Risk Identification FMEA Failure Mode Effects Analysis Failure

Risk Identification FMEA Failure Mode Effects Analysis

Failure at 30, 000 feet Jeff Prahst Quality Solutions 2

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 7

PFMEA - Critical Questions n What in the process can go wrong? – Potential Failure Modes n When failure happens what is the effect on the customer and how bad is ailure? – Effect and Severity n Why does it happen and how often? – Causes and Occurrence n How will failure be detected and corrected before it leaves the process? – Controls and Detection Jeff Prahst Quality Solutions 8

Risk Identification Process Failure Mode and Effect Analysis Function: Process Step Effects Failure Mode Controls Detectability (1 -10) Severity (1 -10) Causes Occurrence (1 -10) RPN =Risk Priority Number RPN = S x O x D = 1 to 1000 Quality Solutions 9

PFMEA Form 10

Quality by Design DFMEA Design Failure Mode and Effects Analysis Jeff Prahst Quality Solutions 11

Design - DFMEA Format Jeff Prahst Quality Solutions 12

Benefits - Design FMEA n Aids in design to reduce risks. n Evaluates design requirements / alternatives. n Identifies how a product may fail to meet its intended function. n Examines potential consequences of failure. n Prioritizes corrective actions needed. Jeff Prahst Quality Solutions 13

Information Source n Boundaries for Customer change notification n Identifies special characteristics for PFMEA n Ranks potential failure modes according to their effect on the custome n Prioritizes risks & improvement opportunities n Problem Solving Tool when analyzing customer product concerns Jeff Prahst Quality Solutions 14

Team Requirement ? n Team Activity • • n Others Participate as Needed • • Jeff Prahst Team Leader / Facilitator Design and Development Engineers Process Engineers Manufacturing Supervisors and Operators Quality Assurance Quality Engineers Customers of Product Suppliers of Raw Materials and Equipment Quality Solutions 15

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. . . Jeff Prahst Quality Solutions 16

Functions & Failure Modes Jeff Prahst Quality Solutions 17

Effects or Consequences n Identify Effects as perceived by Customer. n What could be the result of failure mode? n Describe in terms of what the customer might experience or notice. – Customer Dissatisfaction – Warranty Costs and Production Line Rework n Consider “Customer” to also be “internal customers” as well as final or ultimate end users. Jeff Prahst Quality Solutions 18

Severity Ratings Jeff Prahst Quality Solutions 19

Design Matrix n 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 % n 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 ) Jeff Prahst Quality Solutions 20

Design Matrix n 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 n Process Constraints Identify significant manufacturing constraints – Equipment Required: Stainless, special tools – Space and Line Requirements: Sq Footage; height Jeff Prahst Quality Solutions 21

Design Matrix n 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 Jeff Prahst Quality Solutions 22

Design Matrix - Jeff Prahst Quality Solutions 23

Occurrence Table Jeff Prahst Quality Solutions 24

DFMEA Form Jeff Prahst Quality Solutions 25

Design Controls n Identify Design Controls · Designed Experiments (DOE) · Customer Validation Tests, Trial Runs · Test Protocols, Test Methods · Subcontractor Third Party Testing · Engineering General Practice Ranges Jeff Prahst Quality Solutions 26

Detection - Chance of Escape n How likely will design failures escape through our controls to customer? • High likelihood = High number • Low likelihood = Low number n Will current Design Controls detect and stop the causes of failure. • Designed Experiments (DOE) • MSA and Gage R&R results Jeff Prahst Quality Solutions 27

Design - Detection Table Jeff Prahst Quality Solutions 28

Improvement Action Plan n n Recommended Action(s) Responsibility & Target Dates Actions Taken Resulting Risk Analysis • • Jeff Prahst Severity Occurrence Detection RPN Quality Solutions 29

DFMEA Form Jeff Prahst Quality Solutions 30

“Living Document” n Select Areas for Improvement. (high risk) • Formulate plans for corrective actions. • Implement additional corrective actions. • Re-compute the risk assessment (RPN). n Up-Date and Maintain • Update as new information is available. • Record all changes made to Product or Process. • Revise as experience grows. Jeff Prahst Quality Solutions 31

Importance of Prioritization Jeff Prahst Quality Solutions 32

Priority and Practicality Jeff Prahst Quality Solutions 33

DFMEA – Cup of Coffee Jeff Prahst Quality Solutions 34

DFMEA for Making Coffee Jeff Prahst Quality Solutions 35

Functions & Failure Modes Jeff Prahst Quality Solutions 36

Design Matrix - Jeff Prahst Quality Solutions 37

DFMEA Form Jeff Prahst Quality Solutions 38

Design FMEA Thank You! Jeff Prahst Quality Solutions 39