Where does Failure Mode and Effects Analysis (FMEA) come from?  Developed by the Aerospace industry in the1960s  Spread to the Automotive industry  Now used extensively across all industry sectors Root Cause Analysis: Documenting, implementing and closing non- conformances

Different Types of FMEA Design An analytical technique used primarily by Design Responsible Engineer/Team as a means to assure potential failure modes, causes and effects have been addressed for design related characteristics Process An analytical technique used primarily by a Manufacturing Engineer/Team as a means to assure potential failure modes, causes and effects have been addressed for process related characteristics Root Cause Analysis: Documenting, implementing and closing non- conformances

Process FMEA A structured approach to: Identifying the way in which a process can fail to meet critical customer requirements Estimating the risk of specific causes with regard to these failures Evaluating the current control plan for preventing these failures from occurring Prioritizing the actions that should be taken to improve the process Root Cause Analysis: Documenting, implementing and closing non- conformances

Our Focus is on Process FMEA Concept: To identify ways the product or process can fail and then plan to prevent those failures, utilizing mistake proofing tools and techniques. Refer to sample sheet 2 – FMEA template Root Cause Analysis: Documenting, implementing and closing non- conformances

Why we use FMEA? Prevention rather than cure.  Increase probability of DETECTION  Identify biggest contributor to failures and eliminate them  Reduce probability of failure occurring  Build quality into the product & process. Root Cause Analysis: Documenting, implementing and closing non- conformances

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When to use FMEA? FMEA is most beneficial as a “before the- event” action  Design FMEA should be done during initial design of product  Process FMEA should be done during design of manufacturing process Root Cause Analysis: Documenting, implementing and closing non- conformances

Potential Applications for PFMEA  Outsourcing / Resourcing of product  Develop Suppliers to achieve Quality Renaissance / Scorecard Targets  Major Process / Equipment / Technology Changes  Cost Reductions  New Product / Design Analysis. Root Cause Analysis: Documenting, implementing and closing non- conformances

Guide to Process FMEA?. Root Cause Analysis: Documenting, implementing and closing non- conformances Step 1 Scope the project Step 2 Step 3 Brainstorm all potential failure modes Identify potential effects of failure Determine severity rankings Step 4 Identify causes of failure Step 5

Guide to Process FMEA?. Root Cause Analysis: Documenting, implementing and closing non- conformances Step 6 Determine occurrence ranking Step 7 Step 8 Define current control methods Determine Detection rankings Calculate Risk Priority Rankings Step 9 Prioritize actions Step 10

Step 1 - Scope Process Formulate cross functional team Understand customer/process requirements Define start and end of process All team members walk and observe the process Get the ‘process worker’ to explain the operation/process under review. Make notes/observations. Root Cause Analysis: Documenting, implementing and closing non- conformances

Definition of a failure mode The way in which a specific process input fails - if not detected and either corrected or removed, will cause an effect to occur. Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 2 – Brainstorm all potential failure modes Utilize process flow chart - break down each step Use knowledge of previous and existing parts/processes Review all quality information -complaints, scrap, rework, turn backs, etc. Talk to internal and external customers. Refer to handout Root Cause Analysis: Documenting, implementing and closing non- conformances

Definition -Effects of failure Effect - impact on customer requirements. Generally focused on impact on external customer, but can also include downstream processes.  Does not fit/Cannot load or fasten  Intermittent operation/Unscheduled Downtime  Poor performance of product  Lost sales Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 3 – Identify potential effects of failures  For each failure mode, identify the effect(s) on the current or next process or customer downstream in the manufacturing/assembly process.  Describe the effects of the failure in terms of what the customer might notice or experience Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 4 – Determine severity ranking Refer to handout Root Cause Analysis: Documenting, implementing and closing non- conformances

Definition - Causes Sources of process variation that causes the failure mode to occur. E.g.  Part not in fixture properly  Incorrect tool  Inaccurate Gauge  Inaccurate quote/invoicing Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 5 – Identify all potential causes off failure How the failure could occur, described in terms of something that can be corrected or controlled Experiments may have to be conducted to determine causes - use Technical Problem Solving There could be more than one cause for each failure Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 6 – Determine occurrence ranking Refer to handout Root Cause Analysis: Documenting, implementing and closing non- conformances

Definition –Current Controls Systematic methods/devices in place to prevent or detect failure modes or causes (before causing effects)  Prevention consists of mistake proofing,  Automated control and set up verifications  Controls consists of audits, inspection, training, etc. Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 8 -Determine detection ranking Refer to handout Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 9 -Calculate the Risk Priority Number RPN = Risk Priority Number Multiply severity, occurrence and detection rankings together Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 10 - Prioritize corrective actions Tackle highest RPN’s first How can we reduce the occurrence? How can we improve the detection? Use process improvement skills Where possible apply mistake proofing techniques. Root Cause Analysis: Documenting, implementing and closing non- conformances

Step 10 - Prioritize corrective actions  Standardization across all products or processes  Introduce any change in a controlled manner. Note :- Mistake proofing process will result in either lower occurrence or detection rankings Root Cause Analysis: Documenting, implementing and closing non- conformances

Reassess rankings when action completed FMEA must be a live document  Review regularly  Reassess rankings whenever changes made to product and/or process  Add any new defects or potential problems when found Root Cause Analysis: Documenting, implementing and closing non- conformances