October 25 2016 Failure Mode Effect Analysis FMEA

Content This session will provide a basic understanding of the Process FMEA quality tool. • FMEA overview 4 • Steps in performing FMEA 7 • Do’s and Don’ts 9 After a brief description of the tool we will use the tool on an example • Example – practice the FMEA 11 Siemens AG 2016 All rights reserved. Page 2 2016 -05 -17 Stefano Paoli / RASD QM

“If you don’t have time to do it right you must have time to

Failure Modes & Effects Analysis (FMEA) overview FMEA is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. “Failure modes” = the ways, or modes, in which something might fail. Failures are any errors or defects, especially ones that affect the customer, and can be potential or actual. “Effects analysis” = studying the consequences of those failures. Failures are prioritized according to: • how serious their consequences are, • how frequently they occur, • how easily they can be detected. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highestpriority ones. Siemens AG 2016 All rights reserved. Page 4 2016 -05 -17 Stefano Paoli / RASD QM

FMEA – an example from the service industry Siemens AG 2016 All rights reserved.

When to use FMEA • • • When a process, product or service is being designed or redesigned, after quality function deployment. When an existing process, product or service is being applied in a new way. Before developing control plans for a new or modified process. When improvement goals are planned for an existing process, product or service. When analyzing failures of an existing process, product or service. Periodically throughout the life of the process, product or service FMEA is used during design to prevent failures. Later it’s used for control, before and during ongoing operation of the process. Ideally, FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service. . Siemens AG 2016 All rights reserved. Page 6 2016 -05 -17 Stefano Paoli / RASD QM

Steps in performing FMEA 1. Assemble a cross-functional team of people with diverse knowledge about the process, product or service and customer needs. Functions often included are: design, manufacturing, quality, testing, reliability, maintenance, purchasing (and suppliers), sales, marketing (and customers) and customer service. 2. Identify the scope of the FMEA. Is it for concept, system, design, process or service? What are the boundaries? How detailed should we be? 3. Review the design/process; identify list of Process Steps (INPUT to meeting) 4. Brainstorm potential failure modes 5. For each failure mode, identify all potential effects of failure 6. Assign severity rating (S) 7. For each failure effect, identify all potential causes 8. Assign occurrence rating (O) 9. For each failure cause, identify all controls that could detect the cause 10. Assign detection rating (D) 11. Calculate Risk Priority Number (RPN) = S x O x D Siemens AG 2016 All rights reserved. Page 7 2016 -05 -17 Stefano Paoli / RASD QM

Steps in performing FMEA 12. Develop action plan * : tasks to improve the current controls or reduce O. To reduce S a redesign of product or service may be required. 13. Take action: this is the step where many FMEAs fall apart due to lack of management support, conflicting priorities, lack of resources and lack of team leadership. The actions have to be implemented and results should be validated. 14. Recalculate the RPN: bring the team back and recalculate RPN. Use objective evidence. 15. Periodically review and update * Once the initial RPN scores are tabulated, the team may decide on a cutoff score (if not standardized in the organization). Not too low (spend time/resources on too many risks) nor too high (not address important risks). Suggest cutoff = 250 The whole meeting should last no more than 4 hours. Siemens AG 2016 All rights reserved. Page 8 2016 -05 -17 Stefano Paoli / RASD QM

Do’s • • • Provide FMEA training to involved team Always use the approach Ask for SME if required Talk to your customer about how they intend to use the product/service Brainstorm all possible failure modes if they can happen occasionally When two risks have the same overall score, the risk with the higher Severity rating is escalated • Complete the action and reassess the risk as a team • Update the FMEA with new learned risks. Siemens AG 2016 All rights reserved. Page 9 2016 -05 -17 Stefano Paoli / RASD QM

Don’ts • Don’t fight over ratings of small difference. Analyze the impact thoroughly if the team is divided by two or three rating points (e. g. 4 and 7) • Don’t get hung up on a number game; the objective is t create a reduced-risk product and/or service • Don’t perform FMEA to comply with procedures or standards. FMEA is a business risk management tool. It has to be used with commitment to make it work. Siemens AG 2016 All rights reserved. Page 10 2016 -05 -17 Stefano Paoli / RASD QM

Example – practice the FMEA Case study: self-checkout product What to do: • Fill in the FMEA template • Don’t overthink it; the purpose is to learn the tool • Complete a few lines; pretend you implemented the recommended actions and recalculate RPN Siemens AG 2016 All rights reserved. Page 11 2016 -05 -17 Stefano Paoli / RASD QM