no preventive maintenance will be conducted once installed Document on the FMEA startup form,FMEA; Step by Step,Scope of the FMEA,Points to consider: Who are the customers for the FMEA, and what are their requirements / expectations Example: Conduct (Process) FMEA on the assembly line for Product A, covering operations 110 through 230 When will this FMEA be considered complete under the given conditions (Remember, FMEAs are considered living documents, as such they need to be updated / revised as things change.) Example: FMEA will be considered complete when the team has implemented all corrective actions as agreed upon based on the RPN threshold,This will form the basis for deciding the level at which you should conduct the FMEA, and the scope of work involved. .,Level FocusFailure CauseEffect Mode System CarOverheating Cooling syst. Stranded on failurethe road Sub System Cooling SystemInadequate Thermostat Car Overheating coolant flow stuck closed Sub Assembly ThermostatStuck closed Bi Metal SpringInadequate brokencoolant flow ComponentBi Metal SpringBroken FatigueThermostat stuck closed,Important: You must be able to see a cascading of failure modes, causes, and effects similar to above,The Influence of Level,Company Plant 1Plant 2Plant 3Plant 4,PCB LinePower SuppliesFHP Motors,Op 10Op 20. Op 250,FMEA can be conducted at any of these levels; it all depends on your objective,The Influence of Level,Level FocusFailure CauseEffect Mode System Factory (Plant 2)Late deliveries Low FPY Lost to customer on Line 2business Sub System Line 2 (Power Supplies)Low FPY High ReworkLate deliveries at / after testing Operation TestingHigh rework Testing resultsLow FPY Op 210 inconsistent,Example of a Process,Op 120,Op A20,Op A10,Op 10,Op 210,Op 240,Op 250,Important: You must be able to see a cascading of failure modes, causes, and effects similar to above,The Influence of Level,2Identify team members, customer, and knowledge expert/s Get the team together, identify the customer and involve them in the process. Some preliminary work must be done to understand the product / process / service, so the right team can be assembled. Example:Team members include John Patton, Kirit Chawla (Customer rep) Kim Heaston, and Betty Chung (Team Lead) No one knows enough about the process at this time. Document on the FMEA startup form,FMEA - Step by Step,3Develop roles and responsibilities for team members Who does what in the team. Clearly define the roles and responsibilities for each of the team members. At this time, it is important to consider the strengths of each individual and leverage the same. Example:Team Lead:Coordinate the activities of the team, and keep on track Act as cheer leader, and interface with management Ensure the decisions are made with consensus Customer:Define requirements Participate in developing rating scales, especially for Severity Knowledge Expert:As consultant provide info on details of product / process or service,FMEA - Step by Step,4Study the Product / Process / Service The objective of this step is to acquire as much knowledge as possible. It is highly recommended that all team members delve into this, since there is no other way to familiarize yourself with the product / process / service. Example 1:The team responsible for conducting Process FMEA on gas panels production line spends 2 weeks on the line building gas panels, and testing the same. Example 2:The FMEA team responsible for Design FMEA on a medical implant studies the way the product is going to be handled in the operating room, and used by the surgeon. Example 3:Four out of five members of the FMEA team spend 3 days with the phone operators, and order processing group to get first hand understanding of all the steps