Technique to effectively manage and reduce risks

1. Failure Modes and Effects Analysis (FMEA) Technique to effectively manage and reduce risks Anand Subramaniam

3. Risk Exposure Risks Ineffective Control Plans Unclear Customer Expectations Inefficient Process Capability Unreliable Machines Unclear specification Limits Ineffective Training Material Variations No Standard Operating Procedures Variation in Measurements Potential Safety Hazards

4. FMEA – Why & What Why & What Focuses on operations & system safety Required by Quality System Standard Identify potential design failure for a product or a process Improve internal & external customer satisfaction Estimate risks that are associated with causes Evaluate product design validation & process control plan Multi-step process to facilitate process improvement Customer requirement Risk minimisation strategy

5. FMEA – When When done.. Carry-over designs are used in new applications Existing designs or processes are being changed Early in the process improvement investigation After system, product, or process functions are defined, but before specific hardware is selected or released to manufacturing New systems, products and processes are being designed

6. FMEA - Types Types Concept Services Machine System Process Design

7. FMEA – Process & Design Process FMEA Assumes that the design is sound Analyses manufacturing & assembly processes at the system, subsystem or component levels Focuses on potential failure modes of the process that are caused by manufacturing or assembly process deficiencies Recommends actions targeted at eliminating the Root Cause of the potential failures Design FMEA Analyses products before released to production Focuses on potential failure modes of products caused by design deficiencies Done at three levels – system, sub-system, and component levels Analyses hardware, functions or a combination

8. FMEA – Application Application Scorecards / Targets Process / Equipment / Technology Out-sourcing / In-sourcing Cost Reduction Supplier Scorecards / Quality Assurance New Product / Design Analysis Pareto Chart Analysis Resourcing Change Management

9. FMEA – Data Data Design changes Customer complaints Unscheduled outages Excess returned material charges Excess shipping charges Process capability studies Non-conformance reports Equipment failures

10. FMEA – Benefits Benefits Problem prevention Proactive identification & elimination of potential product / process failure modes Increased customer satisfaction Knowledge capture and sharing, improved organisation learning Prioritised product / process deficiencies from VOC perspective Improved product / process reliability and quality Risk minimised Improved CTQs

11. FMEA – Process Roadmap Define project & team scope Develop flow chart Identify all functions, failures, effects, causes and controls for each process to be analysed Define ratings & rate each failure mode Determine the risks including residual risk Calculate primary outcome measure Identify failure modes greater than a designated score and develop action plan Propose steps to implement action plan Re-score the primary outcome measure

15. FMEA – Organisation Guidelines Guidelines Failure modes, effects, causes, and controls Communicate with relevant parties - for review, approval, implementation of required actions, and updating of rankings Construct FMEA (working example) and make these readily available Describe the nomenclature and coding systems used to ensure repeatability, traceability and maintainability Construct, update, reflect changes and provide design guidance Develop / modify standard rating scheme for severity, occurrence and detection rankings Develop cost / benefit analysis to ensure that the analysis meets quality, delivery and cost requirements

16. FMEA – Challenges Challenges Forgetting interfaces Not having cross functional teams Lengthy consensus building Inability to capture all possible issues Process to determine risks Forgetting to address high risk failure modes Lacks continuous brainstorming

17. FMEA – Limitation Limitation Data redundancies and non-simultaneous failure modes Consumes time and resource No follow up on mitigation plans Inability to analyse compound failure effects Limited expertise, experience and competency of team members Lack of understanding on the characteristics and performance of the different components Avoiding major failure modes Failure to follow through a structured approach RPNs rankings can be subjective