1 / 35

Risk Identification FMEA

Risk Identification FMEA. F ailure M ode E ffects A nalysis. Failure at 30,000 feet. FMEA Tool Identifies Risks. Risks of Failure in both Design and Process Identified risks for customers, the business, our personnel and the environment, etc.

isabellaj
Download Presentation

Risk Identification FMEA

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Risk IdentificationFMEA Failure Mode Effects Analysis

  2. Failure at 30,000 feet Quality Solutions

  3. FMEA Tool Identifies Risks • Risks of Failure in both Design and Process • Identified risks for customers, the business, our personnel and the environment, etc. • Tool to help identify and prioritize risks • Types of FMEA: • Design FMEA – DFMEA • Process FMEA - PFMEA • Implementation FMEAs (for starting new processes) • Special PFMEA (used as a specific problem solving tool) Quality Solutions

  4. PFMEA - Critical Questions • What in the process can go wrong? • Potential Failure Modes • Whenfailure happens what is the effect on the customer and how bad is ailure? • Effect and Severity • Why does it happen and how often? • Causes and Occurrence • How will failure be detected and corrected before it leaves the process? • Controls and Detection Quality Solutions

  5. Risk Identification Process Failure Mode and Effect Analysis Function: Process Step Failure Mode Controls Detectability (1-10) Effects Severity (1-10) Causes Occurrence (1-10) RPN =Risk Priority Number RPN = S x O x D = 1 to 1000 Quality Solutions

  6. PFMEA Form

  7. Quality by Design DFMEA Design Failure Mode and Effects Analysis Quality Solutions

  8. Design - DFMEA Format Quality Solutions

  9. Benefits - Design FMEA • Aidsin design to reduce risks. • Evaluatesdesign requirements / alternatives. • Identifieshow a product may fail to meet its intended function. • Examinespotential consequences of failure. • Prioritizes corrective actions needed. Quality Solutions

  10. Information Source • Boundariesfor Customer change notification • Identifiesspecial characteristics for PFMEA • Rankspotential failure modes according to their effect on the custome • Prioritizesrisks & improvement opportunities • Problem Solving Tool when analyzing customer product concerns Quality Solutions

  11. Team Requirement ? • Team Activity • Team Leader / Facilitator • Design and Development Engineers • Process Engineers • Manufacturing Supervisors and Operators • Others Participate as Needed • Quality Assurance • Quality Engineers • Customers of Product • Suppliers of Raw Materials and Equipment Quality Solutions

  12. Function, Expectation, Failure 1. List Product Functions • Appearance, Performance, Processability, ... 2. List Customer Expectations • Appearance – Looks Good; Clean; Shiny; No defects... • Performance – Resistant to damage; Starts and runs ... • Processability – Easy to use & Easy to make... 3. Translate into Failure Modes • Looks Good – Not shiny; Dirty; Not at expectations ... • No Defects – Scratches; Dents; Broken parts ... • Starts Easy – Will not start; Hard to start... Quality Solutions

  13. Functions & Failure Modes Quality Solutions

  14. Effects or Consequences • Identify Effects as perceived by Customer. • What could be the result of failure mode? • Describe in terms of what the customer might experience or notice. • Customer Dissatisfaction • Warranty Costs and Production Line Rework • Consider “Customer” to also be “internal customers” as well as final or ultimate end users. Quality Solutions

  15. Severity Ratings Quality Solutions

  16. Design Matrix • Materials and Parts Select Materials, Parts and Quantity Levels • Material - Failure under 47% to over 58% by Weight • Part - Failure under X % to over Z % • Material and Part Characteristics Establish Material and Part Specifications Identify significant properties which have a major impact on final product performance • Material: Failure under or over amounts used • Part : Failure to meet specification (under/over ) Quality Solutions

  17. Design Matrix • Product Characteristics Select tests and specifications which determine the ultimate performance of the product. • Time to Temp.: Failure under or over specification • Solids - Failure under 65% to over 73% by weight • Pressure Test: Failure @ 5 psi • Process Constraints Identify significant manufacturing constraints • Equipment Required: Stainless, special tools • Space and Line Requirements: Sq Footage; height Quality Solutions

  18. Design Matrix • Conditions for Use Identify significant constraints in the conditions involved when the Customer uses of the product. • Film Build - Failure under 2.0 mils. • Bake Time @ 350°F - Failure under 20 minutes. • Bake Temperature @ 20 min. - Failure under 350°F. • Shelf Life - Failure after Six Month • Storage Temperature - Failure over 70°F. • Humidity - Failure over 60% relative humidity • Temperature (paint): Failure under 50°F to over 120°F Quality Solutions

  19. Design Matrix - Quality Solutions

  20. Occurrence Table Quality Solutions

  21. DFMEA Form Quality Solutions

  22. Design Controls • Identify Design Controls • Designed Experiments (DOE) • Customer Validation Tests, Trial Runs • Test Protocols, Test Methods • Subcontractor Third Party Testing • Engineering General Practice Ranges Quality Solutions

  23. Detection - Chance of Escape • How likely will design failures escape through our controls to customer? • High likelihood = High number • Low likelihood = Low number • Will current Design Controls detect and stop the causes of failure. • Designed Experiments (DOE) • MSA and Gage R&R results Quality Solutions

  24. Design - Detection Table Quality Solutions

  25. Improvement Action Plan • Recommended Action(s) • Responsibility & Target Dates • Actions Taken • Resulting Risk Analysis • Severity • Occurrence • Detection • RPN Quality Solutions

  26. DFMEA Form Quality Solutions

  27. “Living Document” • Select Areas for Improvement. (high risk) • Formulate plans for corrective actions. • Implement additional corrective actions. • Re-compute the risk assessment (RPN). • Up-Date and Maintain • Update as new information is available. • Record all changes made to Product or Process. • Revise as experience grows. Quality Solutions

  28. Importance of Prioritization Quality Solutions

  29. Priority and Practicality Quality Solutions

  30. DFMEA – Cup of Coffee Quality Solutions

  31. DFMEA for Making Coffee Quality Solutions

  32. Functions & Failure Modes Quality Solutions

  33. Design Matrix - Quality Solutions

  34. DFMEA Form Quality Solutions

  35. Design FMEA Thank You! Quality Solutions

More Related